Solicitation W81XWH20Q0053.docx

W81XWH20Q0053

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested and a written solicitation will not be issued. The solicitation number is W81XWH20Q0053. The solicitation is issued as a request for quotation (RFQ). Provisions and clauses in effect through Federal Acquisition Circular 2005-78 are incorporated. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at https://www.acquisition.gov/. The NAICS code is 339113. All qualified vendors are encouraged to submit a quote.

The United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Walter Reed Army Institute of Research (WRAIR) requests responses from qualified sources capable of providing autoclaves according to specifications listed in the Request for Quote.

Section B - Supplies or Services and Prices

Autoclaves

FFP

Sterilizer 26"x36"x48" Single Door Hinged Rooms 1N53, 2N10, 2N45, 2S21, 2W117, 3E13, 3W47, 3N57, 3N81, 3W24, and 3W74 FOB: Destination

PSC CD: 6530

NET AMT

Autoclave

Sterilizer 26"x36"x48" Single Door Hinged; Recessed Wall Room GW58

NET AMT

Autoclave

Sterilizer 49"x64"x100" Single Door; Recessed Wall Room GE01

NET AMT

Start-up and User Training

NET AMT

Installation

NET AMT

Shipping

NET AMT

Deinstallation and Disposal

NET AMT

Warranty

NET AMT

Contractor Manpower Reporting

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. SCOPE

The scope of this requirement is to furnish all labor, materials, equipment and supervision required to remove 13 existing autoclaves and install 13 newly manufactured autoclaves. This is expected to be a turnkey (vendor will remove, prepare site, install and certify equipment) process that results in fully functional equipment. The contractor shall also provide a one-year warranty covering parts and labor. In addition, the contractor will be required to provide WRAIR personnel with training in how to complete preventive maintenance and repairs. The intent is that WRAIR personnel will then assume responsibility for these activities. The training will be conducted off-site as on-site is not an option for biomedical technicians, and instead is only a requirement for clinical personnel at the contractor facility. The table below includes the autoclaves that will be installed throughout WRAIR by size, location and end-users.

3. PERIOD OF PERFORMANCE

August 2020 to August 2021

4. WORK SCHEDULE AND LOCATION

4.1. Work Location

The work to be performed under this contract will be performed at the Walter Reed Army Institute of Research, Building 503 Robert Grant Avenue, Silver Spring, MD 20910.

4.1.1. Telecommuting

Telecommuting is not feasible for the services provided under this contract. Medical equipment maintenance, administrative, and professional support services must be performed on site

4.2. Federal Holidays

4.2.1.

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

4.2.2.

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

The following are Federal Holidays:

· New Year’s Day

· Martin Luther King, Jr’s. Birthday

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

4.3. Work Schedule

The contractor is responsible for conducting business, between the hours of 7:30 am to 4:30 pm Eastern Time, Monday thru Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

5. PERFORMANCE REQUIREMENTS

5.1. General Requirements

The following general requirements apply to all activities involved with the removal of existing equipment and installation and testing of new equipment:

· To minimize down time, the contractor shall schedule and coordinate with the COR the installation and testing of the new system to ensure that minimal delays in operation are experienced between the shutdown of the old system and full operation of the new system. The schedule may be modified on a periodic basis as required by project activities. The COR will be responsible for approving all schedule modifications.

· All mechanical, piping, and electrical components will be readily accessible for maintenance.

· Prior to the use of any welding or cutting torches, compliance with regulatory requirements and coordination with the COR is the responsibility of the contractor. The contractor shall insure that all safety requirements regarding the use of the freight elevator size and weight capacities are adhered to.

5.2. Specific Tasks / Requirements

Equipment shall comply with all industry and government design, testing, assembly, and fabrication requirements for specified equipment.

5.2.1 Removal of Existing Equipment (Deliverable 1)

The contractor shall be responsible for disconnecting, disassembling and placing the existing equipment on the building 503 loading dock for removal by the government. The schedule for removal of existing equipment shall be coordinated with and approved by the COR.

