B02 Attachment 1 - PWS Final-Feb 2025.docx
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- Attached to
- Veterinary Services Federal contract opportunity
- Solicitation number
- HT942525R0031
- Issued by
- Defense Health Agency
About this file
This is a Performance Work Statement (PWS) for animal husbandry services at Walter Reed Army Institute of Research/Naval Medical Research Center (WRAIR/NMRC) Veterinary Services Program in Silver Spring, MD. The contract requires non-personal services to provide comprehensive animal husbandry, pathology, and veterinary services for various laboratory animals including rodents, rabbits, dogs, small ruminants, pigs, and non-human primates used in medical research.
The contract includes a base period (March 15, 2025 - March 14, 2026) and four one-year option periods through March 14, 2030. Key personnel required include a Project Manager, Building 503 and 511 Animal Facility Managers, Project Administrator, Research Veterinarian, Regulatory Compliance Coordinator, and QA Manager/Trainer. The contractor must maintain AAALAC accreditation standards and comply with all federal regulations governing laboratory animal care. Services will be performed at two connected facilities totaling 115,000 square feet (35,000 sq ft animal holding, 62,000 sq ft support space, 11,000 sq ft laboratory space). Core working hours are 0700-1600 Monday-Friday, with animal care required 7 days per week. The contractor must provide essential services during facility closures and emergencies.
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Performance Work Statement (Includes associated Performance Requirements Summary (PRS)
PERFORMANCE WORK STATEMENT (PWS)
Animal Husbandry Services for Walter Reed Army Institute of Research/Naval Medical Research Center (WRAIR/NMRC), Veterinary Services Program (VSP)
5 May 2024
Part 1 General Information
1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.
1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide animal husbandry, pathology, and associated veterinary services.
1.2 Background: The Walter Reed Army Institute of Research (WRAIR) provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.
Through both times of peace and war, infectious diseases have killed, sickened, and disabled far more Service Members than bombs and bullets. WRAIR has created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance. WRAIR, with its unparalleled expertise, facilities, and international network, has developed many vaccines and drugs in use today by military and civilian medicine around the globe.
In addition to protecting against infectious disease threats, WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. Service Members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance Service Members’ resilience and recovery. Research in military psychiatry and neuroscience has been an integral part of WRAIR's portfolio for more than 70 years. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.
The mission of the Veterinary Services Program (VSP) is to support WRAIR and the Naval Medical Research Center (NMRC) to enable scientific investigation in the creation, development, and delivery of medical capabilities for the warfighter. Various species of animals, including, but not limited to rodents, rabbits, dogs, small ruminants, pigs, and new and old world non-human primates (NHP) are used in a wide variety of experiments and regulatory testing that include microbiological and biohazard procedures. WRAIR/NMRC traditionally conducts scientific investigations in three main areas: (i) biologically active substances, (ii) high energy and trauma, and (iii) stress and performance. The historic emphasis has been researched against naturally occurring infectious agents encountered in military training or operations that depend on the use of laboratory animals. It is essential that the care and use of these animals conform to all applicable rules and regulations and meet acceptable humane standards. Aquatics or other species of animals may be housed from time to time if needed to meet the requirements of the Institute. The historical data and projected estimated quantities of laboratory animals are listed below in Attachment 4.
The WRAIR/NRMC animal facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Maintaining this accreditation without deficiency or comments during inspections and reviews is paramount to total quality performance. Experimental animals for this program must be maintained under carefully controlled conditions to allow the accurate interpretation of research results, and the animal colony must be properly maintained to avoid any situation or condition such as inter-current diseases, animal identification problems, and escaped animals, which might adversely affect experiments or not comply with National Research Council (NRC) Guidelines.
VSP is located within two buildings at the Forest Glenn Annex in Silver Spring, MD. The two facilities are connected and comprise an estimated 115,000 Square Feet of floor space. This estimate can be further divided into 35,000 square feet of animal holding, 62,000 square feet of support space, and 11,000 of laboratory space.
1.3 Scope/Period of Performance:
1.3.1 Scope: The Contractor shall provide non-personal service(s) to support Animal Husbandry and Veterinary services. This shall include personnel, supervision, and other necessary services as described in the Performance Work Statement (PWS) and associated contract documents, except for those items specified in Part 3 Government Property and Services. The Contractor shall perform to the standards and acceptable quality levels identified in this PWS and associated contract documents.
