FDA-23-RFQ-117376.pdf

FDA-23-SOW-117376

Accreditation of testing and calibration laboratories with additional criteria for forensic testing laboratories

Background

The Forensic Chemistry Center (FCC) located in Cincinnati, OH within The Office of Regulatory Affairs/Office of Regulatory Science/Medical Products, and Specialty Labs (ORA/ORS/OMPSLO) requires forensic testing laboratory accreditation based on International Organization of Standardization / International Electrotechnical Commission (ISO/IEC) 17025 general requirements for the accreditation of testing and calibration laboratories with additional criteria for forensic testing laboratories. The requirement covers a four-year cycle of accreditation (2023-2027) which is the standard for forensic testing laboratories. Laboratory accreditation improves the quality of services the FCC provides to the criminal justice system, provides a systematic approach to review and assess FCC’s performance, and allows us to demonstrate that the laboratory meets established standards. Since 2005, FCC has been accredited by an ISO 17025-based accreditation body with additional requirements for forensic testing laboratories. This requirement for accreditation is found in the ORA Quality Manual (see applicable requirements).

Purpose

Forensic testing laboratory accreditation requirements help to ensure that the laboratory provides analytical testing results of documented quality to customers including Federal and State courts in civil and criminal proceedings and specifically that the FCC analysts’ testimonies and analytical findings in criminal cases are readily accepted in court. The goal of an accreditation program is to enhance the reliability and the comparability of test data generated from the accredited laboratory.

Scope

The contractor shall provide the following minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the Project Officer.

• The Offeror shall provide forensic testing laboratory accreditation assessment based on ISO/IEC 17025 general requirements for the accreditation of testing and calibration laboratories with additional criteria for forensic testing.

• The Offeror shall be an internationally recognized, primary assessing body for forensic testing laboratories in the United States as evidenced by the number and types of laboratories accredited.

• The Offeror shall have at least 400 active accreditations of testing and calibration laboratories with an emphasis in forensic testing.

• The Offeror shall have previously accredited other forensic laboratories in the disciplines of Seized Drugs, Materials (Trace), Microbiology and Veterinary and Wildlife.

• The Offeror shall accredit FCC in its current disciplines (Seized Drugs, Materials (Trace), Microbiology and Veterinary and Wildlife and respective Components/Parameters.

• The Offeror shall present to FCC the means to review and assess the technical assessor(s) prior to any on-site assessment.

• The Offeror shall provide proficient technical assessor(s) to cover the key equipment/technology located at FCC

• The Offeror shall provide assessor(s) with comparable skillsets to those found at the FCC to allow for a comprehensive technical review of examination records.

• Upon satisfactory performance by the Forensic Chemistry Center in meeting the accreditation requirements, the Offeror shall provide a Certificate of Accreditation for the laboratory.

• The Offeror shall provide application review and assessment activities for the first year of the contract prior to August 31, 2023 in order to allow a minimum of four months for laboratory responses to any deficiencies found prior to the expiration of the laboratory’s current accreditation on December 31, 2023. This will ensure that no lapse in accreditation occurs.

• The Offeror shall provide an initial application review and on-site assessment of the Forensic Chemistry Center covering all areas of accreditation (including Seized Drugs, Materials (Trace), and Microbiology and Veterinary and Wildlife) and shall provide additional assessments in Years #2, #3 and #4 as Option Years (OY). These option years shall include one additional on-site assessment in OY 2 (2025).

• The Offeror shall complete the initial on-site assessment in no more than five consecutive working days to minimize any disruption of the laboratory.

• The Offeror shall complete any additional on-site assessments in no more than three consecutive working days to minimize any disruption of the laboratory.

• The Offeror shall provide the allowance of laboratory to develop and validate methods and perform on-going quality assurance for any previously accredited science activities also known as a flexible scope.

• The Offeror shall provide forensic testing laboratory accreditation assessment of the Forensic Chemistry Center based on requirements specified in ISO/IEC 17025:2017, “General requirements for the competence of testing and calibration laboratories” with additional requirements specific to forensic science testing laboratories. These additional requirements are necessary to ensure that the laboratory provides analytical testing results of documented quality to federal and state courts in criminal and civil proceedings. At a minimum, these additional requirements shall include the following:

o Ensuring general and structural requirements are in place including:

• Impartiality

• Management Structure

• Designation of specific individuals:

o Responsibility, authority and interrelationship.

o Technical responsibility for each discipline, as defined by the designee having the appropriate technical training and experience in that discipline.

o Ensuring resource requirements are in place including:

• Demonstrating education, training and qualifications that are needed to demonstrate that an analyst is capable of handling and examining evidence.

• Training in the presentation of evidence in courts of law.

• Training in the ethical practices in forensic sciences, a general knowledge of forensic science, and applicable criminal and civil law and procedures.

• Establishment of a proficiency and competency testing program.

• Identification and routine testing of laboratory reagents for reliability.

• Training related to laboratory security and secured evidence storage.

• Measurement traceability.

o Ensuring process requirements are in place including:

• Estimation of uncertainty of measurement.

• Technical review of testimony.

• Writing and release of test reports.

• Technical review of examination records.

• Administrative review of examination records.

• Identification and retention of technical and case-related documents.

• Documentation of technical records.

• “Chain of custody” of evidence, including the tracking of sub-items, and the maintenance, storage and security of items of evidence, to include measures taken to prevent loss, cross transfer, contamination or deleterious change.

• Ensuring those who influence results of testing are competency / proficiency tested.

• Method validation requirements.

o Ensuring management systems are in place including:

• Audit system

• Control of records

• Management review

• The Offeror shall be capable of providing laboratory accreditation services in the following forensic testing disciplines:

Seized Drugs Materials (Trace) Veterinary and Wildlife Microbiology

• The Offeror shall provide base-year accreditation assessment activities for a total of sixty-five proficiency-tested employees and fifteen non-proficiency tested employees. Within the disciplines of forensic testing, the following numbers of employees must be covered under the accreditation:

Seized Drugs - Up to forty employees out of a total of sixty-five proficiency-tested employees Materials (Trace) – Up to twenty employees out of a total of sixty-five proficiency-tested employees Veterinary and Wildlife – Up to five employees out of a total of sixty-five proficiency-tested employees Microbiology – Up to five employees out of a total of sixty proficiency-tested employees

• In option years, the Offeror shall provide accreditation assessment activities for a for a total of sixty-five proficiency-tested employees and fifteen non-proficiency tested employees. The following numbers of employees must be covered under the accreditation:

Seized Drugs - Up to forty employees out of a total of sixty-five

Materials (Trace) – Up to twenty employees out of a total of sixty-five proficiency-tested employees Veterinary and Wildlife – Up to five employees out of a total of sixty-five proficiency-tested employees Microbiology – Up to five employees out of a total of sixty-five

Trade and Service Specifications

1. The Contractor shall provide qualifications of the assessors who are providing the accrediting body standards review and the technical expertise needed to cover the breadth of key equipment and technology used at the Forensic Chemistry Center.

Records and Reports

The Contractor shall, commensurate with the completion of each assessment visit relating to the first-year visit, provide FCC with a report that is a detailed description of the work performed in a written report that outlines the requirements that were conforming and if present any non-conforming elements.

Security and Privacy Requirements

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the FDA mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Availability, which means ensuring timely and reliable access to and use of information.

Note to the Requiring Activity Representative: Complete the following section using the information obtained from the Information Security and Privacy Certification Checklist.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [X] Low [ ] Moderate [ ] High

Integrity: [X] Low [ ] Moderate [ ] High

Availability: [X] Low [ ] Moderate [ ] High

Overall Impact Level: [X] Low [ ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of FDA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below: Note to the Requiring Activity Representative: Complete this section using the information obtained from the Information Security and Privacy Certification Checklist. This information may be included after award in the event it is not yet available at the time of acquisition.

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves: [ ] No

PII [ ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed. If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the

E-Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R.

2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations applicable baseline if handled by a contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel

h. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein. The confidentiality, integrity, and availability of such information must be protected in accordance with HHS and FDA policies.

Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

i. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

iii. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

i. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115- 232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25.

The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

k. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate. Note to the Requiring Activity Representative: See Appendix C for baseline deliverables. Do NOT include in procurement documentation.

m. Standard for Encryption. The Contractor (and/or any subcontractor) must:

i. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

ii. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

n. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable.

Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition. Note to the Requiring Activity Representative: See Appendix D for the FDA Contractor Non-Disclosure Agreement. Do NOT include in procurement documentation.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA CIOCC /Incident Response Team teams within 24 hours, whether the response is positive or negative. FISMA defines an incident as "an occurrence that

(1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

b. In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) must:

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so, instructed by the Contracting Officer or representative, the Contractor must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail; and

Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS and FDA breach response policies when handling PII breaches.

v. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

This may also involve physical access to contractor facilities during a breach/incident investigation on demand.

5. Position Sensitivity Designations All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract (e.g. tier 1, 2, or 4): ____________. Note to the Requiring Activity Representative: The Requiring Activity Representative, in conjunction with Personnel Security, must use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

6. Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. Note to the Requiring Activity Representative: For additional information, see HSPD- 12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12

7. Roster The Contractor (and/or any subcontractor) must 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 government information system(s). The roster must be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes must be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHo me.aspx and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s Office of Acquisitions and Grant Services (OAGS) to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO as soon as it is known that a contract employee will stop working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and FDA policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/d efault.htm as soon as it is known that a contract an employee will terminate work under this contract. The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system.

