ENVIRONMENTAL MONITORING SYSTEM SoR.pdf

STATEMENT OF REQUIREMENTS (SoR)

Freezer and Room Condition Environmental Monitoring System (EMS)

I. BACKGROUND

The Chemical Sciences Division (CSD), part of National Institute of Standards and Technology (NIST) Material Measurement Laboratory (MML), serves as the Nation's reference laboratory for chemical 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 Biorepository and NIST labs at the Hollings Marine Laboratory in Charleston, SC monitor the temperatures of liquid nitrogen (LN2) vapor phase (-150 °C), electric upright (-80 °C) and Vario vapor-phase (-80 °C) freezers and the alarm status of each of the LN2 freezer monitoring controllers. The integrity of the 100,000+ samples is dependent upon the maintenance of the correct temperature over the life of the samples. It is important to have a reliable environmental monitoring system (EMS) that can accurately monitor all existing freezers and be expandable in the future to accommodate the monitoring of additional resources.

The NIST Biorepository also monitors room conditions, including ambient temperature, percent relative humidity and percent oxygen in four (4) locations throughout the NIST Charleston facility. The laboratories of the NIST Biorepository are ISO certified Class 5, 6, and 7 clean rooms and specific temperature and humidity criteria must be monitored and maintained. As the majority of sample processing and storage activities are conducted under cryogenic conditions, using liquid nitrogen as the cryogen, in order to maintain a safe work environment, oxygen monitors are placed throughout the clean room area to monitor the percent oxygen in the NIST Biorepository and when in alarm, an audible and visual alarm engages.

The current EMS is outdated, difficult to service, and contains pieces that are no longer serviceable. The existing EMS cannot be updated to meet the current requirements and must be replaced in its entirety.

II. SCOPE

NIST requires an EMS that will provide reliable monitoring with LCD display dataloggers and user input at the point of source in a cloud-based system accessible outside of the secure NIST network around the clock and through an alarm notification system be able to rapidly alert NIST personnel that an alarm condition exists in time to salvage the samples. The system shall include the monitoring of ambient temperature, percent relative humidity, and percent oxygen in all four (4) rooms of the NIST Biorepository. The system shall accommodate sensors with integrated calibration information that is NIST-traceable which will allow users in the NIST Biorepository to quickly change http://www.nist.gov/ http://www.nist.gov/ http://www.nist.gov/mml/index.cfm probes in case of failure or for future calibrations and validations.

The required equipment will be used to monitor two (2) temperature points and one (1) dry contact port for 28 liquid-nitrogen vapor-phase freezers (LN2), one

(1) temperature point for 13 mechanical upright -80°C freezers (-80°C MF), 2 Vario vapor-phase (-80 °C) Freezers, 1 cryogenic workspace (cryocart) + 1 oxygen sensor (O2 sensor) and 1 ambient temperature and relative humidity (T°C/RH%) in each of the four (4) rooms. This equipment is critical to maintaining the integrity of samples stored for long-term and real-time analysis.

III. REQUIREMENTS

The Contractor shall provide the following OCEASOFT (A Dickson Co.) brand or equal OCEAView Environmental Monitoring System, OCEACloud Software Subscription, OCEAlert Notification Subscription, Installation, Training, and Warranty meeting the minimum requirements defined below:

• Each oxygen sensor shall produce an audible and visual alarm when the percent oxygen falls outside of the user specified alarm limits

• The system shall be compatible with integrated smart temperature probes that come pre-calibrated to NIST-traceable standard ISO 17025 for plug-n-play use

• The system shall be expandable to allow up to 250 measurement points without upgrading the subscriptions or maintenance support contract

• The system shall be wireless capable with single receivers capable of a range of more than 250m to cover the equipment monitored by the NIST Biorepository without the use of wireless relays or extra devices

• Dataloggers at the point of source shall have LCD touchscreen color displays of at least 2.4 inches that allow set-up and alarm acknowledgements

• Internal memory of the dataloggers shall be capable of holding at minimum 4,000-8,000 readings with replaceable batteries and AC adapter capable

• Each datalogger shall accommodate two (2) pre-calibrated smart temperature probes and one (1) dry contact port each to reduce the amount of hardware necessary on the freezers

