HT940624R0024.pdf

SEE ADDENDUM

(No Collect Calls)

HT940624R0024 01-May-2024

b. TELEPHONE NUMBER

301-619-1200

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 21 May 2024

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.

HT94069. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

DERRICK W WALKER

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

0012108597

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

DHA CONTRACTING OFFICE TIDEWATER HT9406

7700 ARLINGTON BLVD

FALLS CHURCH VA 22042

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 HT0311 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NAV HOSP JACKSONVILLE FL

NAV HOSP JACKSONVILLE FL

2080 CHILD STREET

JACKSONVILLE FL 32214-5000

JACKSONVILLE FL 32214-5000

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 OF104

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.

Section SF 1449 - CONTINUATION SHEET

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, Streamlined Procedures for Commercial Items and FAR 13, Simplified Acquisition Procedures, 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 offeror must be registered in the System for Award Management (SAM) database to be considered for award. Registration is free and can be completed online at https://www.sam.gov/content/home. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR clauses may be accessed in full text at these addresses:

www.acquisition.gov/browse/index/far and www.acquisition.gov/dfars. Provisions and clauses in effect through Federal Acquisition Circular 2024-04 are incorporated.

The North American Industry Classification System (NAICS) Code: 811210, with a small business size standard of $34.0M. This is a Full and Open Competition requirement; all qualified Offeror(s) are encouraged to submit a proposal.

The Defense Health Agency Contracting Activity (DHACA), Southeastern Healthcare Operations Contracting Division (SEHO-CD), on behalf of the Naval Hospital Jacksonville (NHJ), Florida, has a maintenance requirement for on-site full-service maintenance/repair on designated Government-owned medical equipment, to include sterilizers, washers, ophthalmology equipment, optometry equipment, stress test systems, ventilators, laboratory equipment, tissue processing, and tissue embedding devices. Reference Technical Exhibit 1 – Equipment List in Part 7 section 7.1 of this PWS for full list of Government-owned medical equipment.

The contractor shall provide preventive maintenance, to include regularly scheduled preventive maintenance and inspections every six (6) months or annually, as per manufacturers recommendations. Corrective maintenance, as required, to include repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

The contractor must be an Original Equipment Manufacturer’s (OEM) certified service provider. Preventive maintenance and corrective maintenance, to include all periodic planned maintenance and unscheduled repairs, on medical equipment must be in accordance with OEM specifications and in compliance with ISO 9001 standards.

The solicitation number is: HT940624R0024

PERFORMANCE WORK STATEMENT

Medical Device Maintenance and Services

Naval Hospital Jacksonville (NHJAX), Florida

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide medical device maintenance and service on designated government owned medical equipment.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and non-personal services necessary to perform preventive maintenance and corrective maintenance on designated Government-owned medical equipment, as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: The Defense Health Agency (DHA) located at Fort Detrick, MD, on behalf of the Naval Hospital Jacksonville (NHJAX), Florida, which is comprised of five (5) Branch Health Clinics (BHC) located in Florida and Georgia. The NHJAX trains, deploys and deliver superior, patient centered, quality healthcare to warfighters’ and their families.

This acquisition is a follow-on to the Firm-Fixed Price (FFP) United States Navy (USN) contract HT940624P0027 for medical device maintenance and service in support of the Naval Hospital Jacksonville (NHJAX), Florida.

1.4 Objectives: Naval Hospital Jacksonville (NHJAX) has a requirement for a non-personal services contract to maintain designated, Government-owned medical equipment.

1.5 Scope: Services includes preventive maintenance and corrective maintenance on designated Government-owned medical equipment. The contractor shall accomplish preventive maintenance and corrective maintenance of all equipment listed in the performance work statement. The contractor shall maintain the systems within the original equipment manufacturer’s (OEM) specifications in accordance with the newest United States, State, and Local law and regulations, DHA regulations, instructions and The Joint Commission (TJC) requirements. The Joint Commission’s requirements are specified in its Comprehensive Accreditation Manual for Hospitals (CAMH), readily found on https://www.jointcommission.org/. DHA regulations and instructions will be available upon request to maintain equipment within OEM specifications. The Contractor must maintain any networkable systems such that they meet DHA cyber security requirements.

