B08. HT9425-25-R-0050 RFP.docx

HT942525R0050

Section SF 1449 - CONTINUATION SHEET

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial services prepared in accordance with subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate solicitation will not be issued.

PERFORMANCE WORK STATEMENT

Title: Food and Drug Administration (FDA) Regulatory Compliance Training

Requiring Activity/Agency Name: Office of Regulated Activities (ORA) in support of the United States Army Medical Research and Development Command (USAMRDC)

1.0 Scope:

This requirement provides competency training for personnel involved in FDA regulated research activities. The USAMRDC requires FDA regulated training in the areas of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Systems Regulations (QSR).

2.0 Background:

The purpose of USAMRDC research and development activities is to provide FDA-approved pharmaceuticals and devices or licensed biologics to members of the United States (U.S) Military. These activities are governed by Federal, Department of Defense (DoD), and Army regulation and result in submissions to the FDA for eventual approval or licensure. Those research and development activities are subject to the compliance requirements of the FDA. The requirements defined in Title 21, Code of Federal Regulations (21 CFR), parts 50, 58, 211, 600, and 820, require all individuals engaged in the conduct or supervision of FDA-regulated studies have education, training, and experience, or a combination thereof, to enable the individual to perform the assigned functions. Therefore, the Command must have in place, as part of its Quality efforts, a compliance program that includes minimum standards for training of all personnel involved in FDA-regulated activities. Training requirements are outlined in accordance with USAMRDC Command Policy Memorandum 2013-60 Requirement for Training of Personnel Involved in FDA-Regulated Activities.

The USAMRDC Headquarters Principal Acquisition Assistant serves as the FDA regulated Sponsor Representative, the responsibility for fulfilling FDA regulated sponsor responsibilities, and providing this training for other Subordinate Commands. USAMRDC ORA will provide technical oversight, guidance, and management of this task order.

3.0 Objective:

Assist personnel involved in FDA regulated product development throughout USAMRDC in maintaining competency in GCP, GLP, and cGMP to comply with U.S FDA and all other applicable DoD and Army regulations, directives, and guidance. The long-term objective of this training is to increase and maintain competency and compliance with FDA regulations governing product development efforts to meet our mission.

4.0 General Information:

4.1 Period of Performance:

Base Year and four one-year Option Periods beginning approximately 1 May 2025.

4.2 Place of Performance: The government anticipates performance of this task order in:

-Fort Detrick, MD (Face to Face) -Microsoft Teams (Virtually)

4.3 Recognized Federal Holidays

The Contractor is not required to perform services on the following recognized Federal Holidays:

New Year’s Day Dr. Martin Luther King Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

4.4 Type of Contract

This task order will be Firm-Fixed-Price. Invoicing will occur after completion of each training course.

5.0 Performance Requirements:

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling the Office of Quality Management to achieve training goals of the Performance Work Statement.

5.1 Training Support. The contractor shall provide expertise in the development of applicable courseware/training materials and conduct classes to increase technical and regulatory knowledge, as follows:

5.1.1. Clinical. Personnel involved in or overseeing clinical trials or studies shall receive training in GCP per ICH E6 Good Clinical Practice: Consolidated Guidance E6 and other applicable FDA and ICH guidance. GCP training shall be conducted at two levels: Introductory and Refresher. The introductory course shall consist of an 8-hour training session with a basic introduction to GCP. The refresher training shall be 4 hours. The refresher component should be limited to recent changes in FDA regulations and guidance and be workshop based. The course should also include training in GCPs for medical device investigations. The workshops should stimulate regulatory discussions of real-world regulatory problems and solutions. Draft training material in electronic format shall be provided for review 21 calendar days prior to the scheduled training (Deliverable 3). Approved training material shall be provided by the contractor 3 business days prior to training and shall include electronic copies when training is performed virtually (Microsoft Teams) and electronic and hard copies when the training is performed face to face (Fort Detrick, MD) (Deliverable 4). The contractor shall record final attendance record and provide Certificates for each trainee to the COR within 10 business days of class completion (Deliverable 5). The contractor shall provide a comprehensive final training report after each training to the COR within 10 business days of class completion (Deliverable 6).

