22-001860 - Combined Synopsis_AMENDMENT.1.w.Att1-4.pdf

AMENDMENT 1

NIMH Postmortem Human Brain Collection

NIMH-22-001860

INTRODUCTION

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items.

The solicitation number is NIMH-22-001860 and the solicitation is issued as a request for quotation (RFQ).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 621991 with a size standard of $35M Dollars.

SET-ASIDE STATUS

This acquisition is not restricted and is available for full and open competition.

ACQUISITION AUTHORITY

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items and is expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-05 dated March 7, 2022. The resultant contract will include all applicable provisions and clauses in effect through this date.

DESCRIPTION OF REQUIREMENT

Background The Human Brain Collection Core (HBCC) at the National Institute of Mental Health (NIMH), is a brain bank dedicated to the acquisition and distribution of brain and associated tissue, to better understand the causes, consequences, and potential treatments of neurological and psychiatric disorders.

HBCC seeks tissue from both psychiatrically healthy and afflicted individuals in order to establish the neuropathological changes underlying complex neuropsychiatric disorders. This research will lead to improved diagnosis, treatment and/or prevention of these illnesses and their consequences. Therefore, the NIMH has a need to locate a source(s) capable of providing donor specimens on an on-going basis from licensed Medical Examiner's Offices or other sources to continue this research. This specific request is for donors within a hundred fifty-mile radius from NIH Bethesda.

Purpose The services required are to procure human postmortem brain tissue, including various other specimens (e.g., dura, hair, blood, pituitary) at autopsy, and provide these specimens to HBCC while also providing the general background of the case and the contact information for the deceased’s next-of-kin to the HBCC. The donated postmortem human brain specimens will be used for research by the HBCC into the neurobiology of complex mental disorders, and also distributed to approved/qualified outside investigators for research.

Project Requirements

See Attached Statement of Work for details.

Delivery Requirements/Period of Performance

Base Period: September 30, 2022 to September 29, 2023 Option Period 1: September 30, 2023 to September 29, 2024 Option Period 2: September 30, 2024 to September 29, 2025 Option Period 3: September 30, 2025 to September 29, 2026 Option Period 4: September 30, 2026 to September 29, 2027

Place of Performance

The place of performance shall be the National Institutes of Health, Bethesda, MD 20892

Contract Type The Government intends to issue a firm fixed price purchase order for this requirement.

Invoicing shall be in accordance with the Prompt Payment Act and payment shall be made via Electronic Funds Transfer (EFT).

Response Format Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the salient characteristics of the product.

The offeror must identify in their response where parts/equipment are manufactured.

The offeror must indicate in their response as to whether the brand-name or equal product proposed can or cannot meet the salient characteristics as stated in this combined solicitation synopsis.

In addition, the quote must provide their company name, Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

TECHNICAL PROPOSAL

Offerors may provide up to 20, 8.5 by 11-inch pages (using no less than 10 font size) as their proposal to be evaluated by the Source Evaluation Panel. The technical submission will address the Statement of Work and be responsive to the attached evaluation factors. The 20-page technical submission limitation does not include and is in addition to the pages relating to relevant resume credentials and the price proposal. Technical submission pages in excess of this page limitation will not be considered.

COST/PRICE PROPOSAL

The cost/price proposal must be completed to include all costs related to the Statement of Work, including the hourly, daily and monthly rates, as appropriate, and all direct and indirect costs for the base and option years. The cost/price proposal shall be submitted in the Microsoft Excel format.

LEVEL OF EFFORT

The following is only an estimate. Offerors are advised to carefully review the requirement in deriving the level of effort they believe are necessary to provide their best value proposal. You are not bound to propose using the below assumptions. Rather, offerors are expected to provide the best solution citing the labor mix and quantity required to accomplish the tasks.

The following data as a basis for estimating the potential volume of referrals for each proposed site (adjust for your own circumstances, with justification):

-Assume an average of 900 autopsies/yr. will result in approximately 100 case referrals/year.

-Provide an estimate of the number of annual referrals that may meet the inclusion criteria in the Statement of Work and include this information as part of your Technical Proposal (explain how it was calculated).

As a basis for preparing cost proposals, the Government estimates the following level of effort to provide these services, per site:

-Up to 460 hrs. effort, per year, per site, to provide all contract services (i.e., referrals, extractions, and for other contract communications and administration);

-It is anticipated that this effort should accommodate a wide range of contract services and volumes of referrals and extractions.

-This estimate is not a requirement, and the offeror can propose differences, with justification.

EVALUATION

The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition.

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. See Evaluation Criteria attachment for details.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the http://www.sam.gov/

Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(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: (i) technical capability of the item offered to meet the Government requirement; (ii) price.

Technical are significantly more important than cost or price

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.”

