A08-Solicitation 20R0080.docx

W81XWH20R0080

Section SF 1449 - CONTINUATION SHEET

PWS AND QASP

PERFORMANCE WORK STATEMENT/QUALITY ASSURANCE SURVEILLANCE PLAN (PWS/QASP)

Title: External Forensic Toxicology Testing

Requiring Activity Name: Defense Health Agency (DHA), Armed Forces Medical Examiner System (AFMES), Division of Forensic Toxicology (DFT).

1. INTRODUCTION

The Division of Forensic Toxicology (DFT) provides toxicological examination for military autopsies, aircraft incidents, criminal investigations (including drug-facilitated sexual assaults and DUI/DWI), fitness-for-duty inquiries, and selected cases of national interest. DFT is the only federal forensic toxicology laboratory capable of testing for alcohol and drugs of abuse in blood, urine, and tissue.

2. PURPOSE AND BACKGROUND

DFT tests for hundreds of drugs, both licit and illicit. However, for drugs that DFT cannot test for, external forensic toxicology testing services are required. The purpose is to secure external testing for these infrequent drugs or analytes that DFT cannot or will not test and quantitate.

3. SCOPE

The contractor shall be certified by the American Board of Forensic Toxicology (ABFT) or the International Organization for Standardization (ISO). The contractor must offer a variety of forensic toxicology testing with an evolving list to incorporate testing for novel psychoactive substances as they are first synthesized.

4. PERIOD OF PERFORMANCE

This Single Award IDIQ will have an ordering period of five years:

5. PERFORMANCE REQUIREMENTS

5.1. Objectives/Tasks

5.1.1. The contractor shall be certified by ABFT or ISO 17025.

5.1.2. Contractor shall provide accurate, forensic analysis and results of any specimens submitted for analysis, to include but not limited to blood, urine, vitreous, and tissue.

5.1.3. Contractor available telephonically Monday through Friday from 0800 - 1700 EST for questions or status updates of testing.

5.1.4. If requested, the contractor shall return specimens to DFT promptly upon completion of testing at no additional charge.

5.1.4.1. The contractor shall use a shipping method that maintains stability of specimens.

5.1.5. The contractor shall continually update the available forensic toxicology tests available in order to maintain relevancy in the field of forensic toxicology, and clearly annotate which tests are validated per ABFT or ISO 17025.

5.1.6. The contractor shall provide a monthly report to the COR via electronic mail no later than the 10th day of the month. This monthly report shall include a summary of orders placed the previous month by providing the following information:

· Contract Number,

· Date of Order,

· Date Received,

· Order Number,

· Description,

· Quantity,

· Unit Price, and

· Total Amount

5.1.7. The contractor may be required to provide expert consultation/testimony on results provided by the contracting laboratory. This will be a separate charge to the requesting legal office, and not the contract.

5.1.8. The contractor shall offer and perform a wide variety of validated, quantitative, forensic toxicology testing, to include but not limited to the following list.

Below is a selected list of external forensic toxicology tests that are commonly used by the DFT, along with the testing matrix. This is not an exhaustive list, merely a list of examples. Because toxicology is a dynamic field, the DFT must be able to order any new forensic toxicology tests (not included on the enclosed lists) as they become available, based off the 10 most requested tests.

Cetirizine, blood Metals/metalloids acute poisoning panel, blood Ethyl glucuronide, urine Cyanide, blood Organophosphate pesticide metabolites, urine Electrolytes and Glucose panel, vitreous Desloratadine, blood Mitragynine, blood Methocarbamol,blood Promethazine, blood

6. QUALITY ASSURANCE SURVEILLANCE PLAN

6.1. Performance measurement: The key area(s) of the Contractor's performance that will be evaluated during the term of the contract. The statement of work reference will be provided for each performance measurement objective.

6.2. Assessment method: Contractor performance is inspected periodically. Method of surveillance is passive by customer feedback.

6.3. Acceptable quality level: The degree to which the Government will allow the Contractor's key areas of performance to vary; the variance from the standard that the Contractor is allowed and the grading/ measurement associated with deviation from the specific performance standard.

