RFP No. 15DDHQ24R00000016- signed.pdf

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15DDHQ24R00000016

Darrell Gooodwin, darrell.goodwin@dea.gov

Drug Enforcement Administration Diversion Control Division

Not applicable.

This RFP is issued to establish a new single BPA award for Toxicological Testing.

The proposals in response to this RFP shall on April 5, 2024 at 11:00 AM EST.

Questions for this RFQ shall be submitted no later than March 25, 2024 at 11:00 AM EST.

3/15/2024 3/15/2024

4/05/2024

11:00 A, EST

Drug Enforcement Administration 8701 Morrissette Drive Springfield, VA 22152-1080

03/15/2024Denise N. Scott

STOCK RECORD (S/R)

STANDARD FORM 1449 (REV. 11/2021) BACK

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COMPLETE PARTIAL FINAL

U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

Toxicological Testing of Samples Obtained From Individual Drug Overdoses Following the Ingestion of Novel Psychoactive Substances

Diversion Control Division (DC)

REQUEST FOR PROPOSAL

Section 1: Schedule of Services

The difference between the funds to cover laboratory supplies will be prorated based upon the number of samples analyzed. These funds will not be used for analytical equipment needed to analyze biological samples for the categories of NPS described. Contractors shall refer to Pricing Sheet Template (Attachment 1) and Sample BPA Call Order (Attachment 2) when submitting the Business/Cost Proposal.

The contractor shall break down the costs of consumable lab supplies, a total amount required for standards (which includes the price to purchase the standard, lab supplies, and validation of standards), the price to analyze the biological samples (price should include total sample cost that include Facilities and Administrative [F & A costs, also referred to as indirect costs]), and any other miscellaneous cost.

Miscellaneous costs should be detailed separately if included to determine the breakdown of items.

The contractor shall provide DEA with de-identified examples of previous testing conducted by their facility within the last three months when submitting their proposal. Ideally, one example each should demonstrate successful testing of a recently encountered (i.e. within the last 90 days) synthetic cannabinoid, a synthetic cathinone, and a synthetic opioid at the minimum. Samples should demonstrate both qualitative and quantitative results, explanation of results found, and raw data of each sample tested for DEA review.

The contractor shall analyze a maximum of one thousand (1,000) sample evaluations during each year of the agreement and will be determined based upon the number of samples received. Results from the sample analysis will be electronically submitted to a DEA designed and maintained portal to include the raw data and an uploaded lab report to be released to the submitting facility. The number of sample evaluations performed can be renegotiated yearly between DEA and the selected contractor should additional samples be requested for analysis. Amendments must be bilaterally executed in writing and signed by authorized representatives of both agencies.

The contractor shall demonstrate that any equipment used in the analysis of samples is currently operational, in addition to supplying valid service contracts for the equipment prior to being awarded funding. A certification letter must be included with the proposal that identifies each instrument that is currently in use by the contractor. The letter should certify that each instrument is currently in operational order, and should include the serial numbers for each instrument that will be used in the analysis of samples.

DEA will be conducting a site visit to ensure the laboratory is operational in accordance with the certification and criteria detailed above, within 30 days after award.

Note, The Government is interested in additional cost savings in the form of a quantity discount. The discounted rate will be applied to all ordering periods, if DEA reaches the threshold.

Discount Threshold Chart:

Amount % Discount

200 Samples 0

300 Samples 0

400 Samples 0

500 Samples 3.5%

600 Samples 6.5%

700 Samples 8%

800 Samples 9%

1000 Samples 10%

The contractor shall propose a single loaded rate per Contract Line Item Number (CLIN) that includes direct labor, overhead, fringe, general and administrative expenses (G&A), and profit. The contractor must verify the calculated totals per labor category, by year, and the grand total for all years.

The following represents the cost schedules for this contract.

** NOTE: Contract is for up to 1000 samples per year, which is expected to be reached for each year. It would be expected that the discount for 1000 samples would be applied**.

