Combined_Synopsis_Solicitation.doc

N62645-16-R-0025

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation of Commercial Items, FAR 13 Simplified Acquisition Procedures, FAR 13.5 Test Program for Certain Commercial Items, and FAR 16.503 Requirements Contracts, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at these addresses: https://www.acquisition.gov/FAR/ and www.acq.osd.mil/dpap/dfars/index.htm.

The NAICS code is 541618, with a business size standard of $15 M.

This Request for Proposal (RFP) is on behalf of the Department of Defense (DOD) Drug Demand Reduction Program (DDRP) Laboratories. This requirement is for Steroid Testing Services for the detection of steroid abuse in urine and telephonic consultation.

The solicitation number is N62645-16-R-0025.

This solicitation will result in one firm fixed price Requirements type contract with a five year period of performance. Period of Performance shall be from 27 February 2017 – 26 February 2022. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

Proposal Submission

Proposals are due by 01 July 2016 by 10:00 AM Local Time. Proposals shall be submitted in accordance with the Instructions to Offeror of this request.

NDSL Jacksonville

FFP

Navy Drug Screening Laboratory Jacksonville, Florida

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

Exact dates of inspections will be provided on individual task orders.

FOB: Destination

ESTIMATED

NET AMT

NDSL San Diego

Navy Drug Screening Laboratory San Diego, California

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

ESTIMATED

NDSL Great Lakes

Navy Drug Screening Laboratory Great Lakes, Illinois

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

ESTIMATED

AFDTL Tripler

Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, Hawaii

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

ESTIMATED

HQ AFDTL Lackland Air Force Base

HQ Air Force Drug Testing Laboratory Lackland Air Force Base, Texas

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

ESTIMATED

AFTDL Fort Meade

Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Maryland

Period of Performance: 27 February 2017 - 26 February 2018

3 Employees. Two inspections per year.

ESTIMATED

AG AFMES

Armed Forces Medical Examiner Services Dover Air Force Base, Delaware

Period of Performance: 27 February 2017 - 26 February 2018

1 Employee. One inspection per year.

Exact date of inspection will be provided on individual task order.

ESTIMATED

SFTDTL

Special Forensic Toxicology Drug Testing Laboratory, Dover, DE

Period of Performance: 27 February 2017 - 26 February 2018

1 Employees. Two inspections per year.

ESTIMATED

FFP

27 February 2017 - 26 February 2018

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED

Lot

COST

27 February 2017 - 26 February 2018

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

Lot

COST

27 February 2017 - 26 February 2018

Exact dates and location of meeting will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

FFP

Navy Drug Screening Laboratory Jacksonville, Florida

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory San Diego, California

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory Great Lakes, Illinois

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

HQ Air Force Drug Testing Laboratory Lackland Air Force Base, Texas

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, Hawaii

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Maryland

Period of Performance: 27 February 2018 - 26 February 2019

3 Employees. Two inspections per year.

ESTIMATED

FFP

Armed Forces Medical Examiner Services Dover Air Force Base, Delaware

Period of Performance: 27 February 2018 - 26 February 2019

1 Employee. One inspection per year.

ESTIMATED

FFP

Special Forensic Toxicology Drug Testing Laboratory, Dover, DE

Period of Performance: 27 February 2018 - 26 February 2019

1 Employees. Two inspections per year.

ESTIMATED

FFP

27 February 2018 - 26 February 2019

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED

Lot

COST

27 February 2018 - 26 February 2019

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

Lot

COST

27 February 2018 - 26 February 2019

Exact dates and location of meeting will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

