FA3047-15-R-0006-0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to incorporate changes to Addendum to 52.212-1 3. Volume II - Technical Proposal 3.1(ii), Addendum to 52.212-2 paragraph 2.4.2, and PWS paragraph 1.5.8.4 revised to remove DoD-Air Force Addendum to the FWA. (See Summary of Changes highlighted)

Contracting Officer: Susan R. Arnold; susan.arnold@us.af.mil Contract Administer: SSgt Timothy D. Smith; timothy.smith.109@us.af.mil

1. CONTRACT ID CODE PAGE OF PAGES

J 1 31

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 13-Apr-2015

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X FA3047-15-R-0006

X 9B. DATED (SEE ITEM 11)

03-Apr-2015

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

13-Apr-2015

CODE

502D CONTRACTING SQUADRON

1655 SELFRIDGE AVE

JBSA LACKLAND TX 78236-5253

FA3047 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

FA3047-15-R-0006

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

ADDENDUM 52.212-1

ADDENDUM TO 52.212-1—(Instructions to Offerors-Commercial Items)

Addenda to 52.212-1(b), Submission of Offers. The paragraph is tailored as follows: 1.Paragraph (b) (10) is deleted in its entirety and replaced below under “Addenda to 52.212-1.

Addendum to 52.212-1(c), Period for Acceptance of Offers. The paragraph is tailored as follows: “The offeror agrees to hold the prices in its offer firm for 120 calendar days from the date specified for receipt of offers.”

Addenda to 52.212-1(e), Multiple Offers. This paragraph is deleted in its entirety.

Addenda to 52.212-1(h), Multiple Awards. This paragraph is deleted in its entirety.

ADDENDA TO 52.212-1 (continued)

1. PROPOSAL PREPARATION INSTRUCTIONS

1.1. Point of Contact. If you have any questions, contact SSgt Timothy Smith at (210) 671-0792; e-mail:

timothy.smith.109@us.af.mil and Ms. Susan Arnold at (210) 671-0929; email: susan.arnold@us.af.mil.

1.2. Page Limitation. The page limit for the technical portion shall not exceed 10 pages. Page limitations shall be treated as maximums. This page limitation does not include the cover page and index of the volumes. If exceeded, the excess pages will not be read or considered in the evaluation of the offer.

1.3. Formatting. A page is defined as each face of a sheet of paper containing information. When both sides of a sheet display printed material, it shall be counted as two pages. Page size shall be 8.5 x 11 inches. Except for the reproduced sections of the solicitation document, the text size shall be no less than 12 pt. Times New Roman font.

Use at least 1 inch margins on the top and bottom and ¾-inch side margins. Pages shall be numbered sequentially by volume.

1.4. Organization. The proposal in response to this solicitation shall consist of two separate volumes: Volume I - Price, and Volume II - Technical. All documents submitted in response to this RFP must be fully responsive to and consistent with the requirements of the RFP.

1.5. Electronic Copies. To assure timely and equitable evaluation of proposals, offeror must follow the instructions contained herein. Proposals must be complete, self-sufficient, and respond directly to the requirement of this solicitation. Each volume shall be in separate PDFs. Proposal response shall be submitted electronically on or before the due date using the US Army Aviation & Missile Research Development & Engineering Center Safe Access File Exchange (AMRDEC SAFE) https://safe.amrdec.army.mil/SAFE/Welcome.aspx.

1.6. Email Response: If the offeror encounters a problem with posting their response, the offeror must provide the proposal directly to SSgt Timothy Smith via email at timothy.smith.109@us.af.mil. The subject line of the email should read “FOUO\\INFO: RFP FA3047-15-R-0006 (Insert Company Name)”. The offeror will still be required by the stated time in the RFP. The offeror’s email response to this RFP shall include all of the information required in this RFP in the required format.

1.7. Late Proposals/Responses. Contractors are responsible for submitting their entire proposal by Friday, 17 April 2015 at 9:00 AM Central Daylight Time (CDT) in order to be considered timely. Any proposal, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of proposals is “late” and will not be considered unless it is received before award is made, mailto:timothy.smith.109@us.af.mil mailto:susan.arnold@us.af.mil https://safe.amrdec.army.mil/SAFE/Welcome.aspx the Contracting Officer determines that accepting the late proposal would not unduly delay the acquisition; and if it was transmitted through an electronic commerce method authorized by the solicitation. However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

1.8. Basis for Award. 502 CONS will issue a Delivery Order to the offeror whose proposal has been determined to offer the Best Value to the Government using Lowest Priced Technically Acceptable (LPTA) Procedures, for performance of all the tasks required in the Performance Work Statement (PWS). For this RFP best value means award will be made to the responsible contractor, whose products/services are technically acceptable and quotes the lowest overall price with inclusion of option years.

1.9. Questions. All questions regarding this requirement shall be submitted by Wednesday, 10 April 2015 at 3:00

PM CDT.

1.10. Notice to Offeror. The Government reserves the right to cancel this RFP, either before or after the closing date. In the event the Government cancels this RFP, the Government has no obligation to reimburse an Offeror for any costs.

2. Volume I – PRICE PROPOSAL

2.1. Complete blocks 12, 17a, and 30a, b, and c of the SF1449. In doing so, the offeror accedes to the contract terms and conditions as written in the SOLICITATION. The SOLICITATION constitutes the model contract.

2.2. Insert proposed unit and extended prices in the Bid Schedule. The extended amount must equal the unit price multiplied by the number of units and rounded to the second decimal only. The proposal(s) must be submitted for the base period plus four (4) option periods. Failure to fill in all space for unpriced unit and total CLIN prices in the Pricing Schedule will render the Offer unacceptable and the Agency will not consider the Offer for award in absence of discussions.

2.3. Complete the necessary fill-ins and certifications in provisions.

2.4. Evaluations:

2.4.1. Proposals will initially be ranked based on total evaluated price. Total price will be determined by multiplying the quantities identified in the Bid Schedule by the proposed unit price for each Contract Line Item Number (CLIN). The extended amounts for each CLIN will then be totaled to obtain the total for each performance period. The extended total for the basic performance will then be added to the extended total for each Option period, to obtain the total evaluated price. Evaluation of option prices will not obligate the Government to exercise options.

2.4.2. If five (5) or fewer proposals are received, the Government will evaluate all proposals for technical acceptability. If more than five (5) proposals are received, the Government will then evaluate the five (5) lowest priced proposals for Technical Acceptability. However, the Government reserves the right to evaluate additional proposals for technical acceptability if deemed to be in the best interest. If additional proposals are evaluated for technical acceptability, they will be evaluated in the order of total evaluated price, when the agency determines that none of the initial five (5) lowest priced proposals are qualified as acceptable. The agency will reject and not consider for award any proposal found technically unacceptable and ineligible for award under the terms of this RFP, in the absence of discussions.

2.4.3. The CLIN pricing structure in the Bid Schedule is based on a Firm-Fixed Price for the period of performance. Offerors must proposal on all unpriced CLINs. Failure to comply will render the proposal unacceptable and ineligible for award in the absence of discussions. Contractors are required to fill in the unit price for all CLINs identified in the Bid Schedule. The Unit Price should be rounded to the penny to avoid rounding errors. Do not alter the Bid Schedule; only fill in the proposed unit price for each CLIN.

Failure to comply with the above instructions will render the proposal unacceptable and ineligible for award in absence of discussions.

http://www.gsa.gov/Portal/gsa/ep/formslibrary.do?viewType=DETAIL&formId=E331497A1FE0AE1F85256A260055A47B

2.4.4. The Total Evaluated Price consists of the base and all options periods including a potential extension exercise under FAR 52.217-8. The contract will include four 1-year option periods and FAR clause 52.217-8, Option to Extend Services, with the potential to extend the contract an additional 6 months beyond the contract performance period. In the event that the Government requires continued performance, the Government’s evaluation of prices proposed will be considered fair and reasonable as applied to an extension of services. Should an extension of services be required, rates will be adjusted only as a result of revisions to applicable prevailing Department of Labor wage rates.

3. Volume II – TECHNICAL PROPOSAL. An Offeror must, at a minimum, demonstrate technical acceptability for each of the following factors:

3.1. The proposals shall be evaluated against the following subfactors identified in Addendum to 52.212-2:

i. Technical Factor 2.4.1. - Evaluation of Compensation Plan for Professional Employees

(personal services), Senior Scientist

ii. Technical Factor 2.4.2. - Evaluation of Compensation Plan for SCA covered employees:

Biomedical Laboratory Technicians, Registered Nurses and Licensed Vocational Nurses

iii. Technical Factor 2.4.3. – Federal Wide Assurance (FWA) certification.

ADDENDUM 52.212-2

ADDENDUM TO 52.212-2 EVALUATION—COMMERCIAL ITEMS (Oct 2014)

1. BASIS FOR CONTRACT AWARD: This is a lowest price technically acceptable selection in which competing offerors' price and technical ability will be evaluated. Only offerors who are determined technically acceptable and whose price is determined reasonable are eligible for award. This award will be based on utilizing the test procedures at FAR 13.5.

2. Unless specifically identified in your proposal, by submission of its offer, the offeror accedes to all solicitation requirements, including terms and conditions, representations and certifications, and technical requirements, in addition to those identified as evaluation factors or subfactors. All technically acceptable offers shall be treated equally except for their prices and performance records. Failure to meet a technical requirement will result in an offer being determined technically unacceptable. Offerors must clearly identify any exception to the solicitation terms and conditions and provide complete accompanying rationale. The evaluation process shall proceed as follows:

2.1. Technical Acceptability. The Government will evaluate the technical proposals on a pass/fail basis and assign ratings of Acceptable or Unacceptable as defined in 2.2 below.

2.2. The ratings consist of:

RATING DEFINITION

Acceptable Proposal clearly meets the minimum requirements of the solicitation

Unacceptable Proposal does not clearly meet the minimum requirements of the solicitation

2.3. The offeror’s proposal shall, at a minimum, address each of the subfactors in 2.4 below, as they apply to the

Performance Work Statement (PWS). Detailed instructions are included in the proposal preparation instructions section of this solicitation. During evaluation of each proposal, the Government will assign each subfactor a rating as shown in 2.2 above. A rating of unacceptable in one or more technical subfactors will constitute an overall rating of unacceptable for the technical evaluation. An overall rating of technical unacceptability will render the proposal ineligible for further award consideration in the absence of discussions.

2.4. The proposals shall be evaluated against the following subfactors:

Technical Factor 2.4.1. - Evaluation of Compensation Plan for Professional Employees (personal services), Senior Scientist:

The Government will assess risk for this subfactor. Risks that are considered to have the potential for disruption of schedule, degradation of performance, the need for increased Government oversight, or the likelihood of unsuccessful contract performance may be deemed unacceptable. A total compensation plan that reflects a sound management approach and understanding of the contract requirements for the professional, non SCA covered personnel ONLY. This evaluation will include assessment of the offerors ability to provide uninterrupted high quality work. All professional employees shall be compensated fairly and properly. Therefore, the provision at FAR 52.222-46 is applicable to this requirement. Each vendor shall submit a compensation plan along with their price proposal. This submittal will be a total compensation plan setting forth the base salaries to be paid and the various fringe benefits offered to the professional employees providing services. The vendor may mark their technical proposal as proprietary, not releasable. However the proposal will be included/incorporated as an attachment into the resulting contract, and the plan will be effective for the life of the contract. Compensation that is unrealistically low or not in reasonable relationship to the various job categories may be viewed as evidence of failure to comprehend the complexity of the contract requirements. Plans indicating unrealistic, low compensation may be assessed adversely.

a. Standard: The compensation levels proposed should reflect a clear understanding of work to be performed and should indicate the capability of the proposed compensation structure to obtain and keep suitably qualified personnel to meet mission objectives.

b. The standard has been met when: Offeror’s compensation plan will ensure the ability to obtain and retain suitably qualified personnel to meet mission objectives.

Technical Factor 2.4.2. - Evaluation of Compensation Plan for SCA covered employees, Biomedical Laboratory Technicians, Registered Nurses and Licensed Vocational Nurses:

The Government will assess risk for this subfactor. Risks that are considered to have the potential for disruption of schedule, degradation of performance, the need for increased Government oversight, or the likelihood of unsuccessful contract performance may be deemed unacceptable. As part of the proposal, offerors will submit a total compensation plan setting forth wages and fringe benefits proposed for service employees who will work under the contract. The Government will evaluate the plan to assure that it reflects a sound management approach and clear understanding of the contract requirements. This evaluation will include an assessment of the offeror's ability to provide uninterrupted high-quality work and the ability to attract, recruit, and retain qualified service personnel. The wage rates must take into account differences in skills, the complexity of various disciplines, and job difficulty.

Offerors will submit supporting information to include data, such as recognized national and regional compensation surveys and studies of professional, public and private organizations, used in establishing the total compensation structure. Offerors are cautioned that lowered compensation for essentially the same work may indicate lack of sound management judgment and lack of understanding of the requirement. Failure to comply with these provisions will constitute sufficient cause to justify rejection of a proposal in the absence of discussions. The vendor may mark their technical proposal as proprietary, not releasable. However the proposal will be included/incorporated as an attachment into the resulting contract, and the plan will be effective for the life of the contract. Compensation that is unrealistically low or not in reasonable relationship to the various job categories may be viewed as evidence of failure to comprehend the complexity of the contract requirements. Plans indicating unrealistic, low compensation may be assessed adversely.

a. Standard: The compensation levels proposed should reflect a clear understanding of work to be performed and should indicate the capability of the proposed compensation structure to obtain and keep suitably qualified personnel to meet mission objectives.

b. The standard has been met when: Offeror’s compensation plan will ensure the ability to obtain and retain suitably qualified personnel to meet mission objectives.

