N6809319Q0005_P00002_Conformed_Copy.docx

N6809319Q0005

Section SF 1449 - CONTINUATION SHEET

SOLICITATION INFORMATION

CAGE: _____________________

DUNS: _____________________

Vendor POC: _____________________

Vendor Phone: ____________________

Vendor Fax: ______________________

Vendor E-mail: ____________________

Note to Vender:

At a minimum, the following must be completed to be considered for this opportunity:

-The SF1449; please respond to blocks 17a and 30a-c on page 1 and the vendor information on page 3, as well as provide your price(s) on the Contract Line Item Number(s) (CLINs).

-Provide a document detailing a breakdown of the number of kits needed to perform the required workload.

-Make and model of the proposed instrumentation.

Vendor to reference request for quotes number (RFQ#) N6809319Q0005 on all inquiries.

Per DFARS 252.225-7000, it is required that non-domestic end products be identified. Please complete the format within DFARS 252.225-7000 to identify non-domestic products and submit as part of the solicitation response. Otherwise, the vendor certifies that each end product is a domestic end product

All proposals should be inclusive of all costs (e.g. Shipping and Handling). Shipping should be included in the quote total, but NOT separately priced; shipping costs are always considered in the evaluation process.

We will consider same or similar offerings; all qualified offers are welcome.

Award will be made on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for non-cost factors.

PROMPT PAYMENT

For Prompt Payment Act purposes, this contract is subject to the 7 calendar day constructive acceptance period.

Billing / Payment in arrears

For all questions, POC:

Diana D. Rivera Contract Specialist Materiel Management Department Naval Medical Center Camp Lejeune Phone: (910)450-3149 diana.d.rivera4.civ@mail.mil

Pathogenic Bacteria Cost Per Reportable

FFP

Cost-Per-Reportable for one (1) Bench Top Analyzer, Laboratory Automated Microbiology System, including equipment use, reagents, maintenance, calibrators, supplies, consumable/disposable items, parts, accessories and other items required for the proper operation of the vendor's equipment and necessary for the generation and reporting of test results.

Minimum Requirements that interested vendors MUST note:

-MUST submit a document detailing the needed quantity of kits required to perform the workload listed on the Performance Work Statement (PWS).

-Requirement will consist of scheduled deliveries. Delivery of supplies needed to meet workload MUST occur the first week of each month during the corresponding Period of Performance. Delivery Schedule will be provided upon contract award.

-MUST provide/specify the make and model of the proposed instrumentation on response to the solicitation that will be used to meet workload.

-Instrumentation MUST be able to fit space (specified in PWS).

-Instrumentation MUST be able to run > (greater than) 60 tests at one time.

** See Performance Work Statement (PWS) for Details **

Period of Performance: 1 July 2019 – 30 June 2020

** Disregard IUID requirement. DFARS 252.211-7003, Item Identification and Valuation, does not apply to this acquisition. **

FOB: Destination

MILSTRIP: N6809319RC05548

PURCHASE REQUEST NUMBER: N6809319RC05548

PSC CD: 6515

NET AMT

FFP

Cost-Per-Reportable for one (1) Bench Top Analyzer, Laboratory Automated Microbiology System, including equipment use, reagents, maintenance, calibrators, supplies, consumable/disposable items, parts, accessories and other items required for the proper operation of the vendor's equipment and necessary for the generation and reporting of test results.

Minimum Requirements that interested vendors MUST note:

-MUST submit a document detailing the needed quantity of kits required to perform the workload listed on the Performance Work Statement (PWS).

-Requirement will consist of scheduled deliveries. Delivery of supplies needed to meet workload MUST occur the first week of each month during the corresponding Period of Performance. Delivery Schedule will be provided upon contract award.

-MUST provide/specify the make and model of the proposed instrumentation on response to the solicitation that will be used to meet workload.

-Instrumentation MUST be able to fit space (specified in PWS).

-Instrumentation MUST be able to run > (greater than) 60 tests at one time.

** See Performance Work Statement (PWS) for Details **

Period of Performance: 1 July 2019 – 30 June 2020

** Disregard IUID requirement. DFARS 252.211-7003, Item Identification and Valuation, does not apply to this acquisition. ** FOB: Destination

NET AMT

FFP

Cost-Per-Reportable for one (1) Bench Top Analyzer, Laboratory Automated Microbiology System, including equipment use, reagents, maintenance, calibrators, supplies, consumable/disposable items, parts, accessories and other items required for the proper operation of the vendor's equipment and necessary for the generation and reporting of test results.

Minimum Requirements that interested vendors MUST note:

-MUST submit a document detailing the needed quantity of kits required to perform the workload listed on the Performance Work Statement (PWS).

