02 02076 SOW Laboratory Monitoring 2025-05-27.pdf

STATEMENT OF WORK

TITLE: Environmental Monitoring System

I. BACKGROUND INFORMATION

NIST's Material Measurement Laboratory (MML) serves as the Nation’s reference laboratory for chemical and biological measurements and standards to enhance U.S. industry’s productivity and competitiveness, assure equity in trade, and provide quality assurance for chemical measurements used for assessing and improving public health, safety, and the environment. The NIST campus in Gaithersburg, MD, has a need to monitor the temperature and alarm status of liquid nitrogen (LN2) vapor phase and air freezers (-150 °C), electric upright and chest freezers (-80 °C and -20 °C), and refrigerators (4 °C), experimental environment of laboratory incubators (temperature, relative humidity, and CO2 concentration), as well as room conditions (ambient temperature, pressure, and relative humidity) in numerous locations across the campus. The integrity of thousands of reference materials and related calibrants and controls is dependent upon the maintenance of the correct temperature over the life of the materials. Additionally, sensitive laboratory equipment and procedures require specific environmental conditions to ensure accuracy and validity of measured results. A reliable environmental monitoring system (EMS) that can accurately monitor the large number of current freezers, refrigerators, and spaces using a single cloud-based interface is required for compliance with the NIST Quality Management System. Given the fluidity of laboratory space usage and potential growth of NIST measurement services, the EMS must also be flexible to allow expansion and modification in the future.

II. SCOPE

NIST requires an EMS that will provide reliable monitoring with LCD display dataloggers and user input at each data collection location as well as a cloud-based system accessible continuously outside of the secure NIST network. The EMS must also provide a notification system at each data collection location and via the cloud to rapidly alert NIST personnel in real time that an alarm condition exists. The system and required equipment shall provide the infrastructure capacity to support the monitoring of ambient temperature, ambient pressure, and relative humidity in fifteen

(15) buildings (approximately 500 laboratory spaces) across the NIST Gaithersburg campus and additional equipment to monitor at least 2500 additional measurement points (e.g., freezers, refrigerators, CO2 incubators) contained in the same spaces through continuous, future expansion.

The system shall accommodate sensors provided with integrated calibration information that is NIST-traceable which will allow users to quickly change measurement probes in case of failure or for future calibrations and validations. This equipment is critical to maintaining the integrity of samples stored for long-term and real-time analysis.

III. SPECIFICATIONS

The Contractor shall provide an Environmental Monitoring System, including software subscription, notification subscription, installation, training, and warranty meeting the minimum requirements defined below and spaces described in Table 1:

http://www.nist.gov/ http://www.nist.gov/mml/index.cfm

System Requirements:

System

• The system shall be compatible with integrated smart measurement probes that come pre-calibrated to NIST-traceable standard ISO 17025 for plug-and-play use with data logging modules.

• The system shall be expandable to allow up to 4000 measurement points through future expansion.

• The system shall be wireless ready with at least fifteen (15) long range wide area network (LoRaWAN) gateways. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $30,000.00. Each gateway must be capable of o A transmit/receive range of more than 400 m (0.25 miles), o Operating at 915 MHz frequency band, o Transmit/receive bandwidth to support at least 250 measurement probes, o Operating without the use of additional wireless relays or extra devices (see Table 1).

• The system shall be capable of allowing a user to log into the cloud-based software system with a username and password to obtain current information and historical data from each probe on demand and in response to alarms.

• The system shall include cloud-based software that meets or exceeds 21 CFR Part 11 for user identification and system auditing.

• The system shall be compatible with measurement probes that are able to monitor the temperature of liquid nitrogen (LN2) vapor-phase freezers (-100 °C to -200 °C), ultralow freezers (-80 °C), standard freezers (-20 °C), refrigerators (4 °C); incubator conditions (temperature, humidity, and CO2); and laboratory conditions (ambient temperature, barometric pressure, and relative humidity).

o For each LN2 freezer: measure temperatures from -70 °C to -200 °C o For each -80 °C freezer: measure temperature from -100 °C to 10°C o For each -20 °C freezer and/or 4 °C refrigerator: measure temperature from -30 °C to

10°C o For each incubator:

Measure temperature (range from 0 °C to 50 °C) Measure percent relative humidity (range from 5 % to 95 %) Measure CO2 concentration (range from 0 % to 20 %) o For each laboratory:

Measure ambient temperature (range from 50 °F to 120 °F) Measure percent relative humidity (range from 0 % to 100 %) Measure ambient pressure (range from 15 kPa to 115 kPa) directly or through conversion using a universal probe/connector capable of recording a third-party barometric pressure reading (input voltage 4 V to 6 V DC; output voltage 0 V to 5 V DC; current draw 4 mA to 10 mA)

• The system shall be compatible with visual alarms that notify users of an alarm state with light and sound in the laboratory space.

• The system shall have user programmable voice tags associated with each measurement probe and when the notification system is prompted be able to specifically identify the name of the measurement probe that is alarming and provide the condition (e.g., temperature, relative humidity) of the measurement probe.

• The alarm notification system shall be programmable by NIST to phone specified users based on the individual measurement probes. The alarm notification system must be programmed to allow for a user tree notification whereby the alarm system will call the first user specified on the user tree then continue to phone users in a sequential manner until a user on the user tree notifies the system that the alarm has been received. If the notification system has made attempts to contact all users on the user tree in the sequential order and no user has notified receipt of the alarm, the alarm system shall recycle the process until a user notifies that the alarm has been received. The notification system shall be able to distinguish between an answered call and a call that has been sent to a voicemail or similar automated answering system.

• The alarm notification system shall be customizable for up to three (3) temperature, time, and/or action alerts per sensor installed and allow users to acknowledge alarms during the phone alert call or in the software.

• Apart from performance testing requirements conducted during installation, NIST personnel will program the alarm system by inputting user data (e.g., name, phone number) and assigning the order of precedence for alarm notification for each measurement probe.

Data loggers

• At least fifty (50) data loggers (or measurement modules), each capable of receiving and recording data from four distinct measurement probes, compatible with the system and sensors described in the previous section. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $85,000.00.

• Dataloggers at the point of source shall have LCD touchscreen color displays that allow measurement set-up and alarm acknowledgements.

• Data loggers shall be capable of delivering an audible and visual alarm in the event of an alarm condition with a connected measurement probe.

• Internal memory of the dataloggers shall be capable of storing at minimum 3,000 readings per logged measurement probe.

• Data loggers shall be compatible with power supplies in the form of replaceable batteries or AC adapters. Data loggers shall be supplied with replaceable batteries for operation.

Table 1. Approximate distribution of spaces to be covered by the EMS on the NIST Gaithersburg campus.

Rooms Building Basement Floor 1 Floor 2 Floor 3 Total

1 All 17 2 All 2 3 2 Labs 2 4 All 32 5 4 Labs 4 6 4 Labs 4 7 NE Quadrant NW Quadrant All 14 8 All W Half 1 Lab All 52 9 All All All 131 10 All W Half W Half 93 11 1 Lab 1 12 All All All 103 13 S Half N Half 25 14 All 18 15 1 Lab 1

Total 499

Software

• The software shall accommodate unlimited users and a future capacity of up to 4000 sensors.

• The software shall be capable of cloud-based API data connectivity to allow for the use of third-party applications.

• The software shall allow for the data reporting via SQL server to export in multiple file formats, including .xlsx, .pdf, and .csv file formats.

• The software shall have a user interface dashboard that displays all sensors and probes and allows for user-programmable alarm limits and alarm parameters.

• The software shall store all calibration certificates for sensors and allow for sensor-swaps to replace with new pre-calibrated sensors.

• The security of the software must meet all requirements of the Federal Information Security Modernization Act (FISMA).

• Contractor shall provide a Secure Software Development Framework attestation for the software platform.

• The Contractor shall ensure that the publicly accessible Federal website(s) and web service(s) are required to provide service only through a secure connection through use of Hypertext Transfer Protocol Secure (HTTPS) and must have HTTP Strict Transport Security (HSTS) enabled.

https://www.cisa.gov/topics/cyber-threats-and-advisories/federal-information-security-modernization-act https://www.cisa.gov/topics/cyber-threats-and-advisories/federal-information-security-modernization-act https://www.cisa.gov/secure-software-attestation-form

• Contractor services shall be accessible through both Internet Protocol Version 6 (IPv6) and IPv4. If not already compliant, the Contractor shall provide the Government with a statement regarding its plans to implement IPv6, including timeframe.

