Attach_J.1_PWS_5.18.18.pdf

DEPARTMENT OF HOMELAND SECURITY (DHS)

PERFORMANCE WORK STATEMENT

FOR

BIOWATCH LABORATORY STAFFING

April 27, 2018 Updated May 18, 20188

1.0 GENERAL

1.1 BACKGROUND

The U.S. Department of Homeland Security (DHS) mission is to ensure a homeland that is safe, secure, and resilient against terrorism and other hazards. The DHS Office of Health Affairs (OHA) in Countering Weapons of Mass Destruction (CWMD) provides medical, health, and scientific expertise in support of the DHS mission to prepare for, respond to, and recover from all threats.

The BioWatch Program Office within DHS CWMD supports this mission through the BioWatch program, the only civilian program that monitors for the aerosol release of bioterrorism agents.

The Mission of the BioWatch program is to provide and maintain a continuous bio-terrorism air monitoring system in large metropolitan areas and coordinate with state and local public health communities to prepare for and respond to a bioterrorist event. Established in 2003, BioWatch continuously monitors select urban environments twenty-four hours a day, seven days a week. The BioWatch program’s Strategic Objectives include:

• Monitor for highest priority biological agents that could result in catastrophic outcomes;

• Provide protection in the most at-risk locations of the nation;

• Maintain the technical oversight of operations in close collaboration with state and local public health partners who execute the program;

• Conduct advanced development, procure and deploy better detection capability at lower cost with Federal research and development (R&D);

• Coordinate Federal, State, and local public health preparedness planning activities to develop operational protocols for a BioWatch Actionable Result (BAR); and

• Continue to strengthen Federal, State, and local partnerships and build efficiencies.

The BioWatch program consists of distinct operational components including field, laboratory and public health. The field component conducts daily collection of air filter samples for delivery to a state or local laboratory. The public health component develops response plans and manages the local public response in the event of a BioWatch Actionable Result. The Laboratory Component includes capabilities to analyze collected samples to detect the presence of select biological agents and report the results. The BioWatch Progam Office currently provides contracted laboratory staff to most BioWatch laboratories to perform the laboratory analysis under the guidance of the local Laboratory Director.

1.2 SCOPE

BioWatch Program consists of distinct operational components, including field, laboratory and public health. The Contractor shall provide laboratory-staffing services to the BioWatch LRN laboratories throughout the United States available to provide analysis twenty-four (24) hours a day, seven (7) days a week, three hundred and sixty five (365) days a year effectively managing and meeting all laboratory training, testing, analysis, logistics, and reporting requirements as further defined in this Performance Work Statement (PWS).

1.3 OBJECTIVE

BioWatch currently maintains operational laboratories in approximately 30 jurisdictions across the country. The Program must ensure each location is able to perform daily sample collection and analysis in a timely manner and be flexible enough to provide additional coverage for large special security or other high-risk events. The objective of this PWS is to identify and define laboratory staffing and support options for the BioWatch Program moving forward. Any Performer supporting the BioWatch Program in this effort must be able to provide qualified, competently trained, proficient, and reliable laboratory staff to ensure the Program maintains the ability to generate high quality, reliable, and actionable laboratory results. It is also expected that laboratory personnel understand the technical work, quality assurance policies, and the national security implications of the results generated. Moreover, due to the evolving threats and vulnerabilities that are identified at the Federal, State, and Local level require operational flexibility and adaptability that must be able to be supported with laboratory staff capable of performing quality analysis in accordance with mission needs. In addition, the evolving operational needs of the Program require that the Performer is able to provide the necessary flexibility and adaptability in schedule and volume to ensure BioWatch can address changes in testing volumes for both planned events and unforeseen incidents.

1.4 APPLICABLE DOCUMENTS

1.4.1 Compliance Documents

The following documents provide specifications, standards, or guidelines that must be complied with in order to meet the requirements of this contract:

The Local Public Health Laboratory may have additional standards and/or certifications based on local policy (such as Clinical Laboratory Improvement Amendments (CLIA) certification, American Society of Clinical Pathology (ASCP) certification, or registration with the Select Agent Program. The Contractor is responsible for coordinating with the Local Laboratory Director to ensure that personnel assigned to the location for BioWatch duties comply with local requirements.

DHS Document: Safeguarding Sensitive but Unclassified (For Official Use Only) Information, January 2005.

https://www.dhs.gov/sites/default/files/publications/Management%20Directive%2011042.1%20Safeguarding%20Sensitive%20But%20Unclassified%20%28For%20Official%20Use%20Only%29%20Information.pdf https://www.dhs.gov/sites/default/files/publications/Management%20Directive%2011042.1%20Safeguarding%20Sensitive%20But%20Unclassified%20%28For%20Official%20Use%20Only%29%20Information.pdf

1.4.2 Reference Documents

The following documents may be helpful to the Contractor in performing the work described in this document:

Associated protocols and guidance documents included in the BioWatch Master Document List_20171031

2.0 SPECIFIC REQUIREMENTS/TASKS

2.1 TASK 1: BioWatch Laboratory Support Staff

The contractor shall perform all required operational sample analysis (screen and confirm) within twelve (12) hours of receipt of samples by the laboratory, under routine day to day operations. The contractor shall provide a PM who is responsible for overall execution of the requirements set forth in this PWS. This is a key personnel position.

