Attachment 2 - Statement of work.docx

RFQ No. 75D30123Q76743

Statement of Work Title: Pipette Calibration, Preventative Maintenance, and Repair in a GLP Environment

The period of performance of this purchase order: September 8, 2023, to September 7, 2025, inclusive of a one-year base period and one-year option period.

Base Period: 9/08/2023 to 9/07/2024.

Option Period 1: 9/08/2024 to 9/07/2025.

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division is responsible for developing Candidate Vaccine Viruses based on circulating and novel influenza strains. Candidate Vaccine Viruses (CVVs) are influenza viruses that are starting materials for seasonal and pandemic vaccines. CDC and the U.S. Food and Drug Administration (FDA) require CVVs meet regulated sterility requirements as defined in Title 21 of the U.S. Code of Federal Regulations (21 CFR), which requires equipment to be calibrated based on use and the manufacturer’s recommendations.

The Influenza Division requires the calibration, preventative maintenance, and repair of its pipettes, repeaters, and motorized pipette controllers. Such calibration is to be done by an organization accredited to the International Organization for Standardization (ISO) 17025:2017 standard, with a preference for American National Standards Institute (ANSI)/ National Conference of Standards Laboratories (NCSL) Z540.3-2016 certification and ISO 8655 accreditation.

Historically, this service has been provided through multiple small transactions handled with credit card orders. The Influenza Division now intends to streamline the process for pipette calibration, preventative maintenance, and repair into a single purchase order that will be used for all required calibration, preventative maintenance, and repair services of the subject pipettes, repeaters, and motorized pipette controllers.

SUBSECTION A – Definitions

1. Manual Single Channel: A manual single-channel pipette is a laboratory tool used to transport a measured volume of liquid. It has one channel, meaning it can dispense one volume of liquid at a time. The user manually adjusts the desired volume and operates the pipette.

2. Electric Single Channel: An electric single-channel pipette is similar to a manual single-channel pipette, but a motor powers it. The motor reduces the effort required to aspirate and dispense the liquid, reducing user fatigue and improving accuracy, particularly for large volumes or viscous liquids.

3. Manual Multichannel: Manual multichannel pipettes have multiple channels (usually 8 or 12), allowing users to simultaneously aspirate or dispense multiple volumes of liquid. This is particularly useful for tasks like filling multi-well plates.

4. Electric Multichannel: An electric multichannel pipette operates similarly to a manual multichannel pipette, but with a motor assisting the aspiration and dispensing of liquids. This can improve accuracy and precision, and reduce user fatigue.

5. Repeater: A repeater pipette allows for multiple dispensing of the same volume of liquid without the need for refilling. This can greatly speed up tasks like filling multi-well plates or dispensing reagents.

6. Motorized Pipette Controller: This device is used with glass or plastic pipettes and uses a motor to control the aspiration and dispensing of liquid. They can handle much larger volumes than single-channel or multichannel pipettes. The leading brand name, Pipette-Aid, is so ubiquitous that it is often used in lieu of the general term for the device, motorized pipette controller.

7. Calibration: Calibration is the process of checking and adjusting a pipette’s accuracy. Over time, pipettes can lose accuracy due to wear and tear, so regular calibration is necessary to ensure they continue to dispense accurate volumes of liquid.

8. Title 21 of the Code of Federal Regulations (21 CFR): 21 CFR governs food and drugs, including how equipment must be maintained and calibrated to be used in cGLP production environments.

9. Current Good Laboratory Practice (cGLP): These are regulations issued by the U.S. Food and Drug Administration (FDA), particularly under 21 CFR Part 58. They provide a framework for properly conducting non-clinical laboratory activity in producing pharmaceutical materials.

10. Candidate Vaccine Virus (CVV): An engineered or wild-type virus used for the manufacturing and developing of vaccines, particularly those created within the cGLP environment at the CDC.

11. ISO/IEC 17025:2017: This is an international standard set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It sets the general requirements for the competence of testing and calibration laboratories. It applies to all organizations performing laboratory activities, regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. The standard covers areas like impartiality, confidentiality, complaints and appeals procedures, risk-based thinking, and management system requirements. Obtaining ISO 17025 Certification also satisfies the requirements of ISO 9001:2015.

12. American National Standards Institute (ANSI): A private, non-profit organization overseeing voluntary consensus standards development in the United States. ANSI's mission is to enhance the competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity.

13. ANSI National Accreditation Board (ANAB): a non-governmental organization that provides accreditation services to public- and private-sector organizations. ANAB is a member of the International Laboratory Accreditation Cooperation (ILAC), and its accreditation standards are recognized internationally.

