SPECIAL NOTICE
J -- Validation and Calibration Services for a Government-owned Rees Scientific Environmental Monitoring-Alarm System
- Notice Date
- 7/13/2021 1:35:12 PM
- Notice Type
- Special Notice
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- NIH National Cancer Institute Rockville MD 20850 USA
- ZIP Code
- 20850
- Solicitation Number
- 75N91021Q00156
- Response Due
- 7/20/2021 12:00:00 PM
- Archive Date
- 08/04/2021
- Point of Contact
- Megan Kisamore, Phone: 2402765261
- E-Mail Address
-
megan.kisamore@nih.gov
(megan.kisamore@nih.gov)
- Description
- 1.0�� �DESCRIPTION The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) plans to procure, on a sole source basis, services for the Validation and Calibration of a Government-owned Rees Scientific Environmental Monitoring-Alarm System from Rees Scientific Corporation, 1007 Whitehead Road, Trenton, NJ 08638. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 811219 and the business size standard is $22 million. The anticipated award shall be a firm fixed price purchase order for severable services. It has been determined there are no opportunities to acquire green products or services for this procurement.� 2.0�� �BACKGROUND� The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) has several current Good Manufacturing Practices (cGMP) manufacturing facilities involved in the production of cellular therapies for infusion into patients enrolled in clinical trials at the NIH for which a monitoring system is required. A Rees Scientific T30 environmental monitoring-alarm system is currently installed at NIH. To ensure the safety and integrity of the products and to meet cGMP requirements, equipment used in manufacturing processes must be monitored for performance to ensure the processes have not been compromised. The facilities and equipment in all aseptic processing and cGMP facilities use the REES monitoring system to achieve compliance. �� 3.0�� �SCOPE � The Contractor shall provide all labor, material and equipment necessary to maintain the Rees Scientific environmental monitoring-alarm system, as follows: Item /�Item/Service Description /� �� Qty 1� /� Calibration for CO2 sensors -3PT� /� 30 2� �/� Calibration for-Differntial Pressure-3pt� /� �22 3� �/� Snap-Cert-Rt1� /� 42 4� �/ Calibration for-3point-Std� /� 20 5� �/ Calibration for-3point-Ul /� �2 6� /� Calibration for-02-3pt� /� 3 7� �/ Calibration-Loop�/ �36 8� �/ Validationl-Kit-Press� /� 2 9� �/ 17 Z3 Batt for-Wifi /� �17 10� /� 1 Validation Documentation of Servb� /� 1 The sensors are monitoring laboratory equipment, including freezers, refrigerators, incubators, which contain clinical and research material critical to programs in NCI/CCR/SB. The primary monitored parameters are temperature, CO2 levels, and cleanroom air pressures and humidity. Service shall include installation qualification (IQ) and operational qualification (OQ) that meets industry and regulatory agency standards. Approximately 241 points shall be verified and calibrated with National Institute of Standards and Technology (NIST)-traceable equipment, or existing customer calibrations certified in a fashion that meets industry standards and the U.S. food and Drug Administration requirements. The Contractor shall provide full documentation to complete the validation and to meet the needs of regulatory authorities. The Government shall provide access to the required facilities and equipment as required to perform the outlined work. All onsite service shall be provided during standard business hours, defined as 7:00 am � 5:00 pm 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/week) for troubleshooting the system and clinical application support (Monday � Friday 8:00 am � 9 :00 pm EST), excluding Federal holidays. Technical support shall be provided by OEM-authorized and trained service personnel. � � 4.0�� �TASKS 4.1�� �PREVENTIVE MAINTENANCE � The Contractor shall perform three (3) planned preventive maintenance inspections (PMIs) during each 12-month performance period. Service shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all equipment in accordance with the manufacturer�s latest established service procedures. �All equipment shall be operationally tested through at least one (1) complete operating cycle at the end of the preventive maintenance inspection to assure optimum and efficient performance. The Contractor shall supply at the completion of the testing, a complete IQ/OQ validation report necessary to satisfy FDA, GMP, GLP, AALAS, AALAC, and other regulatory requirements. As part of the validation, the Contractor shall complete a testing protocol to include the following: ?�� �All sensors (inputs) 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; ?�� �All sensors are reading correctly; ?�� �All sensors are properly calibrated; ?�� �Each piece of monitored equipment shall display a certification label for each sensor. Writing on the certificate shall be protected against loss of readability 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; ?�� �Optional touch-screen shall be tested for proper function of the buttons; ?