Attachment_1_PWS.docx

PERFORMANCE WORK STATEMENT

Contents

PWS

PERFORMANCE WORK STATEMENT (PWS)

Title: Project and study support for Surveillance for Emerging Infectious Disease and Clinical Trials in Cambodia for AFRIMS

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Armed Forces Research Institute of Medical Sciences (AFRIMS).

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

Request a non-personal service contract to support the ongoing AFRIMS research projects involving surveillance for emerging infectious diseases and conduct of clinical trials within Cambodia by the AFRIMS Department of Immunology and Medicine.

3. SCOPE

Procurement support, provision of clinical and epidemiological services, purchase of supplies and equipment, transportation, communications and administrative support.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

Year-round upon request in Cambodia.

5.1. Work Location

The work location is 503 Robert Grant Avenue, Silver Spring, MD 20910.

5.1.1. Telecommuting

Telecommuting is not feasible for the services provided under this contract. Medical equipment maintenance, administrative, and professional support services must be performed on site

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

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

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

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

Contractor shall not report to work on those days the United States Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor employees that are not designated as essential IAW this contract shall not report for work nor will they be compensated for those days. Essential personnel tasks include the following:

5.1.3. Force Protection Condition Info

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander

5.2.2. 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

The following are US Federal Holidays:

· New Year’s Day

· Birthday of Martin Luther King, Jr.

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

The following are Cambodian Federal Holidays:

· 31 Jan: Meak Bojea

· 8 Mar: International Women Day

· 14-16 Apr: Khmer New Year

· 29 Apr: Visak Bojea

· 1 May: International Labor Day

· 3 May: Royal Ploughing Day,

· 13-15 May: His Majesty’s Birthday

· 1 Jun: International Children Day

· 18 Jun: Queen’s Birthday

· 24 Sep: Constitution Day

· 8-10 Oct: Pchum Ben

· 15 Oct: King Norodom Sihanouk memorial day

· 23 Oct: Paris peace accord

· 29 Oct: King coronation

· 9 Nov: National Independence Day

· 21-23 Nov: Water festival

· 10 Dec: International human right day

5.3. Work Schedule

The contractor shall provide/ support eight (8) hours per day, forty (40) hours per week typical Cambodia time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

6.1.1. Provide procurement support for AFRIMS research projects involving surveillance for emerging infectious diseases and conduct of clinical trials within Cambodia. Pathogens that may be the subject of disease surveillance studies include respiratory viral pathogens, leptospirosis, bacterial pathogens, agents of parasitic disease including malaria, and other emerging infections. Products that may be evaluated in clinical trials include anti-malarial drugs and/or vaccines, anti-viral drugs, anti-microbial drugs, and other potential candidates with activity against infectious disease agents. In addition, the contractor must provide office space, utilities, as well as security per the regulations of the United States Embassy Security Office.

6.2. Specific Tasks / Requirements

6.2.1. Clinical and Epidemiological Research Services. Contractor will procure services provided by qualified licensed medical and/or epidemiological staff (i.e. physicians, nurses, allied health professionals, and others) that will best suit project requirements for subject recruitment and enrollment, clinical and epidemiological evaluations, specimen collection, data gathering, and data management. Clinical assessments rendered may include vitals sign measurements, physical examinations, adverse event reports, treatment, and other clinical procedures as specified in clinical research protocols conducted under Good Clinical Practices. Staff will be compensated based on current local law, and the human resources policies of the contractor. (DELIVERABLE 1)

6.2.2. Research Site Infrastructure. Contractor will locate and procure the use of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are appropriate to the scientific requirements of the research projects. Infrastructure costs may include site rental, utilities, and facility upgrades as necessary to meet regulatory requirements and comply with the U.S. Embassy office space requirements for occupational health and safety, as well as U.S. Embassy and U.S. Army physical security requirements.

The Contractor shall include proof that the building rental is in line with Embassy Security Inspections and Approvals; as well as proof of agreements with the Cambodian Ministry of Public Health (MOPH) for access to National Clinics and hospitals for providers; and finally proof of Clinical Research Coordination (CRC) certificate. (DELIVERABLE 2) In Cambodia, health care is primarily provided by the Cambodian Ministry of Public Health (MoPH), and military health care is provided by the Royal Cambodian Armed Forces (RCAF). Through separate agreement, the Cambodian MoPH and the RCAF have allowed AFRIMS personnel to conduct collaborative clinical R&D with them and in their facilities, which affords AFRIMS staff and personnel, including AFRIMS contractor staff, access to sites and the patient population required for AFRIMS DoD studies. The contractor shall provide support personnel under this contract who have access MoPH facilities and privileged to conduct clinical research.