Ordering Period 1 CLIN Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Analysis of Biological Sample (per test) (Quantitative and Qualitative) 1 EA

Total Consumable Lab Supplies (per test) 1 EA

Total Standards Lab Supplies and Validation (per test) 1 EA

TOTAL COST ($)

Ordering Period 2 CLIN Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Analysis of Biological

Ordering Period 3

Item Assay Quantity Unit Unit Price

Estimated Total Price

Analysis of Biological

Ordering Period 4

Item Assay Quantity Unit Unit Price

Estimated Total Price

Analysis of Biological

Ordering Period 5

Item Assay Quantity Unit Unit Price

Estimated Total Price

Analysis of Biological

Section 2: Statement of Work

2.0 Background

The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. These evaluations are used by DEA to support its domestic scheduling activities. In order for DEA to determine the abuse potential of drugs and chemicals, pharmacological, medical, epidemiological, and other scientific data for these drugs, when necessary, are needed to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances Act (CSA).

Recently, numerous novel psychoactive substances (NPS) (i.e. synthetic cannabinoid, synthetic cathinone, synthetic opioid, fentanyl related-substance, or other stimulant, depressant or hallucinogenic substance) have been abused in the United States and pose a significant risk to the public safety. Law enforcement and forensic laboratory databases have reported increased encounters of NPS. Severe consequences of NPS abuse include non-fatal overdoses and deaths. Due to the immediate public health threat associated with these NPS, several of these substances have been placed in Schedule I under a temporary scheduling order which lasts for a period of up to 2 years, extendable for an additional year for a total of 3 years. To further avoid an imminent hazard to the public safety, DEA is interested in obtaining additional toxicological data stemming from the abuse of NPS throughout the United States.

Serious adverse effects have occurred following the ingestion of various NPS in recent years. In many cases, subjects require emergency medical services and transport to a medical facility following an overdose. To determine the substances currently being abused in the United States, DEA would like the contractor to analyze the biological sample provided from such overdoses related to abuse of various NPS. In limited instances, drug paraphernalia related to the overdose will also be submitted for analysis.

Due to the time-sensitivity of this work, DEA is requesting that the toxicological analysis be initiated and completed in an expedient manner (3 weeks [21 calendar days] from receipt of sample).

2.1 Brief Description of Work

For this project, DEA will coordinate the transfer of biological samples obtained from overdose victims that present at medical facilities throughout the United States to the contractor. The samples obtained can include antemortem and/or postmortem biological products such as serum, plasma, whole blood, urine, or other biological tissue (muscle, brain, liver, gastric contents, aqueous and vitreous humor, or other tissues or fluids). In addition, some facilities may request the analysis of a drug product associated with the overdose. In this case, drug products or paraphernalia may be submitted along with the biological samples that will also be tested via the contractor. The toxicology testing of biological samples from overdose patients is intended to gather information on the current abuse of substances within the United States for use by DEA. Lab results will also be disseminated back to the requesting facility for their own use. While forensic investigations leading to potential criminal proceedings cannot be specifically excluded, routine chain of custody will not be required for all samples. Should a facility request a chain of custody, the contractor must comply. The contractor shall conduct toxicological testing on the samples provided for the presence of NPS, commonly abused substances (such as heroin, fentanyl, benzodiazepines, cocaine, etc. ), over the counter medications and dietary supplements, impurities commonly found in the illicit production of these substances, and/or additives used as cutting agents. The contractor is responsible for obtaining standards for the newest substances known to be available on the illicit market. The contractor should already be skilled in the area of toxicology testing and provide the following in response to this request for proposal:

1) A current list of substances their laboratory can currently detect in biological samples;

2) Examples of recent reports generated within the last three months;

3) Proposed staff, including education and experience for proposed role (Lab director, manager, staff, technician, handling of biological samples/hazards etc.);

4) Facility background – to include years of experience, testing capabilities, types of equipment, maintenance and calibration of instruments;

5) Risk mitigation plan

a. Facility security plan preserving patient confidentiality (i.e. proper storage of electronic files; password protection, database security)

b. Laboratory security plan for matters such as preserving samples at proper temperature, avoiding cross contamination, and handling competing priorities with other work demands;

6) Preliminary protocol regarding technical approach for evaluating biological samples;

7) DEA registration for Schedule I through V substances;

8) Any additional information that a contractor would like to submit in support of their testing capabilities as related to this proposal.

2.2 Security Requirements

All contractor personnel supporting this procurement are entrusted with a certain level of trust due to the nature of DEA’s mission. The Government expects the vendor will employ persons of integrity and trustworthiness. To ensure this, DEA reserves the right to conduct background screening or a full background investigation on all employees if a need arises. While all services provided on this contract will be performed outside of DEA, all contractors must be escorted if entering a DEA facility. DEA reserves the right to modify the security requirements found in this contract at any time.

