Performance_Work_Statement.docx

1. GENERAL: This is a non-personal services contract to provide in vivo animal toxicology testing to the Army Public Health Center (Provisional) (APHC(Prov)) at Aberdeen Proving Ground (APG) in Edgewood, Maryland. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform animal toxicology testing as defined in this Performance Work Statement (PWS), section 5 except for those items specified as government material. The Contractor shall perform to the standards in this contract.

1.2 Background: In order to protect Soldier and civilian health, Army and Department of Defense (DoD) regulations require a determination that new materials introduced into the Army inventory be evaluated for their impact on human health and the environment (ESOH). This mission has been tasked to the APHC (Prov). Certain toxicology test procedures required as part of this ESOH evaluation cannot currently be performed by the Toxicology Directorate, APHC (Prov).

1.3 Objective: The objective of this contract is to develop information in support of the toxicological evaluation of new items of Army material, to include the effects of exposures commonly experienced by workers involved in the manufacturing or use of these new items of material, in order to determine the appropriate requirements for personal protection from hazardous effects of these new materials.

1.4 Scope: The projected level of effort is one test of each type during a fiscal year.

1.4.1 Testing will be performed in accordance with the U.S. Environmental Protection Agency (EPA) experimental protocols identified in Table 1.

Table 1. Applicable EPA test protocols.

Notes: *Referenced procedures can be obtained from the EPA website http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-870-health-effects-test-guidelines.

1.4.2 Samples: Samples for testing will be provided by the Government. Samples will be either liquid or solid substances, contained in small sample vials (approximately 15 mL volume). The amount of material provided will be sufficient to accomplish the desired testing. The contractor must maintain a record of the quantity of sample test material used in each test, and provide this information to the Contracting Officer Representative (COR) in the Monthly Status Report (Deliverable 3). Any excess sample remaining at the conclusion of testing should be returned to APHC (Prov) using appropriate shipping procedures as required by the U.S. Department of Transportation.

1.5 Period of Performance (POP): The POP is twelve months from 30 September 2016 through 29 September 2017.

1.6. General Information

1.6.1 Place of Performance: The work to be performed under this contract will be performed at the contractor’s facility.

1.6.2 Explosive and energetic materials: Many of the samples to be tested under this contract are categorized as explosive or energetic materials. The contractor must be certified to receive, handle, and store appropriate quantities of these materials in order to conduct testing.

1.6.3 Good Laboratory Practice (GLP) Standard regulatory compliance:

The APHC (Prov) Director's Policy Notice 070-2 states that “all experiments and studies conducted by any element of the Toxicology Directorate will be compliant with the applicable Good Laboratory Practices (GLPs).” Therefore, all activities conducted through this PWS must be GLP compliant. Prior to contract award, assurance must be obtained to confirm the contractor will do work in accordance with GLPs. To that end, the contractor shall permit authorized employees or duly designated representatives of the APHC (Prov) Contracting Officer’s Representative (COR) and Quality Assurance offices to inspect the contractor’s facility and all records required to be maintained at the contractor’s facility to be in compliance with applicable GLP regulations pertaining to this PWS. The contractor will maintain his/her laboratory in compliance with all generally recognized standards of GLP and can be subject to an audit at any time with minimum notice by the government. Written copies of applicable contractor Standing Operating Procedures (SOPs), when requested, will immediately be furnished for all work being performed for the government without additional costs. Prior submission of documentation may be requested before the contract is awarded.

A Standing Operating Procedure (SOP) with all GLP requirements will be developed by the contractor and must be followed. The SOP clearly specifies the role and responsibilities of all parties, the contents of the final deliverable and the retention of all data requirements.

1.6.4 Quality Assurance: The contractor shall comply with the government’s quality assurance program as defined in the Quality Assurance Surveillance Plan (QASP). It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable quality level(s) (AQL). Government surveillance of contractor performance is not limited to the Performance Objectives as outlined in this PWS. The Government reserves the right to conduct compliance surveillance of any contractual requirement of this acquisition.

1.6.5 Animal care, husbandry, and welfare:

(a) Testing involving animals must comply with DOD Instruction 3216.01, “Use of Animals in DOD Programs”, 13 Sep 2010; Army Regulation 40-33, The Care and Use of Laboratory Animals in DOD Programs, 16 Feb 2005; and follow the guidelines in the National Research Council’s “Guide for the Care and Use of Laboratory Animals”, 2011 (http://www.nap.edu/catalog.php?record_id=12910#toc). The DODI mandates on-site inspections of the contractor facility by a DOD veterinarian within 30 days of delivery of animals.

(b) The contractor shall also comply with the following requirement taken directly from DFARS clause 252.235-7002, Animal Welfare. “The Contractor shall register its research, development, test, and evaluation or training facility with the Secretary of Agriculture in accordance with 7 U.S.C. 2136 and 9 CFR subpart C, and section 2.30, unless otherwise exempt from this requirement by meeting the conditions in 7 U.S.C. 2136 and 9 CFR parts 1 through 4 for the duration of the activity. “The Contractor shall have its proposed animal use approved in accordance with Department of Defense Instruction (DoDI) 3216.01, Use of Animals in DoD Programs, by a DoD Component Headquarters Oversight Office. The Contractor shall furnish evidence of such registration and approval to the Contracting Officer before beginning work under this contract.