2.1.1 The contractor, working directly with the state or local Laboratory Directors (or designees) in each BioWatch jurisdiction, shall provide qualified laboratory personnel to conduct BioWatch analysis activities at state and municipal public health laboratories under the auspices of the local Laboratory Director within the United States. All laboratory personnel shall meet state/local accreditation requirements (e.g.

Select Agent Registration, American Society of Clinical Pathologist (ASCP)) as determined by each local Laboratory Director.

2.1.2 The contractor support, at the Biological Scientist/Laboratory Scientist level shall perform, at a minimum, the following tasks/responsibilities in accordance with BioWatch standard operating procedures under the auspices of the state/local Laboratory Director (or designee).

2.1.2.1 Handling, receipt and processing of operational, Quality Assurance, and proficiency test samples potentially containing biological threat agents;

2.1.2.2 Performing non-research biological science work utilizing microbiological and molecular techniques, which currently includes DNA extraction and real-time polymerase chain reaction (real-time PCR)to identify and characterize pathogenic bacterial and viral agents (analytical methods and technologies may change over the life of the contract);

2.1.2.3 Preparing reagents and samples;

2.1.2.4 Familiarity with Good Laboratory Practice (GLP);

2.1.2.5 Decontamination of work spaces, including Biological safety cabinets, hoods/air boxes, equipment, and other items associated with processing and anlysis activities;

2.1.2.6 Maintaining chain-of-custody (CoC);

2.1.2.7 Interpretation of results;

2.1.2.8 Data entry utilizing computerized or computer-linked systems;

2.1.2.9 Performing routine equipment calibration, cleaning, assembly, and maintenance;

2.1.2.10 Collecting, processing, and analyzing internal laboratory swipes/swabs for Quality Assurance/Quality Control (QA/QC) and contamination monitoring;

2.1.2.11 Proper disposal of bio-hazardous waste;

2.1.2.12 Restocking and maintaining proper inventory of necessary supplies;

2.1.2.13 Supporting BioWatch Program logistics in conducting and documenting annual inventory of DHS-procured durable equipment and property;

2.1.2.14 QA/QC and acceptance testing of reagents in accordance with applicable Standard Operating Procedures (SOPs) and the Laboratory Operations Quality Assurance Program Plan (QAPP);

2.1.2.15 Adhering to QA/QC requirements in accordance with the Public Health Laboratory quality management systems and the BioWatch Laboratory Operations (QAPP);

2.1.2.16 Maintaining documentation of records demonstrating compliance with applicable training/retraining, competencies, document reviews;

2.1.2.17 Analyzing routine external QA samples in accordance with the BioWatch SOP’s and QA Program guidance;

2.1.2.18 Proper archiving, storage, and shipping of samples;

2.1.3 The individual at each location that is designated as the Laboratory Lead shall perform, in addition to the duties listed above:

2.1.3.1 Troubleshoot technical laboratory issues in conjunction with the local

Laboratory Director and/or designee and BioWatch Laboratory Operations personnel;

2.1.3.2 Develop and maintain work schedules for local BioWatch laboratory personnel;

2.1.3.3 Maintain and document training/retraining and competency of all

BioWatch laboratory personnel and observe staff on a quarterly basis;

2.1.3.4 Confirm refresher training is performed following protocols updates/amendments and as required;

2.1.3.5 Generate and maintain documentation in accordance with the SOP’s and QAPP;

2.1.3.6 In compliance with local policy and direction from the Local

Laboratory Director, generate and execute corrective action plans in accordance with the BioWatch Laboratory QAPP to address any findings from audits, proficiency tests, data trend analysis, internal inspection findings, and/or other occurances that have the potential to

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2.1.3.7 Participation in Monthly Laboratory Operations Technical Conference

Call and other BioWatch Program-related communications as appropriate

2.1.4 Laboratory Staff support of multi-center studies. Prior to full operational deployment, the BioWatch Program must have the ability to evaluate the performance of alternative products and processes (e.g., reagents, assays, consumables, equipement, extraction processes, and instruments) utilizing the different workflow and suitability/feasibility constraints at local facilities. In addition, it is essential to have the ability to evaluate potential products and processes against the unique environmental backgrounds that are present in each different operational jurisdiction.

2.1.4.4 2.1.4.1 The Laboratory staff at all locations will be requested to perform, in addition to routine operations, additional studies to evaluate operational effectiveness and suitability of new processes and/or assays.

2.1.4.5 2.1.4.2 The Laboratory staff at all locations will be requested to evaluate potential products and processes against the unique environmental backgrounds present in each different operational jurisdiction.

