FA3047-15-R-0006_CAMD_Solicitation.pdf

502D CONTRACTING SQUADRON

1655 SELFRIDGE AVE

JBSA LACKLAND TX 78236-5253

210-671-1700

210-671-3360

UNDER DPAS (15 CFR 700)

11. DELIVERY FOR FOB

RFQ

SEE SCHEDULE

14. METHOD OF SOLICITATION

IFB RFP

CODE

SEE ADDENDUM

BLOCK IS MARKED

DESTINATION UNLESS

12. DISCOUNT TERMS

(No Collect Calls)

$32.5M

13b. RATING

13a. THIS CONTRACT IS A RATED ORDER

X

CODE

FA3047-15-R-0006 03-Apr-2015

b. TELEPHONE NUMBER

210-671-0792

8. OFFER DUE DATE/LOCAL TIME

09:00 AM 17 Apr 2015

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CONTRACT SERVICES

2200 BERQUIST DR

LACKLAND AFB TX 78236-5300

TEL: 210-292-8371 FAX:

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

TIMOTHY D. SMITH

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621511

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FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

FA3047-15-R-0006

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES ESTIMATED

QUANTITY

UNIT UNIT PRICE ESTIMATED AMOUNT

0001 1,936 Hours

Senior Scientist

FFP

Senior Scientist

In accordance with the attached Performance Work Statement.

FOB: Destination

SIGNAL CODE: A

ESTIMATED

NET AMT

UNIT UNIT PRICE ESTIMATED AMOUNT

0002 3,872 Hours

Registered Research Nurse/Coordinator

FFP

Registered Research Nurse/Coordinator

In accordance with the attached Performance Work Statement.

ITEM NO SUPPLIES/SERVICES EST .

UNIT UNIT PRICE AMOUNT

0003 20,000 Each

Travel

COST

Travel in accordance with the Performance Work Statement.

This is a Not to Exceed Amount of $20,000.00.

NOTE: Each = Dollar

ESTIMATED COST

UNIT UNIT PRICE ESTIMATED AMOUNT

0004 3,872 Hours

Biomedical Laboratory Technician

FFP

Biomedical Laboratroy Technician

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

0005 1,936 Hours

Research License Vocational Nurse

FFP

Research License Vocational Nurse

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

0006 100,000 Each

Expendable Supplies

COST

Expendable Supplies - In accordance with the attached Performance Work

Statement.

This is a Not To Exceed Amount of $100,000.

NOTE: Each = Dollar

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1001 1,936 Hours

OPTION Senior Scientist

FFP

Senior Scientist

In accordance with the attached Performance Work Statement.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1002 3,872 Hours

OPTION Registered Research Nurse/Coordinator

FFP

Registered Research Nurse/Coordinator

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

1003 20,000 Each

OPTION Travel

COST

Travel in accordance with the Performance Work Statement.

This is a Not to Exceed Amount of $20,000.00.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

1004 3,872 Hours

OPTION Biomedical Laboratory Technician

FFP

Biomedical Laboratroy Technician

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

1005 1,936 Hours

OPTION Research Licnensed Vocational Nurse

FFP

Research License Vocational Nurse

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

1006 100,000 Each

OPTION Expendable Supplies

COST

Expendable Supplies - In accordance with the attached Performance Work

Statement.

This is a Not To Exceed Amount of $100,000.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

2001 1,936 Hours

OPTION Senior Scientist

FFP

Senior Scientist

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

2002 3,872 Hours

OPTION Registered Research Nurse/Coordinator

FFP

Registered Research Nurse/Coordinator

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

2003 20,000 Each

OPTION Travel

COST

Travel in accordance with the Performance Work Statement.

This is a Not to Exceed Amount of $20,000.00.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

2004 3,872 Hours

OPTION Biomedical Laboratory Technician

FFP

Biomedical Laboratroy Technician

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

2005 1,936 Hours

OPTION Research Licnensed Vocational Nurse

FFP

Research License Vocational Nurse

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

2006 100,000 Each

OPTION Expendable Supplies

COST

Expendable Supplies - In accordance with the attached Performance Work

Statement.

This is a Not To Exceed Amount of $100,000.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

3001 1,936 Hours

OPTION Senior Scientist

FFP

Senior Scientist

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

3002 3,872 Hours

OPTION Registered Research Nurse/Coordinator

FFP

Registered Research Nurse/Coordinator

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

3003 20,000 Each

OPTION Travel

COST

Travel in accordance with the Performance Work Statement.

This is a Not to Exceed Amount of $20,000.00.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

3004 3,872 Hours

OPTION Biomedical Laboratory Technician

FFP

Biomedical Laboratroy Technician

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

3005 1,936 Hours

OPTION Research Licnensed Vocational Nurse

FFP

Research License Vocational Nurse

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

3006 100,000 Each

OPTION Expendable Supplies

COST

Expendable Supplies - In accordance with the attached Performance Work

Statement.