6.2.3. Supplies and Equipment. Contractor will facilitate procurement of supplies, reagents, and equipment needed to support AFRIMS research projects. This procurement support is especially relevant in situations where such supplies must be purchased locally in the Southeast Asia region. (DELIVERABLE 3)

6.2.4. Laboratory Testing. Contractor will procure services provided by qualified laboratory and technical staff (i.e. medical research technologists, technicians, microscopists, and laboratory workers) that will best suit project requirements for laboratory assessments required to support research activity. Assessments rendered may include complete blood counts, chemistries, urine testing, liver enzyme tests, immunological and diagnostic assays, clinical microscopy, molecular diagnostic analyses such as PCR, and other lab tests as required. (DELIVERABLE 4)

6.2.5. Transportation. Contractor will procure transportation support for personnel, equipment, supplies, reagents, laboratory specimens, and study participants by whatever conveyance is required to meet project needs. (DELIVERABLE 5)

6.2.6. Sample shipment. Contractor will arrange for and ship clinical samples where advanced laboratory analysis is required. This will include obtaining the necessary permits and permissions, and procurement and coordination of shipping services. (DELIVERABLE 6)

6.2.7. Communications. Contractor will procure communications services and support to meet project needs. Communication services can include but are not limited to internet access, mobile phone access, satellite communications, and land-line communications. (DELIVERABLE 7)

6.2.8. Administrative services. Contractor will provide administrative and accounting support necessary to execute the terms of this contract. (DELIVERABLE 8)

6.2.9. The Contractor shall also provide Expert Medical Consultation and liaison-services on an AS-NEEDED basis during management of adverse events (AEs) and serious adverse events (SAEs) that may arise in the course of studies. The Expert Medical Consultant will assist with communication and translation of key patient status and information between AFRIMS medical study staff and Cambodian medical staff to ensure professional and accurate management of AEs and SAEs that are referred to the Cambodian standard health care system. . (DELIVERABLE 9)

6.2.10. Office space and utilities. The contractor shall provide the office space necessary to perform the required work associated with this requirement. In addition, the contractor must provide the utilities in order for the building to function. (DELIVERABLE 10)

6.2.11. Security. The contractor shall provide security services for the office that are in line with the United States Embassy Security Office’s regulations and guidelines. (DELIVERABLE 11)

6.3. Management Reports and Plans

Monthly Financial Tracking Report (Deliverable 12). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter.

Monthly Report (Deliverable 13). The contractor shall provide a monthly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of all tasks.

Quality Control Plan (Deliverable 14). The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 15). 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 AFRIMS 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 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

The contractor shall complete and deliver the QCP No later than 15 days after contract award

The contractor shall complete and deliver the CMRA.

By October 31 or on the last day of contract performance – whichever is first.

The contractor shall provide a Transition-In Plan Due with proposal

The contractor and all of its employees working on this contract must complete the annual HIPAA training, or provide statement of compliance with Cambodian National Law regarding safeguard of Protected Health Information (PHI) Within 30 days after contract award, and then annually thereafter for the remainder of the contract.

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable DFAR clause 252.227-7013, Rights in Technical Data-Noncommercial Items. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the United States 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.

Contractor Performance Assessment Reporting System (CPARS). The Contractor CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a task order. The Contractor has 30 days after the United States Government's evaluation is completed to comment on the evaluation. The United States Government Contractor Representative must either concur or non-concur to each CPAR. If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR. Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

6.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the United States Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

6.3. COR Information

6.3.1. COL Phillip Smith, Philip.Smith.mil@afrims.org, +66.081.902.6756.

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The United States Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The United States Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the United States Government as necessary.

The United States Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

Frequency: Monthly

Positive CPARS Feedback

>99.99%

Frequency: Monthly.

Positive CPARS Feedback

>99.99% Frequency:

By October 31 or on the last day of contract performance – whichever is first.

Positive CPARS Feedback

8. TRANSITION SUPPORT

8.1. Incoming Transition Plan

The Contractor shall provide a plan for 30 days of incoming transition. The Contractor shall coordinate with the United States Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall develop and deliver a Transition-in Plan (Deliverable 16). This transition plan shall include, but is not limited to the following items as applicable:

a. Coordination with Government representatives,

b. Review, evaluation and transition of current support services,

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process, e.

f.

g.

h. Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

i. Distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

j. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance, k.

l.

9. Other Direct Costs (ODCs)

9.1. The Contractor shall deliver, upon request, supplies incidental to the performance of the tasks described in section 6 of this PWS.

10. KEY PERSONNEL

The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key Personnel table.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The United States Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced with 30 days.

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. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

KEY PERSONNEL TABLE

· Contractor shall have high level experience in malaria, parasitology or relevant field to malaria disease surveillance or product development, will have >6 years of experience working in a research laboratory.

· The contractor shall have demonstrated their subject matter expertise in a number of areas, and their ability to conduct team-based research through publication of several technical reports and/or peer-reviewed publications. Knowledge and experience in the development of medical products for licensure is desired.