FFP

Navy Drug Screening Laboratory Jacksonville, Florida

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory San Diego, California

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory Great Lakes, Illinois

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

HQ Air Force Drug Testing Laboratory Lackland Air Force Base, Texas

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, Hawaii

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Maryland

Period of Performance: 27 February 2019 - 26 February 2020

3 Employees. Two inspections per year.

ESTIMATED

FFP

Armed Forces Medical Examiner Services Dover Air Force Base, Delaware

Period of Performance: 27 February 2019 - 26 February 2020

1 Employee. One inspection per year.

ESTIMATED

FFP

Special Forensic Toxicology Drug Testing Laboratory, Dover, DE

Period of Performance: 27 February 2019 - 26 February 2020

1 Employees. Two inspections per year.

ESTIMATED

Hours

FFP

27 February 2019 - 26 February 2020

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED

Lot

COST

27 February 2019 - 26 February 2020

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

Lot

COST

27 February 2019 - 26 February 2020

Exact dates and location of meeting will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

FFP

Navy Drug Screening Laboratory Jacksonville, Florida

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory San Diego, California

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory Great Lakes, Illinois

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

HQ Air Force Drug Testing Laboratory Lackland Air Force Base, Texas

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, Hawaii

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Maryland

Period of Performance: 27 February 2020 - 26 February 2021

3 Employees. Two inspections per year.

ESTIMATED

FFP

Armed Forces Medical Examiner Services Dover Air Force Base, Delaware

Period of Performance: 27 February 2020 - 26 February 2021

1 Employee. One inspection per year.

ESTIMATED

FFP

Special Forensic Toxicology Drug Testing Laboratory, Dover, DE

Period of Performance: 27 February 2020 - 26 February 2021

1 Employees. Two inspections per year.

ESTIMATED

FFP

27 February 2020 - 26 February 2021

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED

Lot

COST

27 February 2020 - 26 February 2021

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

Lot

COST

27 February 2020 - 26 February 2021

Exact dates and location of meeting will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

FFP

Navy Drug Screening Laboratory Jacksonville, Florida

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory San Diego, California

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

Navy Drug Screening Laboratory Great Lakes, Illinois

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

HQ Air Force Drug Testing Laboratory Lackland Air Force Base, Texas

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Tripler Army Medical Center, Hawaii

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

Army Forensic Toxicology Drug Testing Laboratory Fort Meade, Maryland

Period of Performance: 27 February 2021 - 26 February 2022

3 Employees. Two inspections per year.

ESTIMATED

FFP

Armed Forces Medical Examiner Services Dover Air Force Base, Delaware

Period of Performance: 27 February 2021 - 26 February 2022

1 Employee. One inspection per year.

ESTIMATED

FFP

Special Forensic Toxicology Drug Testing Laboratory, Dover, DE

Period of Performance: 27 February 2021 - 26 February 2022

1 Employees. Two inspections per year.

ESTIMATED

FFP

27 February 2021 - 26 February 2022

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED

Lot

COST

27 February 2021 - 26 February 2022

Exact dates and location of consultant services will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

Lot

COST

27 February 2021 - 26 February 2022

Exact dates and location of meeting will be provided on individual task orders for up to two individuals for up to three days.

ESTIMATED COST

PWS

Scope of Work

1.1.

The Contractor shall provide forensic toxicology services in support of the Department of Defense (DOD) Joint-Service Biochemical Testing Program. These services shall ensure that the DOD’s biochemical testing program is forensically sound, scientifically supportable, efficient, and cost effective. These services shall include inspection and evaluation of the six Joint-Service Military Drug Testing Laboratories, the Special Forensic Toxicology Drug Testing Laboratory (SFTDTL), and the Armed Forces Medical Examiner System (AFMES) Quality Assurance Laboratory as listed in Section F; attendance to the Annual DOD Joint-Service Laboratory Managers Meeting; and consultant services provided as a part of this contract.

1.2.

Inspection and Evaluation

The Contractor shall inspect, evaluate, and assess for forensic soundness and scientific supportability of all laboratory procedures. The inspections and evaluations of the drug testing laboratories shall be conducted to assess compliance with the following:

· DOD Instruction 1010.01, “Military Drug Abuse Testing Program” (latest revision);

· DOD Instruction 1010.16, “Technical Procedures for the Military Personnel Drug Abuse Testing Program” (latest revision); and

· The inspection policies as outlined in the AFMES Drug Testing Program Quality Assurance (DODQA) SOP .