1.3.2 Period of Performance:
The period of performance for this requirement shall be as follows:
| Base Period |
| 15 March 2025 – 14 March 2026 |
| Option Period 1 |
| 15 March 2026 – 14 March 2027 |
| Option Period 2 |
| 15 March 2027 – 14 March 2028 |
| Option Period 3 |
| 15 March 2028 – 14 March 2029 |
| Option Period 4 |
| 15 March 2029 – 14 March 2030 |
1.4 Objectives: The objective of this contract is to provide non-personal, comprehensive services for animal husbandry, management, administrative, surgery, pathology, and veterinary services for VSP, WRAIR/NMRC. All services shall be provided in accordance with (IAW) all federal, state, and local regulations including Occupational Safety and Health Administration (OSHA), Animal Welfare Act, Guide for the Care and Use of Laboratory Animals (8th ed), and US Army/Defense Health Agency (DHA) / WRAIR / NMRC guidelines, policies, and procedures. Services shall be provided to continuously operate and maintain the WRAIR/NMRC VSP facilities and animals to the outstanding levels required by the AAALAC.
1.5 General Information:
1.5.1 Quality Control Plan (QCP):
The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.
The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 10 days after date of contract award (A.001).
The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 30 days. If the Government has provided comments, the Contractor shall then have 30 days to submit a final QCP. After receipt of the final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than 30 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:
(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's quality control team;
(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);
(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;
(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance;
(e) How the Contractor will ensure all keys issued will remain controlled items, if applicable (paragraph 1.7.7 Key Control);
(f) How the Contractor will inventory and track maintenance of all Government provided equipment/materials, if applicable;
(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and
(h) How the Contractor will file and save all quality control related documents for the life of the contract plus five years.
(i) How the Contractor will implement a safety program and safety training. The Contractor shall follow a plan that meets the Army, WRAIR/NMRC, AAALAC, and OSHA safety program standards. The plan will be a part of the Contractor’s Quality Control Plan and also address Material Safety Data Sheet use for required items when introduced to the WRAIR/NMRC facility. The Contractor shall submit a copy of the safety program to the COR for approval prior to performance start. The plan will be updated as changes are made.
1.5.1.1 QA Inspection. The Contractor shall provide a QA inspection at least once monthly. The inspection team leader shall be administered by contract personnel not assigned to the on-site contract. The COR will be provided the finding and corrective actions by the 15th of every month (A.002). The inspection shall include the following:
1.5.1.1.1 Management Involvement: Personnel performing management functions shall have distinct, well-defined, duties and responsibilities within the quality program.
1.5.1.1.2 Contractor QA Function: Ensure that timely and effective corrective actions are obtained for all deficiencies identified by the Program and the Government. The Government will evaluate the Contractor’s performance under this contract. When an observation indicates defective performance, the COR will inform the contract manager, or Contractor’s designated representative, at the site. All deficiency responses shall include identification of the cause of the deficiency to preclude recurrence and an analysis of the quality program’s effectiveness in the area of the deficiency. Develop and maintain a training program designed to ensure all Contractor personnel are clearly aware of the contractual requirements and are current from the time of contract start and remain current on any changes throughout the life of the contract. Inspection, auditing, and testing shall be prescribed by clear, complete, and current instructions. The inspection instructions shall include the specific criteria for approval and rejection of services that shall be used in each inspection or audit. Checklists may be used for this purpose. The Contractor's inspection instructions shall be documented and shall be available for review, online, by the COR, throughout the life of the contract. The Contractor shall notify the on-site COR in writing of any changes to Contractor’s inspection instructions. Conduct special item inspections at the KO, COR, VSP Director, or Institute Commander’s written request. Results of the inspection or audit shall be provided, in writing, to the COR in a timeframe as determined by the COR and contract Program Manager.
1.5.1.1.3 Quality Control (QC): The QC inspection system shall satisfy the requirements in the QASP of the Contract. It shall be designed to keep the Contractor's management informed of all issues affecting quality. The QC records of inspections shall indicate the nature and number of observations made, number and type of deficiencies found, and the nature of corrective action taken as appropriate. Records will be available to the COR online and shall be maintained during the contract life. The COR and/or designated Government representative shall determine the corrective actions for findings requiring additional resources beyond the scope of the Contractor. The Contractor shall recommend SOP changes to the COR and/or section veterinarian for deficiencies that can be corrected through the adjustment of work practices.