14. ANAB certification to ISO 17025: When a laboratory is ANAB-certified to ISO 17025, it means that the laboratory has met the requirements of the ISO/IEC 17025:2017 standard and has demonstrated its competence to carry out specific tests or calibrations or types of tests or calibrations. The ANAB certification process includes assessing the laboratory's quality management system and demonstrating the laboratory's technical competence. Once certified, the laboratory undergoes regular assessments to maintain its certification.

15. ANSI/NCSL Z540.3-2016: ANSI and the National Conference of Standards Laboratories (NCSL) titled "Requirements for the Calibration of Measuring and Test Equipment," sets out the requirements for calibration laboratories and the calibration of measuring and test equipment, and is the chief calibration requirement called out in cGLP guidance. The older standard, ANSI/Z540.3, can still be used, but organizations certified under the older guidelines are encouraged to be certified by the newest guidelines by 2026 (10 years post-publication).

16. ISO 8655: A standard developed by the ISO that pertains specifically to piston-operated volumetric apparatuses. These apparatuses, including pipettes, burettes, and dilutors, are largely the types of equipment that need to be calibrated. There is not a requirement under this purchase order to have ISO 8655 certification if ISO 17025 is in place but ISO 8655 is preferred.

SECTION 2 – PURPOSE/OBJECTIVE

The objective of this purchase order is to provide the Influenza Division with ISO 17025-complainant calibration, preventative maintenance, and repair of pipettes, repeaters, and motorized pipette controllers onsite at the CDC Roybal campus.

SECTION 3 – SCOPE OF WORK

The Contractor shall provide calibration, preventative maintenance, and repair services for 422 pipettes, repeaters, and motorized pipette controllers.

Calibration typically occurs during on-site visits in January, February, July, and August, although these dates and the number of visits may vary. The number and dates of visits will be determined in coordination with CDC. Calibration is required for the following types of equipment:

1. Calibration 241 manual single-channel pipettes, of which 117 require an annual calibration and 124 require semi-annual (once every 6 months) calibration.

2. Calibration 14 electronic single-channel pipettes, of which 7 require an annual calibration and 7 require semi-annual (once every 6 months) calibration.

3. Calibration 54 manual multichannel pipettes, of which 19 require an annual calibration and 35 require semi-annual (once every 6 months) calibration.

4. Calibration 34 electronic multichannel pipettes, of which 22 require an annual calibration and 12 require semi-annual (once every 6 months) calibration.

5. Calibration 39 repeaters/repeating dispensers, of which 16 require an annual calibration and 23 require semi-annual (once every 6 months) calibration.

6. Calibration 40 motorized pipette controllers, of which 20 require an annual calibration and 20 require semi-annual (once every 6 months) calibration.

A full list of exact models and their calibration requirements is provided in Appendix 1. Please note that the serial numbers in Appendix 1 may change during performance as like-equipment is replaced.

Concurrent to each calibration, the Contractor shall provide preventative maintenance services in accordance with original equipment manufacturer (OEM) recommendations.

The Contractor shall provide repair services for any pipette, repeater, or motorized pipette controller found to be damaged or defective during calibration or preventative maintenance services. Further, the Contractor shall provide repair services as requested by CDC in-between on-site calibration visits.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Calibration. Calibration shall be performed onsite at the CDC Roybal campus, Building 17. All calibrations must be ISO 17025-compliant, with additional preference for ANSI/NCSL Z540.3-2016 and/or ISO 8655 certifications. A certificate of calibration must be issued for each calibration of each pipette, repeater, and repeating dispenser.

Task 1.1: Annual calibrations of 117 manual single-channel pipettes.

Task 1.2: Sem-annual (once every 6 months) calibrations of 124 manual single-channel pipettes.

Task 1.3: Annual calibrations of 7 electronic single-channel pipettes.

Task 1.4: Sem-annual (once every 6 months) calibrations of 7 electronic single-channel pipettes.

Task 1.5: Annual calibrations of 19 manual multichannel pipettes.

Task 1.6: Sem-annual (once every 6 months) calibrations of 35 manual multichannel pipettes.

Task 1.7: Annual calibrations of 22 electronic multichannel pipettes.

Task 1.8: Sem-annual (once every 6 months) calibrations of 12 electronic multichannel pipettes.

Task 1.9: Annual calibrations of 16 repeaters/repeating dispensers.

Task 1.10: Sem-annual (once every 6 months) calibrations of 23 repeaters/repeating dispensers.

Task 1.11: Annual calibrations of 20 motorized pipette controllers.

