A07-Solicitation_18Q0203.docx

W81XWH18Q0203

Section SF 1449 - CONTINUATION SHEET

QASP

Quality Assurance Surveillance Plan for Locus-Specific DNA methylation Analysis

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: TBD Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: 301-619- Email:

b. Contracting Officer’s Representative (COR) – The COR is located at the US Army Center for Environmental Health Research. The COR will be responsible for technical administration of this contract, and shall assure proper Government surveillance of the contractor’s performance with the assistance of up to two (2) Contracting Officer’s Technical Representatives (COTRs). The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Primary COR: TBD Telephone:

Email:

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager: TBD Title: TBD Telephone: TBD Email: TBD

4. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

Table 1. Performance Requirements

3.1. Zymo DNA Methylation Analysis Support Services

5. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Feedback from Oversight Board

· Feedback from Government Users

· Feedback from Property Book Officers

· Direct Observation

· 100% Inspection

· Review of Quarterly Reports (various)

· Review of Monthly Reports (various)

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

· MANAGEMENT INFORMATION SYSTEMS (MIS). (Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.)

· PERIODIC INSPECTION. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

· Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

· Performance reporting.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

6. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by: COR

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: TBD

2. To: (Contractor Task Manager or on-site representative)

3. From: TBD

4. Date and time observed discrepancy:

5. Discrepancy or Problem:

<Describe in detail. Identify any attachments.>

6. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this

CDR. >

Prepared by: COR

Received by:

PWS

PERFORMANCE WORK STATEMENT (PWS)

Locus-Specific DNA methylation Analysis

US Army Center for Environmental Health Research (US ARMY CEHR)

SECTION 1 PURPOSE

0. Introduction: The Integrative Systems Biology Program (ISBP) at US Army CEHR is part of a consortium of research institutions that has been instructed by the Surgeon’s General of the Army, Navy and Air Force to identify an objective molecular signature for diseases of military relevance such Post-Traumatic stress disorder(PTSD).

0. Mission: The mission of the US Army CEHR is to provide diagnostic and prognostic tools for environmental and occupational health surveillance. As part of a new effort to increase the use of a systems biology approach across the U.S. Army Medical Research and Materiel Command (USAMRMC), the US Army CEHR is expanding its capabilities in genomics, proteomics, and high performance computing. Systems biology offers tremendous opportunities to accelerate the pace of discovery for biomedical applications through the use of biological experimentation that is tightly linked to mathematical models and a better understanding of biological networks and molecular biology. With support from the USAMRMC, the US Army CEHR hopes to expand its efforts in this exciting area while contributing to Command- wide applications of systems biology.

0. Background: In the course of conducting PTSD studies, the expression of biomarkers correlating with several comorbidities for PTSD have been identified. One of these comorbidities, sleep disorders, is associated with changes in levels of specific serum metabolites. In order to more precisely characterize this association and validate the DNA methylation region variabilities that correlate with PTSD comorbidities, our laboratory will assess the levels of methylation for specific gene loci, in multiple DNA samples from PTSD as well non-PTSD participants from different cohorts. These results will be compared with those from healthy control subjects.

0. Scope: Human DNA samples are being tested for PTSD markers by the US ARMY CEHR's Integrative Systems Biology Department. Locus-Specific DNA methylation Analysis – Up to 96 primer designs that may include previous validated primer sets and up to 528 samples. Services Include: sample QC, bisulfite conversion, targeted amplification using novel or previously validated primer designs, NGS library preparation, NGS data generation, and Bioinformatics Pipeline Analysis (alignment, methylation calling, sample and/or group.

0. Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1). This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category 3 - Product Support that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

0. Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2). The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2: GENERAL REQUIREMENT

2.1. PERFORMANCE

0. Place of Performance:

2.1.1.1. Primary On-Site Government Location. 568 Doughten Drive, Fort Detrick, Maryland, 21771

2.1.1.2. Off-Site Location.

TBD

2.1.1.3. Period of Performance. This contract is for one (1) twelve (12) month Base Period, with four additional option years.