The contractor shall follow all other applicable Federal Laws. The directive, instruction and SOP locations are specified in Attachment 8. The Government will provide the individual Laboratory Standard Operating Procedures via CD-ROM one (1) week prior to the scheduled inspection for review.

1.3.

Consultant Services

If requested, the Contractor shall provide forensic toxicology consultant services at any of the laboratories and AFMES. Consultant services may involve on site laboratory inspection of specific items of interest or the technical review and professional evaluation of draft policy documents involving technical changes to drug testing procedures and policy. Consultant services may to also include, but are not limited to, consultants to special laboratory incident inspection teams, consultant services regarding new testing, techniques, procedures, drug classes. Consultant services may be performed on-site at one of the seven locations or remotely depending on the specific need. The Contractor will be given seven (7) days’ notice.

1.4.

All expenses associated with travel in order to support contract requirements (e.g., travel to and from sites to perform inspections and evaluations; consultant services; and attendance at the annual DOD Joint-Service Laboratory Meeting) shall be the responsibility of the contractor. Travel associated with inspection and evaluation of the sites, consultant services, and attendance at the annual DOD Joint-Service Laboratory Manager Meeting shall be conducted in accordance with Joint Travel Regulations (JTR) as prescribed by the General Services Administration (http://www.defensetravel.dod.mil/site/travelreg.cfm).

1.5.

The services provided by the Contractor are rendered in the capacity of an independent Contractor. The Government retains no direct control of the Contractor or their employees and how they render services. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Commander/Commanding Officer maintains administrative and operational responsibility for all activities within the command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and DOD Regulations.

1.6.

The Contracting Officer will designate an individual who is authorized to act as the Contracting Officer's Representative (COR). The appointed COR will be specifically designated, in writing, by the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contract modification or adjustment. Changes in the scope of work can only be made by a properly executed modification by the Contracting Officer. All observations made by persons other than the Contracting Officer or the COR are strictly advisory and shall not influence the Contractor's operations except for specified administrative requirements and responsibilities.

1.7.

The services specified in this contract shall be performed in accordance with established principles and ethics of the forensic toxicology profession. The quality of services provided shall meet or exceed the current recognized standards established by applicable Federal laws, by the American Academy of Forensic Sciences (AAFS), American Board of Forensic Toxicologists, Inc. (ABFT), Department of Defense Drug Demand Reduction Program, and those other professional associations that specify standards of performance for forensic toxicology such as the Society of Forensic Toxicologists. The Government may evaluate the quality of both professional and administrative services for purposes of contract inspection and acceptance.

1.8.

Within thirty (30) calendar days of receipt of award, and yearly thereafter, the Contractor shall submit a Quality Control Plan (QCP) to the COR which identifies the procedures that the Contractor shall implement to ensure the successful completion of tasks identified in this Performance Work Statement. The COR, as the technical liaison, shall provide comments and/or questions within ten (10) calendar days of receipt of the Contractor’s QCP. Within ten (10) calendar days of receipt of the COR’s comments, the Contractor shall provide a final QCP to the COR. The Contractor shall implement and modify, as necessary, the procedures specified within the QCP to maintain quality services.

1.9.

All accidents which may arise out of, or in connection with, the performance of services required herein, and which result in injury, death or property damage, shall be reported immediately to the COR within twenty-four (24) hours of occurrence. Verbal reports shall be followed up in writing within twenty-four (24) hours. Statements of witnesses shall be included.

SECTION C- 2

DEFINITIONS

2.1. BUILDING. A permanent structure, with a roof, that is used for a variety of purposes, such as living quarters, offices or manufacturing. Buildings are real property.

2.2. COMMANDER/COMMANDING OFFICER. The senior Officer who is responsible for the operation of the drug-testing laboratory.

2.3. CONTRACTING OFFICER. The Government employee with the authority to enter into; administer; negotiate terms, conditions and/or amounts; and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the Contracting Officer acting within the limits of their authority as delegated by the Contracting Officer.