3.0 Specific Tasks to be Performed

3.1 Tasks 1. Protocol for Toxicological Testing of Biological Samples

DEA understands that various validated methods exist for testing of antemortem and postmortem biological samples, in addition to drug paraphernalia. The contractor may utilize, upon DEA approval, one of many currently accepted methodologies adopted by their laboratory. Examples of such methods include high performance liquid chromatography (HPLC), liquid chromatography–tandem mass spectrometry (LC–MS–MS), gas chromatography-mass spectrometry (GC-MS) or others. Validated methods will be demonstrated via a current protocol accompanied with contractor-published manuscripts detailing the methodology selected. Regardless of the method chosen, the contractor will include non-targeted analysis in their approach to testing to ensure the detection of all substances present in the biological sample.

The contractor will supply detailed but succinct instructions as described below to be distributed by the DEA to medical facilities that collect the biological specimen. In overdose scenarios, specific samples are not always available (e.g., DEA will coordinate transfer of any sample available). Therefore, contractor-specific instructions for commonly used medical facility collection vessels and the handling of these samples will be prepared. These instructions will be forwarded to medical facilities prior to the transfer of biological samples to the contractor. The instructions should include information such as:

when to transfer samples in a refrigerated state versus freezing the sample and sending on ice;

centrifugation; which vessels to transfer (i.e., “green top/sodium heparin whole blood”, “purple top/EDTA whole blood” etc.); shipping of samples (i.e., overnight only, staffing of laboratory etc.); and labeling of the sample with a predefined system as discussed with DEA.

A phone discussion will be scheduled to discuss the specifics of the protocol and contractor capabilities with respect to the protocol. Any significant deviations or modifications from the protocol by the contractor must be authorized by DEA. The contractor must provide a modified protocol, in writing, to the DEA representative for any deviations or modifications deemed significant by DEA. (See Deliverables’ Table in Section 5).

3.2 Task 2. Toxicological Testing of Biological Samples

DEA expects various biological fluids to be submitted for analysis to include antemortem and/or postmortem biological products such as serum, plasma, whole blood, urine, or other biological tissue (muscle, brain, liver, gastric contents, aqueous and vitreous humor, or other tissues or fluids). The contractor shall consult with the DEA representative with respect to the priority of substances to be tested. The contractor shall follow the DEA-approved protocol for conducting the toxicological analysis. Analysis should ideally commence immediately after receiving the biological sample from the medical facility. The contractor shall have the equipment available for toxicological analysis of the biological samples such that the analysis can be conducted in an expedient manner. A library of currently maintained standards should be supplied to DEA. As NPS are identified by either the contractor or DEA, the contractor will directly purchase additional standards from an available source using the predetermined awarded funds as set forth in section II. A copy of the certificate of analysis shall be provided to DEA at the time the substance is received. For substances developed or produced within the contractor’s facility, a certificate of analysis shall be produced by the developing laboratory or the contractor should they be different, and provided to DEA at the time the substance is received.

Submitted samples should be tested for the entire scope of the contractor’s testing program so as not to rely on self-reporting or medical facility-reporting of suspected drugs ingested. Results of the toxicological analysis will be entered into a DEA developed database within three weeks of receipt of the sample. A lab report, generated via the results of the testing, will then be sent directly to DEA only via this portal. The contractor is prohibited from releasing results directly to a requesting facility or publishing the results in any way. DEA will correspond with the submitting medical facility and coordinate the transfer of toxicological results. Results will include at a minimum the following: unique patient identifier; substance or substances confirmed; method or methods of confirmation; quantitation of substances confirmed or identified; lower limits of detection; list of all substances tested for; location of medical facility where sample was collected (city/state/zip code); and patient information (age/sex only). Over the counter substances will not be quantified unless explicitly stated. All NPS, commonly abused drugs, dietary aids, impurities, additives, and cutting agents, along with their identified metabolites, must be quantified for each sample. DEA will have detailed discussions with the contractor to identify which substances fit these categories requiring quantification.

In cases of mass casualty events involving large numbers of patients or in cases where multiple biological samples are available, medical facilities may send more samples than what was requested/agreed upon between that facility and DEA. The contractor will coordinate with DEA which samples are to be tested under the approved contract. In most cases, only one sample per patient is approved for testing under this contract.

Positive findings for each sample analyzed should report a result that indicates the parent drug ingested.

