Attachment 4 -Technical Evaluation Criteria-NNTC Clinical Sites.pdf

TECHNICAL EVALUATION CRITERIA

TITLE: THE NIH NATIONAL NEUROHIV TISSUE CONSORTIUM – CLINICAL SITES

NOTE: CRITERION 1 BELOW EVALUATES THE QUANTITY, QUALITY AND CHARACTERISTICS OF THE DONOR SPECIMENS THAT CAN REALISTICALLY BE ACQUIRED; CRITERION 2. BELOW EVALUATES OTHER

SITE FUNCTIONS, CAPABILITIES, PROCESSES AND PROCEDURES THAT WILL BE UTILIZED.

The evaluation factors below will be used by the technical evaluation committee when reviewing the technical proposals. Proposals will be evaluated by a Technical Evaluation Panel according to the three

(3) factors outlined below. All of the technical factors are weighted equally. Proposals will be evaluated on the extent to which they provide confidence in accomplishing the functions delineated in the Statement of Work (SOW). Contractors are required to be able to perform the entire SOW.

The following adjectival confidence rating descriptions shall be used for the Technical Evaluation:

High Confidence -The Government has high confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with little or no Government intervention.

Medium Confidence -The Government has some confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with some Government intervention.

Low Confidence -The Government has low confidence that the Offeror understands the requirement, proposes a sound approach, or will be successful in performing the contract even with Government intervention.

Unacceptable -The proposal fails to recognize, address, or consider the Government’s requirements.

FACTOR 1

ACQUISITION CAPABILITIES/CHARACTERISTICS OF DONOR SPECIMENS

The objective of this initiative is to establish contracts with sites that that can, on a continuous basis, collect a significant volume of high quality and high value HIV+ and HIV- donor specimens including specimens with certain characteristics or clinical diagnosis and associated data. This section of the proposal should demonstrate the Offeror’s Acquisition Capabilities/Characteristics of Donor Specimens approach.

Offerors will be evaluated on a composite basis on their approach proposed/demonstrated ability to accomplish the following criteria:

a. PROJECTED COLLECTION SIZE

The ultimate, realistic, projected collection size at the end of a potential five-year contract period will be evaluated (consists of the inclusion of any high-quality current specimens donated to the repository for contract purposes, and the projected acquisition capabilities).

(1) New Specimens: Acquire new brain donors each year. Milestones will be determined in conjunction with the contractor to specify the numbers/types of brains to be collected per given period.

• Contractors shall provide evidence that supports a tentative/proposed new specimen acquisition schedule: by either historical or other data. Contractors shall also provide recruitment capability evidence through historical records and/or a demonstration of having targeted outreach experience and plans (i.e., well-established mechanisms for recruiting and registering potential donors and experience with outreach efforts to appropriate HIV disease organizations and populations).

• Contractors shall demonstrate their ability to effectively acquire new donors each year, and to maximize the quality of available clinical data, NNTC sites shall present evidence of well-established mechanisms for recruiting, pre-registering, and following potential HIV donors.

(2) Current Specimens for Inclusion (if applicable): Requires evidence of high-quality, well-characterized tissue (including quality metrics, e.g., RIN, 260/280 ratio, tissue pH etc.)

and supporting phenotypic data.

(3) Evidence that supports the proposed new specimen acquisition schedule: by either historical or other data. Recruitment capability will be measured/evaluated by historical records and having targeted outreach experience and plans (i.e., well-established mechanisms for recruiting and registering potential donors and experience with outreach efforts to appropriate HIV disease organizations and populations).

b. DONOR COLLECTION CHARACTERISTICS

Offerors will be evaluated on the probability of acquiring specimens with the following attributes/characteristics/data, and the flexibility to acquire specific cases as determined by future initiatives:

(1) NeuroHIV Biobanking Donor specimens relevant to the scientific mission of the participating institutes supporting this project (including unaffected controls) are solicited under this contract (i.e., Office of AIDS Research (OAR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS),the National Institute of Aging (NIA) and the National Institute on Drug Abuse (NIDA))

• The offeror’s ability to acquire donors with HIV

• The offeror’s ability to acquire unaffected controls

• The offeror’s capability and flexibility to target and acquire HIV donor populations as determined by future NIH-HIV initiatives. The extent to which the offeror has specific expertise in NeuroHIV biobanking and are able to acquire as requested should be specified.