• The Contractor shall have at least one (1) of the following. If subcontractors are involved in the provision of the Contractor’s software solution(s), each subcontractor shall also at least one (1) of the following:

o FedRAMP authorization for the Contractor’s software solution(s).

o An Authorization to Operate (ATO) letter issued by a Federal Government agency as evidence that Contractor’s software solution(s) have been assessed and authorized by a Federal Government agency within the prior five (5) calendar years. If using an ATO letter, that letter shall clearly state the impact level (e.g., moderate or high) at which the Contractor has been assessed and authorized.

o Demonstration that the Contractor’s software solution(s) have passed an independent security audit (e.g., Statement on Standards for Attestation Engagements (SSAE), PCI Data Security Standard (PCI DSS)).

o Within 30 calendar days of contract award, the Contractor shall provide to NIST, as a deliverable, evidence of the audit or instructions on how to obtain evidence of the above, if the Contractor has had any audits described above or other security audit.

• The Contractor shall provide either o The ability to restrict government access to the cloud service from government specified networks, in accordance with the Office of Management and Budget (OMB) Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC),” and the Department of Homeland Security’s “Trusted Internet Connections (TIC) Reference Architecture Document Version 2.0.” or o If not currently able to provide this ability, the Contractor shall provide the Government with a statement regarding its plans to have such capability, including timeframe.

Measurement Probes

• At least fifty (50) laboratory sensors capable of measuring ambient temperature (range from 50 °F to 120 °F) and percent relative humidity (range from 0 % to 100 %). Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $35,000.00.

• At least three (3) sensors for LN2 freezers, capable of measuring temperatures from -70 °C to -200 °C. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $3,500.00.

• At least fifteen (15) sensors for -80 °C freezers, capable of measuring temperatures from -100 °C to 10°C. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $10,000.00.

• At least ten (10) sensors for -20 °C freezers and/or 4 °C refrigerators, capable of measuring temperatures from -30 °C to 10°C. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $3,500.00.

• At least five (5) sensors for CO2 incubators, capable of measuring temperatures from 0 °C to 50 °C, percent relative humidity from 5 % to 95 %, and CO2 concentration from 0 % to 20 %. Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $9,000.00.

• At least three (3) barometric pressure sensors, capable of measuring atmospheric pressure from 15 kPa to 115 kPa directly or through conversion using a universal probe capable of recording a third-party barometric pressure reading (input voltage 4 V to 6 V DC; output voltage 0 V to 5 V DC; current draw 4 mA to 10 mA). Contractor may include additional quantity for consideration of best value to a total item cost not-to-exceed $1,000.00.

Additionally, the Contractor shall provide copies of the operations and maintenance manuals for all equipment covering basic operation, maintenance procedures, and troubleshooting.

Installation:

The Contractor shall attend a system planning meeting not later than thirty (30) calendar days after award to draft the installation schematic showing the location of the probes, transmitters, and receivers for NIST review. During the meeting, the Contractor, the NIST Contract Officer Representative (COR), NIST Technical Subject Matter Expert (SME), and NIST IT Personnel will review the installation schematic and may make recommendations for the final placement of probes, transmitters, and receivers. The COR and SME will make all final determinations on installation schematics, equipment moves, and equipment modifications. At the conclusion of the system planning meeting, the Contractor shall revise, based on NIST COR and SME recommendations given, and submit a final installation schematic for review and acceptance by the NIST COR and establish a schedule for delivery, installation and training. NIST will move all equipment as required.

The Contractor shall provide to the NIST COR and SME a list of contractor personnel that will be installing the equipment and conducting the system qualifications and training no later than five

(5) business days prior to entry for each Contractor personnel. The system, including the software, all gateways, at least 25 data loggers, and at least 25 probes, shall be installed by the Contractor’s authorized personnel. Installation, at a minimum, shall include unpackaging of all equipment, setup of the system, demonstration of all specifications, and removal of trash. If other than the

Prime Contractor’s authorized personnel will be providing installation, the Prime Contractor shall be the primary point of contact. The Government has no privity of contract with sub-contractors.

