Attachment_1_-_PWS.pdf

Attachment 1 - PWS

PERFORMANCE WORK STATEMENT (PWS)

Scientific, Technical, Administrative and Logistical Support Services (STALSS) to the Armed Forces Medical Examiner System (AFMES)

1. GENERAL.

This is a non-personal services contract to provide scientific, technical, administrative and logistical support services to the Armed Forces Medical Examiner System

(AFMES).

The Government shall not exercise any control over the contract service providers (CSPs) (includes Subcontractor personnel) performing the services herein in regards to discipline, hiring or firing actions. Such CSPs shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

At no time will the CSPs hold positions of decision-making responsibilities.

The Government shall exercise setting priority of daily operations and tasks.

1.1. LOCATION.

All services will be performed on-site at AFMES, 115 Purple Heart Drive, Dover AFB, DE. This is a secure, Government-owned facility located on a military installation.

1.2. OCCUPATIONAL HEALTH SCREENING.

This contract includes occupational health screening requirements for all CSPs employed under this contract regardless of position in accordance with (IAW) Paragraph 8.4.

This is wholly a Contractor funded and managed requirement. This requirement shall not be charged to or reimbursed by the Government under any award type.

1.3. SECURITY.

All CSPs, at a minimum, will require basic National Agency Checks with Inquiries (NACIs) IAW Paragraph 8.6.12 to perform services IAW this PWS.

1.4. CONTRACTOR IDENTIFICATION.

All CSPs shall wear distinctive nametags or company badges for identification purposes, and shall self-identify as a contract employee on correspondence, in telephone conversations and meeting attendance IAW CONTRACTOR IDENTIFICATION (June 2015)(USAMRAA).

Contractor badges are wholly a Contractor funded and managed requirement. This requirement shall not be charged to or reimbursed by the Government under any award type.

1.5. SUPPORT OF EXISTING AGREEMENTS.

The Contractor shall support AFMES’ ongoing collaborative instruments and agreements with federal agencies and Department of Defense (DoD) entities including, but not limited to, Memoranda of Agreement (MOA), Memoranda of Understanding (MOU) and Inter-Agency Agreements (IAA).

1.6. CONTINGENCY OPERATIONS.

The Contractor shall support contingency operations, as required and deemed necessary by the cognizant Government representative. CSPs shall not report to work in a base closure situation, unless identified as mission essential personnel and/or Continuity of Operations Plan (COOP) point of contact (POC) and directed to report to work by the Contractor Program Manager (CPM). All of the aforementioned positions will be identified at the task order level.

1.7. RECORDS MANAGEMENT.

The Contractor shall be required to maintain its official documentation file(s) IAW the following:

Health Affairs/Defense Health Agency (HA/DHA) file plan Federal Records Act (USC Chapters 21, 29, 31, 33 of Title 44), Code of Federal Regulations (CFR)(36 CFR, Chapter 12), Administrative Instruction (AI) 15, OSD Records and Information Management Program.

http://www.dtic.mil/whs/directives/corres/pdf/a015p.pdf OSD Records Disposition Schedule, http://www.dtic.mil/whs/esd/rdd/recordsmgt.html 36 CFR Part 1236, Records Management; Electronic Mail; Electronic Records;

Disposition of Records DoD Memorandum on “Networks and information Integration; Electronic Mail Records and Electronic Mail Retention Policies for the Department of Defense,” May 22, 2005.

All records custodians will be identified at the task order level.

All records and documentation maintained are considered official DoD property and shall not be released without the appropriate level of approval from Government officials.

http://www.dtic.mil/whs/directives/corres/pdf/a015p.pdf http://www.dtic.mil/whs/esd/rdd/recordsmgt.html

1.8. REQUEST FOR FEEDBACK.

The Contractor shall require its CSPs to participate in Government requests for feedback when AFMES is undergoing audits and/or developing strategic planning initiatives.

1.9. RECRUITMENT.

The Contractor shall initiate advertisement for new/backfill hiring actions no more than five (5) working days from the date of the Contracting Officer’s Representative (COR) approved request. The Contractor shall provide a monthly report to the COR to demonstrate recruitment status. (Deliverable 1)

1.9.1. The Contractor shall fill positions based on the Government’s requirements and any minimum qualifications directed by DoDI 1010.16, Technical Procedures for the Military Personnel Drug Abuse Testing Program (MPDATP), Federal Bureau of Investigation Quality Assurance Standards (FBI-QAS), American Academy of Forensic Sciences (AAFS), American Board of Forensic Toxicology (ABFT), College of Pathologists (CAP), Society of Forensic Toxicologists (SOFT) and/or any other accreditation standards within 45 days of notification of a vacancy and/or a new requirement. The Contractor must notify the COR if more time is required.

1.10. CONTRACTOR PROGRAM MANAGER (CPM) SERVICES.

The Contractor shall provide a Program Manager (CPM) to manage the contract and to serve as the Contractor’s primary point of contact (POC) for all contract activities and issues. The CPM shall be considered a Key Personnel position.

The Contractor shall ensure that its CPM has adequate experience as a technical manager and provides sufficient management to ensure that the contract tasks are performed efficiently, accurately, on time, and in compliance with all requirements.

The CPM shall be the sole POC for the COR during changes in the base posture (e.g., closures or threat conditions). The CPM shall notify the CSPs considered mission essential (ME) or Continuity of Operations Plan (COOP) personnel, to be identified at the task order level.

