SOW-Tecan- FOR VSDB IPB.pdf

Statement of Work

Title: ID Maintenance Service Contract for Tecan Instruments

Period of performance of this contract is: September 1, 2024 – August 31, 2029

Base Period: September 1, 2024 – August 31, 2025

Option Period One: September 1, 2025 – August 31, 2026

Option Period Two: September 1, 2026 – August 31, 2027

Option Period Three: September 1, 2027 – August 31, 2028

Option Period Four: September 1, 2028 – August 31, 2029

SECTION 1 – BACKGROUND

The Influenza Division (ID) of the National Center for Immunization and Respiratory Diseases

(NCIRD), Centers for Disease Control and Prevention (CDC) is a World Health Organization

(WHO) Collaborating Centre for Reference and Research on Influenza at CDC and is part of the

WHO Global Influenza Surveillance Network (GISN). The network was established in 1947 to monitor the frequent changes in influenza viruses with the aim of reducing the impact of influenza through the use of vaccines containing currently circulating strains. Together with the

WHO Collaborating Centers in Beijing, London, Melbourne, and Tokyo, the Influenza Division is responsible for antigenically characterizing influenza viruses that are currently circulating in the human population in different countries around the world. This information is used by the

WHO to make recommendations on appropriate viruses to be included in annual seasonal influenza vaccines for the northern and southern hemispheres. The Tecan liquid handling systems allow for automation of the antigenic assays used in the Influenza Division.

The Influenza Division (ID) of the National Center for Immunization and Respiratory Diseases

(NCIRD), CDC owns a significant number of Tecan laboratory equipment which are used to perform critical virology/genomics and immunology/pathogenesis analyses related to influenza viruses in support of its public health mission. These instruments are used in analyses performed for high-throughput influenza surveillance, emergency response, and research and development in preventing the spread of influenza viruses, reducing the severity of the disease, and protecting vulnerable populations from serious complications. These instruments are highly complex, and maintenance/repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond to an emergency, it is crucial that these instruments are efficiently and accurately performed.

SECTION 2 – PURPOSE

The purpose of this action is to procure an on-site preventative maintenance contract that covers the below Tecan instruments, as well as any Tecan instruments that may be replaced/exchanged and added during the lifetime of this contract for the Influenza Division (ID):

1. Tecan Freedom EVO 200 (Serial number 1705000945) with associated MCA96, RoMA, Thermoshake, 2 Bioshakes, Recirculator, Incubator, TeStack, 2 scanners, and

SciRobotic FluHema Reader.

2. Fluent 1080 (Serial number 1810013003) with associated MCA96, RGA, Air FCA, Julabo Recirculator, Thermoshake, Carousel R-version, and FluHema Reader.

3. NGS Instrument Fluent 1080 (Serial number 1908005436) Base Air FCA, 2 of MCA, RGA, ThemoshakeX2, plate sealer, and de-sealer.

4. Extraction Instrument Fluent 1080 ( serial number 1908012162) Base AIr FCA, MCA, RGA, TeVacS, FluetID.

5. Plate Reader Instrument Infinite 200 PRO (Serial Number 1908005022) Plate Reader

Instrument Infinite 200 Pro installed on NGS instrument.

6. Tecan Fluent 780 (Serial Number 1908014354) with associated Air FCA (Part No

30042200), RGA (Part No 30042400) MCA96 (Part No 30042351), Thermocycler

ODTC 96 (Part No. 30101852), Inheco single Deep Well Plate incubator-shaker (Part

No 30101184).

This maintenance agreement serves to keep all instruments running optimally while costly repairs due to damaged or malfunctioning equipment. The Contractor must also provide factory-trained personnel with expertise in preventative and remedial maintenance for all these Tecan instruments.

SECTION 3 – SCOPE OF WORK

The Contractor shall provide ON-SITE maintenance and repair services to keep the covered instruments properly calibrated, serviced, and maintained in accordance with or to exceed the

Original Equipment Manufacturer (OEM) recommendations throughout the contract period, renewable up to three additional option years. The Contractor will also provide at least one annual ON-SITE preventative maintenance with labor and travel costs covered under the contract, including any follow-on protocols necessary to maintain regulatory compliance. The

Contractor shall provide telephone support, ON-SITE maintenance and repairs by qualified, factory certified/authorized service engineers, priority response time (within 48 hours), and coverage of any and all parts, travel to CDC, labor costs, and software/firmware updates and support. Maintenance service includes periodic preventative maintenance according to the specific needs of the instrument as determined by the manufacturer. The Contractor selected for this contract shall be registered in SAM and comply with all specifications, clauses, and terms and conditions in this contract’s Statement of Work.