In cases where metabolites of substances were discovered, it is the contractor’s responsibility to determine and explain the specific drug/drugs that could produce the metabolite identified. Should a shared metabolite between two or more substances be identified, each substance that could produce the identified metabolite should be referenced. Results showing metabolites only will not be accepted. The contractor should demonstrate in their proposal past performance capabilities in which the contractor has determined and explained the specific drug/drugs that have produced a metabolite or shared metabolite(s).

Both qualitative and quantitative results should be provided for submitted samples. For a newly identified substance, qualitative identification will be accepted while a method for quantification is validated. Exceptions will be granted for NPS identified that require the purchase of a new standard as previously discussed. In these cases, every effort will be made by the contractor to purchase the standard, validate the standard, and report the confirmed substance in a timely manner.

Upon completion of toxicological analysis, the return shipment of samples is not required or authorized without DEA approval. If samples are requested to be returned to the requesting facility, that requesting facility will be directed to provide a pre-paid shipping label for the return. However, samples must be appropriately discarded by the contractor. Contractor should include in their proposal their procedures for discarding biological samples including protecting patient confidentiality. (See Deliverables Table in Section 5)

3.3 Task 3. Toxicological Testing of Drug Products or Paraphernalia that Accompany Biological Fluids

The contractor shall consult with the DEA representative with respect to the priority of substances to be tested. The contractor shall follow the DEA-approved protocol for conducting the toxicological analysis. Analysis should ideally commence immediately after receiving the drug product from the medical facility. The contractor shall have the equipment available for analysis of the drug product such that the analysis can be conducted in an expedient manner. A library of currently maintained standards should be supplied to DEA. As NPS are identified by either the contractor or DEA, the contractor will directly purchase additional standards from an available source using the predetermined awarded funds as set forth in section II. A copy of the certificate of analysis shall be provided to DEA at the time the substance is received. For substances developed or produced within the contractor’s facility, a certificate of analysis shall be produced by the developing laboratory or the contractor should they be different, and provided to DEA at the time the substance is received.

Submitted samples should be tested for the entire scope of the contractor’s testing program. Results of the drug product analysis will be entered into a DEA developed database within three weeks of receipt of the sample. A lab report, generated via the results of the testing, will then be sent directly to DEA only via this portal. The contractor is prohibited from releasing results directly to a requesting facility or publishing the results in any way. DEA will correspond with the submitting medical facility and coordinate the transfer of the results. Results will include at a minimum the following: unique patient identifier; substance or substances confirmed; method or methods of confirmation; quantitation of substances confirmed or identified; lower limits of detection; list of all substances tested for; location of medical facility where sample was collected (city/state/zip code). For drug product analysis, all substance detected must be quantified for each sample. Substances determined to be below 0.1 mg (100 µg) should be noted as “trace”. Reports should note the percentage within the drug product including a mg/g amount, the actual amount within the drug product, and the total weight of the sample. (See Deliverables Table in Section 5)

4.0 Period of Performance

The period of performance for this agreement shall be a 12-month base year with the option to extend for four additional years. The exact dates of the period of performance are to be determined. If the agreement at the end of one year is terminated by one or both parties, the period of performance will no longer extend to subsequent years. Prior to shortening the period of performance, a written notification shall be provided with 90-day notice.

The DEA representative reserves the right to visit the location(s) where testing is being conducted.

Period of Performance POP Start POP End

Ordering Period 1 06/01/2024 05/31/2025

Ordering Period 2 06/01/2025 05/31/2026

Ordering Period 3 06/01/2026 05/31/2027

Ordering Period 4 06/01/2027 05/31/2028

Ordering Period 5 06/01/2028 05/31/2029

5.0 Deliverables

If a report on any of the requested studies cannot be provided by the specified timelines, the contractor must notify DEA immediately upon obtaining this knowledge. This notification shall be followed up by a letter to DEA stating the reason for the delay, the anticipated date of completion of investigations, and the anticipated delivery of the results.

TASK NUMBER DELIVERABLE DELIVERY SCHEDULE

1 Project kick-off meeting to discuss overall project expectations, timelines, and deliverables.

1. Contractor shall provide analytical methodology for sample analysis (biological and paraphernalia), in writing, accompanied with supporting documentation.

Within 7 working days following award of contract, a phone call between DEA and the contractor will be scheduled to discuss the received deliverables.

2. Contractor shall provide a handout for medical facilities with instructions for transfer of samples.

3. Modified or revised protocols to be provided to DEA for review within 7 calendar days of discussion/notification by either party that the protocol must be modified or revised.