-Requirement will consist of scheduled deliveries. Delivery of supplies needed to meet workload MUST occur the first week of each month during the corresponding Period of Performance. Delivery Schedule will be provided upon contract award.

-MUST provide/specify the make and model of the proposed instrumentation on response to the solicitation that will be used to meet workload.

-Instrumentation MUST be able to fit space (specified in PWS).

-Instrumentation MUST be able to run > (greater than) 60 tests at one time.

** See Performance Work Statement (PWS) for Details **

Period of Performance: 1 July 2019 – 30 June 2020

** Disregard IUID requirement. DFARS 252.211-7003, Item Identification and Valuation, does not apply to this acquisition. **

NET AMT

FFP

Cost-Per-Reportable for one (1) Bench Top Analyzer, Laboratory Automated Microbiology System, including equipment use, reagents, maintenance, calibrators, supplies, consumable/disposable items, parts, accessories and other items required for the proper operation of the vendor's equipment and necessary for the generation and reporting of test results.

Minimum Requirements that interested vendors MUST note:

-MUST submit a document detailing the needed quantity of kits required to perform the workload listed on the Performance Work Statement (PWS).

-Requirement will consist of scheduled deliveries. Delivery of supplies needed to meet workload MUST occur the first week of each month during the corresponding Period of Performance. Delivery Schedule will be provided upon contract award.

-MUST provide/specify the make and model of the proposed instrumentation on response to the solicitation that will be used to meet workload.

-Instrumentation MUST be able to fit space (specified in PWS).

-Instrumentation MUST be able to run > (greater than) 60 tests at one time.

** See Performance Work Statement (PWS) for Details **

Period of Performance: 1 July 2019 – 30 June 2020

** Disregard IUID requirement. DFARS 252.211-7003, Item Identification and Valuation, does not apply to this acquisition. **

NET AMT

Each

FFP

*** CLIN Removed ***

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

SUPPLY OFFICER

100 BREWSTER BLVD.

CAMP LEJEUNE NC 28547-2538

910-450-4836

N68093

N68093

N68093

N68093

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 6 months.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 6 months provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 48 months.

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR Clauses http://acquisition.gov/far DFAR Clauses http://www.acq.osd.mil/dpap/dars/dfars/index.htm

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JUN 2012)

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

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the Central Contractor Registration at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

INVOICE AND RECEIVING REPORT COMBO

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

DESTINATION / DESTINATION

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Acceptor/COR Email Address: erin.m.wagner2.civ@mail.mil

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

PERFORMANCE WORK STATEMENT

Performance Work Statement

The requirement is for a cost-per-reportable contract for 1 bench top analyzer, Laboratory automated microbiology system including reagents, maintenance, and consumables for Naval Medical Center Camp Lejeune (NMCCL). The integrated system for NMCCL will consist of one analyzer, automated system utilizing growth-based technology. The contracted units shall be capable of performing general microbiology identification and Susceptibility with a minimum annual workload of approximately 5,500 tests. The analyzer shall be capable of performing the tests listed below with the minimum workload indicated. analyzer Cost-Per-Reportable Naval Medical Center Camp Lejeune

Automated integrated system for NMCCL The fully automated system for NMCCL shall be capable of performing automated Identification and Susceptibility of gram negative fermenting and non-fermenting bacteria, gram positive cocci and non-spore forming bacteria, yeast and yeast-like organisms and gram positive spore forming bacteria. The Analyzer must have an integrated vacuum apparatus for inoculation and a barcode reader for data entry. The Analyzer will be used for patients in the emergency room, operating rooms, labor and delivery, and adult intensive care units (ICU). Instruments must maintain current testing menu for susceptibility as listed below:

Penicillin, Linezolid, Nitrofurantoin, Oxacillin, Rifampicin, Trimethoprim/Sulfamethoxazole, Vancomycin, Clindamycin, Erythromycin, Tetracycline, Gentamicin, Ciprofloxacin, Levofloxacin, Moxifloxacin, Ampicillin, Streptomycin, Ceftriaxone, Cefotaxime, Doxycycline, Azithromycin, Amox/Clavulanic, Cefazolin, Ertapenem, ESBL, Imipenem, Meropenem, Piperacillin/Tazo, Aztreonam, Cefepime.

The analyzer shall not require an external water source or drainage for operation. The integrated instrument must be free standing on floor and may include a wagon or cart to satisfy requirement. The dimensions for the integrated analyzer shall not exceed 67in. x 30 in. (L x W). The electrical requirements are 120 VAC and 50/60 Hz and 2 dedicated 20 amp circuits.