This preventative maintenance may be performed during the course of remedial maintenance.

Repair includes any action performed on instrumentation that restores the instrument to its originally designed working order. Certified replacement parts must be new, factory-remanufactured parts unless mutually agreed to by the CDC program. Any software presented under the contract, whether transferred to CDC via portable media (CDs, thumb drives, etc.), FTP sites, email, or other means, must be scanned using CDC-approved antivirus programs with up-to-date definitions prior to installation on CDC computers. In addition, portable media

(except for required software downloads under the terms of the contract – see above) and mobile devices (laptops, PDAs, phones, MP3 players, cameras, or similar equipment) will not be connected to CDC networks or computers. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above. A copy of CDC standards and procedures, including the

“Mobile Device/Portable Media Standard”, will be provided to the Contractor with a properly executed non-discloser agreement under CDC policy.

SECTION 4 – TECHNICAL REQUIREMENTS

1) Repair Services –

a. The Contractor shall provide at least one annual ON-SITE preventative maintenance with labor and travel costs covered under the contract and continued ON-SITE repair and inspection/maintenance that includes full coverage for parts, labor, and travel.

b. Tecan certification to repair, qualify, calibrate, upgrade, maintain, and move

Tecan instruments as requested and necessary.

c. Software Upgrades - Access to Tecan technical developments, repair procedures, software application updates, and planned maintenance procedures.

i. The Contractor shall provide software and firmware upgrades and support at no extra charge. Any software presented under the contract, whether transferred to CDC via portable media (CDs, thumb drives, etc.), FTP sites, email, or other means, must be scanned using a CDC-approved anti-virus program with up-to-date definitions prior to installation on CDC computers. In addition, portable media (except for required software downloads under the terms of the contract--see above) and mobile devices (laptops, PDAs, phones, MP3 players, cameras, or similar equipment) shall not be connected to CDC networks or computers.

1. A copy of CDC standards and procedures, including the

“OCISO Standard for Portable Media and Mobile Device

Security,” will be provided to the Contractor with a properly executed non-disclosure agreement under CDC policy.

2. The Contractor shall ensure that currently supported versions of information technology products meet the latest FDCC major version and subsequent major versions.

3. The Contractor shall use Security Content Automation Protocol

(SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings--see http://nvd.nist.gov/validation.cfm. The Contractor shall test applicable product versions with all relevant and current updates and patches installed.

4. The Contractor shall ensure IT applications operated on behalf of CDC/NCIRD/ID are fully functional and operate correctly on systems configured in accordance with the above configuration requirements.

5. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above

6. The Contractor shall ensure IT applications designed for end users are fully functional and run in the standard user context without requiring elevated administrative privileges.

d. Use of new quality specifically developed replacement parts certified to manufacturers’ specifications.

e. No third-party providers will perform maintenance or repair any

CDC/NCIRD/ID Tecan instruments.

f. Labor and travel fees are included in the maintenance agreement. Contractor costs.

g. Preventative Maintenance – The annual preventative maintenance must follow specific, standardized service protocols tested and developed by Tecan for its instrumentation and, as such, must use Tecan preventative maintenance kit parts and supplies.

i. Provide service and preventative maintenance to all CDC/NCIRD/ID http://nvd.nist.gov/validation.cfm

Tecan instruments listed in Section 2 – Purpose and components attached to these instruments, as well as any Tecan equipment that may be replaced/exchanged and added during the lifetime of this contract.

ii. Scheduled planned yearly maintenance, with all costs for labor and parts included in the cost of this contract, and periodic inspections (as needed) and on-site service of installed equipment, in accordance with

OEM recommendation, or exceeding them; including, but not limited to cleaning, calibration, adjustments, replacement or restoration of parts, as necessary, and all services required to return equipment to

OEM operational and design specifications.

iii. Preventive maintenance services shall be performed in accordance with a

Contractor's proposed schedule, which shall be coordinated with CDC scientists.

iv. The Contractor shall provide a copy of the preventative maintenance schedule to the Contracting Officer’s Representative (COR) within 2 months of contract award or new option year to minimize disruption to planned laboratory experiments.

v. To the maximum extent possible, individual equipment preventative maintenance services shall be coordinated to maximize efficiency and reduce preventative maintenance costs.