Base Year: 24 September 2018 – 23 September 2019

Option Period 1: 24 September 2019 – 23 September 2020 Option Period 2: 24 September 2020 – 23 September 2021 Option Period 3: 24 September 2021 – 23 September 2022 Option Period 4: 24 September 2022 – 23 September 2023

2.2. NON-PERSONAL SERVICES:

2.2.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service Contracting.”

The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT:

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.3.2.2. The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more thirty (30) days, the Contracting Officer (KO) shall immediately be notified in writing.

2.3.2.3. Contract Management Plan (CMP) (Deliverable #3). The Contractor shall develop and provide a Contract Management Plan (CMP) with their proposal. The CMP shall include a detailed staffing plan which includes a listing of the key personnel utilizing a job description to describe the position that will be required to meet the objectives of the Performance Work Statement (PWS). Key personnel include: Administrative researchers and staff.

2.3.2.4. Quality Control Plan (QCP) (Deliverable #4). The Contractor shall provide a DRAFT QCP with their proposal and a FINAL QCP no later than Fifteen (15) days after contract award. The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contracts to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.3.3. Subcontract Management. The Contractor shall be responsible for the management and performance of Subcontractors during this contract. Contractors may add Subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR. Cross Teaming shall be permitted.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.1.1. Monthly Status Reports (Deliverable #5). The contractor shall provide monthly reports detailing all work completed. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency.

2.4.1.2. Quarterly Reports (Deliverable #6). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the Contract Specialist, Contracting Officer, and COR no later than fifteen (15) calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.4.1.3. Contractor Manpower Reporting (Deliverable #7). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the AFPMB via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2018. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

2.5. PERSONNEL TRAINING REQUIREMENTS

2.5.1. Completion of All Training Requirements (Deliverable #8). The contractor shall track and complete all initial and refresher trainings to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each contractor and subcontractor personnel working under this contract to the COR within Five (5) calendar days after completion of training.

2.5.1.1. Contractor Attendance at Government Training Opportunities. The Government may require contractor attendance at Government provided or Government sponsored training offered by the Research, Development and Acquisition Support Office, or as outlined in the current version of USAMRMC Command Policy Memorandums “US Army Medical Research and Materiel Command (USAMRMC) Decision Gate (DG) Training Requirements” and “Requirement for Training of Personnel Involved in Food and Drug Administration (FDA)-Regulated Activities”. These training opportunities will be provided via web-based offerings, at on-site classroom settings or at local venues that will not otherwise incur travel expenses by the attendee. The Government determination for contractor attendance at one or more of the aforementioned training opportunities will be based on the applicability of the specific training opportunity to tasks being performed in this PWS and the above referenced USAMRMC Command Policy Memorandums. The COR will document all government training determinations made for each contractor personnel performing under this contract as well as training opportunity attendance/completion.

2.5.1.2. Anti-Terrorism (AT) Level 1 Training. All contractor personnel, including subcontractor personnel, requiring access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contractor personnel and subcontractor personnel to the COR (or to the contracting officer, if a COR is not assigned) with 5 calendar days after completion of training by all personnel and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.3. iWATCH Training. The contractor and all associated subcontractors shall brief all personnel on the Fort Detrick iWATCH program, available on-line at http://www.detrick.army.mil/ready/iwatch.cfm. This locally developed on-line training will be used to inform contractor personnel on how to report suspicious activity. This training shall be completed with the results reported to the COR within Thirty (30) calendar days of contract award.

2.5.1.4. DoD Cyber Awareness Challenge Training. In order to enroll in this training, contractor personnel need to register on the Army Training Certification Tracking System (ATCTS) website. Registration is required for all contractor personnel who require access to government information systems. All contractor personnel with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter. This required non-residential training is on-line at https://ia.signal.army.mil/DoDIAA/default.asp. This training takes approximately one-hour to complete.

2.5.1.5. Operations Security Training (OPSEC) Training. Per Army Regulation (AR) 530-1, Operations Security, new contractor personnel shall complete Level I OPSEC Awareness Training within Thirty (30) days of reporting for duty. This non-residential training is required every 365 days, available on-line at http://cdsetrain.dtic.mil/opsec/index.htm. This training takes approximately 30 minutes to complete.