The vendor shall provide installation, validation testing, onsite and offsite user training and preventive maintenance coverage. Vendor must supply and maintain and uninterrupted power supply (UPS). The vendor shall provide validation of the analyzer, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies and establishment of initial control ranges using laboratory supplied control materials. Corrective system maintenance coverage shall include response times, as specified in the Statement of Work (SOW). Training shall be provided by the vendor, as specified in the SOW. The system shall bi-directionally interface with the Composite Health Care System (CHCS) and with the laboratory information system (LIS), as specified in the SOW. The contract will have an initial Base year (Partial) with four (4) subsequent option years.

Base year: 01 July 2019 – 30 June 2020 Option year 1: 01 July 2020 to 30 June 2021 Option year 2: 01 July 2021 to 30 June 2022 Option year 3: 01 July 2022 to 30 June 2023

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

1. Reagent and supply delivery

a. All supplied items and reagents shall be certified for use with the vendor equipment provided.

b. All supplied items and reagents shall be delivered with maximum shelf life In Accordance with (IAW) manufacturer guidelines. Deliveries will be based on volume of testing performed at each location and coordinated with the Lab Supervisor.

c. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label that is easily read, understandable, and a minimum of 3” x 3” (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

d. The contractor shall provide deliveries to the delivery point identified below:

Naval Medical Center Camp Lejeune Laboratory Department 100 Brewster Blvd Camp Lejeune, NC 28547

2. Facility Constraints

a. Laboratory Footprint: The integrated unit shall be installed in the microbiology area of the main laboratory. Current available space: 67 in. x 30 in. The bench top analyzer will be placed in the microbiology department of the laboratory, room space is 19ft x15ft. Available bench top space for analyzer is 62 x 67 x 30 in (HxWxD).

b. Equipment shall not need additional plumbing or drainage.

c. Facility has biohazard collection and daily pickup.

d. Facility shall maintain operating temperature between 15-30°C, the analyzer shall not have ventilation requirements, and shall not have exhaust requirements.

e. Analyzer power requirements shall be 120VAC and 50/60Hz per analyzer and 20 amp dedicated circuits.

3. Maintenance.

a. The vendor shall provide OEM-trained, experienced, English-speaking personnel. The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

b. The vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturer’s (OEM’s) specifications/equipment certification.

d. The vendor shall provide maintenance services Monday through Friday from 0730-1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay. This includes annually required performance maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week.

4. Preventive Maintenance Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0730-1700 local time, excluding Federal Government holidays. Vendor shall provide full service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. The vendor shall perform PM service checks during the base contract period at the OEM’s recommended intervals. Vendor will also perform PM service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

d. All test equipment and test provided used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

5. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance from 0730-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within 72 hours of receipt of trouble call.

c. The Government’s request for corrective maintenance will be placed by laboratory personnel, directly to the vendor or its representatives. Corrective maintenance shall be completed during the hours specified in the contract.

d. The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a vendor Field Service Engineer FSE. Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of a FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

f. The Vendor shall have and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

6. Replacement Parts/Upgrades.

a. The vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor.

d. All replacement parts shall be new and certified as OEM replacement parts.

e. The vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the vendor shall provide installation within 30 days of release regardless of PM schedules.

f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available.

7. Training

a. The vendor shall provide initial on-site operator training to all technicians assigned to the NMCCL laboratory department prior to the initial use of the equipment.

b. The vendor shall provide a minimum of one (1) operator training per analyzer at the vendor’s training facility prior to or concurrent with the delivery and installation of the equipment and annual thereafter. All associated travel cost shall be included.

8. System Interface Requirement

a. The system shall be capable of bi-directionally interfacing with the CHCS and the new DoD Electronic Health Record (EHR) Medical Health Systems (MHS) Genesis

b. The system shall have the ability to receive Health Level 7 (HL7) order messages (ORM) and information from the LIS and provide DICOM (Digital Imaging and Communications in Medicine) Modality Worklist to the modalities.

c. If the vendor is not already approved to connect to CHCS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.

9. Government provided Materials and Services.

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements, necessary for the system to function properly as specified by the OEM.

b. The Government will operate the system in accordance with the instruction manual provided by the OEM.

c. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of vendor supplies, materials, or for the personal belongings brought onto Government property by vendor personnel.

10. Vendor Furnished Property and Material.

a. The vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract.

b. The vendor shall provide two (2) operational and two (2) service manuals, each in English.