4. Contractor will be instructed on how to access and utilize the DEA maintained portal for uploading samples results.

2 and 3 Once the contractor’s protocol and medical facility instruction sheet is approved, the transfer of biological samples and drug paraphernalia from a medical facility may occur at any time. Once a sample is received, results are expected to be uploaded to the DEA database and a lab report transmitted electronically to the DEA within three weeks of receipt of the sample.

Monthly progress (NOT FOR PUBLIC RELEASE) reports will include the following:

1. Number of samples received the previous month

2. Status of credits remaining on current call order

3. Documentation of problems and their resolution

Quarterly and annual reports will be discussed with the contractor as to what material is most pertinent and intended for PUBLIC RELEASE.

Within 30 calendar days of the contract award, the contractor should be prepared to begin accepting samples from medical facilities for analysis.

Results for the analysis of each sample received are to be uploaded to the DEA maintained portal within three weeks of receipt of the sample.

Monthly reports are due by the 15th of each month.

Quarterly reports are due 30 days following each quarter close (i.e. April 30th due date for first quarter report).

Annual reports are due by March 1st of each year.

4 The contractor shall demonstrate that any equipment used in the analysis of samples is currently operational, in addition to supplying valid service contracts for the equipment prior to being

Within 30 calendar days of the contract award awarded funding. A certification letter must be included with the proposal that identifies each instrument that is currently in use by the contractor. The letter should certify that each instrument is currently in operational order, and should include the serial numbers for each instrument that will be used in the analysis of samples.

6.0 Use of Data

All documents, data, materials, records, and information sources provided to the contractor, developed or maintained by the contractor in the performance of this contract under this Statement of Work (SOW) are deemed to be the property of DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release.

None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the SOW, without prior written approval of DEA. DEA and the contractor will mutually agree to discuss matters of Freedom of Information Act (FOIA) policy before each agency independently discloses requested information.

On or before the agreement year expiration, the contractor shall deliver (or otherwise dispose per DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or manipulate data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).

During or after the agreement, no data may be released, presented or published except upon prior approval of DEA. However, DEA will work with the contractor to help inform health and law enforcement partners in an effort to educate the public as to the results of toxicological testing. All requests which the contractor will receive from third parties for access to the data must be referred to

DEA.

Data received from the contractor will be disseminated back to the original medical facility to aid in patient/decedent analysis. Contractor should be aware that once the toxicology report is released to the original medical facility, the contractor could be called upon to support or defend the results including within a court of law. DEA will refer all requests should they arise back to the contractor.

7.0 Retention of Information

The contractor shall retain, for 5 years beyond the duration of this agreement, all laboratory notebooks (which shall include paper copies of raw data) and electronic data files. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and paper copies of raw data. On or before the expiration date of this agreement, if so instructed by DEA, the contractor shall ship these items to the DEA representative in Arlington, VA.

7.1 DEA Representative (Scientific and Technical Contact):

Jordan Trecki, Ph.D.

Pharmacologist Drug and Chemical Evaluation Section Diversion Control Division Drug Enforcement Administration Phone: 202-904-9696 Email: Jordan.Trecki@dea.gov

7.2 Level of Effort

The DEA representatives reserve the right to visit the laboratory where testing is being conducted.

7.0 Staffing Approach/Key Personnel

8.2 Key personnel associated with this acquisition may include, but are not limited to the following:

A. Staffing/Recruitment

I. NAICS 611310 - Colleges, Universities, and Professional Schools, Principal Investigator:

1. Principal Investigator:

a. Ph.D., and 10 years post degree experience in an academic research laboratory setting;

detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

1. Co-Principal Investigator:

a. Ph.D., and 10 years post degree experience in an academic research laboratory setting;

detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

2. Research Technician assigned to analyze samples (Not Key Personnel)

3. Laboratory Manager (Not Key Personnel)

II. NAICS 621511 - Medical Laboratories

1. Principal Investigator (Study Director):

a. Ph.D., and 10 years post degree experience in an academic research laboratory setting; detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

2. Co-Principal Investigator (Project Director):

a. Ph.D., and 10 years post degree experience in an academic research laboratory setting; detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

3. Laboratory Manager (Not Key Personnel).

4. Research Technician assigned to analyze samples (Not Key Personnel).

It is assumed that multiple technicians may be necessary to conduct any one of the tasks associated with this acquisition.

