Diversified Lab Repair/ PM and emergency services for freezers and refrigerators.

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

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to:

Diversified Laboratory Repair, Inc.

7977 Cessna Avenue 

Gaithersburg, MD, 20879-4117 

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 811412 with a Size Standard $16,500,000.00.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-02 November 23, 2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold.


STATUTORY AUTHORITY
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 and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Diversified Lab Repair/ PM and emergency services for freezers and refrigerators.  

2. Background Information:   Department of Transfusion Medicine is in need a service agreement that will cover maintenance, preventive maintenance, support, and emergency servicing for freezers and refrigerators. These Instruments are located in different Sections of the Department of Transfusion Medicine of the Clinical Center at NIH.

The Preventive maintenance (PM) performed on these instruments is required to comply with:

-  FDA 21 CFR 211 Current Good Manufacturing Practice for Finished

-  Pharmaceuticals

-  FDA 21 CFR 606 Current Good Manufacturing Practice for Blood and

-  Blood Components

-  FDA 21 CFR 820 Quality System Regulation

-  FDA 21 CFR 1271 Current Good Tissue Practices

-  FDA Guideline for Quality Assurance in Blood

-  Establishments, July 1995

-  HCFA 42 CFR 493 Clinical Laboratory Improvement Act of 1988

-  AABB Standards for Blood Banks and Transfusion Services

-  AABB Standards for Cellular Therapy Product Services

- AABB Standards for Immunohematology Reference Labs

-  ASHI Standards for Histocompatibility Testing

-  JC Hospital Accreditation Standards

-  AAHRPP Standards for Accrediting Human Research

-  Protection Programs

-  ACGME Common Program Requirements CAAHEP Standards and Guidelines

3. Purpose or Objective: There is an urgent need to have all Department of Transfusion Medicine freezers and refrigerators under PM contract and emergency service response, in case of units failures, in order to guarantee the quality and purity of our blood manufacturing and components supplies.

4.The Scope of Work:

In order to maintain our certifications and operational status, included in this service agreement will be one or more regular preventive maintenance visits, emergency servicing, spare /replacement parts, and support for each listed device(s).

Work to be performed:

• Independently, and not as an agent of the government, the contractor will provide all necessary personnel, supplies, and services to perform the work required by this Service agreement as set forth in the sections.

• Preventive Maintenance (PM)

• The contractor will provide scheduled preventive maintenance once every six months. The PM will be scheduled by a qualified service representative and days in advance of the scheduled due date.

Parts/Supplies

The contractor will supply all parts and supplies needed for service and maintenance; otherwise, a separate quote will be submitted.

MON-FRI 8am to 5 pm. (on Routine service and 24/7 emergency)

Labor and Travel

The contractor will provide full service coverage and telephone support to correct all equipment malfunctions.

4. Period of Performance is Base + 4 Option Years starting on 4/1/2021.

BASE YEAR: April 1, 2021 - March 31, 2022

OPTION YEAR ONE: April 1, 2022 - March 31, 2023

OPTION YEAR TWO: April 1, 2023 - March 31, 2024

OPTION YEAR THREE: April 1, 2024 - March 31, 2025

OPTION YEAR FOUR: April 1, 2025 - March 31, 2026

Delivery Location:

NIH/CC/DTM

10 Center Drive

Bethesda, MD 20892-1288

Attention:  William Puig

The contractor shall bear the cost of replacement for supplies found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.

Government Responsibilities

1.         The NIH CC Center Cellular Engineering shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. 

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

This system is on site and has been validated for use on CC patients.  It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Diversified Laboratory Repair, Inc.  With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.


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 notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. 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 March 15th, 3:00 PM Eastern time and must reference solicitation number 21-004710 in subject line. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted.

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