5.1.2. Non-Clinical. Personnel involved in or overseeing non-clinical laboratory safety studies shall receive training in GLP per 21 CFR 58 and applicable FDA and ICH guidance. GLP training shall be conducted at two levels: Introductory and Refresher. The introductory course shall consist of an 8-hour training session with a basic introduction to GLP. The refresher training shall be 4 hours. The refresher component should be limited to recent changes in FDA regulations and guidance and be workshop based. The workshops should stimulate regulatory discussions of real-world regulatory problems and solutions. Draft training material in electronic format shall be provided for review 21 calendar days prior to the scheduled training (Deliverable 3). Approved training material shall be provided by the contractor 3 business days prior to training and shall include electronic copies (Deliverable 4). The contractor shall record final attendance record and provide Certificates for each trainee to the COR within 10 business days of class completion (Deliverable 5). The contractor shall provide a comprehensive final training report after each training to the COR within 10 business days of class completion (Deliverable 6).

5.1.3 Manufacturing training for drugs, biologics, blood, and tissue products. Personnel involved in or overseeing manufacturing operations shall receive training in cGMP per 21 CFR 210 and 211 and applicable FDA and International Conference for Harmonization (ICH) guidance. GMP training shall be conducted at two levels: Introductory and Refresher. The introductory course shall consist of an 8-hour training session with a basic introduction to cGMP. The refresher training shall be 4 hours. The refresher component shall be limited to recent changes in FDA regulations and guidance and be workshop based. The workshops shall stimulate regulatory discussions of real-world regulatory problems and solutions. Draft training material in electronic format shall be provided for review 21 calendar days prior to the scheduled training (Deliverable 3). Approved training material shall be provided by the contractor 3 business days prior to training and shall include electronic copies (Deliverable 4). The contractor shall record final attendance record and provide Certificates for each trainee to the COR within 10 business days of class completion (Deliverable 5). The contractor shall provide a comprehensive final training report after each training to the COR within 10 business days of class completion (Deliverable 6).

5.1.4. Manufacturing training for medical devices. Personnel involved in or overseeing manufacturing operations shall receive training in QSR for medical devices per 21 CFR 820 and applicable FDA and ICH guidance. QSR training shall be conducted at two levels: Introductory and refresher. The introductory course shall consist of an 8-hour training session with a basic introduction to QSR. The refresher training shall be 4 hours. The refresher component should be limited to recent changes in FDA regulations and guidance and be workshop based. The workshops should stimulate regulatory discussions of real-world regulatory problems and solutions. Draft training material in electronic format shall be provided for review 21 calendar days prior to the scheduled training (Deliverable 3). Approved training material shall be provided by the contractor 3 business days prior to training and shall include electronic copies (Deliverable 4). The contractor shall record final attendance record and provide Certificates to each trainee (Deliverable 5). The contractor shall provide a comprehensive training final report after each training (Deliverable 6).

Estimated schedule and number of courses:

Introductory GCP

Refresher GCP

Introductory GLP

1 Training (Virtual on Microsoft Teams)

Refresher GLP

1 Training (Virtual on Microsoft Teams)

Introductory GMP

1 Training (Virtual on Microsoft Teams)

1 Training (Virtual on Microsoft Teams)

The number of participants will be determined prior to each course. It is estimated each course shall not exceed 30 participants when the training is conducted face to face, and when the training is conducted virtually the course shall not exceed 40 participants. Basic and refresher courses shall be provided on back-to-back days, when the trainings will be conducted face to face (in one trip to each location), when the training is conducted virtually the basic and refresher courses shall be provided within the same week.

For all courses, the Contractor shall conduct a skill assessment and identify training gap needs. The Contractor shall facilitate subject matter experts into providing necessary information, employ state of the art teaching materials, and utilize skilled instructors to ensure quality of training delivered. The Contractor shall conduct post training surveys to provide ready feedback on content and quality and adjust the courseware as necessary. A rating scale shall be used to determine a positive, neutral, or negative outcome for evaluation feedback. The Contractor shall participate in change management and process actions and then incorporate into ongoing courseware or develop specific courseware to help facilitate desired objectives.