The installation of the system shall ensure the safety and continued operation of the equipment and any laboratories in which the equipment resides. The Contractor shall adequately secure wires and cables so that these do not dangle, hang, or fall loosely onto floors, equipment (inside and outside), or work surfaces. The Contractor shall not create trip, slip, or fall hazard conditions during the installation process. Except in specific instances deemed necessary by the approved installation schematic, the Contractor shall not puncture or in any way permanently alter walls, ceilings, work surfaces or floors. Additionally, the Contractor shall not run wires or cables into or through ceilings, or on the ground under walls.

Modifications to the equipment, such as drilling holes or puncturing the exteriors to accommodate the installation of the temperature probes must be minimized to the maximum extent practicable and must be performed by NIST personnel.

After completion of all installation, the Contractor shall test the system to ensure that all installed temperature measurement probe inputs are calibrated and working correctly.

To demonstrate the alarm notification system, the Government will provide the Contractor with phone numbers for up to four (4) NIST personnel. The Contractor shall create a demonstration user tree notification hierarchy for one probe using the contact information provided by the Government. The Contractor shall demonstrate the alarm notification system in the following ways:

a) The alarm notification is sent to the correct phone numbers provided in the demonstration user tree.

b) The alarm notification is sent in the correct order specified by the demonstration user tree.

c) The alarm notification repeats to the first user specified if no other users on the demonstration user tree answer the notification and repeats notifications through the demonstration user tree until a user receives the alarm.

d) The alarm notification ceases after the alarm is received by a specified user on the demonstration tree.

If any defects or performance deficiencies are discovered during or after installation or during testing, the Contractor shall take corrective action and replace any defective parts and resolve any performance deficiencies detected to ensure the system is functioning IAW OEM specifications prior to acceptance by the Government.

Installation and testing shall be performed by the Contractor concurrently and be completed not later than 45 business days after delivery of the EMS. Installation will take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Contract Officer Representative (COR) and the Technical Subject Matter Expert (SME).

Warranty:

The Contractor shall provide, at a minimum, a 1-year warranty for the EMS. The warranty provided shall cover all of the following:

• Parts, labor, and travel

• Software and firmware updates

• Unlimited email support

• Remote support to expedite a solution for NIST in the event that NIST is unable to resolve a problem

• Telephone support for the covered equipment during regular business hours to include responses to questions about operating practices, application use, and service issues that can be diagnosed and resolved over the telephone

During the warranty period, the Contractor shall provide telephone support during regular business hours, software and firmware updates, remote and/or on-site service, and replacement of any defective equipment or software. The Contractor shall respond to NIST personnel requesting service by telephone not later than two business hours after receiving a request for service or technical support. The Contractor must provide their best effort to be on-site at the NIST Gaithersburg facility within two business days of the initial request for service. At the conclusion of each service and/or maintenance request, the Contractor shall provide the SME with a system Operational Qualification (OQ) report which clearly documents that the system is fully operational, all probes are reporting the correct temperatures, pressures, or relative humidity, all probes are correctly calibrated, and the alarm notification system is functioning correctly.

All software or firmware updates issued by the OEM during the warranty period, developed for the purpose of system optimization, shall be made available no later than 60 days after any such update is released. Updates shall be installed by either the Contractor and/or NIST personnel.

The warranty shall commence at the conclusion of

a) installation,

b) a demonstration that all salient characteristics have been met,

c) system performance testing leading to receipt of a system Operational Qualification (OQ) report documenting the system is fully operational; and,

d) advanced training session.

Maintenance Support Contract:

The Contract shall provide a Maintenance Support Contract that shall commence immediately after the warranty period concludes. The Maintenance Support Contract shall include telephone and priority technical support for the supplied measurement points within the cloud-based software.

Any software or firmware updates issued by the OEM shall be included and made available no later than 60 days after any such update is released. The Maintenance Support Contract shall include additional user/admin. training sessions post installation, conducted virtually, plus one (1) on-site visit within ninety (90) days of full project completion.