The CPM shall coordinate as necessary with the COR to ensure that the contract is managed consistently with overall contract requirements. The CPM shall ensure timely and accurate submission of invoices and reports.

The CPM shall assist the COR with in/out processing of CSPs, submission of travel requests and security clearances.

The CPM shall assist Government leadership in analyzing, verifying, and formulating responses to data calls and suspenses.

1.11. DUTY HOURS.

1.11.1. Normal duty hours are determined by class of Contractor employee as defined by the Fair Labor Standards Act.

1.11.1.1. Full-time exempt personnel shall have normal duty hours of an eight (8) hour shift per day during any combination of seven (7) days, with an expected workload of 80 hours per biweekly period.

1.11.1.2. Non-exempt personnel, both full-time and part-time, shall have normal duty hours not to exceed 40 hours per workweek. If overtime is required for non-exempt personnel, the Contractor shall submit overtime requests to the civilian or military Department Chair and then through the COR for approval by the Contracting Officer (KO). If possible, requests for overtime should be submitted for approval at least 72 hours prior to the need for such overtime.

In no case shall the requested overtime exceed the accepted proposal without prior approval by the KO. Failure to obtain advanced written authorization may result in costs/charges being deemed unallowable and rejection of invoices.

1.11.1.3. The Contractor shall provide the government a list of non-exempt and exempt personnel upon contract implementation and semi-annually thereafter. (Deliverable 2)

1.11.2. ALTERNATIVE WORK SCHEDULE (AWS).

CSPs may be authorized an AWS. Certain positions may be identified as ineligible at the task order level due to mission responsibilities and/or work associated with the contract.

The Contractor shall provide the CSPs’ work schedules (including regular schedules and AWS) to the COR upon task order execution and semi-annually thereafter.

The Contractor-designated POC will coordinate with the COR for approval of all alternative schedules. If approved, the CSPs’ time and attendance report must accurately reflect all service hours as worked.

AWS schedules shall ensure that full-time personnel account for a minimum of 80 hours (work or paid absence) each biweekly period. AWS schedules shall not result in increased cost to the Government.

1.12. MINIMUM WAGE AND OVERTIME PAY.

Contractor shall comply with the Fair Labor Standards Act (FLSA) as defined by Regulations, 29 CFR Part 541, unless an exemption applies for minimum wage and overtime pay provided by Section 13(A)(1) of the Fair Labor Standards Act as defined by Regulations.

1.12.1. The FLSA requires that most employees in the United States be paid at least the federal minimum wage for all hours worked and overtime pay at time and one-half the regular rate of pay for all hours worked over 40 hours in a workweek. However, Section 13(a)(1) of the FLSA provides an exemption from both minimum wage and overtime pay for employees employed as bona fide executive, administrative, professional and outside sales employees.

1.12.2. Fair Labor Standards Act Section 13(a) (1) and Section 13(a) (17) also exempt certain computer employees.

2. DEFINITIONS AND ACRONYMS.

2.1. DEFINITIONS.

2.1.1. ALTERNATIVE WORK SCHEDULE (AWS). The Government defines alternative work schedules as both flexible work schedules and compressed work schedules. AWS days are allowed at a rate of one per pay period, equaling nine (9) hour work days and one Regular Day Off (RDO) IAW 5 U.S.C. 6121(5).

2.1.2. CONTRACTOR. The term as used in this contract refers to the prime Contractor.

2.1.3. CONTRACTING OFFICER (KO). A person with authority to enter into a contract, administer the contract, and/or terminate the contract. The Contracting Officer can make related determinations and findings on behalf of the Government. Note: The Contracting Officer is only individual who can legally bind the Government.

2.1.4. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the KO to monitor Contractor performance. 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.

2.1.5. FOREIGN TRAVEL. Any travel outside the United States and its territories and possessions.

2.1.6. GOVERNMENT FURNISHED PROPERTY/EQUIPMENT. Property/equipment in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of the contract. For the purposes of this contract, will include laptop computers and Blackberry devices.

2.1.7. GOVERNMENT OFFICE EQUIPMENT. Includes but is not limited to desktop computers and related peripheral equipment and software, library resources, telephones, facsimile machines, photocopiers, scanners, Internet connectivity and access to Internet services and email.

2.1.8. HOURS. Hours are described using a 24-hour clock.

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

2.1.10. NON-WORK TIME. Time when the CSP is not otherwise expected to be conducting official business (i.e. before or after the workday, during lunch, or during authorized breaks).

2.1.11. QUALITY ASSURANCE. Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.12. QUALITY CONTROL. All necessary measures taken by the Contractor to ensure the quality of a product or service shall meet contract requirements.

2.1.13. SUBCONTRACTOR. Any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor.

2.1.14. WEEKEND WORK. Work performed on Saturday or Sunday.

2.1.15. WORK DAY. Hours of Performance are as follows: Core laboratory hours are 0900 to 1500 hours with a minimum 8-hour workday and 40-hour workweek, unless working an AWS. Start time shall be between 0600 and 0800.