1.5.1.2 Annual analysis of quality control and timeliness of submittals (i.e., deliverables) shall be provided to the COR within 30 days upon completion of each option period or task order (A.002)
1.5.1.3 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 48 hours of identifying those issues. Verbal reports shall be followed up by written reports within two days (A.003).
1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract IAW the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed IAW the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).
1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g., deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.
| 1.5.3.1 | U.S. Holidays: Work shall be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the KO. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively. | ||
| New Year’s Day January 1st | M. L. King Memorial Day 3rd Monday in Jan | ||
| Presidents’ Day 3rd Monday in February | Memorial Day last Monday in May |
Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th
1.5.3.2 Host Nation Holidays: Reserved.
1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.
1.5.4.1 Government Facility Office Hours: The Government facility office hours occur between the hours of 0600 and 1800, Monday through Friday, except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.
1.5.4.2 Government Facility Operating Hours: The Government facility operating hours occur between the hours of 0600 and 1800, Monday through Saturday. The Government facility is open for operations during the recognized U.S. Holidays identified in paragraph 1.5.3.1 above. The facility may close due to local or national emergencies or administrative closings
1.5.4.3 Contractor Support Hours: The core working hours for Contractor operations shall be 0700 to 1600, Eastern Time, Monday through Friday. No work shall be performed outside the core working hours without coordination with the COR or designee. Continuous service shall be provided during the core hours based on staggered start times not to exceed a normal 8.5-to-9-hour workday (which must include 0.5 to one hour for lunch) for each contract personnel.
The Contractor shall provide all required services on a full-time basis to meet the contract work quality standards and requirements of the VSP. Caretaker services shall be provided seven days a week.
The Contractor shall designate all on-site animal care personnel and management personnel as "essential employees" and shall require staff to report for duty during periods of inclement and severe weather, or other adverse working conditions, including situations where WRAIR/NMRC facilities have been temporarily closed. Administrative and pathology contract personnel will not be designated as “essential”.
The Contractor shall always maintain an adequate workforce, for the uninterrupted performance of all tasks defined within this PWS. The Contractor shall ensure that the support staff workforce services have stability and maintain continuity to meet performance requirements.
1.5.4.3.1 Contractor Work Plan: The Contractor shall provide an initial organizational chart and by the 8th day of each month thereafter with name, title, and position of each Contractor associated with this contract. The work plan, as a minimum, shall identify regularly scheduled work (to include location, work to be completed, timeline, etc.). The Contractor’s proposed work plan shall be submitted to the KO via the COR for review within ten days after date of contract award. The Government will review and either accept or return their comments to the Contractor within ten days. The Contractor shall then have three days to submit a final work plan. Any proposed change to the accepted final work plan is required to be resubmitted via the COR for review and acceptance by the KO at a minimum 30 days prior to implementation. The timeline noted above shall apply for review and acceptance for proposed changes (A.004).
A fail-safe procedure will be included in the Contractors Quality Control Plan to ensure adequately staffed crews are available every day of the year to provide essential animal husbandry services and non-interrupted animal protocol support (A.001).
1.5.4.3.2 Working During Emergency Situations: Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within 12 hours of activation, and shall be sustainable until the emergency situation is resolved, and normal conditions are restored, or the contract is terminated, whichever comes first. In case of a life-threatening emergency, the COR will immediately contact the contract managers to ascertain the status of any Contractor personnel who were located in Government-controlled space affected by the emergency. When any disruption of normal, daily operations occurs, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:
a. Key points of contact (Government and Contractor)
b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)
c. Means of communication available under the circumstances (e.g. email, webmail, telephone, Teams, etc.)
d. Essential duty personnel for emergency and contingency operations
e. Essential work products expected to continue production by priority
The Contract Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and KO prior to incurring costs over and above those allowed for under the terms of this contract.
The Contractor shall provide essential tasks services on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander for any other reason. Essential tasks include the following:
· timed/scheduled animal dosing and/or treatments
· feeding
· watering
· environmental parameter checks
· daily observations
1.5.5 Unscheduled Days Off: Contract staff will perform normal operations during military personnel unscheduled days off, training holidays, minimal manning days, etc.