1.5.1 The contractor shall provide preventive maintenance and corrective maintenance on designated Government-owned medical equipment. Services on the designated medical equipment includes sterilizers, washers, ophthalmology equipment, optometry equipment, stress test systems, ventilators, laboratory equipment, tissue processing, and tissue embedding devices. Reference Technical Exhibit 1 – Equipment List in Part 7 section 7.1 of this PWS for full list of Government-owned medical equipment.

The contractor shall provide preventive maintenance to include regularly scheduled preventive maintenance and inspections every six (6) months or annually, as per manufactures recommendations. Corrective maintenance, as required, to include, Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

1.5.2 The contractor shall accomplish and provide telephone support during normal business hours 0730-1600, preventive maintenance and inspections, corrective maintenance tasks, and unlimited emergency responses by the Contractor’s Field Service Engineers for all medical devices listed in the PWS, to include Technical Exhibit 1. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

The contractor shall provide all parts, labor, materials, travel, personnel, supervision, and freight shipping for the scheduled preventive maintenance and/or corrective maintenance of all equipment listed in the PWS, to include Technical Exhibit 1.

1.5.3 When product recalls, updates, or upgrades are necessary to maintain the contractual equipment inventory within the OEM’s specifications, the Contractor shall obtain and install same.

1.5.4 The aggregate amount of equipment covered under the contract shall fluctuate over time, as hardware and software eclipse useful life and as new equipment come off warranty. However, the aggregate requirement and level of effort will remain relatively constant over the life of the contract. Any changes to the equipment list will be executed through an official contract modification.

1.5.5 The contractor shall provide unscheduled support/service coverage between the hours of 0730 and 1600 (Eastern Standard Time), Monday through Friday, excluding United States Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. Indicated in Technical Exhibit 1, select sterilization equipment shall have 24-hour support, Monday through Friday, and weekend coverage 0730 and 1600.

1.5.6 Should the contractor chose to subcontract any services within this PWS, the subcontractor must also meet all requirements herein. If, at any point, the subcontractor(s) does not meet the requirements, the contractor shall be held accountable and/or requested to realign the method of completing those specific services via a different subcontractor.

1.6 Period of Performance (PoP): The estimated base period of performance (PoP) is 10 September 2024 through 09 September 2025, including four (4) twelve (12) month option periods (if exercised).

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Naval Hospital Jacksonville, Florida, located at 2080 Child Street, Jacksonville, Florida, 32214, to include the five (5) Branch Health Clinics (BHC) located in Florida and Georgia. The BHC commands are included, as follows:

BHC Key West, Naval Air Station (NAS), 1300 Douglas Circle, Key West, FL 33040;

BHC Albany, Marine Corp Logistics Base (MCLB), 814 Radford Blvd Ste 20325, Albany, GA 31704;

BHC Jacksonville, Naval Air Station (NAS), 964 Ajax St, Jacksonville, FL 32212;

BHC Kings Bay, Naval Submarine Base (NSB), 881 Uss James Madison Rd, Kings Bay, GA 31547;

BHC Mayport, Naval Station (NS), 2104 Massey Ave, Jacksonville Fl. 32228.

1.7.2 Recognized Federal holidays: Contractor is not required to perform services on holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business 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 at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. Indicated in Technical Exhibit 1, select sterilization equipment shall have 24-hour support, Monday through Friday, and weekend coverage between 0730 and 1600.

1.8 Contractor travel: Contractor shall be authorized travel expenses consistent with the cost principles and procedures in Federal Acquisition Regulation (FAR) Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR).

Travel costs will be considered reasonable and allowable only to the extent that they do not exceed on a daily basis, the minimum per diem rates in effect at the time of travel per the Joint Travel Regulation (JTR). Maximum use is to be made of the lowest-cost travel available.

