Draft PWS.docx

Performance Work Statement Title: CDC Biorepository it & Cryogenics Services Support

SECTION 1 – BACKGROUND

The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) support public health programs, including biorepository activities. The Preparedness, Response, and Outbreak Services Branch (PROSB) within the Division of Core Laboratory Services and Response (DCLSR) operates the CDC Biorepository (CBR), located at the CDC Lawrenceville campus, Georgia, with an additional sample storage location at the CDC Chamblee campus in Atlanta, Georgia. The CBR serves as a centralized biorepository whose mission is to preserve CDC’s valuable samples and facilitate CDC program activities that are fundamental to public health surveillance, research, and outbreak response. CBR is responsible for the integrity, management, disposition, and security of approximately 6.7 million samples belonging to CDC programs and collaborators across the Agency. Samples are organized into collections and projects and, along with their data and associated information, are considered unique and irreplaceable. Over time, the number of samples is anticipated to change and grow as CDC collects and generates samples from program activities. CBR, along with the rest of the Agency, is working toward developing ways for designated collections, known as Institutional Collections, to be shared externally. The CBR maintains the goals of providing expertise to assist CDC programs with all aspects of sample management and working with programs to facilitate compliance with CDC sample-related policies. Services associated with sample management and storage are provided that includes 1) sample disposition (e.g., accessioning, retrieval, transfers, destructions, aliquoting), 2) courier services within the Atlanta-area campuses, 3) block administrator for the issuance of CDC Identifiers (CSIDs and CUIDs), 4) sample labels, 5) cryogenic services 6) sample storage equipment management, and 7) 24/7 sample storage equipment monitoring and emergency response.

In alignment with its comprehensive Quality Management System (QMS) and vision to achieve excellence in biorepository science, CBR operates as a facility accredited by the College of American Pathologists’ (CAP) Biorepository Accreditation Program (BAP). This accreditation provides assurance to CDC programs and stakeholders that CBR maintains the highest standards in sample management. CBR goals and objectives are in alignment with a strategic plan of expanding access by preserving sample quality and enhancing collection and data standards. This will be achieved through a culture of 1) excellence and continuous quality improvements, 2) standards to minimize risks to both the workforce and samples, 3) enhanced services and tools to address the evolving needs for sample management across the Agency, and 4) developing an infrastructure to implement sample sharing for customers. CDC programs and stakeholders should associate the CBR with trust and respect, quality, excellent customer service, first-class operations, accreditation, and expertise in biorepository science.

CBR CRYOGENICS SYSTEMS AND EQUIPMENT MANAGEMENT SERVICES

CBR is responsible for procurement and supplying liquid nitrogen at all Atlanta-area CDC campuses that includes Lawrenceville, Roybal, and Chamblee. There are bulk tanks of varying models and sizes located at each of these campuses. CDC owns the bulk tanks but works collaboratively with CBR to ensure functionality.

The CBR provides continuous, monitoring for samples stored in a variety of temperature environments including vapor-phase, liquid nitrogen (LN2) storage units (-80℃ to -190℃), low and ultra-low freezers (-20℃ to -80℃), refrigerators (1℃ to 4℃), and ambient storage at both the Lawrenceville and Chamblee campuses. Additionally, CBR is responsible for monitoring LN2 storage units across all Atlanta-area campuses (Roybal and Chamblee) and is actively expanding to include mechanical freezers (low- and ultra-low freezers, refrigerators) at these and other campuses (e.g., Alaska) for the first time. The CBR provides continuous monitoring of these sample storage units and other environmental aspects (e.g., room temperature, humidity) through its custom-built sample storage monitoring system, known as SampleGuard. The system continuously monitors the status of liquid nitrogen equipment, critical notifications, and continuous temperature recording for low- and ultra-low freezers, ensuring proper function to maintain sample integrity while in storage. CBR is responsible for managing these critical alarm events by communicating with CBR and CDC staff, relocating samples, and facilitating other response activities.

Samples stored and managed by CBR are distributed amongst 212 liquid nitrogen vapor-phase sample storage units, 48 ultra-low freezers, 12 low freezers, and 5 refrigerators. The quantity and diversity of these units vary depending on inventory replacement and growth. As part of its accreditation requirements, CBR must always maintain sample integrity and cold chain during sample storage, disposition, and handling. This includes any equipment, devices or systems used in these workflows such as cryocarts and crypods. Documentation and reports of unit performance is also a necessary part of CBR’s QMS and accreditation requirements.