2.1.52.1.4 Laboratory Response Network (LRN) Staff Support. The Contractor shall provide

BioWatch laboratory staff the opportunity to support laboratory activities and response to public health emergencies by allowing them to receive cross-training on CDC LRN and Public Health Laboratory protocols/procedures. This cross-training will be performed at the discretion of the Local Laboratory Director (or designee) to ensure readiness and proficiency in the case of a public health emergency. These activities shall not interfere with the work required for the BioWatch Program and shall be accomplished within the normal workday with no additional cost to the Federal, State, or Local government being incurred.

2.2 Task 2 Continuity of Support (Performance Based)

The Contractor shall ensure that the contractually required level of support for this requirement is maintained at all times. The Contractor shall ensure that all contract support personnel are present for all hours of the workday. If for any reason the Contractor staffing levels are not maintained due to vacation, leave, appointments, vacancies, etc., and replacement personnel will not be provided, the Contractor shall provide e-mail notification to the Contracting Officer’s Representative (COR) prior to reduction of staff below the established thresholds. Otherwise, the Contractor shall provide a fully qualified replacement.

Staffing Levels:

2.2.1 Staffing Levels. The contractor shall provide appropriate staffing levels over the life of the contract to support once-a-day sample analysis across all jurisdictions and accommodate analysis of multiple collections in at least one location.

2.2.2 The Laboratory staffing levels overall shall not fall below 90 percent per year and

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Formatted: Font: 12 pt thestaffing level shall not fall below 75 percent in excess of one month for any BioWatch laboratory.

2.2.3 The Contractor shall notify the Contracting Officer (CO) and Contracting Officer Representative (COR) of the departure of personnel 24 hours of the contractor receiving notice, and at least 10 business days prior to the outgoing person’s departure.

The date of departure is defined as the date on which the outgoing person returns their badge to the Laboratory or contractor.

2.2.4 Resumes for at least 3 proposed candidates shall be provided to local Laboratory Director for review within 12 business days of personnel notification of intent to leave positions and/or if the positions are vacated without notice. The contractor shall solicit feedback from the local Laboratory Director or their designee concerning suitability of candidates to work in their laboratory.

2.2.5 Changes in the staffing levels for BioWatch Laboratory Operations may be impacted by addition and/or subtraction of jurisdictions by the BioWatch Program or changes to the Program’s Concept of Operations.

2.2.6 In the event that additional BioWatch laboratories are established, the Contractor shall, upon notification by the Contracting Officer and addition of sufficient funding via modification, provide appropriate staffing as described above. Personnel shall be available for training within 30 days of notification. It is not anticipated that new laboratories will exceed 15% of the current required capability.

2.2.7 Staffing at some current locations may be reduced or discontinued as the result of Public Health Laboratory electing to use its own personnel or other means to staff laboratory operations. The Government will advise the contractor of such a change 60 days in advance.

2.2.8 Advances in technology that are successfully deployed by the Program may result inreductions (e.g. deployment of an autonomous detection capability) or increases (e.g.deployment of orthogonal technologies) in the level of staff required at a given jurisdication. The Program will provide notification 60 days in advance of changes to staffing requirements due to changes in Program Concepts of Operations.

2.3 TASK 3: Training (Performance Based)

Laboratory Staff Training. The Contractor shall provide the required training to staff to address vacancies or newly formed positions and ensure that they have successfully completed competency requirements to support operations at the Local laboratory.

2.3.1 The minimum competency levels will be provided by the BioWatch Program as well as all of the necessary process and procedural information necessary to perform the training.

2.3.2 The Contractor will ensure that the individual(s) is capable of demonstrating sufficient competency prior to arrival at the operational laboratory to minimize additional burdens on the remaining incumbent staff. Dependence on personnel from an operational laboratory to conduct basic procedural training should be minimized. Use of alternative or centralized facilities and designated training support staff is preferred.

2.3.2.1 Prior to arrival at an operational laboratory, the new staff must have reviewed each of the BioWatch laboratory operations protocols listed on the current version of the Master Document List and have documentation indicating they achieved an understanding of the content.

2.3.2.2 Prior to arrival at an operational laboratory, any new staff must have, at a minimum, demonstrated competency at sample processing and PCR set-up processes.

2.3.2.3 It is expected that new staff successfully complete Demonstration of Competency within 90 days of the initiation of training. Any extensions beyond 90 days will require communication to the Program with justification (email is acceptable). If justifications or extended delays are deemed to indicate a need for additional training, the Program may request removal of the individual from the operational lab for additional training.

2.4 Task 4 Surge and Special Event Support

Laboratory Operations Surge and Special Event Support for BioWatch Program Activities.

