Response_to_Sellers_Questions.docx

SPECIFICATION SHEET NO. 1

TEMPERATURE MONITORING DEVICE

1. SCOPE

1.1 This Specification Sheet covers the requirements for various types and sizes of wireless cloud-based remote temperature monitoring systems/devices that must meet specific guidelines that are published by other entities such as Centers for Disease Control (CDC), Food and Drug Administration (FDA), AABB (formerly known as the American Association of Blood Banks), American Association of Tissue Banks (AATB), product manufacturers, etc. addressing proper vaccine and other TSMP storage and handling requirements.

1.2 Intended use. The cloud-based temperature monitoring systems/devices shall be suitable for use in medical and scientific facilities and is completely scalable from a single fridge to a fully integrated multi-fixture system across multiple sites - all visible from one web user interface. The interface must be simple to use with minimal training and by using web-based technology, data and records are securely accessible 24/7 anywhere in the world on any device able to support a web-browser. Must be able to monitor a minimum of 223 points.

2. CLASSIFICATION

2.1 Remote temperature monitoring systems/devices covered by this document shall be suitable for use in medical and scientific facilities requiring compliance with controlled room temperature/humidity, pressure differential, incubators, and refrigerated or frozen temperature requirements for Vaccines, blood products, tissue products, temperature sensitive reagents and other temperature sensitive items that are collectively referred to as Temperature Sensitive Medical Products (TSMP).

2.2 Related activities in order that this guidance can be fully applied, the following steps also have to be completed:

2.2.1 Identify the storage areas and equipment which will be used for storing TSMP and their relevant temperature regimes – ambient, controlled ambient, refrigerated and frozen.

Question: Who provides this information?

Response: Refer to Attachment 1 TSMP Worksheet

2.2.2 Map these storage areas and equipment and determine hot and cold points.

Question: Who performs the mapping?

Response: Mapping must be perform by the sellers certified installer. The mapping will be conducted on our walk-in refrigerators and freezers after post award and during the first year of the contract during our hottest and coldest seven (7) to ten (10) day period in the El Paso, Texas area. Also, it will be conducted on any new walk-in refrigerators or freezers added to the monitoring system. Post award site walk required to validate requirement.

2.2.3 Ensure that all storage areas and equipment complies with applicable regulations and guidelines on the storage of TSMP before these products are used.

Question: Who decides that equipment complies?

Response: William Beaumont Army Medical Center Logistics Division, Equipment Management Branch and Facilities Engineer during technical acquisition process.

3. SALIENT CHARACTERISTICS

3.1 Specific requirements for wireless networks.

3.1.1 Wireless sensor networks shall have the following technical characteristics:

Question: Please define self-adaptable and self-healing?

Response: A hardware self-healing and self-adaptable method is proposed to recover sensor nodes when only some parts of the nodes' hardware have faults or fail. This method is based on reconfigurable hardware, whose architecture can be dynamically reconfigured. Using the method, when part of the circuits in the sensor node fail, the node can diagnose its own fault and repair itself.

3.1.9 The wireless sensor network shall automatically detect and incorporate newly installed sensors.

Question: Please elaborate on how the network shall automatically incorporate newly installed sensors?

Response: When we purchase new requirements and temperature sensors, they will connect thru routers automatically to the cloud based server.

3.1.10 Also for a wireless system, the sensor-reader subsystem shall also be evaluated in terms of transmission capability, efficacy (e.g. ability to transmit through walls or doors) and power consumption. In a complex or extended monitoring scenario, wireless configurations shall be tested to avoid dead zones or wireless transmission concerns.

Question: Who will evaluate and test the transmission capabilities?

Response: This will be accomplished by the vendor’s certified installer.

3.2 Web-based systems.

3.2.1 Web-based systems shall be user-friendly, even if they are required to perform complex operations. This minimizes training requirements, reduces the time taken to deploy the system and enables the user organization to obtain maximum performance.

3.2.2 Monitoring system shall operate over existing cellular network and shall provide the ability to manage multiple users, buildings and sites.

Question: Please clarify if the software needs to be accessible on the cellular network? Can an architecture map of the site network be provided? How are the physical devices to be paired to the cellular network?

Response: Using vendors routers/gateways, which will be connected to an existing cellular network (AT&T or Version) that seller provides.

3.2.3 Web-based systems generally emphasize ease of use, with system dashboards enabling the user to trace operations and activities, to see and follow-up all alarms, and to compile data into preformatted reports. Web-based systems also allow the data to be stored in the internet ‘cloud’ rather than at a specific facility. Authorized users have access to an online database via secure access arrangements. When systems of this type are adopted they shall be subject to system validation/qualification before any use.