· The contractor will have experience managing a research laboratory, including technicians and other junior scientists. The contractor will be expected to execute their assigned tasks, and to share their findings and expertise with other members of the project team.

· Excellent written and oral communication skills are essential, and the contractor is expected to write reports and publications, and present their findings in meetings.

· Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

· Experience: regulated clinical trial experience with drugs or vaccine under

· Certifications: Fluent in English

· Specialized Training: experience in Malaria, influenza, and or other endemic diseases

· Experience: working experience in clinical trials and clinical investigations

· Certifications: current GCPs and bio-medical ethics training

· Certifications: valid Cambodian driver’s license

11. TRAVEL/TEMPORY DUTY (TDY)

Travel will take place within Cambodia. All travel requires approval/authorization by the Study Principal Investigator (PI) or Study Coordinator and the COR. The Contractor shall provide for all necessary travel documents and approvals, immunization support, and safety plans that may be required for some destinations. The Contractor will provide a comprehensive travel estimate to be approved by the Study Principal Investigator (PI) or Study Coordinator prior to commencing travel arrangements. The Contractor must maintain on file receipts for travel expenses, vouchers, and copies of receipts.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Travel costs and reimbursements will be in accordance with local policy and rates.

All travel and transportation shall be conducted using the most cost-effective means, preferably commercial sources and carriers, provided the method used is appropriate for the geographical area and results in reasonable charges to the United States Government. The United States Government will not pay for business class or first-class travel.

Please see below for the list of travel locations and the expected trip details:

Phnom Penh

12. GOVERNMENT FURNISHED PROPERTY

Not applicable for this requirement.

13. Subcontracting

Subcontracting will be allowed in this requirement.

14. Contract Management

14.1. Government Management

The Contracting Officer’s Representative (COR) 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. Only the KO has the authority to enact changes to this award.

14.2. 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.

14.3. Contractor Organization

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.

14.4. Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

14.5. Subcontract management

14.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

14.5.2. The contractor is responsible and accountable for subcontractor performance on this contract

14.5.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

14.5.4. Contractor my add subcontractors to their team after notification and written approval from the KO.

14.5.5. Privy of contract is with the contractor and the subcontractor…..

15. COMPLIANCE DOCUMENTS

15.1. General Compliance

15.1.1. United States Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

15.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

e) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

f) DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

g) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

h) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

i) Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

j) Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

k) Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

l) College of American Pathologists Inspection Checklists. http://www.cap.org

m) Clinical Laboratory Standards Institute. Standards and Guides for Laboratories: http://clsi.org/standards

n) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

o) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

p) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

q) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

r) Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

s) Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

t) Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

u) Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

v) Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

w) Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910

x) Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

y) Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

z) Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

aa) Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

15.2. Human Research Protections

15.2.1. Research Involving Human Subjects

The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 USC. 980, and, when applicable, FDA policies and regulations.

The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met:

a) The Contractor furnishes to the ORP, with a copy to the KO, an assurance of compliance and IRB approval and receives notification from the KO that the ORP has approved the assurance as appropriate for the research under the Statement of Work and also that the ORP has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the ORP, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the KO immediately of any suspensions or terminations of the assurance.

b) (2) The Contractor furnishes to the ORP, with a copy to the KO, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the KO that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor’s furnished exemption determination, the ORP retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

c) The Contractor shall adhere to all applicable DoD regulations pertaining to Human Subjects Protection and Ethical Standards. Specifically, 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of Human Subjects; Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011; Army Regulation (AR) 70-25 (under revision): Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990. Applicable US CFR regulations are: Title 21, CFR Part 50 Protection of Human Subjects, Title 21 CFR Part 56, Institutional Review Boards; Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014; Title 32 CFR Part 219, Protection of Human Subjects; Title 45 CFR 46, Protection of Human Subjects, April 1, 2014

15.2.2. Medical Malpractice and Indemnification

The contractor and contract Physician Health Care Provider (HCP) shall abide by all Government standards, regulations, rules, and procedures including requirements for any licensure, credentialing and quality assurance requirements. Such regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, Joint Commission (JC), and patient safety initiatives.

For the contracts awarded as non-personal service contracts, the United States Government will not be liable for malpractice allegations against contract Physician HCP’s based upon performance of this contract. The contractor shall be required to carry malpractice insurance for its contract Physician HCPs, at a level stated in the solicitation and included in any resulting contract for subject acquisition in tailored FAR Clause 52.237-7. If an apparent successful Offeror, the contractor shall provide evidence of insurability concerning medical liability insurance prior to task order award. Upon task order award, the contractor shall provide evidence of insurance demonstrating the required coverage prior to commencement of performance. In accordance with FAR Clause 52.237-7, the contractor will indemnify the United States Government for any liability producing act or omission by the contractor, its contract HCPs and agents occurring during contract performance. If the contractor uses subcontractors in the performance of this contract, the contractor is required to ensure that its subcontracts for provisions of healthcare services contain the requirements of FAR 52.237-7, including the maintenance of medical liability insurance.

