RFQ_19-Q-0190.docx

N0018319Q0190

Section A - Solicitation/Contract Form

VENDOR TO COMPLETE THE FOLLOWING:

TIN:

CAGE:

DUNS:

Vendor Point of Contact:

Vendor Phone:

Vendor Fax:

Vendor E-Mail:

Vendor shall include along with quote an invoice(s) with the same/similar items or a Published Price List.

Vendor shall include along with quote a current GSA/VA FSS Contract (Ordering Information/Terms & Conditions/Pricing) and complete the following information. (if applicable)

GSA/VA FSS Contract Number:_________________________________________

Expiration Date: Maximum Order Limitation:

Special Item Number (SIN): FSC:

NOTICE: Should the Contractor's FSS/GSA contract expires during the requested period of performance, including option years, the following information will be listed in Section A of the contract award document:

"The terms and conditions of this contract award are in accordance with your FSS/GSA contract _______________ which expires ______________. It is anticipated that your FSS/GSA contract will be renewed. At that time, the Naval Medical Center reserves the right to review the renewed contract and issue a modification, if needed, to either cancel the remaining services or revise the terms and conditions to reflect the new period of performance; however, all pricing herein are guaranteed for the entire period of performance, including option years.

VENDOR shall reference Request for Quotation (RFQ) Number N0018319Q0190 on all correspondence relating to this RFQ.

PAYMENT INFORMATION:

Invoice/Payment,, Net 30 Days

Payment in Arrears (Check One): Monthly Quarterly Semi-Annually Annually

NOTE: Payment for all supplies/services will be in arrears. Vendor may choose to invoice monthly, quarterly, semi-annually or annually. Invoice shall be submitted on or after the selected period of performance end date (i.e., if “annually” is selected, vendor will not receive payment until the end of the period of performance date). Invoice payments are made Net 30 Days upon certification in WAWF.

NOTE: Vendor will be required to provide billing electronically via the WAWF Electronic Invoicing Method per Section G of this RFQ. For additional information, a review of the following web sites may be required: https://wawf.eb.mil; http://wawftraining; Email: usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

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

NOTE TO BIDDERS:

Vendor required to quote as stated.

The Government will make the award based on an “All or None” determination and/or based on a “Best Value” determination.

Best Value Evaluation factors are technical capability (ability to provide items as specified), technical, and price with each factor weighted equally. In addition, priority consideration will be given to federal supply schedule holders quoting items under GSA/FSS contracts. The Government reserves the right to eliminate quotes, without discussion, that are deemed technically unacceptable. Technically unacceptable offers are not eligible for contract award.

Section B - Supplies or Services and Prices

FY20 - Maintenance Service Agreement

FFP

in accordance with Section C, Performance Work Statement; to include semi-annual on-site recertification of (CACI/CAI) Containment Technologies Group Mobile Isolation Chamber (MIC), Laminar Flow Work Stations (LAFW's), Total Particulate Count (ISO Classification) of Hoods and Clean Rooms, Viable Air Sampling (Bio-aerosol sample) of Hoods and Clean Rooms Validation to USP 797 criteria as follows:

Period of Performance: 01 OCT 2019 - 30 SEP 2020

MILSTRIP: N0018320RCPH001

PURCHASE REQUEST NUMBER: N0018320RCPH001

NET AMT

0001AA

Containment Technologies Group

(CAC/CACI) Mobile Isolation Chamber (MIC), 6 Hoods 6 hoods X 2 certifications per year = 12 quantity

Manufacturer: Containment Technologies Group Inc Nomenclature: Barrier Isolators Model, S/N, ECN as follows:

(1)MIC Single, 0805-MPA-363, 063436 (2)MIC Single, 0805-MPA-364, 063437 (3)MIC Dual, 1206-MPD-568, 069956 (4)MIC Dual, 1106-MPD-558, 069957

(5)MIC TPN, 1206-TPN-567, 069958

(6)MIC Single, 1206-MPD-566, 069959 FOB: Destination

MILSTRIP: N0018320RCPH001

PSC CD: J065

NET AMT

0001AB

Laminar Flow Work Stations

3 hoods X 2 certifications per year = 6 quantity

Manufacturer: Baker CO Inc Nomenclature: Laminar Flow Work Stations Model, S/N, ECN as follows:

(1)EG-4252, 98676, 104089

(2)EG-4252, 97805, 104090

(3)EG-6252, 98687, 104091

FOB: Destination

MILSTRIP: N0018320RCPH001

NET AMT

0001AC

Total Particulate Count Testing

(ISO Classification) Series for Clean Rooms

6 Clean Rooms X 2 per year = 12 quantity FOB: Destination

MILSTRIP: N0018320RCPH001

NET AMT

0001AD

HEPA Air Changes & Room Pressure

Verification

4 Clean rooms X 2 = 8 quantity FOB: Destination

MILSTRIP: N0018320RCPH001

NET AMT

0001AE

Biannual Viable Air Sampling

2 samples (Bacterial, Fungi)

29 locations X 2 each location = 58 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

MILSTRIP: N0018320RCPH001

NET AMT

0001AF

Biannual Viable Surface Sampling

2 samples (Bacterial, Fungi)

45 locations X 2 each location = 90 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

MILSTRIP: N0018320RCPH001

NET AMT

0001AG

Biosafety Cabinets

Manufacturer: NUAIRE INC Nomenclature: Biosafety Cabinets Model, S/N, ECN as follows:

(1)NU-430-400, 63723 ACT, 047118

(2)NU-430-400, 102051101805, 065246

(3)NU-430-400, 102044101705, 065247

(4)NU-430-400, 102049101805, 065248

(5)NU-430-400, 101941101205, 065249

(6)NU-430-400, 102050101805, 065251

(7)NU-430-400, 63725 ACT, 01966B

(8)NU-425-300, 72827 AES, 047121

FOB: Destination

MILSTRIP: N0018320RCLC022

PURCHASE REQUEST NUMBER: N0018320RCLC022

NET AMT

0001AH

Chemical Fume Hood

Manufacturer: Hamilton Co.

Nomenclature: Chemical Fume Hood Model, S/N, ECN as follows:

(1)Safeaire, 70532, 01819B FOB: Destination

MILSTRIP: N0018320RCLC022

NET AMT

FFP

in accordance with Section C, Performance Work Statement; to include semi-annual on-site recertification of (CACI/CAI) Containment Technologies Group Mobile Isolation Chamber (MIC), Laminar Flow Work Stations (LAFW's), Total Particulate Count (ISO Classification) of Hoods and Clean Rooms, Viable Air Sampling (Bio-aerosol sample) of Hoods and Clean Rooms Validation to USP 797 criteria as follows:

Period of Performance: 01 OCT 2020 - 30 SEP 2021

NET AMT

0002AA

FFP

(CAC/CACI) Mobile Isolation Chamber (MIC), 6 Hoods 6 hoods X 2 certifications per year = 12 quantity

Manufacturer: Containment Technologies Group Inc Nomenclature: Barrier Isolators Model, S/N, ECN as follows:

(1)MIC Single, 0805-MPA-363, 063436 (2)MIC Single, 0805-MPA-364, 063437 (3)MIC Dual, 1206-MPD-568, 069956 (4)MIC Dual, 1106-MPD-558, 069957

(5)MIC TPN, 1206-TPN-567, 069958

(6)MIC Single, 1206-MPD-566, 069959 FOB: Destination

NET AMT

0002AB

FFP

3 hoods X 2 certifications per year = 6 quantity

Manufacturer: Baker CO Inc Nomenclature: Laminar Flow Work Stations Model, S/N, ECN as follows:

(1)EG-4252, 98676, 104089

(2)EG-4252, 97805, 104090

(3)EG-6252, 98687, 104091

NET AMT

0002AC

FFP

(ISO Classification) Series for Clean Rooms

6 Clean Rooms X 2 per year = 12 quantity

NET AMT

0002AD

FFP

Verification

4 Clean rooms X 2 = 8 quantity

NET AMT

0002AE

FFP

2 samples (Bacterial, Fungi)

29 locations X 2 each location = 58 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0002AF

FFP

2 samples (Bacterial, Fungi)

45 locations X 2 each location = 90 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0002AG

FFP

Manufacturer: NUAIRE INC Nomenclature: Biosafety Cabinets Model, S/N, ECN as follows:

(1)NU-430-400, 63723 ACT, 047118

(2)NU-430-400, 102051101805, 065246

(3)NU-430-400, 102044101705, 065247

(4)NU-430-400, 102049101805, 065248

(5)NU-430-400, 101941101205, 065249

(6)NU-430-400, 102050101805, 065251

(7)NU-430-400, 63725 ACT, 01966B

(8)NU-425-300, 72827 AES, 047121

NET AMT

0002AH

FFP

Manufacturer: Hamilton Co.