8.2 Management Plan:

The management plan must include:

A proposed approach for managing unforeseen personnel shortages.

A description of the Offeror’s quality control process and how the staffing plan supports managing the quality of services provided.

A description of how the Offeror will overcome the challenges, mitigate the risks and deliver the performance outcomes and deliverables described in the SOW. Include the proposed approach to utilizing and managing subcontractors if they will be utilized.

Shall explicitly detail relevant professional training, certifications, and verifiable, previous successful program experience/expertise.

Shall include resumes of start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualification. The claimed experience duration must equal detail level experience durations for each category.

A letter of commitment, signed by the person proposed for one of the key personnel labor categories. The letter must express their ability to work at the proposed labor category.

8.3 Staff Retention:

The contractor shall explain current employee benefits and commitments that will ensure retention of personnel hired to work under the contract for 5 years beyond the duration of the contract agreement period of performance.

8.4 Past Performance:

The contractor shall provide past performance examples relevant to the SOW. The Offeror shall also specifically address its resilience in the face of trouble, resourcefulness, and management determination to see that the organization lived up to commitments or standards.

8.0 Transition Plan [Phase-In & Phase-Out]

The contractor shall submit a transition phase-in/out plan that will not affect the operations of the program during the transition periods during the contract performance. The contractor shall transition in accordance with its timeline to complete all phase-in activities within 60 days of the effective date of the contract. The transition plan of the successful contractor will be incorporated into the contract after award.

A. Transition Phase-In

Transition is an integral part of contract startup. The plan for transition-in shall include, but is not limited to:

1. Management of Phase-In Activities

2. Initial staffing levels and timeline to achieve to perform tasks stated in the SOW

3. Management of Knowledge Transfer Activities

4. Development and Dissemination of Operational Instructions, Procedures, and Control

Directives

5. Ensuring No Disruption of Work and Maintaining Continuity of Operations

6. Transfer of Government Furnished Property, Material, Equipment and Data, if applicable

7. Monitoring and Reporting of Transition Progress

B. Transition Phase-Out

The contractor shall submit a transition-out plan. The plan shall include, but is not limited to:

1. Management of Knowledge Transfer

2. Transfer and/or return of Government Data, Material, Equipment, and Furnished Property

a. Provides any data/documentation/task completed in performance of contract includes final version, drafts, and research and analysis report.

3. Ensuring no disruption of work and maintaining continuity of operations

a. Hiring and retention personnel.

4. Monitoring and Reporting of Transition Progress.

Section 3: RFP Instructions to Offerors

Submittal Requirements: Proposals shall be submitted electronically to Darrell Goodwin, Contract Specialist at darrell.goodwin@dea.gov and Nanaesi Amoo, Contracting Officer at Nanaesi.amoo@dea.gov. Submittal shall be on Offeror’s letterhead clearly labeled with company name, address, phone number, Cage Number, Unique Entity ID, business size/socio economic category, and point of contact(s) and email address(s). The Offeror’s executive summary must include the name and signature of an official authorized to bind the submitting organization.

Proposals must be received by the published due date and time; electronic email. Be advised that late proposals will not be considered.

Time, Date, and Place for Submission: The proposal submitted in response to this RFP No:

15DDHQ24R00000016 are due no later than 11:00 AM EST on April 05, 2024.

Questions in regard to the RFP are to be submitted to DEA by 11:00 AM EST on March 25, 2024.

Any question received after this due date will not be addressed. Offerors shall submit their question in the format shown below.

Page, Section and Paragraph # and/or Attachment

Questions Comments

Note, Offeror’s questions and DEA responses may result in the form of an amendment to the RFP.

Responses to questions will not reveal the Offerors who proposed the questions.

1. Basis for Award: The basis of award will be best value trade-off approach. The government intends to issue a competitive firm fixed price single award BPA in accordance with FAR 13; in the best interest of the Government. The basis of award will be best value trade-off approach

2. Proposal Period: The Vendor’s proposals shall be good for not less than 90 calendar days.

3. Expenses Related to Vendor Submission: The Government will not pay any cost incurred in the preparation and submission of any proposal.

4. Determination of Vendor Responsibility: Separate and independent of this evaluation, the Contracting Officer will make a determination of responsibility using the standards listed in FAR 9.104-1. In the event a Vendor is deemed not responsible, that Vendor will be notified and removed from participation in this procurement.

