W81XWH-22-R-0073 Amendment 0003.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 W81XWH22R0073 Amendment 0003 is as follow s:

1. Revise Section 3.3.2 and Section 3.3.3 of the PWS

2. Reopen the solicitation for all Offerors and to extend the proposal due date to 10AM EST on 22 August 2022. All Offerors must submit a proposal to Kristen.K.Law rence.civ@health.mil or send an email stating that USAMRAA is already in receipt of the Offeror's submission.

Please ensure all proposals provide suff icient detail for evaluation.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 17

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

16C. DATE SIGNED

BY 17-Aug-2022

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 W81XWH22R0073

X 9B. DATED (SEE ITEM 11)

08-Jul-2022

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 X is extended, 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

17-Aug-2022

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:

W81XWH22R0073

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

PROVIDE TWO (2) CONTINUIOUS FLOW THERMAL EFFLUENT DECONTAMINTAION SYSTEM

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DIESEAES (USAMRIID),

FORT DETRICK, MARYLAND

1.0. Introduction

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is the Department of Defense’s

(DoD) lead laboratory for medical biological defense research. USAMRIID’s core mission is to protect the warfighter from biological threats; USAMRIID also investigates disease outbreaks and threat to the public health.

The research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information that benefit both the military personnel and civilians. USAMRIID has a mission to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.1. Mission

1.1.1. The USAMRIID mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.1.2. The USAMRIID has a new requirement to procure two (2) Continuous Flow Thermal Effluent

Decontamination System.

1.2. Background

1.2.1. In accordance with the CDC Guidance Document, Biosafety in Microbiological and Biomedical Laboratories

(BMBL) 6th Edition, Biosafety Level-4, Liquid effluents from chemical showers, sinks, floor drains, autoclave chambers, and other sources within the laboratory must be decontaminated by a proven method, preferably heat treatment, before being discharged to the sanitary sewer.

2.0. General Requirements.

a. Delivery. The primary delivery address is as follows:

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

1425 Porter Street

Fort Detrick, MD 21702-5011

2.1. Business Relations

The Contractor shall successfully coordinate all activities needed to execute the requirements. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide timely identification of issues and effective management of the Contract. The Contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all Contractor personnel.

2.2. Contract Administration

The following subsections specify requirements for Contract management and administration.

2.2.1. Contract Management

2.2.1.1. Contract Management Activities

a. Government Management of the Contract. The Contracting Officer will officially designate (in writing) a

Contracting Officer’s Representative (COR) to oversee the contract. The Government’s COR will have responsibility for:

(1) Conduct evaluations of contract performance.

2) Providing advice and assistance in resolving any delivery issues.

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

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

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

b. Contractor Management of the Contract. The Contractor shall designate a single point-of-contact between the

Government and the Contractor to oversee the contract. The Contractor’s designated single point-of-contact shall be responsible for addressing contract issues, quality issues, and overall Contractor performance. This may include coordination with the Contracting Officer, Contract Specialist, and the COR to resolve any issues that may arise, trends relating to the contract or proposed changes or modifications to the Contract.

2.2.2. Contract Administration

2.2.2.1. The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to Government requests for contractual actions in a timely fashion. The

Contract Administration Team will consist of the following members:

2.2.2.2. The Contracting Officer will have overall responsibility for administering the Contract. The Contracting

Officer is the only person authorized to obligate the Government and make changes to the Contract. The Contracting

Officer will manage Contract administration and performance delivery surveillance supported by

Contract administrators and COR.

2.2.2.3. The COR will be appointed in writing and will be directly responsible to the Contracting Officer. The COR serves as the Government’s point-of-contact for Contract-level coordination of administration and performance matters. The COR will notify the Contracting Officer of any disputes, performance issues, or contractual issues that cannot be resolved and conduct other activities as specified by appointment.

2.3 Organizational Conflicts of Interest

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

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

Category 2: Program Management Support: Services which assist USAMRDC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or

Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

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

USAMRDC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAMRIID organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan (Deliverable

1). The Contractor shall complete the OCI Certification at time of proposal submission. OCI is Attachment 3.