Nomenclature: Chemical Fume Hood Model, S/N, ECN as follows:

(1)Safeaire, 70532, 01819B

NET AMT

FFP

in accordance with Section C, Performance Work Statement; to include semi-annual on-site recertification of (CACI/CAI) Containment Technologies Group Mobile Isolation Chamber (MIC), Laminar Flow Work Stations (LAFW's), Total Particulate Count (ISO Classification) of Hoods and Clean Rooms, Viable Air Sampling (Bio-aerosol sample) of Hoods and Clean Rooms Validation to USP 797 criteria as follows:

Period of Performance: 01 OCT 2021- 30 SEP 2022

NET AMT

0003AA

FFP

(CAC/CACI) Mobile Isolation Chamber (MIC), 6 Hoods 6 hoods X 2 certifications per year = 12 quantity

Manufacturer: Containment Technologies Group Inc Nomenclature: Barrier Isolators Model, S/N, ECN as follows:

(1)MIC Single, 0805-MPA-363, 063436 (2)MIC Single, 0805-MPA-364, 063437 (3)MIC Dual, 1206-MPD-568, 069956 (4)MIC Dual, 1106-MPD-558, 069957

(5)MIC TPN, 1206-TPN-567, 069958

(6)MIC Single, 1206-MPD-566, 069959

NET AMT

0003AB

FFP

3 hoods X 2 certifications per year = 6 quantity

Manufacturer: Baker CO Inc Nomenclature: Laminar Flow Work Stations Model, S/N, ECN as follows:

(1)EG-4252, 98676, 104089

(2)EG-4252, 97805, 104090

(3)EG-6252, 98687, 104091

NET AMT

0003AC

FFP

(ISO Classification) Series for Clean Rooms

6 Clean Rooms X 2 per year = 12 quantity

NET AMT

0003AD

FFP

Verification

4 Clean rooms X 2 = 8 quantity

NET AMT

0003AE

FFP

2 samples (Bacterial, Fungi)

29 locations X 2 each location = 58 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0003AF

FFP

2 samples (Bacterial, Fungi)

45 locations X 2 each location = 90 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0003AG

FFP

Manufacturer: NUAIRE INC Nomenclature: Biosafety Cabinets Model, S/N, ECN as follows:

(1)NU-430-400, 63723 ACT, 047118

(2)NU-430-400, 102051101805, 065246

(3)NU-430-400, 102044101705, 065247

(4)NU-430-400, 102049101805, 065248

(5)NU-430-400, 101941101205, 065249

(6)NU-430-400, 102050101805, 065251

(7)NU-430-400, 63725 ACT, 01966B

(8)NU-425-300, 72827 AES, 047121

NET AMT

0003AH

FFP

Manufacturer: Hamilton Co.

Nomenclature: Chemical Fume Hood Model, S/N, ECN as follows:

(1)Safeaire, 70532, 01819B

NET AMT

FFP

in accordance with Section C, Performance Work Statement; to include semi-annual on-site recertification of (CACI/CAI) Containment Technologies Group Mobile Isolation Chamber (MIC), Laminar Flow Work Stations (LAFW's), Total Particulate Count (ISO Classification) of Hoods and Clean Rooms, Viable Air Sampling (Bio-aerosol sample) of Hoods and Clean Rooms Validation to USP 797 criteria as follows:

Period of Performance: 01 OCT 2022 - 30 SEP 2023

NET AMT

0004AA

FFP

(CAC/CACI) Mobile Isolation Chamber (MIC), 6 Hoods 6 hoods X 2 certifications per year = 12 quantity

Manufacturer: Containment Technologies Group Inc Nomenclature: Barrier Isolators Model, S/N, ECN as follows:

(1)MIC Single, 0805-MPA-363, 063436 (2)MIC Single, 0805-MPA-364, 063437 (3)MIC Dual, 1206-MPD-568, 069956 (4)MIC Dual, 1106-MPD-558, 069957

(5)MIC TPN, 1206-TPN-567, 069958

(6)MIC Single, 1206-MPD-566, 069959

NET AMT

0004AB

FFP

3 hoods X 2 certifications per year = 6 quantity

Manufacturer: Baker CO Inc Nomenclature: Laminar Flow Work Stations Model, S/N, ECN as follows:

(1)EG-4252, 98676, 104089

(2)EG-4252, 97805, 104090

(3)EG-6252, 98687, 104091

NET AMT

0004AC

FFP

(ISO Classification) Series for Clean Rooms

6 Clean Rooms X 2 per year = 12 quantity

NET AMT

0004AD

FFP

Verification

4 Clean rooms X 2 = 8 quantity

NET AMT

0004AE

FFP

2 samples (Bacterial, Fungi)

29 locations X 2 each location = 58 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0004AF

FFP

2 samples (Bacterial, Fungi)

45 locations X 2 each location = 90 quantity NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

NET AMT

0004AG

FFP

Manufacturer: NUAIRE INC Nomenclature: Biosafety Cabinets Model, S/N, ECN as follows:

(1)NU-430-400, 63723 ACT, 047118

(2)NU-430-400, 102051101805, 065246

(3)NU-430-400, 102044101705, 065247

(4)NU-430-400, 102049101805, 065248

(5)NU-430-400, 101941101205, 065249

(6)NU-430-400, 102050101805, 065251

(7)NU-430-400, 63725 ACT, 01966B

(8)NU-425-300, 72827 AES, 047121

MILSTRIP: N0018320RCLC022

NET AMT

0004AH

FFP

Manufacturer: Hamilton Co.

Nomenclature: Chemical Fume Hood Model, S/N, ECN as follows:

(1)Safeaire, 70532, 01819B

NET AMT

Section C - Descriptions and Specifications

PWS

DESCRIPTION/SPECIFICATION/WORK STATEMENT

Performance Work Statement

As a minimum, Contractor shall:

Perform Semi-Annual on-site recertification of Mobile Isolation Chambers (MIC) (two (2) negative pressure and four (4) positive pressure), three (3) Laminar Flow Hoods identified in the SubCLINs of Section B, as required by USP Chapter 797, ISO 14644, and NSF/ANSI 49-2004a specifications. Airflow monitors on all hoods and chambers must be adjusted and tested to be compliant with manufacturer’s specifications and NSF/NASI49-2004a.

Contractor shall also perform Total Particulate Count Series (ISO Classification) for Clean Rooms/Ante Rooms and Total Particulate Count (ISO Classification) of Hoods to the above referenced Mobile Isolation Chambers, Laminar Flow Hoods, and Pharmacy Clean Rooms/Ante Rooms identified below to include semi-annual reports with diagram of clean rooms with location of particulate counts. Each room’s particulate count will be compared to ISO 14644-1 classifications and the class shall be listed in the report.

The seven (7) Pharmacy Clean Rooms/Ante Rooms are located as follows: (Subject to change due to construction, but will remain 7 locations)

(1) Charette Health Care Center, Building #2, 2nd Floor, Main Pharmacy

(2) Charette Health Care Center, Building #2, 2nd Floor, Main Pharmacy Ante Room

(3) Charette Health Care Center, Building #2, 2nd Floor, Chemo Pharmacy

(4) Charette Health Care Center, Building #2, 2nd Floor, Chemo Pharmacy Ante Room

(5) Charette Health Care Center, Building #2, 4th Floor, NICU Pharmacy

(6) Charette Health Care Center, Building #2, 4th Floor, Chemo

In accordance with the SubCLINs in Section B, a minimum* of two (2) particle samples per each Mobile Isolation Chamber and each flow hood and two (2) particle samples per each clean room from separate locations shall be obtained to establish average high and low.

In accordance with the SubCLINs in Section B, a minimum* of one (1) bacteria and one (1) fungus sample on each of the 9 pharmacy hoods: Three (3) Laminar Flow Hoods, Two (2) Negative Pressure MIC, Four (4) Positive Pressure MIC, and Two (2) each from separate locations in each of the six (6) clean rooms/ante rooms is required monthly.

*Minimum sampling stated or as required per ISO 14644. (Contractor’s proposal shall indicate number of samples to be obtained.)

Semi-annual recertifications and particle counts shall be conducted as soon as possible after receipt of award but no later than 31 Mar 2020 and 30 September 2020. Contractor shall contact Point of Contact, HM1 Jason Borsellino@ (757) 953-5336/5764 to coordinate dates and times for each site visit.

Contractor shall change filters of hoods when needed.

Contractor shall provide semi-annual reports to Point of Contact no later than 7 working days after collection of sampling.

Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information (Jan 2017)

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 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD-12)” dated November 26, 2008 (or its subsequent DoD instruction) 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 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, 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 Department of Defense Common Access Card (DoD 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 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 SYSTEMS

In accordance with 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 Protected Health Information (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.

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 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 Technical Level 1, and must be trained and certified on the Operating System or Computing Environment 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 Information Assurance 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 Information Technology 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 Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 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 Assurance (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 Command's Security Manager 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 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 Command Security Manager.

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 Protected Health Information (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 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 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 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 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 Command’s Security Manager 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 Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 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 Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager 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 Command’s Security Manager 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.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-SEP-2020

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2020

N00183

30-SEP-2020

N00183

30-SEP-2020

N00183

30-SEP-2020

N00183

30-SEP-2020

N00183

30-SEP-2020

N00183

30-SEP-2021

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2021

N00183

30-SEP-2021

N00183

30-SEP-2021

N00183

30-SEP-2021

N00183

30-SEP-2021

N00183

30-SEP-2021

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2022

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2022

N00183

30-SEP-2023

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

30-SEP-2023

N00183

CLAUSES INCORPORATED BY REFERENCE

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(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.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (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 System for Award Management at https://www.sam.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 shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

____Invoice 2-in-1 Service________________________________________________________

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(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*

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”) (**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(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_____

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Section H - Special Contract Requirements

NMCARS 5237.102-90 Enterprise-wide Contractor Manpower Reporting Application (ECMRA)

The contractor shall report contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Naval Medical Center Portsmouth via a secure data collection site. Contracted services excluded from reporting are based on Product Service Codes (PSCs). The excluded PSCs are:

(1) W, Lease/Rental of Equipment;

(2) X, Lease/Rental of Facilities;

(3) Y, Construction of Structures and Facilities;

(4) S, Utilities ONLY;

(5) V, Freight and Shipping ONLY.

The contractor is required to completely fill in all required data fields using the following web address https://doncmra.nmci.navy.mil.

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

(End of Text)

Base Access (NMCP)

Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting Naval Medical Center Portsmouth (NMCP) may obtain daily passes directly from Naval Station Norfolk (NSN) Pass and ID office, located at NSN (Bldg CD-9), 9040 Hampton Blvd, Norfolk, Virginia, 23505, by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractor NCACS service providers. Credentials will be issued every five years and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding NCACS can be found at http://cnic.navy.mil/CNIC_HQ_Site/index.htm.

PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION

1. Introduction

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Business Associate agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02, as amended. Additional requirements will be addressed when implemented.

a. Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02.

(1) HITECH Act shall mean the Health Information Technology for Economic and Clinical Health Act included in the American Recovery and Reinvestment Act of 2009.

(2) Individual has the same meaning as the term “individual” in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

(3) Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

(4) Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 160.103, limited to the information created or received by the Business Associate from or on behalf of the Government pursuant to the Contract.

(5) Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

(6) Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103.

(7) Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

(8) Security Incident will have the same meaning as the term “security incident” in 45 CFR 164.304, limited to the information created or received by Business Associate from or on behalf of Covered Entity.

(9) Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C.

(10) Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501.

b. The Business Associate shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

c. The Business Associate shall use appropriate safeguards to maintain the privacy of the Protected Health Information and to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

d. The HIPAA Security administrative, physical, and technical safeguards in 45 CFR 164.308, 164.310, and 164.312, and the requirements for policies and procedures and documentation in 45 CFR 164.316 shall apply to Business Associate. The additional requirements of Title XIII of the HITECH Act that relate to the security and that are made applicable with respect to covered entities shall also be applicable to Business Associate. The Business Associate agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

e. The Business Associate shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Business Associate of a use or disclosure of Protected Health Information by the Business Associate in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm

f. The Business Associate shall report to the Government any security incident involving protected health information of which it becomes aware.

g. The Business Associate shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Business Associate becomes aware.

h. The Business Associate shall ensure that any agent, including a sub Business Associate, to whom it provides Protected Health Information received from, or created or received by the Business Associate, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Business Associate with respect to such information.

i. The Business Associate shall ensure that any agent, including a subBusiness Associate, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

j. The Business Associate shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

k. The Business Associate shall make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government.

l. The Business Associate shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Business Associate, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

m. The Business Associate shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

n. The Business Associate shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

2. General Use and Disclosure Provisions

Except as otherwise…