5.2.2 Installation of New Equipment (Deliverable 2)

The installation is intended to be turn-key. If current utilities are not adequate for proposed equipment, contractor will ensure proposal includes all costs to provide utilities (electrical, plumbing, HVAC) necessary for normal operation of equipment. The contractor shall be responsible for ensuring equipment can be moved from loading dock to installation location. Any damage or changes to door openings shall be the responsibility of the contractor to repair to existing condition.

5.2.3 Equipment Testing (Deliverable 3)

The contractor shall test all equipment following the completion of installation and ensure that the equipment is operating in accordance with Original Equipment Manufacturer (OEM) performance specifications.

5.2.4 Installation of Information Plate (Deliverable 4)

Vendor shall supply an information plate permanently affixed to the autoclaves with the following information:

· Name and Address of Manufacturer

· Serial number and Unit Identification

· Chamber Pressure and Temperature Ratings

· Jacket Pressure and temperature Ratings

· Stamp of the Inspection Authority

5.2.5 Safety Training (Deliverable 5)

All contractor employees will be required to attend any safety orientation provided by the Veterinary Services Program prior to commencement of work at WRAIR.

5.2.6 Warranty (Deliverable 6)

The contractor will propose as a separate item a one-year warranty and service/maintenance agreement providing a “next business day” response time. If accepted, this will commence from the last day of the standard commercial warranty, or one year post-award.

5.2.7 Training (Deliverable 7)

The contractor will provide one session on-site user training to include basic operation, operator level maintenance and troubleshooting for two sessions for not less than four hours. Contractor will provide off-site training for medical maintenance staff on preventive maintenance schedules and procedures, calibration instructions, piping and electrical schematic diagrams, and cycle descriptions that describe the sequence of events controlling the individual cycles during each session. Training dates and times shall be coordinated with the Government appointed COR.

5.2.8 Equipment Specific Documentations (Deliverable 8)

The contractor shall provide three full sets of Operation and Maintenance manuals for each piece of equipment. At a minimum, manuals shall include Programmable Logic Controller (PLC) ladder diagrams and Operator Interface Terminal (OIT) diagrams. In addition, a complete list of purchased parts including original manufactures’ part numbers, descriptive information and where the parts were purchased shall be included in the manuals. Operation manuals shall also include a description of operator-level periodic (e.g. daily, bi-weekly, monthly) maintenance requirements as well as a trouble-shooting guide for common problems. Software copies of the PLC and OIT programs shall be supplied. Maintenance manuals shall include preventive maintenance schedules and procedures, calibration instructions, piping and electrical schematic diagrams, and cycle descriptions that describe the sequence of events controlling the individual cycles.

5.3. Management Reports and Plans

5.3.1 Monthly Financial Tracking Report (Deliverable 9)

The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter.

5.3.2 Bi-Weekly Status Meeting (Deliverable 10)

The contractor shall conduct a bi-weekly progress meeting with the COR throughout the duration of contract activities. The final bi-weekly status report will be conducted after all project activities have been completed and the COR has accepted and approved all deliverables. The bi-weekly status meeting will also be the time when to address and any changes and/or updates to the QASP.

5.3.3 Bi-Weekly Status Meeting Minutes (Deliverable 11)

The contractor shall provide minutes for each weekly status meeting. The minutes shall include a list of open issues, newly identified issues, and recommended future actions to be taken.

5.3.4 Quality Control Plan (Deliverable 12)

The contractor shall provide a draft Quality Control Plan (QCP) with their proposal. The QCP will be finalized within 15 days of contract award following the review and approval of the COR. 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. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. As part of the QCP, the contractor shall provide documentation that all personnel assigned to equipment removal and installation have been trained and certified by the OEM.

5.3.5 Contract Manpower Reporting Application (CMRA) (Deliverable 13)

This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

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.