5. RFP Response - The proposal shall conform DEA provisions and clauses included in the

RFP. To aid its evaluation:

The proposal shall be clearly and concisely written as well as being neat, indexed, and logically assembled.

The proposal shall be specific and complete in every detail.

The proposal shall be practical, straightforward with concise delineation of what it is the Offeror will do to satisfy the requirements of the Statement of Work.

The proposal shall not merely offer to perform work in accordance with the scope of the work.

It shall outline the actual work proposed as specifically as practical. The Statement of Work (SOW) reflects the objectives of the program, therefore merely stating or affirming that the Vendor will execute the performance requirements without sufficient elaboration will not be acceptable.

All pages shall be appropriately numbered and identified with the name of the Vendor, the date, and RFP number.

A. 52.215-1 Instructions to Offerors—Competitive Acquisition. (JAN 2017) North American Industry Classification System (NAICS) code.

B. As a result of the solicitation, the Government intends to issue a competitive firm fixed price single award BPA to the responsible Offeror’s whose proposal(s) are conforming to the solicitation and represents the best value to the Government.

C. NAICS 611310 - Colleges, Universities, and Professional Schools, 621511 - Medical Laboratories, 541715 - Research and Development, and 541380 - Testing Laboratories and Services with fixed priced CLINS for five (5) ordering periods.

D. An official authorized to by your organization must sign the RFP responses. Proposals shall provide convincing rationale to address how the Offeror intends to meet these requirements. Offeror are reminded that Government reserves the right to award this effort based on the initial proposal, as received, without discussions. Proposals must be clear, coherent, and prepared in sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposals shall not simply rephrase or restate the Department’s requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. Each volume shall be written on a stand-alone basis so that its contents may be evaluated without seeking information from other volumes of the proposal. Information required for evaluation, which is not found in its designated volume, will be assumed to have been omitted from the proposal.

6. Proposal Format and Content:

All proposals shall contain the two separate volumes (and sections) identified in the chart below and be submitted as two (2) separate PDF files, subject to the quantities and page limits as specified below:

Table 3.0

Volume Title Document Format Maximum Page Limit* I Factor 1: Technical

Capability

Subfactor 1: Transition Plan (Phase-In/Phase-Out)

1 Original – Electronic Version Page Limit: 15 pages (Table of contents and

Executive Summary be excluded from the page count).

I Factor 2: Staffing Approach

Subfactor 1: Recruitment:

Subfactor 2: Management Plan:

1 Original – Electronic Version Page Limit: 10 pages (Resumes 2 pages each and excluded from the total page limits).

I Factor 3: Past Performance 1 Original – Electronic Version

Page Limit: 3 pages.

II Factor 4: Business Proposal/Cost

1 Original – Electronic Version

No Page Limit

Pricing Spreadsheet (Attachment 1).

Sample BPA Call Order (Attachment 2)

*Pages submitted in excess of the page limitations described above will not be evaluated. *

(a) Paper, Page Size and Markings: Each volume shall have a Table of Contents for easy reference. The proposals shall be formatted such that, if printed, they fit within 8 ½ x 11- inch paper, in a commercially standard font size (no smaller than 11-point). The offeror should mark its RFP response with any proprietary marking, if needed, based on their assessment of the contents of each of these volumes.

(b) Illustrations and Tables: Pages shall not contain any graphics or illustrations other than for the purposes of depicting the management/staffing plan and relevant corporate experience. Illustrations, charts, and graphs other than for depicting the management/staffing plan and relevant corporate experience are not permitted. Tables, charts, graphs, diagrams, and figures shall be used wherever practical to depict organizations, systems and layout, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 8.5 x 11 inches. Text shall be no smaller than 10 point for tables, charts, graphs, and figures. Elaborate formats or color presentations are not required.

(c) After evaluation, selection, and award, the files of each unsuccessful proposal will be retained per FAR 13.

Section 4: Basis of Award

The government intends to award a Firm Fixed Price, single award BPA in accordance with FAR Part 13. The basis of award will be best value trade-off approach. All Non- Cost evaluation factors when combined are significantly more important than Cost (Factor 4). In the event proposals are evaluated as technically equal in quality, cost will become a major consideration in selecting the successful Offeror.

The government will utilize the Confidence Adjectival ratings– Low, Some, and High and may or may not award to the lowest cost offer and highest technically rated Offeror.