Expansion of CBR cryogenic services and space management to the rest of the Atlanta-area campuses began in 2022. CBR provides preventive maintenance and repairs for approximately 200 LN2 sample storage units stored in several spaces, referred to as “Shared Spaces” at both Roybal and Chamblee as well as room management (e.g., general housekeeping, biohazardous waste disposal). Regular communications between CBR staff and CDC programs is critical to effectively execute equipment and room management activities (e.g., addressing locked units, excessing equipment).

CBR IT SYSTEMS

The CDC Biorepository has stewardship responsibility for the integrity, management, disposition, and security of sample collections for CDC programs and collaborators. CDC programs have collected these samples managed by CBR and are not associated with any personally identifiable information (PII). The Sample Information Management System LabVantage (SIMS-LV), is used to provide inventory management of CBR project collections, sample level data, and associated information and metadata. SIMS-LV is a configurable, web-based system that is used primarily to capture and maintain sample information, it is also used to track sample locations, inventory control, shipping and receiving, and other related tasks. Software upgrades are required to maintain SIMS-LV. Information stored and tracked in SIMS-LV is done in accordance with all CDC sample-related policies. The CBR has made a strategic decision to migrate from the existing SIMS-LV into CDC’s enterprise LIMS (ELIMS). The majority of CDC programs utilize ELIMS for accessioning, managing and tracking samples, storage locations, and reporting. ELIMS functions as the central data management system enabling organization of laboratory data throughout much of CDC and migration into ELIMS will provide improved technological capabilities to better support the CDC mission and CDC programs.

The CBR serves as the block administrator for the issuance of CDC Identifiers (CSIDs and CUIDs) to all programs at the CDC. This agency-wide standardization ensures that each CDC sample and its aliquots and derivatives are uniquely and consistently identified. This facilitates traceability and tracking across the agency while maintaining parent-child relationships. As a service to the agency, the CBR offers a variety of both standardized sample labels and customized formatting options to CDC Programs. It is the role of CBR to make recommendations that shall ensure compliance with CDC sample-related policies. In 2022, CBR launched a new, custom-built system known as the CDC Identifiers and Label Management System (CIDLMS), replacing a manual process for identifier management.

CBR utilizes a custom-built sample storage and room monitoring system, known as SampleGuard. It is made up of several components: window services, web-based user interface, equipment sensors, compatibility with LIMS for data pulls, and a variety of other features such as system checks. SampleGuard is deployed at several locations at CDC Lawrenceville, Chamblee, and Roybal campuses and functions by interacting with a freezer’s controller, mechanical temperature sensors, and room monitoring sensors. It is currently being expanded beyond its current footprint to begin expansion of monitoring across the Agency.

In alignment with the CBR strategic plan, CBR aims to develop an infrastructure and facilitate sample sharing for CDC Programs. Under CDC policies, collections of samples and supporting metadata that are identified for preservation and management for future scientific applications are known as Institutional Collections (ICs). These are preserved, cataloged, and managed as permanent or long-term valuable assets to support a variety of scientific research and other activities within the broader scientific community. As part of CBR’s role, it is the goal to establish systems to provide support for these collections that can include 1) a website or homepage that provides information about these collections, 2) a data portal for queries made by both internal and external customers, and 3) serve as a liaison to the Registry of Federal Scientific Collections.

SUBSECTION A – Definitions

· Accessioning – the act of recording the addition of new samples, collection of samples, or associated documentation into the CDC Biorepository

· Associated documentation – any factual information affiliated with a sample collection including protocols, consent, permits, etc.

· ATSDR – Agency for Toxic Substances and Disease Registry

· CAP – College of American Pathologists

· CBR – CDC Biorepository (includes program operations, facility, services, federal employees, other staff)

· CDC – Centers for Disease Control and Prevention

· CIDLMS – CDC Identifiers and Label Management System (CIDLMS) – CBR custom-built system used to manage administration of CDC Identifiers

· Collection – a group of related samples assembled because of a project, of any specific type, for which meaningful epidemiological, population demographics, exposure, geography, and laboratory results data exists

· CSID – CDC Sample Identifier – a unique number assigned to identify the original submitted samples to CDC and used to establish a lineage of other samples (i.e., parent sample)

· CUID – CDC Unique Identifier – a unique number assigned to identify each physical sample (i.e., sample, aliquot, or derivative)

· Dewar – vacuum-insulated container used to maintain internal temperatures for extended periods

· Disposition – the removal of samples and their associated information for the purposes of recall to the affiliated program, transfer to or sharing with CDC programs or third parties, or for destruction