1.6 Place of Performance: The work to be performed under this contract will be performed at 503 and 511 Robert Grant Avenue, Silver Spring, MD 20910.
1.7 Security Requirements: The following information is provided on security related matters.
1.7.1 Security Program: Reserved.
1.7.2 Personnel Security Clearance Requirements: Background checks will be required as stated below in section 1.7.4.
1.7.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.
The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.
The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.
1.7.3.1 Installation Pass Log: The Contractor shall provide the KO, via the COR, an initial installation pass log within three days after contract award. The log shall be updated as employees are added or removed. The updated installation pass log shall be current and available at any time upon request by the Government and submitted to the COR within five days after any changes to the log (A.005).
1.7.3.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within five days.
1.7.3.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office within five days.
1.7.3.4 Common Access Cards (CAC) and CAC Log: The Contractor shall provide the following information: last, first and middle names, Government issued personal identifier (e.g. social security number, federal identification number, or tax identification number), date of birth, primary email address (this email address will be used to contact the individual) and any other necessary information required to obtain a CAC or installation access card, to the COR with ten days after award unless circumstances require otherwise and as directed by the KO. The Contractor shall ensure safeguarding of Personally Identifiable Information (PII) and comply with requirements under 1.21.5. The Contractor shall provide a CAC log within 30 days after contract award and within five days after changes have been made (unless circumstances require otherwise and as directed by the KO). The COR will provide format and content for the log during the post award meeting. CACs are Government property, and all CACs must be accounted for (A.006).
1.7.3.4.1 Contractors Requiring a Common Access Card (CAC): Before CAC issuance, the Contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with DHA-AI 5200.04. The Contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of six months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management (A.007).
1.7.4 Access and General Protection/Security Policy and Procedures/ Background Checks: The Contractor and all associated sub-Contractor’s employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Defense Health Headquarters (DHHQ), and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes (A.007).
1.7.4.1 U.S. Citizen: Contractors that work with or teach youth under the age of 18 years are subject to U.S. and host nation background checks. The Requiring Activity Manager will determine the extent of background checks required. The Contractor employee may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace the employee should results of the background check, if required, be unfavorable as determined by the Requiring Activity Manager. The Contractor’s replacement of the employee with the unfavorable background check shall be within a timeframe provided by the Requiring Activity Manager. The Contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the Requiring Activity Manager. The Contractor shall forward a copy to the KO via the COR and the Requiring Activity Manager of each favorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number. The Contractor shall forward a copy to the KO via the COR and the Requiring Activity Manager of each unfavorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number. When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination (A.007).
1.7.4.2 Local Nationals and Third Country Nationals: Reserved.
1.7.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program, Army Regulation (AR) 190-13 and the DHA Physical Security Program, DHA-AI 5210.01.
1.7.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions in accordance with AR 530-1. The Contractor shall immediately report suspicious activities to security personnel. Government issued access
1.7.7 Key Control: The Contractor shall establish and implement methods of making sure all keys issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be IAW WRAIR policies to ensure satisfactory Department of the Army Inspector General (DAIG) inspections. These procedures shall be included in the Contractor’s security plan and the quality control plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any incidents of lost or duplicate keys to the KO/COR. In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the KO/COR, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from payment due to the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the payment due to the Contractor. The Contractor shall prohibit the use of Government issued keys by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the KO/COR. The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the QCP (A.001).
1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office IAW FAR Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically at least quarterly with the Contractor to review the Contractor's performance. At these meetings the KO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.
The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.
1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the KO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the KO. The designation letter states the responsibilities and limitations of the COR, especially regarding 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. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. 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, specifications, monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.
1.10 Personnel Requirements
1.10.1 Key Personnel: The following personnel are considered key personnel by the Government:
· Project Manager (PM)/Contract Manager
· Building 503 Animal Facility Manager (FM)
· Building 511 Animal Facility Manager
· Project Administrator (PA)
· Research Veterinarian (RV)
· Regulatory Compliance Coordinator (RCC)
· QA Manager/Trainer
Substitutions of proposed key personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement key personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of key personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of key personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced within 30 days (A.008).