This is a Not To Exceed Amount of $100,000.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

4001 1,936 Hours

OPTION Senior Scientist

FFP

Senior Scientist

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

4002 3,872 Hours

OPTION Registered Research Nurse/Coordinator

FFP

Registered Research Nurse/Coordinator

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

4003 20,000 Each

OPTION Travel

COST

Travel in accordance with the Performance Work Statement.

This is a Not to Exceed Amount of $20,000.00.

NOTE: Each = Dollar

UNIT UNIT PRICE ESTIMATED AMOUNT

4004 3,872 Hours

OPTION Biomedical Laboratory Technician

FFP

Biomedical Laboratroy Technician

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE ESTIMATED AMOUNT

4005 1,936 Hours

OPTION Research Licnensed Vocational Nurse

FFP

Research License Vocational Nurse

In accordance with the attached Performance Work Statement.

UNIT UNIT PRICE AMOUNT

4006 100,000 Each

OPTION Expendable Supplies

COST

Expendable Supplies - In accordance with the attached Performance Work

Statement.

This is a Not To Exceed Amount of $100,000.

NOTE: Each = Dollar

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

FOR

CENTER FOR ADVANCED MOLECULAR

DETECTION (CAMD) LABORATORY

6 MARCH 2015

1. Description of Services/General Information. The Contract Personnel (CP) shall provide personal services for the Center for Advanced Molecular Detection (CAMD) Laboratory at San Antonio Texas, Department of Defense

(DoD) Military Treatment Facilities (MTF). The CP shall perform services and support compatible with the medical facility’s operating capacity and equipment.

1.1. All services shall be provided in accordance with (IAW) established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission standards, Accreditation

Association for Ambulatory Health Care, applicable DoD, military specific regulations, directives, and policies, and

MTF specific policies and procedures. CP shall give the highest regard to patient dignity and observe the precepts of the American Hospital Association’s Bill of Rights for Patients.

1.2. Relationship of the Parties and Professional Liability.

1.2.1. This is a personal services contract (as defined by Federal Acquisition Regulation [FAR] Subpart 37.104) and is intended to create an employer-employee relationship between the Government and the CP only to the extent necessary for providing the health care services required under the contract. The performance of the CP under this contract is subject to day-to-day supervision, clinical oversight and control by healthcare facility personnel comparable to that exercised over military and civil service personnel engaged in comparable work. The personal services contract does not create an employer-employee relationship between the Government and any corporation, partnership, business association, or other party or legal entity with which the CP may be associated.

1.2.2. Any personal injury claims alleging negligence by the CP within the scope of the CP’s performance of the personal services contract shall be processed by DoD in the same manner as claims alleging negligence by DoD military or civil service personnel. The authority for this contract is 10 United States Code 1089 and 10 United

States Code 1091.

1.2.3. If any suit or action is filed or any claim is made against the CP, which occurred as a result of work performed by the CP under this contract, the CP shall immediately notify the Contracting Officer (CO) and furnish copies of all pertinent correspondence received.

1.2.4. The CP shall also cooperate with the Government, without further compensation, in the processing, review, settlement, or defense of the suit, action, or claim; and authorize Government representatives to settle or defend the claim and to represent the CP in, or take charge of, any litigation involved in such an action. The CP may, at the

CP’s own expense; participate in defense of such claim or litigation.

1.3. Description of Services. CP shall perform the following duties IAW CAMD Standard Operating Procedures

(SOPs), CAMD Operating Instructions (OIs) and Applicable Institutional Review Board (IRB) approved protocols:

1.3.1. Laboratory Operation Duties:

1.3.1.1. Log in samples and assign Personal Identification Numbers (PINs) to samples.

1.3.1.2. Prepare, process, analyze and store samples using molecular-based methods including but not limited to

Deoxyribonucleic Acid (DNA)/Ribonucleic Acid (RNA) extraction and Polymerase Chain Reaction (PCR), instrumentation, and Good Laboratory Practice (GLP) and supporting the Genomic Personalized Healthcare

Initiative (genetics, genomics, metabolomics, bioinformatics; “G2P”).

1.3.1.3. Document sample results in lab notebooks and shall enter results into spreadsheets and databases as required. The Contractor shall follow the specimen processing schedule set by the Government Lab Manager at weekly lab team meetings. Prepare reports with tables and graphs showing de-identified testing results and trends;

minimum of weekly reporting, maximum of daily reporting based on priority and quantity of specimens collected.

1.3.1.4. Provide appropriate technical recommendations regarding best strategies and scientific approaches to achieve program objectives. Review CAMD SOPs and CAMD OIs every six months. Provide recommended updates to Government as appropriate in support of CAMD protocols and on-site equipment. CAMD protocols include but are not limited to: Diagnosis and Epidemiology of Upper Respiratory Tract Infections in the Basic

Military Trainee Population, Genetic Epidemiology of Risk-Associated Single Nucleotide Polymorphisms of Type 2

Diabetes Mellitus, Genetic Repository study of upper respiratory blood and genetic material specimens, Surveillance of Respiratory, Viruses in Wilford Hall Ambulatory Surgical Center Clinic Patients, Retrospective Analysis of the

Incidence of Viral and Bacterial Pathogens Associated with Respiratory Illness. Author new CAMD SOPs and/or

CAMD OIs as necessary for new CAMD pieces of equipment and/or protocols.