vi. The Contractor shall provide all consumables and reagents used for troubleshooting and performance verification testing both for preventative maintenance visits and repairs.

h. Provide no-cost repairs to any nonoperational or defective instrumentation that results from normal operation and usage.

i. Provide response time within 48 hours to all service calls.

j. Provide Tecan factory-trained service engineers with all specialized training, necessary tools, required service instrumentation, controlled proprietary stock parts and that are qualified to Tecan systems.

i. Supply CDC with access to training records and certifications for all field service engineers who will be servicing CDC equipment in order to maintain records necessary for CDC equipment Clinical Laboratory

Improvement Amendments (CLIA) certification.

k. Service Records – The Contractor shall provide a service invoice (field service report) to the instrument user and the COR/technical monitor detailing the work that was completed following remedial and preventative maintenance.

l. Provide to the user a printout and electronic copy of calibration verification performed during preventative maintenance to include in instrument logs.

m. At a minimum, service tickets shall contain the following information:

Contract Order #, Manufacturer, Model Number, Serial Number, CDC

Property Number (if applicable), Program Contact, Location, Type of Service

(preventive maintenance, routine repair, etc.), Date of Service and a

Description of Service that was performed (i.e., calibration, parts replaced, etc.) for each instrument.

n. Inspection and Acceptance Criteria - The CDC COR and/or designee will monitor the

Contractor's performance and shall be responsible for documenting acceptance or rejection of Contractor services within five (5) calendar days of services being rendered. If inspection and written (e-mail) notice of rejection has not been provided to the Contractor within ten (10) days of service, such services will be determined acceptable.

o. Point of Contact - At a minimum, the Contractor shall designate someone as the project manager to coordinate all activities, including but not limited to contract administration, billing, ordering, and shipping, and serve as the primary Point of

Contact (POC) between the Contractor and CDC Contracting Officer (CO) or designated CDC COR.

p. Annual Meeting: An annual onsite meeting visit initiated and led by the Contractor to discuss service issues/continuous improvement. The meeting should include the

Contractor program manager, field service engineers, CDC COR/Technical monitor, and end users in the meeting.

2) General Service Requirements – At the completion of work at each service location, the Contractor Service Representative shall restore the work site to its original condition. Contractor site clean-up shall include disposal of any discarded parts, empty containers, packing materials, trash, and debris. All chemical spills on equipment and/or surrounding floor shall be removed, and these areas shall be cleaned to return to their original condition. The Contractor shall not create or permit any safety or fire hazard to exist at the equipment site. Government-owned dumpsters may be used for disposal of waste materials except for metal parts and components, which shall be removed by the Contractor. The general area of serviced equipment shall be left in a clean and orderly condition, free of any trash or debris resulting from preventative maintenance and/or service activities. The Contractor is responsible for all labor, parts, and travel costs associated with services rendered, whether for repair or preventative maintenance. Warranty instruments will automatically be provided the same entitlements/response times as instruments in the program, excluding PMs, which will be performed as the instruments come out of warranty.

SECTION 5 – GOVERNMENT-FURNISHED MATERIALS

1. If the Contractor requires access to the Government’s intranet for any purpose, the Contractor must meet all Government security requirements to acquire this access. Upon meeting all

Government security requirements for access, the Government will provide a Smart Card

Contractor staff directly responsible directly needing access to the Government’s intranet.

2. Contractor Request for Government Furnished Materials. If the Contractor needs any additional government-furnished items to perform the work described in this SOW, the

Contractor should identify such additional government-furnished items in the Contractor’s proposal.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

The Contractor shall provide CDC with on-site maintenance, and the support hours are based on the terms outlined in the contract.

SUBSECTION A – PLACE OF PERFORMANCE

The Contractor shall provide CDC on-site maintenance.

SUBSECTION B – CONTRACT SUPPORT HOURS

See SECTION 4 – TECHNICAL REQUIREMENTS, #2 – Repair Services, above.

SECTION 7 – TRAVEL

The Contractor shall cover any and all travel costs to CDC that are incurred in support of this maintenance agreement.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Item Description Quantity Delivery Date Format Deliver To

1. Report on Preventative

Maintenance performed.

1 per service request/PM

Within 30 days upon completion of the service.

An email/or

Word document

ID COR/ID End

User

2. Preventative Maintenance

Instrument Schedule 1 per year

Within 2 months of initial contract award or option year exercise.

