Storage of freezer repository samples

INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to:

Precision Bioservices, Inc.
8425 Progress Dr Ste M
Frederick, MD, 21701-4766 ,
UNITED STATES

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 493120 with a Size Standard $27.5 million.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAR FAC 2005-101 October 26, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13.5 - Simplified Procedures for Certain Commercial Items.

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR subpart 13.5 - Simplified Procedures for Certain Commercial Items. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION
1. Title: Storage of freezer repository samples
2. Background Information: The Transfusion-Transmitted Viruses (TTV) laboratory within the Infectious Diseases Section (IDS) in the Department of Transfusion Medicine (DTM) collects and stores aliquots of serum/plasma from research protocol consented patients within the NIH Clinical Center. These samples are used for potential testing of infectious disease markers for research purposes. These samples have chronicled the history of Hepatitis C and other infectious markers from their actual discovery to diagnosis to disease progress or recovery. Some of these samples have been used to assist with the development of new assays, expanded research on the progress of the disease and have aided in the discovery of new agents/disease so are extremely rare and important

There are currently over 180K samples requiring storage with additional research samples collected on an ongoing basis. In order to access these samples for ongoing research, the department must utilize a repository that can provide an accurate inventory of the samples that are also easily accessible as well as queried for data and sample collection. The samples must be stored in an environment that is monitored 24/7 and are maintained in an environment that will limit degradation, i.e., limit freeze/thaws, maintain temperatures of
(-70deg C to -99deg C) or other temperatures as required by the government. The database utilized for the sample data must be accurate to reflect the correct samples with the correct data and the staffing performing the functions of data entry, sample management must be adequately trained, and competency maintained to ensure sample integrity and data integrity.
3. Purpose or Objective: The objective of this proposal is to procure repository services for the Department of Transfusion Medicine. These services include the storage and maintenance of Government-owned freezers which currently includes 18 freezers (2 chest freezers and 16 upright freezers) in a highly maintained environment, into which the Dept. will store, monitor, inventory and retrieve samples. The repository must utilize a database that manages and tracks the specimen inventory accurately and reliably. This system must track sample identities, identifies location in the freezer and also must provide reporting options including historical information related to each vial such as study ID, freeze thaw information, retrieval and return information, volume and sample type. The database should be accessible to the government for query purposes or the information readily available. Currently the government has 18 freezers which consists of the 2 chest freezers and 16 upright freezers) and an inventory of >180,000 samples.

4. Period of Performance:
BASE: 06/24/2019- 06/23/2020
OPTION PERIOD 1: 06/24/2020 - 06/23/2021
OPTION PERIOD 2: 06/24/2021 - 06/23/2022
OPTION PERIOD 3: 06/24/2022 - 06/23/2023
OPTION PERIOD 4: 06/24/2023 - 06/24/2024

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1. Performance Requirements/Work Areas
The contractor shall be responsible for, independently, and not as an agent of the government, the contractor shall provide all necessary personnel, supplies, materials and services to fulfill the requirement.
The contractor shall perform the following:

Tasks and associated Deliverables
1. The contractor shall:
a. Demonstrate the ability to Convert and Maintain legacy data if conversion is necessary.
i. Convert existing legacy data to a format fully supported by the new database system.
ii. Provide a data element mapping guide from legacy data to the new database (if needed)
iii. The conversion programmatic routine shall produce a report that clearly shows a record-by-record accounting of converted data.
iv. The conversion programmatic routine shall produce an outlier report that shows records with conversion errors and records that did not convert.
v. Provide a record-by-record plan of action for those records that do not convert
vi. Demonstrate a "data byte-for-byte" transfer of data from the converted database to the new database.
2. Utilize an Inventory management system that will manage and track specimen inventory. The information must contain but is not limited to the following:
a. Primary identifier,
b. Specimen type; ie. Plasma, serum, CSF, tissue, whole blood, etc.
c. Volume
d. Collection date,
e. Must track the number of freeze/ thaw each sample has undergone as well as track the dates of each freeze/thaw
f. Retrieval information and storage location.
g. Should also provide reporting options such as all historical information of the samples such as freeze thaw information, retrieval information and volume remaining
h. Shall permit an efficient user interface compatible with Microsoft Windows 10 Operating System
3. Maintain an accurate electronic inventory of samples
a. Readily accessible to designated DTM staff
b. Readily queried by designated DTM staff by select sample information not limited to sample ID, study ID, study name, sample type, date, name (if historical samples)
c. Ability to generate reports by designated DTM staff with specific criteria such as by date ranges, study ID, study name, sample type, patient name (if historical samples)
d. Must track and maintain positive identification of all vials, location of all vials and historical information such as volume, availability and other historical information on the vial located within the repository to ensure the ability of accessing the correct samples by the Infectious disease section for ongoing purposes.
e. The electronic inventory must be updated whenever a new action has occurred in the repository, i.e., new samples added, retrieved, thawed or edits.
f. The electronic inventory system must maintain and track all new actions of samples. I.e., freeze thaws, volume of samples removed, volume of sample remaining and must maintain an audit trail of the staff member performing these updates.
g. A mechanism must be in place to obtain files of inventory via upload, disk or equivalent.
4. Inventory samples upon receipt into Inventory management system
a. Must have the ability to store serum, plasma, cerebral spinal fluid (CSF), tissue, whole blood, and other biological specimen types upon request
b. Must maintain sample suitability requirements (i.e. frozen) during process of delivery and receipt
c. Receive samples with an importable electronic manifest
d. Receive samples with barcoded vials
e. Receive samples with non-barcoded vials (historical samples that have been maintained frozen).
f. Ability to Receive, accession and store samples in GLASS vials (these are historical samples)
5. Maintain samples in appropriate storage units
a. Capable of storage at -60°C to -90°C or colder (or other temperature as required by the COR
b. Capable of maintaining storage at temperatureStorage in government owned units and/or rented units from contractor that have been maintained according to manufacturer instructions and local standard operation standards.
c. Procedures are in place to ensure Routine preventive maintenance and repairs are performed on all units on a scheduled basis and as needed to maintain appropriate storage
d. Procedures in place to ensure adequate storage of samples if units fail
6. Maintain samples in a monitored facility
a. Continuous temperature monitoring 24/7 of units to ensure accurate storage of samples (i.e. manual and automated monitoring systems)
b. Procedures in place to address units out of compliance of storage temperature (eg., Maintenance of units to return to use, move contents to another unit until unit can be fixed and placed back in service.
i. The COR must be notified of movement of samples due to and any corrective action taken on government owned units.eg., unit has lost power and cannot maintain temperature and samples have to be moved. This movement must also be captured in the electronic inventory management system.
ii. DTM staff must be notified of any government owned units that have been removed from service as well as action needed such as replacement of government owned units.
7. Retrieve and deliver samples upon request by DTM IDS staff
a. Requests for sample retrieval or delivery will be either by phone or be email and on an as needed basis
b. Requests for sample pick up from DTM shall be retrieved from DTM within 3 days of request or by approved upon timeframe of DTM staff
c. Requests for delivery of less than 100 samples requested from the repository must be delivered within 24-72 hours or an agreed upon timeframe by DTM staff
d. Requests for delivery of greater than 100 samples should be delivered within 1 week of the request or by an agreed upon timeframe by DTM IDS staff
8. Have a robust Quality and training program for staff to ensure