The Contractor shall provide support, on an ad hoc basis, to maintain operations during public health incidents, natural disasters, and other emergency requirements, as needed. This may include, but is not limited to, increased sample burdens, relocation of testing, or implementation of alternative schedules. The Contractor shall provide experienced, trained, and competent laboratory personnel to support analysis in an appropriate laboratory space that may be located anywhere in the United States and its Territories. Personnel supporting emergency response events must be available to travel to the designated location within 72 hours of notification by the COR. This subtask will be initiated against the surge and travel CLINS by the Contracting Officer’s Representative (COR) or BioWatch Laboratory Operations Director and approved by the COR.

2.4.1 The Contractor shall provide support, on an ad hoc basis, to support planned local special events, National Special Security Events (NSSEs), and other events that are deemed to have elevated risk, as needed. The contractor shall provide experienced, trained, and competent laboratory personnel to support analysis in an appropriate laboratory space that may be located anywhere in the United States and its Territories.

This subtask will be initiated against the surge and travel CLINS by the Contracting Officer’s Representative (COR) or BioWatch Laboratory Operations Director and approved by the COR.

2.4.2 Staffing for this requirement will vary based on the size, duration, and collection schedule for each event. Major events (NSSEs or SEAR I) are not anticipated to exceed 2 shifts for a period of 14 days. Multiple special events are anticipated throughout the year, but major events that require significant supplementation of staff are limited and vary based on the number of NSSEs projected (e.g. Inauguration).

2.4.3 Provision of staff to support special event or surge activities must not put routine operations at risk. This includes the location of the event as well as any of the other locations administered by the Contract. Use of staff from other operational locations to supplement the location of the event should be minimized, and use of

Alternative testing facilities is permitted if operational timelines can be maintained. Plans to provide support for events or surge activities by utilizing current staff from operational jurisdictions will be presented to the COR for approval prior to deployment.

2.4.4 The Contractor shall provide the COR with labor, travel, and per diem cost information for personnel deployed in support of special event and/or surge operations for approval prior to the event.

3.0 CONTRACTOR PERSONNEL

3.1 Qualified Personnel

The Contractor shall provide qualified personnel with the specified required skills and technical background to perform all the tasks identified in this PWS.

3.1.1 Laboratory Scientist and all personnel working under this contract should have a minimum of a Bachelor’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences and at least one year of laboratory bench experience, utilizing PCR, aseptic techniques and experience with biological assays.

Laboratory training that is assigned or accompanies an associated course is not considered applicable training. Biological Safety Level (BSL)-3 experience is desirable.

3.1.2 Molecular Biological Scientists should have a Ph.D. or Master’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences with at least one year of laboratory bench experience, utilizing PCR, aseptic techniques and biological assays, and at least one year of experience serving as a Senior Scientist or Team Leader of a laboratory team/project. Bachelor’s degree from an accredited university requires four years of laboratory bench experience, including at least one year of experience as a Team Leader/Senior Scientist. BSL-3 experience is desirable.

3.1.3 Personnel serving in a Laboratory Lead position should have a Ph.D. or Master’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences with at least two years of laboratory bench experience, utilizing PCR, aseptic techniques and biological assays, and at least two years of experience serving as a Senior Scientist or Team Leader of a laboratory team/project. Bachelor’s degree from an accredited university requires five years of laboratory bench experience, including at least two years of experience as a Team Leader/Senior Scientist. BSL-3 experience is desirable.

3.1.4 An initial report, due no later than 90 days from contract award, which lists each BioWatch laboratory individual and their qualifications for their present position. Updates will be required as new personnel are hired. These will be provided as an annual update and will include all BioWatch laboratory personnel (old and new).

3.2 Key Personnel

Key Personnel include: Project Manager; Technical Manager

3.2.1 Before replacing any individual designated as Key by the Government, the Contractor shall notify the Contracting Officer no less than 15 business days in advance, submit written justification for replacement, and provide the name, education, experience, and relevant qualifications of any proposed substitute(s). All proposed substitutes shall possess

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3.55 pt qualifications equal to or superior to those of the Key person being replaced, unless otherwise approved by the Contracting Officer. The Contractor shall not replace Key Contractor personnel without approval from the Contracting Officer. The following Contractor personnel are designated as Key for this requirement. Note: The Government may designate additional Contractor personnel as Key at the time of award.

3.2.2 Key Personnel provided by the Contractor shall have the education and qualifications to address the technical and business management requirements associated with laboratory operations and have the skills and technical background necessary to successfully complete the tasks described in this PWS, including but not limited to, the following:

3.2.2.1 The Project Manager should have a minimum of a Bachelor’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences with at least six years of laboratory bench experience utilizing PCR and other biological laboratory techniques. In addition, at least three years of experience as a Senior Scientist, Project Team Lead, or Laboratory Supervisor is required.

3.2.2.2 The Technical Manager should have a Ph.D. or Master’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences with at least two years of laboratory bench experience, utilizing PCR, aseptic techniques and biological assays, and at least two years of experience serving as a Senior Scientist or Team Leader of a laboratory team/project.

Bachelor’s degree from an accredited university requires five years of laboratory bench experience, including at least two years of experience as a Team Leader/Senior Scientist. BSL-3 experience is desirable.

