Solicitation HT9425-23-Q-0094.pdf

SEE ADDENDUM

(No Collect Calls)

HT942523Q0094 06-Sep-2023

b. TELEPHONE NUMBER

240-313-8523

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 20 Sep 2023

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT94259. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JEFF FLOOK

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0981 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

ARMY MED RES INST OF DISEASE - PB

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$34,000,000

NAICS:

811210

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF76

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT942523Q0094

Section SF 1449 - CONTINUATION SHEET

STATEMENT OF REQUIREMENT

Statement of Requirement The objectives of this IDIQ are to (1) replace biocontainment sterilizer unit(s) (to include removal and disposal of existing units as well as installation of new units with biocontainment bioseal, certification and validation) and (2) upgrade software operating controls of existing pass-through biocontainment autoclaves.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform biocontainment sterilizer replacement (to include removal and disposal of existing biocontainment sterilizer units as well as installation of new units with biocontainment bioseal, certification and validation), and upgrade of existing biocontainment autoclave controls

(MCII, PAC-3000).

Actual requirements will be requested, ordered and funded via the issuance of formal delivery orders.

PWS

PERFORMANCE WORK STATEMENT (PWS)

FOR

AUTOCLAVE REPLACEMENT AND UPGRADE

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES

(USAMRIID)

Part 1

General Information

1. Overview: This is a non-personal service(s) contract to provide biocontainment sterilizer replacement (to include removal and disposal of existing biocontainment sterilizer units as well as installation of new units with biocontainment bioseal, certification and validation), and upgrade of existing biocontainment autoclave controls

(MCII, PAC-3000).

The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

The Contracting Activity will be US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform biocontainment sterilizer replacement (to include removal and disposal of existing biocontainment sterilizer units as well as installation of new units with biocontainment bioseal, certification and validation), and upgrade of existing biocontainment autoclave controls (MCII, PAC-3000). The contractor shall perform to the standards in this contract.

Actual requirements will be requested, ordered and funded via the issuance of formal delivery orders.

1.2 Background: USAMRIID works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, DoD, the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. All regulated medical waste from laboratories and biocontainment spaces (BSL-3 and BSL-4) must be sterilized prior to disposition IAW AR 385-10, DA Pam 385-69, DoDM 6055.18, and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition. Loss of critical autoclave systems will significantly degrade the research mission capability and capacity, as the only DoD BSL-4 containment laboratory.

1.3 Objectives: The objectives of this contract are to (1) replace biocontainment sterilizer unit(s) (to include removal and disposal of existing units as well as installation of new units with biocontainment bioseal, certification and validation) and (2) Upgrade controls of existing pass-through biocontainment autoclaves.

1.4 Scope: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services. The Contractor shall perform to the standards and acceptable quality levels identified in this PWS and associated contract documents. Actual requirements will be requested, ordered and funded via the issuance of formal delivery orders.

1.5 Period of Performance: The contract shall be an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a five-year ordering period for the replacement and upgrades of biocontainment sterilizer unit(s). A six month FAR 52.217-8 Option Period, if required, will be exercised.

1.6 General Information. Actual requirements will be requested, ordered and funded via the issuance of formal delivery orders.

1.6.1 Quality Control: Reserved

1.6.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.6.3 Recognized Holidays: The contractor is not required to perform services on federal holidays.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan Presidents Day 3rd Monday in February Memorial Day last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 6:00 AM to 6:00 PM 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. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks ordered under the PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the below Government facility:

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) 1425 Porter Street Bldgs. 1425 and 1412 Fort Detrick, MD 21702

1.6.6 Type of Contract: The government will award an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a five-year ordering period for the replacement and upgrades of biocontainment sterilizer unit(s).

1.6.7 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.8 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract:

perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially about changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.9 Contractor Travel: As designated, travel shall be used to satisfy the requirements identified at the Task Order level. Travel shall be at the direction of the Government, as authorized in the Federal Acquisition Regulation part 31.205-46. Contractor will be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. All travel requires Government approval/authorization and notification to the COR.

1.6.10 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications, or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

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

Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

The Contractor shall not employ, or continue employment, of persons for work on this contract, if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population. All Contractor employees shall be screened before hiring for active participation in any group that opposes the use of animals in research; such candidates shall not be selected for work on this PWS (all contract employees shall support the humane use of laboratory animals in research). In addition, if it becomes known that an employee is an active member of any group that opposes animal research or in any other way demonstrates a desire to compromise the security or the mission of the Institute, the Contractor employee shall be removed from this requirement immediately.