2.4. CONTRACTING OFFICER’S REPRESENTATIVE (COR). The Government employee responsible for assuring the Contractor’s performance through surveillance and documentation, and provides liaison to the Contracting Officer. The Contracting Officer will designate a COR in writing and authorize the individual to act as the COR. The COR has no authority to resolve disputes or obligate funds. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue change orders, supplemental agreements, or direct any contract performance requiring contractual modifications or adjustment.

2.5. CONTRACTOR. That entity or its representative responsible for the delivery of the services or materials specified in this contract, as designated by contract award.

2.6. CONTRACTOR EMPLOYEE. A person employed by or under contract to the Contractor to provide services under this contract.

2.7. CREDENTIALS. Record of education, clinical experience, medical or professional licenses, professional performance and continuing education that confirms that an individual is professionally competent.

2.8. DAYS. A unit of time that is defined as calendar days unless otherwise stated (e.g., “business days” or “work days”).

2.9. DOCUMENT (verb). To completely, accurately and legibly record information, including on prescribed forms or via a computer terminal, as appropriate.

2.10. EMPLOYEE. See Contractor Employee.

2.11. EQUIPMENT. A moveable object, such as a typewriter, which is used to perform a procedure(s) that results in a work product.

2.12. INDEPENDENT CONTRACTOR. The services provided by the Contractor are rendered in the capacity as an independent, non-personal services Contractor. The Government may evaluate the quality of both professional and administrative services for the purposes of contract inspection and acceptance. The Government retains no direct control of the Contractor or their employees and how they render services. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrument or agency of the United States Government. The Contractor shall recognize that the Commanding Officer of the laboratory maintains administrative and operational responsibility for all activities at the laboratory. This includes taking such actions as necessary to preserve and maintain the integrity of the command, subject to the limitations prescribed by law and DOD regulations.

2.13. KEY PERSONNEL. Experienced contractor professional or technical person who is essential for successful Contractor management.

2.14. QUALITY ASSURANCE (CONTRACT). Government surveillance or monitoring actions to check goods or services to determine if they meet the requirements of the Performance Work Statement.

2.15. QUALITY CONTROL (QC). Actions taken to control the provision of services to ensure they meet the requirements of the contract.

2.16. TRAVEL. For purposes of this contract, travel is defined as all inclusive of transportation, lodging, and per diem costs associated with inspection and evaluation of the sites, consultant services, and attendance at the annual DOD Tri-Service Laboratory Manager Meeting. Salaries are not included in travel.

2.17. VERIFICATION. Confirmation of the authenticity of credentials or professional documents through contact with the issuing agency or an agency that has obtained primary source verification. Verification must be documented.

SECTION C-3

RESERVED

SECTION C-4

CONTRACTOR FURNISHED ITEMS

4.1.

The Contractor shall furnish all personnel required to perform work under this contract, in addition to providing all necessary personal supplies (e.g., office supplies, etc.).

4.2.

The Contractor shall comply with applicable provisions of the Federal Acquisition Regulations (FAR) 52.228-5 included in Section “Clauses Incorporated By Reference.”

4.3.

The Contractor shall comply with the Workers Compensation Insurance Laws of the state in which they are incorporated.

SECTION C-5

GENERAL TASKS

5.1.

Start of Services

The Contractor shall recognize the importance of a successful start-up of contract services and the timely recruitment of qualified personnel in sufficient numbers to meet all contract requirements. The Contractor shall perform all start-up activities required by this section. The Contractor shall provide timely, effective and complete start up of performance of services with a maximum lead time of thirty (30) days.

5.2.

Inspection and Evaluation: Specific Duties

The Contractor shall inspect, evaluate, and provide, to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES, written recommendations on the drug testing laboratories to include, (but not limited to) the following:

a) Specimen receiving

b) Specimen processing and aliquot handling

c) External and internal quality controls

d) Security and safety

e) Information management to include specimen records documentation, maintenance, and storage.

f) Quality Assurance

g) Specimen Screening Procedures

h) Confirmation Testing Procedures

i) Personnel Training

j) Maintenance and calibration records for all laboratory equipment

k) Validation of analytical methodologies utilized to test all specimens

l) Laboratory administration and management

m) Supply procedures and operations

n) Other aspects of laboratory operations that may affect the forensic soundness and scientific supportability of the DOD drug testing program

5.2.1.