3.2.3 The Contractor shall provide a Project Manager(s) who shall be responsible for all

Contractor work performed under this PWS. The Project Manager shall be a single point of contact for the Contracting Officer and the COR. It is anticipated that the Project Manager shall be one of the senior level employees provided by the Contractor for this work effort.

The name of the Project Manager, and the name(s) of any alternate(s) who shall act for the Contractor in the absence of the Project Manager, shall be provided to the Government as part of the Contractor's proposal. The Project Manager is further designated as Key by the Government. During any absence of the Project Manager, only one alternate shall have full authority to act for the Contractor on all matters relating to work performed under this contract. The Project Manager and all designated alternates shall be able to read, write, speak and understand English. Additionally, the Contractor shall not replace the Project Manager without prior approval from the Contracting Officer.

The Project Manager shall be available to the COR via telephone between the hours of 0800 and 1800 EST, Monday through Friday, and shall respond to a request for discussion or resolution of technical problems within 2 hours of notification.

3.2.4 The Technical Manager(s) will provide direct oversight for technical and QA-related issues, ensure compliance with Program protocols and guidance, development of corrective actions, and related operational tasks and issues. Any issues will be communicated to the Program in accordance with the Deliverables (Section 9.0 below) included in this PWS and status updates and/or areas of potential risk associated with staffing performance will be included in the Monthly Status Reports provided to the Program.

3.2.5 A technical visit to each operational location, including those staffed through cooperative agreements, must be performed annually. Due to the large number of laboratory staff and dispersed locations, it is anticipated that the Contractor may require multiple staff to assist the Technical Manager and Project Manager with the daily oversight and management aspects of this effort.

3.2.5.1 Qualifications for individuals that are anticipated to function in these roles must be included as key personnel in the staffing plan and in the Personnel Qualification Report provided to the Program.

3.2.5.2 At a minimum, these individuals must have a Ph.D. or Master’s degree from an accredited university in microbiology, molecular biology or related course work in biological sciences with at least two years of laboratory bench experience, utilizing PCR, aseptic techniques and biological assays, and at least two years of experience serving as a Senior Scientist or Team Leader of a laboratory team/project.

Bachelor’s degree from an accredited university requires five years of laboratory bench experience, including at least two years of experience as a Team Leader/Senior Scientist. BSL-3 experience is desirable.

3.2.6 The Contractor shall provide personnel to conduct and document a yearly inventory of all DHS procured durable laboratory equipment and property that has been provided to each BioWatch laboratory. This can be accomplished during technical visits by Technical Manager(s) or by a separate individual. If performed by a separate individual, that person should have a minimum of a Bachelor’s degree from an accredited university with course work or work experience in microbiology, molecular biology or closely related field with some experience serving as a laboratory supply specialist. Knowledge and background in the following areas are also desirable: laboratory equipment and consumable supplies, and computer systems, methods and applications, including word processing and spreadsheets.

It is acceptable for the Technical Manager or other identified Key Personnel to accomplish this task during the annual technical visit.

3.2.7 Contractor Key personnel shall not be assigned by the Contractor to more than one key position for this requirement.

3.3 Quality Assurance Oversight and Notification Plan

The Contractor shall develop and implement a Quality Assurance Oversight and Notification Plan to ensure contractor personnel are conducting themselves in a professional manner and relating appropriately with other personnel, to include state and/or local personnel in the BioWatch laboratory.

3.3.1 The Contractor shall deliver to the COR and the BioWatch Program Office a copy of the Quality Assurance Oversight and Notification Plan within 30 days of contract award, with updates delivered within 30 days of the Option year being awarded.

3.3.2 Issues raised by Laboratory Directors (or designees) regarding behavior or performance of laboratory procedures shall be communicated to the Program Office via phone and/or email in a timely manner (within 7 days) and documented in the monthly status report.

3.3.3 The Contractor will provide notification via email to the Program of any personnel working in an operational lab that fails to exhibit performance consistent with the guidance for Demonstration of Competency (this will also be captured in the monthly status report).

3.3.4 In the event a personnel issue is of such severity that laboratory operations are negatively impacted, a written notification (email is acceptable) shall be provided to the COR and the BioWatch Program Office within three (3) calendar days of the Contractor becoming aware of the issue. Upon resolution of the issue, a report detailing the issue and its mitigation shall be provided to the COR, Laboratory Director, and BioWatch Program Office within ten (10) business days of resolution. All such incidents must also be documented in the monthly status report.

3.3.5 Any incidents that have the potential to detrimentally affect the safety or health of personnel or the quality of operations at a given location will be communicated to the Program by phone and email within 24 hours of the Contractor becoming aware of the situation. All such incidents must also be documented in the monthly status report.

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3.6 Employee Identification

Contractor employees working in Local Laboratory spaces will comply with the State/Local identification and badging requirements.