a. Technicians performing retrieval and accessioning of samples have been adequately trained and demonstrate and maintain competency to perform function
b. Technicians performing the maintenance and monitoring of equipment have been adequately trained and demonstrate and maintain competency to perform function
c. Staff maintaining and managing the electronic inventory management system have been adequately trained, demonstrate and maintain competency to perform function
d. Supervisors and managers monitoring and managing the repository have been adequately trained, have developed and maintained a robust quality and training plan
9. Reporting
a. The contractor shall provide the following reports upon request: Lists of samples in storage by sample ID, date range, sample type, study ID or other sample criteria; lists of samples by freezer; storage reports of freezer; report of samples, sample storage, Inventory of freezers. This is not an inclusive list of reports
10. Change Management Plan
a. Not applicable
11. Deliveries and pickups will be from the following
a. NIH/CC/DTM (Dept. of Transfusion Medicine)
Transfusion Transmitted Viruses Laboratory (TTVL)
9000 Rockville Pike
Building 10 Room 1N/315
Rockville, MD 20892
12. Delivery/pick up Requirements
a. All shipments shall be packaged and delivered in accordance to DOT/IATA requirements to maintain stability of the samples and in accordance with IATA standards or regulations and within a timely manner. The vendor shall guarantee that all required materials shall be delivered in immediate, usable and acceptable condition
b. The Vendor will notify TTVL of the expected delivery arrival or delay
c. All samples to be picked up for delivery to the contractor will occur within one week or an agreed upon timeframe
13. Reports and Meetings
a. Not applicable
14. Period of Performance
a. June 24, 2019 - June 23, 2020, with 4 additional one-year option periods.
15. Payments
a. Payment will be in accordance with the Prompt Payment Act.
16. Vendor Personnel Requirements
a. Technicians performing retrieval and accessioning of samples have been adequately trained and demonstrate and maintain competency to perform function
b. Technicians performing the maintenance and monitoring of equipment have been adequately trained and demonstrate and maintain competency to perform function
c. Staff maintaining and managing the electronic inventory management system have been adequately trained, demonstrate and maintain competency to perform function
d. Supervisors and managers monitoring and managing the repository have been adequately trained, have developed and maintained a robust quality and training plan
17. Customer/Client-Furnished Equipment and Work Space
a. Not applicable / Remote Support
18. Security Requirements
a. Baseline Security Requirements
i. Safeguarding Information and Information Systems. The Contractor (and/or any subcontractor) is responsible for the following:
1. On behalf of HHS, protecting federal information and information systems in order to ensure:
a. Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information;
b. Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and
c. Availability, which means ensuring timely and reliable access to and use of information.
2. Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location per clause 52.239-1 of the Federal Acquisition Regulation (FAR) (https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html).
a. The Contractor is prohibited from subcontracting to companies to conduct HHS business in which foreign governments that support international terrorism have a "significant interest" per 10 U.S.C. § 2327 (https://www.gpo.gov/fdsys/pkg/USCODE-2011-title10/html/USCODE-2011-title10-subtitleA-partIV-chap137-sec2327.htm).
3. Adopting, and implementing the policies, procedures, controls, and standards required by HHS Information Security Program to ensure the confidentiality, integrity, and availability of federal information and federal information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. The HHS Information Security Program security requirements are outlined in the HHS IS2P, which is accessible on the HHS Office of the Chief Information Officer's (OCIO) website (http://intranet.hhs.gov/it/ocio/).
a. The Information Security Solicitation Checklist and Certification Form (See Appendix A, for the Information Security Solicitation Checklist and Certification Form) must be completed when the acquisition requires contractor personnel to develop or access federal information systems.
ii. Information Security Categorization. The Contractor/subcontractor will coordinate with the system owner, Contracting Officer Representative (COR) and/or Contracting Officer to categorize the system and information to determine applicable information type(s) and the overall level of risk in accordance with FIPS-199 (http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf) and the Federal Information Processing Standard NIST SP 800-60, "Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories", Appendix C, Table C-2 at Vol 2 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf). The security categories and risk level shall be documented in the designated System Security Plan (SSP) for all systems within the proposal.
iii. Internet Protocol Version 6 (IPv6). All acquisitions using Internet Protocol must comply with FAR sections: FAR 7.105(b)(5), FAR 11.002(g), and FAR 12.202(e) (https://www.acquisition.gov/?q=browsefar).
iv. Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.