Inspection and Evaluation: Frequency and Summary

The six military drug-testing laboratories and the SFTDTL shall be inspected approximately two times a year under the contract. The AFMES Quality Assurance Laboratory will be inspected annually under the contract. For laboratory inspections conducted under the contract, the Inspection Team will consist of a minimum of five (5) inspectors – three (3)shall be provided by the Contractor serving as the Lead and Secondary Inspectors, and the remaining members will be provided by the Government. For inspections conducted at the SFTDTL, the Inspection Team will consist of one (1) inspector provided by the Contractor serving as the Lead inspector. For inspections conducted at AFMES, the Inspection Team will consist of one (1) inspector provided by the Contractor serving as the Lead inspector. The Government will provide a thirty (30) day notification via individual task order prior to the Contractor for laboratory inspections. Attachment 3 provides a sample fiscal year inspection schedule.

5.2.1.1.

The inspection period for the six military drug-testing laboratories will average three consecutive business days and include the inspection process itself and the out brief by the Contractor to the Commanding Officer/Director of the Laboratory. The inspection period for the SFTDTL will average two days and include the inspection process itself and the out brief by the Contractor to the Commanding Officer/Director of the Laboratory. The inspection period for AFMES will average two days and include the inspection process itself and the out brief by the Contractor to the Commanding Officer/Director of the Laboratory. The formal out brief summary will be conducted no earlier than 1600 hours on the final inspection day. A daily discussion of the day’s inspection activities shall be conducted with the Laboratory point of contact to ensure timely communication and discussion of recommendations and/or findings. If the Inspection Team consists of seven (7) or more members, the formal summary out brief may occur no earlier than 1500 hours if all inspection items are completed and the earlier formal out brief is approved by the Senior Government Inspection Team Member.

5.2.2.

Inspection and Evaluation: Quality Assurance Report

The Lead Inspector (contractor) shall provide a written, detailed Quality Assurance Report to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES within fifteen (15) working days after the conclusion of each inspection. The Quality Assurance Report is a detailed report of each inspection including an evaluation of the inspection, and recommendations for improvement on all aspects of laboratory operations in accordance with applicable DOD and laboratory-specific instructions.

5.2.2.1.

The Quality Assurance Report in a narrative format shall include, but is not limited to, the following: general information about the laboratory (e.g., laboratory identifier information); standard operating procedures; security and chain-of-custody issues; personnel qualifications and training; equipment management; specimens and receiving; and general safety information. Additionally, the Quality Assurance Report shall assess compliance with DOD Instruction 1010.01, “Military Drug Abuse Testing Program” (latest revision); DOD Instruction 1010.16, “Technical Procedures for the Military Personnel Drug Abuse Testing Program” (latest revision); and DOD Drug Testing Program Quality Assurance (DODQA) Standard Operating Procedures (SOP). The Contractor shall include in their report suggestions and/or recommendations as well as requirements on findings identified in their inspection. All findings of non-compliance shall include sufficient detail, including examples of observed problems, to support the findings.

5.2.2.2.

The report shall meet the formatting and content standard as established by the Government:

a) have all corresponding tabs correctly labeled and indexed;

b) redact social security number (SSN) or DoD EDI-PI identifiers and privacy protected information contained in any enclosure or attachment to such reports;

c) not identify specific laboratory personnel by name within the inspection findings (identification shall use position titles, e.g. Initial Laboratory Certifying Official (ILCO), etc.); and

d) be a consolidated report that combines the input from all participating Contractor inspection staff as well as the input of other inspection team members during the inspection. The quality of the report shall meet the above mentioned criteria without personal bias.

The report format and content shall include the following sections:

1) Introduction

2) Definitions

3) Executive Summary

4) Findings and Discussion

a) Management/Administration

b) Forensic/Technical

5) Response to Previous Inspection Report

5.2.2.3.

