W81XWH20Q0053 Amendment 04.docx

W81XWH20Q0053

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 11-Aug-2020 05:00 PM to 21-Aug-2020 05:00 PM.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

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

September 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 disposing old units to the nearest DRMO location (Fort Meade, MD). The schedule for removal of existing equipment shall be coordinated with and approved by the COR. Due to lack of storage at WRAIR two units (maximum four) can be de-installed and disposed to DRMO at one time.

5.2.2 Installation of New Equipment (Deliverable 2)

The installation is intended to be turn-key. If autoclaves do not meet Mechanical, Electrical, or Plumbing requirements then an explanation as to what needs to be done along with the associated cost will need to be included in the proposal. Contractor will be fully responsible for mechanical, electrical, or plumbing upgrades to the facility as part of this solicitation. 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.

The contractor shall assess the overall integrity and conditions of existing floors/subfloors, concrete slabs, and provide all necessary repair and reinforcement to support new steam sterilizer, if the existent flooring has tile, the tile must be removed. Contractor shall furnish and install new epoxy flooring to cover the entire room including the area under the existing sterilizer and new flooring foundation should be installed, as needed (if rotting or any other anomaly is noticed). New epoxy flooring shall be installed by a qualified professional, have a minimum of 5 years flooring experience and shall be in accordance with the industrial standard.

Self-leveling epoxy or fiberglass epoxy is recommended for the flooring installation. The flooring specifications are as follows:

· The mortar layer shall be at least 6mm thickness with moisture proof to work on damp area.

· Orange peel top surface with the same color as the adjacent area is required.

· The pit floor shall be monolithic and non-slipped surface.

· The new epoxy floor should be bleach and ZEP formula 165™ resistant.

· Flooring shall be able to withstand heave foot traffic and heavy rolling loads.

At minimum two old units need to be removed and two new ones need to be installed every two weeks.

Square footage by room

If moisture removal is need vendor shall provide the moisture removal as required per room.

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. Parts for new units shall be available for the next 15 years after certification of units

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 (manufacturer training site) for two biomedical technicians 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.

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