(c) The Contractor shall make its animals, and all premises, facilities, vehicles, equipment, and records that support animal care available during business hours and at other times mutually agreeable to the Contractor and the United States Department of Agriculture Office of Animal and Plant Health Inspection Service (USDA/APHIS) representative, personnel representing the DoD component oversight offices, as well as the Contracting Officer, to ascertain that the Contractor is compliant with 7 U.S.C. 2131-2159 and 9 CFR parts 1 through 4.

(d) The Contractor shall acquire animals in accordance with DoDI 3216.01, current at time of award (http://www.dtic.mil/whs/directives/corres/pdf/321601p.pdf).

(e) The Contractor agrees that the care and use of animals will conform with the pertinent laws of the United States, regulations of the Department of Agriculture, and policies and procedures of the Department of Defense (see 7 U.S.C. 2131 et seq., and 9 CFR subchapter A, parts 1 through 4, DoDI 3216.01, Army Regulation 40-33/SECNAVINST 3900.38C/AFMAN 40-401(I)/DARPAINST 18/USUHSINST 3203). The Contractor shall also comply with DoDI 1322.24, Medical Readiness Training, if this contract includes acquisition of training.

(f) The Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract for failure to comply with the requirements of paragraphs (a) through (c) of this clause.

(1) The suspension will stay in effect until the Contractor complies with the requirements.

(2) Failure to complete corrective action within the time specified by the Contracting Officer may result in termination of this contract and, if applicable, removal of the Contractor's name from the approved vendor list for live animals used in medical training.

(g) The Contractor may request registration of its facility by contacting USDA/APHIS/AC, 4700 River Road, Unit 84, Riverdale, MD 20737-1234, or via the APHIS Animal Care Web site at: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare.

(h) The Contractor shall include the substance of this clause, including this paragraph (f), in all subcontracts involving research, development, test, and evaluation or training that use live vertebrate animals.”

(i) Prior to beginning work, the contractor Institutional Animal Care and Use Committee (IACUC)-approved animal use protocol for the study will be furnished to the APHC (Prov) IACUC for review and forwarding to the Animal Care and Use Review Office (ACURO) at USAMRMC (U.S. Army Medical Research and Materiel Command). ACURO approval is required prior to beginning any animal work. The animal protocol shall provide all pertinent information contained in the DOD Standard Animal Use Protocol Format. The customer will provide the protocol format template to the vendor upon award of contract.

(j) The Institutional Official (IO) (or equivalent) of the performing organization will sign a written Memorandum of Agreement (MOA) between the APHC (Prov) and the performing organization. The MOA will address and state the responsibilities for animal care and use, ownership of the animals, and that the performing organization’s IACUC will review the protocol and provide post-approval contract monitoring compliance

1.6.6. Type of Contract: The Government will award a fixed-fixed-price contract.

1.6.7. Security Requirements: Contractor personnel performing work under this contract are not required to possess a security clearance.

1.6.8 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. Kick-off meetings will be planned for the beginning of each group of tests to be performed. The KO and COR may meet periodically with the contractor to review the contractor's performance if deemed necessary. At these meetings the KO will apprise the Contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

1.6.9. Contracting Officer’s Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: Assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, and specifications; monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.10. Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.11. The USAMRMC has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating Organizational Conflicts of Interest (OCI) in accordance with In Accordance With (IAW) FAR Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist USAMRMC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

1.6.11.1 OCI Certification (Deliverable 2). USAMRMC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the APHC (Prov) organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of proposal submission.

1.6.12. Antiterrorism (AT) and Operations Security (OPSEC)

1.6.12.1 Access and General Protection/Security Policy and Procedures: In the event that access to the installation is required, contractor employees shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures. Contractor personnel requiring casual access to the installation will be required to enter the installation via the main gate, and will be required to provide identification information for all individuals in the party, as well as registration information for any associated vehicles.

2. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by FAR Part 37 and to ensure there is not an appearance of such this contract will have an identified COR. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer (KO) immediately.

2.1. Business Relations

2.1.1. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timelines, completeness, and quality of problem identification. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel. The Contracting Officer’s Representative (COR), with the approval of the KO, may require the contractor to remove from the job site any employee working under the influence of alcohol, drugs, or other incapacitating agents. Contract employees will be subject to dismissal from the premises upon determination by the COR and the KO that such action is in the best interest of the Government.

2.2. Contract Management and Administration

2.2.1. Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations at stated on-site and the contractor’s corporate offices. No off-site work is authorized.

2.2.1.1. Contract Management Activities.

a. Government Management of the Contract. The KO will officially designate a Contracting Officer’s Representative (COR) to oversee this Contract. The Government’s COR will have responsibility for:

(1) Ensuring that the Surveillance Plan is developed and executed by the COR and any other involved USAISR representative who may have responsibilities monitoring and managing the contract.

