N0018318Q0131.docx

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Attached to
MAINTENANCE MEDICAL LASERS Federal contract opportunity
Solicitation number
N0018318Q0131
Issued by
Department of the Navy Bureau of Medicine and Surgery

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N0018318Q0131

Section A - Solicitation/Contract Form

CONTRACT INFORMATION

VENDOR TO COMPLETE THE FOLLOWING:

TIN:CAGE:DUNS:
Vendor Point of Contact:Email:
Vendor Phone:Fax:

POINTS FO CONTACT

Naval Medical Center Portsmouth Points of Contact:

Name: Shannon Caldow Phone: 757-953-5056 E-Mail: shannon.m.caldow.civ@mail.mil

REQUEST FOR QUOTE INFORMATION & EVALUATUION FACTORS

Vendor to reference Request for Quotation (RFQ) Number N0018318Q0131 on all correspondence relating to this RFQ

The government will make an award based on an “All or None” evaluation and/or based on the “Best Value” proposed for this requirement in terms of technical capabilities/approach, past performance, and price. Vendors must provide all of the below to be considered a “responsive vendor”. The solicitation and contract award is in accordance with FAR 52.211-6 Brand Name or Equal. All evaluation factors are listed in Section M of this RFQ.

PAYMENT INFORMATION

Payment in Arrears (Check One): Monthly Quarterly Semi-Annually Annually *Please ensure that quoted price matches the choice above

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: Websites: 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. This contract is subject to the Availability of funds clause 52.232-18 listed in full text in the Clause section of this contract.

Section B - Supplies or Services and Prices

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Otolaryngolog

CUSTID: BBFA00

FOB: Destination

MILSTRIP: N0018319RCXC102

PURCHASE REQUEST NUMBER: N0018319RCXC102

PSC CD: J065

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Sewell's Point

CUSTID: CAAA02

FOB: Destination

MILSTRIP: N3251019RCD1007

PURCHASE REQUEST NUMBER: N3251019RCD1007

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Oceana Primary Care

CUSTID: BHAK00

FOB: Destination

MILSTRIP: N3252819RCH3005

PURCHASE REQUEST NUMBER: N3252819RCH3005

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Ophthalmology cUSTID: BBDA00 FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RC4P101

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Cardiology O/P

CUSTID: BACA00

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCCC101

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Dental Clinic NMCP

CUSTID: CAAA00

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCD2101

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Dermatology

CUSTID: BAPA00

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCDE101

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Plastic Surgery

CUSTID: BDGA00

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCPL102

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Main Operating Room / DSS

CUSTID: DFBA00

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCSU105

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot

Maintenance - Lasers

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Cross Sectional Radiology

CUSTID: DCAA03

FOB: Destination

PURCHASE REQUEST NUMBER: N0018319RCXR012

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Otolaryngolog

CUSTID: BBFA00

FOB: Destination

MILSTRIP: N0018319RCXC102

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Sewell's Point

CUSTID: CAAA02

FOB: Destination

MILSTRIP: N3251019RCD1007

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Oceana Primary Care

CUSTID: BHAK00

FOB: Destination

MILSTRIP: N3252819RCH3005

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Ophthalmology cUSTID: BBDA00 FOB: Destination

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Cardiology O/P

CUSTID: BACA00

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Dental Clinic NMCP

CUSTID: CAAA00

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Dermatology

CUSTID: BAPA00

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Plastic Surgery

CUSTID: BDGA00

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Main Operating Room / DSS

CUSTID: DFBA00

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Lot
OPTION
Maintenance - Lasers

FFP

To be performed in accordance with Performance Work Statement (PWS) in Section C.

Department: Cross Sectional Radiology

CUSTID: DCAA03

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

LASERS – VARIOUS DEPARTMENTS

This contract shall provide full maintenance services for the items listed in Section B and all support items / components. This contract shall provide for maintenance services which include on-site corrective repairs, normal working hour coverage (8:00 A.M. to 4:30 P.M. Monday through Friday excluding Federal holidays) and 24-hour emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Selected vendor must provide technical assistance and telephone support 24 hours a day, 7 days per week.

1. General

a. The Contractor shall comply with HIPAA and DoD Business Associate Agreement as applicable to the performance of this contract.

b. The Contractor shall be fully qualified in the repair of all equipment listed within this contract. Contractor shall maintain current (within 2 years) qualifications throughout entire contract period. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM, training by independent schools, continuous hands-on repair experience with listed equipment. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance.