Contractor support within a 60-mile radius outside the Naval Hospital Jacksonville (NHJAX) main compound, to include the BHCs located in Florida and Georgia, is not considered travel and is not reimbursable under this contract.

All travel within the NHJAX main compound and BHCs shall be at the Contractor’s expense and is not reimbursable under this contract.

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. The contractor shall provide the QC program to the COR for acceptance no later than 30 days after contract award. The COR will notify the contractor of acceptance or required modifications to the plan within 30 days of receiving the QC program. The contractor shall then make appropriate modifications and obtain acceptance of the QC program by the COR within 15 days. A comprehensive written QC program shall be submitted to the CO and COR within 5 working days when changes are made thereafter. After acceptance of the Quality Control Plan (QCP), the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system.

The QC program shall include the following:

A description of the inspection system to cover all services listed in the PWS, to include Technical Exhibit

1. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combination should be included.

A description of the methods to be used for identifying and preventing defects in the quality of service performed.

A description of the records to be kept to document inspections and corrective or preventive actions taken.

All records of inspections performed shall be retained and made available to the Government upon request throughout the contract period of performance, and for the period after contract completion until final settlement of any claims under this contract.

List of Research WEB sites that may be needed in reference to DOD, DHA, and other Instructions/ Memos:

DoD 8570.01-M: http://www.dtic.mil/whs/directives/corres/pdf/857001m.pdf ADA Section 508: http://www.ada.gov/2010_regs.htm

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and 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 minimum acceptable defect rate(s).

1.11 Contractor personnel

1.11.1 CAC requirements: Reserved.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx.

1.11.2.2 The DHA’s contractor training instructions and onboarding checklist for contractor employees embedded at Part 7 Section 7.1.2.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD and DHA directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note:

Public Key Infrastructure (PKI)-restricted, printed versions available).

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Reserved.

1.11.5 Reserved.

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 0730 and 1600 Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

1.12.1 Contract Manager and Alternate. The Contract Manager and Alternate must meet the performance requirements in Section 3 of this PWS. The Contract Manager and Alternate must be an OEM-certified services provider and authorized by the OEM-certified service vendor to perform the required maintenance services. The Contract Manager and Alternate must be fluent and easily understandable in English, to include being fully capable of performing in an efficient, reliable, and professional manner. All maintenance service provided by the contractor must meet OEM certification standards. Upon request, contractor shall provide training certificates (or notarized copies) of OEM training on medical devices listed in the PWS and Technical Exhibit 1.

1.13 Reserved.

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 Non-Disclosure Agreement (NDA): N/A

1.14.3 Government’s COR: 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 CO 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 with regard to 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 contract.

1.14.4 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 FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO 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.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system. Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI)

6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

1.17.1.4 Contractor Requirements for Background Checks: It is the Contractor’s responsibility to ensure its employees undergo proper criminal history background checks by providing the Government support, cooperation, and active assistance throughout the process.

1.7.1.4.1 The Contractor shall ensure that employment applications for potential healthcare workers contain a question asking whether the individual has a criminal history, and if so, requiring a description of the disposition of the arrest or charge. The application shall further state that it is being signed under penalty of perjury, with the applicable Federal punishment for perjury stated on the application.

1.7.1.4.2 Government Requirements for Background Checks: The Contractor shall comply with DoDD 8500.1,“Information Assurance (IA)”, DoD Instruction (DODI) 8500.2 “Information Assurance (IA) Implementation”, DoDD 5400.11, “DoD Privacy Program”, DoD 6025.18-R, DoD Health Information Privacy

Regulation and DoD 5200.2-R, “Personnel Security Program Requirements”. Contractor responsibilities for ensuring personnel security include, but are not limited to meeting the following requirements: Follow the Privacy Office guidelines for submittal of IT security clearances and ensure all Contractor personnel are designated as IT-I, ITII or IT-III where their duties meet the criteria of the position sensitivity designations.