An award will be made to the Offeror offering the “best value to the government based on the evaluation of all non-cost factors and review of cost, along with the proposal(s) demonstrating an understanding of the contract requirements and their ability to satisfy those requirements based on the required SOW.

The Government will make an award without discussions based on initial offer received. Therefore, all submitted Proposals should be best and final.

Section 5: Technical Instructions to Offerors

Volume I- Page limit: (15)

Factor 1 – Technical Capability

The Offeror shall demonstrate a technical understanding of the requirement, the approach, and techniques to satisfy all tasks as identified in the Statement of Work (SOW). Specifically, the Offeror shall demonstrate a technical approach to accomplishing the objectives and/or tasks to be performed including its ability to organize, manage its project personnel and resources, anticipate risks to ensure quality of services provided based on past experiences, and reference services required in accordance with the SOW.

Subfactor 1 - Transition Plan (Phase-In & Phase-Out):

Offeror’s Transition plan, shall also include an operational and cost-effective transition plan clearly identifying phase-in and phase-in out strategies. This plan shall be for all services referenced in the SOW, and shall include how the transition will be completed to ensure continuity of services. At a minimum, the transition A shall include the following:

A. Phase-In

1. Management of Phase-In Activities within 60 days of the effective date of the contract

2. Initial staffing levels and timeline to achieve to perform tasks stated in the SOW

3. Management of Knowledge Transfer Activities

4. Development and Dissemination of Operational Instructions, Procedures, and Control Directives

5. Ensuring No Disruption of Work and Maintaining Continuity of Operations

6. Transfer of Government Furnished Property, Material, Equipment and Data, if applicable

7. Monitoring and Reporting of Transition Progress

B. Phase-Out

8. Management of Knowledge Transfer

9. Transfer and/or return of Government Data, Material, Equipment, and Furnished Property

10. Provides any data/documentation/task completed in performance of contract includes final version, drafts, and research and analysis report.

11. Ensuring no disruption of work and maintaining continuity of operations

12. Hiring and retention personnel.

13. Monitoring and Reporting of Transition Progress

Factor 2 – Staffing Approach:

The Offeror shall provide a Staffing approach with innovative techniques to demonstrate its capabilities to recruit qualified candidates to fill all the positions required in the Statement of Work who meet the qualifications for each labor category.

The Offeror’s shall also explain their approach as to the following:

How they will forecast their hiring needs What is their sourcing strategy?

What is their selection process?

What is their onboarding process?

Are they going to utilize any subcontractors for this requirement? If so, clearly identify and explain which section of the works in accordance with the SOW, subcontractors will be working?

What is the total percentage of the requirement subcontractors will be performing? Prime must perform 50% of the total requirement in the SOW.

Subfactor 1 - Recruitment:

A Principal Investigator and Co-Principal Investigator (NAICS 611310, 541715) and a Principal Investigator (Study Director) and Co-Principal Investigator (Project Director) (NAICS 621511, 541380) shall explicitly detail relevant professional training, certifications, and verifiable, previous successful program experience/ expertise. The Offeror shall provide resumes for Key Personnel under either NAICS code dependent on the Offeror’s choice to provide recruitment/staffing solution specified in the Section 2 of the RFP. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualification. The claimed experience duration must equal detail level experience durations for each category.

Summary paragraph or matrix claiming total years of qualified experience is not sufficient, nor shall it be accepted as a substitute to providing the detailed, verifiable qualifications in each work experience in the resume. The Government must be able to clearly ascertain and validate required experience in the individual work history, or the resume may be considered a deficiency.

A letter of commitment, signed by the person proposed for one of the key personnel labor categories. The letter must express their ability to work at the proposed labor category if the Offeror was awarded the BPA.

Subfactor 2 - Management Plan:

The management plan must include:

o A proposed approach for managing unforeseen personnel shortages.

o A description of the Offeror’s quality control process and how the staffing plan supports managing the quality of services provided.

o A description of how the Offeror shall overcome the challenges, mitigate the risks and deliver the performance outcomes and deliverables described in the SOW. Include the proposed approach to utilizing and managing subcontractors if they will be utilized.

Factor 3: Past Performance:

Past performance shall include, at a minimum, the following information for both the Offeror and major subcontractors (a major subcontractor is defined here as a company/vendor for which over 25% of the total contract effort will be subcontracted over the life of the contract):

The Offeror shall provide total two (2) examples of Past Performance relevant to the SOW completed during the past three (3) years…