· ELIMS – Enterprise Laboratory Information Management System – CDC’s enterprise LIMS

· Incident – any circumstance that causes injury or illness to yourself or your coworkers, or damage to property, products, or the environment

· LIMS – Laboratory Information System – software system that manages and track samples, including associated information

· LN2 – liquid nitrogen

· Near miss – event that occurred that did not result in injury or damage but had the potential to cause an incident

· PPE – personal protective equipment

· PII – personally identifiable information – information that can be used to distinguish or trace an individual’s identity, such as his or her name, social security number, or biometric records that alone, or when combined with other personal or identifying information, is linked or linkable to a specific individual, such as date and place of birth

· Project – a study that has been designed for a specific purpose to answer a specific scientific question or public health need; a project is comprised of a single or multiple collections

· Sample – any material – biological, clinical, or environmental – taken as a representation of a whole, used for analysis or medical diagnosis

· SampleGuard – CBR in house-built system that provides continuous monitoring of sample storage units and other environmental aspects (e.g., room temperature, humidity)

· Sample storage unit – equipment such as liquid nitrogen (LN2) sample storage unit, low- and ultra-low freezers, refrigeration, and ambient storage

· Shared Spaces – rooms located at CDC Roybal and Chamblee campuses where LN2 sample storage units owned by different CDC programs that are kept and managed

· SIMS- Sample Inventory Management System

· SIMS-LV - Sample Inventory Management System LabVantage – is used to provide inventory management of CBR project collections, sample level data, and associated information and metadata

· SQL – Structured Query Language

· Storage – maintenance of physical samples under specified conditions for future use

· Supporting data and meta data – descriptive data that describes a sample that is part of a scientific collection

· UAT – User Acceptance Testing

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this contract is to obtain support, expertise, and guidance for CDC Biorepository Services that includes 1) continued cryogenic operations required for continuity of CDC and CDC Biorepository cryogenic systems and related services, and 2) continuity of CDC Biorepository IT systems. This includes, but not limited to:

Cryogenic Services:

· Providing liquid nitrogen supply to Atlanta-area CDC campuses

· Cryogenic systems management for all CBR sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units), infrastructure (e.g., bulk tanks, supply lines), and ancillary equipment (e.g., cryocarts, crypods)

· Monitoring and emergency response to alarms and related events for sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units)

· "Shared Spaces” management at Roybal and Chamblee campuses

IT Systems:

· Facilitating with electronic sample inventory management

· Providing CDC sample label services and enhancements toward standardizations

· Providing CDC Identifier services

· SampleGuard support and expansion

· Data portal development for sample sharing

· CBR informatics, metrics and reporting

Given the diversity of services that are provided by CBR (e.g., electronic sample data management, labels and identifiers, equipment management and monitoring, cryogenic services, sample disposition), it is necessary to provide reporting for all these activities for leadership, CDC programs, and stakeholders as needed or requested. The CBR is funded through a cost recovery process that requires standardized metrics to be pulled at regular intervals (e.g., quarterly, annually) for reporting. Reporting of CBR activities is also necessary for the CBR Governance Board, a group made up of various stakeholders that provide guidance and oversight.

The contractor, as an independent organization, and not as an agent of the government, shall provide all labor, materials, equipment, and supplies (that are not furnished by the Government) and shall perform all services required to execute the CBR activities according to CDC, DCLSR, and CBR regulations, policies, processes, procedures, established standards, and best practices. All vendor requirements shall be accomplished in the most highly efficient, rapid, secure, and cost-effective manner to serve the main objective of supporting the CDC Biorepository in its core activities. Core activities include sample and collection management, services, facility operations, IT and data management, quality management, and project management. Providing efficient and effective support and services will ensure a strong reputation among CDC programs and collaborators.

SECTION 3 – SCOPE OF WORK

The scope of this contract, as required by DCLSR, are in support of CBR’s programmatic mission and vision related to stewardship of CDC’s valuable sample collections. To help accomplish this, CDC requires the vendor’s independent advice, guidance, assistance, and technical support. The vendor shall:

· Provide liquid nitrogen supply procurement and management

· Perform liquid nitrogen equipment daily management activities (e.g., LN2 sample storage units (freezers), bulk tanks)

· Monitor and perform emergency response 24/7 to alarms and related events (e.g., planned outages) during business hours and after hours (on-call for weekends and federal holidays) for all CBR sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units)

