A-2 RAPID DNA SoR v4.pdf

STATEMENT OF REQUIREMENTS (SoR)

Rapid DNA Platform

I. BACKGROUND

The Applied Genetics Group (AGG) in the Biomolecular Measurement Division (BMD) of the Materials Measurement Laboratory (MML) at the National Institute of Standards and Technology (NIST) conducts research to support the forensic human identification and clinical genetics communities. A key aspect of this research is the ability to conduct interlaboratory studies for emerging and current technologies within the forensic DNA community. The AGG has been involved in the testing, validation, and the performing of interlaboratory comparison studies with Rapid DNA technologies since 2012.

The AGG has plans to organize and run several interlaboratory comparison studies using rapid DNA technologies and the purchase of a RapidHIT ID would allow for internal quality control of samples to be sent to participants. In the past, NIST has relied on outside agencies to do confirmatory testing of interlaboratory samples. Having the RapidHIT ID at NIST will allow for orthogonal measurements to be made using traditional benchtop technologies already validated and in place at NIST. This would allow for confirmational testing of the RapidHIT ID results with conventional measurement capabilities. The RapidHIT ID integrates several benchtop technologies (extraction, amplification, separation, and interpretation) into one instrument, eliminating the need for three benchtop instruments (extraction robot, thermal cycler, capillary electrophoresis instrument) and analysis software. The chemistry used on the RapidHIT ID (GlobalFiler Express) is also commercially marketed for benchtop sample processing which will allow for concordance testing to be provided between the RapidHIT ID and conventional laboratory measurement capabilities and will allow for confirmation testing of the RapidHIT ID results with conventional measurement capabilities.

For prior interlaboratory studies, NIST has had to rely on outside agencies to perform the RapidHIT ID confirmation testing for comparison to conventional laboratory methods. Acquiring the RapidHIT ID will accommodate all testing and confirmation to be conducted at NIST. Furthermore, acquiring the RapidHIT ID would add to the capabilities of NIST and the AGG to test, evaluate, and validate emerging technologies within the forensic DNA community with capabilities of confirmation testing using conventional laboratory methods previously validated in our laboratory.

II. SCOPE

The Contractor shall provide an automated system capable of generating a high quality short tandem repeat (STR) profile in less than two hours through the integration of all DNA typing processes (extraction, amplification, separation, detection, and interpretation) and necessary software to review data and make comparisons to existing confirmation data. An automated system is defined as a sample in DNA profile out system that integrates extraction, amplification, separation, detection, and interpretation without analyst intervention.

III. REQUIREMENTS

The Contractor shall provide one (1) RapidHIT ID Rapid DNA Platform System that meets the following technical requirements:

System:

• Must be a benchtop Rapid DNA instrument

• Includes laptop computer for data analysis and review and associated

RapidLINK software

• Must be able to produce a DNA profile in less than two hours with less than ten minutes of hands-on interaction

• Must have no less than six fluorescent dye channel capabilities

• Instrument software shall allow for comparison to onboard databases for staff elimination (e.g., for external profiles to be uploaded into a database for contamination monitoring)

• DNA profiles generated shall be compatible and comparable with commercial chemistries currently employed in the AGG for genotyping (e.g., GlobalFiler Express)

• DNA profiles generated must contain the FBI required 20-core CODIS loci

• Must have an internal refrigeration mechanism

• Should have an ability for facial recognition and a barcode camera for operation

• Should have the ability of consumable tracking through RFID technology

• Should allow walk-away operation with minimal user training

• includes cartridges capable of generating DNA profiles from reference samples and low-level DNA samples (i.e., casework samples) and the primary cartridge

• Includes an operations and maintenance manual supplied in hardcopy or electronic format (or both) that covers proper operation, routine maintenance, and basic troubleshooting for the instrument and software

Installation:

The Contractor shall install the instrument in Building 227, Room B223, at NIST’s Gaithersburg, MD facility. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and assembly, hook-up of all equipment, software installation, start-up, demonstration of all required specifications, and removal of all trash.

Contractor authorized personnel shall install the instrument and perform all activities necessary to ensure the instrument is fully functional and meets all required minimum specifications.

The instrument shall operate to OEM specifications upon completion of installation.

The installation shall occur during regular business hours, between 8:30AM and 5:00PM ET M-F except for Federal Holidays and shall be coordinated with the NIST Technical Point of Contact (TPoC). Installation is to occur within 90 days of award.

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the system.

The warranty shall cover all parts, labor, and travel. The warranty shall commence upon successful completion of delivery, installation, inspection, training, and demonstration of all required specifications.