6.0 Management and Administration

6.1 Contract Management: The Contractor shall provide a Contractor Task Manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the Contractor when the manager is absent shall be designated in writing to the Contracting Officer. The Contractor Task Manager or alternate shall have full authority to act for the Contractor on all contractual matters relating to daily operation of this task order. The Contractor Task manager or alternate shall be available between 0800 – 1600 Eastern Time, Monday through Friday except Federal holidays or when the Government facility is closed due to national emergencies, administrative closings, or similar Government-directed facility closings.

6.2 Monthly Task Progress Report (Deliverable 1): The Contractor shall submit a Monthly Task Progress Report as a deliverable to the Government. The Contractor shall submit the report with a transmittal letter not to exceed two pages that highlights major events and deliverables in the reporting period. The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, a comprehensive list of all work being performed (projects, tasks, and deliverables), and any problems/issues encountered. The Contractor shall require and incorporate input from subcontractors where there are critical or significant tasks and milestones. Critical or significant tasks and milestones shall be defined by mutual agreement between the Government and contractor. The format for the report shall be agreed upon by the Government and Contractor.

6.3 Meetings: (Kick-Off Meeting): The Contractor shall conduct a kick-off meeting (teleconference) in coordination with the Government within 7 business days after task order award. The Contractor shall meet via teleconference with the Government to present an overview of their approach and established schedules, procedures, and points of contact necessary to conduct the required tasks. This meeting shall not exceed 1 hour in length.

6.4 Schedule: The Contractor shall provide the Government the projected schedule of all trainings during the period of performance of this task order within 45 calendar days of task order start (Deliverable 7). The Government will work with the Contractor to finalize the projected schedule.

6.5 Organizational and Consultant Conflicts of Interest (OCI) Certification

The Federal Acquisition Regulation (FAR) Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving OCI, provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 DoD Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses –

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract. The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine, or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

The Contractor is encouraged to present its best strategy for mitigation of any potential OCI under this contract. The Contractor shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, IAW the requirements of FAR Subpart 9.5 OCI to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable OCI disclosure or an update of the previously submitted disclosure or representation.

7.0 Training/Security Requirements

7.1 General Training Requirements

ORA utilizes a training management Excel Spreadsheet to centrally manage and track all DoD-mandated training requirements for support Contractor personnel. Once Contractor personnel have been issued a Government laptop, they will have access to the spreadsheet to track annual training requirements. All Contractor personnel shall complete all training as mandated by ORA and USAMRDC. Training may be face to face at Fort Detrick or accessed online. Contractor personnel shall upload completed training certificates to SharePoint. During the period of performance, Contractor personnel shall comply with any new training requirements that may be required. All training requirements are at no cost to the Contractor and time spent in training is billable to the task order. Compliance with DoD Cyber Awareness Training and Health Information Portability and Accountability Act training requirements is required. Contractor personnel failing to complete training in the requested timeline may lose access to Government-issued laptops and Government-controlled accounts until delinquent training has been completed.

The Government may require Contractor personnel 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 USAMRDC Command Policy Memoranda Decision Gate Training Requirements and “Requirement for Training of Personnel Involved in 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 personnel 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 Performance Work Statement and the above referenced USAMRDC Command Policy Memoranda. The COR will document all Government training determinations made for each Contractor employee performing under this task order as well as training opportunity attendance/completion.

7.2 Antiterrorism (AT)/Operations Security (OPSEC) Training Requirements

7.2.1 AT Level 1 Training

All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and 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 is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 7 calendar days after completion of training by all employees and subcontractor personnel. AT level I Awareness training is available at the following website: http://jko.jten.mil.

7.2.2 Access and General Protection Policy and Procedures

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204‐9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

7.2.2.1 Contractors Requiring Common Access Card (CAC)

Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014‐05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on‐site or remotely; (2) remote access, via logon, to a DoD network using DoD‐approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non‐DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

7.2.2.2 Contractors That Do Not Require a CAC but Require Access to a DoD Facility or Installation. CAC not required.

Contractor and all associated sub‐contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC‐III) and Terrorist Screening Database (Army Directive 2014‐05/AR 190‐13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative); or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

7.2.3 AT Awareness Training for US Based Contractor Personnel Traveling Overseas

This standard language required US based contractor employees and associated subcontractor employees to make available and to receive Government provided area of responsibility (AOR)-specific AT awareness training as directed by AR 525‐13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

7.2.4 iWATCH Training

The contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 7 calendar days after contract award.