· Monitor and perform emergency response 24/7 to alarms and related events (e.g., planned outages) during business hours and after hours (on-call for weekends and federal holidays) for non-CBR sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units) that participate in CBR services (e.g., SampleGuard monitoring, PMs, equipment management)

· Perform scheduled preventive maintenance to a variety of LN2 sample storage units and other equipment (e.g., cryocarts, cryopods)

· Provide recommendations for improvements and to mitigate risks for CDC cryogenics systems (e.g., LN2 sample storage units, LN2 piping, cryovents, bulk tanks) and other sample storage systems (e.g., mechanical freezers)

· Perform repairs of LN2 sample storage units, including order parts as needed to perform related activities on equipment (repair valves, vacuum pumps) and accessories (e.g., controllers)

· Provide documentation for all activities as needed (e.g., tasks performed, equipment failures, events, preventive maintenance reports, service reports)

· Perform tasks associated with shared space management at CDC Roybal and Chamblee campuses including disposal of biohazardous waste, routine housekeeping, management of cleaning and PPE supplies, and decontamination when necessary

· Assist in ensuring CBR’s ability to electronically perform activities associated with sample collection management including accessioning, disposition, inventory, queries, storage locations, and data management

· Assist in activities associated with electronic collections management (e.g., SIMS-LV, ELIMS, Access, SharePoint), including the successful migration of CBR SIMS-LV to CDC enterprise ELIMS

· Assist in providing continued sample label services and CDC Identifiers in compliance with CDC sample-related policies, including enhancements and standardizations to improve customer services

· Assist with technical support for SampleGuard

· Assist in the development of SampleGuard to support its expansion across the Agency

· Assist in development and maintenance of tools (e.g., Power BI dashboards, Access databases, SharePoint) to facilitate CBR sample management

· Assist in the development of an external data portal for Institutional Collections to facilitate sharing outside of CDC

The period of performance shall consist of a base year plus four (4) options years. Options years are exercised at the discretion of the Government.

SECTION 4 – KEY PERSONNEL

The following positions have been identified as "key personnel" and must be approved by the government before employment under the resulting contract.

Position Title Cryogenics Systems Team Lead Cryogenics Systems Technician IT Systems Support Specialist IT Systems Software Developer Contract Project Manager

· Cryogenics Systems Team Lead Description: The Lead Cryogenic Systems Specialist supervises the Cryogenic System Technician team and its activities. They are primarily responsible for the monitoring and maintenance of cryogenic systems, including bulk tanks, LN2 sample storage units, and low/ultra-low freezers. This also includes overseeing the maintenance of the temperature alarm system and supporting associated systems such as oxygen monitoring systems and freezer emergency response, as required.

Minimum Qualifications: BA/BS degree preferred; 10+ years of cryogenic systems or biorepository experience; experience managing cryogenic biorepository operations preferred.

· Cryogenics Systems Technician Description: Cryogenic Systems Technicians primarily monitor and maintain the cryogenic systems, including bulk tanks, LN2 sample storage units, and low/ultra-low freezers. This also includes maintenance of the temperature alarm system and supporting associated systems such as oxygen monitoring systems and freezer emergency response, as required.

Minimum Qualifications: BA/BS degree preferred, 1+ years of cryogenic systems or biorepository experience.

· IT Systems Support Specialist Description: IT Support Specialists support all IT systems operations and development. They are responsible for performing daily IT system activities, data entry, issue tracking, and change control processes. Support continuity of services and work to help government IT services and SMEs. Supports compliance with all agency IT policies. Supports management of CDC Identifiers as part of customer services. Provides IT systems-related training as needed. Manages and processes sample label requests as part of customer services.

Minimum Qualifications: BA/BS degree preferred; 2+ years of IT Services experience; knowledge of R, R shiny, and SQL preferred.

· IT Systems Software Developer Description: Supports in the continued development and maintenance of CBR’s in-house built, sample monitoring system, SampleGuard. Ensures continuity of services and work with the government IT services and SMEs. Supports compliance to all agency IT policies.

Minimum Qualifications: BA/BS in computer science or other relevant technical field; minimum of 2 years software engineering experience; expert knowledge designing, developing, and testing software and applications for computers; basic electrical and wiring experience.

· Contract Project Manager Description: The Contract Program Manager (CPM) works with the CBR Team and COR to coordinate contract staff and activities in fulfillment of Statement of Work deliverables and goals. CPM manages financial aspects of contract work and is the primary liaison to CBR Contract Officer (CO), Contract Officer Representative, (COR), CBR Team, and CBR Director. CPM also ensures safe work environments and all staff compliance to CDC policies including safety, quality, and training.