The Government will review and return the Quality Assurance Report to the Contractor within ten (10) business days after the initial receipt of the Quality Assurance Report with recommended changes if the Contractor fails to meet the above mentioned criteria. The Contractor will then have five (5) business days to submit a revised copy with the applicable changes to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES.

5.2.2.4.

The inspection shall be considered complete within ten (10) working days after the final report is received and approved by the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES.

5.2.2.5.

The Contractor shall provide the final report submitted two ways: first, two signed hard copies bound and sent via overnight carrier; and secondly, electronically via email in the Adobe “.PDF” format. The specific email and mailing address will be provided at the time of issuance of each task order.

5.2.3.

Inspection and Evaluation: Out Briefing and Executive Summary

The Contractor shall conduct an out briefing to the Commanding Officer/Director of the Laboratory at the conclusion of each inspection. The Contractor Lead Inspector shall provide a written Executive Summary report to be available on the last inspection day for the out brief that summarizes the inspection’s major findings and/or recommendations. The Executive Summary report shall be incorporated into the Quality Assurance Report as an attachment.

5.3.

Consultant Services: Specific Duties

The Contractor shall provide forensic toxicology consultant services to review and provide written recommendations on the following:

a) Drug testing technologies

b) Policies and procedures of drug testing operations.

c) Other consultant services as required to support and enhance the DOD drug-testing program

5.3.1.

Consultant Services: Frequency and Summary

The COR will provide the Contractor with a written notification at least seven (7) days prior to any requests for consultation services.

5.3.2.

Consultant Services: Report

The Contractor shall provide a written, detailed Consultant Services Report to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES for all consultant services performed to include meetings and seminars in support of this contract within fifteen (15) working days after the conclusion of the consultant services provided. The Contractor shall sign the Consultant Services Report.

5.3.2.1.

The contractor shall provide a written report of findings with recommendations or comments, if required, to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES within fifteen (15) days of the completion of consultative service inspection or receipt of documents for technical review.

5.3.2.2.

The report shall meet the formatting and content standard as established by the Government:

a) have all corresponding tabs correctly labeled and indexed;

b) redact social security number (SSN) or DoD EDI-PI identifiers and privacy protected information contained in any enclosure or attachment to such reports;

c) not identify specific laboratory personnel by name within the inspection findings (identification shall use position titles, e.g. Initial Laboratory Certifying Official (ILCO), etc.); and

d) be a consolidated report that combines the input from all participating Contractor inspection staff as well as the input of other inspection team members provided to the Contractor during the inspection. The quality of the report shall meet the above mentioned criteria without personal bias.

The report format and content shall include the following sections:

1) Introduction

2) Executive Summary

3) Findings and Discussion

a) Management/Administration

b) Forensic/Technical

5.3.2.3.

The Government will review and return the consultant services report to the Contractor within ten (10) business days after the initial receipt of the consultant services report with recommended changes if the Contractor fails to meet the above mentioned criteria. The Contractor will then have five (5) business days to submit a revised copy with the applicable changes to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES.

5.3.2.4.

The consultant services shall be considered complete within ten (10) working days after the final report is received and approved by the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES.

5.3.2.5.

The Contractor shall provide the final report submitted two ways: first, two signed hard copies bound and sent via overnight carrier; and secondly, electronically via e-mail in the Adobe “.PDF” format. The specific email and mailing address will be provided at the time of issuance of each Task Order.

5.4

Annual DOD Joint-Service Laboratory Managers Meeting

a) The contractor shall provide up to two (2) inspectors to attend and participate in discussion items of technical and programmatic interest at the annual DOD Joint-Service Laboratory Managers Meeting. The contractor inspectors are required to present at the Annual DOD Joint-Service meeting on a subject relevant to the DOD Drug Testing Program to include but not limited to drug testing technologies and policies and procedures of drug testing operations. The dates and location of this meeting shall be identified on an individual task order.

5.5.

Correspondence and Contractor Files

5.5.1.

These files shall be made available to the COR upon request. At a minimum, these files shall contain the following:

a) Copies of all correspondence relating to contract operations, and

b) Reports of inspection and/or audits conducted by the Contractor.

