Inactive

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E156 Bethesda, MD... Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E156 Bethesda, MD 20892, UNITED STATES. DESCRIPTION The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) intends to procure validation and calibration services for the current Rees NIH040 system on a sole source basis from Rees Scientific located at Rees Scientific USA, 1007 Whitehead Road Ext., Trenton, NJ 08638. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. Only one award will be made as a result of this solicitation. This will be awarded as a Severable Firm-fixed price type contract with base and four option periods. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND The NCI Surgery Branch has many research labs/equipment and several cGMP manufacturing facilities involved in the production of cellular therapies for infusion into patients enrolled in clinical trials at the NIH. To ensure the safety and integrity of the products and research samples, and to meet cGMP requirements, equipment used in manufacturing processes must be monitored for performance to ensure the processes have not been compromised. The CRC research labs and all aseptic processing and cGMP facilities use the REES monitoring system to achieve compliance. The sensors are monitoring laboratory equipment, including freezers, refrigerators, incubators, which contain clinical and research material critical to programs in the Center. The primary monitored parameters are temperature, CO2 levels, and cleanroom air pressures and humidity. TYPE OF ORDER This is a severable firm fixed-price purchase order. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The service contract shall include all items outlined in the attached quote. This includes an annual qualification and validation of the entire system and software. As part of the validation, a complete testing protocol that tests and reports at a minimum on the following: Calibration, qualification, and validation of all exciting sensors. This includes factory calibration at time of purchase of certified combination temperature/ humidity sensor. All sensors (inputs) will be validated and calibrated to confirm these are working properly. All sensors, hardwired or wireless, 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. Calibration of all differential pressure sensors will be performed and within the acceptable tolerance using an NIST traceable instrument within date certificates Calibration of all CO2 sensors will be performed and within the acceptable tolerance using an NIST traceable instrument within date certificates Calibration of all Temperature Input of Sensors using a NIST traceable instrument will be performed and within the acceptable tolerance using an NIST traceable instrument within date certificates. Rees system upgrade to allow for connection to an SQL database using TLS 1.2. All traffic to and from the database will be encrypted with the latest protocol, preventing eaves dropping for passwords and risk of hacking. Included with this upgrade, SNMP will be disabled in all of your V2/Z3 network devices, and the latest Rees Scientific approved version of Apache Web Server with only strong cipher suites enabled will be installed. The REES system must meet 21CFR211.68(a), 21CFR211.68(b), and 21CFR11 requirements pertaining to calibration, inspection, record retention, change management, input/output verification, audit trail, data back-up, electronic signatures, electronic data, qualification, and validation. At minimum, the system shall undergo defined lifecycles including, but not limited to, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification. If data is leveraged from a prior qualification program, access to all data meeting the above stated requirements shall be requested by NIH and reviewed appropriately. All changes following NIH review shall be subjected to change control. Validation Kit for Centron with Centron Presidio Software. Confirm all sensors are reading correctly. Confirm all sensors are properly calibrated. Each piece of monitored equipment will display a certification label for each sensor. Writing on the certificate will be protected against loss of legibility following treatment of a room and equipment with cleaning and antiseptic solutions. The system properly identifies an alarm situation. The local alarm system is operational. The remote alarm contacts are functional. The proper voice and data telephone calls are made and emails sent. The system accepts the proper acknowledging signal over the phone. The Processor, RAM, and PROM will be tested to ensure that the program is as originally installed. The A/D converter, voice chip, phone interface, display interface, and remote panel communications will be tested. All output relays that are in use will be tested to ensure proper function. Comprehensive Once Yearly IQ/OQ of System with full documentation provided to satisfy regulatory authorities. Comprehensive system test verifies, calibrates and documents all system functions including readings, databases, alarms, dial-outs, outputs, reports, and user programming. Includes One Year Onsite Service Plan with 24/7 Technical Support. Includes approximately 100 page GMP/GLP IQ/OQ validation report, 1000 page software validation test report, calibration of temperature and humidity with traceable equipment, copies of reference equipment calibration certificates and onsite refresher training at PM visit. At a minimum, the vendor shall have in place a quality management system similar to or exceeding ISO 9001:2015 requirements. The vendor must provide services meeting, at minimum, the requirements of ISO/IEC 17025:2017 applicable to calibration laboratories. The vendor shall be subjected to periodic NIH audits to assess cGMP compliance to applicable quality systems. A change management process must be established by the vendor to manage all software and hardware changes to the system. All quality events shall be investigated and resolved with input from end user. All personnel performing contracted service for the NIH shall have combination of education, training, experience, and certification needed to work in a cGMP environment. Records of all personnel qualifications shall be submitted to NIH for review before personnel are allowed to perform assigned task. All subcontracting shall be pre-approved by the NIH before implementation. Calibration stickers will have to be placed on all calibrated probe/sensor. SERVICE EXCLUSIONS The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water. These repairs shall be the subject of a separate purchase order and shall not be performed under this contract. PERIOD OF PERFORMANCE This award shall have a base period of twelve (12) months with four twelve (12) month option periods. Base Period: May 21, 2021 to May 20, 2022 Option Period 1: May 21, 2022 to May 20, 2023 Option Period 2: May 21, 2023 to May 20, 2024 Option Period 3: May 21, 2024 to May 20, 2025 Option Period 4: May 21, 2025 to May 20, 2026 PLACE OF PERFORMANCE Onsite services shall be performed at the following location: NIH/NCI Surgery Branch 10 Center Drive Building 10/CRC 3 West Corridor, room 3808 Bethesda, MD 20892 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written deliverable products shall be submitted in draft format for review, comment and approval by the TPOC. Final copies of approved drafts shall be delivered to the TPOC within five (5) business days after receipt of the Government’s comments. All written draft and final deliverable products shall be submitted in electronic copy for review and comment, if available. If electronic copies are not available, hard copies will be delivered for review and comment. If requested, final deliverable products shall be submitted in hard copy; two (2) final bound copies and one (1) unbound flat final copy suitable for reproduction, in addition to an electronic copy. Other quantities and formats may be submitted after prior approval from the TPOC. Electronic copies shall be submitted in Microsoft Office 2007 OR Word format or more recent version, unless prior approval for another format has been obtained from the TPOC. All deliverables shall be sent electronically (Microsoft Word or Excel 2013, unless approved by the COR) per the following deliverable schedule: DELIVERABLES 1 Comprehensive Once Yearly IQ/OQ of System with full documentation provided to satisfy regulatory authorities. Comprehensive system test verifies, calibrates and documents all system functions including readings, databases, alarms, dial-outs, outputs, reports, and user programming. DUE: 30 days after completion of service 2 Software validation test report, calibration of temperature and humidity with traceable equipment, copies of reference equipment calibration certificates and onsite refresher training at PM visit. DUE: 30 days after completion of service This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST on April 26, 2021. All responses and questions must be emailed to Elizabeth Tucker, Contract Specialist via electronic mail at elizabeth.tucker@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: NOI_75N91021Q00068 on all correspondence.