3.0. Requirements

3.1 General Design and Deliverables

3.1.1. The USAMRIID is requesting the purchase of two (2) Continuous Flow Thermal Decontamination System

(CFTEDS). The individual systems shall have a capability of processing of 28,800 gallons/day. The two (2) continuous Flow thermal effluent decontamination system shall be a skid mounted package system with a combined capability of processing 57,600 gallons/day of BSL3 and BSL4 laboratory effluent to be delivered onsite within 18 months after contract award.

3.1.2. The Contractor shall provide a turn-key (installation, testing, and commissioning) performance-based design/build project to provide two (2) Continuous Flow Thermal Decontamination System (CFTEDS) to include all features of work described below. The two separate thermal CFTEDS to decontaminate liquid effluent generated by the containment laboratories in Building 1412 and Building 1425. The CFTEDS must be designed and provided in accordance with the most current Federal, State, and Installation regulations, national consensus codes, other codes, laws, Centers for Disease Control and Prevention (CDC)/Division of Select Agents and Toxins (DSAT) Guidance

Document, Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition, and standards as published during the time of award. The CFTEDS must be able to be validated physically and biologically on at least an annual basis per CDC/DSAT requirements after installation and commissioning. Validation procedure shall be accomplished by a dry well method design.

3.1.3. The Contractor shall construct all design features per applicable codes and standards to provide two complete and usable CFTEDS per the design requirements stated in the Performance Work Statement document.

3.1.3.1 30% design drawings is required 30 business days after award of contract. Deliverable #2

3.1.3.2. 60% design drawings is required 60 business days after award of contract. Deliverable #3

3.1.3.3. 95% design drawings is required 90 business days after award of contract. Deliverable #4

3.1.3.4. 100% design drawings is required 120 business days after award of contract. Deliverable #5

3.1.4. The CFTEDS shall be installed in a double stack container style enclosure having two levels.

3.1.4.1. Bottom level shall contain a 7,000 gallon (26,498 Liters) capacity effluent storage tank with a containment barrier capable of containing 110% of the storage tank capacity. The containment barrier shall contain a bottom drain outlet with a leak proof cavity filled valve installed on the exterior of the structure for an emergency evacuation of the effluent liquid.

3.1.4.2 Top level shall contain other equipment required by the system.

3.1.4.3 Container shall comply with D.O.T. Double Stack Requirements.

3.1.4.4 Container shall be 100% water-tight and leak-free.

3.1.4.5 Provide water-tight removable panels for equipment and components requiring accessibility.

3.1.4.6The container shall be approximately 40 ft. long (12m) x 10 ft. (3m) wide x 2 levels high, or approved option.

3.1.4.7 Install a CCTV monitoring system on upper and lower sections of the structures for full visibility of all processing equipment, storage tank and duplex pump/sump, provide laptop and monitor. System will be connected from structure point of connection to Bldg. 8150 by others.

3.1.4.8 Provide additional circuit breakers for heat tracing of CA, DWI, DWO and BCW.

3.1.5 Electronic submittals of equipment and components shall be delivered thirty (30) calendar days of contract award. Deliverable #6

3.1.6. CFTEDS shall have Factory Acceptance Testing (FAT) no later than the 16th month after contract award.

Deliverable #7

3.1.7. Site Acceptance Testing/Final Acceptance CFTEDS Units third party commissioning shall commence on the twenty-first (21st) month and be completed in its entirety on the twenty fourth (24) month of contract award. (SAT).

Deliverable #8

3.1.8 Accident Prevention Plan shall be delivered within 15 days of contract award through electronic submittal.

Deliverable #9

3.2. Energy Conservation Requirements

3.2.1. The CFTEDS shall have a method of energy recovery in place.

3.3. Existing Conditions

3.3.1. The Contractor shall conduct a site survey and develop a design to route contaminated laboratory waste water from the exterior of Building 8150, point of connections, to each of the auxiliary CFTEDS’s connection points outside of Building 8150. A pressure-reducing station and connection for the steam condensate return shall be provided by the government for the CFTEDS. The Contractor’s site survey and design shall include steam and condensate to and from a high pressure steam vault. Design shall also include any utility and network routing required outside of Building 8150 to enable the CFTEDS to be operational. Design shall include the spatial layout of this system. Utility connections will be provided by others in coordination with Contractor outside the building. The

Contractor is required to ensure efficacy and compatibility with existing biological agents used and ensure no damage to the sanitary sewer system or sanitary sewer plant. Discharge effluent temperature from the CFTEDS shall not exceed 140 degrees Fahrenheit (60 degrees Celsius). Control interface shall be achieved using a stand-alone computer inside the control room of Building 8150 and shall not connect to other Government networks.

