W81XWH21R0084 SOLICITATION FBO 09-13-2021.docx

W81XWH21R0084

Section A - Solicitation/Contract Form

COMBINED SYNOPSIS/SOLICITATION

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 13 September 2021

2. Close Date: 17 September 2021; 1000 AM Eastern Standard Time (EST)

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702

4. Requiring Activity: Armed Forces Medical Examiner System (AFMES)/Armed Forces DNA Identification Laboratory (AFDIL)

5. Subject: External ISO/IEC 17025 International Assessment and Accreditation Services

6. Solicitation Number: W81XWH-21-R-0084

7. Description of Requirement: Services needed for this requirement is to obtain re-accreditation for American Society of Laboratory Directors Laboratory Accreditation Board (ASCLD-LAB) international ISO/IEC 17025 and Federal Bureau of Investigation- Quality Assurance Standards (FBI-QAS) standards. The services include surveillance assessments, document compliance, and non-conformances; providing the customer with the assessment records and corrective action suggestions to correct areas of non-conformance, and assessment and accreditation performed utilizing at a minimum the ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories standards and the FBI-QAS.

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are requested.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05; effective 10 March 2021.

7.3. This combined synopsis/solicitation is Full and Open competition. The North American Industry Classification System (NAICS) code is - 541690- Other Scientific and Technical Consulting Services with a Small Business Size Standard of $16,500,000.00.

7.4. Contract award shall be made on a best value basis using Lowest Price Technically Acceptable “LPTA” approach.

7.5. The Contract Line Item Numbers (CLINs) numbers and items, quantities units of measure, and description are identified under the Supplies/Services Section of the RFQ.

7.6. The anticipated Period-of- Performance (POP): see DELIVERY INFORMATION for POP.

8. Point-of-Contact: The point-of-contact for this acquisition is Michael Baughman, Contract Specialist michael.e.baughman.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes.

9.1. Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212 -1 Instructions to Offerors- Commercial Items including the Addendum to 52.212-1, which is included with the attached RFQ.

9.2. All quotes shall be evaluated in accordance with the evaluation criteria identified in FAR 52.212-2 Evaluation— Commercial Items included with the attached RFQ.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions-Commercial Items applies to this acquisition. Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quote (s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Michael Baughman, Contract Specialist michael.e.baughman.civ@mail.mil., no later than (NLT) 15 September 2021 at 1500 EST. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted to Beta.SAM.gov with responses to the questions received. Only one set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7. Quotes: Quotes in response to this RFQ are due via e-mail NLT 17 September 2021 at 1000 EST.

to Mr. Michael Baughman, Contract Specialist michael.e.baughman.civ@mail.mil

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of quotes.

Section B - Supplies or Services and Prices

LAB ACCREDITATION/SURVEILLANCE

FFP

BASE YEAR

FOB: Destination

PURCHASE REQUEST NUMBER: 0011631363

PSC CD: R420

NET AMT

FFP

OPTION YEAR ONE

FOB: Destination

NET AMT

FFP

OPTION YEAR TWO

NET AMT

FFP

OPTION YEAR THREE

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

External ISO/IEC 17025 International Assessment and Accreditation Services Armed Forces Medical Examiner System/Armed Forces DNA Identification Laboratory

SECTION 1 PURPOSE

1.1. Introduction The Armed Forces Medical Examiner System's Armed Forces DNA Identification Laboratory (AFDIL) is the only Department of Defense (DoD) human remains DNA testing laboratory.

1.2. Mission The primary missions of the AFDIL are to (1) provide the Armed Forces Medical Examiner system (AFMES), the Defense Prisoner of War/Missing in Action (POW/MIA) Accounting Agency (DPAA) and other DoD Agencies with human remains DNA testing services; and (2) to support the AFMES’s Office of the Armed Forces Medical Examiner (OAFME) in their role of scientifically identifying and returning fallen United States (US) service members from current theaters of operation and combatant commands as well as service members Missing In Action (MIA) from World War II, Korea, Vietnam and the Cold War.