5.3.6 Inspection and Acceptance (Deliverable 14)

The COR delegated oversight of specific technical, functional and oversight responsibilities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

6. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

Per project schedule.

Test all equipment following the completion of installation and ensure that the equipment is operating in accordance with OEM performance specifications.

On completion of installation. Within 24 hours.

One year warranty covering parts and labor.

One year after installation of equipment.

The contractor shall complete and deliver the CMRA.

By October 31 or on the last day of contract performance – whichever is first.

6.1. Reports and Documents

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.

COR Information

To be determined upon award.

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Ref.

99.0 - 99.99% Direct observation by COR to ensure site is ready for installation of new equipment.

Weekly status meetings to review progress and schedule.

Positive Past Performance.

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

Verifying accuracy of information.

Meets:

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 - 99.99%

99.0 – 99.99%

CONTRACT MANAGEMENT

Government Management

The Contracting Officer’s Representative (COR) 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. Only the KO has the authority to enact changes to this award.

Contractor Organization

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.

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.

8. COMPLIANCE DOCUMENTS

8.1. General Compliance

8.1.1 Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

8.1.2 Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number 1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable 14)

8.1.3 DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

e) DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

f) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

g) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5- part493/content-detail.html

a) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/g clp.pdf

b) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical- practice.html

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

d) Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

9. OTHER TERMS, CONDITIONS, AND PROVISIONS

9.1. Non-Personal Services

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.

9.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

9.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

9.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

Not applicable for this award.

9.5. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and parts. Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for parts shall include a list of all parts required for repairs and unit costs. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

9.6 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

9.7 Anti-Terrorism and Operational Security (Deliverable 15)

9.7.1 AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and 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 is applicable.

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, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

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.

9.8 Access and general protection/security policy and procedures.

This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9 or NAF Clause BI.142, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

9.9 For contractors that do not require CAC, but require access to a DoD facility or installation.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

9.10 For Contracts That Require an OPSEC Standing Operating program

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it, and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

9.11 For Contracts That Require OPSEC Training

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

9.12 For IA/IT training

Not applicable.

9.13 For Information Assurance (IA)/Information Technology (IT) Certification.

Per DoD 8570.01-M , DFARS 252.239.7001, and AR 25-2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon contract award.

The contractor employee must be able to maintain a safe workplace and comply with 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 COR immediately.

The Contractor will be required to ensure compliance with Occupational Health physicals or vaccinations in support of the PWS. These shall be documented and charged as an ODC.

The contractor shall maintain an OSHA 300a log for all reportable (greater than first aid, lost time, lost days, transfer). The contractor shall provide a quarterly report of all mishaps, regardless of class or report ability. Annually, the contractor shall provide a 300A (summary) report to the COR and KO.

MECS

Minimal Essential Characteristics

Autoclaves (LOG)

The 12 Autoclaves are located in rooms 1N53, 2N10, 2N45, 2S21, 2W117, 3E13, 3W47, 3N57, 3N81, 3W24, 3W74 and GW58 (Autoclave located at GW58 is a Single Door, air Differential Seal, recessed in Modular Wall). Vendor shall replace existing autoclave with new autoclave with the following features:

· Shall not exceed more than 6” outside the footprint of the existing autoclave, footprint dimensions: 44” W x 76” H x 72” D

· Sterilization chamber shall be approximately 26” W x 36” H x 48” L

· Single door shall be either right hand swing or sliding

· Approximately 10” touch screen operator interface panel

· Shall be insulated on all sides, ends and top to reduce hot surfaces and heat loss

· Shall have audible and visual alarms

· Parts shall be non-proprietary

· Shall provide a vacuum source that reduces water consumption

· Shall have a Thermal Printer provided

· Shall provide a pressure relief valve to ensure rated pressure within the vessel is not exceeded