Emergency steam shutdown shall be provided through the computer control in Building 8150.

3.3.2 The government shall provide all utilities such as electricity, domestic water, steam and condensate return, sanitary discharge line, bio-waste line, instrument air and data fiber to the CFTEDS.

3.3.3. The contractor shall find alternative cooling measures then utilizing on-site chilled water supply and return lines. The government has maximized the flow capacity allowed through Bldg. 8150 to TEDS 2.

3.4. Continuous Flow Thermal Effluent Decontamination System Design Requirements

3.4.1. The system shall provide a method for thermal processing effluent at a temperature of at least 284 degrees

Fahrenheit (140 degrees Celsius) for a 2 minute hold time , a volumetric flowrate of 20 gallons per minute (75.7

Liters per minute), with fully adjustable capabilities for temperature and flow time parameters. The system shall monitor, record, trend, and alarm treatment time, steam pressure, processing temperature, and other essential parameters throughout the process. The system shall provide a dual HEPA-filtered plumbing ventilation system as well as secondary containment. The automated control system shall be a stand-alone data acquisition system located in Building 8150.

3.4.2. The system shall provide the ability to temper the treated effluent discharge to a temperature below 140 degrees Fahrenheit (60 degrees Celsius) and minimal residual chemical disinfectant as not to affect adversely the

Fort Detrick Sewer Treatment Plant nor degrade related infrastructure.

3.4.3. The Continuous Flow System shall be fabricated with AL6XN piping & Fittings with Tuffsteel Gaskets.

3.4.4. The system shall incorporate strainers to remove debris from effluent before the effluent enters the thermal process.

3.4.5. The System and components shall be leak-free in accordance with the CDC Guidance Document, Biosafety in

Microbiological and Biomedical Laboratories (BMBL) 6th Edition.

3.5. The Contractor shall provide as part of this installation a set of engineered drawings and calculations covering:

3.5.1. Pump coordination with automatic

3.5.1.2. Storage Tank Selection

3.5.1.3. Controls and Sequence of Operation

3.5.1.4. Quantitative analysis of spill protection

3.5.1.5. Operations & Maintenance manual to include start-up, shut-down

3.5.1.6. Include system and equipment malfunction, and decontamination plan

3.5.1.7. Include dry well biological insert design.

3.5.1.8. Emergency Response Plan

3.5.1.9. Operator training

3.5.1.10. The system shall prevent discharge of untreated effluent.

3.5.1.11. The system shall provide alarms and protective measures for critical efficacy and thermal treatment issues to include:

3.5.1.11. Sequence malfunction.

3.5.1.13. Processing temperature and time (high/low).

3.5.1.14. Data logging for process characteristics (to include at a minimum time and temperature) and shall be retained on the stand-alone computer for a period of up to 3 months. It will be the responsibility of the system operators to download data and archive for inspection and other reporting.

3.5.1.15. Tempering of discharge to meet Ft Detrick waste water treatment plant effluent temperature threshold of less than 140 degrees Fahrenheit (60 degrees Celsius).

3.5.1.16. Pump operation (On/Off/Fault)

3.5.1.17. Storage tank liquid level detection

3.5.1.18. Sampling port

3.6. Process Effluent Volume Monitoring:

3.6.1. The contractor shall design laboratory effluent supply piping for the CFTEDS outside of Building 8150 provided by others which must be constructed in a manner capable to be decontaminated by 90 psi (758 kPa) steam.

Designed system must include material selection, protective measures, or isolation to accommodate this steam decontamination cycle and remain usable.