1.6.11.1 Security Requirements

The Contractor shall protect all Controlled Unclassified Information (CUI) and unclassified information involved in the performance under this contract.

1.6.11.2 Installation Access Requirements.

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

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

1.6.11.4 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. The Contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the Contract is completed or when a Contractor employee no longer requires access to the installation and facility as defined in the contract.

1.6.11.5 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:

1.6.11.6 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.

1.6.11.7 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.

1.6.11.8 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.

1.6.11.9 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.

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. This will be done at no additional cost to the government.

1.7.20 Workplace Safety

1.7.21 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/TPOC immediately.

1.7.22 Foreign Nationals Requirements

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. The investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access may be approved, but the process has to be approved by the Fort Detrick Designated Approving Authority. Foreign Nationals with requirements for access to Tier 1 BSAT will be processed for a Limited Access Authorization.

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) 5210.89, 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 190-51, Security of Unclassified Army Resources (Sensitive and Non-sensitive)

9. AR 190-13, The Army Physical Security Program

10. AR 385-10, The Army Safety Program

11. AR 600-85, Army Substance Abuse Program

12. DA Pamphlet 385-69, Safety Standards for Microbiological and Biomedical Laboratories

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

14. USAMRIID Regulation 385-69, Biological Safety Program

15. USAMRIID Pamphlet 190-17-7, Escorted Entry into FSAP-Registered Areas Within USAMRIID

16. USAMRIID Pamphlet 190-17-4, Biological Select Agents and Toxins Security Program

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

ACOR Alternate Contracting Officer's Representative CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DOD Department of Defense FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 KO Contracting Officer OCI Organizational Conflict of Interest ODC Other Direct Costs OSHA Occupational Safety and Health Administration PgMP Program Management Professional POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program TE Technical Exhibit VTC Video Tele-Conferencing

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Equipment. The Contractor shall furnish and maintain all tools and test equipment required by the Contractor’s personnel to complete work outlined in the IDIQ contract and task orders to include but not limited to hand tools, power tools, generators, fans, lights, heaters, presses, fiber optic cable testers, fiber optic cable splicers, copper cable testers and other telecommunications and network test equipment, confined space entry atmospheric testers, replacement parts and calibration etc. unless otherwise identified in an individual task order.

4.3 Personnel. The Contractor shall furnish personnel that are qualified in accordance with OSHA 29 CFR §

1910.146 that can perform all facets of their job as required in a Confined Space environment when required.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1 Basic Services: The installation of the upgrades i.e., control systems, on board printers, and control solenoids/hardware that are required for operation of the existing autoclave function in accordance with Getinge USA technical manuals for the models list in the equipment list. Removal, installation, and verification of operation for the replacement units.

5.2 Tasks: Tasks consist of the following:

The tasks of this contract are to (1) replace biocontainment sterilizer unit(s) (to include removal and disposal of existing units as well as installation of new units with biocontainment BioSeal, certification and validation) and (2) Upgrade controls of existing pass-through biocontainment autoclaves. Objectives are provided below and options for each objective would be exercised based on funding received. Actual requirements will be requested, ordered and funded via the issuance of formal delivery orders.

5.3 Biocontainment (Biosafety Level-3) Sterilizer Replacement(s):

5.3.1 Existing pass-through biocontainment sterilizer(s) will need to be disassembled, removed, and disposed offsite.

New sterilizer units of the specifications provided will be manufactured, delivered, installed with biocontainment BioSeal, tested, and validated with biological indicators to demonstrate performance in accordance with DoDM

6055.18 and DA-PAM 385-69. All biocontainment pass-through sterilizers must meet the minimum essential characteristics (MECs) provided.

Sterilizer(s) within biocontainment (Biosafety Level-3) will be disassembled, removed, and disposed offsite. New sterilizer units of the specifications provided will be manufactured, delivered, installed in an operational BSL-3 Federal Select Agent Program (FSAP)-registered space, tested, and validated with biological indicators to demonstrate performance in accordance with DoDM 6055.18 and DA-PAM 385-69.

5.3.2 Controls upgrade for this objective, existing sterilizers with obsolete controls will need upgraded controls and corresponding components needed to ensure availability of repair and preventive maintenance parts. The new control system will allow the update of cycle parameter printing.

