SOW_ Draft.docx

Statement of Work

Calibration and Technical Support Services for SEAHAFL Temperature Monitoring Sensors

Background According to the ISO/IEC 17025 accreditation standard, Seattle Human and Animal Food Laboratory (SEAHAFL) is required to engage in, at minimum, daily monitoring of temperature- dependent equipment, such as refrigerators, freezers, and incubators, used to store regulatory samples and/or used as part of the regulatory sample analysis. In order to comply with this requirement and to have a greater capability to respond to temperature related equipment failure, SEAHAFL purchased and installed in 2018 a proprietary temperature monitoring system that provides continuous temperature data in real time. This proprietary system includes VPx sensors to continuously monitor temperature-dependent equipment as well as DataTrace and MPRF sensors used to qualify the equipment through temperature distribution mapping study. This system frees FDA laboratory personnel of the burden of manually checking thermometers multiple times daily. It also allows for a much faster diagnosis of problems than is possible with manual temperature readings. Adverse temperature changes which might go unnoticed for a day, holiday, or over a weekend are alerted to multiple personnel through email and government smartphones.

The original equipment manufacturer (OEM), Mesa Laboratories, of the VPx, DataTrace and MPRF sensors require the sensors be calibrated on an annual basis. The VPx sensors connect through wireless access points to a government-owned computer server that collects, trends, and monitors the temperature readings and is accessible 24/7 for FDA personnel to review on FDA issued laptops. This computer server also sends notifications through email and phone text messages of sensor temperature readings that exceed either the upper or lower temperature limits for each equipment.

The calibration of the sensors as well as providing technical support of the patented technology on both the hardware and software require special qualifications and training to meet the original equipment manufacturer’s (OEM) specifications. These qualifications and trainings can only be obtained from the OEM.

Objective To provide calibration and technical support services for Mesa Labs’ proprietary, patented, and SEAHAFL-owned VPx and DataTrace sensors that meets or exceeds the OEM’s specifications by OEM trained and qualified technicians.

Scope Vendor shall calibrate SEAHAFL’s 92 VPx sensors, 20 DataTrace MPIII sensors, and 5 MPRF sensors on an annual basis and provide documentation of such calibration as specified in the requirements of this statement of work. The vendor shall use OEM qualified and trained technicians to calibrate each sensor and if required, to repair sensors that do not meet OEM specifications. The vendor shall also provide 24/7 technical support over a period of one-year by OEM trained and qualified technical support personnel to support SEAHAFL’s VPx sensors and wireless access points (WAPs).

Task Requirements

1. Vendor shall schedule and calibrate PNL’s 92 VPx sensors on-site at SEAHAFL on or before December 31st of each calendar year as the sensors cannot be taken offline beyond 24-hours for calibration service. The calibrated VPx sensors shall meet or exceed OEM specifications and requirements.

2. 10 DataTrace MPIII sensors shall be sent to Mesa Labs in Lakewood, Colorado sequentially (10 at a time) on or before April 15th for calibration service so that SEAHAFL does not lose temperature distribution mapping capability at any given period of time. 10 DataTrace sensors are expected to be returned to SEAHAFL no later than 3 weeks after receipt. All return shipping cost shall be included in the awarded contract. The calibrated DataTrace sensors shall meet or exceed OEM specifications and requirements.

3. 5 MPRF sensors shall be sent to Mesa Labs in Lakewood, Colorado during the contract performance period for calibration. The calibrated MPRF sensors shall be returned no later than 3 weeks after receipt and meet or exceed OEM specifications and requirements. All return shipping cost shall be included in the awarded contract.

4. Each DataTrace, MPRF and VPx sensor shall be calibrated once per calendar year.

5. After calibration, the DataTrace, MPRF and VPx sensors shall meet or exceed the manufacturer’s published specifications for at a minimum of one calendar year. Vendor shall include statements in the Certificate of Calibration to state the following:

a. Calibration results “As received” and “After calibration” for each calibrated sensor probe.

b. Serial number of the calibrated sensor probe.

c. Date when the next calibration is due.

d. DataTrace, MPRF and VPx sensor calibration results were obtained using equipment capable of producing results that are traceable through NIST to the International System of Units (SI)

e. DataTrace, MPRF and VPx sensor calibration results are in compliance with ISO/IEC17025 requirements.

f. DataTrace, MPRF and VPx sensor calibration process has a Test Uncertainty Ratio of 4:1 or greater.

g. DataTrace, MPRF and VPx sensor calibration data acquisition software has been validated and complies with Title 21, Code of Federal Regulations Part 11 requirements for electronic records, if applicable.

6. If needed, DataTrace, MPRF and VPx sensors found to be out-of-specifications or broken at time of calibration shall be repaired or replaced such that the sensor meets OEM specifications prior to returning the sensors to SEAHAFL.

7. Vendor shall provide a signed and dated Certificate of Calibration for each sensor submitted for calibration.

8. Vendor shall provide 178 AA 3.6V batteries for the VPx sensors (2 AA 3.6V batteries per sensor) and replace any AA 3.6V batteries in each VPx sensor as needed. Any unused AA 3.6V batteries shall be turned over to SEAHAFL POC at the end of the calibration service.