3.2.4 Monitoring solutions shall incorporate a complete management system that includes the following features:

3.3 Alarm system.

3.3.1 The monitoring system shall include an integrated alarm function that reports out-of-range events. Alarms shall be managed automatically. Alarm limits shall only be set by authorized users and shall automatically alert responsible staff via email, SMS text message or other communication medium in case of out-of-range events or incidents.

3.3.2 Available equipment includes combinations of audible and visual alarms and electronic messaging systems; the latter allow authorized users to be alerted via e-mail, phone or text (SMS) message. A fully integrated system shall allow the user to set an alarm schedule for different alert levels – for example work days, weekends and holidays.

3.4 User controls.

3.4.1 Data needs to be recorded accurately and in real-time, and shall be provided in the form of reports, charts, and graphs, which users are able to customize.

3.4.2 The system shall allow all sensor and alarm parameters to be configured and customized by users. For instance, it shall be possible to configure the sensor recording (sampling) rate or set a variety of parameters for the alarm settings. These could include:

3.4.2.4 Reports shall be customizable by users: format (text, pdf, graph…), time period and content (high and low temperature events, MKT analysis).

3.5 Adaptability and expandability.

3.5.1 Unless the user requirement is very simple, it is wise to choose an adaptable and scalable system. A fully flexible system shall support the following features:

3.5.1.1 Ease of configuration for small-scale or large-scale facilities;

3.6 Security and compliance.

3.6.1 There are specific security and compliance requirements which apply to monitoring systems and they shall be installed and managed in accordance with relevant standards and regulations such as 21CFR part 11, and GAMP. Specifically:

3.7 Maintenance and support.

3.7.1 Monitoring systems are a crucial to compliance with industry regulations and any system failures have to be resolved as rapidly as possible. Whether the system is organizational or contractor, this means that a 24/7 technical support plan shall be part of the contract package. This package shall include a requirement for the installer or service provider to cover maintenance, support and warranties for both hardware and software. The support period and the renewal arrangements need to be defined in the statement of work.

3.8 System extent.

3.8.1 A comprehensive monitoring system for Temperature Sensitive Medical Products (TSMP) shall be designed to record temperature and relative humidity for all storage areas where these products are stored or temporarily held. The system shall extend to include the following areas:

3.9 Number of monitoring points.

3.9.1 For ambient warehousing, controlled ambient stores, preparation rooms, temporary holding areas, freezer rooms, cold rooms and other spaces that people can physically enter, the number of monitoring points depends on the size of the space and on the diurnal and seasonal temperature variations observed during the mapping studies. This may change from one facility to another. Refer to Technical Supplement: Temperature mapping of storage areas.

Question: Where is the technical supplement located?

Response: Supplement_8 Temperature mapping of storage areas, Technical supplement to World Health Organization (WHO) Technical Report Series, No. 961, 2011.

3.9.2 For small-scale reach-in equipment such as refrigerators and freezers, a minimum of one monitoring point or monitoring device shall be installed in the storage chamber. Note: some national regulatory agencies require two sensors: one positioned at the coolest point and one positioned at the warmest point. The correct locations may be determined by on-site temperature mapping, or they may be determined during laboratory testing at the design qualification (DQ) stage.

Question: Who will perform mapping and/or laboratory testing?

Response: Mapping must be perform by the sellers certified installer.

3.10 Location of monitoring points.

3.10.1 As previously noted, monitoring points shall be located in all places where TSMP are stored or handled. The correct locations are established as follows:

3.10.1.1 Ambient and controlled ambient storage areas: Position sensors in the places where seasonal hot and cold spots have been observed during the mapping studies.

3.10.1.3.1 Monitoring points shall NOT be placed in areas where transient events such as a door opening may affect the monitoring and generate an abnormally high number of alarms. If such transient events generate out-of-range temperatures alarms too frequently and the problem cannot be resolved technically or operationally (e.g. by limiting the number of door opening events), these areas shall not be used to store TSMP and shall not be monitored.

3.11 Complimentary services.

3.11.1 Implementing an effective and reliable monitoring system is a complex task; its installation, operation and maintenance involves a number of complimentary linked services. The scopes of these complimentary services need to be clearly defined in terms of:

Yes Response: Maintenance of system, components and upgrades must be managed by the seller as part of the manufacture warranty. System will require Cloud-Based Cellular Network Monitoring from Go-Live date to 30 September 2019. Separate Service Contract for base and options years will be requested after 30 September 2019.

3.11.1.4 Calibration: How are sensors calibrated and by whom? How is calibration performed without system disruption?

Question: How are such questions answered?

Response: Calibration of system must be conducted by manufacturer certified personnel. Minimum system disruption is required during calibration.

How are the sellers sensors calibrated and by whom? During calibration, is the entire system need to be down?