�� �The Processor, RAM, and PROM shall 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 shall be tested; ?�� �All output relays that are in use shall be tested to ensure proper function; and ?�� �Lighting override controls (timers) shall be tested to ensure proper function. For all test results, the Contractor shall complete the test system configuration information and test setup information. The results provided shall show all backup data documenting printouts and appropriate signatures and approvals as required by the FDA and other regulatory agencies. The FDA and other regulatory agencies consider simple pass/fail signoffs insufficient. 4.2�� �EMERGENCY SERVICE On-site, emergency repair service visit shall be provided during each 12-month performance period at no additional cost to the Government. Emergency service shall be provided during standard business hours, as defined in section 3.0 above. Upon receipt of notice that any part of the system is not functioning properly the Contractor shall, within one (1) hour, provide an initial response via phone/email; and, within four (4) hours, provide onsite service personnel to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition. �Emergency service calls shall not replace the necessity for planned preventative maintenance. � �� � 4.3�� �REPLACEMENT PARTS � The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. Parts shall be genuine OEM parts that are new or remanufactured to OEM specifications. Parts shall be delivered and installed within 24 business hours, or on the next business day should the request fall on a Friday or a day preceding a Federal Holiday. All scheduling necessary for servicing and installation of replacement parts shall be communicated with the CCR/SB technical point of contact.� 4.4�� �SOFTWARE UPDATES/SERVICE � The Contractor shall provide Software Service and updates in accordance with the manufacturer�s latest established service procedures, to include telephone and onsite access to technical support for use of program software and troubleshooting of the operating systems, at no additional cost to the Government. �The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government. �Defective software shall be replaced at no additional cost to the Government. The Contractor shall provide unlimited clinical technical toll-free telephone support for troubleshooting for the system and clinical application support, in accordance with section 3.0. � 4.5�� �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 purchase order. �� 5.0�� �TYPE OF ORDER This is a firm fixed-price purchase order. 6.0�� �SEVERABLE SERVICES The services acquired under this purchase order are severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods. 7.0�� �PERIOD OF PERFORMANCE The period of performance shall consist of one (1) 12-month base period with two (2), 12-month option periods, as follows: Base Period:�� ��� �September 7, 2021 to September 6, 2022 Option Period 1:�� �September 7, 2022 to September 6, 2023 Option Period 2:�� �September 7, 2023 to September 6, 2024 8.0�� �PLACE OF PERFORMANCE Onsite services shall be performed at the following location: T30 (Tumor Infiltrating Lymphocyte (TIL) Modular Building) and Trailer 10B and 10A facilities ��� ��� � NIH/NCI Surgery Branch NIH T30 T30 Convent Drive Bethesda MD 20892-2845 9.0�� �UNIQUE QUALIFICATIONS OF THE CONTRACTOR Only authorized vendors are permitted to perform services in accordance with FDA Guidance for cGMP practices, which the Rees Scientific system must adhere to. �The Rees Scientific system and the associated products are proprietary and the validation and calibration for their probes are unique to their system and protocols. �The Rees Scientific software, which is integral to the function of the monitoring system, is both proprietary and operates on a secure server database. The required services are not authorized through any other entity. Any delays in procuring the required services for the Rees Scientific system and inputs, would result in an interruption of proper system function and would require an additional review and approval from NIH GMP advisory groups. �Continuity is critical for record keeping, data analysis and for continued service. Any service interruptions or lack of a validated monitoring system would put production of clinical products at risk, and in a state of non-compliance with the regulatory requirements for drug manufacturing.� 10.0�� �SUBMISSION INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote for the Government to consider. The response 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. �All responses and questions must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Tuesday, July 20, 2021 (7/20/20). 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. In order to receive an award, Contractors must be registered and have valid certification through SAM.GOV. Reference: 75N91021Q00156 on all correspondence.
- Web Link
-
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- Record
- SN06059019-F 20210715/210713230116 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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