SPECIAL NOTICE
J -- Annual Maitnenance Environmental Monitoring System
- Notice Date
- 2/26/2009
- Notice Type
- Special Notice
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P156126
- Archive Date
- 3/17/2009
- Point of Contact
- Gail Akinbinu,, Phone: 301-496-0692
- E-Mail Address
-
gakinbinu@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Notice of Intent to procure maintenance services for environmental monitoring system from Rees Scientific Corp for a period of the year. Rees Scientific is the original manufacturer and the company possesesthe combination of proprietary technical knowledge, new replacement parts, software licenses, and patents covering the intricate designs of the instruments that cannot be purchased from other sources. Statement of Work Project Title: Annual Maintenance for EnvironmentalMonitoring System Department: NIH Clinical Center, Pharmaceutical Development Section, Pharmacy Department Period of Performance: 3/1/2009 to 2/28/2010 1. Background 1.1 The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs. 1.2 The NIH Clinical Center Pharmacy Department provides pharmaceutical care and dispenses medications to inpatient out outpatients. Clinical Center pharmacists provide research support to health care providers and investigators. Pharmacy staff members conduct and participate in research programs that enhance knowledge regarding optimal dosing and appropriate use of investigational and commercially available agents. The Pharmacy Department’s Pharmaceutical Development Section manages investigational drug inventories through a computerized information system, prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA. 1.3 An essential service of this group is to maintain all drugs at their assigned temperatures. It is also required by FDA current Good Manufacturing Practices (cGMPs) that pharmacy be able to document the proper storage of drugs stored at room temperature, under refrigeration and in -20C and -70C freezers. This practice is also required by the JCOAH. 1.4 As a regulated facility, Rees Scientific Corporation has annually validated, calibrated and serviced their proprietary system for the past 5 years. This system and their strict validation protocols have met all our needs and the requirements of the various regulatory agencies we must comply with. 2. Purpose The purpose of this Contract is to engage in the annual validation / calibration maintenance services of Rees Scientific Corporation to ensure that our monitoring system for the Pharmaceutical Development Section of the Pharmacy meets the full requirements of our regulating agencies. 3. Scope of Work 3.1 Task 1: Perform annual validation, calibration, and maintenance of existing system setup. The contractor shall review and check all system panels and ports. Maintenance shall include software updates, semi-annual measurements of system functionality and connection status. Provide alarm alerts and means of obtaining graphical reports and all other needs commonly associated with environmental management. 3.2 Task 2: 1. Provide 24 hours per day and seven days per week monitoring of the equipment associated with the alarm system by a technical support group. During an emergency, the RSC technician(s) usually be on site within 4-Hours with the rare exception where new parts are required from the factory. 2. Should the power fail or temperatures rise out of the safe range, the RSC shall assure that the freezer alarm system electronically notifies the appropriate person(s) on duty by telephone, e-mail, and pager. The RSC shall also assure also that the system is programmed to notify one or more scientists, if needed, by telephone. This notification is needed to ensure that someone responds to the alarm condition. 3. RSC shall perform an annual Installation Qualification/Operational Qualification test of the freezer alarm system in Bldg.#10 Pharmacy. All system inputs will be verified and calibrated, or existing customer calibrations certified as appropriate. 4. Vendor must have legal access to RSC software licenses and must be supplied during service and upgrades. Vendor must also supply only new hardware components/modules. Annual maintenance must also include the latest software release from RSC at the time of validation. Currently this release is Centron Software version 2.0 5. Services include: Annual On-Site IQ/OQ Validation Current Software Validation Manual Software updates to current version Calibration of all temperature & humidity sensors with NIST traceable device On-Site training at the time of validation 24/7/365 telephone technical support On site service that includes new parts and labor. 3.0 QUALIFICATIONS OF THE INSTALLER A. All installation personnel shall be fully qualified by the manufacturer (Rees Scientific) to install systems of this type, and must be either employees of the system manufacturer, or have completed a manufacturer administered training program. The winning contractor shall provide notarized proof from Rees Scientific that the installation personnel meets the above requirements. B. Vendor must have legal access to Rees Scientific software licenses and must be supplied during service and upgrades. Vendor must also supply only new hardware components/modules. Maintenance must also include the latest software release Centron SQL Version (2) from Rees Scientific at the time of validation. C. Vendor must be ISO 9001 certified Fact and Reasons to Justify Other Than Full and Open Competition Rees Scientific Corp. is the original manufacturer and they possess the combination of proprietary technical knowledge, new replacement parts, software licenses, and patents covering the intricate designs of the instruments that cannot be purchased from other sources.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6fc23fba3b4b03e578a2736cec0febe3&tab=core&_cview=1)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, Pharmacy department, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01757985-W 20090228/090226220832-6fc23fba3b4b03e578a2736cec0febe3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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