1.7.1.4.3 Because of the unique circumstances presented by DoD and DON networks, personnel security requirements shall be followed to ensure appropriate precautions are taken prior to allowing Contractor personnel access to the network. Any Contractor personnel that will be accessing the medical device/system while installed on the hospital network will be required to have a National Agency Check (NAC) completed. Typically, this requires an investigation to support a “Public Trust Position” and requires the person(s) to complete and submit a Standard Form 85P (SF85P), Questionnaire for Public Trust Positions, via the Electronic Personnel Security Questionnaire (EPSQ).

Questions relating to SF85Ps and the EPSQ process may be directed to 1-888-282-7682 or online at http://www.dss.mil/index.htm. Contractor personnel accessing equipment connected to the hospital network will be required to complete a DD Form 2875, “System Authorization Access Request (SAAR)”. Copies of this form can be obtained from the Naval Medical Logistics Command (NMLC), or the local MTF. Additionally, Contractor personnel are required to complete the annual DoD IA training requirements.

1.7.1.4.4 The Contractor shall initiate, maintain and document personnel security investigations appropriate to the individual’s responsibilities and required access to Sensitive Information (SI).

1.7.1.4.5 Immediately report to the appropriate DHA and NHJAX POC and deny access to any automated information system (AIS), network, or information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate DHA and/or NHJAX representative for security reasons.

1.7.1.4.6 Ensure that all Contractor personnel receive DoD IA training before being granted access to DoD AIS’s.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.7 Calibration: This activity should be the procedures for the mechanical adjustments of the device to ensure consistent, standardized performance or output as per the original equipment manufacturer recommendations.

2.1.8 Contractor Performance Assessment Reporting System (CPARS): Web enabled application that collects and manages the library of automated CPAR’s.

2.1.9 Corrective Maintenance: Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

2.1.10 Defense Medical Logistics Standard Support (DMLSS): The automated procurement, maintenance, and supply system utilized to document various material management functions within the command, and throughout the Department of Defense.

2.1.11 Field Service Report (FSR): Documentation completed by vendor personnel to officially record all instances of contracted troubleshooting, work, and services conducted on equipment. Specifics on required reporting details can be seen in Section 5.9.2.

2.1.12 Inspections: The activity of doing functional testing and safety inspections of a medical device at regular intervals to ensure that the equipment is safe for use in accordance with manufacturer’s recommended procedures.

2.1.13 ISO 9001: The ISO 9000 series is a set of five individual, but related, international standards on quality management and assurance. These standards were developed to effectively document the quality system elements to be implemented in order to maintain an efficient quality system in a company. ISO 9001 is the most comprehensive standard covering design, manufacturing, installation, and servicing systems.

2.1.14 Medical Treatment Facility (MTF) or Patient Care Facility: All gross square footage for building with a primary function of delivering Government health care services. (i.e. hospital or clinic, including all activities providing outpatient and/or inpatient health services for authorized patient care)

2.1.15 Original Equipment Manufacturer (OEM): The company which has created a specific model of product/device.

2.1.16 Preventive Maintenance: Preventive maintenance is used to describe those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating software for security, safety or system functionality issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

2.1.17 Quality Assurance (QA): Actions, including inspections, performed by the Government to determine whether products and services conform to contract requirements.

2.1.18 Quality Assurance Evaluator (QAE): A Government employee responsible for performing quality assurance functions for a contracted service.

2.1.19 Quality Control (QC): Actions, including inspections and preparation of inspection records, performed by the Contractor to ensure that products and services conform to contract requirements.

2.1.20 Scheduled Parts Replacement (SPR): This is the activity of listing of parts that need replacing at certain intervals. This may be either hour-based or date-based, in accordance with manufacturer’s specifications.

2.1.21 Uptime: Uptime is defined as that time, during the clinical areas’ normal business hours, when the equipment is available for clinical use without restrictions to the quality of the results, and without safety hazards to the patient, staff, or visitors.

