Scientific environmental monitoring system

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 Laboratory Medicine (DLM), 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 ,
UNITED STATES

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334519 with a Size Standard 500 employees.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-101 October 26, 2018. 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 ($250,000).

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: Scientific environmental monitoring system
2. Background Information: The Department of Laboratory Medicine (DLM) serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so, DLM provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas that utilize the unique strengths of the National Institutes of Health.

The Sterility Testing Service, within DLM, is constructing a new GMP Laboratory for product sterility testing and environmental monitoring, in support of the GMP manufacturing facilities across the NIH Bethesda campus. To comply with cGMP requirements, specifically 21CFR211 §68(a), FDA Validation Guidance, and WHO Annex 3-GMP, 4.3, equipment used in the manufacture of drug products must be validated and continuously monitored for performance to ensure the processes in use have not been compromised. The CRC and many cGMP aseptic production facilities in Building 10 utilize the REES Scientific environmental monitoring system to achieve this compliance. REES Scientific EM sensors continuously monitor laboratory equipment, including freezers, refrigerators, and incubators, which contain clinical material, research material, and testing samples critical to programs in the Clinical Center. The primary monitored parameters are temperature, relative humidity and cleanroom air differential pressures.

The REES Scientific EM sensors communicate data processing and storage equipment via hardwired and wireless connections. Backup and security facilities are part of the monitoring system. The data is transmitted to a NIH CC server. The system maintains long-term records of the data collected by the monitors, which provide a history of equipment performance. Reports of monitored equipment and the facility are also produced. Both real time and historic data are accessible in a secure fashion on the Internet.

3. Purpose or Objective: The purpose of this procurement is to obtain a REES Scientific environmental monitoring system with 38 wired and wireless monitoring sensors, Enterprise Centron system with Presido web interface and Comwatch monitoring software (capable of monitoring 128 sensors), associated installation and configuration of the system, and installation and operational qualification (IQ/OQ) of the system to ensure the desired performance of the system. This system is required to ensure the Sterility Testing Service can continue to support the cGMP product sterility and environmental monitoring testing needs of the various cGMP programs across the NIH Bethesda campus. These programs manufacture cellular therapies, PET drugs, and compounded pharmaceuticals used in clinical trial protocols. Additionally, approval of this purchase order will also ensure the Sterility Testing Service is compliant with the cGMP regulatory requirements set forth in the Code of Federal Regulations and the World Health Organization.

REES is the environmental monitoring system that has been installed into the nearly all aseptic processing facilities and research facilities at the NIH. Of importance is the service and contract that is held between REES Scientific and the aseptic GMP manufacturing facilities which are manufacturing patient therapies. An environmental monitoring system is a regulatory requirement and the response time and caliber of service, performance, documentation and understanding of the difference between what is needed for these facilities compared to research only facilities, is a critical component of the service contract needs. Because of the criticality of this system, only fully GMP/GDP trained technicians, certified and trained with the REES system, can service the inputs in these facilities. A lapse in monitoring or a failure for the system to properly monitor and report data can directly impact patient products and the ability to treat patients.

The FDA expects cGMP product manufacturing facilities and testing laboratories to perform vendor audits and establish quality agreements with vendors providing supplies, equipment, and services which are to be used in support of cGMP product manufacturing. This requirement is established in ICH Q10, 2.7 and 2.7a, and ICH Q10, 2.7(b). REES Scientific is an approved vendor with documented products that meets the cGMP requirements and has been qualified for use in aseptic processing facilities across the NIH campus. Per the cGMP requirements only approved and qualified vendors are allowed to perform such services in accordance with FDA Guidance for Industry: Q10 Pharmaceutical Quality System.

4. Delivery: Dependent on ongoing construction project (Delivery of complete system is anticipated to be scheduled prior to November of 2020).

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The Contractor shall supply at the completion of the system installation and IQ/OQ a validation test report necessary to satisfy FDA, cGMP, GLP, and other regulatory requirements that has been reviewed and approved by REES Scientific Quality Assurance.

As part of the validation, a complete testing protocol that tests and reports on as a minimum:
a. All sensors (inputs) are installed in the correct locations as detailed in the construction plans and working properly.
b. All sensors are installed in the correct places as indicated by their IDs and locations listed for users of their monitored equipment, in the complete REES node program printout and online.
c. All sensors are reading correctly.
d. All sensors are calibrated to ISO 17025 standards when available. For sensors that cannot be calibrated to ISO 17025 standards, the sensors are calibrated using at least three points or measure (e.g. low range, mid-range, and high range).
e. All calibration reports must include the as found and as left data.
f. Each piece of monitored equipment will display a certification label for each sensor. Writing on the certificate will be protected against loss of readability following treatment of a room and equipment with cleaning and antiseptic solutions.
g. The system properly identifies an alarm situation.
h. The local alarm system is operational.
i. The remote alarm contacts are functional.
j. The proper voice and data telephone calls are placed, and emails sent.
k. The system accepts the proper acknowledging signal over the phone and email.
l. The Processor, RAM, and PROM will be tested to ensure that the program is as originally installed.
m. The A/D converter, voice chip, phone interface, display interface, and remote panel communications will be tested.
n. All output relays that are in use will be tested to ensure proper function.
o. Lighting over ride controls (timers) will be tested to ensure proper function.

As part of the on-site service warranty, the contractor shall supply the following at a minimum:
a. 24/7 technical support and on-site service to repair or replace, as needed, to restore full system operation for one-year from date of review and acceptance of the Installation/Operational Qualification report by NIH.
b. For onsite service, cGMP trained technicians must be utilized to maintain compliance with cGMP regulations. All on-site service personnel must comply with all applicable NIH access and escort policies.
c. Any onsite repair work will require a work plan be submitted to NIH for review and approval before any work is performed.
d. A direct point of contact for all cGMP related technical support or service requests.

Deliverables:
Period of performance requested for the duration of the construction project C104603. The tentative timeline for this to occur is prior to 2020. The installation and validation of the REES System must coincide with the construction timeline and be coordinated with the Design/Build contractor overseeing the Sterility Testing Lab buildout under construction project C104603.

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

This scientific monitoring system is to be added to a current existing system including compatible hardware and software requirements. 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 August 16, 2019, 3:00 PM Eastern time and must reference solicitation number 19-012207. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted.

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