3.6.1 Contractor employees visiting Government facilities shall wear an identification badge that, at a minimum, displays the Contractor name, the employee’s photo, name, clearance-level and badge expiration date. Visiting Contractor employees shall comply with all Government escort rules and requirements. All Contractor employees shall identify themselves as Contractors when their status is not readily apparent and display all identification and visitor badges in plain view above the waist at all times.

3.6.2 Contractor employees working on-site at Government facilities shall wear a Government issued identification badge. All Contractor employees shall identify themselves as Contractors when their status is not readily apparent (in meetings, when answering Government telephones, in e-mail messages, etc.) and display the Government issued badge in plain view above the waist at all times.

3.7 Employee Conduct

Contractor’s employees shall comply with all applicable Government regulations, policies and procedures (e.g., fire, safety, sanitation, environmental protection, security, “off limits” areas, wearing of parts of DHS uniforms, and possession of weapons) when visiting or working at Government facilities. The Contractor shall ensure Contractor employees present a professional appearance at all times and that their conduct shall not reflect discredit on the United States or the Department of Homeland Security. The Project Manager shall ensure Contractor employees understand and abide by Department of Homeland Security established rules, regulations and policies concerning safety and security.

3.8 Removing Employees for Misconduct or Security Reasons

The Government may, at its sole discretion (via the Contracting Officer and/or COR), direct the Contractor to remove any Contractor employee from DHS facilities for misconduct or security reasons. Removal does not relieve the Contractor of the responsibility to continue providing the services required under the contract. The Contracting Officer will provide the Contractor with a written explanation to support any request to remove an employee.

4.0 OTHER APPLICABLE CONDITIONS

4.1 TRANSITION IN/OUT

Operational staffing and support must continue during any periods associated with contractual transition of performance to another performer. A 90-day transition period will be required at both the beginning of performance (assuming duties from a previous performer) as well as at the end of the period of performance (transitioning duties to a subsequent performer). The Contractor shall deliver to the COR and the BioWatch Program Office a copy of the transition plan within 30 days of contract award.

4.1.1 The transition-in phase shall identify those actions, plans, procedures, and timelines necessary to ensure a smooth transition from contract start date to full operational status by the Contractor. The Contractor shall continue to perform contract requirements during the period between the initial decision date and completion of the phase-in transition period. The Government will provide the Contractor office space and telephone access as available. The phase-in transition period shall begin at date of contract award and shall conclude 90 days later. Upon completion of the phase-in transition period, the Contractor shall assume full operating accountability and responsibility. The Contractor shall deliver to the COR and the BioWatch Program Office a copy of the initial transition in plan within 10 days of contract award.

4.1.2 The transition-out phase shall identify those actions, plans, procedures, and timelines necessary to ensure a smooth transition to a new contractor from start date to full operational status by the new contractor. The Contractor shall continue to perform contract requirements during the period between the initial decision date and completion of the phase-out period. A final transition plan that covers any remaining initial transition activities, but also outlines the close-out transition activities is due within 30 days on contract award.

4.2 SECURITY

Contractor access to unclassified, but Security Sensitive Information may be required under this PWS. Contractor employees shall safeguard this information against unauthorized disclosure or dissemination.

All personnel working within the contract shall pass a background check, all laboratory personnel shall register with the CDC Select Agent Program (if their local laboratory requires registration and/or non-BioWatch/BioWatch duties require them to work with select agents, including quality control), and all personnel shall sign a non-disclosure agreement (NDA) with the Contractor that meets or exceeds the requirements of a DHS NDA.

4.3 PERIOD OF PERFORMANCE

This contract will be structured as a one-year base period with four one-year option periods.

4.4 PLACE OF PERFORMANCE

The primary place of performance will be a combination of the Contractor’s facilities and the Department of Homeland Security at state or local Public Health Laboratories and Jurisdictions, as listed in this PWS and its appendices (note changes in the pricing schedule of the contract). In addition, the Contractor will be expected to travel to the BioWatch Program Office in the Washington, DC area, for briefings and meetings, as required.

The current location of the BioWatch Program Office is 1120 Vermont Ave, NW, Washington, DC 20005, but another location may be selected if the Program Office staff is relocated or a more appropriate venue is identified.

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4.5 HOURS OF OPERATION

Personnel will typically be working at State and Local Laboratory sites and can expect normal work hours to include eight hours per day with varying start and finish times dependent on the site. BioWatch Laboratory operations occur 7 days a week, 365 days a year.

In addition, laboratory personnel will work under the following conditions:

• Shall require working on weekends and holidays (24/7 coverage)

• May require working past 5:00 pm

• One laboratory requires a second shift

• 24-hour coverage for laboratory response to a bioterrorism event or public health emergency; extended work hours and alternative shift work, including weekends, may be required to maintain 24/7 readiness

4.6 TRAVEL

Contractor travel shall be required to support this requirement. All travel required by the Government outside the local commuting area(s) will be reimbursed to the Contractor in accordance with the Federal Travel Regulations (FTR). The Contractor shall be responsible for obtaining COR approval (electronic mail is acceptable) for all reimbursable travel in advance of each travel event.