2.5.1.6. Information assurance/Information Technology (IA/IT training). All contractor personnel and associated sub-contractor personnel must complete the DoD IA Awareness Training before issuance of network access with a refresher training to be taken annually thereafter. All contractor personnel working in IA/IT functions must comply with DoD and Army training regulations DoD 8570.01, DoD 8570.01-M and AR 25-2 within six (6) months of appointment to IA/IT functions.

2.5.1.7. Threat Awareness and Response Program (TARP). Training applies to those contract personnel who have a security clearance. Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil. It takes approximately two hours to complete.

2.5.1.8. Initial Security Orientation and Annual Security Refresher Training. Per requirements in Office of the Surgeon General (OTSG)/ Medical Command (MEDCOM) Policy Memo 14-004, Standardized Security Training darted 15 January 2014. All contractors shall complete the Initial Security Orientation within Thirty (30) days, and then must complete the Annual Security Refresher due every 365 days. This training is available on-line at https://www.lms.army.mil.

2.5.1.9. Army-Wide Network Security Focus (AWSNF) Training. Contractors shall complete this required non-residential training course to include (1) AWNSF-Phishing Awareness, (2) AWNSF-Personally Identifiable Information, (3) AWNSF-Portable Electronic Devices and Removable Storage Media, and (4) AWNSF-Safe Home Computing. Trainings are available on-line at https://iatraining.us.army.mil. All 4 courses shall be completed; this is a one-time only type training, and is required for the establishment of a government network account. These trainings take approximately one-hour to complete.

2.5.1.10. Combat Trafficking in Persons (CTIP) General Awareness Course. DoD mandates compliance, and has a zero tolerance policy regarding CTIP on all Government Contracts. Contractor personnel are therefore required to complete this required training initially, and then once every 365 days. It is available on-line at https://www.lms.army.mil (AKO, then select ALMS) and takes approximately 30 minutes to complete.

2.5.1.11. Emergency Preparedness Response Program. Contractors shall complete this required non-residential training every three years, available on-line at Joint Knowledge Online (JKO) Home Page accessed via https://jko.jfcom.mil. It takes approximately one hour to complete.

2.5.1.12. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training. Contractor personnel shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil. It takes approximately two-hours to complete.

2.5.2. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training (Deliverable #9, Exhibit 3). This paragraph is added to incorporate reporting and training requirements and to reference the OTSG/MEDCOM Policy Memo 16-033, dated 29 March 2016 as an attachment to the contract, Sharp AKO ALMS instructions and the SHARP Self Study slides. This training is in accordance with USAMRAA Policy 17-01, and is applicable to all on-site contractors and contractor personnel supporting all Services type Contracts over the Simplified Acquisition Threshold (SAT), that are awarded by USAMRAA, and who are performing those services on-site in a Government facility or work space, leased or owned. Training may be obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or it can be taken in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the personnel has an AKO account, they can access training online at Army AKO https://www.us.army.mil/.

2.5.2.1. In addition, All contractor personnel shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program which states that All allegations of sexual harassment and sexual assault shall be immediately addressed, no matter where they occur or who are involved. This includes all personnel working in Government facilities in support of contracts awarded by United States Army Medical Research Acquisition Activity (USAMRAA). Department of Defense and Department of the Army (DoDDA) civilian complaints of sexual harassment or sexual assault will be investigated and processed in accordance with the Equal Employment Opportunity (EEO) Program and AR 690-600. Contract personnel with knowledge of an incident of sexual harassment or assault will immediately report the incident to their employer and their employer will immediately report the incident to the Government’s Contracting Officer Representative (COR) or Contracting Officer.

2.6 DUTY HOURS

2.6.1 Duty hours. Contractor personnel shall perform services during regular duty hours, Monday through Friday, during core hours of operation 7:30am to 4:30pm.

2.6.1.1. The contractor shall not perform services on days designated as a Federal Holidays by Federal Status, Executive Order, Presidential Proclamation or Notice from the Installation Commander.

2.6.1.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

New Year’s Day, 1 January

Martin Luther King’s Birthday, 3rd Monday in January

President’s Day, 3rd Monday in February

Memorial Day, last Monday in May

Independence Day, 4 July Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran’s Day, 11 November

Thanksgiving Day, 4th Thursday in November

Christmas Day, 25 December

2.6.1.3. Contractor Personnel shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel shall not report for work nor shall they be compensated for those days.