An email/or

Word document

ID COR/

Technical

Monitor

3. Prompt confirmation of formal service request.

1 per service request

Within 4 hours of service call

An email/or

Word document

ID End User

4. Prompt response to formal calls for service through troubleshooting telephone assistance, shipment of parts, and/or on-site repairs provided as necessary for remediation.

1 per service request

Within 24 hours of service call placement.

An email/or

Word document ID End User

5. Documentation of no cost software and firmware upgrades performed and support/training provided for upgrades performed

1 per service request

Within 30 days upon completion of the service.

An email/or

Word document

ID COR/ID End

User

6. Service invoice/record (field service reports) provided following all remedial and preventative maintenance for inclusion in instrument logs.

1 per service request/ PM

Throughout award period due upon completion of PM or remedial service.

An email/or

Word document

ID End User and

COR/ Technical

Monitor

7. Meeting minutes of on-site visit by Contractor to discuss service issues including account service manager, field service engineers, and CDC users in the meeting.

Due 4-5 months after initial award.

An email/or

Word document

ID COR/

Technical

Monitor

SUBSECTION A – PERFORMANCE MATRIX

Performance Requirements Summary:

PERFORMANCE

OBJECTIVE

PERFORMANCE

THRESHOLD

ACCEPTABLE QUALITY

LEVELS (AQLs)

METHOD OF

SURVEILLANCE

1. Preventive maintenance of instruments

Performed for each qualifying instrument on or ahead of schedule at least 80% of time allowing flexibility if needed by end user.

Review Contractor reports/ COR survey/End user feedback

2. Preventative Maintenance

Instrument Schedule

Delivered within 2 months of contract award.

Review by COR/

Technical Monitor

3. Prompt confirmation of formal service request.

Within 4 hours of initial service request at least 95% of the time.

RevEnd-userractor reports/ COR survey/

End user feedback

4. Prompt response to formal calls for service through telephone assistance, shipment of parts, and/or on-site repairs provided as necessary for remediation.

Withi 24 hours of initial service request,t at least 95% of the time.

Review Contractor reports/ COR survey/End-user feedback.

5. Successful repair of instruments covered by the agreement.

, as a general rule, if the repair requires additional time,ditional time a written plan must be agreed upon.

Review Contractor reports/ COR survey/

End-user feedback

6. No-cost software and firmware upgrades and support.

As needed/required by instruments.

Review Contractor

7. Service invoice/record (field service reports) provided following all remedial and preventative maintenance for inclusion in instrument logs.

1 per service call or PM included 100% of the time.

Review Contractor

8. On-site visit by Contractor to discuss service issues, including account service manager, field service engineers, and CDC users in the meeting.

1 per year, must demonstrate a commitment to continuous improvement of service delivery.

Review by COR/

Technical Monitor

SECTION 9-REFERENCE MATERIALS

OCISO Standard for Portable Media and Mobile Device Security

Quality Assurance Surveillance Plan

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Minimum qualifications include:

1. Factory-trained and certified service engineers.

2. Access to the Tecan factory and application scientists for support.

3. No third-party providers will perform maintenance or repair any CDC/NCIRD/ID Tecan instruments.

4. Offer priority onsite response times (within 48 hours).

SECTION 11 – ADDITIONAL REQUIREMENTS

The Contractor shall waive any re-certification/reinstatement fee for new equipment to be added to the contract for at least 90 days following the warranty period.

Section 508 Compliance

(Start of verbiage)

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

402 Closed Functionality

403 Biometrics

404 Preservation of Information Provided for Accessibility http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm

405 Privacy

406 Standard Connections

407 Operable Parts

408 Display Screens

409 Status Indicators

410 Color Coding

411 Audible Signals

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

http://hhs.gov/web/508

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(End of verbiage) http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

SECTION 1 – PROPOSED CONTRACT TYPE

The Government anticipates a fixed-price contract. The contract will specify a list of equipment to be covered by the contract. The equipment list will be evaluated at least quarterly to determine if new equipment needs to be added or taken off the list. Changes to the equipment list will be done by modification to the contract. The Government does not guarantee any quantity of equipment for any of the services.

SECTION 2 – OPTIONAL SPECIAL CONSIDERATIONS

SUBSECTION A – PAYMENT CLAUSES

Payments will be made on a monthly basis using the IPP invoicing system.

PROCUREMENT POINT OF CONTACT (POC) INFORMATION

SUBSECTION B – DATA RIGHTS CLAUSES

None

OTHER CONSIDERATIONS AND ADDITIONAL INFORMATION FOR OFFICE

OF ACQUISITION SERVICES