7.2.5 Army Training Certification Tracking System (ATCTS) Registration for Contractor Personnel Who Require Access to Government Information Systems

All Contractor personnel and associated Subcontractors working at a Government facility with access to a government info system must be registered in the ATCTS at commencement of services and must successfully complete the DOD Information Assurance (IA) Awareness prior to access to the information system and then annually thereafter.

7.2.6 OPSEC Training

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530‐1. Per AR 530‐1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

7.2.7 Information Assurance (IA)/Information Technology (IT) Training

All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01‐M and AR 25‐2 within six months of appointment to IA/IT functions.

7.2.8 Information Assurance/Information Technology Certification

Per DoD 8570.01‐M , DFARS 252.239.7001 and AR 25‐2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01‐M must be completed upon contract award.

7.2.9 Contract Requiring Performance or Delivery in a Foreign Country

DFARS Clause 252.225‐7043, Antiterrorism/Force Protection for Defense Contractors Outside the US . The clause shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non‐contingency support. The key AT requirement is for non‐local national contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the contractor’ compliance with combatant commander and subordinate task force commander policies and directives.

7.2.10 Threat Awareness Reporting Program

For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b. TARP training will be conducted face-to-face in a classroom setting unless instructed to accomplish on MS-Teams by the instructors.

7.3 Information Assurance Training Requirements

All Contractor Personnel shall meet applicable training and certification requirements, including but not limited to:

a. DoD-approved information assurance workforce certifications appropriate for each category and level as listed in the current version of DoD 8570.01-M

b. Appropriate operating system certification for IA technical positions as required by DoD 8570.01-M.

The Contractor personnel must comply with DFARS 252.239.7001 and be up to date on all training and certification requirements per SOPs, regulations, and policies, as appropriate.

As directed by AR-25-2, the Contractor shall ensure that all Contractor personnel appointed to IA or network operations positions successfully complete an IA security training certification course of instruction equivalent to the duties assigned to them. The Contractor shall also ensure that individuals are certified IAW the DoD baseline requirements of DoDD 8570.1. Contractor personnel with privileged access shall sign a privileged level user agreement. Contractor personnel in technical level positions shall complete the applicable computing environment certifications.

7.4 Privacy Act and HIPAA Training

The Contractor shall ensure that all staff including Subcontractors and consultants comply with the training requirements of the Privacy Act of 1974 (5 U.S.C. 552a) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191). The training requirements are mandated by Office of the Secretary of Defense (OSD) Memorandum 1504-07, “Safeguarding Against and Responding to the Breach of Personally Identifiable Information”: DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs”; US Army Medical Command Memorandum, dated October 18, 2007, on the subject, “Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Training”.

The Contractor shall ensure that the annual Privacy Act and HIPAA training is completed by all staff assigned to or performing on this task order, including Subcontractors and consultants. All required Privacy Act and HIPAA training will be conducted online at Joint Knowledge online at https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf. The Contractor shall ensure all personnel and Subcontractors supply a certificate of Privacy Act and HIPAA training completion to the COR prior to network access being granted and on an annual basis based on the trainee’s birth month thereafter.

7.5 Initial Security Training and Annual Security Refresher Training

For Contractor personnel working at a U.S. government facility per DoD Manual 5200.01, Volume IV, DoD Information Security Program: Controlled Unclassified Information, all personnel within a DoD organization -- i.e., military members, DoD civilians, and on-site support contractors -- must complete DoD Information Security Program training initially within thirty (30) calendar days of reporting for duty and thereafter once every 365 calendar days. The on-line training is available at the ALMS website under the course name, Information Security Program Training.

7.6 Controlled Unclassified Information (CUI)

Initial and Annual Refresher CUI Training is covered in section 12.0 paragraph 6. Per DoD Instruction 5200.48, Controlled Unclassified Information (CUI), all personnel within a DoD organization --i.e., military members, DoD civilians, and on-site support contractors --must complete CUI training initially within thirty (30) calendar days of reporting for duty and thereafter once every 365 calendar days. The training is located at https://securityhub.usalearning.gov/index.html.