2.2 Acronyms:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business BHC Branch Health Clinics BIOMED Biomedical Department BMET Biomedical Equipment Technician CAC Common Access Card CAP Cloud Access Point CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer CJCSM Chairman of the Joint Chiefs of Staff Manual CM Corrective Maintenance CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CPARS Contractor Performance Assessment Reporting System (CPARS) CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information

DAD-A Deputy Assistant Director for Acquisition DBIDS Defense Biometric Identification System DC3 DoD Cyber Crime Center DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DMLSS Defense Medical Logistics Standard Support DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement EOSL End of Service Life eMSM Enhanced Multi-Service Markets ECN Equipment Control Number EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FDA Food and Drug Administration FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer FSR Field Service Report HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring KO Contracting Officer IV&V Independent Verification & Validation MedCOI Medical Community of Interest MTF Medical Treatment Facility MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NHJAX Naval Hospital Jacksonville

NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OEM Original Equipment Manufacturer (OEM) OPM Office of Personal Management OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PM Preventive Maintenance PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAE Quality Assurance Evaluator QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication SPR Scheduled Parts Replacement SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TL Technician Liaison TOS Terms of Service US United States UFC Unified Facilities Criteria UTL Unable to Locate VPN Virtual Private Network XML Extensible Markup Language

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

2.3.1 1910.147, Occupational Safety and Health Standards, Code of Federal Regulations.

2.3.2 DoD Instruction 8510, Risk Management Framework (RMF) for DoD Information Technology (IT)

2.3.3 NIST SP 800-37, Rev. 2, Risk Management Framework (RMF) for Information Systems and Organization: A System Life Cycle Approach for Security and Privacy, December 2018, as amended.

2.3.4 NIST SP 800-53, Rev 5, Security and Privacy Controls for Information Systems and Organizations, as amended.

2.3.5 NIST SP 800-171, Rev 2, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations

2.3.6. DHA Administrative Instruction No. 77, dated 28 May 2015

2.3.7 DoD Instruction 6025.18-R, DoD Health Information Privacy Regulation, dated 13 March 2019

2.3.8 DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, dated 12 August 2015

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

3.1.1 Physical Security. The Contractor shall safeguard all Government property provided for contract use. The contractor shall designate an individual and alternate(s) to receipt and account for Government-furnished facilities and equipment.

3.1.2 The contractor shall protect all facilities from damage caused by the contractor and shall repair, at no additional cost to the Government, all damages caused by the contractor’s activities. During performance of services, contractor shall keep the facility, neat, clean and orderly. Contractor shall be responsible for all means, methods, techniques, sequences, and procedures of the services. Contractor employees shall demonstrate appropriate behavior and dress at all times.

3.2 Facilities: The Government:

☐ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below: The Government will provide the necessary workspace for the contractor staff to provide the support outlined in the PWS and Technical Exhibit 1, to include desk space, telephones, and other items necessary to maintain the equipment within the OEM specifications. The work shall be performed at the Government provided facilities described below:

BHC Key West, Naval Air Station (NAS), 1300 Douglas Circle, Key West, FL 33040;

BHC Albany, Marine Corp Logistics Base (MCLB), 814 Radford Blvd Ste 20325, Albany, GA 31704;

BHC Jacksonville, Naval Air Station (NAS), 964 Ajax St, Jacksonville, FL 32212;

BHC Kings Bay, Naval Submarine Base (NSB), 881 Uss James Madison Rd, Kings Bay, GA 31547;

BHC May Port, Naval Station (NS), 2104 Massey Ave, Jacksonville Fl. 32228.

3.3 Utilities: The Government:

☐ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

The Government will provide all necessary utilities for the contractor staff to provide the support at the Government provided facilities, as outlined in the PWS and Technical Exhibit 1.

BHC Key West, Naval Air Station (NAS), 1300 Douglas Circle, Key West, FL 33040;

BHC Albany, Marine Corp Logistics Base (MCLB), 814 Radford Blvd Ste 20325, Albany, GA 31704;

BHC Jacksonville, Naval Air Station (NAS), 964 Ajax St, Jacksonville, FL 32212;

BHC Kings Bay, Naval Submarine Base (NSB), 881 Uss James Madison Rd, Kings Bay, GA 31547;

BHC May Port, Naval Station (NS), 2104 Massey Ave, Jacksonville Fl. 32228.