Existing sterilizers identified in the equipment list, will need upgraded controls and components consistent with new equipment to include cycle parameter printing. The obsolete systems will be upgraded, and units must tested/validated with biological indicators to demonstrate performance in accordance with DoDM 6055.18 and DA-

PAM 385-69.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

Federal Acquisition Regulation (FAR) Department of Defense FAR Supplement (DFARS) Army FAR Supplement (AFARS) Department of Defense Financial Management Regulation (DoD 7000.14-R)

6.2 Agency Standards.

CNSSI No. 7003, Protected Distribution Systems (PDS) (September 2015) CNSSAM TEMPEST/1-13 (U) RED/BLACK Installation Guidance (17 Jan 2014) ICD 705 Sensitive Compartmented Information Facilities (26 May 2010) DCID DNI Annex Pt1 & 2 2006 700 - (12 July 2006) DoDD 5000.01, The Defense Acquisition System (August 2018) (https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/500001p.pdf) DoDI 5000.02, Operation of the Defense Acquisition System (23 Jan 2020) (https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/500002p.pdf) DoDI 8510.01 Risk Management Framework (RMF) (28 Jul 2017) (https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/851001p.pdf) Defense Information Systems Agency (DISA) Security Technical Implementation Guides (STIGS) (http://iase.disa.mil/stigs/stig/index.html).

Department of Defense, Civilian Personnel Joint Travel Regulation, Volume 2 (http://www.belvoir.army.mil/JPPSOWA/files/Outbound/JTRvol2_ch1_16.pdf).

DOD Information Technology Standards Registry (DISR-online) (https://www.dsp.dla.mil/Specs-Standards/List-of-DISR-documents/).

DODISS, DOD Index of Specifications and Standards (https://www.dsp.dla.mil/Specs-Standards/).

MIL-HDBK-232A, Red/Black Engineering-Installation Guidelines (24 Oct 2000) (http://www.tscm.com/MIL-HDBK-232.PDF).

MIL-HDBK-419A, Grounding, Bonding & Shielding for Electronic Military Systems, VOL I&II Facilities (30 May 1988) (http://www.tscm.com/MIL-HDBK-419A.PDF).

MIL HDBK-1004/6, Lightning Protection (1 Feb 1992) MIL-STD-188-124B, Grounding, Bonding and Shielding for Long Haul/Tactical Communications Systems Including Ground Bases Communication-Electronics Facilities and Equipment (1 Feb 1992) (http://www.tscm.com/MIL-STD-188-124B.PDF).

Technical Guide for Installation Information Infrastructure Architecture, United States Army Information Systems Engineering Command, July 2008

6.4 Commercial Standards:

ANSI/TIA-526-7 - OFSTP-7, Measurement of Optical Power Loss of Installed Single-mode Fiber Cable Plant (Feb 2002).

ANSI/TIA-526-14-A, OFSTP-14 - Optical Power Loss Measurement of Installed Multimode Fiber Cable Plant (Aug 1998) (revised 2003).

ANSI/TIA-568.0-D, Generic Telecommunications Cabling for Customer Premises (Sept 2015) ANSI/TIA-568.1-D, Commercial Building Telecommunications Cabling Standard (Sept 2015) ANSI/TIA-568.2-D Balanced Twisted-Pair Telecommunications Cabling and Components Standards (Jun 2016) ANSI/TIA-568.3-D, Optical Fiber Cabling and Components Standard (Oct 2016)

ANSI/TIA-568-C.1 Commercial Building Telecommunications Cabling Standard (24 Mar 2020) ANSI/TIA-568-C.2, Balanced Twisted-Pair Telecommunication Cabling and Components Standard (Sept 2018) ANSI/TIA-568-C.3, Optical Fiber Cabling Components Standard (25 Oct 2016) ANSI/TIA- 568-C.4 Broadband Coaxial Cabling and Components Standard (27 Jun 2017) ANSI/TIA 569, Commercial Building Standard for Telecommunications Pathways and Spaces (May 2019).

ANSI/TIA-598-C, Optical Fiber Cable Color Coding (Jan 2005).

ANSI/TIA-606-C, Administration Standard for the Commercial Telecommunications Infrastructure (Jun 2017).

ANSI/TIA 607B:2011 Telecommunication Bonding and Grounding ANSI/TIA-942-B, Telecommunications Infrastructure Standard for Data Centers (Aug 2017).

ASHRAE 90.1 Energy Standard for Buildings Except Low-Rise Residential Buildings NFPA 70, National Electrical Code (Current Edition).