2.7. TRAVEL

2.7.1. Travel/Temporary Duty (TDY) Reporting. The Government may require contract personnel to travel on a temporary duty basis; the Government will reimburse the contractor for travel expenses where Government billeting and dining facilities are not available to contractor personnel. All travel shall be conducted IAW Government Joint Travel Regulations (JTRs). Reimbursement to the contractor shall be in accordance with the JTR. The contractor shall submit receipts and other documentation to the COR in order to support amounts requested along with invoices. Travel is estimated at $20,000 per year.

2.7.1.1. Travel Request Procedures. The contractor shall coordinate with the COR for all travel. The contractor shall provide a travel estimate in an official written memorandum for approval (contractor format) no later than Fifteen (15) calendar days prior to the travel date. The travel estimate shall include the cost for airline tickets, car rentals, per diem, registration fees, and any other allowable costs associated with the travel request.

2.7.1.2. Travel Approval Process. In accordance with the Paragraph above, any request for Temporary Duty will be coordinated through the COR, and approved in writing from the Contacting Officer in response to a formal written request from the Contractor. No plans will be finalized, commitments made, or funds expended until the KO has provided written approval.

2.7.2. Travel Claim Procedures (Deliverable #10). The contractor shall provide written documentation following each trip. The COR will verify that travel receipts are valid and match the travel requirements identified in the travel request and letter of authorization. Contractor invoices to include costs associated with the travel is due to the COR within Ten (10) calendar days after the completion of the trip. All travel costs shall be billed within Thirty (30) days after completion of travel, unless written approved is obtained from the KO for later billing. Travel costs shall provide detail of all authorized expenses associated with the travel and all receipts including ticket stubs to substantiate claims for all expense items in excess of $75.00. The Government will not reimburse for economy plus, business class, or first –class travel. Travel costs are billed on a strictly cost-reimbursable basis and shall be IAW the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs (subject to local policy and procedures).

2.7.2.1. The estimated travel for these Administrative Business Operations Support Services is Four (4) trips annually. The contractor shall be willing to travel on extremely short notice and numerous occasions throughout the duration of the contract.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide all necessary personnel required to perform services for US Army CEHR. The contractor shall provide Technical Support Services and Laboratory Services. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1. Zymo shall provide locus specific DNA methylation analysis on up to 528 samples.

3.2. Performance Requirement Summary Matrix

3.1. Zymo DNA Methylation Analysis Support Services

Periodic Surveillance

3.3. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4: SPECIAL CONTRACT REQUIREMENTS

4.1.1. Phones. At contract start date, on-site, work areas with desks, chairs, telephones, scanner and computers (laptop or desktop). Cell phone/Blackberry devices will be provided at the discretion of the COR.

4.1.2. Information Technology. The Government shall provide standard software for the desktops, along with office supplies, and reproduction facilities with access to the server(s) located in Building 172. The Contractor shall make any updates as directed by the KO to government-furnished equipment for required compliance and security updates prior to any compliance or security deadlines. The Contractor shall make all government-furnished equipment available to the government upon request for random security scans by the AFPMB Information Assurance Security Officer (IASO).

4.1.2.1. The Contractor shall submit requests for replacement or repair of government-furnished equipment to the COR for processing. Such requests shall specify the reason for the replacement or repair request.

4.1.3. Government Information Systems. All contractor personnel with access to a government information system will be registered in the ATCTS (Army Training Certification Tracking System) and shall successfully complete the DoD Information Awareness Training prior to access to the information system and then annually thereafter.

4.1.3.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.1.3.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the contracting officer grants specific exception.

4.1.3.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.1.3.4. All products including files, software, and other information, which are created, produced or developed during the period of performance, is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.1.4. Custodial Services. Custodial services are provided by Forest Glenn Post contractors.

4.1.5. Recycling. Office materials will be collected for recycling in assigned bins. Recycle when possible.

4.1.6. Fire and Safety Protection. Every workplace will have enough exits suitably located to enable everyone to get out of the facility quickly. Fire extinguishers and hands on training for this equipment will be made available to contractor personnel.