• Travel to Workshops. The Contractor shall provide travel and per diem for three individuals per BioWatch laboratory to attend the National BioWatch Workshop, as determined by the Laboratory Director (or their designee). This requirement extends to all BioWatch laboratories, including those staffed by the State or Local Laboratory.

o At least one individual from each location shall be a State/Local official, such as the Laboratory Director (or designee);

o At least one individual shall be a BioWatch laboratorian;

o The remaining individual must be associated with the BioWatch

Program, but can be assigned to another laboratorian or State/Local official as determined by the jurisdiction;

o If a particular location is unable to utilize or does not require travel for three personnel, the Contractor, upon approval by the COR, may utilize the open travel slot to provide travel for personnel from another Program laboratory.

• Travel to Exercises. the Contractor shall provide travel and per diem for one BioWatch laboratorian per year, on an as-needed basis and at the discretion of the Laboratory Director and approval of the COR, to participate in their local BioWatch Jurisdictional Exercise. For planning purposes, the Government anticipates five Program-coordinated exercises per year.

4.7 ODCs

ODCs may include, but are not limited to applicable biosafety training, transport/packaging and shipping training for biological material and/or hazardous material, shipping and postage costs, copying, faxing, long distance phone usage, materials and supplies, courier services, costs related to publication/documentation/dissemination of information to operational locations and/or Federal Program Management.

ODCs must be approved prior to incurring any costs.

ODCs must be approved by the COR, and must be necessary, allowable, and allocable for performance of this contract.

ODCs must be submitted in sufficient time to the COR to give prior approval, and must identify the purpose of the ODCs and cost breakdown.

Contractors will be reimbursed for other direct costs as provided in contract to be reimbursed, invoices, including ODCs must provide a detailed breakdown of the actual expenditures invoiced directly related to this contract. Contractor shall maintain the original or legible copy of receipts for all ODCs invoiced.

4.8 POST AWARD CONFERENCE

The Contractor shall attend a Post Award Conference with the Contracting Officer and the COR no later than 10 business days after the date of award. The purpose of the Post Award Conference, which will be chaired by the Contracting Officer, is to discuss technical and contracting objectives of this contract and review the Contractor's draft project plan. The Post Award Conference will be held at the Government’s facility, located at 1120 Vermont Ave, NW, Washington, DC 20005, or via teleconference.

4.9 PROJECT PLAN

The Contractor shall provide a draft Project Plan at the Post Award Conference for Government review and comment. The Contractor shall provide a final Project Plan to the COR not later than 30 business days after the Post Award Conference.

4.10 BUSINESS CONTINUITY PLAN

The Contractor shall prepare and submit a Business Continuity Plan (BCP) to the Government.

The BCP Plan shall be due 90 business days after the date of award, and will be updated on an annual basis. The BCP shall document Contractor plans and procedures to maintain support during an emergency, including natural disasters and acts of terrorism.

4.10.1 The BCP, at a minimum, shall include the following:

4.10.24.10.1 A description of the Contractor’s emergency management procedures and policy

4.10.34.10.2 A description of how the Contractor will account for their employees during an emergency

4.10.44.10.3 How the Contractor will communicate with the Government during emergencies

4.10.54.10.4 A list of primary and alternate Contractor points of contact, each with primary and alternate a) Telephone numbers, b) E-mail addresses

4.10.64.10.5 Individual BCPs shall be activated immediately after determining that an emergency has occurred, shall be operational within 24 hours of activation or as directed by the Government, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first.

In case of a life threatening emergency, the COR shall immediately make contact with the Contractor Project Manager to ascertain the status of any Contractor personnel who were

Formatted: Body Text, Indent: Left: 0.65", Right: 0.81", No bullets or numbering, Tab stops: Not at 1.15" located in operational spaces affected by the emergency. When any disruption of normal, daily operations occur, the Contractor Project Manager and the COR shall promptly open an effective means of communication and verify:

4.10.6.1 Key points of contact (Government and contractor)

4.10.5.1

4.10.6.24.10.5.2 Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

4.10.6.34.10.5.3 Means of communication available under the circumstances

(e.g. email, webmail, telephone, FAX, courier, etc.)

4.10.5.4 Essential Contractor work products expected to be continued, by priority 4.10.6.4

4.10.74.10.6 The Government and Contractor Project Manager shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. Contractors shall obtain approval from the Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

4.10.84.10.7 A BioWatch Staff Management, Utilization, and Training report by laboratory and by position is to be provided on a monthly basis (to the COR) that lists which staff positions are filled and which are vacant, as well as a summary list of current training statuses, recruitment efforts, and non-routine utilization of personnel.

4.10.94.10.8 The Contractor will meet with BioWatch Program Management, as determined, to assess required staffing levels and address challenges that arise over the life of the contract.