3.6.1.2. The system shall decontaminate effluent in a method approved by Fort Detrick Environmental Office, Fort

Detrick DPW, and USAMRIID (Engineering, Biosafety, Biosurety, and Environmental) in coordination with higher headquarters; and in accordance with CDC requirements.

3.6.1.3. The system shall provide a method for thermal processing effluent at a temperature of at least 284 degrees

Fahrenheit (140 degrees Celsius) for a 2 minute hold time, a volumetric flowrate of 20 gallons per minute (75.7

Liters per minute), with fully adjustable capabilities for temperature and flow time parameters. The system shall monitor, record, trend, and alarm treatment time, steam pressure, processing temperature, and other essential parameters throughout the process. The system shall provide a dual HEPA-filtered plumbing ventilation system, canister heating blankets and condensate drain lines as well as secondary containment. The automated control system shall be a stand-alone data acquisition system located in Building 8150.

3.6.1.4. Provide controls to operate ejector tank level/low lift pumps and communication from storage tanks to

Pumps

3.6.1.5. Provide flash tank / condensate receivers as required (i.e. no mixing of differing steam pressures without a means to condense).

3.6.1.6. All processing equipment, valves, and piping shall have sterilization capabilities (i.e. ports) where required for proper decontamination of the system. Piping shall be in-place in order to eliminate the need for any temporary equipment or piping to be used during decontamination activities. Discharge piping shall be permanently routed to the effluent piping prior to the storage tank before draining into the storage tank.

3.7. Provide duplex filter skids with the following:

3.7.1. Sterilization ports as required

3.7.1.2. Compressed air

3.7.1.3. Step-down regulator, 0 – 25 psi

3.7.1.4. Piping, valves, and associated fittings shall support decontamination process as follows; compressed air will be utilized to dry the filter housing after decontamination and water intrusion testing. Piping on the “clean” side of the filter housing shall be routed to provide floor sink with deep seal trap connected to the storage tank below.

3.7.1.5. All Isolations valves associated with the processing equipment must be leak proof and cavity filled.

3.7.1.6. Utilities services interior to the structure shall be insulated with fiberglass insulation 1” wall thickness with all service jacket (ASJ) and self-sealing lap (SSL) joints. Mastic shall be applied to exposed insulation

3.7.1.7. Utilities services exterior to the structure shall be insulated with fiberglass insulation 1-1//2 thickness wall with all service jacket (ASJ) and self-sealing lap (SSL) joints. Aluminum Metal Jacketing shall be applied to exposed insulation, fittings and end caps. They shall be banded and sealed.

3.7.1.8. The placement of support hangers, seismic bracing, anchoring and restraints shall limit the axial and lateral movement of the piping systems and associated equipment.

3.7.1.9. The contractor shall engineer the system and devices to comply with manufacturers specifications.

3.7.1.10. Environmental controls shall ensure the processing sectional areas maintains a .02 negative to the atrium entry through the measurement of a differential or magnehelic gauges.

3.7.1.11. Third party Commissioning of the environmental control systems shall be required.

3.7.1.12. The redundant AHU’s shall be engineered to accommodate the structural pressures and cooling for the redundant servers, control systems and equipment.

3.7.1.13. The HVAC systems shall include DDC with full administrative rights. Contractor shall supply software licenses and laptops for monitoring purposes.

3.7.1.14. The Redundant HEPA Filter Skid System shall contain decontamination ports and ability to perform a yearly bio-challenge for validation purposes. Isolation dampers to the individual system shall be included with zero pass through rate.

3.8. Redundant Servers:

3.8.1. Servers will include (unlimited calls)/3 year on-site warranty.

3.8.1.2. The system hardware will be sized properly to store at least 3 years’ worth of data, with a minimum of one

(10)Tb memory.

3.8.1.3. Provide and test primary and secondary redundancy software so servers mirror each other and automatically rotate lead and provide alarms in the event of a failure.

3.8.1.4. Provide an updated server and controller architecture drawing in software Format.

3.8.1.5. Provide full audit capability for the system.

3.8.1.6. Provide additional remote desk top licensing for one additional remote work station.

3.8.1.7. Provide all necessary licenses necessary to include licensing to communicate with the existing

Rockwell/Allen Bradley systems.