1.3. Background In support of AFMES as cited in Section 1471 and 1509 of Title 10, United State Code (USC) and Department of Defense Instruction (DoDI) 5145.30 “Armed Forces Medical Examiner Operations”, the AFMES is charged with forensic pathology investigations and is the scientific authority for the identification of human remains from current day operations and previous conflicts. The AFDIL became accredited to the American Society of Laboratory Directors Laboratory Accreditation Board (ASCLD-LAB) and the Federal Bureau of Investigation- Quality Assurance Standards (FBI-QAS) in 1998 and has maintained uninterrupted accreditation since. Pursuant to DNA Forensic testing requirements, AFDIL was re-accredited to the ASCLD/LAB International Organization of Standardization/International Electrotechnical Commission (ISO/IEC) 17025, the ASCLD/LAB ISO-17025 supplemental guidelines, and the FBI-QAS standards in August of 2014. In 2016 ASCLD/LAB merged with the ANSI-ASQ National Accreditation Board (ANAB) and AFDIL’s accreditation was transferred to ANAB. The contractor shall provide professional, external and/or on-site, ISO/IEC 17025 International and FBI-QAS assessment and accreditation services to the AFDIL, Forensic DNA Testing Laboratory. Assessment and accreditation shall be performed utilizing at a minimum the ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories standards, the Federal Bureau of Investigation Quality Assurance Standards for Forensic DNA Testing Laboratories, and contractor-associated supplemental Forensic Science Testing & Calibration Laboratories Accreditation Requirements needed to achieve ISO/IEC 17025 International re-accreditation at the AFDIL located on Dover AFB, DE. The contractor shall be a recognized ISO/IEC 17011 compliant accredited body in the field of forensic science by the International Laboratory Accreditation Cooperation (ILAC). The contractor shall be a well-established accredited body that has at least 10 years of accreditation experience in the field of forensic science.

1.4. Scope

1.4.1. AFDIL is accredited to the ANAB International ISO/IEC 17025 and ANAB ISO-1705 supplemental guidelines, and the FBI-QAS standards. In August of 2022, AFDIL's current accreditation certificate will expire and AFDIL will need to be reaccredited. AFDIL is required to submit an annual maintenance fee and semi-annual surveillance accreditation assessments using both ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories standards and contractor associated supplemental forensic specific requirements document(s) and the FBI-QAS standards. The contractor shall conduct the surveillance assessments for both ISO-17025 and the FBI-QAS in accordance with accreditation requirements and shall document compliance and non-conformances. The contractor shall provide the customer with the assessment records detailing the areas of non-conformance. Assessment and accreditation shall be performed utilizing at a minimum the ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories standards and contractor associated supplemental forensic specific requirements document(s) needed to achieve ISO/IEC 17025 International Accreditation as well as the FBI-QAS, at AFDIL located on Dover AFB, DE. In the case of extenuating circumstances that would prevent an on-site audit from occurring (i.e. Pandemic), the AFDIL will work with Contracting Officer (KO) and the contractor to establish a virtual audit that meets this performance work statement and the needs of the AFDIL.

1.4.2. AFDIL will require the following sections and laboratories to be assessed:

1.4.2.1. Present Day DNA section – Short Tandem Repeat (autosomal and Y Chromosomal STR) and mtDNA sequencing methodologies (manual and automated);

1.4.2.2. Past Accounting DNA section – mtDNA sequencing (Sanger and Next Generation) methodologies and STR (autosomal and Y Chromosomal) methodologies (manual and automated);

1.4.2.3. Family Reference Specimen and Laboratory Automation section – Short Tandem Repeat (autosomal and Y Chromosomal STR) and mtDNA Sanger and NGS sequencing methodologies (manual and automated).

1.4.3. ISO accreditation standards require an initial accreditation assessment to gain accreditation approval. Upon approval the assessment cycle is a minimum of two years and a maximum of four years. At least once every two years, an external audit shall be conducted by an audit team comprised of qualified ANAB auditors and having at least one team member who is or has been previously qualified in the laboratory’s current DNA technologies and platforms according to the FBI-QAS guidelines. During the external audit, AFDIL will need to be assessed to both the ISO-17025 and FBI-QAS standards. The accreditation surveillance assessment shall consist of reviewing the customer’s quality and technical management system and determining if the laboratories operational procedures, testing environments, equipment, reference materials, data, and records system is effectively implemented and meets all applicable ISO/IEC 17025 requirements for accreditation. The surveillance assessment shall consist of at a minimum:

1.4.3.1. Opening meeting with customer’s management.

1.4.3.2. Review of customer’s compliance to the requirements of each applicable conformity assessment standard.

1.4.3.3. Daily assessor meetings and customer debriefings.

1.4.3.4. Review of any open issues from the document review and planning visits, if applicable.

1.4.3.5. Review of the laboratories plan for proficiency testing (PT) participation during the accreditation cycle.

1.4.3.6. Verification of recent PT participation for the categories identified for the laboratory sections.

1.4.3.7. Verification and documentation of staff qualifications to include education, experience, and training that have not previously been approved from two successive external audits for the laboratory sections.

1.4.3.8. Witness and verify laboratory sections meet technical competence requirements needed for ISO/IEC 17025 accreditation.

1.4.3.9. Final audit assessment closing team meeting to discuss any findings and non-conformities and suggestive guidance on how to mitigate the non-conformities.

1.4.3.10. Document listing of all non-conformities which is signed by both the lead assessor and the lab at the conclusion of the closing meeting.