Training:

The Contractor shall conduct training at NIST’s Gaithersburg, MD facility for up to 2 NIST personnel covering normal operation, basic troubleshooting, and routine maintenance procedures. Training shall be provided during regular business hours, between 8:30AM and 5:00PM ET M-F except Federal Holidays and shall be coordinated with the NIST Technical Point of Contact (TPoC) to ensure maximum availability of NIST personnel. Training may be mutually scheduled to occur within 10 days of installation. Alternatively, training may be conducted on-site at NIST’s Gaithersburg, MD facility immediately after installation and demonstration of specifications.

IV. SERVICE PLAN

Option Yr. 1: beginning the day following expiration of the 1-yr. warranty through 365 days

Option Yr. 2: beginning the day following expiration of Option Yr. 1 through 365 days

Option Yr. 3: beginning the day following expiration of Option Yr. 2 through 365 days

Option Yr. 4: beginning the day following expiration of Option Yr. 3 through 365 days

The Contractor shall the AB Assurance Premium Service Plan covering unlimited repair and maintenance incidents with 2-day on-site response time for the RapidHIT ID system; to include factory-certified repl. parts, engineer labor, travel, (1) planned maintenance (PM) visit, and update service for instrument software and firmware.

The Contractor shall not be responsible for PC service. The Government will be responsible to obtain PC service. However, if PC service does occur, re-installation of the RapidHIT ID provided software and PC re-configuration shall be covered by the AB Assurance Premium Service Plan.

Planned Maintenance (PM)

The Contractor shall provide one (1) planned maintenance (PM) visit during the term of the AB Assurance Premium Service Plan. The PM shall include replacing and/or cleaning all necessary parts in order for the instrument to meet the Original Equipment Manufacturers (OEM) specifications.

Scheduling of the PM shall be consistent with the maintenance requirements of the instrument as detailed in the operations and maintenance manual for the instrument and in accordance with the most recent service practices and maintenance protocols.

The PM shall occur during regular business hours of 8:30AM-5:00PM ET M-F, excluding Federal holidays. The Contractor shall contact the NIST TPoC to schedule a mutually acceptable date and time to conduct the PM. The scheduled PM may be performed in conjunction with an unscheduled or emergency service visit for corrective or other action if such a visit occurs within one (1) month before a scheduled PM. The visit shall be scheduled in advance with the NIST TPoC or designated representative.

Service Calls

The Contractor shall respond to an unlimited number of on-site requests for service calls in the event of instrument failure(s), which may require immediate repair. The Contractor shall make a reasonable effort to respond to a service call request and schedule the on-site visit within a targeted 48-hr. timeline. The Contractor shall provide travel, per diem, labor, and OEM factory-certified parts that require replacement. Due to timelines associated with clearance of non- U.S. citizens, personnel performing repairs must be U.S. citizens.

All repairs must result in the RapidHIT ID system meeting OEM specifications.

The Contractor shall conduct service calls during regular business hours M-F only. The Contractor’s service technician/engineer shall exert his/her best effort to provide on-site service at NIST’s Gaithersburg, MD facility not later than two

(2) business days from the date and time a performance issue is diagnosed, and a determination is made by a technical support engineer that the resolution will be conducting an on-site service call.

No weekend service visits shall be required. If the Contractor is unable to resolve the problem during the on-site service call, the Contractor shall provide telephone and on-site support thereafter, as needed, to expedite a resolution for

NIST. Telephone support shall occur during the Contractor’s regular business hours.

The Contractor shall obtain all parts and software/firmware updates required for all repairs and maintenance. The Contractor shall make a commercially reasonable effort to secure parts and software/firmware updates within 72-hrs.

after identifying the need.

Replacement parts provided under the AB Assurance Premium Service Plan shall be OEM certified and may be either new or remanufactured. The Contractor may exchange and/or repair existing components of the system.

Prior to completion of the service call, the Contractor shall test the RapidHIT ID system, review the RapidHIT ID system’s performance, and take whatever additional corrective action is necessary to ensure the RapidHIT ID system is functioning in accordance with the OEM specifications.

All labor and OEM replacement parts/components (excluding consumables) provided by the Contractor shall be guaranteed for a period of ninety (90) days from the service visit completion date.

Any parts or components removed for replacement will become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the NIST campus at the time of the service call or provide shipping instructions and return shipping information so that NIST may return the parts to the Contractor within three (3) days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

Service Conditions

All service provided hereunder shall be provided by factory trained and certified personnel who are fluent in the operation of the covered RapidHIT ID system.

All parts shall be approved for use with the RapidHIT ID system by the OEM. The Contractor shall only employ tools, equipment, instruments, software, test apparatus, methodologies, techniques, and practices approved for use with the RapidHIT ID system by the OEM. The service protocols and equipment specifications shall be adhered to at all times.