1.3.1.5. Monitor and report scientific progress to ensure that appropriate protocols, Quality Assurance (QA), Quality

Control (QC) IAW GLP are followed. The Contractor shall ensure procedures are followed to properly optimize and document any new assays used.

1.3.1.6. Notify Contracting Officer Representative (COR) or onsite Government representative of any issues with potential to affect CAMD Lab’s ability to process samples (e.g., personnel absences, low supplies, equipment problems).

1.3.1.7. Test and evaluate equipment assessment and research platforms. Author final technical reports of test outcomes and evaluations of diagnostic platforms and provide to appropriate personnel IAW as determined at weekly lab meetings with Government.

1.3.1.8. Maintain repository of samples. May be required to ship samples upon request to other Federal Agencies

IAW established procedures. Shall have at least two (2) personnel who possess current International Air Transport

Association (IATA) shipping certification.

1.3.1.9. Use established checklists (daily and weekly) for all equipment and perform routine maintenance IAW the original equipment manufacturer (OEM) instructions on all Government Owned Property and special test equipment within and assigned to the CAMD.

1.3.1.10. Perform PCR-based techniques such as quantitative Real-Time Polymerase Chain Reaction (qPCR) and end-point PCR. Use gel electrophoresis for downstream analysis of end-point PCR products. Prepare wet/dry Master

Mix for PCR reactions.

1.3.1.11. Perform both manual and automated nucleic acid extraction/isolation methods. Methods employed at the

CAMD Laboratory include both magnetic bead and spin column based extractions.

1.3.1.12. Perform DNA sequencing studies to determine biomarkers and other relevant parameters in support of approved protocols as determined by 59th MDW/ST to include, but not limited to, Genetic Epidemiology of Risk-

Associated Single Nucleotide Polymorphisms of Types 2 Diabetes Mellitus. In coordination with Government

Laboratory Manager or other designated Government representative, provide supplemental support in processing patient biological samples using molecular-based methods, instrumentation, and GLP and techniques to support various types of study protocols including, but not limited to, Diagnosis and Epidemiology of Upper Respiratory

Tract Infections in the Basic Military Trainee Population and Viruses in Wilford Hall Ambulatory Surgical Center

Clinic Patients.

1.3.1.13. Operate Next-Generation Sequencers (NGS) such as the Illumina MiSeq, Roche FLX/GS Junior

Sequencers, and the Qiagen PyroMark Q96.

1.3.1.14. Assist in ordering study materials, supplies and equipment as specified in the research protocols.

1.3.1.15. Support compliance and inspection activities.

1.3.1.16. Supply Management.

1.3.1.16.1. Surveillance Supplies. The Government will provide Government-furnished supplies such as reagents and assays to the Contractor for weekly surveillance sample testing requirements.

1.3.1.16.2. Research Project Reimbursable Supplies (more details provided in paragraphs 1.4.6 through 1.4.6.4). For new and ongoing research activities, the Contractor shall be responsible for determining types of supplies required, amount of supplies required, and provide multiple quotes for supplier. In coordination with the Government

Laboratory Manager, the Contractor shall order supplies required to support outbreaks and the testing of pathogens of military interest. The Contractor will be reimbursed through the reimbursable supply contract line item number

(CLIN).

1.3.2. Clinical Research Duties. The Contractor shall perform the following duties IAW CAMD Standard

Operating Procedures (SOPs) and applicable Institutional Review Board (IRB) approved protocols:

1.3.2.1. Provide manpower to identify and interview potential study participants IAW the designated study protocol designs. Design recruitment materials, as required, and develop advertising strategy for recruitment. If the potential study participant consents, the Contractor shall enroll subject, obtain written consent, and collect appropriate samples at established collection sites.

1.3.2.2. Accurately record data collected from patients/study participants and medical databases to include information recorded in Case Report Forms (CRFs), Informed Consent Documents (ICDs) and other important study documentation. Submit surveys as required for protocol or surveillance activities. The Contractor shall have established Quality Assurance/Quality Control processes and procedures to ensure data accuracy and integrity in hard copy documentation and in electronic spreadsheets and databases.

1.3.2.3. Collect, record, store and maintain Personal Identifiable Information (PII) and Personal Health Information

(PHI) in compliance with “Government regulations”. The Contractor shall ensure that contractor personnel receive quarterly refresher training on Health Insurance Portability and Accountability Act (HIPAA) rules and PHI/PII protection associated with approved studies.

1.3.2.4. Schedule study participants for research appointment(s) as determined by the protocol. Screen patients, patient records, and databases to determine study eligibility and participation using advanced professional skills acquired through nursing training and experience. When appropriate, coordinate and monitor patient response to protocol treatment in clinical trials and communicates results to the Principal Investigator (PI) as specified in protocol or at the request of the PI.

1.3.2.5. Collect patient samples including, but not limited to, blood draws, nasal swabs/washes, fecal samples and saliva specimens. Perform preparation of specimens as required by the protocol or SOP. Unless otherwise approved by the Government in advance and IAW approved protocols, all samples shall be brought to the CAMD Lab for appropriate storage by the end of each workday.

1.3.2.6. Perform initial coding and data entry of structured questionnaires and data collection tools, when applicable.

1.3.2.7. File and manage study documentation to include accurate and timely preparing and filing of all study-related documents. Maintain and update files for all applicable regulatory documentation for the IRB including protocols, approvals, amendments, modifications, etc. as well as any communications with the sponsor of any other Federal or regulatory office. Comply with all rules and regulations as applicable to assigned work area. Adhere to CAMD and

WHASC data quality and quality assurance plans for protocol documentation.

1.3.2.8. Draft amendments for existing protocols and help draft new protocols IAW established IRB procedures and templates. Protocol amendments will be provided for PI and/or Government Lab Director review no later than (NLT)

5 working days prior to IRB submission date.

1.3.2.9. Attend weekly research team meetings to include protocol and research coordinator meetings.

1.3.2.10. Support protocol and lab compliance and inspection-related activities.

1.3.2.11. Perform data entry tasks to include entering patient information and laboratory results into approved Excel, Access and Structured Query Language (SQL) databases.

1.3.2.12. Collect data elements from paper, electronic patient records or other existing documents, clinical computer databases such as the Armed Forces Health Longitudinal Technology Application (AHLTA), Composite Health Care

System (CHCS) or Joint Patient Tracking Application (JPTA), and/or electronic diagnostic reports IAW the research protocol and entering this data into spreadsheets, databases, and/or statistic software.

1.3.3. Senior Scientist Duties. The Contractor shall perform the following duties IAW CAMD SOPs, OIs and applicable IRB approved protocols:

1.3.3.1. Assist in directing and overseeing institutional research conducted at the CAMD Laboratory for the 59 th

Medical Wing.

1.3.3.2. As directed by the Government, work with the Government and Contractor PIs to design research studies and methods to collect data in a scientifically accepted manner. As required shall have responsibility as Principal

Investigator or Associate Investigators on specific protocol(s).

1.3.3.3. Upon request from the COR in support of proposals and special PI protocols shall develop a top level project plan as described in 1.3.4.6.

1.3.3.4. Coordinate with CAMD Government personnel to structure and manage tasks to accomplish the efficient recruitment and enrollment of study participants and processing of samples.

1.3.3.5. Develop detailed analysis plans, descriptions of analyses and findings for research protocols or reports IAW

IRB approved protocols. Shall review and approve all reports and data releases prior to submission to the

Government.

1.3.3.6. Review clinical or medical research protocols and recommend appropriate statistical analyses. Develop project plans, timelines, or technical objectives for statistical aspects of biological research studies.

1.3.3.7. Provide Government with collaboration recommendations on a quarterly basis as a minimum, to include objectives, personnel and supply resource requirements, and approximate timeline for study.

1.3.3.8. Assist Government in drafting research agreements with other Government, Military and Commercial entities to include Cooperative Research and Development Agreements (CRADAs) and Memorandums of

Agreement (MOAs)

1.3.3.9. Develop abstracts and manuscripts on study results for IRB-approved protocols.

1.3.3.10. Develop presentations and posters communicating scientific results for conferences, research activities and official visitors. Present oral presentations on results and CAMD activities to senior staff from Government, Academia and Industry organizations.

1.3.3.11. Assist with basic biostatistical consultation support to PIs or colleagues. Coordinate database preparation for data analysis, including assessment for any data transformation requirements. Assist in designing randomization schemes when required for the studies.

1.3.3.12. Work with the designated statistician to clean and prepare data sets for analyses. Analyze clinical or survey data using statistical approaches. Translate statistical and research outcome information into documents relevant to manuscripts/presentations being published by investigators. Prepare written synthesis of analysis results for inclusion in research manuscripts, presentations, and reports, as requested. Assesses the adequacy of the presentation of data, methods and purported objectives of the research projects. Reports should be submitted fifteen workdays prior to abstract or manuscript submission deadline to account for Government review and Public Affairs Office approval.

1.3.3.13. Assist the PIs in refining the specific goals, questions, hypotheses, and/or objectives of the research protocols.

1.3.3.14. Develop progress reports for Government review for study sponsors and appropriate compliance committees as required by local policies and each protocol. Identifies delays and other obstacles in meeting objective and develop a contingency plan as required. For sponsor reports or special compliance reports the

Contractor and Government will establish a mutually agreed upon timeline.

1.3.3.15. Collect, record, store and maintain Personal Identifiable Information (PII) and Personal Health

Information (PHI) IAW Public Law and in compliance with Government regulations AFI 33-332 Privacy Program.

1.3.3.16. Provide semi-annual technology assessment for associated molecular diagnostic technology developments.

1.3.4. Report Development Duties. The Contractor shall develop written project, protocol and status reports and other support documentation. Contractor written reports shall include, but not are limited to, the following:

1.3.4.1. Daily Enrollment Report. A daily e-mail from Contractor Clinical Research Coordinator(s) indicating number of patient encounters and number of patients enrolled, by protocol number, will be provided to CAMD

Government personnel to include the CAMD Lab Director, CAMD Lab Manager and CAMD Program

Manager/Nurse Coordinator.

1.3.4.2. Weekly Protocol Enrollment and Status Report. For each open protocol with active enrollments, the

Contractor shall provide a spreadsheet capturing the number of patient encounters and enrollments for the week along with number of samples processed.

1.3.4.3. Monthly Status Report. The Contractor shall prepare a monthly written report capturing information on major accomplishments and technical information generated from data collection, analyzed data from various protocols, and trends of analysis outcomes. The report is due by the 10th of each month reporting on the previous month’s activities.

1.3.4.4. Protocol Annual Progress Report and Closeout Report inputs. The Contractor shall provide inputs for each protocol annual report IAW established Protocol Office templates. The Contractor Senior Scientist shall provide analysis and technical support as required; the Contractor Senior Scientist shall review inputs prior to submission to the Government. The Government will provide the Contractor the annual report due dates IAW each protocol requirement. The Contractor shall provide inputs NLT 15 work days before report due date to IRB.

1.3.4.5. Quick Look Results Reports and Bi-weekly Trend Reports. As requested by Government in support for specific surveillance activities and/or protocols, the Contractor shall be required to provide a Quick Look Results

Report and/or Bi-weekly Trend Report to the Government. The Contractor Senior Scientist shall approve the report and provide it to the Government Lab Director or his/her designee for dissemination. Specific days and times will be coordinated with the Contractor after Contract Award.

1.3.4.6. Special Project Plans and Results Reports. Upon request from the COR, in support of proposals and special

PI support, the Contractor shall develop a top level project plan that includes objectives, type of support to be provided by CAMD, manpower and supply estimates, reporting requirements and an approximate timeline. Upon receiving Government approval, the Contractor, will provide a results report in the format, and frequency agreed, to with the PI.

1.4. Special Qualifications. The CP shall meet the following education, certification and experience requirements per category.

1.4.1. Laboratory Technicians:

1.4.1.1. Shall have, at a minimum, a Bachelor’s degree and three (3) years of laboratory experience in the required laboratory sciences specialty.

1.4.1.2. Shall have at least two (2) personnel who possess current International Air Transport Association (IATA) shipping certification.

1.4.1.3. Shall have experience and/or qualified to do research testing in various fields of medical technology to include but not limited to toxicology, chemistry, microbiology, hematology/coagulation, cell biology, and molecular biology. Be familiar with solid phase and liquid extractions; gas chromatography, liquid chromatography and mass spectrometry.

1.4.1.3.1. Shall have experience isolating nucleic acids from specimens/samples non-stored and from samples stored in the laboratory repository. Test and evaluate results of analyses obtained from genomic sequencing test platforms.

Perform and document quality control procedures to ensure instrumentation is functioning properly. Shall have experience with testing and evaluating specimens/samples for amplification of nucleic acids for reverse-transcription polymerase chain reaction studies. Shall have experience using/operating bio-safety cabinets, incubators, centrifuges, pH meters, balances and other supporting laboratory equipment.

1.4.1.3.2. Shall have computer, data management and processing skills, to include a minimum intermediate level experience with Excel and other Microsoft Office Software.

1.4.2. Clinical Research Coordinator (CRC) – Registered Nurse:

1.4.2.1. Shall have, at a minimum, a Bachelor’s Degree in Nursing and five (5) years clinical experience.

1.4.2.2. Shall have current Certified Clinical Research Coordinator (CCRC) certification. Must have held CCRC certification for a minimum of two (2) years.

1.4.2.3. Shall have experience in collecting patient samples to include ability to competently draw blood.

1.4.2.4. Shall have experience in developing, updating and maintaining IRB protocol documentation.

1.4.2.5. Shall possess intermediate computer skills with Microsoft Office software suite to include ability to work with MS Excel spreadsheets, modify MS Word documents, and use track changes in MS Word.

1.4.2.6. Physical abilities. The enrollment environment requires that the CRC RN work in rustic field environments and is able to climb several sets of stairs and walk unassisted over uneven terrain unassisted in order to obtain samples from military personnel in hospital and field environments (e.g., Camp Bullis). CRCs must be able to carry medical and supply kits weighing up to 20 pounds without assistance in both indoor and outdoor environments.

CRCs must be able to stand for extended periods of time without sitting. The CRC will frequently be exposed to common infectious respiratory diseases (e.g., cold virus, flu) and should not have a chronic immunodeficiency condition in which his/her ability to fight infectious disease is compromised or absent whether from the result of natural causes or due to medication side effect.

1.4.2.7. Shall have current Collaborative Institutional Training Initiative (CITI) training prior to starting work and shall maintain currency at all times.

1.4.3. Clinical Research Coordinator – Licensed Vocational Nurse

1.4.3.1. Shall have, at a minimum, of Licensed Vocational Nurse (LVN) Associate Degree. Minimum of three (3) years clinical experience.

1.4.3.2. Shall have Certified Clinical Research Coordinator (CCRC) certification.

1.4.3.3. Shall be experienced in collecting patient samples to include ability to competently draw blood.

1.4.3.4. Shall possess intermediate computer skills with Microsoft Office software suite to include ability to work with MS Excel spreadsheets, modify MS Word documents, and use track changes in MS Word.

1.4.3.5. Physical abilities. The enrollment environment requires that the CRC LVN work in rustic field environments and is able to climb several sets of stairs and walk unassisted over uneven terrain in order to obtain samples from military personnel in hospital and field environments (e.g., Camp Bullis). CRCs must be able to carry medical and supply kits weighing up to 20 pounds without assistance in both indoor and outdoor environments. CRCs must be able to stand for extended periods of time without sitting. The CRC will frequently be exposed to common infectious respiratory diseases (e.g., cold virus, flu) and should not have a chronic immunodeficiency condition in which his/her ability to fight infectious disease is compromised or absent whether from the result of natural causes or due to medication side effect.

1.4.3.6. Shall hold current Collaborative Institutional Training Initiative (CITI) training prior to starting work and shall maintain currency at all times.

1.4.4. Clinical Research – Senior Scientist

1.4.4.1. Shall have a (PhD) Doctorate in Molecular Biology or a related life science field. Shall, have at a minimum, five (5) years’ experience in conducting clinical research. Minimum of two (2) years’ experience in leading a research team within the past five (5) years.

1.4.4.2. Shall have published in a peer-reviewed scientific journal as first author, preferably on respiratory or genetic marker research. Shall have experience presenting research findings at major conferences.

1.4.4.3. Shall have experience in developing human research studies, drafting approved human research protocols and coordinating protocols with Institutional Review Board(s).

1.4.4.4. Shall have at least one (1) year experience within the past ten (10) years in respiratory pathogen research.

1.4.4.5. Shall have at least one (1) year experience within the past ten (10) years in analysis of genetic markers.

1.4.4.6. Shall have experience in determining sensitivity and specificity of molecular detection assays.

1.4.4.7. Shall have experience coordinating or collaborating research with major health agencies such as the National

Institute of Health (NIH) or Centers for Disease Control and Prevention (CDC).

1.4.4.8. Shall have experience in conducting and supporting research in a military environment preferred.

1.4.4.9. Shall have current Collaborative Institutional Training Initiative (CITI) training prior to starting work and shall maintain updated training throughout the duration of contract performance.

1.4.4.10. Continuing Medical Education (CME). The CP shall provide appropriate CME documentation to the COR within one (1) month after all CME accredited events.

1.4.5. License and Certification Verification. (AFI 44-119, Medical Quality Operation (Chapter 4 Paragraph 4.6)

1.4.5.1. The CP shall have and maintain a current Basic Life Support (BLS) certification.

1.4.5.2. The CP shall perform all primary and annual licensure or certification document verifications. The CP shall maintain these certifications in a current status throughout the life of this contract. Verifications shall be submitted to the Government at least ten (10) working days prior in accordance with appendix B.

1.4.5.3. The CP shall confirm that the clinical licenses or certifications have not been suspended or revoked by any healthcare facility, public or private, anywhere in the world. This does not preclude any CP whose licensure or certification, although originally suspended or revoked by a healthcare facility, were subsequently fully reinstated by the same.

1.4.5.4. Healthcare professionals who fail to maintain a license, registration or certification will be removed from independent practice and privileged providers will be placed in abeyance. If time exceeds 30 days of abeyance, the provider will be placed in summary suspension IAW AFI 44-119, paragraph 9.16. until the license, registration or certification is renewed. Issuing agency grace periods are not honored by the AFMS when renewing a license, certification, or registration.

1.4.6. Reimbursable Supply: the following is an estimation of the supply purchases under the reimbursable supply

CLIN for each year, the estimated quantity and frequency is unknown; purchases will include but not limited to:

Description Cost

Customized Assays (probes/primers, single nucleotide polymorphism assays, ELISAs)

$40,000.00

Specialized Reagents (nucleic acid extraction buffers, fluorescent dyes for nucleic acid quantitation, next-generation sequence reagents/buffers)

$30,000.00

Calibration/Verification Plates

$10,000.00

RNA/DNA Quality Control, Verification Standards/Calibrators, Specialized consumables (sterile micropipette tips, polyethylene tubes)

1.4.6.1. Before any purchase of equipment or materials valued at $750 or higher, the Contractor shall obtain approval from the COR. For materials with an estimated value of $2,500 or more, the Contractor shall seek at least two competitive price quotations and award to the lowest price or best value.

1.4.6.2. For the purpose of cost reimbursement, evidence of competitive pricing shall be submitted with detailed list of all reimbursable supply equipment and materials purchased. The list shall include complete manufacturer information (part number, quantity, unit of issue prices) as part of the monthly billing and status report.

1.4.6.3. The Government will reimburse the Contractor on the basis of actual cost. The Contractor shall not incur any reimbursable supply expenditure that is not agreed to in the contract or pre-approved by the COR. The Contractor shall provide receipts and other supporting documentation for verification of the reimbursable supplies incurred.

The COR assigned to the contract will verify reimbursable supply for accuracy, allocability and allowability.

1.5. General Information.

1.5.1. Contractor Representative. The contractor shall identify the name and telephone number of the contractor’s point of contact to the Contracting Officer (CO) in writing prior to beginning performance. The contractor shall identify in the designation letter any limitations on its representative's authority to act on behalf of the contractor.

The contractor shall provide an updated designation letter whenever any changes occur. The contractor representative may be required to meet with the Government during the performance of this contract at the request of the CO.

1.5.1.1. The Contractor Representative shall respond to a request to meet with the CO within twenty-four (24) hours of notification under routine circumstances.

1.5.2. Hours of Performance.

1.5.2.1. Contract performance requirements are governed by the contract. The Contractor shall provide qualified and trained personnel to cover the required hours of performance. Normal hours of operation are 7:30 AM to 4:30 PM

Monday through Friday, not to exceed 40 hours per week. Any deviation to these days and times will be only as authorized by the Contracting Officer Representative.

1.5.2.2. The CP is advised that special activities including but not limited to commander’s calls, sports days, employee quality of life meetings, late reporting, staggered reporting times, early release, physical fitness time, office picnics, and holiday parties are for Government personnel only and do not apply to the CP unless expressly stated otherwise in the contract. If any special activity occurs, the CP will continue to perform contract requirements unless expressly excused by the contracting officer. In the event that the contracting officer excuses performance, the contractor understands that its employees’ participation in such event will not be at government expense. The CP is further advised that any special time off granted by the President or other competent authority is for Government personnel only and does not apply to the CP.

1.5.2.3. Absences. The CP shall ensure that scheduled absences do not interrupt service performance. Scheduled absences shall be scheduled at least thirty (30) calendar days in advance and mutually agreed upon by the

Contracting Officer Representative (COR). Unscheduled absences shall be reported to the COR by the CP no later than two (2) hours prior to the start of the shift by the CP.

1.5.2.4. If the CP are prevented from performing due to acts beyond the CP’s control including emergency base closure the standards in FAR clause 52.212-4(f) and or 52.249-8/9/10 as appropriate will be applied to determine if the non-performance is excusable. In the event of an emergency base closure due to weather or other contingency situation the COR will notify the CP of any changes in performance requirements. Under no circumstances will the contractor be paid for services not delivered.

1.5.2.5. Federal Holidays: The MTF will observe the ten federal holidays listed below.

Holiday Projected Date

New Year's Day January 1

Martin Luther King Jr's Birthday 3 rd

Monday in January

President’s Day 3 rd

Monday in February

Memorial Day Last Monday in May

Independence Day July 4

Labor Day 1 st Monday in September

Columbus Day 2 nd

Monday in October

Veterans' Day November 11

Thanksgiving Day 4th Thursday in November

Christmas Day December 25

Should the official holiday fall on Saturday then the observed holiday is the previous Friday.

Should the official holiday fall on Sunday then the observed holiday is the following Monday.

1.5.2.6. CP performing under this contract shall abide by the provisions of MDWI 41-101 Medical Expense and

Performance Reporting System (MEPRS), (Paragraph 2.1.3.). The contractor shall provide documentation or records of units worked through Wide Area Work Flow (WAWF) under inspector extension code: F9CSPG

1.5.2.7. Services performed under this contract have been determined not to be essential for performance during crisis declared by the National Command Authority.

1.5.3. Compliance.

1.5.3.1. The CP shall comply with all applicable Air Force Instructions (AFI), Department of Defense (DoD)

Regulations, and Medical Wing Instructions (MDWI) as outlined in Appendix A.

1.5.3.2. MTF Orientation. The CP shall attend the MTF Orientation at the outset of their working at MTF. The

MTF Orientation will familiarize the CPs with the policies and procedures of the MTF and will be scheduled by the

COR within two (2) months of employment. Orientation attendance shall be required of the CP during Government paid working hours.

1.5.3.3. In/Out processing. All personnel performing service under this contract shall be required to in-process through the 59 MDW Medical Logistics Contract Personnel Office upon reporting for duty. At this time, the CP shall initiate the process to receive a Common Access Card (CAC), Base Identification Passes, Restricted Area Badges, and keys. Upon termination or expiration of the contract, contract personnel shall be required to out-process through the same office and turn in the CAC, Base Identification Passes, Restricted Area Badges, and keys.

1.5.4. Conduct Requirements.

1.5.4.1. The Government will restrict the performance on this contract by any individual who is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the MTF and its population.

1.5.4.2. The CP shall not advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such person should receive care at an outside agency or provider at any place other than as designated under this contract.

1.5.4.3. The CP shall not use Government facilities or other Government property for personal use or other business not related to this contract.

1.5.4.4. CP shall not respond to any media inquiries nor provide interviews, comments, or any other responses to the media regarding any subject related to this contract. All inquiries or complaints from the media or other sources shall be immediately relayed to the COR.

1.5.4.5. The CP shall ensure that its employees conduct themselves in a professional manner while on the installation and refrain from disruptive, offensive, or otherwise improper behavior that undermines order and discipline. The CO may direct the contractor to remove from performance of this contract on this installation any contractor employee engaging in such misconduct.

1.5.4.6. Abide by federal and local MTF regulations concerning the confidentiality of patient records, as embodied in federal statutes including the Privacy Act of 1974 and the Health Insurance Portability & Accountability Act of

1996. All medical records and reports will remain the property of the Government. All financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the CP during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract. The CP shall not release any of the above information without prior written consent of the contracting officer.

1.5.4.7. Smoking in AF Facilities. CP are advised that the Air Force has placed restrictions on the smoking of tobacco products in AF facilities. AFI 40-102, Tobacco Use in the Air Force, outlines the procedures used by the commander to control smoking in our facilities. CP and visitors are subject to the same restrictions as government personnel. Smoking is permitted only in designated smoking areas.

1.5.4.8. Joint Base San Antonio (JBSA) Traffic Code. All applicable Traffic Codes will be enforced and apply to all personnel operating vehicles on a JBSA installation. The governing instruction for all Traffic Codes is AFI 31-

218(I) and AFMAN 31-116 Air Force Vehicle Traffic Supervision. For a complete listing of all JBSA Traffic Codes and all other applicable traffic policies and procedures, please contact the Contracting Office.

1.5.4.9. Cell Phone Usage. CP are advised that DoD Instruction (DoDI) 6055.04 prohibits cellular telephone usage when approaching, entering or exiting any installation gate. Cell phone usage by drivers on installations is prohibited in moving vehicles unless used with a hands-free device. The installation Security Forces Squadron (SFS) is strictly enforcing this regulation. Those found in violation of this regulation are subject to be ticketed.

1.5.4.10. Base Fire Prevention Program. The CP will be required to comply with the applicable Fire Prevention

Program, for JBSA Lackland the applicable directive is AFI 91-203.

1.5.5. Security.

1.5.5.1. General Security Requirements. The CP shall follow all guidelines found in the Security Requirements for

Solicitation and Contract clause.

1.5.5.2. Internal Operating Instructions (OI). The CP shall abide by the MTFs current OIs for internal circulation control, the protection of resources, and the regulated entry into Air Force controlled areas during normal, simulated, and actual emergency operations.

1.5.5.3. Reporting Requirements. The CP shall comply with AFI 71-101, Volume 1, Criminal Investigations

Program (Chapter 2, paragraph 2.7) and Volume-2, Protective Service Matters, (Paragraph 1.2). CP shall report to

Security Forces any information or circumstances which may pose a threat to DoD or CP, resources, or DoD information.

1.5.5.4. Removal of CP. The Government, through the CO, reserves the right to require immediate removal from contract performance on the installation or any Government facility, any individual whose actions raise reasonable suspicion that patient care or services may be compromised in any way, or that pose a threat of harm to other

CP/Government personnel or self. Removal under other circumstances will be subsequent to and at the direction of the CO only.

1.5.5.4.1. If a situation meriting removal occurs as outlined in the previous paragraph, the COR will contact the CO and the contractor’s representative within twenty-four (24) hours. A meeting may be required with the CO, COR and contractor representative to discuss further action.

1.5.5.4.2. The CO will notify the Contractor if and when permanent removal is required. In the event of a disagreement between the Government and the Contractor, the decision of the CO will be final. During the period of time between the removal and the final decision of the CO, the Contractor agrees to provide backup/replacement CP in accordance with the terms of this contract.

1.5.5.4.3. The CP may be required to submit to drug/alcohol testing. The Government may require temporary or permanent removal from contract performance any individual who refuses or fails testing.

1.5.5.5. Government Computer Access Requirements. If this contract requires contractor personnel to have access to government computers, contractor personnel requiring access to government computers shall successfully complete, a National Agency Check with Inquiries (NACI) request, before obtaining access to the computer. These investigations shall be submitted by the government at no additional cost to the contractor. All contractor employees affected by this requirement must have completed an acceptable submission that complies with all directions for completion of the investigation request through the government security office within 30 calendar days of Contract

Award or Notice of Award. To begin this process, all affected contractor employees must complete within 15 calendar days after Contract Award or Notice of Award Standard Form 85P worksheet that can be downloaded from http://www.opm.gov/forms/pdf_fill/SF85P.pdf . The contractor shall notify the Contracting Officer Representative

(COR) or Government Inspector when the worksheet is complete. The affected employee will then be scheduled by the government…