3.8.1.8. Provide training for a minimum of five (5) USAMRIID personnel to be trained for working understanding of system functionality, and troubleshooting of the devices/system.

3.8.1.9. The System and components shall be leak-free in accordance with the CDC Guidance Document, Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.

3.10. The contractor shall design laboratory effluent supply piping for the CFTEDS outside of Building 8150 provided by others which must be constructed in a manner capable to be decontaminated by 90 psi steam. Designed system must include material selection, protective measures, or isolation to accommodate this steam decontamination cycle and remain usable.

4.0 N+1 Redundancy Capabilities

4.1. The contractor shall provide an additional CFTEDS in order to provide for N+1 redundancy.

4.1.1. The additional system shall be of identical design as described in Section 3 above.

4.1.1.2. The additional system shall be connected with the CFTEDS described in Section 3 with respect to the capability to be able to select which CFTEDS is operating at any given point in time. This connection shall also enable the systems to be cycled to prolong each systems life cycle.

4.1.1.3. The contractor shall provide a sequence of operations to describe the above requirements.

5.0 Inspection and Acceptance

5.1. The Government requires a commissioning by a third party to ensure that The CFTEDS is delivered and in compliance with the Contract.

5.2. The Government shall provide certification of satisfaction upon receipt of each of the CFTEDS’s in accordance with the terms and conditions of the Contract. If the delivery fails to meet the specifications defined in the Contract, the delivery will be returned to the Offeror within 30 days.

5.3. The Government may reject or require correction of any deficiencies found in the invoice or receiving report in the event of a rejected invoice or receiving report, the Contractor will be notified in writing with the specific reasons for rejection.

5.4. The CFTEDS’s must pass all physical and biological validation and CDC inspection after installation and testing.

5.5. Annual validations (BSL3/4) shall be performed and conform to BMBL 6th Edition with G. stearothermophilus

(1.0 E+06) biological indicators.

5.6. Perform a pressure and hold test for 30 minutes to verify system is leak-free.

6.0 Preventative Maintenance

6.1. The contractor shall perform the preventive maintenance requirements during the warranty period which starts upon government acceptance.

6.2. The Contractor shall provide a monthly, semi-annual and annual preventative maintenance schedule for the

CFTEDS for the life of the equipment Deliverable #10. The CFTEDS are critical to USAMRIID’s mission and must be fully operational 24x7.

6.3. Annual preventive maintenance shall include sterilization and certification of the Pall Filters and HEPA Exhaust

System.

6.4. Annual calibration of equipment sensor will be performed on-site.

6.1 Programmable Logic Controller (PLC) Software Updates will be performed on a quarterly basis. The

Contractor shall provide software updates, when available as part of the monthly preventative maintenance. Alterations of all software changes shall be approved by the COR or designated representative during monthly preventative maintenance. The Government assumes the software updates shall be performed on-site; however, the Contractor, as required, shall request permission from the COR to access the Programmable Logic Controller (PLC) remotely to perform the software updates.

6.2 The monthly, semi-annual and annual preventative maintenance schedule will prevent the likelihood of the CFTEDS failing. Included with the schedule shall be the Contractor’s proposed price to perform the monthly preventative maintenance.

6.3 The Contractor shall supply all of the necessary equipment, tools, labor and miscellaneous supplies to perform the required preventative and corrective maintenance. The Contractor shall refer to

Department of the Army (DA) EM-385-1.1., Occupational Safety and Health Administration (OSHA), Federal and State Regulations while performing the scope of work required by the contract.

6.4 The Contractor shall provide the COR with a list of critical spare parts (defined by the contractor) for the system. The critical spare parts will be purchased by the Contractor and stocked on-site at

USAMRIID for use when unscheduled or emergency failures occurs. The Government will replenish the spare part(s) as used.

6.5 If parts are required to correct the failure, the Contractor shall utilize USAMRIID’s stock spare parts and if not available, the Contractor shall purchase the part(s) to restore the CFTEDS to fully operational. The Government will replenish the stock spare parts used to correct all failures.