2.1.16. WORK WEEK. Monday through Sunday (dependent on workload and mobilization requirements).

2.2. ACRONYMS.

AAFS American Academy of Forensic Sciences ABFT American Board of Forensic Toxicology AFB Air Force Base AFDIL Armed Forces DNA Identification Laboratory AFME Armed Forces Medical Examiner AFMES Armed Forces Medical Examiner System AFMETS Armed Forces Medical Examiner Tracking System AFRSSIR Armed Forces Repository of Specimen Samples for Identification of

Remains APACS Aircraft and Personnel Automated Clearance System ASCLD American Society of Crime Laboratory Directors ASCLD/LAB American Society of Crime Laboratory Directors/Laboratory

Accreditation Board AWS Alternative Work Schedule

CAC Common Access Card CAP College of American Pathologists CDR Contract Discrepancy Report CE Continuing Education CEU Continuing Education Units CFR Code of Federal Regulations CMR Contractor Manpower Reporting CoC Chain of Custody CONUS Continental United States (excludes Alaska and Hawaii) COOP Continuity of Operations Plan COR Contracting Officer’s Representative CR Contractor Representative CSP Contract Service Provider CVS Contractor Verification System CWS Compressed Work Schedule DEERS/RAPIDS Defense Eligibility Enrollment Reporting System/Real-Time

Automated Personnel Identification System DFT Division of Forensic Toxicology DHA Defense Health Agency DHP Defense Health Program DMLSS Defense Medical Logistics Supply System DNA Deoxyribonucleic Acid DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DUI Driving Under the Influence ECAT Electronic Catalog EMALL Electronic Mall FBI Federal Bureau of Investigation FCG Foreign Clearance Guide FIPS PUB Federal Information Processing Standards Publication FPI Forensic Pathology Investigation FRS Family Reference Sample FS Forensic Scientist FSO Facility Security Officer FTDTL Forensic Toxicology Drug Testing Laboratory GLP/GMP Good Laboratory Practices/Good Manufacturing Practices GSA General Services Administration HIPAA Health Insurance Portability and Accountability Act of 1996 HSPD Homeland Security Presidential Directive IAW In Accordance With IA Information Assurance ID Identification IMR Individual Medical Readiness IS Internal Standard ISO International Organization for Standardization

IT Information Technology KO Contracting Officer LCO Laboratory Certifying Official MFR Memorandum for Record MIA Missing in Action MOA Memorandum of Agreement MOU Memorandum of Understanding MPDATP Military Personnel Drug Abuse Testing Program mtDNA Mitochondrial Deoxyribonucleic Acid NACI National Agency Check with Inquiries NCE Non-Conforming Event nucDNA Nuclear Deoxyribonucleic Acid OAFME Office of the Armed Forces Medical Examiner OCONUS Outside Continental United States (includes Alaska and Hawaii) OMB Office of Management and Budget OP Operating Procedure OSHA Occupational Safety and Health Administration PCR Polymerase Chain Reaction PDA Personal Digital Assistant PhD Doctorate of Philosophy PHI Protected Health Information PII Personally Identifiable Information POC Point of Contact POW Prisoner of War PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RDO Regular Day Off SFTDTL Special Forensic Toxicology Drug Testing Laboratory SIPRNET Secure Internet Protocol Routing Network SOP Standard Operating Procedure STR Short Tandem Repeat TA Trusted Agent TASS Trusted Associate Sponsorship System TE Technical Exhibit UIC Unit Identification Code URL Uniform Resource Locator US United States USAMRAA United States Army Medical Research Acquisition Activity USC United States Code VO Verifying Office XML Extensible Markup Language Y-STR Short Tandem Repeat on the Y-Chromosome

3. BACKGROUND.

3.1. ARMED FORCES MEDICAL EXAMINER SYSTEM (AFMES).

AFMES is a Tri-Service organization, comprised of administrative Support Staff (S- Staff) and three (3) integrated Divisions (Office of the Armed Forces Medical Examiner, DoD DNA Registry, and Forensic Toxicology) whose overall mission is to provide comprehensive and innovative medico-legal services worldwide.

AFMES provides mission support to the Department of Defense (DoD) in the fields of human remains identification from both current and previous conflicts; forensic toxicology; medico-legal death investigations; forensic DNA analytical services; mass-fatality specimen collection and management services; and human reference specimen collection, cataloging, archival, and retrieval repository services. AFMES is comprised of several subordinate elements providing support to this critical worldwide mission.

3.2. SUPPORT STAFF (S-STAFF).

The S-Staff performs the support/administrative functions serving the AFMES organization. It is comprised of Personnel (S1), Operations/Security (S2/3), Logistics (S4), Information Management/Information Technology (IM/IT) (S6), and Resource Management (S8).

3.3. OFFICE OF THE ARMED FORCES MEDICAL EXAMINER (OAFME).

The Office of the Armed Forces Medical Examiner (OAFME) is divided into three (3) separate branches: Forensic Pathology (Medico-legal Death) Investigations (FPI), Mortality Surveillance (MS), and Education. The OAFME serves as the Nation’s only federal Medical Examiner System. Additionally, the OAFME is the office of primary responsibility for the DoD medical fellowship training program in forensic pathology.

3.3.1. Forensic Pathology Investigations (FPI).

Conducts investigations worldwide for the primary purpose of identifying the decedent and determining cause and manner of death in those cases under the jurisdiction of the Armed Forces Medical Examiner (AFME) IAW Title 10 U.S. Code § 1471.

3.3.2. Mortality Surveillance (MS).

Provides real time monitoring of all deaths under the jurisdiction of the AFME IAW Title 10 U.S. Code § 1471. Analyzed data from this branch is reported to multiple agencies.

3.3.3. Education.

Responsible for the training of forensic pathology fellows, pathology residents, medical students, mortuary affairs specialists and investigative personnel.