The AB Assurance Premium Service Plan shall include correcting, repairing and/or replacing, as applicable, a non-conforming or defective RapidHIT ID system product/component, as determined by the Contractor at its sole discretion.

To the maximum extent practicable, service shall be rendered on-site at the

NIST Gaithersburg, MD campus.

In the event that a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping and transportation costs. The Contractor shall assume all charges and liability for shipments to and from NIST Gaithersburg, MD. Prior to shipment, the Contractor shall be responsible for providing NIST with packaging instructions, a shipping account number, and a Return Authorization Number authorizing return of the part(s).

Service Ticket

The Contractor shall submit a service ticket to the NIST TPoC prior to departure from NIST for all maintenance and/or repair service calls. The service ticket must include the following:

a. Model number

b. Serial number

c. Date and time of arrival to NIST

d. Description of service performed

e. Name and quantity of any parts that were repaired

f. Name and quantity of any parts that were replaced

g. Date and time of departure from NIST

h. Diagnostic test results or narrative summary demonstrating that the instrument is meeting OEM specifications

i. Any comments or recommendations

j. Printed name and signature of service technician/engineer

k. Signature block for the NIST TPOC accepting the services rendered

Priority Technical Telephone Support

The Contractor shall provide telephone support during normal business hours M-F, 8:30AM to 5PM EST except for Federal holidays.

Telephone support shall include responses to questions about operating practices, applications use, and service issues that can be diagnosed and resolved over the telephone.

V. DELIVERY

Delivery shall be FOB Destination (or equivalent terms, such as INCOTERMS Delivered Duties Paid) and shall occur not later than (NLT) 60 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 100 Bureau Drive Building 301, Shipping and Receiving Gaithersburg, MD 20899

VI. GOVERNMENT-FURNISHED PROPERTY, DATA AND/OR INFORMATION

The Government will provide access to the NIST facility for the purpose of instrument installation, training and PM + on-site service calls associated with the AB Assurance Premium Service Plan.

VII. PLACE OF PERFORMANCE

Installation of the instrument, training, PMs and service incidents shall be accomplished at the NIST, Gaithersburg, MD facility. Normal duty hours are M-F 8:30AM to 5:00PM except for Federal holidays.

VIII. DELIVERABLES

Description Quantity Due Date

RapidHIT ID Rapid DNA Platform System

One (1) NLT 60 calendar days

ARO

RapidLINK SW License One (1) NLT 60 calendar days

ARO

ACE GFE 50 Sample Kit One (1) NLT 60 calendar days

ARO

Primary Cartridge GFE 100 Kit One (1) NLT 60 calendar days

ARO

Laptop System + Power Cords One (1) NLT 60 calendar days

ARO

RapidINTEL Sample Cartridge 50 Kit

One (1) NLT 60 calendar days

ARO

Operations and Maintenance Manual

One (1) NLT 60 calendar days

ARO

On-Site Installation Once NLT 30 calendar days after delivery

On-Site Training Once NLT 10 calendar days after installation

IX. ACCEPTANCE CRITERIA

In addition to the inspection and acceptance terms articulated in FAR 52.212-4, a visual inspection of the instrument will be performed by the NIST TPoC to identify surface defects or any form of indication that the instrument was damaged during transport to NIST. The Government shall have the sole discretion to require repair or replacement of damaged and/or nonconforming componentry at no cost to the Government. The Government at any time prior to acceptance may reject the instrument due to defects and/or nonconformance.

To verify the system conforms to all technical requirements, during installation, the Contractor shall run test samples for the purpose of confirming the RapidHIT ID system is fully operational. NIST staff will remain present during these testing protocols to observe results. System acceptance is contingent on the outcome.

Final acceptance by the Government shall be granted after confirmation that the instrument meets all minimum required specifications defined in the SoR, including satisfactory test results achieved, installation and training successfully completed. The warranty shall not commence until final acceptance has been granted by the Government.

X. PAYMENT

The Contractor shall invoice in one lump sum after all required items and services (i.e., installation and training) have been accepted by the Government.

Partial payments are not authorized. Advanced payments are not authorized.

For the AB Assurance Premium Service Plan, the Contractor shall invoice quarterly, in arrears. Advanced payments are not authorized.

XI. GENERAL INFORMATION

Safety: The Contractor 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.

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

Identification Badges: The Contractor 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 TPoC prior to arrival. The TPoC will submit the name(s) and citizenship information to the NIST Office of Security in order 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. The Contractor employee shall surrender the NIST identification badge to the TPoC upon conclusion 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/