v. Contract Documentation. The Contractor shall contact the Contracting Officer and/or COR for any templates, policies, forms and other documents necessary to comply with the requirements of this section. All contract deliverables shall be compliant with Section 508 (http://www.hhs.gov/ocio/policy/508_policy.html#3Scope).
vi. Standard for Encryption
1. The Contractor (and/or any subcontractor) shall comply with the HHS Standard for Encryption Language in HHS Contracts (http://www.hhs.gov/ocio/policy/2009-0002.001s.html) to prevent unauthorized access to HHS information.
2. The Contractor (and/or any subcontractor) shall use FIPS 140-2, Security Requirements for Cryptographic Module (http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf) compliant encryption to protect all instances of HHS sensitive information during storage and transmission
(NOTE: The HHS Standard for the Definition of Sensitive Information (http://intranet.hhs.gov/it/cybersecurity/docs/policies_guides/HM/dept_standard_for_def_of_sens_info-051809.pdf), latest revision, must be used to determine if information under this contract is sensitive).
3. The Contractor (and/or any subcontractor) shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (http://csrc.nist.gov/groups/STM/cmvp/) to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR and/or Contracting Officer.
4. The Contractor (and/or any subcontractor) shall ensure that their equipment and devices meet HHS specific encryption standard requirements or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information (including PII).
vii. Protection of Sensitive Information. All federal information that may be sensitive (as defined in the Departmental Standard for the Definition of Sensitive Information) shall be protected in accordance with Office of Management and Budget (OMB) Memorandum (M) 06-16 (https://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2006/m06-16.pdf), Protection of Sensitive Agency Information and encrypted with Federal Information Processing Standard (FIPS) 140-2 compliant solution.
viii. Contractor Agreement. The Contractor (and/or any subcontractor), performing under this contract, shall not release, publish, or disclose non-public federal information to unauthorized individuals. The confidentiality, integrity, and availability of such information shall be protected by the Contractor in accordance with the governing laws and regulations listed as follows:
1. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) (https://www.gpo.gov/fdsys/granule/USCODE-2011-title18/USCODE-2011-title18-partI-chap31-sec641/content-detail.html)
2. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) (https://www.gpo.gov/fdsys/pkg/USCODE-2014-title18/pdf/USCODE-2014-title18-partI-chap93-sec1905.pdf)
3. Public Law 96-511 (Paperwork Reduction Act) (http://ciog6.army.mil/Portals/1/Policy/Paper Reduction 1980.pdf)
Note: "Non-public" in this document refers to information only to be used by authorized individuals including authorized contractors.
ix. Contractor Employee Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public federal information under this contract shall complete the appropriate Commitment to Protect Non-Public Information. A copy of each signed and witnessed NDA shall be submitted to the COR and/or Contracting Officer prior to performing any work under this acquisition (See Appendix C for the HHS Contractor Non-Disclosure Agreement).
x. System Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU). Systems that interconnect exchange or share sensitive information need to meet the OMB A-130 requirement that "written management authorization (often in the form of a Memorandum of Understanding or Agreement,) be obtained prior to connecting with other systems and/or sharing sensitive data/information. The written authorization shall detail the rules of behavior and controls that must be maintained by the interconnecting systems." To meet this requirement it is required a System Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) focused on protecting the data exchanged.
1. An MOU and/or ISA will be required for any remote vendor access the NIHnet in order to ensure adequate security and the protection of the NIHnet.
2. NIH ISA Template and NIH MOU Template are available at https://ocio.nih.gov/InfoSecurity/Policy/Pages/NIH_ISA_Templates.aspx
xi. Privacy or Security Safeguards (FAR Clause 48 CFR § 52.239-1). The Contractor (and/or any subcontractor) shall comply with FAR Clause 48 CsFR § 52.239-1 privacy and security requirements, which can be located at: https://www.acquisition.gov/?q=browsefar. If new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.
xii. Confidential Information (HHSAR Clause 48 CFR § 352.224-71). The Contractor (and/or any subcontractor) shall comply with HHSAR Clause 48 CFR § 352.224-71 requirements, which can be located at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.
1. (Note: Refer to the Departmental Standard for the Definition of Sensitive Information for assistance in tailoring section b. of this clause).
b. Position Sensitivity Designations- Not Applicable
None of the contractor positions will be here on site. All Contractor (and/or any subcontractor) employees must obtain a security clearance commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR) (https://www.opm.gov/investigations/background-investigations/position-designation-tool/). The following position sensitivity designations apply to this contract:

[ ] Level 6: Public Trust - High Risk. Contractor (and/or any subcontractor) employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (BI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor (and/or any subcontractor) employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 4: Special Sensitive. Contractor (and/or any subcontractor) employees assigned to Level 4 positions with no previous investigation and approval shall undergo a Suitability Determination and a Single Scope Background Investigation (SSBI),

[ ] Level 3: Top Secret - Critical Sensitive. Contractor (and/or any subcontractor) employees assigned to Level 3 positions with no previous investigation and approval shall undergo a Suitability Determination and Single Scope Background Investigation (SSBI),

[ ] Level 2: Confidential or Secret - Noncritical Sensitive. Contractor (and/or any subcontractor) employees assigned to Level 2 positions with no previous investigation and approval shall undergo a Suitability Determination and a Access National Agency Check, Inquiries (ANACI)

[X ] Level 1: Non-Sensitive Contractor (and/or any subcontractor) employees assigned to Level 1 positions shall undergo a Suitability Determination and National Agency Check and Inquiry Investigation (NACI).
i. All Contractor (and/or any subcontractor) employees shall comply with the conditions established for their designated position sensitivity levels prior to performing any work under this contract (See Appendix A).
ii. Suitability Investigations are required for contractors (and/or any subcontractor) who will need access to federal information systems and/or to federally controlled physical space.
c. Personnel Security Responsibilities -
i. The Contractor shall provide the COR and/or Contracting Officer, and Information System Security Officer (ISSO) the name, position title, e-mail address, and phone number of all contract employees working under the contract per the National Industrial Security Program Operating Manual (NISPOM) Section 2-200 (http://intranet.hhs.gov/security/ossi/documents/nispom.pdf), the HHS Contract Closeout Guide (2012) (http://intranet.hhs.gov/abouthhs/contracts-grants-support/acquisition-policies-guidance/acquisition-worktools/contract-closeout-tableofcontents/), and the HHS Personnel Security & Suitability Policy, Section 7.6 (http://intranet.hhs.gov/security/ossi/documents/pssp.pdf).
1. If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.
2. If the employee is filling an existing position, the Contractor shall provide the name, position title and suitability determination level held by the former incumbent.
ii. The Contractor shall notify the COR and/or Contracting Officer and system ISSO before an employee stops working under this contract.
1. The Contractor shall provide the name, position title, and suitability determination level held by or pending for departing employees to the COR and/or Contracting Officer.
2. The Government will stop pending background investigations for employees that no longer work under this acquisition.
iii. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the Contractor Employee document, when a Contractor (and/or any subcontractor) employee terminates work under this contract, the employee's exit from the contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.
iv. After the Government's final acceptance of the work under this contract, or in the event of a termination of this contract, the Contractor shall return all identification badges to the Contracting Officer or designee.
Homeland Security Presidential Directive (HSPD)-12 - Not applicable as Contractor will not be on site. All off site work so this will not apply. They will not have access to any of our systems remotely
v. To gain routine physical access to an HHS facility, logical access to an HHS-controlled information system, and/or access to sensitive data or information, the Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; Office of Management and Budget (OMB) Memorandum (M)05-24; and Federal Information Processing Standards Publication (FIPS PUB) Number 201, Federal Acquisition Regulation (FAR) Subpart 4.13 (https://www.acquisition.gov/sites/default/files/current/far/html/Subpart 4_13.html), FAR Subpart 52.204-9 (https://www.acquisition.gov/sites/default/files/current/far/pdf/FAR.pdf); and with the personal identity verification and investigation procedures contained in the following documents:
1. HHS Information Security and Privacy Policy (IS2P) (http://intranet.hhs.gov/it/cybersecurity/policies/index.html)
2. HHS Personnel Security and Suitability Policy (http://intranet.hhs.gov/security/ossi/documents/pssp.pdf).
3. HSPD-12 Implementation Policy for the Use of the Personal Identity Verification (PIV) Card for Strong Authentication (http://intranet.hhs.gov/security/ossi/hspd-12/implementation-policy.html).
vi. This includes foreign national Contractor/subcontractor employees that perform work under this acquisition and meet the requirements to complete a NACI background investigation as residents of the United States for three (3) or more of the last five (5) years (http://intranet.hhs.gov/security/ossi/hspd-12/implementation-policy.html).
d. Fingerprinting - Not applicable
i. All Contractor (including any subcontractor) employees must have a successfully adjudicated fingerprint check before gaining access to HHS-controlled information systems in compliance with FAR Subpart 52.204-2 Security Requirements (including Alternate II) (https://www.acquisition.gov/?q=/browse/far/52).
ii. To gain logical access to HHS-controlled information systems, contract employees working under the contract are subject to a fingerprint check.
iii. If a Contractor (and/or any subcontractor) must appear at an HHS facility to be fingerprinted, any costs associated with getting to that facility are to be borne by the Contractor.
e. Background Investigations - Not applicable
i. All Contractor (including any subcontractor) personnel must undergo a background investigation based on the position designation and type of investigation required as determined by the agency (See the Position Sensitivity Designations Section) in compliance with FAR Part 52.222-54 -- Employment Eligibility Verification (https://www.acquisition.gov/?q=/browse/far/52) and FAR Subpart 22.18-Employment Eligibility Verification (https://www.acquisition.gov/?q=/browse/far/22).