7.0 Equipment Warranty

7.1. The Contractor shall provide Standard Terms and Conditions and the Contractor shall warrant to the

Government that equipment is free from manufacturing defects for one (1) year from the date of SAT.

7.2. The Contractor guarantees to either repair or replace parts found to be defective, provided written or verbal notice of the alleged defect is provided within one (1) year from date of shipment. Warranty service and labor are included and are to be provided at the customer site of the equipment installation.

8.0. Federal Holidays

The following Federal holidays are observed and no work or deliveries shall occur on the dates specified. Any of the below holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

New Years Day, 1 January

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

President’s Day, 3rd Monday in February

Memorial Day, last Monday in May

Juneteenth National Independence Day, 19th of June

Independence Day, 4 July

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran’s Day, 11 November

Thanksgiving Day, 4th Thursday in November

Christmas Day, 25 December

9.0. USAMRIID Personnel Clearances

9.1. National Agency Check (NAC) Personnel Clearances will be required.

9.1.1. All Contractor personnel shall be subject to National Agency Check (NAC) clearances. All personnel assigned to this task must have a working employee's security background Investigations.

10.0 Special Requirements

This section describes the special requirements and the subsections provide details of various considerations for this requirement.

10.1. Security Requirements- Some may not be applicable to the requirement.

10.2. Access to DoD-controlled installations, facilities, and personnel badging. Applicable for all Contractor employees with an area of performance within a DoD-controlled installation, facility or area. The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative

10.3. Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON change, the Government may require changes in Contractor security matters or process. IAW DoDI 2000.16, the FPCON is defined as follows:

A. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

B.FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists.

The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

C. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

D. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this

THREATCON is declared as a localized condition.

10.4. Installation Access. 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. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to the 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.

10.5. Weapons, Firearms, and Ammunition. Contractor and subcontractor employees are prohibited from possessing weapons, firearms, or ammunition, on themselves or within their Contractor-owned vehicle or privately-owned vehicle while on a DoD facility.

10.6. Security Clearance Requirements (if applicable). 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.

10.7. 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 (not applicable).

10.8. Contractor employees enrolled in the Biological Personnel Reliability Program (BPRP) will require a T3 investigation (NACLC/ANACI is acceptable if completed within five (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 five (5) years. An unfavorably-adjudicated reinvestigation that renders an individual ineligible for a security clearance will result in termination from the BPRP.

10.9. 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 U.S. Army Medical Research and

Development Command (USAMRDC) laboratories or customers will be specified in each contract or task order.

Any additional security requirements will be provided in the contract or task order Performance Work Statement

(PWS). The appropriate security clearance forms will be provided to the Contractor in accordance with FAR Clause

52.204-2 in Section I.

10.10. Biosecurity Requirements (if applicable). 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

Contracting Officer Representative (COR) or the Task Order Contracting Officer Representative (TOCOR) immediately. Training is designed to safeguard both the biological materials used 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.

10.11. Requirements for BPRP Enrollment (if applicable). Contractors needing unescorted access to Biological

Select Agent and Toxins (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.

10.12. 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 an “other direct cost” on contracts or 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.

10.13. 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, 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.

10.14. 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 Program

Positions

10.15. Services for Contractors who have completed the BPRP Enrollment Process (if applicable)

10.16. Government Furnished Services. Contract employees in the Army’s BPRP are authorized medical examinations related to screening for infectious diseases and toxins at the BPRP Barquist Army Health Clinic, vaccinations as recommended, and personal protective equipment as required.

10.17. Contractor Furnished Services. The Contractor shall provide drug screening services in accordance with

Army Regulation (AR) 190-17 and AR 600-85 and provide testing results to the BPRP Manager in accordance with local procedures. If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents and toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider.

10.18. 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, Escorted

Entry to CDC Registered Areas.

10.19. Services for Contractors Not enrolled in the BPRP (if applicable)

10.20. 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.

10.21. Contractor Furnished Services (if applicable). If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents or toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider.

10.22. Workplace Safety (if applicable). The Contractor employee must be able to maintain a safe workplace and comply with all occupational health and safety rules and regulations. Each Contractor employee is required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR/TOCOR immediately.