NFPA 76, Standard for Fire Protection of Telecommunications Facilities (Current Edition) OSHA 29 CFR § 1910.23 Ladders OSHA 29 CFR § 1910.28 Duty to have fall protection and falling object protection OSHA 29 CFR § 1910.132 Personal Protective Equipment OSHA 29 CFR § 1910.140 Personal fall protection systems OSHA 29 CFR § 1910.146 Permit-required and Non-permit Confined Spaces Standards OSHA 29 CFR § 1910.147 Control of hazardous energy OSHA 29 CFR § 1926.102 Eye and Face Protection OSHA 29 CFR § 1910.268 Telecommunications OSHA 29 CFR § 1910.146 Permit-required and Non-permit Confined Spaces

6.5 Order of precedence for standards and guidelines are as follows:

6.5.1 Telecommunications Industry Association (TIA)/Electronic Industry Alliance (EIA) standards, and then guidelines, for installation and testing procedures, take precedence over manufacturer's recommended installation and test procedures for all structured cabling systems installed under the base contract.

6.5.2 In the event of conflict between installation, testing, quality control and workmanship standards, the order of preference to be adhered to during the completion of task orders under the base contract is:

6.5.2.1 Specific standards identified in task orders, which are more stringent than those in the base contract.

6.5.2.2 The TIA/EIA standards delineated in the base contract.

6.5.2.3 Manufacturer's recommended installation, testing, quality control, and workmanship standards.

6.5.3 Loss budgets for fiber-optic installations shall be established by performing an insertion loss test with a light source and power meter. That measurement shall be compared to an estimate of a reasonable loss for the subject cable plant installation based on anticipated loss due to the components in the cable plant - fiber, connectors and splices, plus any passive optical components such as splitters, using loss budgets established by TIA/EIA. Optical Time Domain Reflectometer (OTDR), or other testing methodologies, while permissible for troubleshooting or for use during the course of installation, are not acceptable as a final acceptance test for inside-plant cable installation.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule- TBD

7.3 Attachment 3/Technical Exhibit 3 – Equipment List

7.4 Attachment 4/ Technical Exhibit 4 - Minimum Essential Characteristics (MEC’s)

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

A formal delivery order is required before any work is to be performed. All contractor performance is contingent on issuance of a funded delivery order.

Performance Objective

Standard Performance Threshold

Method of Surveillance

PRS # 1

Upon award of a funded delivery order, the Contractor shall begin production and provide lead times for delivery;

PWS 5.1

Upon issuance of a formal delivery order, the Contractor shall begin production and follow lead times specified in the delivery order.

Zero deviation from standard.

100% inspection by

COR

PRS # 2

Upon award of a funded delivery order, the Contractor shall supply replacement autoclaves; PWS 5.3.1

The Contractor shall work with the Government to de-install and install replacement units and test per PWS on the issued delivery order.

Install units in accordance with all applicable electrical, plumbing, and safety standards. Zero deviation from standard

100% inspection by

COR

PRS # 3

Upon award of a funded delivery order, the Contractor shall provide and install control system upgrades; PWS 5.3.2

The Contractor shall provide, install, and test control systems on existing autoclave units per PWS on the issued delivery order.

Upon completion, must pass biological verification IAW DoDM 6055.18 and DA-PAM 385-69. Zero deviation from standard.

100% inspection by

COR

TECHNICAL EXHIBIT 2

Deliverables Schedule

Note: The milestone objectives in the schedule below are subject to change.

A formal delivery order is required before any work is to be performed. All performance is contingent on issuance of a written funded delivery order.

Deliverables Table

Item Ref. Title Distribute

To Subsequent Comments

Deliverable 1 Yr 1

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence production of autoclaves per lead times and delivery schedules specified in the delivery order.

COR

Updated as required by review processes with COR.

None

Deliverable 2 Yr 2

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence production of autoclaves per lead times and delivery schedules specified in the delivery order.

Milestone objective is to replace the 1st autoclave system.

Updated as required by review processes with COR.

None

Deliverable 3 Yr 2

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence installation of software system upgrades per lead times and delivery schedules specified in the required by review processes with COR.

None

Distribute

To Subsequent Comments install four control system upgrades.

Deliverable 2 Yr 3

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence production of autoclaves per lead times and delivery schedules replace 2nd autoclave.

required by review processes with COR.

None

Deliverable 3 Yr 3

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence installation of software operating control systems per lead times and delivery schedules issue two control system upgrades.

required by review processes with COR.

None

Deliverable 2 Yr 4

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence production of autoclaves per lead times and delivery schedules

COR

Updated as required by review processes

Distribute

To Subsequent Comments replace 3rd

Deliverable 3 Yr 4

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence installation of software operating control systems per lead times and delivery schedules install two control system upgrades required by review processes with COR.

None

Deliverable 2 Yr 5

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence production of autoclaves per lead times and delivery schedules replace 4th and 5th required by review processes with COR.