1.10.1.1 Project/Contract Manager. The Contractor shall provide a Project/Contract Manager who shall be responsible for the performance of the work. The name of this person and an Alternate Project/Contract Manager, who shall act for the Contractor when the Project/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the KO no later than five days after contract award. Acceptance of the CV by the KO is required before these individuals are permitted to perform any task on this contract. The Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract (A.008).
The Project/Contract Manager shall be the central point of contact for the COR and KO on this contract. The Project/Contract Manager or designated alternate shall be available during normal Monday-Friday operating hours, (7:00 AM - 3:30 PM / 1/2-hour lunch, or 7:00 AM – 4:00 PM / one hour lunch) within one hour, to meet on post with the Contracting Officer, COR, or a designated representative, to discuss problem areas.
At all other times when Contractor personnel are performing services under the contract, a contract person in an assigned manager position must be on- site. This person must have authority to act on behalf of the Contractor.
The PM shall provide/perform the following:
· On-site supervision to ensure that all functions of the contract are carried out in an efficient, professional manner, and shall assure that the policies and procedures for the WRAIR/NMRC are followed.
· Monthly progress reports and other related reports. Knowledge of Microsoft Office software and database systems is necessary.
· Direct the implementation and maintenance of the QC/QA program with the assistance of the contract managers. The PM shall have knowledge of Federal Regulations governing animal husbandry. The PM shall implement the Contractors quality program in accordance with the approved quality control plan. Added duties include ensuring that timely and effective corrective actions are obtained for all deficiencies identified. The plan will require all Contractor personnel to be involved in the quality control process. PM shall establish, implement and maintain the quality control program to assure that requirements of the contract are met as specified (e.g., timeliness, accuracy, appearance, completeness, consistency, and conformity to standards, guidelines, specifications and SOPs).
· Develop and maintain both a Training and Occupational Health and Safety (OHS) program designed to ensure all Contractor personnel are clearly aware of the contractual requirements and are current from the time of contract start and remain current on any animal husbandry and OHS changes and updates throughout the life of the contract.
· Minimum Requirements: Bachelor of Science/Bachelor of Arts (BS/BA) desired, required to be Certified Manager Animal Resources (CMAR) and AALAS certified at the Laboratory Animal Technologist Level (LATg) with eight years of supervisory experience in an animal research facility of similar size and scope.
1.10.1.2 Building 503 Animal Facility Manager: The Contractor shall provide a FM to oversee the management and husbandry services for the WRAIR/NMRC animal care facilities. The Facility Manager shall have oversight of the building 503 vivarium and provide daily direction of husbandry and cage wash duties through the caretaker and cage wash leads.
The FM shall provide/perform the following:
· Work directly with VSP customers to ensure vivarium operations are conducted efficiently and with minimum research interruptions.
· Ensure the daily duties of the animal husbandry staff are performed.
· Coordinate all vivarium activities; provide animal care and technical support, as needed; provide assistance to the Project Manager as required; document and initiate repair requests on an as-needed basis; provide professional interaction with the customer and fellow staff and emphasizes team building; review Standard Operating Procedures (SOPs) as requested; brings discrepancies between operations and SOPs to management’s attention and revises as needed; ensures appropriate adherence to all customer SOPs and other technical/administrative directives.
· Provide SOP training and reviews current SOPs for functionality; attend customer meetings as requested; assist in the training program for employees to ensure AALAS certifications are obtained in a timely manner; and perform routine inspections of areas of responsibility to ensure compliance with all applicable guidelines.
· Minimum requirements: BS/BA and CMAR desired; and required to be AALAS certified at the LATG level with a minimum of five years of supervisory experience in an animal facility of similar size and scope.
1.10.1.3 Building 511 Animal Facility Manager: The Contractor shall provide a FM to oversee the management and husbandry services for the WRAIR/NMRC animal care facilities for building 511 meeting the same requirements specified section 1.10.1.2 above.
1.10.1.4 Project Administrator: The Contractor shall provide a Project Administrator (PA) to provide administrative support to the contract as well as manage the ordering, receipt, and processing of logistical supplies.
The PA shall provide/perform the following:
· Assist employees with in-processing and out-processing procedures specific to the WRAIR/NMRC contract site; schedule all employees for annual physicals and twice a year Tb testing; file records and documents related to the operation and maintenance of a research animal facility; prepare and submit written reports, records, charts, logs and inventories as requested by your supervisor; order Contractor purchased supplies of feed, bedding, and supply orders to the client representative.