3.4. DoD DNA REGISTRY (AFDIL and AFRSSIR).

The DoD DNA Registry is divided into two separate branches: the Armed Forces DNA Identification Laboratory (AFDIL) and the Armed Forces Repository of Specimen Samples for the Identification of Remains (AFRSSIR).

3.4.1. Armed Forces DNA Identification Laboratory (AFDIL).

AFDIL provides DNA typing services utilizing STR, Y-STR and mitochondrial technology on degraded and/or ancient remains for the purpose of identifying human remains, or to determine the probable contributor of biological samples of human origin in criminal investigations for AFMES, DoD, other Agencies/Bureaus of the Federal Government, and civilian medical institutions in the following areas:

3.4.1.1. Current Day Operations (CDO).

Primary mission support is to OAFME, including the processing of DNA samples from accident scene investigations or mass disasters IAW multiple memoranda of agreement. Lead DNA laboratory processing is nuclear polymerase chain reaction (PCR)-based DNA typing methods but also uses other DNA typing methods.

3.4.1.2. Past Accounting (PA).

Primary mission support is to the Defense POW-MIA Accounting Agency (DPAA) to include supporting DPAA Family Updates and Service Notification Visits. Performs laboratory processing primarily using Mitochondrial PCR-based DNA typing methods but also uses other DNA typing methods. Provides identification through the extraction of mtDNA from samples recovered from previous conflicts or airplane crashes.

3.4.1.3. Family Reference Sample (FRS) Database/Lab Automation

Primary mission support is to provide direct support to the Armed Forces Medical Examiners and the Defense POW-MIA Accounting Agency (DPAA) missions.

Secondly, the Contractor will provide support to DPAA Family Updates. Additionally, the CSPs will perform laboratory processing using Mitochondrial and nuclear PCR -based DNA typing methods. The Laboratory Automation and Bioinformatics section support of the primary mission will be accomplished through the utilization of automated systems for the processing of references samples in support of current day and past accounting operations. Secondary, they will assist with current day and past accounting operations casework as specified by the Government.

3.4.1.4. Quality Management (QM).

Supports the division’s Quality Assurance/Quality Control programs and proficiency programs to meet established standards following standard operating procedures;

OSHA safety regulations; and Good Laboratory Practices and Good Manufacturing Practices. Assists in the production of QC samples, laboratory inspections, collection of data, and generation of reports. Supports successful completion of annual/bi-annual audits conducted by the following accrediting bodies and oversight committees:

American Society of Crime Laboratory Directors - Laboratory Accreditation Board (ASCLD-LAB), International Organization for Standardization (ISO) 17025; Federal Bureau of Investigation Quality Assurance Standards (FBI-QAS); and Blind Proficiency Testing program administered by the Defense POW-MIA Accounting Agency-Central Identification Laboratory (DPAA-CIL).

3.4.1.5. Emerging Technologies.

Provides a research and development program that focuses upon optimization and validation of genetic marker systems.

3.4.2. Armed Forces Repository of Specimen Samples for the Identification of Remains

(AFRSSIR)

AFRSSIR is tasked with collection, storage and retrieval of DNA specimens from active duty and reserve components of the US Armed Forces as well as other selected individuals.

3.5. DIVISION OF FORENSIC TOXICOLOGY (DFT).

DFT provides forensic toxicology analysis, method development, method validation and consultation services for AFMES, DoD, other Agencies/Bureaus of the Federal Government, and civilian medical institutions in the following areas:

3.5.1. Post Mortem Forensic Toxicology.

Determines the absence or presence of drugs and their metabolites, chemicals such as ethanol and other volatile substances, carbon monoxide and other poisonous gases, and toxic chemicals in human fluids and tissues, and evaluates their role as a determinant or contributory factor in the cause and manner of death.

3.5.2. Human-Performance Forensic Toxicology.

Determines the absence or presence of ethanol and other drugs and chemicals in blood or other appropriate specimen(s), and evaluates their role in modifying human performance or behavior.

3.5.3. DoD Quality Assurance (QA).

Provides quality assurance support for the DoD Drug Demand Reduction Program (DDRP) by production, testing and evaluation of forensic proficiency samples.

Administers the laboratory inspection program which entails coordinating and executing inspection services for the seven (7) DDRP drug testing laboratories.

3.5.4. Special Forensic Toxicology Drug Testing Laboratory (SFTDTL).

Provides production level confirmation analysis to the Services for emerging synthetic illicit drugs.

3.5.5. In addition to the above, DFT provides technical expertise in support of the military drug testing program in the areas of expert witness testimony, laboratory inspections and consultative reports to all branches of service, program managers and civilian agencies.

4. SCOPE OF WORK.

4.1. The Contractor shall provide the professional scientific and technical expertise, and administrative and logistical support in one or more of the functional categories to meet the mission needs of AFMES.

4.2. The Contractor shall furnish the necessary personnel and services required to satisfy the necessary level of capability with no degradation to mission and/or accreditation.

4.3. Contractor work requires travel for expert witness testimony, laboratory inspections, mission support, meetings, industry conferences and seminars. Contractor travel requirements are identified in Paragraph 5.5.

5. DESCRIPTION OF WORK.

5.1. SUPPORT STAFF (S-STAFF).

The Contractor shall provide the following services:

5.1.1. Logistics (S4).

Provide logistics support services to other AFMES components.

5.1.1.1. MAJOR TASK 1: Laboratory Support Services.

5.1.1.1.1. Provide augmentation support to government purchasing and resources management staff. These CSPs will work very closely with their government counterparts in providing administrative, resources management, and laboratory support.

5.1.1.1.2. Provide supply and inventory management support to ensure all laboratories remain operational and stocked with required supplies and equipment. This includes the stocking of supplies and equipment.

5.1.1.1.3. Provide technical recommendations and specifications of anticipated Government supply and equipment purchases to ensure appropriateness for established protocols and laboratory procedures.

5.1.1.1.4. Conduct market research for supplies/equipment using web enabled and automated systems including internet, Defense Medical Logistics Supply System (DMLSS), DoD Electronic Catalog (ECAT), DoD Electronic Mall (EMALL), GSA Advantage!, etc.

5.1.1.1.5. Provide technical and administrative support to laboratories as required.

5.1.1.2. MAJOR TASK 2: Biomedical Equipment Repair.

Manage and perform laboratory equipment preventive maintenance, repair requests, equipment failures, and status updates regarding equipment warranties, maintenance, and one-time repairs. Support requires coordination between Government and third-party maintenance staff.

5.1.2. IM/IT (S6).

5.1.2.1. Provide subject matter expertise to AFMES and Division Chiefs on information technology, application development and automation processes pertaining to Medical Examiner and forensic laboratory operations.

5.1.2.2. Advise AFMES leadership on Medical Examiner and laboratory information technology initiatives to ensure mission sustainment.

5.1.2.3. Function as a liaison between Medical Examiners/laboratory scientists and information technology/information assurance professionals.

5.1.2.4. Oversee application development of Medical Examiner and laboratory information systems to ensure they fully support the current and future mission requirements of AFMES.

5.1.2.5. Provide AFMES with needs assessment and requirements gathering for new and emerging forensic laboratory and medical technologies. Provide guidance on integrating laboratory equipment and technologies into AFMES’ automated systems and applications.

5.1.2.6. Assist the AFMES information assurance staff with the certification and accreditation of networks and systems in accordance with applicable DoD, DHA, Army and/or MEDCOM directives and policies. Personnel must meet all training and certification requirements per the DoD 8570.01M, AR 25-1 and AR 25-2 for Information Assurance and Technology (IAT) level II.

5.1.3. Resource Management (RM) Support.

5.1.3.1. Provide support to AFMES with Systems, Application, and Products (SAP) capability in its resource management (RM) office. The RM office will rely on the SAP expertise to leverage the Enterprise Resource Planning (ERP) financial system, General Fund Enterprise Business System (GFEBS).

5.2. OFFICE OF THE ARMED FORCES MEDICAL EXAMINER (OAFME).

The Contractor shall provide the following services:

5.2.1. Provide professional and administrative support necessary to successfully carry out multiple daily operations related to the overall effective functioning of the division.

Such tasks will include family correspondence, processing death certificates and facilitating incoming/outgoing correspondence/inquiries.

5.2.2. Provide professional and administrative support necessary to successfully carry out the daily operations related to the QA/QC program of the division.

5.2.3. Provide administrative support to the staff of the division for successful archiving and records management of all casework.

5.3. DOD DNA REPOSITORY

5.3.1. Armed Forces DNA Identification Laboratory (AFDIL).

The Contractor shall provide AFDIL scientific, technical, administrative, and logistical support to the operations of these work areas to successfully accomplish the various missions and research work assigned to AFDIL.

The support to AFDIL will be provided under the following major tasks:

5.3.1.1. MAJOR TASK 1: Current Day Operations (CDO).

Primary mission support is to OAFME with current day operations which includes the processing of DNA samples from accident scene investigations or mass disasters IAW multiple memoranda of agreement. Lead DNA laboratory processing is nuclear polymerase chain reaction (PCR)-based DNA typing methods but will include proficiency in the other DNA typing methods.

AFDIL exclusively applies PCR-based DNA typing methods of both nucDNA and mtDNA to optimize and validate new genetic marker systems and advancing automated technologies. Automated technologies are actively pursued to prepare for both peacetime and wartime mass disaster contingencies for rapid, accurate, and cost effective DNA-based identifications of casualties.

The Contractor shall be responsible for the following functions:

5.3.1.1.1. Provide scientific, technical, and administrative support for all types of casework accomplished by AFDIL. This includes providing support to QA/QC Program requirements as specified by the Government. Provide AFDIL with support ensuring the daily operational success of casework activities, to include training activities and programs; proper day-to-day case management; evaluation of new equipment and materials for potential purchases; policy and procedures reviews; and ensure stock levels of laboratory supplies are maintained so that no degradation of services occurs.

5.3.1.1.2. Travel and testify as expert witnesses and participate in the development and presentation of educational activities for the benefit of the scientific community.

Technical personnel will also travel to actively participate in the scientific discourse of subjects relevant to the mission of the DoD DNA Registry. Travel outside the continental US may be necessary.

5.3.1.1.3. Provide appropriate contractor supervisory structure to ensure daily operational success and be responsible for assigning and monitoring caseload activities of the contractor staff. Conduct technical training activities and programs necessary ensure daily casework management.

5.3.1.1.4. Provide a DNA collection and coordination team for deployment to sites of mass fatality incidents. Additionally, must be able to perform scheduled and unscheduled travel in support of accident scene investigations or mass disasters to assist in the collection of biological samples from victims who may have suffered violent and disfiguring deaths. Deployments to crash sites or mass disasters for specimen collection and assignments as a Mass Disaster Team Leader are routine.

5.3.1.1.5. Provide 24/7 staffing support for this requirement. 24/7 support includes a normal workday in addition to a pre-scheduled on-call rotation. Must be able to receive and respond to inquiries immediately and process submitted samples. This exclusively applies to Nuclear PCR-based DNA typing methods.

5.3.1.1.6. A minimum of two (2) qualified scientific staff (Forensic Scientist 2 or higher) must be available for 24/7 on-call response and recall at all times. Response types include telephone consultations and laboratory processing. 24-hour cell phone coverage requires a response time not to exceed two (2) hours. This requirement applies during duty hours as well as non-duty hours, weekends, and holidays, 365 days a year. The Contractor shall provide the monthly on-call schedule 15 days prior to start of each month. The Contractor shall provide a monthly performance report to the COR, identifying all completed tasks by performance metrics.

5.3.1.1.7. All determinations regarding the necessity of CSP recall and which CSPs will be recalled will be made by a Government representative (i.e., Division Director, On-call Pathologist, or designee).

5.3.1.1.8. On-call compensation will be reimbursed at a flat rate for each seven (7) day period. If the CSP is called to come perform duty at the facility, reimbursement will be at an hourly rate for hours worked.

5.3.1.2. MAJOR TASK 2: Operations and Management Support/Technical Services.

5.3.1.2.1. Provide professional advisory and assistance services to support and improve policy, decision-making, management, and administration of AFDIL.

5.3.1.2.2. Provide support in the areas of human resources, personal security requirements, in-and-out processing of staff, travel, medical and casework records management, organizational schedules, visitors and outreach, and family reference collections.

5.3.1.3. MAJOR TASK 3: Past Accounting (PA)

5.3.1.3.1. Provide direct support to DPAA to include supporting DPAA Family Updates and Service Notification Visits. Additionally, the CSPs will perform laboratory processing using Mitochondrial PCR-based DNA typing methods but shall be proficient in other DNA typing methods. The PA section provides identification through the extraction of mtDNA from samples recovered from previous conflicts or airplane crashes. The Contractor shall be responsible for the following functions:

5.3.1.3.2. AFDIL exclusively applies PCR-based DNA typing methods of both nucDNA and mtDNA to optimize and validate new genetic marker systems and advancing automated technologies. Automated technologies are actively pursued to prepare for both peacetime and wartime mass disaster contingencies for rapid, accurate, and cost effective DNA based identifications of casualties. (Emerging Technologies)

5.3.1.3.3. Provide appropriate contractor supervisory structure to ensure daily operational success of AFDIL and be responsible for assigning and monitoring caseload activities of contractor staff. Conduct technical training activities and programs necessary to ensure effective daily casework management.

5.3.1.3.4. Travel to actively participate in the scientific discourse of subjects relevant to the AFDIL mission. Required travel includes meetings, family updates, family notifications, and scientific exchange visits. Travel outside the continental US may be necessary.

5.3.1.3.5. Provide a DNA collection and coordination team for deployment to sites of mass fatality incidents.

5.3.1.4. MAJOR TASK 4: Family Reference Sample Database/Lab Automation

5.3.1.4.1. Provide professional, technical, and administrative support for all types of references and casework performed by AFDIL. This includes providing support to the QA/QC Program, the Current Day Operations Program, and the Past Accounting Program requirements as specified by the Government.

5.3.1.4.2. Provide AFDIL with support ensuring the daily operational success of reference and casework activities, to include training activities and programs; proper day-to-day case management; responsible for assigning and monitoring turn-around times for reference sample and casework processing; evaluation of new equipment and materials for potential purchases; policy and procedures reviews; and ensure stock levels of laboratory supplies are maintained so that no degradation of services occurs.

5.3.1.4.3. Provide technical and management personnel to manage: Laboratory Automation and Bioinformatics automation issues for the AFDIL and DoD DNA Registry. Create reference and statistical databases as determined by the Government.

5.3.1.4.4. Provide appropriate contractor supervisory structure to ensure daily operational success of AFDIL and be responsible for assigning and monitoring caseload activities of subordinate CSPs. Conduct technical training activities and programs necessary to ensure daily casework management.

5.3.1.4.5. Provide a DNA collection and coordination team for deployment to sites of mass fatality incidents.

5.3.1.4.6. AFDIL exclusively applies PCR-based DNA typing methods of both nuclear and mitochondrial DNA (nucDNA and mtDNA, respectively) to optimize and validate new genetic marker systems and advancing automated technologies. Automated technologies are actively pursued to prepare for both peacetime and wartime mass disaster contingencies for rapid, accurate, and cost effective DNA-based identifications of casualties.

5.3.1.5. MAJOR TASK 5: QC/QM Quality Management

5.3.1.5.1. Provide support to the division’s Quality Assurance/Quality Control programs and proficiency programs to meet established standards following standard operating procedures, OSHA safety, and Good Laboratory Practices and Good Manufacturing Practices. Assist in the production of QC samples, laboratory inspections, collection of data, and generation of reports.

5.3.1.5.2. Provide support to ensure successful completion of annual/bi-annual audits conducted by the following accrediting bodies and oversight committees: American Society of Crime Laboratory Directors - Laboratory Accreditation Board (ASCLD-LAB), ISO 17025; Federal Bureau of Investigations Quality Assurance Standards (FBI-QAS);

and Blind Proficiency Testing program administered by DPAA-CIL.

5.3.1.5.3. Recommend new equipment and materiel for potential Government purchases; prepare and maintain stock levels of critical laboratory reagents, chemicals, and primers; and review and edit, as necessary, experimental protocols, standard operating procedures, and operating instructions.

