Description
Amega System Monitoring of Temperature-sensitive Product Areas: 160 probes, 1 year service and qualification package, 1 year of 24/7 technical support, on-site parts and labor warranty, qualification and calibration of CMS and existing points on system and PM of system. Documentation is kept and supplied. Free on-site training and free software upgrade. All requirements must be met via compatability with Amega Scientific System already on site. The Government intends to award a sole source contract for this requirement. The suggested contractor is Amega Scientific Corporation, 617 Stokes Road Suite 4334, Medford, NJ 08055. This is not a request for proposal. However, companies that can provide an equal service must submit their technical capabilities to include technical specifications of their product, past performance information, price and delivery time. This information will be reviewed by the Government technical representatives for consideration for future requirements. The following is the Performance Work Statement for this requirement: PERFORMANCE WORK STATEMENT FOR TEMPERATURE SENSITIVE PRODUCT MONITORING SYSTEM DWIGHT D. EISENHOWER ARMY MEDICAL CENTER, FORT GORDON, GEORGIA 1.0 Scope. 1.1 Objective: The objective of this performance-based contract is to obtain approval for the procurement of temperature sensitive medical product monitoring applications capable of ensuring that Dwight D Eisenhower Army Medical Center (DDEAMC) provides quality controlled medical products to its supported population. This will also meet the secondary objective of ensuring compliance with all Army Regulations, Medical Command Directives, and Local Policies. 1.2 Background. DDEAMC utilizes the Amega Scientific Temperature Monitoring Application to monitor all refrigerators with vaccines and TSMP with a dollar value greater than $3,000. This application was put into place in FY08. Prior to the implementation of this application the medical facility utilized manual procedures to record temperatures and ensure compliance with cold chain standards. . In 2007 the MEDCOM policy changed to require more physical checks and 24/7 electronic monitoring for all vaccines and any product storage greater than the designated regional threshold. Southeast Regional Medical Command established a threshold of $3,000. 2.0 Definitions and References. 2.1 Definitions. TSMP: Acronym that stands for Temperature Sensitive Medical Products and applies to all medical supplies, Pharmaceuticals, and vaccines that must be maintained at a controlled temperature or humidity level. 24/7 Monitoring: A monitoring system that is always active and records values for historical background and later use. Temperature Range: An establishment of high and low temperatures that the TSMP items must be maintained. Storage Unit: Any location that is used to store TSMP for temperature or humidity control. 2.2 References. SB 8-75-S11: The annual update to the Army Medical Logistics Regulation (AR 40-61). Chapter 3-68 contains current standards for the management of TSMP material. DDEAMC Regulation 700-3: Establishes the specific standards for TSMP management at Dwight D Eisenhower Army Medical Center. 3.0 Tasks. The Contractor shall perform the following tasks: 3.1 Provide an automated tissue tracking application capable of: 3.1.1 Assigning temperature sensors to specific sections and storage units. 3.1.2 Assigning a temperature range that is adjustable for each storage unit. 3.1.3 Executing an alarm when temperatures are outside of the temperature range for a time period designated by the Government. This alarm shall be able to send a telephonic and email alert individuals designated by the system administrator. 3.1.4 The TSMP system should be flexible and have the ability to be tailored to the needs of the Government without support from the Contractor. 3.1.5 Providing password level security for users to identify when users adjust calibrate, inhibit, or turn off temperature probes. 3.2 The TSMP Software Application must provide output data that is readable by software platforms standardized throughout the Army. These platforms include Microsoft Office Products, Sharepoint, and Adobe Acrobat PDF Reader capabilities. 3.3 The TSMP Software Application must adhere to the following requirements: 3.3.1 Encryption: Equal to, or greater than 128 bit. 3.3.2 Browser: Application must be accessible by any web browser if it is web server application. 3.3.3 Customizable: The web server application must contain the ability to customize reports, web pages, and form design. 3.3.4 Accessibility: The TSMP Software Application must be available to the Government 24 hours per day and seven day per week with the exception of scheduled maintenance periods. Notification of scheduled maintenance periods will be published at least 4 days prior to the execution of stated maintenance. The probes must continue to record temperatures while the application is being maintained. 