ii. Based upon information provided by the Contractor (including any subcontractor), the Contracting Officer shall insert references to HHS procedural guideline(s), if any; indicate if they are readily accessible to the public; and, if so, specify where they may be found. If they are not readily accessible, the Contracting Officer shall attach a copy to the solicitation and contract and reference the guideline(s) here.
iii. All positions within the contract shall be designated a sensitivity level in the solicitation. At the time of solicitation, based upon information provided by the Contractor (including any subcontractor), the Contracting Officer shall specify all known levels. If the position sensitivity levels are not known at that time, the Contracting Officer shall insert the words "To Be Determined at the Time of Award." However, the Contracting Officer must include the definitive position sensitivity levels in the awarded contract/order.
iv. The personnel investigation procedures for Contractor personnel (and/or any subcontractor) require that the Contractor (and/or any subcontractor) prepare and submit background check/investigation forms based on the type of investigation required. The minimum Government investigation for a non-sensitive position is a National Agency Check and Inquiries (NACI) with fingerprinting. More restricted positions - i.e., those above non-sensitive, require more extensive documentation and investigation.
1. The Contractor shall notify the CO/COR of its proposed personnel who will be subject to a background check/investigation.
2. The Contractor shall notify the CO/COR whether any of its proposed personnel who will work under the contract have previously been the subject of national agency checks or background investigations.
v. Investigations are expansive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations shall not be an excusable delay in accordance with the FAR section, Excusable Delays - see FAR 52.249-14, if applicable (https://www.acquisition.gov/sites/default/files/current/far/html/52_248_253.html).
1. The Contractor shall ensure that the employees it proposes for work under this contract have a reasonable chance for approval.
vi. The Government may investigate personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more than the cost of the additional investigation(s).
f. Contract Initiation and Close Out
i. General Security Requirements. IT security requirements must be incorporated into all phases of program planning and execution, from budgeting to close-out and the implementation of those requirements should align with the HHS Enterprise Performance Life Cycle (EPLC). The Contractor (and/or any subcontractor) shall comply with security requirements, EPLC processes, and HHS Enterprise Architecture requirements, to ensure proper and confidential handling of data and information (including privacy data and information). All IT systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology (http://www.hhs.gov/ocio/eplc-lifecycle-framework.pdf) and the HHS Contract Closeout Guide (2012).
ii. Providing System Documentation at Contract Close Out. Contractors (and/or any subcontractors) must follow and adhere to National Institute of Standards and Technology NIST SP 800-64, Security Considerations in the System Development Life Cycle (latest revision), at a minimum, for system development. This requirement may include providing system documentation at designated intervals (specifically, at the close out of the contract) within the EPLC that require artifact review.
iii. Certification of Sanitization of Government and Government-Activity-Related Files and Information. As part of contract closeout, the Contractor shall submit the certification to the COR and/or Contracting Officer following the template provided in NIST SP 800-88, Guidelines for Media Sanitization (http://www.nist.gov/manuscript-publication-search.cfm?pub_id=50819).
iv. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all HHS provided information and IT resources (to include contractor-owned and/or sub-contractor systems and backup systems) for this contract at completion of contractor performance to the CO and/or COR. Additionally, the Contractor shall certify that all HHS information has been properly sanitized and purged, in accordance with HHS policies, from Contractor-owned (and/or any subcontractor) systems, including backup systems, used during contract performance.
v. Failure to Comply. Failure on the part of the Contractor (and/or any subcontractor) to comply with the terms and conditions stated within this document may be grounds for the Contracting Officer to terminate this contract.
19. Non-Personal Services
a. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer immediately.
20. Business Relations
a. The Contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.
21. Contract Management
a. The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor must maintain continuity between the support operations on-site at NIH and the Contractor's corporate offices.
22. Training Requirements
a. The contractor will not perform any government training; however, they need to maintain qualified and trained staff to perform the services; and have a Training program, Competency Assessment program and Quality Assurance program which ensures staff are capable of performing the testing and other functions related to the contract.
23. Contract Administration
a. The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The Contractor shall have a single point of contact between the Government and Contractor personnel assigned to support contracts or task orders. The Contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

This requirement is for continued storage using an existing repository. It may be detrimental to the government to attempt to change storage solutions and introduce the risk of contamination or degradation of 30+ years of samples by moving or partially thawing the samples. The continued utilization of the same storage solution will help reduce the risk of a disruption in research outcomes. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by March 11th, 2019, 10:00 AM Eastern time and must reference solicitation number 19-002363. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."

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