Training:

The Contractor shall schedule and facilitate one (1) advanced user training session of a minimum of three (3) days for up to ten (10) users at the NIST Gaithersburg facility. The training shall provide a thorough demonstration of all equipment functions, maintenance, data administration, data acquisition, and basic troubleshooting. The training shall be completed immediately after delivery/installation/set-up/testing has concluded.

IV. PERIOD OF PERFORMANCE

Delivery, installation, acceptance testing, and training shall occur not later than 175 days after award.

V. DELIVERY

Delivery shall be F.O.B Destination and shall occur within 60 calendar days of award.

F.O.B. Destination means: The contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the order, and pay all charges to the specified point of delivery.

Delivery shall occur during normal business hours, between 8:30 am and 5:00 pm Eastern time, Monday through Friday, with the exception of Federal holidays and shall be made to:

National Institute of Standards and Technology 100 Bureau Drive, MailStop 8390 Gaithersburg, MD 20899 ATTN: Melissa Phillips

VI. DELIVERABLES

Description (and Format) Quantity Due Date

Evidence of the audit or instructions on how to obtain evidence of the above, if the Contractor has had any audits described above or other security audit.

One (1) 30 calendar days after award

Response to an action plan and schedule to mitigate any security risks identified by

NIST

One (1) 30 calendar days after receipt of written notification from COR

Draft and final installation schematic One (1) 30 calendar days after award Contractor personnel list for installation One (1) set No later than 5 business days prior to campus entry for each contractor personnel

Gateways Not to exceed a total cost of $30,000.00

180 calendar days after award

Data loggers Not to exceed a total cost of $85,000.00

180 calendar days after award

Room temperature/relative humidity sensors

Not to exceed a total cost of $35,000.00

180 calendar days after award

LN2 freezer sensors Not to exceed a total cost of $3,500.00

180 calendar days after award

-80 C freezer sensors Not to exceed a total cost of $10,000.00

180 calendar days after award

-20 C freezer/+4 C fridge sensors Not to exceed a total cost of $3,500.00

180 calendar days after award

CO2 incubator sensors Not to exceed a total cost of $9,000.00

180 calendar days after award

Barometric pressure sensors or universal sensors

Not to exceed a total cost of $1,000.00

180 calendar days after award

Operation manuals and maintenance manuals

One (1) set 180 calendar days after award

Installation/testing of EMS Once 45 calendar days after delivery of equipment

Advanced operations and maintenance training session

Once 10 business days after installation and testing

VII. BEST VALUE CRITERIA

The Government will evaluate proposals on a best value basis in which technical approach and total price will be considered equally and both with more weight than Contractor’s past performance.

Technical approach will be evaluated as exceeding minimum requirements for proposals that

1. Provide above minimum quantities of data loggers (modules) to equip additional laboratory spaces on the campus.

2. Provide above minimum quantities of measurement probes to equip additional laboratory spaces on the campus.

3. Demonstrate Contractor’s software solution(s) have successfully undergone FedRAMP authorization.

4. Demonstrate Contractor’s software solution(s) have successfully undergone review of terms and conditions for the Service Level Agreement for the cloud software/platform/service by the Department of Commerce or another Federal Agency.

VIII. ACCEPTANCE CRITERIA

Formal acceptance of the system shall be given at the time the Contractor successfully demonstrates that all performance specifications in this Statement of Work have been met including installation and training. The NIST COR shall review all deliverables and determine if these criteria are met.

IX. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

IT Security: Post contract award, the Government will perform a review for a local ATO decision, required for go-live, and ongoing security assessments for continuous monitoring thereafter. The Government will determine the risk rating of identified vulnerabilities. The Contractor shall respond to the Government with an action plan and schedule to mitigate security risks found within 30 business days of notification of security risks. The Government will notify the Contractor of whether or not the action plan and schedule are acceptable. The Contractor shall implement the action plan according to the agreed-upon schedule.

Physical Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST COR and/or SME prior to arrival. The COR and/or SME will submit the name(s) and citizenship information to the NIST Office of Security for a given Contractor employee to enter the NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. A valid driver’s license, Government-furnished, REAL ID compliant civilian ID (which in most cases can be a valid driver's license), proof of insurance and current registration must be presented to the NIST Security Office.