7. TERMS AND CONDITIONS

7.1. Description of the Agreement

The contractor shall provide forensic toxicology testing on specimens ordered by the Contracting Officer or the designated authorized individuals throughout the established period of performance. Total call orders against this Single Award IDIQ will not collectively exceed $150,000.00.

7.2. Extent of Obligations

The Contractor’s full catalog and published price lists will be incorporated into this agreement. The price list in effect at the time of the order will be used to determine the price of the order, less any discounts offered by the supplier. The Government is obligated only to the extent of authorized purchases ordered and received under this Single Award IDIQ.

Upon bilateral agreement between the Government and the Contractor, products and supplies not originally listed on the product list may be added to the Single Award IDIQ product list.

7.3. Purchase Limitation

Individual call orders will not exceed $20,000.00.

7.4. Notice of Individuals Authorized to Purchase under the BPA

The following offices are hereby authorized to place orders under this Single Award IDIQ:

· Armed Forces Medical Examiner System (AFMES), Division of Forensic Toxicology (DFT)

The contracting officer and the following individuals are authorized to place Orders:

· MSgt Iesha Stanley

· TSgt Timothy Simants Orders will be placed against this Single Award IDIQ by the controlling contracting office authorized callers only. Only those contracting actions signed by one of the authorized representatives identified above or other authorized representative as provided in writing shall be considered valid.

8.5 Call Order Procedures and Invoices

· Itemized invoices shall be submitted at least monthly or upon expiration of this Single Award IDIQ, whichever occurs first, for all testing made during a billing period and for which payment has not been received.

· The majority of the Orders will be placed by DFT utilizing a Government Purchase Card (GPC). However, the Contracting Activity reserves the right to write Call Orders from the Single Award IDIQ.

8.6 Annual Reviews

This Single Award IDIQ shall be reviewed annually and as necessary to conform to FAR requirements.

8.7 Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsibilities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services. The laboratory performing testing shall allow the DFT to perform an inspection of services in accordance with FAR 52.212-4 up to two (2) times a year.

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

8.8 Termination for the Government’s convenience

The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

OCI

ORGANIZATIONAL CONFLICT OF INTEREST

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

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

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

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

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

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

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

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

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

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

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

Offerors are encouraged to present their best strategy for mitigation of any potential OCI under this requirement. Offerors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

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

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

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

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

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

· Does the Offeror or any intended Subcontractors, teaming partners, proposed employees, or affiliates have? Would award to the Offeror result in the Offeror having the opportunity Unequal Access to Information to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

· Budget(s), or Budget Information?

· Acquisition Sensitive Information related to the procurement process to include, but not limited to Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

· Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a Government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

· Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

NON-DISCLOSURE

NON DISCLOSURE STATEMENT

Non-Disclosure Agreement for Contractor Employees and Subcontractors I, __________, am an employee of or a subcontractor to [Company Name] , a Contractor acting under contract to the Division of Medicine under Prime Contract No. ____ , through Task Order ______. I understand that in the performance of this task, I may have access to sensitive or proprietary business, technical, financial, and/or source selection information belonging to the Government or other Contractors. This information includes, but is not limited to, cost/ pricing data; Government spend plan data; Planning, Programming, Budgeting and Execution (PPBE) documents and information, as defined in DoD Directive 7045.14; Contractor technical proposal data; independent government cost estimates; negotiation strategies and Contractor data presented in negotiations; contracting plans and statements of work. I agree not to use, discuss, divulge, or disclose any such information or data to any person or entity except those persons directly concerned with the use or performance of this delivery order. I have been advised that the unauthorized disclosure, use or negligent handling of the information by me could cause irreparable injury to the owner of the information. The injury could be source sensitive procurement information of the government or proprietary/trade secret information of another company.

I understand that the United States Government may seek any remedy available to it to enforce this Agreement, including, but not limited to, application for a court order prohibiting disclosure of information in breach of this agreement. Court costs and reasonable attorney fees incurred by the United States Government may be assessed against me if I lose such action. I understand that another company might file a separate claim against me if I have misused its proprietary information.