Minimum Qualifications: MA/MS degree in business or sciences and 10+ years of experience; Project management professional certification is preferred.

SECTION 5 – TASKS TO BE PERFORMED

Task 1: Cryogenic Services Management

1. Staffing. Provide experienced staff with advanced knowledge, expertise, and experience in operations and maintenance of cryogenic systems. Staff must have at least 1-year prior experience with maintenance of and repairing liquid nitrogen sample storage equipment.

2. Contract Support Hours. Provide staff for cryogenic services (e.g., monitor liquid nitrogen sample storage units, repairs, emergency response) at all Atlanta-area campuses where required during business hours (8:00 am EST to 5:00 pm EST) Monday-Friday, excluding weekends and federal holidays.

3. On-call Support. Provide on-call support for response to an emergency notification. Emergencies include activities related to CDC services, operations facilities, equipment, and samples that may result in the loss of property, compromise sample integrity, or create a safety issue. Afterhours is any time outside 8:00 am EST to 5:00 pm EST, Monday through Friday, including weekends and federal holidays. The on-call responses must be initiated within one hour of being notified and may require the contractor to report onsite to any of the specified locations within two hours of the notification or sooner.

4. Emergency Response. Monitor and provide 24/7 emergency response to alarms (e.g., equipment failure, overfills) and related events (e.g., planned outages) during business hours and after hours (on-call for weekends and federal holidays) and other events for all CBR sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units).

5. Improvements. Provide recommendations for improvements and mitigate risks for CDC cryogenic systems (e.g., LN2 sample storage units, LN2 piping, cryovents, bulk tanks). Provide expertise and assist with CDC facility planning and management for liquid nitrogen systems, including liquid nitrogen storage areas, bulk tank supply equipment, and sample storage units.

6. Quality. Perform all cryogenic services by establishing quality management systems, accreditation requirements, policies, standard operating procedures (SOPs), standards, and best practices. Participate in the identification, development, and revision of SOPs.

Task 2: Liquid Nitrogen Supply and Management

1. Procure and maintain LN2 supply in bulk tanks at CDC Lawrenceville, Roybal, and Chamblee campuses.

Provide management of all bulk tanks at each of the three Atlanta-area campuses, Lawrenceville, Roybal, and Chamblee, for activities relating to liquid nitrogen supply.

1. Develop a written Liquid Nitrogen (LN2) Management Plan to procure, distribute, deliver, and load liquid nitrogen into bulk tanks, including recommendations for preventive maintenance and mitigating risks.

2. Monitor and ensure bulk tanks stay within a minimum level that will impact CDC operations.

Task 3: Equipment Management

1. Equipment. Have expertise and working knowledge in working with a variety of liquid nitrogen units as listed below:

a. MVE 1536P-190F MVE XLC 1841

b. MVE 1539P-190 Cryo-Forma F21 MVE 1839F Cryoplus 3

c. MVE 1879 150 Cryoplus 4

d. MVE 1894R-190F MVE 1520 HE

e. MVE 815P-150F MVE 1800 Series-150

f. MVE 819P-190F MVE 810 HE

g. MVE Vario 1800 MVE XLC 1840

h. MVE Vario 1879P-TS MVE XLC 1211

i. MVE XLC 1830 HE Taylor Wharton K Series

2. Preventive Maintenance. Perform preventive, routine maintenance for all CBR sample storage units (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units). The type of activities may vary between CBR, non-CBR-owned equipment, and other temperature-dependent equipment (e.g., cryocarts, cryopods). Assist with ordering parts to perform maintenance on liquid nitrogen equipment and accessories.

3. Repairs. Repair liquid nitrogen sample storage units as needed (e.g., valves, bulk storage, vacuum pumps). Mitigate issues for all other temperature-dependent equipment (e.g., low ultra-low freezers, refrigerators, cryocarts, cryopods).

4. Equipment Installation. Perform installation activities, including Installation Qualification/Operational Qualification/Performance Qualification and temperature mapping as required for temperature-dependent equipment (e.g., low ultra-low freezers, refrigerators, LN2 sample storage units, cryo-carts, cryoprobes).

5. Relocation. Propose configurations and liquid nitrogen transfer assembly and develop specifications for installation of specialized cryogenic equipment parts or accessories. Operate, test, and maintain cryogenic systems.

6. Monitoring. Monitor temperature-dependent equipment (e.g., low-and ultra-low freezers, refrigerators, LN2 sample storage units) and prepare and review records of operating performance generated from SampleGuard or other continuous monitoring systems to track and trend equipment operation.