3.11.1.5 Regulatory compliance: What is the regulatory package provided with the system? (Training, SOPs and Qualification).

Question: Training and Qualification, guidance can be given on SOPs.

Response: On-site training required for Clinical Engineers and Staff.

QUESTION #574809: Document mentions a technical supplement; please provide *need to know: # locations # of buildings at each location # of floors in each building at each location # departments # users -detail for use of each sensor; for example how many are temp versus ambient temp/humidity versus ultra-low or other -# notification profiles

Response: Refer to Attachment 1 TSMP Worksheet

QUESTION# 574831: We have provided these systems to the VA and other commercial hospitals. Please state if there are any security restrictions or DOD clearances or credentials required for the setup of wireless, cloud-based system and devices. Thank you.

Response: This is a cloud base system and seller will not require access to Government Network. Contractor must comply with all DOD policy for access to DOD facilities.

QUESTION# 574861: QUESTION FROM A SELLER: We have a question in regards to the RFQ. The RFQ is for quantity 1 unit. Should we be quoting one sensor unit and associated hardware, costs, etc? Also the Description is for a 220 Wireless Display Sensor. Do you know what the description means in regards to a 220 Wireless Display Sensor? Just want to make sure what we are quoting is correct.

Response: Refer to Attachment 1 TSMP Worksheet//Updated sensors quantity with equipment inventory.

QUESTION# 574886: QUESTIONS FROM A SELLER: The bid description references 220 display sensor. Is 220 the quantity of refrigeration units to be monitored? Are all 220 units to be deployed at the same location, or at separate sites? Please confirm if scope includes thermal mapping, installation, set-up, training, maintenance, calibration, annual certification and cloud services. The specifications discuss all these components, but the bid description suggests only the sensor. Regards, Response: Refer to Attachment 1 TSMP Worksheet//Updated sensors quantity with equipment inventory.

QUESTION# 574911: QUESTIONS FROM A SUGGESTED SOURCE: Please see our questions/information needed below : 1. Please provide a list of assets (refrigerators, freezers, incubators, rooms, labs, etc.) that need to be monitored. Please include the type of appliance or area and its measurement (temperature, humidity, CO2, differential pressure, etc.) range. 2. Please provide floor plan diagrams of the facilities where monitoring is to take place with the monitoring points (appliances or assets) identified and referenced to the above list. Please make sure a few major dimensions are included on the diagrams. Remember cleanrooms for compounding pharmacies and operating rooms will required temperature/humidity and differential pressure monitoring. 3. We are assuming Wi-Fi access is available in all the spaces where monitoring is to take place. If Wi-Fi is generally available, please identify the locations where Wi-Fi may not be usable on the floor plan diagrams.

Response: Refer to Attachment 1 TSMP Worksheet//Updated sensors quantity with equipment inventory.

QUESTION# 575048: EXTENSION REQUEST FROM A SELLER: Can you extend the buy for one additional week?

Response: Bid extended until 2/19/2019 1100hrs EST.

QUESTION# 575047: FOLLOW UP QUESTIONS FROM A SELLER: Please provide a list of assets (refrigerators, freezers, incubators, rooms, labs, etc.) that need to be monitored. Please include the type of appliance or area and its measurement (temperature, humidity, CO2, differential pressure, etc.) range. Please provide floor plan diagrams of the facilities where monitoring is to take place with the monitoring points (appliances or assets) identified and referenced to the above list. Please make sure a few major dimensions are included on the diagrams. Remember cleanrooms for compounding pharmacies and operating rooms will required temperature/humidity and differential pressure monitoring. We are assuming Wi-Fi access is available in all the spaces where monitoring is to take place. If Wi-Fi is generally available, please identify the locations where Wi-Fi may not be usable on the floor plan diagrams.

Response: 1. Refer to Attachment 1 TSMP Worksheet//Updated sensors quantity with equipment inventory.

2. Cleanroom is not required as part of this statement of work.

QUESTION# 575216: QUESTIONS FROM A SELLER: 1. Is there a more specific equipment list of the 220 points to be monitored for this bid that can be shared? 2. In order to have as accurate a bid as possible there should be a floor plan or a walk through of the areas to be monitored to ensure complete coverage. Are floor plans available? 3. The Salient SOW states several things that must be accomplished in Section 2.2. Will the vendor that wins the auction be required to complete those or will these be completed and furnished by the buyer? 4. The majority of our clients do not require full PQ (only IQ/OQ documentation) and create their own internal SOP's. Will there be a requirement of adding a full PQ and SOP generation to this bid? 5. Will a quote for the annual costs be needed for this bid? 6. What is the preferred cellular network vendor for the hospital? i.e. Verizon, Sprint etc.

Response: Using vendors routers/gateways, which will be connected to an existing cellular network (AT&T or Version) that seller provides.

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