ADDITIONAL INFORMATION

The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021)

• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov

2021)

• FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014)> https://www.acquisition.gov/browse/index/far

• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Nov 2021).

Addendum to this FAR clause applies to this acquisition and is attached.

• The clause at FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000).

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015)>

• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December

18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

(End of clause) The following provisions and clauses apply to this acquisition and are attached in full text.

Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jan 2022) https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

• NIH Invoice and Payment Provisions (Feb 2021)

The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

CLOSING INFORMATION

All responses must be received by 5:00 PM EST, on Monday, June 20, 2022 and reference number NIMH-22-001860. Responses may be submitted electronically to jeff.moore@nih.gov, and robin.knightly@nih.gov. Any questions must be submitted by 3:00 PM EST, on Thursday, May 26, 2022.

Fax responses will not be accepted.

ATTACHMENTS

Attachment 1 – Statement of Work Attachment 2 – Technical Evaluation Criteria Attachment 2 – 52.212-4 and 52.212-5 Attachment 3 – 52.204-24, 52.204-26, 52.212-3 Clauses Attachment 4 – Invoice Instructions mailto:jeff.moore@nih.gov mailto:robin.knightly@nih.gov

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

NIMH Postmortem Human Brain Collection

Statement of Need and Purpose:

The Contractor shall provide contract services to the Human Brain Collection Core (HBCC) at the National Institute of Mental Health (NIMH), to acquire donor specimens for HBCC research purposes during the contract period, based upon the requirements outlined below. The services are to procure human postmortem brain tissue, including various other specimens (e.g., dura, hair, blood, pituitary) at autopsy, and provide these specimens to HBCC. The Contractor also provides information contained in the death investigation report and any other medical/toxicological information related to the donor. The donated postmortem human brain specimens will be used for research by the HBCC into the neurobiology of complex mental disorders, and also distributed to approved/qualified outside investigators for research.

Background Information and Objective:

The Human Brain Collection Core at the NIMH explores the causes, consequences, and potential treatments of numerous neurological and psychiatric disorders. HBCC research is supplemented by studying postmortem brain tissue from both psychiatrically healthy and afflicted individuals in order to establish the neuropathological changes underlying these complex neuropsychiatric disorders. This research will lead to improved diagnosis, treatment and/or prevention of these illnesses and their consequences.

Period of Performance:

The period of performance is one 12-month base year with four 12-month option years.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

On a daily basis, the Contractor shall review case documents for potential donation and determine which cases may be eligible for HBCC research (see below for inclusion/exclusion criteria). Eligible cases include those with a reasonable suspicion of a history of mental or neurological illness (particularly schizophrenia), or as non-psychiatric controls across the lifespan. The HBCC shall obtain basic clinical histories or other collateral information that surface in the conduction of their routine investigation to help determine eligibility. Brains from all ages (including children), both sexes, and all races are eligible. Brains within a 150 mile radius from NIH Bethesda are eligible to be considered. Shipments must be received no later than 46 hours after death and within 12 hours after extraction which includes all the packing of the brain. This time requirement is necessary in order to minimize biochemical degradation of the tissue.

1. Inclusion criteria:

a. Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, including schizophrenia, anxiety disorders, suicide, bipolar disorder, and depression.

b. In addition, brains from individuals without a history of neuropsychiatric disease will be needed as controls.

c. Cases with known history of COVID-19 infection.

2. Exclusion criteria:

a. History exclusive for substance use disorders (cocaine, alcohol, heroin, or the like). If there is indication of a concomitant disorder such as schizophrenia, a history of psychiatric hospitalization or there is a high suspicion that the individual died of suicide, the case will be referred to HBCC.

b. Well documented, long lasting seizure disorder.

c. Infections known to affect the brain such as syphilis, tuberculosis, with the exception of HIV or COVID-19 infection.

d. The body is decomposed. We will consider collecting the brain if we can complete processing within 48 hours after death.

e. There is obvious damage to the brain by closed head injury or other trauma

(gunshot wound, fall, etc.).

f. There are brain infarcts, hemorrhages, tumors, stroke, or other brain lesions that destroy the normal brain structure.

g. The patient has been maintained on a respirator (ventilator) for more than 12 hours.

h. Major sepsis.

j. Alzheimer’s disease and other dementias and degenerative diseases.

3. Once a case is identified/selected, the Contractor shall contact HBCC personnel and provide: 1) the general background of the case (name, demographics, circumstances of death, medical and social history); and 2) the name, relationship, and telephone number of the decedent’s next-of-kin.