(2) Providing advice and assistance in resolving any performance issues that may arise during the life of the order.

(3) Initiating and coordinating global contract changes such as changes in the paying office.

(4) Conducting other activities as specified in their appointment memorandum.

(5) Elevating to the KO any problems that cannot be addressed by the COR.

(6) COR does not have the 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.

(7) The COR DOES NOT have the authority to change the terms and conditions of the contract.

b. Contractor Management of the Contract. The contractor shall designate a single program manager to oversee the contract. The Contractor’s designated program manager shall serve as the single point of contact for addressing contract issues, quality issues, and overall contractor performance. This may include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract or proposed changes or modifications to the contract. Contract management activities may include:

(1) Non-Disclosure Statement . The Contractor shall sign the Non-Disclosure Statement and ensure that all staff including all employees, subcontractors, and consultants assigned to or performing under the contract, execute, sign, and adhere to the terms of the Non-Disclosure Statement. The Contractor and Employee shall also execute a Non-Disclosure Agreement during in-processing to the USAISR.

2.2.2. Contract Administration.

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support the contract. The contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement. The Contract Administration Team will consist of the following members:

2.2.2.1 The KO will have overall responsibility for administering the contract. The KO is the only person authorized to obligate the Government and make changes to the contract. The KO will manage contract administration and ensure COR responsibilities are being performed.

2.2.2.2. The COR will be appointed in writing and will be directly responsible to the KO. The COR serves as the Government’s point of contact for contract-level coordination of administration and technical performance matters. The COR will assist in resolving performance issues; initiate and coordinate contract-level changes; notify the KO of any disputes, performance issues, or contractual issues that cannot be resolved at the COR level; and conduct other activities as specified by appointment.

2.2.2.3. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contract for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; complete Contractor Manpower Reporting (CMR); conduct surveillance by uploading a monthly report in the Contracting Officer Representative Tracking (CORT) tool; and conduct other activities as may be specified by the COR appointment letter.

2.2.2.4. The Contractor’s Program Manager is the point of contact with the COR. This position is responsible for the overall management of the contract. Responsible for formulating and enforcing work standards, assigning contractor schedules, reviewing work quality.

3.0. Performance Requirements.

3.1. Objective: The Contractor shall provide services for toxicology testing of submitted samples. See Table 2.

3.1.1. Key Task 1: Perform Dermal Toxicity test: In accordance with EPA Protocol OPPTS 870.1200.

3.1.2. Key Task 2: Perform Ocular Irritation/Corrosion test: In accordance with EPA Protocol OPPTS 870.2400.

3.1.3. Key Task 3: Perform Dermal Irritation/Corrosion test: In accordance with EPA Protocol OPPTS 870.2500.

3.1.4. Key Task 4: Perform Dermal Sensitization test: In accordance with EPA Protocol OPPTS 870.2600.

Table 2.

3.2. Contractor Manpower Reporting (Deliverable 1)

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2015. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

3.3. Monthly Report. The contractor shall also provide monthly reports as to the status of testing to the COR via email. These monthly reports shall include the status of each task, noting any problems and the corrective actions taken.

3.4. Final Report. The contractor shall produce a final report for each protocol detailing the conduct of the experiment, all raw data collected during the testing, and the final results. One electronic and two hard copies of the final report will be provided to the contract COR.

4. Supplies, Equipment and Facilities.

4.1. Government Furnished Supplies/Equipment/Facilities

4.1.1 Services: Not applicable.

4.1.2. Facilities: Not applicable.

4.1.3. Utilities: Not applicable.

4.1.4. Equipment: Not applicable

4.1.5. Materials: The Government will provide test samples as outlined in the PWS paragraph 1.4.2.

4.2 Contractor Furnished Material and Equipment.

The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are provided by the Government in section 4.1.

4.2.1. Materials, Facility and Equipment: The Contractor shall furnish all equipment and supplies, including consumables, necessary to meet the requirements under this PWS.

5. Government Requirements/Support.

5.1. Deliverables/Delivery Schedule:

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1 The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures. Any Contractor provided publications are to be procured and maintained at Contractor’s expense.

6.1.1 Good Laboratory Practice regulations: EPA: 40 CFR parts 160 and 792, FDA:21 CFR 58.

6.1.2 OPPTS 870.1200 Acute Dermal Toxicity Testing. Available at URL: https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic

6.1.3 OPPTS 870.2400 Acute Eye Irritation. Available at URL: https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic

6.1.4 OPPTS 870.2500. Acute Dermal Irritation. Available at URL: https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic

6.1.5 OPPTS 870.2600 Skin Sensitization. Available at URL: https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic

6.1.6 DOD Instruction 3216.01, “Use of Animals in DOD Programs”, 13 Sep 2010.

6.1.7 Army Regulation 40-33, The Care and Use of Laboratory Animals in DOD Programs, 16 Feb 2005

6.1.8 National Research Council “Guide for the Care and Use of Laboratory Animals”, 2011 (http://www.nap.edu/catalog.php?record_id=12910#toc).