4.1.7. Postage Services. Government- Related Only.

4.2. Safety and Security. The contractor and all associated subcontractors’ personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures. The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation, the Provost Marshal Office, the Director of Emergency Services, and/or the Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Headquarters Department of the Army (HQDA), and/or local policy. Should the Force Protection Condition (FPCON) level at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.1 Common Access Card (CAC). Before a CAC can be issued to contractor personnel, a favorably adjudicated National Agency Check with Inquiries (NACI), IAW Army Directive 2014-05, Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractor, shall be obtained.

4.3.2. CAC-Eligible. An Army contractor who is eligible for a common access card, but is not subject to a higher-level vetting that has been favorably adjudicated.

4.3.2.1. Army contractor personnel requiring access to DoD-controlled installations or facilities on behalf of the Department of the Army on a recurring basis for a period of six (6) months or more, or an individual requiring both access to a DoD-controlled installation or facility and onsite or remote access to DoD or Army-controlled information networks, are eligible for a CAC.

4.3.2.2. Prior to commencement of services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers of all personnel who will be entering Army-controlled installations and facilities.

4.3.2.3. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes in accordance with facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services. The contractor shall contact the COR or Trusted Agent who is responsible to facilitate and sponsor the contractor’s Army Knowledge Online (AKO) registration, and in-processing and out-processing; to include approval, rejection and re-verification.

4.3.2.4. The contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the contract is completed, or when contractor personnel no longer require access to the installation and facility.

4.3.3. Non-CAC Eligible. Personnel of a Department of Defense contractor who is not eligible for a CAC credential, but still requires access to an Army installation or facility.

4.3.3.1. Contractors and all associated sub-contractor personnel shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05), applicable installation, facility and area commander installation/facility access and local security policies and procedures.

4.3.4. Force Protection Condition (FPCON). The Force Protection Conditions system has been approved by the Department of Defense to standardize the identification and recommended preventive actions and responses to terrorist threats against United States personnel and facilities. Strict adherence to FPCON measures is required. A terrorist attack can take place at any time. The greater the perceived threat based on the intelligence received, the higher the awareness needs to be to prevent the loss of life.

4.3.4.1. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels, unless otherwise directed by the contracting officer via the appropriate COR.

4.3.4.2. FPCON Normal. This condition applies when a general global threat of possible terrorist activity exists and warrants a routine security posture. At a minimum, access control will be conducted at all DOD installations and facilities.

4.3.4.3. FPCON Alpha. This applies when there is an increased general threat of possible terrorist activity against personnel or facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON Bravo measures. However, it may be necessary to implement certain measures from higher FPCONs as an additional deterrent or resulting from intelligence received. The measures in this FPCON must be capable of being maintained indefinitely.

4.3.4.4. FPCON Bravo. This applies when an increased or more predictable threat of terrorist activity exists. Sustaining Bravo measures for a prolonged period may affect operational capability and relationships with local authorities.

4.3.4.5. FPCON Charlie. This applies when an incident occurs or intelligence is received indicating that some form of terrorist action or targeting against personnel or facilities is likely. Prolonged implementation of Charlie measures may create hardship and affect the activities of the unit and its personnel.

4.3.4.6. FPCON Delta. This applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is imminent. FPCON Delta is usually declared as a localized condition. FPCON Delta measures are not intended to be sustained for an extended duration.

4.4. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.4.1. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4.4.2. Unclassified Contract Security Requirements: The contractor shall ensure all personnel performing under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the COR will coordinate with the United States Army Garrison (USAG) Fort Detrick Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate or a U.S. passport or the original Naturalization Certificate to the USAG Fort Detrick Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, and USAG Fort Detrick Security Office.

4.5 Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.5.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.5.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.5.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.5.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed.

5.1.2 – Data: Locus-specific DNA methylation analysis for up to 96 new/previously validated primer designs and up to 528 samples

6.2. Applicable Directives.

6.2.1. The contractor shall comply with all documents listed below as mandatory and referenced under Section 3, Performance Requirements.

6.3. Mandatory Compliance.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1 Definitions

7.1.1. Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

7.1.2. Contractor Officer. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. Contractor Officer’s Representative (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.5. Deliverable. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

7.1.6. Key Personnel. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS.