Amendment 0001 to W81XWH21R0017.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to adjust the Performance Work Statement, Section 2 General Requirement, paragraph 2.1.2 – chart POP End Dates to reflect:

Base Year: 01 April 2021 – 31 March 22 Option Year 1: 01 April 2022 – 31 March 23 Option Year 2: 01 April 2023 – 31 March 24 Option Year 3: 01 April 2024 – 31 March 25 Option Year 4: 01 April 2025 – 31 March 26

52.217-8 Option 01 April 2026 – 30 Sept 2026

All other infomation remains the same.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 34

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 09-Mar-2021

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH21R0017

X 9B. DATED (SEE ITEM 11)

16-Feb-2021

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

09-Mar-2021

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH21R0017

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

PREVENTATIVE MAINTENANCE AND REPAIR OF USAMRIID STERILIZATION AND

CENTRAL VACUUM EQUIPMENT IN BIOSAFETY LABS (BSL 1, 2, 3 AND 4)

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

SECTION 1 PURPOSE

1.1. Introduction:

The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) is located in Fort Detrick, MD. Since 1969, USAMRIID has served as the Department of Defense’s (DoD) lead laboratory for medical biological defense research.

1.2. Mission:

While our core mission is to protect the warfighter from biological threats, we also investigate disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions – therapeutics, vaccines, diagnostics, and information – that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Futures Command.

1.3.Background:

The ability to readily obtain (1) repair of economically repairable service and (2) and provide for maintenance and technical support services for sterilization and central vacuum equipment is necessary in order for the USAMRIID to effectively achieve its mission. This PWS will satisfy the USAMRIID requirement for the repair, maintenance, and service of sterilization and central vacuum equipment.

1.4.Scope:

1.4.1. Repair of Repairables. The Contractor shall provide all labor, services, equipment, tools, facilities, technical data, and parts and material to accomplish overhaul and repair of sterilization and central vacuum equipment, assemblies and components.

1.4.2. Maintenance and Technical Support Services. The Contractor shall provide all necessary trained, experienced personnel, labor, tools, diagnostic equipment and software, materiel, supplies, transportation and shipping throughout the United States, parts, and equipment necessary to perform corrective service, repairs and Preventive Maintenance Checks and Services (PMCS), Calibration, and Electrical Safety testing . Services performed on-site, at USAMRIID, shall be conducted during normal core operating hours(0600-1800), Monday through Friday.

1.5.Organizational Conflict of Interest:

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

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

1.5.3. Organizational Conflict of Interest Requirements:

1.5.3.1. The Federal Acquisition Regulation (FAR) 9.5 (Organizational and Consultant Conflicts of Interest) prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements Section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses –

1.5.3.1.1. Proprietary information that was obtained from a Government official without proper authorization; or

1.5.3.1.2. Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

1.5.3.2. The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

1.5.3.2.1. It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

1.5.3.2.2. Contractors shall sign a Non-Disclosure Agreement (Deliverable 2) at the start of their performance on the contract.

1.5.3.2.3. If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

1.5.3.2.4. If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

1.5.3.2.5. If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service, unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

1.5.3.2.6. If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services, unless proper safeguards are established to ensure objectivity.

1.5.3.2.7. If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

1.5.3.3. The Contracting Officer has significant discretion as to the acceptability of any Mitigation Plan (Deliverable 1) offered.

1.5.3.3.1. Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a Mitigation Plan (Deliverable 1) at the Contract level and update it as often as necessary throughout the life of the Contract.

1.5.3.3.2. The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan (Deliverable 1), in accordance with the requirements of FAR Subpart 9.5 to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan (Deliverable 1) adequately protects the interests of the Government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or Avoidance/Mitigation Plan (Deliverable 1), or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

1.5.3.3.3. If the Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI (Deliverable 1) status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI (Deliverable 1) status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

1.5.3.4. For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

1.5.3.5. Prior to a contract modification involving a change to the Performance Work Statement (PWS), or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance:

2.1.1. Place of Performance

USAMRIID

1425 Porter Street Frederick, Maryland 21702

2.1.2. Period of Performance. This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) months Option Periods. The periods of performance for this contract are as follows:

Option POP Start POP End Base Year 01 April 2021 31 March 2022

Option Year 1 01 April 2022 31 March 2023 Option Year 2 01 April 2023 31 March 2024 Option Year 3 01 April 2024 31 March 2025 Option Year 4 01 April 2025 31 March 2026

52.217-8 Option 01 April 2026 30 Sept 2026

2.2. Non-Personal Services:

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

2.3. Contract Management:

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

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

The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

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

2.3.2.2. The contractor shall provide a draft Quality Control Plan (QCP) (Deliverable 3) with their proposal and a final QCP no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP.

2.3.3. Subcontract Management. The subcontractor shall be:

2.3.3.1. Responsible for any subcontract management necessary to integrate services performed on this contract.

2.3.3.2. Responsible and accountable for subcontractor performance on this contract.

2.3.3.3. Responsible to manage task distribution to ensure there are no OCI considerations.

2.3.3.4. Contractors may add subcontractors to their team after notification and approval from the PCO and COR. Cross teaming shall be permitted.

2.4. Reports:

2.4.1. Reports and documents (Deliverable 6) delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227- 14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract. Scheduled service report shall be provided by the 2nd to the last business day of the month to ensure timely closeout of asset control system (DMLSS). For repair services reports shall be provided within three business of work completion.

2.4.2. Monthly Report (Deliverable 7). The contractor shall provide a monthly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments.

2.4.3. Services Contract Reporting (SCR) (Deliverable 8). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. Refer to FAR 52.204-14 for Services Contract Reporting (SCR) instructions.

2.4.3.1. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the equipment on the list.

2.5. Training Requirements:

2.5.1. Completion of Training Requirements (Deliverable 5). The contractor shall track and complete refresher training to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each affected contractor and subcontractor personnel to the COR within 5 calendar days after completion of training by all personnel and subcontractor personnel. Contractor shall track and complete refresher training to maintain training compliance and readiness status as required.

2.5.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR (or to the contracting officer, if a COR is not assigned) with 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.2. iWATCH Training. The contractor and all associated subcontractors shall brief all employees on Fort Detrick iWATCH program, available on-line at http://www.detrick.army.mil/ready/iwatch.cfm. This locally developed on-line training will be used to inform contractor personnel of the types of behavior to watch for and instruct them how to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new contractor personnel commencing performance, with the results reported to the COR no later than 30 days after contract award.

2.5.1.3 MAINTAIN SAFETY, SECURITY, AND BIOSECURITY STANDARDS Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities.

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom— no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. Other personal protective equipment may be required as well, depending on the tasks to be performed. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites.

Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures.

Investigators in the laboratories study tiny amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks. Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and -4. As described above, approved work in biocontainment suites and using biological select agents and toxins requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

Security USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel who work here. USAMRIID is frequently inspected by those regulating agencies, and successful completion of those inspections is required for USAMRIID to continue its operation. It is therefore critical that all employees, including contractor employees, meet standards and maintain compliance with all regulations, policies, and procedures that have been instituted for their protection and the protection of others. Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

2.6. Security Requirements:

The Contractor shall protect all For Official Use Only (FOUO) and unclassified information involved in the performance under this contract.

2.6.1. Installation Access Requirements:

All visitors must enter through the Nallin Gate which is open 24 hours per day, seven (7) days per week.

Contractors are to provide proof of identification to the Fort Detrick security staff at the Visitor Center located at the Nallin Gate. A Criminal History Check will be conducted on all Contractor and subcontractor employees requiring base access. Acceptable forms of Government issued identification include a passport or Driver’s License that complies with the REAL ID ACT. Non- U.S. citizens visiting Fort Detrick will require a Federal employee escort onto the Base. Non- U.S. Citizens visiting or working at USAMRIID will require USAMRDC approval. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to your vehicle, the trunk, boxes, bags, or other items located in the vehicle is subject to search. Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives and blades over 2 ½ inches, alcoholic beverages and open containers of alcohol. No photographs may be taken while on Fort Derick. Cell phones may be used while driving only if hands free.

2.6.2. Security Clearance Requirements:

The Contractor shall provide all information required for background checks to meet installation access requirements to be accomplished by the USAMRIID Security Office. All background investigation forms and fingerprints must be completed prior to start. The Contractor shall initiate the necessary personnel background checks for successful processing of contract employees through the USAMRIID Security Office. USAMRIID will submit the investigation through the Personnel Security Investigations Portal (PSIP). Once the Security Office reviews the Questionnaire for Non-sensitive Positions (SF85) or Questionnaire for National Security Positions (SF86) and the investigation is scheduled at the Office of Personnel Management (OPM), the Security Office will notify the Contracting Agency and USAMRIID Human Resources that they are cleared for an EOD date. The minimum personnel background investigations will be a T1, previously known as National Agency Check with Inquiries (NACI).

A NACI is also acceptable provided the individual has not had a 24 month break-in-service from the previous Government employment. It is anticipated that the highest clearance required will be SECRET. A T3 investigation may also be required for other positions as required depending on the duties performed.

A facility clearance through a servicing Defense Security Service is required to be maintained and updated when applicable as established on the DD Form 254 (Attached). Contractor employees enrolled in the Biological Personnel Reliability Program (BPRP) will require a T3 investigation (NACLC/ANACI is acceptable if completed within 5 years prior to enrollment). A favorably adjudicated SECRET security clearance eligibility, with no access to classified, is required. Periodic reinvestigations will be completed every 5 years. An unfavorably-adjudicated reinvestigation that renders an individual ineligible for a security clearance will result in termination from the BPRP.

Any delays in recruitment caused by security issues are the responsibility of the Contractor unless an exception is authorized by the Contracting Officer. The security requirements for other USAMRDC laboratories or customers will be specified on each individual task order. Any additional security requirements will be provided in the individual task order PWS. The appropriate security clearance forms will be provided to the Contractor in accordance with FAR Clause 52.204-2 in Section I.

2.7. Biosecurity Requirements:

Contractor employees are required to complete biosecurity training(s) relative to his/her position or function and report any infractions of biosecurity procedures to the TOCOR immediately.

Training is designed to safeguard both the biological materials use in the laboratories (BSL-2 through BSL-4) and the personnel who work within and outside the laboratories. Training will cover, at a minimum, biological safety, biosecurity, and agent accountability.

Requirements for BPRP Enrollment (if applicable) Contractors needing unescorted access to BSAT at USAMRIID will enroll in Army’s BPRP. When entering a CDC-registered space at the USAMRIID of Fort Detrick, MD, the Contractor shall comply with all applicable Federal, DoD, and Army regulations governing BSAT. In addition, the Contractor shall comply with any local biosecurity policies and procedures. The Contractor shall ensure that all subcontractors comply with the aforementioned.

Contractor personnel assigned to BPRP duty positions will enroll in the Army BPRP subject to occupational health screening provided by the government on a reimbursable basis as another direct cost on individual task orders. The Contractor shall provide records of employment, medical and urinalysis required for BPRP screening to the BPRP Manager in accordance with local procedures. The Contractor will provide drug abuse screening services consistent with AR 190-17 and AR 600-85 in accordance with local procedures.

Personnel provided under the contract must successfully obtain and maintain a Department of Health and Human Services SRA, have a Secret clearance with T3 investigation (as identified in para. 2.6.2), and shall be medically qualified to wear appropriate respiratory protection. When required, as a part of services being provided, contractor personnel are eligible to receive vaccinations. Potentially Disqualifying Information discovered during the contract period will be provided to the BPRP Manager in accordance with local procedures.

References (Available for review in USAMRIID library):

1. 7 CFR part 331, Possession, Use and Transfer of Biological Select Agents and Toxins

2. 9 CFR part 121, Possession, Use and Transfer of Biological Select Agents and Toxins

3. 29 CFR part 1910, OSHA General Industry Regulations

4. 42 CFR part 73. Select Agents and Toxins

5. Department of Defense Instruction (DoDI) 5210.88, Minimum Security Standards for Safeguarding Biological Select Agents and Toxins

6. AR 40-400 Patient Administration

7. AR 190-17, Biological Select Agents and Toxins Security Program

8. AR 385-10, The Army Safety Program

9. AR 600-85, Army Substance Abuse Program

10. DA Pamphlet (PAM) 385-69, Safety Standards for Microbiological and Biomedical Laboratories

11. MEDCOM Regulation 40-55, Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Biological Select Agents and Toxins (BSAT)

12. USAMRIID Regulation 385-69, Biological Safety Program

13. USAMRIID Policy 11-24 Escorted Entry to Centers for Disease Control and Prevention (CDC) Registered Areas

14. USAMRIID PAM 50-1, Biological Duty Position Roster

15. USAMRIID PAM 50-2, Personnel Reliability Program Screening Process

16. USAMRIID PAM 50-3, Removal from Personnel Reliability Program Duties

17. USAMRIID PAM 50-4, Continuing Evaluation of Personnel in Personnel Reliability

2.7.1. Program Positions

Services for Contractors Enrolled in the BPRP (if applicable) Government Furnished Services Contract employees in the Army’s BPRP are authorized medical examinations at the BPRP Barquist Army Health Clinic, vaccinations as recommended, and personal protective equipment as required.

2.7.2. Contractor Furnished Services

The Contractor shall provide drug screening services in accordance with AR 190-17 and AR 600-85 and provide testing results to the BPRP Manager in accordance with local procedures.

The Contractor will be billed for each USAMRIID-sponsored contract employee enrolled in

BPRP.

2.7.3. Requirements for Escorted Visitor Entry to CDC-registered Spaces Contractors not routinely working in CDC registered areas will not be enrolled in the BPRP and will comply with USAMRIID’s Visitor Policy 50-5, Escorted Entry to CDC Registered Areas.

Requirements for Escorted Visitor Entry to CDC-registered Spaces Contractors not routinely working in CDC registered areas will not be enrolled in the BPRP and will comply with USAMRIID’s Visitor Pamphlet 50-5, Escorted Entry to CDC Registered Areas.

Services for Contractors Not Enrolled in the BPRP Government Furnished Services USAMRIID will provide the contract employee a copy of the latest risk assessments and expected work conditions for the private Board-Certified Occupational Health Physician (BCOMP) to review.

This will enable the private BCOMP to evaluate the health status of the contractor for medical suitability for entry into USAMRIID’s containment laboratories and BSAT storage spaces.

Contractor Furnished Services (if applicable) The Contractor shall employ the services of a BCOMP to conduct physical examinations and determine fit-for-duty for non-BPRP workers entering CDC registered spaces.

The Contractor shall ensure the BCOMP provides USAMRIID Medical Division with a written summary of this evaluation including an assessment of the workers’ ability to safely wear the required dermal and/or respiratory protective equipment, and a medical clearance letter signed by the certifying physician for the period in which the employee will be visiting USAMRIID and entering biocontainment suites. The examination will be conducted within the previous 365 days and the certifying letter will be provided annually to the USAMRIID Medical Division within two weeks prior to suite access.

*Services for Contractors Not Enrolled in the BPRP but operating or maintaining the USAMRIID Effluent Decontamination System (EDS.)

2.7.4. Government Furnished Services

USAMRIID will provide the contract employee a copy of the latest risk assessments and expected work conditions for the private Board-Certified Occupational Health Physician (BCOMP) to review. This will enable the private BCOMP to evaluate the health status of the contractor for medical suitability for operations or maintenance of USAMRIID's effluent decontamination system (EDS). The BCOMP and/or appropriate clinical support personnel will be provided access to USAMRIID to include clinical encounter space for the purpose of providing timely occupational health care and appropriate continuity.

Onsite care may be provided on an as-needed or on-call basis depending on the need for services.

An N100, or equivalent protection factor, respirator will be required to enter a TEDS cook tank room during an active cycling operation to conduct routing checks and services. Preventive and/or emergency maintenance activities on pretreated effluent piping, or equipment systems where there is a potential for exposure, will require a Powered Air Purifying Respirator (PAPR) and Tyvek with gloves be worn.

Contractor Furnished Services (if applicable) The Contractor shall employ the services of a BCOMP to conduct physical examinations and determine fit-for-duty for non-BPRP workers operating or conducting preventative maintenance on the EDS.

The Contractor shall ensure the BCOMP provides USAMRIID supervisory personnel with a written summary of this evaluation including an assessment of the workers' ability to safely wear the required dermal and/or respiratory protective equipment, and a medical clearance letter signed by the certifying physician for the period in which the employee will be operating or conducting maintenance on the EDS. The examination will be conducted within the previous 365 days and the certifying letter will be provided annually to the USAMRIID Medical Division two weeks prior to operating or conducting preventative maintenance on the EDS.

2.7.5. Workplace Safety

The contractor employee must be able to maintain a safe workplace and comply with all occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the TOCOR immediately.

2.7.5.1. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to government information systems. All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter. This required non-residential training on-line at.

https://ia.signal.army.mil/DoDIAA/default.asp. It takes approximately one-hour to complete.

2.7.5.2. Operations Security Training (OPSEC). Per Army Regulation (AR) 530-1, Operations Security, new contractor personnel shall complete Level I OPSEC Awareness Training within 30 days of reporting for duty. This non-residential training is required every 365 days, available on-line at http://cdsetrain.dtic.mil/opsec/index.htm. It takes approximately 30 minutes to complete.

2.7.5.3. For information assurance (IA/information technology (IT) training). All contractor employees and associated sub-contractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions.

2.7.5.4. Threat Awareness and Response Program (TARP). Training applies to those contract personnel who have a security clearance. Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil. It takes approximately two hours to complete.

2.7.5.5. Initial Security Orientation or Annual Security Refresher Training. Per requirements in Office of the Surgeon General (OTSG)/ Medical Command (MEDCOM) Policy Memo 14-004, Standardized Security Training darted 15 January 2014. All contractors shall complete the Initial Security Orientation within 30 days then must complete the Annual Security Refresher due every 365 days. Available on-line at https://www.lms.army.mil.

2.7.5.6. Army-Wide Network Security Focus Training (AWSNF). Contractor shall complete this required non-residential training course to include (1) AWNSF-Phishing Awareness, (2) AWNSF-Personally Identifiable Information, (3) AWNSF-Portable Electronic Devices and Removable Storage Media, and (4) AWNSF-Safe Home Computing. Available on-line at https://iatraining.us.army.mil. All 4 courses shall be completed; this is a one-time only and is required for the establishment of a government network account. It takes approximately one-hour to complete.

2.7.5.7. Combat Trafficking in Persons General Awareness Course (CTIP). Training applies to those contractor personnel who perform contract requirements Outside Continental United States (OCONUS). Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil (AKO, then select ALMS). It takes approximately 30 minutes to complete.

2.7.5.8 Emergency Preparedness Response Program. Contractor shall complete this required non-residential training every three years, available on-line at Joint Knowledge Online (JKO) Home Page accessed via https://jko.jfcom.mil. It takes approximately one hour to complete.

2.7.5.9. Environmental Awareness Training. Training applies to those contract personnel who perform contract requirements on Fort Detrick installation. Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://installation.detrick.army.mil/training/emoTraining/index.cfm. It takes approximately 30 minutes to complete.

2.7.5.10. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training. Contractor shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil. It takes approximately two-hours to complete.

2.7.5.11. AT Awareness Training for Contractor Personnel Traveling Overseas. This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)–specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

2.7.5.12. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training.

This training is IAW USAMRAA Policy 17-01, Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Guidance.

2.7.5.12.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

2.7.5.12.2. The contractor shall require all contractor personnel with knowledge to an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s COR or Contracting Officer.

All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

2.7.5.12.3. Government Unique Training. The contractor shall ensure all services providers receive SHARP Training no later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the provided slides, obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting (301) 619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO: https://www.us.army.mil/. (Deliverable 5)

2.7.5.13. Contractor Attendance at Government Training Opportunities. The Government may require contractor attendance at Government provided or Government sponsored training offered by the Research, Development and Acquisition Support Office, or as outlined in the current version of USAMRMC Command Policy Memorandums “US Army Medical Research and Materiel Command (USAMRMC) Decision Gate (DG) Training Requirements” and “Requirement for Training of Personnel Involved in Food and Drug Administration (FDA)- Regulated Activities”. These training opportunities will be provided via web-based offerings, at on-site classroom settings or at local venues that will not otherwise incur travel expenses by the attendee. The Government determination for contractor attendance at one or more of the aforementioned training opportunities will be based on the applicability of the specific training opportunity to tasks being performed in this PWS and the above referenced USAMRMC Command Policy Memorandums. The COR will document all government training determinations made for each contractor employee performing under this contract as well as training opportunity attendance/completion. Additionally there will be initial, annual, and just in time training requirements to maintain compliance of BPRP these will be posted on network available systems and through Government only email.

2.8. Contractor Personnel, Disciplines, and Specialties:

2.8.1. Labor Categories and Descriptions.

The contractor shall accomplish the assigned tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the task with a minimum of under or over employment of resources.

2.8.2. Duty Hours.

2.8.2.1. Contractor personnel shall perform services during regular duty hours.

Depending on the location can range from 0600 to 1800 hours, Monday through Friday.

The 8 hour regular duty day will be determined by the Depot Chief and Shop Supervisor at each location. When the services require work at other on-site Government locations, an adjustment to the regular duty hours may be necessary.

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

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

2.8.2.2.1. New Year’s Day, 1 January

2.8.2.2.2. Martin Luther King’s Birthday, 3rd Monday in January

2.8.2.2.3. President’s Day, 3rd Monday in February

2.8.2.2.4. Memorial Day, last Monday in May

2.8.2.2.5. Independence Day, 4 July

2.8.2.2.6. Labor Day, 1st Monday in September

2.8.2.2.7. Columbus Day, 2nd Monday in October

2.8.2.2.8. Veteran’s Day, 11 November

2.8.2.2.9. Thanksgiving Day, 4th Thursday in November

2.8.2.2.10. Christmas Day, 25 December

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

2.8.4. Telecommuting.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1. Repair of Repairables:

3.1.1. The contractor shall be responsible for execution of the requirements outlined in this PWS for the repair of sterilization and central vacuum equipment. The Contractor shall provide all necessary labor, tools, diagnostic equipment and software, materiel, supplies, transportation and shipping throughout the United States, parts, and equipment necessary to repair Government owned sterilization and central vacuum equipment. The service shall be provided within 2 business days. The Contractor shall provide repair or replacement of all components including photodiodes, laser and power supplies, light sources, optical components, panel meters, circuit boards, filters, prisms, amplifier boards, PC boards and switches; reconditioning or modifications to the equipment to assure satisfactory operating performance of the equipment; replacement of malfunctioning cables supplied with the equipment; software upgrades. The contractor should bring outstanding repair issues to the COR to verify if Beyond economical repair.

3.1.2. The contractor must operate and maintain an appropriately rated repair facility in compliance with Federal, State and Local regulations and laws applicable to the performance of this contract, and other regulations including but not limited to:

AR 40-61, Medical Logistics Policies TB MED 750-1, Opera ting Guide for Medical Equipment Maintenance TB MED 521, Occupational and Environmental Health Management and Control of Diagnostic, Therapeutic, and Medical Research X-Ray Systems and Facilities.

FDA CDRH CFR Title 21, 1020.30 FDA CDRH CFR Title 21, 1020.31 USAMRIID Regulation 750-1, Medical & Research Equipment Maintenance

3.1.3. It is the Contractor's responsibility to obtain any proprietary data and drawings that may be required to perform equipment overhaul and repair requirements.

3.1.4. All components and material utilized for overhaul and repair shall be new or refurbished and shall meet authorized parts manufacturer authorization (PMA) requirements.

3.1.5. The price for equipment repair and overhaul shall include receiving inspection, disassembly, inspection, refurbishment, reassembly, packaging, preservation, and all required material included in the component maintenance manuals,…