9. Records Management and Retention

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS Policy for Records Management and HHS and FDA policies and must not dispose of any records unless authorized by HHSFDA.

b. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with HHS and FDA policies.

10. High Value Asset (HVA) If a system is identified as HVA,24 the contractor must comply with the FDA IS2P Appendix AB: High Value Asset (HVA) Program, the HHS Policy for the High Value Asset (HVA) Program, and the DHS HVA Control Overlay25 in addition to the above requirements.

All documentation must be available to the CO and/or COR upon request.

HHS Section 508 and Accessibility Standards

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. §

1194.1 & Apps. A, B, C & D, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

For each proposed product, platform, or service, a fully completed Accessibility Conformance Report (ACR) using the Voluntary Product Accessibility Template (VPAT)

(https://www.itic.org/policy/accessibility/vpat) must be submitted. Evaluation will be on an Acceptable/Unacceptable basis.

Prior to acceptance of deliverables, the offeror must demonstrate conformance to the HHS Section 508 requirements via HHS Section 508 checklist(s) (https://www.hhs.gov/web/section-508/accessibility-checklists/index.html). The government reserves the right to perform testing on required ICT items to validate the offeror’s Section 508 conformance claims. If the government determines that Section 508 conformance does not meet the HHS Section 508 requirements, the government shall, at its option, require the offeror to remediate the item, at no additional cost to the government, to align with the HHS Section 508 conformance requirements prior to acceptance.

References:

• •Section 508 Standards: https://www.access-board.gov/ict/

• •HHS Policy on Section 508 Compliance and Accessibility of Information and CommunicationsTechnology (ICT): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/department-of-health-and-human-services-hhs-policy-on-section- 508-and-accessibility-of-technology.html

• •HHS Accessibility and Section 508 Compliance Checklists:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Deliverables

Deliverable Quantity Delivery Date

Application Review for Accreditation or Re- Accreditation of (1) Forensic Laboratory with up to 65 Proficiency Tested Staff Members

On or before 08/31/2023

On-site Assessment for one (1) Forensic Laboratory with up to 65 Proficiency Tested Staff Members

On or before 08/31/2023

Option Year #1 - Annual/Assessment for continued accreditation of (1) Forensic Laboratory with up to 65 Proficiency Tested Staff Members

Estimated August, Option Year #2 - Annual/Assessment for continued accreditation of (1) Forensic Laboratory with up to 65 Proficiency Tested

Option Year #3 - Annual/Assessment for continued accreditation of (1) Forensic 1

Deliverable Quantity Delivery Date

Laboratory with up to 65 Proficiency Tested

Shipping Destinations:

Forensic Chemistry Center 6751 Steger Dr.

Cincinnati, OH 45237

Period of Performance

(12) Month Base and 3 (12) Month Option Periods.

Base: 06/01/2023 - 05/31/2024 Opt1: 06/01/2024 - 05/31/2025 Opt2: 06/01/2025 - 05/31/2026 Opt3: 06/01/2026 - 05/31/2027

Instructions to Quoters

All Quoter’s who can provide these items are strongly encouraged to submit a quote.

Quotes are due no later than 12:00 PM (Eastern Time) on April 14, 2013.

Quoter’s shall submit quotes via email to kyle.smith@fda.hhs.gov that comply with all technical requirements of the solicitation and contain the best terms from a price standpoint.

Within the quote, each period of the contract (base and each option period) should be separately priced. Option period pricing must be fixed price in order to be considered.

Quotes must clearly state the overall price to the Government (base and options).

Quoter’s shall submit all assumptions in their quotation. All Quotes shall remain valid for a minimum of sixty (60) days.

Quoter’s shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits.

Quoters are advised that additional terms and conditions submitted with their quotation that are in conflict of the terms and conditions of this solicitation may be deemed to be technically unacceptable and may not be considered for award.

Evaluation

FDA will evaluate all quotes received in response to this solicitation by using the lowest-price-technically-acceptable (LPTA) methodology. Quotes must meet all the salient functional characteristics and requirements of this solicitation in order to be considered technically acceptable. Quotes providing an equivalent solution will not be considered further, if the requisite functionality/compatibility explanation is not provided. FDA will issue the award to the Quoter whose proposed solution meets all technical requirements, including the Terms and Conditions identified within the solicitation, and whose overall price is lowest. Quoter’s are advised that additional terms and conditions submitted with their quotation that are in conflict of the terms and conditions of this solicitation may be deemed technically unacceptable and may not be considered for award.

Clauses:

52.217-9 Option to Extend the Term of the Contract (MAR 2000)

52.212-4 Contract Terms and Conditions Commercial Items (DEC 2022)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. (MAR 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

_x_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C.

6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] _x_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Oct 2014) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

_x_ (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

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