3.3.5 Data Redundancy: If the application is on a web based server then the Contractor will back up all Government files once every 24 hours to ensure redundancy of information. At least two weeks worth of back up data will be maintained by the Contractor. 3.3.6 DISA Network Compliance: The TSMP Software Application must meet all security requirements for web based applications and perform Anti-Virus Software updates no less than every seven days. If the application is located on the Government's Network then the Government Information Management Division must be able to execute anti-virus updates and scans IAW local policies. 3.3.7 Certificate: The Contractor will provide an SSL certificate, or other equivalent security certificate, to enable secure and encrypted communications between the Government and Contractor Systems. 3.4 Server Maintenance: If the TSMP Software Application becomes unavailable to users, other than scheduled maintenance, then the Contractor will have qualified personnel to respond within 24 hours of notification to remedy the problem. 3.5 Provide a one year subscription to the Contractor TSMP Software Application. 3.6 The Contractor must monitor 160 probes, owned by the Government, as part of this Contract and provide a pricing option for the purchase of additional probes that must be valid though FY10. If the Government requires additional Gateway, Dialers, and other hardware the current contract must be modified ad the Contractor must provide quotes, including installation, separately. 4.0 The Government shall provide the following: 4.1 COR: A Contracting Office Representative (COR) will be assigned to evaluate that performance based execution of this project and to ensure that the Contractor and Government are adhering to the requirements outlined in the contracting document 4.2 Information Management: 4.2.1 Each user will have a Government provided laptop/PC system to load client software. An administrator will be available throughout training and user changes to authorize software modifications to the designated system. 4.2.2 Any change in policy or regulatory requirement will be submitted to the Contractor in writing as soon as they are identified. Any changes in requirements that go beyond the Contractor provided requirements outlined in paragraph 3 will require the Government to create a modification to the contract. 4.4 The Government will provide the Contractor with a point of contact list within 5 days of the contract award. This list will include: 4.4.2 COR: The person responsible for evaluating compliance with contractual requirements. 5.0 Reports. The Contractor shall prepare the following reports and submit them as specified. 5.1 Unscheduled Maintenance Report. This report will be submitted to the COR whenever there is an unscheduled maintenance event that results in the loss of web server application use. This report will include the time of the event, when the issue was resolved, what the issue was, and what the Contractor has done to ensure the incident does not become a recurring event. 6.0 Performance Requirements Summary. Task Performance Standard 3.1 System Capabilities 1. Temperature probes can be assigned a range designated by the Government and affiliated to specif storage units 2. The TSMP Software Application sends a telephonic and email message when temperature of TSMP products is outside of the temperature range. 3. The TSMP Software Application can be tailored to meet the regulatory requirements and needs of the Government. 3.2 System Requirements 1. The web server application must be acceptable ninety-five (95) percent of the month. This accessibility requirement does not include scheduled maintenance time. 3.4 Server Maintenance 1. A qualified technician is available to remedy unscheduled maintenance problems within 24 hours of notification by the Government. Quality Assurance Surveillance Plan Temperature Sensitive Medical Product Monitoring Application Contract No.____________, date:____________ Inspections will be based on the standards in the Performance Works Statement. Task What will be inspected? Who will inspect it? When will it be Inspected? Where will it be inspected? How will it be inspected? 3.1 TSMP Alarm Efficiency TSMP Monitor Random Monthly Checks DDEAMC Random checks completed during monthly alarm tests.. 3.1 TSMP Regulations and Standards TSMP Monitor First Wednesday of each quarter DDEAMC inspector observations basd on published guidelines though the inspecting organziation 3.2 Accessibility COR Last Work Day of Every Month COR Location Client comments, unscheduled maintenance reports, and personal observation. 3.4 Server Maintenance COR Last Work Day of Every Month COR Location Client comments, unscheduled maiuntenance reports, and personal observation.