11.0 Biosecurity Standards

USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD, and U.S. Army regulations and policies which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel and Contractor personnel who are required to work onsite. 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 for the protection of all employees, including Contractor and subcontractor employees to meet standards and maintain compliance with all regulations, policies, and procedures.

11.1. 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 (BOMP) to review. This will enable the private BCOMP to evaluate the health status of the Contractor for medical suitability for operations or maintenance of CFTEDS. 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.

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

11.3. The Contractor is required to use an N100, or equivalent protection factor, respirator to enter a CFTEDS 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 requires the Contractor to wear a Powered Air Purifying Respirator (PAPR) and Tyvek with gloves.

11.4. Contractor Furnished Services. The Contractor shall employ the services of a BCOMP to conduct physical examinations and determine fit-for-duty for non-Biological Personnel Reliability Program (BPRP) employees operating or conducting preventative maintenance on the CFTEDS. The Contractor shall ensure the BCOMP provides.

11.5. 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 CFTEDS. 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 CFTEDS.

12.0. APPLICABLE DOCUMENTS

12.1. Boiler Pressure Vessel Code

12.2. AISC American Institute of Steel Construction

12.3. ANSI American National Standards Institute

12.4. ASME American Society of Mechanical Engineers

12.5. ASTM American Society for Testing and Materials

12.6. AWS American Welding Society

12.7. NEC National Electrical Code

12.8. NEMA National Electrical Manufacturers Association

12.9. NFPA National Fire Protection Association

12.10. ASTM D1988 Tank Standards

12.11. Manufacturer’s recommendations and instructions

12.12. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition

12.13. AFBMA Anti-Friction Bearings Manufacturers Association

12.14. AISI American Iron and Steel Institute

12.15. ISA Instrument Society of America

12.16. NPI National Petroleum Institute

12.17. 29 CFR 1910 OSHA Standards

All documents can be found in the USAMRIID Library and can be made available with advanced coordination.

13.0. Performance Requirements and Method of Surveillance

A Quality Assurance Surveillance Plan (QASP) (Attachment 1) will be used to ensure that contractor performance is effectively monitored and documented.

13.1. Deliverables

Deliverable Table

PWS Deliverable Description When Method Who

Deliverable #1 OCI Mitigation Plan As soon as identified by the

Contractor

PDF Email Contracting Officer

(KO), COR

Deliverable #2

PWS 3.1.3.1

30% Design

Drawings

30 business days after Notice to

Proceed

PDF Email COR

Deliverable #3

PWS 3.1.3.2

60% Design

Drawings

60 business days after Notice to

Proceed

PDF Email COR

Deliverable #4

PWS 3.1.3.3

95% Design

Drawings

90 business days after Notice to

Proceed

PDF Email COR

Deliverable #5

PWS 3.1.3.4

100% Design

Drawings

120 business days after Notice to

Proceed

PDF Email COR

Deliverable #6

PWS 3.1.5

Submission of

Equipment list and

Components

30 days after contract award

PDF/Excel via

Email

COR

Deliverable #7

PWS 3.1.6

Factory Acceptance

Testing

16 months after contract award

In person COR

Deliverable #8

PWS 3.1.7

Site Acceptance

Testing / Final

Acceptance

24 months after award

In person COR

Deliverable #9

PWS 3.1.8

Accident Prevention

Plan

15 days after contract award

PDF/Word via

Email

COR

Deliverable #10

PWS 6.2

Preventative

Maintenance

Schedule

Monthly, Semi PDF COR

W81XWH-22-R-0073

Solicitation Number: W81XWH-22-R-0073

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; “proposals” are being requested, and a written solicitation document will not be issued.

The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2022-06.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541330, with a small business size standard of $16.5M. This action is set-aside 100% for small business.

Offeror Definition. “Offeror”, as used in this solicitation, encompasses either a single entity, or a consortium of entities including subcontractors or teaming partners, that submit a proposal in response to this solicitation. If the

Offeror consists of a consortium of entities, one shall be clearly designated as the Prime Offeror.

Award without Discussions. The Government intends to evaluate proposals and award a contract without discussions with Offerors, except clarifications. The Government reserves the right to conduct discussions if the

Contracting…