In the event that I seek other employment, I will reveal to any prospective employer the continuing obligation in this agreement prior to accepting any employment offer.

The obligations imposed herein do not extend to information/data which is:

a. in the public domain at the time of receipt or it came into the public domain thereafter through no act of mine;

b. disclosed with the prior written approval of the USAMRIID designated Contracting Officer;

c. demonstrated to have been developed by [Company Name] , or me independently of disclosures made hereunder;

d. disclosed pursuant to court order, after notification to the USAMRIID designated Contracting Officer;

e. disclosed inadvertently despite the exercise of the same reasonable degree of care a party normally uses to protect its own proprietary information.

I have read this agreement carefully and my questions, if any, have been answered to my satisfaction.

(Signature)

Organization

(Printed Name of Corporate Official) (Printed Title –Task Manager or higher)

CONTRACTOR MANPOWER REPT

CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)

The contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the AFMES via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code (UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is W4GPAA.

INVOICE PROCEDURES

INVOICE AND RECEIVING REPORT PROCEDURES WHEN EFFECTING PAYMENT VIA THE GOVERNMENT PURCHASE CARD (NOV 2006) (USAMRAA)

Payment (GPC) will be made by the Armed Forces Medical Examiner System (AFMES), Dover, DE.

The Contractor shall submit an original invoice to the appointed Contracting Officer's Representative (COR) or the designated Technical Point of Contact (POC). Concurrently, the Contractor shall send a copy of the invoice to the applicable USAMRAA Contract Specialist.

The COR/Technical POC shall forward the original invoice and an original receiving report to the USAMRAA Contract Specialist.

The name, address, e-mail address, and telephone number for the COR/Technical POC is:

TBD

The name, address, e-mail address, and telephone number of the USAMRAA Contract Specialist is:

Michael Baughman 820 Chandler St. Fort Detrick, MD 21702 Michael.e.baughman.civ@mail.mil 301-619-2315