1.4.4. In accordance with the ISO standards, new validations shall be evaluated and approved during an external assessment. Approved validation studies shall be documented in the audit document. Detailed information on the validation studies will be supplied to the contractor no later than one month prior to the scheduled pre-assessment and then again no later than one month prior to the scheduled accreditation assessment.

1.4.5. In accordance with the ISO standards, the following items will be made accessible to the contractor and any other documentation as requested and necessary:

1.4.5.1. Quality Assurance Items

1.4.5.1.1. Staff personnel Folders

1.4.5.1.2. Proficiency Folders

1.4.5.1.3. Casework Folders for nuclear, mtDNA, and Family Reference sections only

1.4.5.1.4. Equipment Records

1.4.5.1.5. Training Folders

1.4.5.1.6. Quality Assurance and Quality Control Folders

1.4.5.1.7. Quality Manual and Supporting Documentation

1.4.5.1.8. Standard Operating Procedures

1.4.5.1.9. Controlled Copies will be presented to the Awardees’ no later than one month prior to the scheduled audit.

1.4.6. The audit team shall consist of qualified individuals as determined by contractor in conjunction with the FBI-QAS audit document and/or additional contractor specific requirements. The contractor shall designate a lead auditor and determine the number of individual qualified auditors needed for the accreditation process based on size and complexity of the laboratory. The contractor shall provide the list of audit team to the AFDIL no later than two months prior to the scheduled audit for AFDIL’s review and acceptance. AFDIL will provide the contractor written acceptance of the proposed number of auditors and individual auditors. The audit team members can’t have possible conflict of interest such as being a previous Government employee (Civilian, Military, or Contractor) of AFDIL. Auditors shall coordinate with the Quality Manager or designee for individual staff interviews. The AFDIL will escort the auditors to the interviewee or vice versa. Audits shall be executed within a minimum of 3 days from start of audit and not to exceed 5 days of on-site time.

1.4.7. Auditors shall not be allowed to access the Government internet, to use MIFI or hotspots within the AFMES and/or be granted computer access to Laboratory Information Systems Application (LISA), the AFDIL Management System pursuant with DoD and AFMES information technology policies. The AFDIL’s Quality Manager or designee will be available for requests to see specific items within LISA or specific validation data. The Quality Manager or designee will log-in to the computer, retrieve item/data and if necessary, print out additional information as needed as long as it does not violate DoD or AFMES Information Assurance or Health Insurance Portability and Accountability Act (HIPAA) policies.

1.4.8. Auditors that may require laboratory entrance shall review the following:

1.4.8.1. AFDIL laboratory room numbers and order of access; Listed is the Dover laboratory room number.

233B

Ultra Clean

1.4.8.2. Auditors shall sign a swab Donor consent DNA form 273B, and provide a staff elimination swab if they choose to enter a laboratory.

1.4.8.3. Auditors shall be escorted into the laboratory by a trained AFDIL staff member and shall wear at a minimum a laboratory coat, nitrile or latex gloves, and safety glasses while in the laboratory.

1.4.9. The contractor shall conduct an out brief to the senior staff to report any deficiencies, comments or suggestions. The contractor shall complete the current ISO/IEC 17025 audit document and any supplemental documents within 30 days of completion of the audit. The AFDIL will have 30 days to respond/appeal any findings by the audit team once the final audit document has been completed and supplied to the contractor and the AFDIL.

1.5. Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1). This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.6. Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2). The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance: 115 Purple Heart Drive, Dover AFB, DE 19902 or off-site at ANAB designated site.

2.1.1.1. Primary On-Site Government Location

2.1.2. Period of Performance. This contract is for one (1) twelve (12) months Base Period and three (3) twelve (12) months Option Periods.

Base Period 25 September 2021 – 24 September 2021 Option Period One 25 September 2022 – 24 September 2023 Option Period Two 25 September 2023 – 24 September 2024 Option Period Three 25 September 2024 – 24 September 2024

2.2. Non-Personal Services: This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that 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 Contractor Officer (KO) immediately.

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.2. Reserved.

2.5. Contractor Personnel, Disciplines, and Specialties

2.5.1. Access to the Dover Air Force Base, specifically the Armed Forces Medical Examiner System and the AFDIL, will be granted during regular duty hours 8 AM to 6 PM, Monday through Friday. Auditors will be picked up and escorted from the Base Visitor Center. Details about getting visitor base access will be provided to contractor upon award, such that sufficient time is in place to submit the proper paperwork to gain access to a secured facility. Point of contact will be the Quality Manager or designee. The Quality Manager or designee will be responsible for escorting auditors onto the base and around the laboratory.

2.5.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

2.5.3. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

New Year’s Day, 1 January Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, last Monday in May Juneteenth Day, 19 June Independence Day, 4 July Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, 11 November Thanksgiving Day, 4th Thursday in November Christmas Day, 25 December

2.5.4. The contractor shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide all necessary personnel required to perform services in the AFDIL. The contractor shall provide professional external ISO/IEC 17025 International Assessment and Accreditation Support Services. The following section specifies the Performance Objectives and Performance Standards for the contract.

3.2. Performance Requirement Summary Matrix

SECTION 4 SPECIAL REQUIREMENT

4.1. Security and Safety

4.1.1. Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures (provided by the Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.1.2. Contractors That Do Not Require CAC, But Require Access to a DoD Facility or Installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, IAW status of forces agreements and other theater regulations.

4.1.3. Prior to commencement of services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers (or equivalent identification numbers for non-U.S. citizens) of all personnel who will be entering Army-controlled installation and facilities.

4.1.4. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements as directed by DoD, Headquarters Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.1.5. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher the Terrorist Threat Conditions (THREATCONS) resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

4.1.6. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

4.1.7. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

4.1.8. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition. See also anti-terrorism

4.1.9. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

4.1.10. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4.2. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.2.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, HIPAA IAW applicable statutory, regulations, local policies and procedures.

4.2.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.2.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.2.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.3. Quality Assurance Surveillance Plan See QASP Section. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed.

Certificate of Accreditation, Scope of Accreditation Document

Due within 30 days of completion of the on-site audit.

SECTION 6 DEFINITIONS AND ACRONYMS

6.1. Definitions

6.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

6.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

6.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

6.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

6.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

6.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

6.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

6.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

6.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

6.1.10. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

6.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

6.1.12. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

6.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

QASP

Quality Assurance Surveillance Plan for External ISO/IEC 17025 International Assessment and Accreditation Support Services

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) This plan provides a quality surveillance strategy for professional auditing services for the initial ISO/IEC 17025 International assessment audit to obtain ISO/IEC 17025 International accreditation at The Armed Forces DNA Identification Laboratory in Dover AFB, DE. The primary purpose of this plan is to provide a basis for the government’s evaluation of the Contractor’s key areas of performance under this contract. The Contracting Officer (KO), in conjunction with input provided by the Contracting Officer’s Representative (COR), will evaluate the Contractor’s performance. Oversight of the Contractor’s performance will assure quality and consistency of contract performance.

This QASP explains the following:

· What will be monitored?

· How monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Erik J. Przygocki Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: N/A Email: erik.j.przygocki.civ@mail.mil

b. Contracting Officer’s Representative (COR) – The COR is located at the Armed Forces Medical Examiner System at 115 Purple Heart Drive, Dover AFB, DE 19902. The COR will be responsible for technical administration of this contract, and shall assure proper Government surveillance of the contractor’s performance with the assistance of the Quality Manager. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Primary COR: Shairose Lalani Telephone: 302-346-8918 Email: shairose.a.lalani.civ@mail.mil

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager: TBD Title: TBD Telephone: TBD Email: TBD

4. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

Table 1. Performance Requirements

5. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Feedback from Oversight Board

· Direct Observation

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. 100% surveillance through passive and direct surveillance

6. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract performance, the COR shall take measurements, as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated requirements are conducted.

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

3. Date and time of observation:

4. Observation:

Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.

Prepared by: COR

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: W81XWH-TBD

2. To: (Contractor Task Manager or on-site representative)

3. From: TBD

4. Date and time observed discrepancy:

5. Discrepancy or Problem:

Describe in detail. Identify any attachments.

6. Corrective action plan:

A written corrective action plan is / is not required.

If a written corrective action plan is required include the following. The written Corrective Action Plan will be provided to the undersigned not later than number of days after receipt of this CDR.

Prepared by: COR

Received by:

The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.

CONTRACTOR IDENTIFICATION

CONTRACTOR IDENTIFICATION (June 2015) (USAMRAA)

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

KEY PERSONNEL

KEY PERSONNEL (June 2015) (USAMRAA)

a. The Contractor agrees to utilize the following Key Personnel on this contract/solicitation W81XWH-21-R-0084:

b. The above Key Personnel shall be utilized as necessary to fulfill the requirements of this contract.

c. The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Key Personnel under this contract in the form of resumes or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

d. The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or termination of employment. In any of these events, the contractor shall promptly notify the Contracting Officer and provide the information required by paragraph (e) below.

e. All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the Contracting Officer needed to approve or disapprove the proposed substitution(s). All proposed substitutes shall have qualifications that are equal to or higher than the qualifications of the person to be replaced. The Contracting Officer or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

f. If any of the listed Key Personnel are subcontractor personnel, the contractor shall include the substance of this clause in any subcontract which he awards under this contract.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

24-SEP-2022

W03K AFME SYSTEM

115 PURPLE HEART DRIVE

DOVER AIR FORCE BASE DE 19902

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24-SEP-2023

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24-SEP-2024

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24-SEP-2025

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CLAUSES INCORPORATED BY REFERENCE

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

Invoice 2-in-1

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

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(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*