REES SCIENTIFIC CORP. / A loop calibration of 156 probes and installation and calibration of O2 sensors.

INTRODUCTION
This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

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 Center for Cellular Engineering (CCE), 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:

REES SCIENTIFIC CORPORATION

1007 WHITEHEAD ROAD EXT STE 1

EWING, NJ, 08638-2405 ,USA

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334519 with a Size Standard 750.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-01 December 6, 2021. 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: REES SCIENTIFIC CORP. / A loop calibration of 156 probes and installation and calibration of O2 sensors.

2. Background Information:  The U.S. Department of Health and Human Services, National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) operates several current Good Manufacturing Practices (cGMP) facilities which are utilized to manufacture cellular therapies for patients enrolled on Clinical Trials at the NIH. In order to be compliant with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Maintenance and Cleaning), a service contract is required for the system that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies. A Rees Scientific environmental monitoring system is installed in the 3T, 2J and T10B facilities operated by the CCE to meet this requirement. This Statement of Work details the tasks and responsibilities of the Contractor (Rees Scientific) in providing support services including annual validation, calibration and preventative maintenance required to maintain the monitoring system used by the CCE in its manufacturing facilities.

3. Purpose or Objective: Request to procure a loop calibration of 156 probes and installation and calibration of O2 sensors contract from Rees Scientific.

4. Period of Performance: 12 months.

5. CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

SCOPE:

The Contractor (Rees Scientific) shall provide all the labor, material, equipment and reference standards necessary to maintain the Rees Scientific monitoring/alarm system, as follows: 

Item             Item/Service Description                                                                    Quantity

1               Field Calibration of the 4-20mA loop at 3 calibration points                       156

2               Oxygen sensor replacement for existing Tox Guard II sensor, 0-25%          5

3               Calibration of Oxygen sensor, sent to site for onsite calibration                    5

4               Shipping                                                                                                        1

5               Additional Calibrations and Testing                                                               1

The sensors/probes are monitoring laboratory equipment, including freezers, refrigerators and incubators which contain clinical material, media components, and biologics that are critical to the manufacturing of cell-based therapies by the CCE for NIH sponsored clinical trials. The primary parameters that are monitored are Temperature, Humidity, Differential Air Pressures, CO2 and O2 Levels. Approximately 156 points shall be verified and calibrated using a National Institute of Standards and Technology (NIST)-traceable standard/instrumentation, or existing customer calibration instrumentation that is NIST traceable that meets industry standards and the US Food and Drug Administration mandates.  All calibrations will include “as-found” and “as-left” measurements for any calibrations performed.   All qualification/validation protocols will be reviewed and agreed upon prior to approval by the customer.  Qualification/Validation protocols will not be executed prior to approval of protocols.  The Contractor shall provide full documentation to complete validation that meets the needs of regulatory authorities. The Government shall provide access to the required facilities and equipment as required to perform the outlined work. All routine onsite service shall be provided during standard business hours, defined as 7:00am-5:00pm EST, Monday through Friday, excluding Federal Holidays found at: https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/. Service shall be performed in accordance with the original equipment manufacturer’s (OEM) most current commercial maintenance procedures by OEM-authorized and trained service personnel. All travel, labor and related charges shall be included.

The Contractor shall provide unlimited clinical technical toll-free telephone support (24  hours/day, 7 days a week) for troubleshooting the system and clinical application support (Monday-Friday 8:00am to 9:00p, EST), excluding Federal Holidays. Technical support shall be provided OEM authorized and trained service personnel.

1. TASKS

Calibration:

The contractor shall provide field calibration of 156 4-20mA loops at 3 points to ensure overall system accuracy using a certified 4 to 20mA sensor. The Contractor shall provide replacement sensors for existing ToxGuard II sensors (5). The contractor shall calibrate 5 oxygen sensors on site.

2. PLACE OF PERFORMANCE

Onsite services include the following facilities locations

3T, 2J and T10B cGMP facilities located at the Clinical Center

NIH/CC/DTM/CCE

10 Center Drive

Bethesda MD 20892

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 Rees Scientific Corp.  With the continuation of using the same supplies 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, and 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 3rd, 2022, 10:00 AM Eastern time and must reference solicitation number 22-004260. 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."