5.3.1.6. Personnel Requirements

5.3.1.6.1. As part of AFDIL’s ASCLD accreditation, the laboratory must adhere to ISO 17025 requirements, the FBI Quality Assurance Standards (QAS) for Forensic DNA Testing Laboratories, and ASCLD supplement. AFDIL’s technicians, expert witnesses, and management level staff must possess all qualifications required by these standards, to include any necessary proficiency testing. This testing, as required by laboratory accreditation standards, is performed in-house and takes from 6 to 8 months to complete.

5.3.1.6.2. AFDIL requires compliance with FBI QAS requirements for Technical Leaders (TL). TLs must have a minimum of three (3) years of forensic DNA laboratory experience obtained at a laboratory where forensic DNA testing was conducted for the identification and evaluation of biological evidence in criminal matters.

5.3.1.6.3. TLs and ATLs must complete the FBI-sponsored auditor training course within one year of appointment.

5.3.1.6.4. Upon appointment, TLs must review the validation studies and methodologies currently used by the laboratory. They also must review the educational qualifications and training records of all qualified analysts. This requirement usually takes 1 to 2 months.

5.3.1.6.5. Additional responsibilities of the technical leader include review of internal and external DNA audit documents and, if applicable, approval of corrective action(s);

annual review of laboratory procedures and documentation of such review; review and approve training, quality assurance, and proficiency testing programs in the laboratory.

5.3.1.6.6. Analysts must possess a bachelor’s (or its equivalent) or an advanced degree in a biology-, chemistry-, or forensic science- related area and shall have successfully completed course work (graduate or undergraduate level) covering the following subject areas: biochemistry, genetics, molecular biology; and course work and/or training in statistics and/or population genetics as it applies to forensic DNA analysis.

5.3.1.6.7. Each Analyst must have six (6) months of forensic human DNA laboratory experience. If prior forensic human DNA laboratory experience is accepted by the laboratory (AFDIL), the prior experience shall be documented and augmented by additional training, as needed, in the analytical methodologies, platforms and interpretations of human DNA results used by the laboratory (AFDIL). The analyst shall complete the analysis of a range of samples routinely encountered in forensic casework prior to independent work using DNA technology. The analyst shall successfully complete a competency test before beginning independent DNA analysis.

5.3.1.6.8. A technical reviewer is a currently or previously qualified analyst in the methodology being reviewed who performs a technical review of, and is not an author of, the applicable report or its contents. A technical reviewer must be qualified or previously qualified in the technology, platform and typing amplification test kit used to generate the data being reviewed. This would mean reviewer must have a minimum of six (6) months of casework in the methodology being reviewed.

5.3.2. Armed Forces Repository of Specimen Samples for the Identification of Remains (AFRSSIR)

The Contractor shall provide the following services pertaining to AFRSSIR operations, including bloodstain card collection, storage, and warehousing.

5.3.2.1. Provide AFRSSIR with the technical, administrative and logistical support necessary to maintain the QA/QC program established by the Government. The QA/QC program provides QC inspections; collects QC data for all aspects of AFRSSIR operations; identifies QC deficiencies and risks; proposes corrective actions;

coordinates and document use of samples for QA testing; and provides summary reports of QA/QC issues for Government review.

5.3.2.2. Access and process all blood stain cards received each week. No monthly backlog will be permitted. Historically, between 4,500 and 7,500 samples have been received each week

5.3.2.3. Conduct and supervise the QA/QC program established by the Government, and accordingly provide QC inspections and collection of QC data for all aspects of AFRSSIR operations; identify QC deficiencies and risks, and propose corrective action;

coordinate and document the use of samples for QA testing; and prepare summary reports of QA/QC issues for review by the Government.

5.3.2.4. Provide administrative services that coordinate the daily activities at AFRSSIR.

Services may include processing destruction requests, requests for cards in AFMETS and SMS, process requests for supplies to be sent to collection sites, etc.

5.3.2.5. Provide DNA collection and coordination support during deployment to sites of mass fatality incidents.

5.4. DIVISION OF FORENSIC TOXICOLOGY (DFT)

5.4.1. MAJOR TASK 1: Post-Mortem Human Performance Testing Laboratory

5.4.1.1. Provide comprehensive forensic toxicological services for AFMES, to include all post-mortem death investigations; all Armed Forces air, ground, and sea based mishap/accident investigations; criminal investigations; fitness for duty investigations;

and medico-legal death determinations (e.g., DUI).

5.4.1.2. Provide technical and scientific support to DFT with specific regard to processing specimens (i.e., urine, blood, bodily fluids, and soft tissue) arriving for forensic testing (IAW DFT’s SOPs) especially in performing confirmation and quantitative assays in biological media with particular attention to accuracy and precision as well as chain of custody (CoC).

5.4.1.3. Assist in method development and analytical procedures, and preparation of manuscripts and scientific presentations. As applicable to casework, identify, plan, organize, direct, and carry out original method development projects and programs to produce innovative advances in drugs of abuse in human tissues and fluids from various sources.

5.4.2. MAJOR TASK 2: DoD Drug Detection Quality Assurance (QA) Laboratory

5.4.2.1. Provide support to the MPDATP and manage the DDRP laboratory certification process to include three (3) on-site, annual inspections for each of the seven (7) DoD Forensic Drug Testing Laboratories (consisting of 3 Navy, 2 Army, 1 Air Force laboratory and the SFTDTL).