· Manage the receipt of animals, prepare documentation and process animal receiving information.
· Collect and process per diem billing for submission to investigator for payment.
· Interface with VSP purchasing agents and ensure documentation is received and forwarded to the Resources and Operations Branch.
· Collect and file facility documentation for immediate retrieval as requested.
· In the absence of the Project Manager, the PA possesses knowledge and experience to provide management over site of the contract.
· It is desired that the PA have at least three years of experience preparing per diem billing, ordering facility supplies and equipment, and maintaining facility documentation.
· Minimum Requirements: Required AALAS certified at the LAT level, desires three years of experience working in an animal research facility; working knowledge of Microsoft programs and other general office equipment; knowledge of ordering feed, bedding, animal supplies and equipment; knowledge of calculating per diem billing.
1.10.1.5 Research Veterinarian: The Contractor shall provide a Research Veterinarian (RV) to work collaboratively with the research investigators and staff, facility personnel, the Institutional Animal Care and Use Committee (IACUC), and others to maintain a quality program.
The RV shall provide/perform the following:
· Direct and ensure compliance with all regulations governing care, husbandry, health, and welfare components to maintain AAALAC International accreditation.
· Responsible as the direct line and program authority and responsibility for the welfare and well-being of all animals approved for use through the IACUC.
· Provide veterinary care for animals approved for use by the IACUC; participate in IACUC activities including post-approval compliance monitoring, teaching, and training of residents and WRAIR/NMRC research staff; provide periodic training to investigators and their research personnel; develop, update, and maintain use and care standards operating procedures according to The Guide for Care and Use of Laboratory Animals; interact with, and advise investigators regarding animal model selection, proposed procedures, animal procurement, coordinate housing/husbandry; manages a program of disease detection and surveillance, prevention, diagnosis, treatment, and resolution; advise and oversee the surgical and post-surgical care; advise and provide oversight on animal handling, restraint, use of analgesics and tranquilizers and methods of euthanasia in accord with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals; advise on the occupational health safety program including monitoring for zoonotic diseases; advise and monitor biohazard control policies and procedures relevant to the animal care and use program; assist government veterinary staff with the management of the off-site nonhuman primate colony; provide on-call availability for consultations for emergencies via telephone; share "on-call" responsibilities with Veterinary Corps Officers on weekends and holidays; serves on the IACUC and other committees, as appropriate; conduct pre-review of protocols prior to IACUC submission; provides assistance to government veterinary staff
· Minimum Requirements: Required Doctor of Veterinary Medicine (DVM), American College of Laboratory: Animal Medicine (ACLAM) Certified, USDA level II accreditation. Desires five years of experience with overseeing a pre-clinical research laboratory in a supervisory or management role.
1.10.1.6 Regulatory Compliance Coordinator: The Contractor shall provide a Regulatory Compliance Coordinator (RCC) that shall have detailed knowledge of federal regulations and policies related to use of animals in research. The RCC shall be the principal liaison between VSP, the IACUC, and the Animal Research Compliance Office (ARCO) and shall support operations of those components.
The RCC shall provide/perform the following:
· Collect, store, and distribute regulatory documentation required by DoD regulation and local SOPs; process work using word processor; working knowledge of database and spreadsheet operations and file management; wear and use appropriate personal protective equipment; work independently, according to deadlines; have strong interpersonal skills, frequent interaction with high level faculty members and staff; have a high degree of attention to detail and excellent organizational skills; have strong verbal and written communication skills and good customer service skills.
· Consolidate and maintain all documentation associated with vivarium activities, assist the VSP in preparing for compliance inspections and site visits; oversee management of SOPs, including working with authors to appropriately revise and format SOPs, working with Safety to ensure appropriate risk assessments are completed, and ensuring that SOPs are revised on an appropriate review cycle; maintaining databases; preparing and distributing reports on compliance activities.
· Minimum Requirements: Required AALAS certified at the LATg level. BS/BA with three years of experience in an animal facility of similar size and scope is desired. Education and experience may be substituted for certification with COR approval.
1.10.1.7 QA Manager/Trainer: The Contractor shall provide a Quality Assurance Manager/Trainer to generate plans to enhance the learning abilities and performance of the staff working on laboratory animals.