9. The technician performing calibration services shall be OEM qualified and trained technicians. Documentation of such training and qualification by the OEM shall be furnished for inspection by FDA upon request.

10. Technical support for VPx sensors and WAPs to include 24/7 phone support covering replacement parts for manufacturing defects.

11. Technical support personnel shall be OEM trained and qualified to provide such support. Documentation of such training and qualification by the OEM shall be furnished for inspection by FDA upon request.

12. Vendor shall, upon FDA request and approval, update and/or upgrade the ViewPoint software at minimum twice per year. All software updates/upgrades shall be documented in a field service report and provided to SEAHAFL no later than 5-business days after such work. All software and license installed on government-owned server shall be the property of the government in perpetuity.

13. Vendor shall, upon FDA request and approval, update the sensor firmware. All firmware updates shall be documented in the field service report and provided to SEAHAFL no later than 5-business days after such work. All firmware updates installed on government-owned sensors shall be the property of the government in perpetuity.

Deliverables, Delivery and Place of Performance

April 30th

April 30th

Upon completion of the calibration service, vendor shall provide to the SEAHAFL POC a signed and dated certificate of calibration for each sensor submitted for calibration to include the above listed Requirements section upon either completion of such calibration services or within 5- business days after completing such calibration services.

Calibration of the VPx sensors shall take place at the below government site. Calibration of the DataTrace and MPRF sensors shall take place at an OEM specified location and the calibrated sensors shall be delivered to the below government site.

Vendor shall provide technical support services through phone, on-site, or remote videoconference 365/24/7 to include hardware, software and network technologies, and priority technical support in system-down incidents.

Government-Furnished Equipment and Government-Furnished Information PNL shall provide the vendor with access to or deliver the following Government-Furnished Equipment: 92 VPx sensors, 20 DataTrace MPIII sensors, 5 MPRF sensors and 7 Wireless Access Points as specified in the above Task Requirements section for calibration services or for troubleshooting, repair, or replacement, if warranted. If the vendor determines any of the listed government-furnished equipment requires replacement in part or in whole due to manufacturing defect or recall, the vendor shall provide a suitable replacement that meets or exceeds the performance characteristics of the government-owned equipment for purchase or free of charge. The replacement shall be able to connect, communicate, and perform under OEM specifications on the government-furnished computer server and computer program (ViewPoint System) to store and monitor the temperature and relative humidity of the government-owned equipment.

However, if the Government-Furnished Equipment was working prior to the vendor performing any services or other acts on such equipment and during the course of the vendor’s actions, the equipment malfunctions or stops working, it shall be the vendor’s responsibility to repair or replace such equipment at the vendor’s expense.

Security When vendor representatives arrive on site to deliver / install equipment, they will need to provide proper U.S. photo identification to check-in with the Federal Protective Service (FPS) Security Guards in order to enter the building. The vendor representatives will receive an “Escort Required” temporary badge, which must be worn at all times in the building and will remain escorted by lab personnel during their visit. If vendors need to enter into the laboratory, safety glasses must be worn. When their work is complete, the vendor representatives will provide the lab personnel a work order or service report detailing the work performed. The vendor representatives will check-out with the same FPS Security Guards, turning in their temporary badge. Tobacco, of any form, e-cigarettes, firearms and any weapons are not permitted on Federal Property, in Federal Buildings or parking lots.

Travel The vendor shall schedule and send one technician that has been trained and certified by the OEM to SEAHAFL to calibrate the 92 VPx sensors. The vendor shall be responsible for all aspects of travel cost and accommodation of the technician they send to SEAHAFL.

Place of Performance Calibration of the DataTrace MPIII and MPRF sensors shall take place at the vendor’s specified location.

Calibration of the VPx sensors shall take place at the below government location: US Food & Drug Administration Seattle Human and Animal Food Laboratory 22201 23rd Drive SE Bothell, WA 98021

POC: To be identified at time of award.

Vendor must contact Peter Chow at 425-487-5306 or the Contract Officer’s Representative (COR) at a minimum of 3-business days prior to arrival to conduct calibration services.

Delivery must be during regular business hours (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding holidays as follows:

New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Period of Performance The period of performance begins the date of contract award execution. The base period of the contract will be 1 year from the date of formal Government acceptance of the instrument(s). The contract also contains four, one-year option periods that the Government may exercise unilaterally.

Option periods are for the period of one year each. If exercised, the options may extend the length of the contract by four additional years for a total of five years.

If exercised, the contract period of performance for option years are to be identified in each modification that exercises the respective option(s). The aforementioned period of performance terms for the options shall extend the performance period of the contract if the Government exercises the option(s) in accordance with FAR 52.217-9.

The anticipated performance period for the contract is as follows:

The calibration of the VPx sensors shall occur on or before December 31st of each calendar year.

The calibration of the DataTrace sensors shall occur on or before April 30th of each calendar year. The calibration of the first 10 of 20 DataTrace sensors shall occur on or before April 15th.

The 365/24/7 technical support for the VPx sensors, DataTrace and MPRF sensors, and Wireless Access Points shall begin on the date of contract award execution.