11. Vendor Report Requirements.

a. The vendor FSEs shall personally notify Laboratory Supervisor of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, vendor FSEs shall notify the Officer of the Day Desk and the systems’ operator designated by Laboratory Supervisor.

b. The vendor shall provide to Laboratory Supervisor a full service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

i. Name of Vendor

ii. Contract Number

iii. Name of field service technician performing service

iv. Vendor log/control number

v. Date, time (beginning and ending), and hours on-site for service call

vi. Description of problem reported by user

vii. Equipment identification factors to include manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

viii. Itemized description of service performed to include parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (NMCCL)

xi. In the event that agents/sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name, point of contact, and contact information (i.e. telephone number and email)

12. Vendor Responsibility.

a. The vendor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property, resulting from the negligence of the vendor or its representatives. All such replacement or repair shall be completed at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

13. Removal of Government Property

a. No equipment shall be removed without the approval of the Laboratory Supervisor and Materials Management Department (MMD) of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the MMD of the MTF. Any failure to obtain such passes, which results in detainment or prosecution of service vendor personnel, is the sole responsibility of the service vendor and their personnel.

b. The vendor shall provide a detailed description of removed items on the vendor’s company letterhead. For associated items/accessories, the vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment/items removed. In the event that items/sub-assemblies/accessories are “repaired by replacement”, a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a vendor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the vendor. The vendor shall provide insurance coverage for damage to or loss of equipment while in vendor or service vendor’s custody.

d. In regards to patient information confidentiality and privacy, all vendors and/or service vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard drive (HDD) shall be removed by MTF personnel prior to equipment removal from the site. If HDD are to be replaced, the HDD in disrepair shall be left at the MTF for disposal.

14. Service Beyond the Scope of the Contract

a. The vendor shall immediately, but not later than 24 consecutive hours after discovery, notify Laboratory Supervisor in writing of the existence of or the development of any defects in the scheduled equipment, for which the Vendor considers they are not responsible for repairing under the terms of this contract.

b. At the same time of this notification, the vendor shall furnish BIOMED with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

c. No work outside of the contract shall be performed without a contract modification.

15. Deliverables

a. The vendor shall provide two (2) operational and two (2) service manuals, each English.

b. The vendor shall provide to the Technical POC a full service report within 2 days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English.

FACILITY ACCESS

CONTRACTOR UNCLASSIFIED ACCESS TO FEDERALLY CONTROLLED FACILITIES, SENSITIVE INFORMATION, IT SYSTEMS OR PROTECTED HEALTH INFORMATION Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement federal security standards for federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 Department of Defense (DoD) Implementation of HSPD-12 dated November 26, 2008 (or its subsequent DoD Instruction (INST)) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a Department of the Navy (DoN) or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy command under this contract is required to obtain a DoD Common Access Card (CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command's Security Manager (CSM) upon arrival to the command and shall out-process prior to their departure at the completion of the individual's performance under the contract.

ACCESS TO DOD IT SYSTEM

In accordance with Secretary of the Navy (SECNAV) M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include PHI. All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity's Command Information Assurance Manager (CIAM).

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check (NAC) with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance (IA) Technical Level 1, and must be trained and certified on the Operating System (OS) or Computing Environment (CE) they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee's duties, such employees shall in-process with the Navy command's security manager and IA manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual's performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy IT resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N; therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the supervisor.

The SAAR-N shall be forwarded to the CSM at least thirty (30) days prior to the individual's start date. Failure to provide the required documentation at least thirty (30) days prior to the individual's start date may result in delaying the individual's start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Awareness (IA) training, and maintain a current requisite background investigation. The contractor's security representative shall contact the command security manager for guidance when reinvestigations are required.

INTERIM ACCESS

The CSM may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR'S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the contractor's security representative. Within three (3) work days after contract award, the contractor shall provide to the requiring activity's Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the contractor's security representative. The contractor's security representative shall be the primary point of contact on any security matter. The contractor's security representative shall not be replaced or removed without prior notice to the Contracting Officer and CSM.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and PHI, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a Federal Bureau of Investigation (FBI) fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

· SF-86 Questionnaire for National Security Positions (or equivalent Office of Personnel Management (OPM) investigative product)

· Two FD-258 Applicant Fingerprint Cards (or an electronic fingerprint submission

· Original Signed Release Statements Failure to provide the required documentation at least thirty (30) days prior to the individual's start date shall result in delaying the individual's start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than ten (10) years) throughout the contract performance period. The contractor's security representative shall contact the command security manager for guidance when reinvestigations are required.

Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the CSM upon arrival to the command and shall out-process prior to their departure at the completion of the individual's performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy command's information assurance manager. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy IT resources. The SAAR-N shall be forwarded to the Navy command's security manager at least thirty (30) days prior to the individual's start date. Failure to provide the required documentation at least thirty (30) days prior to the individual's start date shall result in delaying the individual's start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual IA training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the CSM. The CSM will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF-86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The CSM will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor's Security Representative. Although the contractor will take JPAS owning role over the contractor employee, the command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT position category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee's performance under the contract.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO OR PERFORMING NON-SENSITIVE DUTIES Contractor employee whose work is unclassified and non-sensitive (e.g., performing certain duties such as lawn…