Pharmacy Monitoring System Upgrade, Maintenance and Validations

The National Institutes of Health, Clinical Center is conducting a market survey/sources sought to help determine the availability and technical capability of qualified small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses, HUBZONE small businesses, small businesses under the 8(a) program, and/or businesses under GSA Schedule, capable of serving the needs mentioned below. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this market survey. The Inpatient Pharmacy Section in conjunction with the Pharmaceutical Development Section (PDS) of the Pharmacy Department, National Institutes of Health (NIH), Clinical Center Bethesda, Maryland is responsible for the temperature monitoring of all medication refrigerators in the Clinical Center. In addition to complying with all Joint Commission standards for the proper storage of drugs, study sponsors now require constant monitoring of storage conditions for their Investigational New Drugs (INDs). The system must also be able to produce a record by date and time of the multiple measured temperature points. Over 220 probes are monitoring temperatures, humidity, pressure differentials, and particle counters in the numerous medication refrigerators and freezers are in clinic areas, the audible alarm will not be heard after normal operating hours of the clinic. It is essential that these medication refrigerators are networked to an alarm in the Inpatient Pharmacy which is staffed 24 hours a day, 7 days a week. Scope of Work - Software/Hardware upgrade ?- The system must be able to provide constant digital recording of temperature, room humidity, pressure differentials and particulate levels, monitoring via an NIH CIT installed network. The device should be able to produce a printout for any time period specified including specific time intervals. ?- All the installation shall be accomplished professionally with the knowledge, experience and skills of temperature, humidity, differential pressure and particulate level monitoring. ?- The system requires at least 222 probes that would be suitable for detection of temperature levels at room temperature, refrigerated temperature, -30 degree (C) freezers, -80 degree (C) freezers, incubators, humidity sensors, pressure differentials detectors and particle detectors that will give a count of particles above 0.5 micrometers and a count of particles above 5 micrometers that have Multiplex Remote 16 input Expansion Panel with RJ45 Connectors (can handle a total of 1000mA sensor load when using 2 HUM-BAT-BACK), 15 modular cord assembly with RJ45 Plug. ?- It will be capable of interfacing with a documentation system installed remotely that will automatically and continuously display and save data indefinitely with the capability of being able to print out data in a span from 5 minutes to more than 4 years. This interface must also have the capability of giving audible and visible alarms when specifications are exceeded. ?- The interface must be effective with a 4-20 mA signal. ?- The contractor will work with the interface and with the documentation device which will be provided by the Department of Clinical Research Informatics (DCRI). The system must be compatible with the DCRI servers. ?- The contractor will demonstrate and document that all probes are operating within specifications and provide a training session to familiarize staff with the new aspects of the upgrade. ?- The documentation shall be in the form of an IQ/OQ for the system in the same fashion as provided with the system being replaced. This validation must be available at least every 6 months. ?- The contractor must provide 24/7 technical support. ?- The contractor must provide copies of reference equipment and calibration certificates. ?- The system must provide a "Buddy Watch" or equivalent feature so that if one portion of the apparatus goes down, another working portion will alert the users. ?- The system must include cellular back up of a phone tree alert system. ?- The system must be compatible in a hard wired, wireless(418 MHz, 900 MHz and 2.4 GHz), or in a combination of all three types in a hybrid design in a single system. ?- The main monitoring nodes must provide power outage notification, dead man alarms, watchdog timers and back-up battery. ?- The system should be ISO 9001:2000 certified. Scope of Work - Maintenance/Validation agreement: Our current REES monitoring system consists of 16 pressure sensors and 206 temperature, humidity and particulate counting points. The pressure sensors are located within PDS. The temperature points are located throughout the Clinical Center. There are no points outside the Clinical Center. REES Scientific Corp. is the sole manufacturer of REES Centron SQL monitoring system hardware and software already installed in Bldg. 10, ACRF and CRC. This is proprietary software and maintenance of the system requires intimate knowledge of the system software (Current version is 2.0 Build 1015 but will be changed by the upgrade included in this statement of work). We are requesting twice a year service with on-site calibration of our differential pressures using a NIST traceable manometer and validation of the 206 other points in the system, including humidity, temperature and particulate counting. The comprehensive system tests shall verify, calibrate and document all system functions including readings, databases, alarms, dial-outs, outputs, reports and use programming. The vendor shall provide the following: - 24/7 technical support - A GMP/GLP IQ/OQ validation report and a software validation test report. - Calibration of temperature and humidity with traceable equipment. - Calibration of particulate matter is not required but evidence that system responds to particulate challenge is required. - Differential pressures must be read using a certified manometer and documented. - Copies of reference equipment calibration certificates. - Onsite refresher training at each preventive maintenance visit. - Upgrading of software as upgrades become available. The vendor responses must demonstrate their capability of providing a machine with the characteristics described above. Please note that failure to specifically demonstrate capability to provide the required equipment in your response to this market survey may affect the Government's review of industry's ability to perform these services. The vendor's response shall be in sufficient detail to allow the Government to assess the capability of your firm. The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information". Vendors must send written capability responses by March 24, 2015, 9:00 a.m. Eastern Time to Lisa Schaupp, the Contract Specialist at the e-mail address contact@example.gov. For any questions regarding the response submission process, please respond in writing to the email address provided.