If any suit or action is filed or any claim is made against the contract Physician HCP which occurred as a result of work performed by the Physician HCP under this contract, the Physician HCP shall immediately notify the contractor, the KO and the chief of the appropriate services and promptly furnish them copies of all pertinent documents received.

The contractor or contract Physician HCPs shall not bill the patient, any insurer, or any other person, for services rendered under this contract. The contractor or contract Physician HCPs shall not request or accept compensation of any kind for patients treated, procedures performed, or any other actions performed.

The contractor or contract Physician HCPs shall not, while performing services under this contract, advice, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the contractor or contract Physician HCPs or from any third party at any place other than as designated under this contract.

The contractor shall not use patient care rendered pursuant to this contract or any subsequently awarded task order as part of a study, research grant, or publication without the prior written consent of the KO.

The contractor shall comply with each of the following:

a) Title 32, Part 219 Protection of Human Subjects also known as the Common Rule (PDF, 2011) Electronic Code of Federal Regulations 32 CFR 219 (2011)

b) Title 48, Part 252.235-7004 Part 207.172 , Federal Acquisition Regulations Part 207.172 applies to human research

c) United States Code Section 980 of Title 10 (PDF, 2001), Limitation on Use of Humans as Experimental Subjects

d) DoD Instruction 3216.02 , Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (2011)

e) DoD Instruction 5134.01 , Under Secretary of Defense for Acquisition, Technology, and Logistics (2005)

f) DoD Instruction 6200.02 , Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs (2008)

g) DoD Instruction 6000.08 , Funding and Administration of Clinical Investigation Programs (2007)

h) DoD Directive 2310.01E , Department of Defense Detainee Program (2006)

i) DoD Directive 5400.11 and 5400.11R , Department of Defense Privacy Program (2007)

j) DoD Instruction 6025.18 , Privacy of Individually Identifiable Health Information in DoD Health Care Programs (2009)

k) DoD 6025.18-R , Health Information Privacy Regulation (2003)

l) AR 70-25 , Use of Volunteers as Subjects of Research (1990)

m) AR 40-7 , Use of U.S. Food and Drug Administration-Regulated Investigational Products in Humans Including Schedule I Controlled Substances (2009)

15.3. Information Technology Compliance

15.3.1. Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at: http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

15.3.2. Army Regulation 25-2, Information Assurance

Compliance information regarding Army Information Assurance may be found at: https://ia.signal.army.mil/docs/AR25-2.pdf

15.3.3. Cyber-security

Department of Defense (DOD) Instruction 8500.01 Cybersecurity

15.3.4. Risk Management Framework

Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

15.4. Medical and Laboratory Compliance

15.4.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at: http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

15.4.2. Protection of Human Subjects

Compliance information regarding Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011, may be found at: http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

15.4.3. DOD Health Information Privacy

Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

15.4.4. Research Integrity and Misconduct

DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

15.4.5. Volunteers as Subjects of Research

Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

15.4.6. Clinical Laboratory Improvement

Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

15.4.7. Clinical Laboratory Improvement Program

Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

15.4.8. Pathology Inspection

College of American Pathologists Inspection Checklists. http://www.cap.org

15.4.9. Laboratory Standards

Clinical Laboratory Standards Institute. Standards and Guides for Laboratories: http://clsi.org/standards

15.4.10. Laboratory Requirements

Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

15.4.11. Clinical Laboratory Practice Standards

National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

15.4.12. Clinical Practice

ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

15.4.13. Clinical Practice

Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

15.4.14. Clinical Practice

Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

15.4.15. Financial Disclosure by Clinical Investigators

Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

15.4.16. Institutional Review Boards

Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

15.4.17. Investigational Device Exemptions

Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

15.4.18. National Defense, Protection of Human Subjects

Title 32 CFR Part 219, National Defense, Protection of Human Subjects, http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title32/32cfr219_main_02.tpl

15.4.19. Protection of Human Subjects

Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

15.4.20. Bloodborne Pathogens

Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910

15.4.21. Transportation of Materials Containing Certain Etiologic Agents Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

15.4.22. Category B Infectious Substances

Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

15.4.23. Dangerous Goods Regulations of the International Air Transport Association Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

15.4.24. Records Maintained on Individuals

Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

16. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013. http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

b) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

c) Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

d) Army Regulation 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

e) Army Regulation 40-501, Standards of Medical Fitness

f) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

g) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

17. OTHER TERMS, CONDITIONS, AND PROVISIONS

17.1. Non-Personal Services

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 United States Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the United States Government assign tasks or prepare work schedules for individual contractor personnel.