Table 1 specifies how many temperature probes per piece of equipment are required, the location and model of the current equipment and if the equipment is located in an ISO certified clean room. Where more than one temperature probe is specified in Table 1, the equipment has separate compartments requiring independent temperature monitoring. For these types of equipment, the Contractor shall install one temperature probe into each compartment so that each probe operates independently. A layout of the laboratories where the equipment resides and the relative position of each piece of equipment in the laboratories is included as

Appendix A, Laboratory Layout and Schematic. For reference, the number listed under the “Map Code” column on Table 1 corresponds to the numbers written on Appendix A denoting the location for that specific piece of equipment.

• The system shall be able to monitor the temperature of liquid nitrogen (LN2) vapor-phase freezers (-100 °C to -200 °C), ultralow freezers (-80 °C), and room conditions (ambient temperature, percent relative humidity, percent oxygen).

a. For each LN2 freezer:

i. Point 1 to measure bottom of LN2 freezer temperatures

(range between -100 °C and -200 °C)

ii. Point 2 to measure top of LN2 freezer temperatures (range between -70 °C and -200 °C)

iii. Point 3 is a dry contact that is connected to the freezer’s monitoring system and will alarm if the freezer controller goes into alarm

b. For each -80 °C Freezer:

i. Point 1 to measure freezer temperature (range between -100

°C and +10°C)

c. For each oxygen sensor: measures percent oxygen with a 4-20mA connection

d. For each room temperature: measure temperature (range between

50 °F and 120 °F)

e. For each room humidity: measure percent relative humidity (range between 0% - 100%)

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

• The system shall include cloud-based software that meets or exceeds 21 CFR Part 11

• The system shall be capable of allowing a user to log into the cloud-based software system with a username and password 24/7 to obtain current information on each probe

• The software shall accommodate unlimited users and up to 250 sensors

• The software shall be capable of cloud-based API data connectivity to allow for the use of 3rd party applications

• The software shall allow for the data reporting via SQL server to export in multiple file formats, including Excel, 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 system shall have user programable voice tags associated with each monitoring probe and when the notification system is prompted be able to specifically identify the name of the probe that is alarming and provide the condition (i.e., temperature, percent oxygen or percent relative humidity) of the probe

• The alarm notification system shall be programmable by NIST to phone specified users based on the individual input 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 answering machine.

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

Table 1. Number of Probes and Dry Contact Sensors, Locations, Map Code (Appendix A. Map 1), and Model of Equipment to be Monitored.

Map Code

Lab Name/Number Floor Temperature deg C Probes Dry

Contact Model/NIST Name In a Clean Room

WF1 Specimen Bank/C105

Liquid nitrogen freezer (-90 to - 190)