5.5.2.

The Contractor shall ensure the confidentiality of all records containing SSN or DoD EDI-PI as personal identifiers copied in the course of normal business in preparation of inspection reports. All SSN or DoD EDI-PI used as personal identifiers shall be redacted in enclosures accompanying laboratory inspection reports.

5.5.3.

All records produced in the performance of this contract are the property of, and subject to the exclusive control of DOD and shall be maintained in accordance with DOD directives and instructions (DOD Directive 1010.01, “Military Drug Abuse Testing Program” (latest revision); DOD Instruction 1010.16, “Technical Procedures for the Military Personnel Drug Abuse Testing Program” (latest revision); and the inspection policies as outlined in the DOD Drug Testing Program Quality Assurance (DODQA) SOP). The Contractor may retain a copy of all such records, but will not provide further copies or disclose the information from such records to third parties. All documents are considered as internal working papers and shall be kept confidential. Requests for copies of laboratory inspection reports/audits will be referred to the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES.

5.6.

Contract Completion

Upon contract completion, the Contractor shall return all existing records or copies of records belonging to the Government. Any documentation containing sensitive information shall also be returned to the Government within sixty (60) days after completion of the contract to the COR.

SECTION C-6

OTHER REQUIREMENTS

6.1

The Contractor shall be available to provide services in accordance with the terms and conditions of this contract as described herein.

6.1.1

The Contractor shall have a sufficient number of qualified personnel (whose credentials have been reviewed and approved to work under this contract by the Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES per Section 8.2) to perform inspections that may be scheduled simultaneously, at different geographical locations. The number of said qualified personnel engaged for inspections under the contract shall be no more than eighteen (18) individuals. After the first round of inspections, during any given twelve (12) month period, at least one (1) of the three (3) inspectors should be involved in the inspection of the laboratory undergoing a current inspection. The Lead Inspector shall coordinate the inspection, conducts out briefs, and writes the Quality Assurance Report. The Secondary Inspectors shall be assigned only from the list of no more than eighteen (18) names proposed under the contract. This is to ensure continuity and familiarity with laboratory specific issues and operating procedures. Inspectors shall adhere to inspection schedule, arrive on time and remain for the entire inspection.

6.1.2.

All replacements shall require prior approval by the Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES prior to participation in any laboratory inspection or service under this solicitation. The contractor shall remove individuals not approved from the inspectors listing.

SECTION C-7

OTHER PROVISIONS

7.1.

Standards of Conduct 7.1.1.

As part of the Quality Control program, the Contractor shall maintain and enforce standards of conduct for contract employees. The Contractor shall take appropriate corrective action in cases of violation of standards of conduct. A report of corrective action taken shall be provided to the COR for concurrence.

7.1.2.

The Contractor shall not employ persons convicted of violations of criminal statutes, felonies, or misdemeanors involving crimes against persons or moral turpitude. At the Contractor’s expense, a background check of prospective employees shall be conducted to ensure compliance with this paragraph.

7.1.3.

The Contractor shall not employ any alien in the performance of the contract in violation of the Immigration Laws of the United States.

7.1.4.

Employees charged or indicted for a felony involving crimes against persons or moral turpitude, or drug related misdemeanors should be removed until the legal process is complete. If the legal proceeding results in a finding of not guilty on the merits of the case, the employee may be allowed to return to work. The COR shall be notified. In all other cases, the employee may be allowed to return only with prior Government approval.

7.1.5.

Unless otherwise specified, all financial, statistical, personnel and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract nor be released by the Contractor without prior written consent of the Commanding Officer via the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from the studies covered by this contract, will be subject to review and approval by the Commanding Officer via the COR before publication or dissemination.

7.1.

Conflict of Interest The Contractor and contract employees shall not use any Government facilities or other Government property in connection with outside employment.

7.2.

Employee Standards

7.2.1.

Contract employees shall maintain a standard of personal hygiene and grooming such that their image as professionals is compatible with the expectations of the professional community.

7.2.2.