• The offeror’s ability to access unique or difficult to reach patient populations

(2) Clinical Data Donor specimens that are accompanied by rich demographic, genotypic, phenotypic, neuropathological and other types of clinical data are of the greatest value to the research community. Offeror will be evaluated on the ability to acquire donor clinical data including longitudinal clinical assessments to support specimen use.

Specimens with the following types of associated antemortem and postmortem data:

i. Clinical findings and clinical history including ARV medication history

ii. Concomitant medication use

iii. Laboratory testing results

iv. Venous blood collection and testing collected for CBC, CD4+ T cell enumeration, plasma HIV load, and research samples of PBMC, serum, and plasma

v. CSF extraction and testing for white blood cell count, total protein, glucose, and HIV load

vi. Urine toxicology

vii. Neuromedical evaluation

viii. Neuropsychological testing and assessment

ix. Neuropsychiatric assessment that includes that includes the CIDI and BDI and medication adherence/activities of daily living questionnaires

x. Anthropomorphic measurements

xi. Demographics including gender, race, ethnicity

xii. Medical history updates, examinations, and laboratory should be repeated every 6- 24 months depending on the participants’ health and/or likelihood of loss to follow-up

xiii. Tailored domain-based neuropsychological assessments data using the RDoC framework

xiv. Longitudinal neuroimaging data for study participants

xv. Longitudinal Data pertaining to pathway linked biological measures such as signaling pathways, neuroinflammation, and immune profiles

xvi. Measures of mechanistic biological signatures/targets to aid in diagnosis and for developing pre-clinical therapeutic interventions for CNS co-morbidities

xvii. Neuropathological indices, Neuroimaging data, Biomarkers

xviii. Measures of viral dynamics in the CNS and periphery including state of the science assays to quantify viral reservoirs

xix. Viral and host genetic data that could aid in neuropathogenesis research

xx. Data related to aging associated co-morbidities such as Alzheimer’s disease (AD) and

Alzheimer's Disease-Related Dementias (ADRD) (neuropsychological indices, neuroimaging data, biomarkers)

xxi. All the above data resources in the context of substance use (nicotine, cocaine, methamphetamine, stimulants, opioids, prescription drugs, and cannabinoids) and substance use data across the lifespan

xxii. Neuropathologic evaluation – histologically categorize human brain and spinal cord based on diagnostic protocols pre-established by NNTC

xxiii. Neuropathologic evaluation specific to Alzheimer’s disease (AD) and Alzheimer's Disease-Related Dementias (ADRD)

xxiv. Organ HIV-related pathology

xxv. Organ Pathology - non-HIV related

xxvi. Collection of fluids may occur during scheduled study visits or, if necessary, upon a participant’s demise

xxvii. Cause and manner of death xxviii. Medications at the time of death (ATOD)

xxix. If unavailable during antemortem assessment and/or if contacted after an individual’s death:

xxx. Collect family legal guardian’s consent for tissue donation and release of medical records

xxxi. Collect family history information such as date of birth, education level, ethnicity, medical problems, genetic disorders, and mental illness including substance use for first-degree relatives, when available.

xxxii. Phenotypic information such as cranial MRI findings (deidentified images and/or reports), other radiological reports, results of genetic tests and/or diagnostic evaluations, other clinical notes and evaluations by specialists.

(3) Other Criteria

i. Geographic Distribution - Donors from different geographical areas

ii. Donations of other tissues and pre-mortem biopsies

iii. Community engagement and participatory research approaches for longitudinal HIV cohort studies

FACTOR 2

OTHER NNTC CLINICAL SITE CHARACTERISTICS/METHODS (STANDARDS

SOPS/ QUALITY ASSURANCE SYSTEMS), TISSUE ACQUISITION/REGULATIONS,

CURRENT INFRASTRUCTURE, DATA MANAGEMENT, TISSUE ANALYSIS SUB-CONTRACT)

This section of the proposal should demonstrate the Offeror’s other NNTC clinical site characteristics/methods, tissue acquisition/regulations, current infrastructure, data management, and tissue analysis approach. Offerors will be evaluated on an overall basis on their approach proposed/demonstrated ability for providing the items below to successfully start this Project upon award, and without start-up delays.

a. General

(1) Methodology to acquire, track (including all daughter specimens), store, catalog, maintain, and distribute tissues required under this contract, in adherence to the highest ethical standards and state and federal regulations.

b. Standards

(1) Standard Operating Procedures. As evidenced by the Table of Contents from the SOP

Manual, appropriate types of SOPs are in place for all tasks involved including the prevention of duplicate submissions of non-brain tissues. Methods for tissue distribution and sharing. Stated willingness to adopt standardized protocols and measures, when possible, and to modify existing SOPs accordingly.