4. It is important that the next-of-kin be notified of the death of their loved one prior to referral to HBCC.

5. In order to maximize the number of referrals, formal identification of the body by the next-of-kin is not required by HBCC. This process can significantly delay tissue acquisition, easily exceeding the timeframe proposed above. HBCC inquires with all next-of-kin what their relationship to the decedent is and tries to determine in good faith whether the next-of-kin is indeed the legal primary decision maker regarding the brain donation.

6. HBCC staff will promptly contact the next-of-kin to obtain permission (via a recorded telephone call) and to obtain the deceased subject’s brain and skull contents for research (including dura, pituitary, blood, and hair sample). Other tissues may be requested at this time. HBCC staff will also solicit the release of medical records from decedent’s treatment facilities or medical and behavioral providers.

7. Extraction and Shipping

a. Once permission is obtained by HBCC personnel, the Contractor shall be notified by phone to procure the brain, 40-90 cc of blood, a nasopharyngeal swab for Sars-CoV-2 testing, and possibly other tissues at the time of autopsy. The Contractor will begin extraction promptly upon notification of approval from the NIMH. The process should begin no later than within 24 hours of death; unless approved by the NIMH Project

Officer and/or Contracting Officer’s Representative (COR). The Contractor will provide to the HBCC any relevant documents related to a specimen including cause and manner of death, relevant history and/or toxicology in order to allow optimal characterization of the specimen.

b. After extraction, the Contractor shall promptly prepare the specimens for shipping to the NIMH. An ice-making machine is required in order to pack the brain on ice for transportation. This will be provided by the Contractor and costs reimbursed through the contract. HBCC personnel will provide transportation of the samples to the NIH campus.

c. Prior to shipping, the NIMH shall be contacted with shipping details, including the courier tracking number.

d. Shipments must be received as soon as possible after extraction (no longer than 12 hours) which includes all the packing of the brain. In no case will specimens be accepted by NIMH beyond 48 hours after death; a much shorter time period is highly desirable.

Delay in receiving the brain results in degradation of the tissue that makes it unsuitable for research.

e. The Contractor will ensure that specimens are packaged in accordance with all federal, state, and local regulations.

f. The Contractor will provide HBCC with a report on the Cause of Death of the individual as soon as this is generated.

LEVEL OF EFFORT:

It is very difficult to estimate the level of effort for this work. Our latest data related to the contract for the past year (post-pandemic lock-down), indicate that 7-10% of autopsies are referred to HBCC for consent, resulting in 50-100 referrals per site/year. 30-60% of referrals result in a brain donation and therefore in approximately 25-30 brain extractions per site/year.

The number of referrals and successful donations is difficult to estimate and will vary from year to year. The Contractor has no control over the number of cases presented for autopsy, or those that may be suitable for inclusion into the NIMH brain bank.

Use the following data as a basis for estimating the potential volume of referrals for each proposed site (adjust for your own circumstances, with justification):

-Assume an average of 900 autopsies/yr. will result in approximately 100 case referrals/year.

-Provide an estimate of the number of annual referrals that may meet the inclusion criteria in the Statement of Work and include this information as part of your Technical

Proposal (explain how it was calculated).

As a basis for preparing cost proposals, the Government estimates the following level of effort to provide these services, per site:

-Up to 460 hrs. effort, per year, per site, to provide all contract services (i.e., referrals, extractions, and for other contract communications and administration);

-It is anticipated that this effort should accommodate a wide range of contract services and volumes of referrals and extractions.

-This estimate is not a requirement, and the offeror can propose differences, with justification.

• It should be noted that the brain extraction procedure that is estimated here would occur in the customary execution of duties of the medical examiner and the autopsy technicians. The additional time required to set aside the brain for shipment to HBCC, collection of blood or other tissues is approximately 10 minutes per case. Different considerations would apply to a hospital environment, where an autopsy is not necessarily required as part of customary workflow.

GOVERNMENT RESPONSIBILITIES

HBCC will provide transportation of the specimens to the NIH campus in Bethesda, MD, by identifying the appropriate courier for contractors located within a 150-mile radius from the NIH campus. HBCC will pick up the brain from facilities located within a 50 mile radius from NIH.

Rare cases with schizophrenia, bipolar disorder, or children below the age of 15, will be referred to HBCC on weekends or on Federal Holidays. HBCC may provide coolers for transport, supplies to preserve the blood (tubes), supplies for testing for Sars-CoV-2 (swabs), or other equipment required for the extraction and preservation of the brain that would burden the

Contractor with extra costs. The Contractor will not need access to government facilities.

Additionally, the Contractor (MEO) will receive a neuropathological report from HBCC within 31 days of the extraction of the specimens delivered to the HBCC.

REPORTING REQUIREMENTS

See below under Deliverables.

DELIVERY OR DELIVERABLES

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the

DELIVERIES Article of this contract:

1. Technical Progress Reports

a. All technical reports shall be submitted to the Contracting Officer’s

Representative (COR) electronically, in Microsoft Excel or Microsoft Word format.