7. Emergency Response. Mitigate any emergency issues (e.g., relocate samples stored from one unit to another compatible unit) and provide notifications when equipment needs repairs.

8. LN2 Related Tasks. Facilitate and perform other liquid-nitrogen equipment-related tasks (e.g., filling dewars, moving equipment).

9. Safety. Provide risk assessments, recommendations, and solutions for continuous improvements to CBR cryogenic equipment in support of CDC and CBR Safety.

10. Quality and Records. Prepare and review records of operating performance generated from continuous monitoring to track and trend equipment operation for constant improvements. Provide documentation for all equipment (e.g., LN2 sample storage units, cryo-carts, freezers, and refrigerators) tasks performed, failures, events, and other issues associated with the equipment, including service reports as required by CBR (e.g., use and operation, calibration and maintenance, monitoring equipment events, management of out of service equipment, decommissioning).

11. Documentation. Use CBR systems to capture and report activities associated with equipment management (e.g., SharePoint, Access).

Task 4: Shared Spaces Management

1. Waste Management. Assist in managing and disposing of biohazardous waste at locations where LN2 equipment is stored at Roybal and Chamblee campuses.

2. Routine Housekeeping. Perform routine housekeeping to maintain clean spaces at specified locations where LN2 equipment is stored at the Roybal and Chamblee campuses. Perform regular decontamination of high-touch surfaces.

3. Supply Management. Monitor inventory of cleaning and PPE supplies and maintain inventories at each location.

4. Safety. Assist in identifying and reporting near misses or safety incidents (e.g., thawed samples, individuals not wearing appropriate PPE).

Task 5: CBR IT Systems Management and Services

1. Provide experienced staff with advanced knowledge, expertise, and experience to support the management, maintenance, and administration of CBR systems (e.g., user access roles, adding data and content, providing new user assistance, and addressing requests for assistance).

2. Assist with software support and maintenance, including planning and implementing updates required for functionality or compliance, providing expertise for input on improving systems software, assisting with data migrations, and implementing necessary software and equipment upgrades.

3. Develop and assist in maintaining a LIMS data dictionary (e.g., name of the field, why it is used, how it is formatted, limitations to entry, examples of entry, standardized entry options, picklists).

4. Ensure activities (e.g., validation, UAT) align with associated with DCLSR, CBR, quality management systems, CDC and CBR policies, procedures, guidance, and CAP accreditation requirements. Assist in developing or updating CBR user guides, methods, and job aids. Maintain complete, detailed records of all work performed.

5. Assist in the development and implementation of staff training.

Task 6: CDC Identifiers

1. Perform services relating to the allocation of CDC Identifiers, which include CDC Sample Identifier (CSID) and CDC Unique Identifier (CUID), in compliance with CBR and CDC sample-related policies and procedures.

2. Assist in the management and continued development of the software used to create these identifiers (e.g., CIDLMS). This system must be interoperable (exchange data) with CBR sample label production systems and production, SIMS-LV, ELIMS, and other CDC laboratory information systems (LIMS).

3. Provide assistance and support to CDC programs following CDC policy and CBR guidance outlined in guidelines for standardizing and administering CDC identifiers.

Task 7: Sample Label Production Services

1. Perform services relating to creating and producing CDC sample labels in compliance with CBR and CDC sample-related policies and procedures.

2. Assist in the continued development, maintenance, and utilization of approved CBR systems, equipment, and software to create sample labels for CDC Programs according to CBR and CDC sample-related policies and guidance.

3. Provide assistance and support to CDC programs following CDC policy and CBR guidance outlined in guidelines for the standardization and administration of sample labels, printing software, equipment, and supplies.

4. Maintain contingency operations at the second location as indicated by CBR.

Task 8: SampleGuard Support

1. Assist in implementing and managing the CBR sample storage (liquid nitrogen sample storage units, mechanical freezers, refrigerators), door and room monitoring system known as SampleGuard.

2. Provide technical support for routine system maintenance tasks, such as updating security patches, performing password changes, and configuring controllers and computers.

3. Assist with installing and managing sensors and wiring for the monitoring system as needed.

4. Assist in ensuring SampleGuard is compatible with CBR LIMS (e.g., SIMS-LV, ELIMS) for operability as defined by CBR.

5. Collaborate with CDC staff on software development efforts for web and desktop applications related to SampleGuard.

Task 9: Customer Service, Communications, and Reporting

1. Prepare metrics and routine reports utilizing charts, graphs, and spreadsheets to report any metrics, inconsistencies, or other data as requested or by established procedures.