(2) Quality Assurance Systems/Program/Plan

A comprehensive QMP to monitor the entire specimen management process, from specimen receipt to storage and distribution including documentation of data such as post-mortem interval; specimen processing; monitoring of storage conditions at the box and freezer level; inspection of shipping containers and storage facilities including the central alarm system, air conditioning systems, and the back-up power system; specimen quality data management; requisitioning; and shipping of all requested specimens.

The QMP should operate in an autonomous manner, separate from the technical staff, and report results directly to the contract Principal Investigator and/or other senior institutional or corporate management and the NIMH COR.

(3) Regulatory

i. Indicate which Internal Review Board approves brain bank activities

ii. Compliance with all applicable health and safety regulations

iii. Evidence of appropriate shipping licenses and permits from local, State, Federal and international authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable.

c. Equipment/Storage/Freezers, etc.

Materials, equipment, and facilities are sufficient to successfully carry out the Project.

This will include:

(1) Providing sufficient floor space and/or vertical storage as needed for contract startup in a single facility to accommodate samples and equipment;

(2) Appropriate back-up systems as considered state-of-the-art for biobanking;

(3) Appropriate laboratory and office space; and

(4) Plans to accommodate an increasing collection size throughout the contract.

d. Data Management Systems and Databases

Evidence of an adequate data management system/process to perform this Project.

A comprehensive Laboratory Information Management System (LIMS) for tracking, cataloging, photographing, digitally recording information about tissue quality and integrity of samples. This system will be required to provide accurate inventory and associated data through a federated IT system referred to as the NIH NNTC DCC, which will serve as the primary portal for researchers, potential tissue donors, and others in the general public interested in the NNTC’s services.

FACTOR 3 - PERSONNEL

This section of the proposal should demonstrate the Offeror’s Personnel. Offerors will be evaluated on their approach/ability related to the quality, availability and competence of the offeror’s proposed personnel, management abilities, and efficiency of the staffing plan will be evaluated as follows:

a. Evidence of expertise and experience from years of work experience in NeuroHIV biobanking field, as evidenced through publications in peer-reviewed scientific journals and history as a site investigator for NeuroHIV biobanking program

b. Knowledge of state-of-the-art methods for tracking, handling, characterizing, processing, and distributing human infectious tissue. As advances occur, ability to propose and/or adopt new state-of-the-art procedures in NeuroHIV biospecimen and biorepository research for implementation into this contract.

c. Knowledge of cutting-edge scientific approaches/methods utilizing human post-mortem tissue, and ability to assess the landscape of needs of the NeuroHIV research community to refine collection, processing, and/or preservation approaches to accommodates these changes in technology.

d. Availability and necessary expertise for working with HIV populations and coordinating antemortem clinical data and postmortem biospecimen data with a DCC for database management and maintenance.

e. Appropriateness, and efficiency of the staffing plan to accomplish the work.

f. Ability to manage the project, ensure appropriate staffing, knowledge with all applicable laws and ethical standards.

Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

The following rating method shall be used in the evaluation of past performance information:

Excellent - Based on the offeror's performance record, no doubt exists that the offeror will successfully perform the required effort. Sources of information are consistently firm in stating that the offeror's performance was superior and that they would unhesitatingly do business with the offeror again.

PAST PERFORMANCE

Good - Based on the offeror's performance record, little doubt exists that the offeror will successfully perform the required effort. Sources of information state that the offeror's performance was good, better than average, etc., and that they would do business with the offeror again.

Neutral - No past performance history identifiable.

Marginal - Based on the offeror's performance record, some doubt exists that the offeror will successfully perform the required effort. Sources of information make unfavorable reports about the offeror's performance and express concern about doing business with the offeror again.

Poor - Based on the offeror's performance record, serious doubt exists that the offeror will successfully perform the required effort. Sources of information consistently stated that the offeror's performance was entirely unsatisfactory and that they would not do business with the offeror again.