The Contracting Officer shall also receive electronic copies of Final Technical

Report, in addition to signed hard copies of each Annual Report and the Final

Report. The specific content of technical reports will be determined by the COR, but it is not expected that reports will exceed 1 page in length. If options to extend the term of this contract are exercised, this reporting schedule will continue during any/all contract extensions.

b. All electronic reports submitted shall be compliant with Section 508 of the

Rehabilitation Act of 1973. Additional information about testing documents for

Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

c. Scheduled/Recurring Progress Reports

2. Annual Report(s)

Annual Reports shall be submitted to the COR within 15 calendar days after the end of each 12-month contract period. This report should include the number of referrals to HBCC, the number of donations that occurred in the previous year, and any problems that were experienced during the reporting period. This report shall be in sufficient detail to describe comprehensively the results achieved.

3. Final Report

i. This report is to include a summation of the work performed and results obtained for the entire contract period of performance.

ii. The Final Report shall be submitted in accordance with the

DELIVERIES Article of this contract. An Annual report will not be required for the period when the Final Report is due.

http://www.hhs.gov/web/508/index.html

iii. If options to extend the term of this contract are exercised, Final Reports will be due at the end of the revised/extended period of performance.

OTHER CONSIDERATIONS:

Travel:

No travel is required by the Contractor.

Key Personnel:

Key personnel needed for this contract are:

Medical Examiner* or Pathologist if in a hospital setting

Autopsy Technician*

As needed:

Medical Examiner- Investigator

Administrator

Information System Security Plan:

The contractor is not required to access federal information systems. The contractor will communicate sensitive personal data to HBCC in a secure way (phone call or secure email).

Data Rights:

The National Institute of Mental Health shall have unlimited rights to and ownership of the data collection platform and all data including reports. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in

Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in

Data-General,” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 if appliable.

Publications and Publicity:

The contractor will not write or publish articles of data produced as a result of the requirements of the SOW.

Confidentiality of Information:

For this requirement, the government may provide to the contractor(s) information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor(s) shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

Additionally, HBCC will provide a neuropathological report to the contractor. This information is expected to be part of the contractor’s report on the cause of death, and this information will be treated in conformity to local laws.

HBCC will also provide the contractor with positive results of a nasopharyngeal swab for Sars-

CoV-2. If the case is unexpectedly positive, the contractor is expected to notify the next-of-kin and all personnel that came in contact with the decedent within 24 hours of the receipt of this information, in order to allow for public health related measures.

ATTACHMENTS

1. Independent Government’s Cost Estimate

2. Evaluation / Selection Criteria

STATEMENT OF WORK (SOW) SERVICES ATTACHMENT

NIH Postmortem Human Brain Collection

ATTACHMENT 2: Technical Evaluation Criteria

The Government will award a contract or purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below:

Factor 1: Technical Approach

The Contractor’s proposal shall address each area of the statement of work in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them. The proposed technical approach shall be evaluated for:

• Annual Estimated Volume of Referrals: The projected annual volume of cases that could potentially be referred to the NIMH for consent (with a sufficient annual volume of total autopsy cases to reasonably support the projections); a higher volume of referrals is considered more valuable to the government than fewer;

• Regulatory: Approval from the appropriate Government body(ies) that sanction the extraction, processing, and donating of human organs; the possession of any required permits, licenses, etc.;

• Facilities: Appropriateness and availability of laboratory space, facilities, and equipment to accomplish the contract objectives;

• Quality of Specimens: The perceived ability to provide cases to NIMH as soon as possible after death, and consent is provided by the next of kin, and within 12 hours of extraction and no later than 48 hours after death; avoidance of any delays or logistical problems due to location (Courier will pick up the specimen and bring to the NIH Bethesda campus); and

• Identified Issues and Solutions: Adequacy of any proposed solutions to identified problems

Factor 2: Personnel Qualifications

The demonstrated qualifications, availability, and experience of proposed professional and technical personnel to perform the tasks of the contract, as evidenced by resumes or CVs.

Factor 3: Past Performance

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work.

References shall include the following information:

a. Name of Organization

b. Brief Description of Contractor’s Responsibilities

c. Contact Name and Title

Past Performance shall be evaluated for relevance to the current requirements.

Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:

Excellent The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. The risk of unsuccessful performance is very low as the proposal provides a clear understanding of the requirements and demonstrates the offerors’ ability to meet the requirement. Risk Level: Very Low

Good The proposal demonstrates an approach which is expected to meet all requirements and objectives. This approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains alternative solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low

Acceptable The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral

Marginal The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High

Unacceptable The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages.

Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High

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