4.11 PROGRESS REPORTS

The Project Manager shall provide a monthly progress report to the Contracting Officer and COR via electronic mail. This report shall include a summary of all Contractor work performed, including a breakdown of labor hours by labor category, all direct costs by line item, an assessment of technical progress, areas of risk, schedule status, any travel conducted and any Contractor concerns or recommendations for the previous reporting period. A template for reporting will be provided to the Contractor by the BioWatch Program. The Contractor will also provide an annual performance review to the BioWatch Program at a location designated by the Program near the midterm of the period of performance.

4.12 PROGRESS MEETINGS

The Project Manager shall be responsible for keeping the COR informed about Contractor progress throughout the performance period of this contract, and ensure Contractor activities are aligned with DHS objectives. The Project Manager and other Key Personnel shall be available to meet with the CO and COR upon request to present deliverables, discuss progress, exchange information and resolve emergent technical problems and issues. At a minimum, this meeting shall take place on an annual basis and be held at a Government facility (1120 Vermont Ave, Formatted: List Paragraph, Indent: Hanging: 0.75", Outline numbered + Level: 4 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 1.57" + Indent at: 2.34", Tab stops: 2.36", Left + 2.36", Left

Formatted: Indent: Left: 2.4", No bullets or

Formatted: Left

NW, Washington, DC 20005) unless all parties agree to an alternative location or schedule.

4.13 GENERAL REPORT REQUIREMENTS

The Contractor shall provide all written reports in electronic format with read/write capability using applications that are compatible with DHS workstations (Windows and Microsoft Office Applications).

4.14 INTELLECTUAL PROPERTY

DHS will provide certain DHS information, materials, and forms unique to DHS to the Contractor to support certain tasks under this PWS. Such DHS-provided information, materials, and forms shall remain the property of DHS, unless otherwise indicated in writing by DHS, and may not be distributed beyond the Contractor project performers without DHS' prior written permission. The OHA Technical Representative identified in this PWS will be the Point of Contact (POC) for identifying required information to be supplied by DHS

4.15 PROTECTION OF INFORMATION

Contractor access to proprietary information is not required under this PWS. Contractor employees shall safeguard BioWatch Program information against unauthorized disclosure or dissemination in accordance with DHS MD 11042.1, Safeguarding Sensitive But Unclassified (For Official Use Only) Information. If Contractor personnel are exposed to to business or procurement sensitive information, the Contractor shall ensure that all personnel having access sign a non-disclosure agreement (DHS Form 11000-6).

4.16 SECTION 508 COMPLIANCE

Section 508 Comliance is not anticipated for activities contained in this PWS. However, pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by P.L.

105-220 under Title IV (Rehabilitation Act Amendments of 1998) all Electronic and Information Technology (EIT) developed, procured, maintained and/or used under this contract shall be in compliance with the “Electronic and Information Technology Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR Part 1194. The complete text of Section 508 Standards can be accessed at http://www.access-board.gov/ or at http://www.section508.gov.

5.0 GOVERNMENT TERMS & DEFINITIONS

5.1 BAR – BioWatch Actionable Result

5.2 CO – Contracting Officer

5.3 COR – Contracting Officer’s Representative

5.4 DHS − Department of Homeland Security

5.5 DOD - Department of Defense

5.6 GFI - Government Furnished Information

5.7 GFP - Government Furnished Property

5.8 NDA - Non Disclosure Agreement

5.85.9 Alternate/Centralized facilities – a common training location that is separate for the labs http://www.access-board.gov/ http://www.section508.gov/

6.0 6.0 GOVERNMENT FURNISHED RESOURCES

DHS will provide certain information, materials, and forms unique to DHS to the Contractor to support certain tasks under this PWS. Such DHS-provided information, materials, and forms shall remain the property of DHS, unless otherwise indicated in writing by DHS, and may not be distributed beyond the Contractor project performers without DHS' prior written permission.

6.1 DHS will provide Government furnished property (GFP) to the Contractor to perform laboratory analysis in each BioWatch Laboratory. This includes equipment and instruments associated with the daily processing and analysis of samples. The contractor shall maintain appropriate property management on the GFP. The Government will provide the complete inventory of GFP to the Contractor for work required under this contract upon award.

6.2 DHS will provide information and documentation to the Contractor relevant to performing operations in a BioWatch Laboratory. This includes Best Practices and workflow guidance, laboratory protocols, Program response guidance documents, and other applicable Program policies.

7.0 CONTRACTOR FURNISHED PROPERTY

The Contractor shall furnish all facilities, materials, equipment and services necessary to fulfill the requirements of this contract, except for the Government Furnished Resources specified in PWS 2.0 and PWS 6.0.

8.0 GOVERNMENT ACCEPTANCE PERIOD

The COR will review deliverables prior to acceptance and provide the contractor with an e-mail that provides documented reasons for non-acceptance. If the deliverable is acceptable, the COR will send an e-mail to the Contractor notifying it that the deliverable has been accepted.

8.1 The COR…