· Shall provide a signal when door seal is energized

· Shall provide an emergency stop button

· Shall add cooling water to ensure discharge temperature is below 140oF

· Shall provide up to 25 programmable cycles to include:

· Prevacuum cycles

· Gravity cycles

· Liquid cycles

· Leak Test cycle

· Shall allow cycle parameters to be selected and programmed by the operator

· Shall allow for operator to name cycles

· Shall provide a minimum of four custom configurable authorization levels

· Shall provide maintenance staff the ability to monitor the life cycle of parts

· Shall allow for visual monitoring of cycle phases

· Shall have two loading levels

· Shall have a minimum 316L SS chamber and 304 SS jacket

· Shall have cabinet enclosure panels

· Cabinet shall be enclosed

· Shall have a Minimum Available utilities Autoclave 1:

· 120V, 1Ph, 30A

· House steam 80 PSIG dynamic pressure

· Floor Drain

· Cold Water

Autoclave (VSP) The 1 Autoclave for VSP is located in room GE01.

Dirty Cage Wash Autoclave Features located in Room GE01:

· Autoclave shall allow four load carts to be rolled into chamber via a ramp

· Vendor shall provide 6 load carts that shall be no less than 48”W x 24”D x 60”H

· Load carts shall be 3-sided carts with a removable or hinged door

· Autoclave (excluding sliding door) shall not exceed a knockdown footprint of 70”W x 84”H x 120”L

· Autoclave shall include a single load/unload door

· Autoclave shall be placed along the left wall (see room diagram below). No mechanicals or need to access the side next to the wall shall be required

· Contractor shall install a new modular wall to separate the GE01 mechanical space from room GE03, dirty cage wash

· Sterilization chamber shall be a minimum of 48” W x 62” H x 100” L

· Shall be insulated on all sides to reduce hot surfaces and heat loss

· Vendor shall provide a ramp not to exceed 5’W x 10’L with no more than a 10” rise to the chamber entrance

· Shall have touch screen operator interface panel on the load and unload side

· Parts shall be non-proprietary

· Vendor shall provide a steam filter

· Shall provide audible and visual alarms

· Shall provide a vacuum source that reduces water consumption

· Printer shall be provided

· Shall provide an emergency stop button

· Shall add cooling water to ensure discharge temperature is below 140oF

· Shall provide up to 15 programmable cycles to include:

· Prevacuum cycles

· Gravity cycles

· Liquid cycles

· Leak Test cycle

· Shall allow cycle parameters to be selected and programmed by the operator

· Shall allow for operator to name cycles

· Shall provide a minimum of three custom configurable authorization levels

· Shall provide maintenance staff the ability to monitor the life cycle of parts

· Shall allow for visual monitoring of cycle phases

· Shall have a minimum 316L SS chamber and 304 SS jacket

· Shall have the following minimum available utilities:

· 115V, 1Ph, 15A

· 230/460, 60HZ, 3 phase

· 1” NPT House steam 80 PSIG dynamic pressure

· 80 PSI compressed air

· 1 1/2 “ Floor Drain

· 1” NPT Cold Water 40-60 PSI, 20 GPM

· Enclosure dimensions (Room GE01): 133”W x 109” H x 144”D

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

02-AUG-2021

WALTER REED ARMY INST. OF RESEARCH

503 ROBERT GRANT AVE.,(RECEIVING)

SILVER SPRING, MD DC 20910-7500

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

02-AUG-2021

W74MYF

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS--REPRESENTATION (NOV 2015)

(a) Definitions. Inverted domestic corporation and subsidiary have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).

(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

(c) Representation. The Offeror represents that--

(1) It [ ___ ] is, [ ___ ] is not an inverted domestic corporation; and

(2) It [ ___ ] is, [ ___ ] is not a subsidiary of an inverted domestic corporation.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAR 2020)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision --

“Covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

“Economically disadvantaged women-owned small business (EDWOSB) Concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”--

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as…