1 MVE Working Freezer #1

Yes

WF2 Specimen Bank/C105 1

Liquid nitrogen freezer (-90 to -

MVE Working Freezer #2

Yes

CC CryoCart/C103 1 Liquid nitrogen cart (-90 to -190) 1

MVE Cryocart Yes

A Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - A Yes

B Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

Abeyance - B Yes

C Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - C Yes

D Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - D Yes

E Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - E Yes

F Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - F Yes

G Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - G Yes

H Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - H Yes

I Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - I Yes

J Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - J Yes

K Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - K Yes

L Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - L Yes

M Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - M Yes

N Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE -N Yes

O Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - O Yes

P Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - P Yes

Q Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - Q Yes

R Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - R Yes

S Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - S Yes

T Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - T Yes

U Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - U Yes

V Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - V Yes

W Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - W Yes

X Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

MVE - X Yes

Y Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to -

Abeyance – Y Yes

Z Specimen Bank/D104

1 Liquid nitrogen freezer (-90 to - 190)

1 Empty - Z Yes

V1 Specimen Bank/D104

1 Vario Freezer (-

80) 1 0 MVE – Vario #1 Yes

V2 Specimen Bank/D104

1 Vario Freezer (-

80) 1 0 MVE – Vario #2 Yes

4 Specimen Bank/D104

1 Freezer (-80) 1 0 Thermo – 4 Yes

5 Specimen Bank/D104

1 Freezer (-80) 1 0 Thermo – 5 Yes

6 Specimen Bank/D104

1 Freezer (-80) 1 0 Empty – 6 Yes

7 Specimen Bank/D104

1 Freezer (-80) 1 0 Thermo – 7 Yes

8 Specimen Bank/D104 1 Freezer (-80) 1 0 Thermo – 8 Yes

9 Specimen Bank/D104 1 Freezer (-80) 1 0 Panasonic – 9 Yes

10 Specimen Bank/D104 1 Freezer (-80) 1 0 Thermo – 10 Yes

11 Specimen Bank/D104 1 Freezer (-80) 1 0 Thermo – 11 Yes

12 Specimen Bank/D104 1 Freezer (-80) 1 0 Thermo – 12 Yes

IO-1 Inorganic/C20 3 2 Freezer (-80) 1 0 Thermo – Inorganic No

O-1 Organic/C205 2 Freezer (-80) 1 0 Thermo –Organic #1

No

O-2 Organic/C205 2 Freezer (-80) 1 0 Thermo –Organic #2

No

O-3 Organic/D202 2 Freezer (-80) 1 0 Thermo –Organic #3

No

OX-1 Specimen Bank/C103

1 Percent oxygen 1 0 Yes

OX-2 Specimen Bank/C104

1 Percent oxygen 1 0 Yes

OX-3 Specimen Bank/C105

1 Percent oxygen 1 0 Yes

OX-4 Specimen Bank/D104

1 Percent oxygen 1 0 Yes

T-1 Specimen Bank/C103 1

Room Temperature 1

0 Yes

T-2 Specimen Bank/C104 1

Room Temperature 1

0 Yes

T-3 Specimen Bank/C105 1

Room Temperature 1

0 Yes

T-4 Specimen Bank/D104

1 Room Temperature 1 0 Yes

H-1 Specimen Bank/C103

1 Percent Humidity

1 0 Yes

H-2 Specimen Bank/C104

1 Percent Humidity 1 0 Yes

H-3 Specimen Bank/C105

1 Percent Humidity 1 0 Yes

H-4 Specimen Bank/D104 1

Percent Humidity 1

0 Yes

Office/C106

Current monitoring system hardware location

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

System Planning and Review Meetings

The Contractor shall attend, in person, a system planning meeting not later than ten (10) business days ARO to draft the installation schematic showing the location of the probes, transmitters, and receivers for NIST review and produce a list of contractor personnel that will be installing the equipment and conducting the system qualifications and training. During the meeting, the Contractor, the NIST Technical Point of Contact (TPoC), and NIST IT Personnel will review the installation schematic and may make recommendations for the final placement of probes, transmitters and receivers. The TPoC 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 any NIST TPoC recommendations given, and submit a final installation schematic for review and acceptance by the NIST TPoC and establish a schedule for delivery, installation and training. NIST will move all equipment as required and will work in coordination with the Contractor to remove the current EMS.

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; Telephone support shall 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 Charleston 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 TPoC with a system Operational Qualification (OQ) report which clearly documents that the system is fully operational, all probes are reporting the correct temperatures, percent relative humidity or percent oxygen, 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 Biorepository 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.

Installation and Testing

The system, including the receivers, software, and all probes, shall be installed by the Contractor’s authorized personnel. Installation, at a minimum, shall include unpackaging of all equipment, setup and hook-up 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 the clean room 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 temperature probe inputs are calibrated, securely installed, and working correctly. The Contractor shall provide a system Operational Qualification (OQ) report on the results. The Contractor shall determine the temperature of the freezer using probes that have been calibrated using a NIST traceable temperature device and then ensure that the probe is reporting the correct temperature to the monitoring system. NIST Traceable Temperature devices are widely available in the commercial marketplace and the Contractor is responsible for providing their own device for use during probe calibration. The Contractor shall include the brand, make and model of the temperature device used to calibrate the probes in the system Operational Qualification (OQ) report.

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:

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

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

3. 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

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

The system Operational Qualification (OQ) report must provide documentation that shows that the probes are reporting the correct temperatures, percent (%) oxygen and percent (%) relative humidity, temperature, oxygen and humidity probes are correctly calibrated, and the alarm notification system is functioning correctly. This includes the connection to the existing audio/visual alarm via standard audio/visual stereo cables throughout the NIST Biorepository. 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. Acceptance of the system shall not occur if the Operational Qualification (OQ) report notes any defects or performance deficiencies.