Quantitative Testing

FFP

Cetirizine, blood FOB: Destination

PURCHASE REQUEST NUMBER: 0011492072

PSC CD: Q301

NET AMT

Quantitative Testing

Metals/metalloids, blood FOB: Destination

NET AMT

Quantitative Testing

Ethyl glucuronide, urine

NET AMT

Quantitative Testing

Cyanide, blood

NET AMT

Quantitative Testing

Organophosphate pesticide metabolites, urine

NET AMT

Quantitative Testing

Electrolytes and Glucose panel, vitreous

NET AMT

Quantitative Testing

Desloratadine, blood

NET AMT

Quantitative Testing

Mitragynine, blood

NET AMT

Quantitative Testing

Methocarbamol, blood

NET AMT

Quantitative Testing

Promethazine, blood

NET AMT

Contractor Manpower Reporting

See CMRA instructions

NET AMT

FFP

Cetirizine, blood

NET AMT

FFP

Metals/metalloids, blood

NET AMT

FFP

Ethyl glucuronide, urine

NET AMT

FFP

Cyanide, blood

NET AMT

FFP

Organophosphate pesticide metabolites, urine

NET AMT

FFP

Electrolytes and Glucose panel, vitreous

NET AMT

FFP

Desloratadine, blood

NET AMT

FFP

Mitragynine, blood

NET AMT

FFP

Methocarbamol, blood

NET AMT

FFP

Promethazine, blood

NET AMT

FFP

See CMRA instructions

NET AMT

FFP

Cetirizine, blood

NET AMT

FFP

Metals/metalloids, blood

NET AMT

FFP

Ethyl glucuronide, urine

NET AMT

FFP

Cyanide, blood

NET AMT

FFP

Organophosphate pesticide metabolites, urine

NET AMT

FFP

Electrolytes and Glucose panel, vitreous

NET AMT

FFP

Desloratadine, blood

NET AMT

FFP

Mitragynine, blood

NET AMT

FFP

Methocarbamol, blood

NET AMT

FFP

Promethazine, blood

NET AMT

FFP

See CMRA instructions

NET AMT

FFP

Cetirizine, blood

NET AMT

FFP

Metals/metalloids, blood

NET AMT

FFP

Ethyl glucuronide, urine

NET AMT

FFP

Cyanide, blood

NET AMT

FFP

Organophosphate pesticide metabolites, urine

NET AMT

FFP

Electrolytes and Glucose panel, vitreous

NET AMT

FFP

Desloratadine, blood

NET AMT

FFP

Mitragynine, blood

NET AMT

FFP

Methocarbamol, blood

NET AMT

FFP

Promethazine, blood

NET AMT

FFP

See CMRA instructions

NET AMT

FFP

Cetirizine, blood

NET AMT

FFP

Metals/metalloids, blood

NET AMT

FFP

Ethyl glucuronide, urine

NET AMT

FFP

Cyanide, blood

NET AMT

FFP

Organophosphate pesticide metabolites, urine

NET AMT

FFP

Electrolytes and Glucose panel, vitreous

NET AMT

FFP

Desloratadine, blood

NET AMT

FFP

Mitragynine, blood

NET AMT

FFP

Methocarbamol, blood

NET AMT

FFP

Promethazine, blood

NET AMT

FFP

See CMRA instructions

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

14-SEP-2021

W03K AFME SYSTEM

115 PURPLE HEART DRIVE

DOVER AIR FORCE BASE DE 19902

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CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

BASIS FOR AWARD

The Government intends to award a Single-Award IDIQ in accordance with Federal Acquisition Regulation (FAR) 13.303 for medical waste disposal services as a result of this solicitation. Award will be made to the offeror, conforming to the solicitation, that offer the best value to the Government based on the source selection process of lowest price technically acceptable. The IDIQ will be established including a base year and four option periods beginning as early as early as 15 September 2020.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. BASIS FOR AWARD

1.1. The Government will make a single award firm-fixed price contract on a competitive basis, using the Best Value Tradeoff process among price and non-price factors described at FAR 15.101-1, Best Value Continuum and Army Source Selection Supplement determining if contractor quote is “Highly Technically Rated”. A Best Value Tradeoff Process will be used, thus the Government may award to other than the lowest priced Offeror or other than the Offeror with the highest rated non-cost quote. Award will be made based on the overall Best Value quote that is determined to be most beneficial to the Government, with appropriate consideration given to the three (3) evaluation factors: Technical Approach (Quality Control), and Past Performance, and Price. All quotes shall be subject to evaluation by a Source Selection Team (SST). Past Performance will be evaluated independently from the other non-cost evaluation factors utilizing different standards.

1.2. The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror’s initial offer should contain the offeror’s best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

Factor 1 – Technical Approach Factor 2 – Past Performance Factor 3 – Price

1.4. The non-cost evaluation factors: Technical Approach and Past Performance are equal in importance and more important than Price. Price is the least importance of all factors. To receive consideration for award, a rating of no less than “Acceptable” must be achieved for Technical Approach and Past Performance factors.

1.5. The Government will not assume that the offeror possesses any capability or knowledge unless it is specified in the quote.

1.6. After Factors 1 and 2 are rated individually, an overall rating will be assigned to these factors collectively. If Factor 1 or 2 receives an individual rating of “Unacceptable,” the overall rating will also be “Unacceptable.” Quotes that receive a rating of “Marginal” for Factor 1 or 2 will not be considered in the tradeoff process. Only quotess receiving an overall rating of “Acceptable” or higher will be considered for award.

Non-cost factors will be evaluated prior to past performance and the cost factor. Upon completion of the evaluation of the non-cost factors (less Past Performance) a competitive range determination may be made by the Source Selection Authority. If any Offeror’s quote is rated unacceptable it will be eliminated from the competitive range without discussions or further consideration. Offerors eliminated from the competitive range will be notified in writing of the determination and provided the reasons for elimination.

The Government will utilize information contained within the Offeror’s quote as well as external sources consulted during the past performance evaluation to determine contractor responsibility in accordance with the criteria in FAR 9.104-1. An award will not be made to any Offeror determined to be non-responsible regardless of the ratings given to any of the evaluation factors above.