2. Work collaboratively with staff (e.g., CBR, DCLSR, other contract staff) to pull metrics required for annual assessment, reporting, and other informatics as needed and assist in the preparation of reports for all CBR activities (e.g., operations, quality, cryogenic services, collections management, sample management).

3. Prepare and deliver written and oral reports to various individuals and groups in both informal and formal settings within CBR, the branch, or the division.

4. Respond to questions for inclusion in a formal, comprehensive report.

5. Process CBR-approved requests and communicate with CDC customers via established procedures (e.g., CBR mailbox) or platforms (e.g., CBR online request system, forms).

6. Report customer requests that do not comply with CBR and CDC sample-related policies and guidance to CBR before processing.

7. Contact customers (e.g., CDC programs that own LN2 sample storage units) during events (e.g., overfills, equipment failures, PMs) via CBR SharePoint tools.

8. Assist in developing and managing the SharePoint site as needed.

Option Task 1: Management of SIMS-LV and Migration to ELIMS

1. Assist in maintaining and managing CBR Sample Inventory Management System – LabVantage (SIMS-LV), ensuring that all required sample data is entered accurately according to CDC and CBR policies, processes, and procedures.

2. Support upgrades and data migration to any new system environment as needed.

3. Work collaboratively with LabVantage staff, CDC staff, and ELIMS staff to ensure migrations are completed successfully by providing the expertise needed to provide SIMS-LV information, data, workflows, associated information, and other information as requested.

4. Assist with data mapping required for migration by performing data cleaning for standardization.

5. Prepare data currently not in SIMS-LV for mapping and importation into ELIMS.

6. Participate in user acceptance testing (UAT) to test and determine that CBR needs and requirements are met.

7. Ensure migrations align with activities associated with DCLSR and CBR quality management systems and CAP accreditation requirements by developing or updating CBR procedures and job aids and facilitating staff training of new ELIMS processes and procedures.

8. Assist in management and communications for the SIMS-LV mailbox, a tool for reporting and managing issues.

Optional Task 2: SampleGuard Development

1. Assist in the development and expansion of SampleGuard.

2. Provide support in the implementation of expanded services for SampleGuard.

Optional Task 3: Development of tool(s) for sample sharing

1. Support the development, implementation, and management of a web-based portal with searching capabilities for information about CDC samples defined as Institutional Collections by CDC sample-related policies.

2. The portal should offer tools for searching, filtering, and downloading datasets in various formats, allowing users to explore and utilize data.

3. Data may originate from different sources but align with CDC data requirements (e.g., etiologic agent, epidemiologic data, sample type, collecting locations).

4. The portal should meet goals associated with CBR strategic planning and CDC Sample Policy Board planning and include identified vital components (e.g., access, searchability, standardization, restrictions, and organization).

SECTION 6 – GOVERNMENT FURNISHED PROPERTY

The Government will furnish to the vendor all facilities, equipment, materials, supplies, support services such as all the necessary workspaces, computers, printers, copiers, office supplies, personal protective equipment, and equipment for maintaining IT systems.

The government is responsible for property accountability and recordkeeping of government furnished equipment, and the vendor shall comply with government procedures for periodic inventories. Use of vendor’s own computers shall be limited to their own business recordkeeping.

SECTION 7 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Contract work shall be performed entirely at a government facility (onsite). Onsite locations are within the United States in the Atlanta, Georgia area. The majority of CBR operations and activities take place primarily at the CDC Lawrenceville campus. The vendor shall perform other work detailed in this SOW as needed at either the CDC Roybal or Chamblee campuses. Sample Label services are conducted primarily at the CDC Roybal campus. Contract activities are expected to take place only on days on which government operations are being conducted unless directed by CDC during an emergency (e.g., emergency response to power outage).

SUBSECTION B – CONTRACT SUPPORT HOURS

CBR Customer Service hours are 8:00 am EST to 5:00 pm EST (Monday through Friday, excluding federal holidays), during which the vendor shall provide services as defined within this SOW. CDC core hours are 9:00 am to 3:00 pm EST (Monday through Friday, excluding federal holidays) during which time customer services peak and the vendor will need to meet service demands.

The vendor shall provide on-call support for response to an emergencies afterhours that may result in the loss of property, compromise sample integrity, loss of data, or create a safety issue. CBR afterhours is defined as anytime outside 8:00 am EST to 5:00 pm EST Monday through Friday, including weekends and federal holidays. On-call response must be initiated within one hour of being notified and may require the contractor to report onsite to any of the specified locations within two hours of the notification or sooner.