2. Scope of Work

a. The Contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.

b. The Contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. The Contractor will provide the name and phone number of a Government point of contact within 5 business days after receipt of award. A Contractor’s systems operator will be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet the original equipment manufacturers (OEM’s) specifications.

d. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government. The contractor shall provide contact information within 5 business days after contract award. In the event a replacement is made, the contractor shall provide the replacement’s contact information within 5 business days.

3. Government furnished property, Materials and Services.

a. The Contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the award of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start whichever occurs first. All non-apparent / hidden discrepancies must be identified no later than the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor’s normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without corrective maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects either are a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

b. 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.

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

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

4. Contractor Furnished Property and Material.

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

5. Replacement Parts.

a. The Contractor 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 replacements parts are required to be shipped. Shipping shall be performed with Next Day Air at no additional cost to the Government. If Next Day is not available, then contractor shall ship by the next fastest means.

b. The Contractor shall at their expense; replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the Contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

d. 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.

e. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, the COR must approve the use of rebuilt parts and sub-assemblies prior to ordering and installing. Use of rebuilt parts is allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall specifically annotate on the final Field Service Report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality.

f. The Contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of Preventative Maintenance Schedules.

Specific Tasks

6. Contractor Report Requirements.

a. During normal duty hours, Contracted Field Service Engineer (FSE) personnel shall check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. (Biomedical Engineering located in Build-250 1st floor; 757-953-5336). The Contractor FSEs shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Contractor FSE’s shall notify the duty Biomedical Engineer (BME) via cell phone 757-544-4506 to provide status of service performed, including PMs and corrective maintenance.

b. The Contractor shall provide to BME a full service report within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, par value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended and the hourly rate normally charged for the type of service performed, model and serial numbers, and the name of the FSE performing the service. In the event that agents / sub-contractors are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed.

7. Contractor Responsibility.

a. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor’s expense and shall be inspected to the satisfaction of the KO or appointed representative.

8. Preventive Maintenance Services.

a. In accordance with Naval Medical Logistics Command (NAVMEDLOGCOM) Risk Assessment Criteria, preventive maintenance shall be performed two (2) times per year in accordance with the Original Equipment Manufacturers (OEM) recommendations.

b. The preventive maintenance visits shall be performed during the following months:

First PM by end of
Second PM by end of
December 2018
June 2019
December 2019
June 2020

The Contractor shall schedule and complete preventive maintenance services prior to the 15th of the selected month.

c. During each scheduled preventive maintenance visit performed during the Base and each Option Year, the Contractor shall replace the steam, water and exhaust manifolds, door gaskets and other worn or defective parts as required completing the preventive maintenance.

d. All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required by Bureau of Medicine and Surgery (BUMED) Equipment Management Manual NAVMED P-5132 (CH-1, rev.1-2008).

9. Corrective Maintenance

a. Normal Working Hour Maintenance Coverage Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 2 hours after receipt of trouble call, and provide on-site service no later than the close of business (4:30 pm) on the next business day. Equipment shall be operational within 48 hours.

b. Government request for corrective maintenance will be placed by BME, to the Contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract.

c. The Contractor shall assign a unique Log/Reference Number to each Government request for Corrective Maintenance.

d. Contractor’s response to requests for service may include telephone consultation with the equipment user/operator and a Contractor 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. Contractor’s pricing shall be inclusive of all cost including parts, labor, travel and shipping.

f. The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

10. Removal of Government Property

a. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify BME who will make arrangements for the Contractor to remove the item to the Contractor’s designated site. The Contractor will be required to sign a Government form accepting responsibility for the Government equipment. The Contractor shall provide a detailed description and quantities of items to be removed. Description shall include manufacturer’s serial numbers and equipment control number (ECN). In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

b. In the event that that contractor determines the equipment must be moved to an alternate location for repair, the Contractor is responsible for transporting the equipment to the alternate location and returning the repair equipment back to the Government site.

11. Equipment Modification Upgrades

a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME COR prior to the Contractor installation of any modification, alteration, or upgrades.

b. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

c. The Government shall not alter the system without prior notification to the Contractor.

d. The contractor shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

12. Service beyond the Scope of the Contract

a. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the Contractor considers they are not responsible for under the terms of this contract. The Contractor shall state why this existence or development is not within scope.