Installation and testing shall be performed by the Contractor concurrently and be completed not later than 10 business days after delivery of the EMS.

On-Site Training

The Contractor shall schedule and facilitate one (1) advanced user training session of a minimum of three (3) days for up to ten (1) users at the NIST Charleston 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.

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 up to 250 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.

IV. PERIOD OF PERFORMANCE

Delivery, installation, acceptance testing, and training shall occur not later than 70 days ARO.

V. PLACE OF PERFORMANCE

Delivery, installation, testing, training and warranty services on the system shall occur at NIST, Charleston, SC. Normal duty hours are M-F 8:30AM to 5:00PM ET with the exception of Federal holidays.

VI. DELIVERY

Delivery shall be FOB Destination and shall occur NLT 60 calendar days ARO.

FOB 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 purchase order; and pay all charges to the specified point of delivery. The

Contractor shall deliver to:

National Institute of Standards and Technology Hollings Marine Laboratory ATTN: Jennifer Ness 331 Ft. Johnson Rd.

Charleston, SC 29412

VII. DELIVERABLES

Description Due Date

Draft and Final Installation Schematic and Contractor Personnel List

10 business days ARO

Equipment, Operations Manuals, and Maintenance Manuals

NLT 60 calendar days

ARO

Installation/Testing + Advanced Operations and Maintenance Training Session

NLT 10 business days after delivery of the equipment

OQ Report for System Immediately after installation of equipment

VIII. ACCEPTANCE CRITERIA AND PAYMENT

After installation of the EMS, the Contractor shall demonstrate to the TPoC that all minimum required specifications have been achieved. The demonstration of specifications may occur before or during training.

Final acceptance of the EMS by the Government will be granted after delivery, installation, testing, receipt of Operational Qualification (OQ) report, demonstration of system specifications and advanced training session have successfully concluded.

Advance payment is not authorized. Partial payment is not authorized. The Contractor will be paid in one lump sum upon successful completion of all requirements.

IX. GENERAL

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

ISO Certified Clean Room: Ninety (90) percent of the equipment to be monitored by the EMS resides in ISO Certified Class 5 and 7 Clean Rooms. The Contractor must attend a Cleanroom Policy and Procedures training of approximately 20 minutes given by NIST personnel at the Hollings Marine Laboratory prior to entry into the clean room area and comply with the NIST policies and procedures.

Security: The Hollings Marine Laboratory is a restricted building. An identification badge is required for access for entry into the building and a NIST employee must escort the Contractor throughout the building during the installation and validation.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor employee is responsible for absences due to expired identification and access documents.

Each Contractor employee shall wear a visible ‘visitor’ badge provided by the NOAA front desk. The Contractor employee shall turn in the NOAA visitor badge to the TPoC upon completion of any services rendered.

NIST VISITOR AND CONTRACTOR PROTOCOLS FOR MITIGATING COVID-19

EXPOSURE:

For onsite installation and training, the Contractor shall review and adhere to the directive: NIST Visitor and Contractor Protocols for Mitigating COVID-19 Exposure on NIST Campuses.

Any individual coming onto campus must conduct a personal health screening by reviewing the COVID-19 Screening Questionnaire. This self-screening must be performed every day an individual wants to access a NIST campus. Anyone answering “Yes” to any question should immediately contact their sponsor and not attempt to access the campus.

The directive and questionnaire are available to view at:

https://www.nist.gov/about-nist/visit/nist-visitor-and-contractor-protocols-mitigating-covid-19-exposure-nist-campuses

The directive and questionnaire are subject to change and should be monitored by the Contractor via the NIST website: https://www.nist.gov https://www.nist.gov/about-nist/visit/nist-visitor-and-contractor-protocols-mitigating-covid-19-exposure-nist-campuses https://www.nist.gov/about-nist/visit/nist-visitor-and-contractor-protocols-mitigating-covid-19-exposure-nist-campuses https://www.nist.gov/

Appendix A. Map 1. Laboratory Layout and Schematic