The QA Manager/Trainer shall provide/perform the following:
· Strong verbal communication, teaching skills and be knowledgeable of veterinary medical terminology and animal facility operations and understand and follow appropriate regulatory guidelines, SOPs, policies, safety procedures, and quality assurance standards.
· Develop staff training curriculum to consist of hands-on demonstrations, instructional classroom, or a combination of these.
· Ensure each employee is trained/proficient in such a way that the work is accomplished in accordance with SOPs and facility policies and perform employee assessments to verify proficiency in technical tasks; prepare, review, and maintain required training forms, employee training folders, and training database in accordance with requirements.
· Work with the ARCO to ensure that IACUC requirements are met for training and documentation and work with management to identify and prioritize topics for staff training.
· Assist with contract research study execution with husbandry and technical procedures as needed.
· Develop and conduct Quality Control schedules and inspections; generate QA/QC reports based on findings and evaluate corrective actions; monitor performance over time, perform remedial trainings as necessary based on results; assist with AAALAC International site visits and other inspections; oversee and schedule occupational health appointments for new hires and annual physicals; maintain appropriate documentation of results; assist with VSP QA or training needs, such as SOP or policy writing; use computer-based programs, and database management to comply with company and program requirements; perform other duties as assigned by management.
· Minimum Requirements: BS/BA is desired; required to be AALAS certified at the LATg level with a minimum of three years of experience in an animal facility of similar size and scope and one year of training experience.
1.10.2 AALAS Certification Requirements: All personnel shall possess the level of education, experience, licensing, and certification required for the position. Personnel in non-key position may be placed on the contract at one level below the certification required for no more than one year from the date of hire. AALAS Certification levels from lowest to highest are: 1. Assistant Laboratory Animal Technician (ALAT); 2, Laboratory Animal Technician (LAT); 3. LATg. Personnel in positions that require ALAT at the time of hire may be placed on the contract with no certification for the first year of employment.
1.10.3 Personnel Appearance and Uniforms: Contractor personnel shall wear uniforms, safety shoes, scrubs, or protective equipment at all times during work hours. Uniforms shall be worn by animal technicians, animal husbandry staff, and cage wash personnel in the performance of their duties. Uniforms may also be worn by other contract personnel as required by Project Manager. The uniforms must be changed if personnel leave the facility area for any reason. Civilian clothing worn on the WRAIR campus shall be in compliance with WRAIR policy.
1.10.4 Personnel Conduct. Contractor personnel shall work in a professional and courteous manner, present a neat appearance, and abide by applicable WRAIR/NMRC rules, regulations, and procedures while working at WRAIR/NMRC facilities. Contractor personnel shall observe and comply with the rules and regulations prescribed by the Installation Commander concerning fire, safety, sanitation, security, vehicle operation, and possession of drugs, firearms or other lethal weapons, when on the installation. Contractor personnel shall be subject to such checks as may be deemed necessary to ensure that no violations occur. Contractor employees shall perform all contract duties in a professional and timely manner. The Contractor shall remove from duty any employee who is under the influence of alcohol, drugs, or other incapacitating agent. The Contractor shall not employ, or continue employment, of persons for work on this contract if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population.
1.10.5 Medical Examinations. The Contractor shall not knowingly employ any person who is identified as a potential threat to the health, or general well-being of the animals housed in the facility, or the research occurring in the facility. The Contractor shall provide baseline physical exams for its personnel, and the Contractor shall verify in writing to the COR that personnel have received a baseline physical examination and are medically fit for work prior to reporting to work.
Thereafter an annual Occupational Health evaluation to meet the WRAIR/NMRC requirements will be performed for each employee (A.009). The Contractor must have an Occupational Health Program that includes an Occupational Health Provider familiar with animal husbandry.
The baseline physical examination to be provided by the Contractor (or designated subcontractor) shall include, but not be limited to the following procedures:
· Medical history review.
· Screening for allergies to fur, animals, and latex.
· Vital signs (blood pressure, temperature and pulse).
· All employees must be enrolled in a Hearing and Respiratory Protection Program.
· Negative urine drug screen
· TB test / screen, within the last year, and every year thereafter. If positive, a chest x-ray will be performed initially and every five years thereafter as well as an annual questionnaire and certification from the occupational health provider that the TB is…
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