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below: The Government will provide to the contractor for preventive maintenance the Government-owned medical equipment listed in the PWS, to include Technical Exhibit 1. This medical equipment is authorized for transaction of official Government business only and shall not be used for personal business. Government-owned medical equipment issued shall remain the property of the Government and the contractor must maintain proper accountability of issued medical equipment. Medical equipment shall not be removed from the facilities shown in paragraph 3.2 above, unless otherwise specified in the PWS.

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below:

4.1.1 Contractor shall furnish all supplies, materials, repair or replacement parts, tools, equipment software upgrading and labor necessary to efficiently and satisfactorily perform the requirements of this contract.

4.1.2 Contractor Supplies and Equipment. The Contractor supplies and equipment shall comply with Federal, State, municipal, and industry or OEM specifications.

4.1.3 Government Responsibility for Damage. The Government shall not be responsible, in any way, for damage to the Contractor’s stored supplies, material, equipment, or to Contractor’s employees’ personal belongings brought onto the site.

4.1.4 The Contractors personnel shall comply with the DoD Information Assurance Policies applicable.

4.1.5 Contractors are required to maintain a Drug Free Workplace.

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.3 Secret Facility Clearance: Not applicable.

4.4 Materials: The contractor shall provide coverage for all repair and replacement parts necessary to maintain the equipment, listed in the PWS and Technical Exhibit 1, within the parameters of the original manufacturer’s specifications. The Contractor shall supply new, non-refurbished OEM parts, lubricants, and lubricant wear points for all repairs. Contractor installed replacement parts shall become the property of the Government. The Contractor shall extend to the Government all commercial warranties on replacement parts, consistent with standard industry practices. Replaced items shall be properly disposed of at no additional cost to the Government (Contractor shall pay all “environmental fees”, where required). Replacement parts shall be furnished within one (1) business day of initial request or next day by 10:30 AM (local time), whichever is quicker. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts, shall be the responsibility of the Contractor.

4.5 Equipment: Not applicable.

4.6 Facilities: Not applicable.

PART 5

5.0 SPECIFIC TASKS

5.1 Performance Requirements: The contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs, in accordance with original equipment manufacturer’s (OEM) specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error.

Upon completion of each preventive maintenance visit and each corrective maintenance visit, Field Service Engineers must submit a signed field service report (FSR), in English, to officially record all instances of contracted troubleshooting, work, and services conducted on equipment within 3 working days to the COR and Biomedical Equipment Technician (BMET) Technical Liaison (TL), and Biomedical Department for data entry into DMLSS.

The FSR shall include all information outlined in Section 5.9.2 of the contract. The contractor will report to BMET to check in and out with every service provided.

5.1.1 Service Vendor’s Qualification: The Contractor must be an OEM-certified service provider. Contractors must verify that an individual whom they plan to employ or continue to employ in the United States is authorized to accept employment in the United States. Individuals such as those who have been admitted as permanent residents, granted asylum or refugee status, or admitted in work-related nonimmigrant classifications may have employment authorization as a direct result of their immigration status. Contractor Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product.

5.1.2 Field Service Engineers (Engineers) shall be authorized by the OEM-certified service vendor to perform the required maintenance services. The Contractor shall ensure that all field engineers possess current OEM-certification level training on all devices encompassed in the equipment list. Field Service Engineers shall have sufficient experience to demonstrate proficiency in maintenance of the Government-owned product(s).

5.1.2.1 Experience of at least three (3) years working on a class of equipment, or over one (1) year on the specific make and model is sufficient to indicate experience. Substantially more time may be required based upon the technology involved. Occasional experience with a limited set of equipment does not meet the requirements of this contract.

5.1.2.2 Service vendors shall provide, to the COR, written assurance of the competency of their personnel as well as a list of credentials of approved Field Service Engineers.