7.7 Personally Identifiable Information (PII) and Protected Health Information (PHI)

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, IAW Defense Federal Acquisition Regulation Supplement Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD Directive 5400.11, “DoD Privacy Program,” and DoD 5400.11-R, “DoD Privacy Program”. The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the HIPAA (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” and DoDI 8580.02, “Security of Individually Identifiable Health Information in DoD Health Care Programs.”

8.0 Contractor Travel:

The Contractor will be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR. The contractor shall be responsible for the safety and security of its employees.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor personnel shall submit travel requests with estimated costs to the COR NLT 15 calendar days prior to travel. Travel costs shall be incurred and billed IAW FAR Part 31. Costs for these expenses will be reviewed, certified, and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the Government. The Government will typically not pay for business class or first-class travel.

9.0 Other Requirements

9.1 Contractor Identification

When Contractor personnel perform the services required in this task order on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The Contractor shall ensure that Contractor personnel identify themselves as Contractor personnel when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a Contractor capacity, Contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

10.0 Non-Disclosure/Non-Use Agreement (Deliverable 2)

The Contractor shall ensure that the Non-Disclosure/Non-Use Agreement is signed by all staff assigned to or performing on this task order before performing any work, including all Subcontractors and consultants. The Non-Disclosure/Non-Use Agreement shall be cosigned by a corporate official (Contractor Task Manager(s) or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of staff members who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. Contractors will submit a signed Non-Disclosure Agreement. Requiring activity must ensure the NDA has been approved by its supporting Staff Judge Advocate.

QASP

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.

The following FAR clause will apply:

52.246-4 Inspection of Services – Fixed-Price

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer- The Contracting Officer 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 Contracting Officer shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The Contracting Officer is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned Contracting Officer:

Organization or Agency: USAMRAA Telephone:

Email:

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall ensure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file and record all quality assurance activities in the Procurement Integrated Enterprise Environment (PIEE) Surveillance and Performance Monitoring (SPM) system. At the conclusion of the contract or when requested by the Contracting Officer, the COR shall provide documentation to the Contracting Officer. The 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 Contracting Officer for action.

Assigned COR:

Title: Acquisition Management Liaison Officer Telephone:

Email:

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as the contractor’s Program Manager and Contract Manager for this contract.

a. Contractor POC- TBD Title: Contract Task Manager Telephone:

Email:

b. Alternate POC – TBD Title:

Telephone:

Email:

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.

The Performance Requirements Summary Matrix, shown below, includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

The COR/TO-COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period, the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

5. INCENTIVES.

The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. 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.

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.

PERIODIC INSPECTION: Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

100% INSPECTION: Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.

PERIODIC SAMPLING: Relies on the user of the service to identify deficiencies. Complaints are then investigated and validated. Highly applicable to services provided in quantity and where quality is highly subjective.

RANDOM SAMPLING: Designed to evaluate the outputs of the award requirement by randomly selecting and inspecting a statistically significant sample. Highly recommended for large quantity repetitive activities with objective and measurable quality attributes.

7. 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:

8. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report will be generated each month in SPM. 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 Program or Contracts Manager. 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 Contracting Officer.

9. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract performance, the COR shall take periodic measurements, as specified in the AQL column of the Performance Requirements 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.

Introductory GCP

FFP

Introductory Good Clinical Practice Training in accordance with PWS Section 5.1.4.

FOB: Destination

PSC CD: R499

NET AMT

Refresher GCP

Refresher Good Clinical Practice Training in accordance with PWS Section 5.1.4.

NET AMT

Introductory GMP

Introductory Good Manufacturing Practice Training in accordance with PWS Section 5.1.4.

NET AMT

Refresher GMP

Refresher Good Manufacturing Practice Training in accordance with PWS Section 5.1.4.

NET AMT

Introductory QSR

Introductory Quality Systems Regulations Training in accordance with PWS Section 5.1.4.

NET AMT

Refresher QSR

Refresher Quality Systems Regulations Training in accordance with PWS Section 5.1.4

NET AMT

FFP

Option Year One: Introductory Good Clinical Practice Training (Face to Face at Fort Detrick, MD) in accordance with PWS Section 5.1.4.

NET AMT

FFP

Option Year One: Refresher Good Clinical Practice Training (Face to Face Training at Fort Detrick, MD) in accordance with PWS Section 5.1.4.

NET AMT