Technical Factor 2.4.3. – Federal Wide Assurance (FWA) certification.

Provide documentation of Federal Wide Assurance certification. The offeror’s FWA will be evaluated on a pass/fail basis, and assigned ratings of Acceptable or Unacceptable.

a. Standard: The offerors is to provide current FWA certification.

b. The standard has been met when: Current FWA certification is provided.

3. Price Evaluation. The Government will evaluate the price information submitted in each offeror’s price proposal, as required by Addendum to FAR 52.212-1, paragraph 2. Volume I – PRICE PROPOSAL as described below. Any other data provided by the offeror with their price proposal that is not required by Addendum to FAR 52.212-1. Volume I – PRICE PROPOSAL will not be considered or evaluated. Evaluation of the options will not obligate the Government to exercise the option(s).

3.1. Price Reasonableness: The price information submitted in each offeror’s price proposal, as required by Addendum to FAR 52.212-1, 2. Volume I – PRICE PROPOSAL will be evaluated to determine if proposed prices are fair and reasonable IAW FAR 15.404 (which may include, but not limited to, one or more of the following proposal analysis techniques listed below) based on each offeror’s proposed approach. A contract will not be awarded to an offeror whose price is not determined to be fair and reasonable.

3.1.1. The Government may use any of the following price analysis techniques IAW FAR 15.404-1(b) to determine price reasonableness: comparison of proposed prices received, comparison of previously proposed prices and previous Government and commercial contract prices, use of parametric estimating/rough yardsticks, comparison with competitive published price lists or market prices, comparison with independent Government cost estimates, comparison with market research, and analysis of pricing information provided by the offeror.

3.1.2. The Government may also use price and/or technical analysis IAW FAR 15.404(c) and (e), respectively, to determine price reasonableness.

3.1.3. In addition, proposed unit prices may be evaluated for unbalanced pricing IAW FAR 15.404-1(g).

Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items or sub-line item(s) appear to be significantly overstated or understated as indicated by the application of cost or price analysis techniques. An offeror’s proposal may be rejected if the Contracting Officer determines the lack of balance poses an unacceptable risk to the Government.

3.1.4. If the proposal analysis techniques listed above are insufficient to make a determination of price reasonableness or, if the Contracting Officer determines that adequate price competition no longer exists, the Contracting Officer may request submission of certified cost or pricing data or data other than certified cost or pricing data, as appropriate, and/or may use other proposal analysis techniques as described in FAR 15.404, to the extent necessary, in order to make a determination of price reasonableness.

3.2 Contractor Responsibility: The Government will verify contractor responsibility in accordance with FAR 9.104-1.

3.3 Discussions: The Government intends to award without discussions, however, if discussions are to be conducted, the Government will first establish the competitive range comprised of the most highly rated proposal, unless the range is further reduced for the purposes of efficiency. If after discussions have begun, the Government determines that a proposal should no longer be included in the competitive range, that proposal will be eliminated from consideration for award. Prior to establishing the competitive range, the Government will evaluate all revisions, the Government will then award to the Offeror remaining in the competitive range with the lowest evaluated price whose proposal is technically acceptable and balanced.

3.2. TOTAL EVALUATED PRICE: A Total Evaluated Price (TEP) will be presented to the Contracting Officer (CO) for award decision purposes. The offeror’s TEP will be determined by multiplying the quantities identified in the Section B Price Schedule of the RFP by the offeror’s proposed unit price for each Firm Fixed Price (FFP) Contract Line Item Number (CLIN) for the base period and all options periods (CLINs X001, X002, X003, X004, X005, X006 and X007) to confirm the extended total amount for each FFP CLIN. The extended amount must equal the unit price multiplied by the number of units and rounded to the second decimal only. The extended total amounts for each FFP CLIN for the base period and each option period will then be added together to calculate the TEP. Each option year’s prices will be evaluated for potential exercise under FAR 52.217-9. The TEP will not include the cost reimbursable CLINs (CLINs X003). The price evaluation will document the reasonableness of the proposed TEP.

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 59th 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…