C. EVALUATION APPROACH

1. Non Cost Evaluation Criteria: The following criteria will be used to evaluate the non-cost factors.

1. Technical Volume

(1) Technical Approach: The Offeror shall submit a written quote which effectively demonstrates the Offeror’s technical approach. The Offeror’s technical approach should specifically address:

(i) A Clear understanding of all tasks and how the approach is likely to yield the required results within the required timeframe.

(ii) The methodology and flexibility that will be used in accomplishing any resultant award.

(iii) The Offeror’s overall ability to perform.

(iv) How the technical approach is creative and reduces cost, technical, or schedule risk to the Government.

(v) A draft Project Management Plan (PMP) for timely and successful performance of the requirements of the PWS. A final PMP shall be provided 30 days after contract award.

(vi) A draft QCP for timely and successful performance of the requirements of the PWS. A final QCP shall be provided 30 days after contract award.

(vii) A copy of the agreement for the Clinical Research Organization (CRO) to ensure the CRO is certified and adheres to FDA guidelines.

(viii) A copy of the FDA comments from the pre-submission packet to ensure any additional edits and questions are adequately addressed.

(b) Corporate Experience: The Offeror shall submit a written quote which effectively demonstrates the Offeror’s corporate or proposed staff experience. The Offeror’s relevant corporate experience should specifically address:

(i) The degree to which the Offeror quote reflects corporate or proposed staff experience for the same or similar services within the PWS.

(ii) Evidence that the organization (including Subcontractors) has current capabilities; and for ensuring performance of this requirement:

1. Past Performance Volume

Past Performance will be evaluated on the basis of the Offeror’s demonstrated recent and relevant record of performance in services that meet the requirements of the PWS. The Government will conduct a past performance risk evaluation that will be based on the quality, relevance, and currency of the Offeror's past performance on projects of similar size, scope, and complexity within similar periods of performance as it relates to the probability of successful accomplishment of the required effort (as well as that of its Subcontractors). A contract of similar nature is a contract of comparable risk – functions, responsibilities, and control exercised by the Contractor which is essentially the same as required under this solicitation.

A performance confidence assessment rating will be assigned for each Offeror focusing on relevant and recent past performance. The Government will review the past performance information to determine the quality and usefulness as it applies to the performance confidence assessment. The past performance risk evaluation will assess the risks associated with an Offeror’s likelihood of success in performing the PWS requirements indicated by the Offeror’s record of past performance on relevant efforts. In this context, “Offeror” refers to the proposed Prime Contractor and all proposed first tier Subcontractors.

Offerors are reminded that while the Government may elect to consider data obtained from other sources, the burden of demonstrating relevancy of the past performance and expectation based on the relevant past performance that the requirements will successfully be performed rests with the Offeror. Other sources available to the Government include, but are not limited to, the Virtual Contracting Enterprise (VCE) Contracting Officer’s Representative (COR) System, the Past Performance Information Retrieval System (PPIRS), the Federal Awardee Performance and Integrity Information System (FAPIIS), and the Contractor Performance Assessment Reporting System (CPARS).

In the case of an Offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the Offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a) (2) (iv)). Therefore, the Offeror shall be determined to have unknown past performance.

1. Price Volume

The price quote will be evaluated separately from the non-cost quote and past performance and will be evaluated for fairness and reasonableness. The total evaluated price will be evaluated for reasonableness in terms of:

a. Level of effort, in that the proposed labor mix and hours are based on reasonable assumptions

b. Consistency with the labor categories proposed and open market rates for the proposed labor category

c. Consistency with the technical approach, in that the prices are consistent with and reflect the proposed staffing requirement for all years.

The Offeror’s quote shall include a supplemental pricing sheet that provides a detailed breakdown of their proposed pricing, including labor, Overhead, G&A, and profit or fee including sub elements of each. The Supplemental Pricing Worksheet shall include all other direct and indirect costs including materials, equipment, travel, shipping, and any other costs associated with the performance of the resulting contract. Contractor shall ensure mathematical computations are correct.

The contract shall contain the Clause FAR 52.217-8 Option to Extend Services, or an equivalent clause. By submitting a quote for the contract, the contractor agrees to this inclusion in the contract.

The cost quote will be evaluated against an Independent Government…