None

Deliverable 3 Yr 5

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence installation of software operating control systems

COR

Updated as required by review processes

Distribute

To Subsequent Comments per lead times and delivery schedules

Deliverable 3 Yr 5

Technical Exhibit 1

Upon issuance of a formal funded delivery order, contractor will commence installation of software operating control systems per lead times and delivery schedules required by review processes

TECHNICAL EXHIBIT 3

Equipment List

Autoclave for upgrade Current controls

E4116 (AR5 Barrier) MCII D8787 (AR5 Bertha) MCII D8374 (B1 small) MCII D8377 (B1 large) MCII D8784 (AA3 large) MCII D8786 (AA3 small) MCII D8396 (B3 small) MCII D8395 (B3 large) MCII D8785 (V3 small) MCII D8783 (V3 large) MCII D8391(AA5 small) PACS 3000

Autoclave for upgrade Current controls

F7373(AA5 gloveline) Steris controls D8371 (AA4 small MCII F7335(AA4 gloveline) Steris controls D8383 (V1 large) PACS 3000 D8382 (V1 small) PACS 3000 D8384 (Glassware) MCII

MECS

Minimum Essential Characteristics (MEC’s)

Minimum Essential Characteristics for a Steam Sterilizer

Shall have the minimum following dimensions:

26''x26''x39'' Chamber Single automatic Door (BSL2) Double door units (BSL3 and 4) With Interior Rack & 2 Shelves Exports cycle records to USB storage device Shall be a microcomputer-controlled steam sterilizer that offers the option of either prevacuum or gravity displacement cycles for sterilization of laboratory, research, and animal care supplies

Shall feature an Avanti touch-panel control interface with 19 selectable pre-programmed cycles.

Shall have the ability for the door to remain sealed during potential utility failure.

NetCOM enabled Ethernet connection for remote process monitoring; a thermal printer that documents cycle performance, and a user accessible connection for downloading cycle records to a USB flash drive.

Shall have independently validated bioseal flange (For BSL3 and 4 Units) Shall have stainless steel siding enclosing the unit for multiple install method possibilities.

Vendor shall provide installation of purchased unit and deinstallation of existing unit for

Government disposition:

SERVICES requested:

Single mobilization, relating to:

Supervision of Customer's rigging contractor (at building site) Final set-in place Equipment leveling Equipment assembly Identify final utility connection points Perform equipment startup vendor will provide operator & supervisor training

QASP

Quality Assurance Surveillance Plan Autoclave Replacement 1425 & Upgrades

1. Purpose.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored?

How Monitoring will take place?

Who will conduct the monitoring?

How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. Government Roles and Responsibilities

a. Contracting Officer (KO) – The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contract Specialist (CS) – The CS shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

4. Performance Standards. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards.

The below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination for Cause.

Requirement Reference Standard Acceptable

Quality Level Method of

Surveillance Incentive

Upon issuance of a formal delivery order, the Contractor shall commence custom manufacture of autoclave and provide lead times for delivery.

Technical Exhibit 1;

PWS 5.1

Actual requirement will be requested, ordered, and funded via a formal delivery order. The Contractor shall begin production and provide lead times for delivery in the first year.

100% complete

100% inspection by the COR

Positive Performance

Upon issuance of a formal delivery order, the Contractor shall supply replacement autoclaves.

Technical Exhibit 1;

PWS 5.3.1

Actual requirement will be requested, ordered, and funded via a formal delivery order. The

Contractor shall work with the Government to de-install and install five (5) replacement units and test.

100% complete 100% inspection by the COR

Positive Performance

Upon issuance of a formal delivery order, the Contractor shall provide and install software operating system control upgrades.

Technical Exhibit 1;

PWS 5.3.2

Actual requirement will be requested, ordered, and funded via a formal delivery order. The Contractor shall provide, install, and test (15) control systems on existing autoclave units.

100% complete 100% inspection by the COR

Positive Performance

5. Incentives. The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Quality Assurance Surveillance.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's Program Manager and Task Manager when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CS, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

a. Direct Observation. Can be performed periodically or through 100% surveillance.

Periodically

b. Periodic Inspection. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

As requested, or required.

c. 100% Inspection. Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.

Provide reports and documentation as specified in the PWS and the Performance Requirements Summary

Matrix above.

d. Progress or status meetings.

Surveillance results may be used as the basis for actions (to include payment deductions) against the Contractor.

In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

7. Ratings. Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Exceptional Performance significantly exceeds contract requirements to the Government’s benefit.

Satisfactory Performance meets contractual requirements Unsatisfactory Performance does not meet contractual requirements

8. Documenting Performance.

a. Acceptable Performance. The Government shall document positive performance.

b. Unacceptable Performance. When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is…