Eating, drinking, or smoking by a Contractor employee is permitted only in designated areas. Smoking is strictly prohibited inside DOD (Government) spaces.

7.2.3.

The Contractor shall return any locally required security/visitor pass identification furnished for Contractor employees to the Commander/Commanding Officer or his/her authorized representative immediately when such employees are no longer performing services under this contract.

7.3.

Contractor Payment of Wages, Salaries, Taxes, etc.

The Contractor shall be responsible for payment of all wages and salaries, taxes, withholding payments, penalties, fees, fringe benefits. In addition, the Contractor is also responsible for professional liability insurance premiums, contributions to insurance and pension or other deferred compensation plans including, but not limited to, Workers' Compensation and Social Security obligations, licensing fees, etc., and the filing of all necessary documents, forms and returns pertinent to all of the foregoing. The Contractor shall indemnify and hold the Government harmless from and against all claims by Contractor employees for the payment or filing of any of the foregoing compensation. The Contractor agrees to pay all applicable federal, State, and local income taxes, including any and all other Governmental fees, taxes, or expenses levied against it.

SECTION C-8

Required Staffing Levels and Personnel Qualifications for Inspectors and Consultants

8.1.

General

8.1.1.

The Contractor shall provide personnel having the minimum levels of professional and technical experience required by this Section a minimum of eight (8) and a maximum of eighteen (18) inspectors will be approved under this contract by the COR and Deputy Chief Medical Examiner, Division of Forensic Toxicology, AFMES. Of the inspectors submitted, a minimum of four (4) inspectors shall meet the qualifications for the Lead Inspectors and a minimum of four (4) inspectors shall meet the qualifications for the Secondary Inspectors as stated in Section C-8.2.

8.1.2.

The Contractor shall provide to the COR an original signed statement from each contract employee certifying that the he/she now meets and will continue in the future to meet the personnel qualifications set forth in Section C-8.2.

8.1.3.

The Contractor shall ensure that employees providing services under this contract are able to read, write and speak English fluently, and to enunciate with sufficient clarity, in order to effectively communicate and be understood by all personnel.

8.1.4.

For any subsequent personnel that the contractor intends to utilize to provide services under this contract, the contractor shall submit complete credentials documentation, no later than fifteen (15) days prior to their provision of services, to the COR.

8.2.

Personnel Qualifications

8.2.1.

The specified experience included as part of the required qualifications shall have been obtained in the field of endeavor indicated by the applicable labor categories.

8.2.1.1.

Lead Inspectors shall:

a) Possess a doctorate (Ph.D.) degree in Toxicology, Chemistry, Pharmacology or one of the natural sciences from an accredited college or university;

b) Certificate of Qualification (Board certification) as a Fellow of the American Board of Forensic Toxicology

(F-ABFT);

c) A minimum of having conducted at least three forensic laboratory inspections within the past five years with the latest inspection to have been within the past three years; and

d) Proof of attendance at one professional meeting/seminar/conference (e.g. Society of Forensic Toxicologists, AAFS, etc.) within the previous year, to keep abreast of current issues/trends related to drug testing operations.

8.2.1.2.

Secondary Inspectors shall:

a) Possess at a minimum, a bachelors (B.S.) degree in Toxicology, Chemistry, Pharmacology or one of the natural sciences from an accredited college or university;

b) A minimum of five years’ experience working in a forensic toxicology laboratory;

c) A minimum of having conducted a least one forensic laboratory inspection within the past three years.

8.2.1.3.

Consultants shall:

a) Possess a doctorate (Ph.D.) degree in Toxicology, Chemistry, Pharmacology or one of the natural sciences from an accredited college or university;

b) Certificate of Qualification (Board certification) as a Fellow of the American Board of Forensic Toxicology

(F-ABFT);

c) A minimum of having conducted at least three forensic laboratory inspections within the past five years with the latest inspection to have been within the past three years; and

d) Proof of attendance at one professional meeting/seminar/conference (e.g. Society of Forensic Toxicologists, AAFS, etc.) within the previous year, to keep abreast of current…