5.4.2.2. Evaluate, through on-site investigation or document review, all significant non-conforming events (NCEs) that impact the quality of forensic operations.

5.4.2.3. Coordinate DDRP laboratory certification and recertification actions, for the drugs listed on the DoD drug testing panel.

5.4.2.4. Provide open and blind proficiency specimens for military laboratories throughout DoD, ensuring drug test results are reported with 100% accuracy.

5.4.2.5. Assist in method development and analytical procedures, preparation of manuscripts, and scientific presentations. As applicable to casework, identify, plan, organize, direct, and carry-out original method development projects and programs to produce innovative advances in drugs of abuse in human tissues and fluids from various sources.

5.4.3. MAJOR TASK 3: Special Forensic Toxicology Drug Testing Laboratory

(SFTDTL)

5.4.3.1. Provide the DoD’s Drug Demand Reduction Program (DDRP) with specialized forensic analysis for drugs of emerging abuse. For example, this analysis is intended to detect and quantitate synthetic cannabinoid (e.g., Spice, K2) use by identifying synthetic cannabinoid metabolites in randomly collected urine specimens.

5.4.3.2. Provide a surveillance capability to the DDRP for the purpose of identifying emerging drugs of abuse with an operational/readiness impact to the DoD.

5.4.3.3. Assist in method development and analytical procedures, preparation of manuscripts, and scientific presentations. As applicable to casework, identify, plan, organize, direct, and carry out original method development projects and programs to produce innovative advances in drugs of abuse in human tissues and fluids from various sources.

5.4.4. MAJOR TASK 4: Operations and Management Support/Technical Services

5.4.4.1. Ensure that laboratory personnel are adequately trained and experienced to conduct the work of the laboratory.

5.4.4.2. Maintain the competency of laboratory personnel by monitoring their work performance, verifying their skills, and documenting this training and experience.

5.4.4.3. Develop a complete, up-to-date procedure manual that is available to and followed by all personnel performing tests.

5.4.4.4. Establish a procedure for validating new analytical methodologies, and for maintaining a quality assurance program to ensure the proper performance and reporting of all test results.

5.4.4.5. Since forensic toxicology laboratories handle controlled substances and generate results essential to the criminal justice system, to the extent practical or permitted by law, exert reasonable efforts to ensure all personnel meet high ethical and moral standards.

5.4.4.6. Provide administrative support to DFT laboratories and programs.

5.4.4.7. Provide professional advisory and assistance services to support and improve policy, decision-making, management, and administration of DFT.

5.4.4.8. Provide training to ensure personnel are fully trained on the instruments and control systems. Exhibit proficiency in the operation of analytical instrumentation.

5.4.5. MAJOR TASK 5: Quality Assurance/Quality Control Technical Services

5.4.5.1. Participate in laboratory quality control programs and proficiency programs meeting established standards following SOPs, OSHA Safety, and Good Laboratory Practices/Good Manufacturing Practices (GLP/GMP).

5.4.5.2. Provide support in preparing, certifying, writing, and revising all internal standards (IS) and operating procedures (OPs).

5.4.5.3. Assist in conducting and coordinating the QA/QC program established by the Government, and accordingly assist in the production of QC specimens, laboratory inspections, collection of data, and generation of reports.

5.4.5.4. Support managing compliance with all external accreditation programs, including the College of American Pathologists and the American Board of Forensic Toxicology (ABFT) programs.

5.4.5.5. Recommend new equipment and materiel for potential Government purchase;

prepare and maintain stock levels of critical laboratory reagents, chemicals and primers;

review and edit, as necessary, experimental protocols, SOPs, and OPs.

5.4.5.6. Assist in method development and analytical procedures, preparation of manuscripts, and scientific presentations. As applicable to casework, identify, plan, organize, direct, and carry-out original method development projects and programs to produce innovative advances in drugs of abuse in human tissues and fluids from various sources.

5.4.6. Accreditation Requirements

5.4.6.1. To maintain its ABFT accreditation, DFT requires adherence to the standards set forth by DoDI 1010.16, Technical Procedures for the Military Personnel Drug Abuse Testing Program (MPDATP), the College of American Pathologists (CAP), the American Board of Forensic Toxicology, the American Academy of Forensic Sciences (AAFS) and the Society/Academy of Forensic Toxicology (SOFT). These standards identify the qualifications required of technicians, expert witnesses and laboratory certifying officials (LCOs). Some of the qualifications, as required by laboratory accreditation and Standard Operating Procedures (SOP), are performed in-house and take from 3-6 months to complete.

5.4.6.2. IAW DoDI 1010.16, the Directors (Chief, Laboratory Operations and Deputy, Laboratory Operations), Technical Services (Technical Directors) and/or Production Service Managers shall:

5.4.6.2.1. Have as a minimum requirement either a PhD degree in toxicology, biochemistry or the physical or biological sciences from an accredited university and at least three (3) years experience in forensic toxicology; or, have a Master’s degree in toxicology, biochemistry, chemistry or the physical or biological sciences from an accredited university and at least four (4) years experience in forensic toxicology.

5.4.6.2.2. The director should also have documented professional and in-house training and/or experience in the forensic applications of analytical toxicology (such as court testimony, research, participation in continuing education programs, and/or peer review of appropriate manuscripts in the field), including a knowledge of evidentiary procedures that apply when toxicological specimens are acquired, processed, and stored and when toxicological data are submitted as part of a legal proceeding.

5.4.6.2.3. Maintain technical expertise in the science of forensic toxicology by regular review of publications in peer…