SECTION 8 – TRAVEL

Travel will be in accordance with/and not to exceed the Federal Travel Regulation rates. Travel costs need to be approved in advance by the COR. The contractor shall be required to provide their travel policy to the Government for review.

Travel does [not] include conferences. Conference Approval Management Systems (CAMS) approval is required in advance of any travel for conferences. If the need for conference travel occurs, the contract will be modified to separately add funding.

Travel will be required to perform some tasks between the Lawrenceville, Roybal, and Chamblee campuses.

SECTION 9 – DELIVERABLES/REPORTING SCHEDULE

All reporting requirements and written deliverables as part of this contract shall be supplied to the project Contracting Officer Representative (COR). Acceptance of any written deliverables is pending CDC COR review and correction to any resulting comments, to be confirmed in writing and documented in the closest following report. Any schedule of interim deliverables may be revised according to CDC acceptance of an updated written work plan by the COR during the project with the restriction that these changes must not impact the overall period of performance, scope, or specifications of the award, or otherwise impinge on the authority of the contracting officer. It is the responsibility of the contractor to fully understand what changes require contracting officer approval. Reports shall be submitted electronically in MS compatible format specified by CBR that meets CDC security and standards and is readily available at CDC (e.g., Word, Excel, and PowerPoint). The contractor shall submit a draft of the report by the date requested, providing CBR with the opportunity to review prior to submission for formal acceptance. Changes requested by the Contractor will require final written approval/acceptance.

· Task: 2

· Liquid Nitrogen Management Plan – Current processes and previous procedures for liquid nitrogen shall be reviewed and considered for continuity of services to develop plan. Plan should describe all process steps that Vendor shall take to provide service.

· Format: Word (draft), Adobe pdf (final)

· Due date: The plan shall be finalized within 40 days of the contract start date. Draft shall be provided within 15 days of the contract start date to the COR and CBR Team Lead for review. Edits and comments will be provided within 15 days of receipt of the draft plan by the Vendor. The Vendor shall complete the updating of the plan within 5 days so plan can be finalized.

· Deliver to: COR and CBR leadership

· Task: 3

· CDC Program Reports – Reports prepared for distribution to CDC Programs that summarize the overall PM activities, health, recommendations, etc. of non-CBR owned equipment. Reports are distinguished into reports summarizing the overall health and activities of a program’s unit fleet, as well as individual unit profile reports. Reports are spread out over a calendar year.

· Format: 1 per CDC program/per year, Word (draft), PDF (final)

· Due date: Draft due 2 weeks prior to final due date. Final due date 1 week prior to CDC Program delivery date established by CBR

· Deliver to: COR and CBR leadership

· All Tasks

· Quarterly Report – The Contractor shall prepare and submit quarterly technical progress reports in narrative form which shall contain technical results of the work accomplished during the reporting period. This report shall be in sufficient detail to disclose all work started and results achieved during the reporting period, an indication of any current problems which may impede performance, the proposed corrective action, and the work forecast for the next period. This document shall report progress and planning so as to correspond with the established work schedule.

· Format: delivered electronically in MS work

· Due Date: by the 10th calendar day of each month

· Deliver to: COR and CBR leadership

· Final Report – Upon completion of all work under the contract, the Contractor shall prepare and submit to the Government a final report covering in detail all the work accomplished under the contract. The final report shall document and summarize the entire contract work and shall include recommendations and conclusions based on the experience and results obtained. The final report shall include tables, graphs, photos, and diagrams in sufficient detail to comprehensively explain the results achieved under the contract. The report shall also include an analysis of salient findings, a presentation of general conclusions, and any guidance or recommendations deemed pertinent for future consideration CDC Biorepository. The Government shall be allowed sixty days to review the draft and notify the Contractor in writing of approval or of recommended changes to be made in the final copy. If the Government does not approve or recommend changes within sixty days of receipt of the draft final report, the report shall be deemed approved.

· Format: delivered electronically in MS Word

· Due Date: Draft due 60 days before the end of period of performance. Final report due NLT by the end of the period of performance

· Deliver to COR and CBR leadership

SUBSECTION A – PERFORMANCE MATRIX

PERFORMANCE OBJECTIVE

Contractor shall complete program (customer) requests (via service form) for CDC Identifiers.

SECTION 10 – ADDITIONAL REQUIREMENTS

Section 508 Compliance 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

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.