Task 1.12: Sem-annual (once every 6 months) calibrations of 20 motorized pipette controllers.

Task 2: Preventative maintenance. The Contractor shall provide preventative maintenance services in accordance with original equipment manufacturer (OEM) recommendations. Preventative maintenance shall be performed concurrent to calibrations.

Task 2.1: Annual preventative maintenance of 117 manual single-channel pipettes.

Task 2.2: Sem-annual (once every 6 months) preventative maintenance of 124 manual single-channel pipettes.

Task 2.3: Annual preventative maintenance of 7 electronic single-channel pipettes.

Task 2.4: Sem-annual (once every 6 months) preventative maintenance of 7 electronic single-channel pipettes.

Task 2.5: Annual preventative maintenance of 19 manual multichannel pipettes.

Task 2.6: Sem-annual (once every 6 months) preventative maintenance of 35 manual multichannel pipettes.

Task 2.7: Annual preventative maintenance of 22 electronic multichannel pipettes.

Task 2.8: Sem-annual (once every 6 months) preventative maintenance of 12 electronic multichannel pipettes.

Task 2.9: Annual preventative maintenance of 16 repeaters/repeating dispensers.

Task 2.10: Sem-annual (once every 6 months) preventative maintenance of 23 repeaters/repeating dispensers.

Task 2.11: Annual preventative maintenance of 20 motorized pipette controllers.

Task 2.12: Sem-annual (once every 6 months) preventative maintenance of 20 motorized pipette controllers.

Task 3: Repair. The Contractor shall provide repair services for any pipette, repeater, or motorized pipette controller found to be damaged or defective during calibration or preventative maintenance services, including the replacement of worn parts.

Additionally, the Contractor shall provide repair services as requested by CDC in-between on-site calibration visits. Repair services provided in-between on-site visits are anticipated to be performed at the Contractor’s facility; CDC will ship the equipment to be repaired to the Contractor and the Contractor will ship the equipment back to CDC after the repair is completed.

Only original manufacturer’s parts shall be used for replacements.

Before undertaking repairs estimated to exceed $150 in costs for parts and labor, the Contractor shall provide a cost estimate to, and obtain approval from, the Contracting Officer’s Representative (COR).

The costs of parts and labor for repairs shall be invoiced to CDC on a time-and-materials basis.

SECTION 5 – GOVERNMENT-FURNISHED PROPERTY

The Government (CDC) will furnish the pipettes, repeaters, and motorized pipette controllers to the Contractor, as well as clean and safe laboratory space temporarily designated for sole use by the Contractor for calibration, preventative maintenance, and repair.

The Contractor shall furnish all equipment and supplies required to perform the calibration, preventative maintenance, and repair services.

All equipment provided for calibration, preventative maintenance, and repair is expected to be returned to the CDC immediately following the completion of services. Any CDC equipment brought or shipped off-site for repair at the Contractor’s facility(ies) shall be returned within four weeks.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

The principal place of performance will be at Building 17 of the CDC Roybal campus, located at 1600 Clifton Road, Atlanta, Georgia 30333. Performance is also expected at the Contractor’s facility(ies) for repairs that either cannot be completed onsite or are requested by CDC in-between on-site calibration visits.

The Contractor will determine the support hours needed to complete all tasks to be performed under this contract. The number and dates of on-site visits will be determined in coordination with CDC.

The cancellation of a scheduled on-site visit by either the Government or the Contractor requires notice provided to the other party at least three business days in advance.

SECTION 7 – TRAVEL

Travel to the CDC is expected during the performance of this purchase order. No compensation will be provided separately for travel. Transportation costs are to be included within the Contractor’s price(s) for on-site calibration and preventative maintenance services.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

A certificate of calibration will be provided electronically in PDF format to the COR following each calibration.

Following each on-site visit, the Contractor shall provide to the COR a summary report of all services provided during the visit. The report shall be provided by e-mail.

SECTION 9 – REFERENCE MATERIALS

None.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

1. ISO 17025 Certification by an ANSI or ILAC member organization (e.g., ANAB certification)

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy The Contractor (and/or any subcontractor) shall not have access to, or host, and/or maintain any Government information system(s) in relation to the proposed work. All data will be provided via secured web portal or service (e.g., Amazon Web Services or FileShare). No sensitive data, patient information, or personally identifiable information will be provided to the Contractor on the basis of the proposed work.

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Electronic and Information Technology Accessibility

(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-aboard.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 502 Inoperability with Assistive Technology 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.

(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.

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Appendices 1 - Pipette inventory and calibration schedule