13. Locations

a. Locations are specified in Section B of this contract. The majority of the equipment is located at Naval Medical center Portsmouth (required base access). The remaining equipment is at Sewell’s Point Dental Clinic (required clinic access only). Vendor must comply with the requirement to register with Vendormate (Section H) and must check in with the POC in Biomedical Engineering before entering clinic spaces for preventive maintenance services.

EQUIPMENT LIST

CUSTID / CLIN
ECN
Mft Name
Common Model
Mfr. Serial No.
Nameplate Model
Equipment Nomenclature
Customer Name
Acqn Date
Monthly Cost

BACA00/

0005/1005

076666
VASCULAR SOLUTIONS INC.
VARILASE
18604
7550
LASER, DIODE
CARDIO O/P
29/Aug/07

Base Year Cost:

Option Year Cost:

DCAA03/

0010/1010

104737
ANGIODYNAMICS INC
DELTA15
DELTA15004132
DELTA15
LASER, DIODE, SURGICAL
CROSS SECTIONAL RAD DCSS
09/Sep/09

Base Year Cost:

Option Year Cost:

CAAA00/

0006/1006

00152C
COHERENT MEDICAL GROUP
ENCORE
E1226621
UP5000
LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC
DENTAL SERVICES BLDG. 2 - NMCP
13/Jul/01

CAAA00/

0006/1006

129634
MILLENNIUM DENTAL TECHNOLOGIES INC
PL172078
PERIOLASEMVP7
LASER, ND:YAG, DENTAL
DENTAL SERVICES BLDG. 2 - NMCP
17/Mar/17

Base Year Cost:

Option Year Cost:

BAPA00/

0007/1007

076909
CANDELA CORP
GENTLEMAX
991404000106
755
LASER, ND:YAG, DERMATOLOGIC
DERMATOLOGY O/P
27/Sep/07

BAPA00/

076917
CANDELA CORP
ALEX TRIVANTAGE
991404000074
ALEX TRIVANTAGE
LASER, ALEXANDRITE, DERMATOLOGIC
DERMATOLOGY O/P
02/Oct/07

BAPA00/

121491
CANDELA CORP
VBEAMPERFECTA
991403001998
VBEAM PERFECTA
LASER, DYE, DERMATOLOGIC
DERMATOLOGY O/P
02/Jul/14

BAPA00/

111478
LUMENIS INC
ULTRAPULSE
585
GA0000530
LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC
DERMATOLOGY O/P
30/Sep/11

BAPA00/

076774
PALOMAR MEDICAL TECHNOLOGIES INC
550337
STARLUX500
LASER, ND:YAG, FREQUENCY-DOUBLED, DERMATOLOGIC
DERMATOLOGY O/P
08/Sep/07

BAPA00/

105225
RA MEDICAL SYSTEMS
471
EX308
LASER, EXCIMER
DERMATOLOGY O/P
05/Oct/09

BAPA00/

117843
SCITON INC
1448346068
JOULE7
LASER, ER:YAG, DERMATOLOGIC
DERMATOLOGY O/P
03/Jun/13

BAPA00/

128439
SOLTA MEDICAL
J0592
FRAXELRESTOREDUA
LASER, DUAL WAVELENGTH SYSTEM,DERMATOLOGIC
DERMATOLOGY O/P
09/Oct/12

Base Year Cost:

Option Year Cost:

DFBA00/

0009/1009

100679
LUMENIS INC
01475912
064240701
LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC
DSS MAIN OPERATING ROOM/SU
30/Sep/08

Base Year Cost:

Option Year Cost:

BHAK00/

0003/1003

103328
SIRONA USA
03587
6088749
LASER, DIODE, DENTAL
OCEANA PRIMARY CARE
01/Jun/09

Base Year Cost:

Option Year Cost:

BBDA00/

0004/1004

053646
IRIDEX CORP
OCULIGHTSL
1622
OCULIGHT SL
LASER, DIODE, OPHTHALMIC
OPHTHALMOLOGY OP
13/Apr/04

BBDA00/

076798
IRIDEX CORP
GL16477C30
OCULIGHT GLX
LASER, DIODE, OPHTHALMIC
OPHTHALMOLOGY OP
15/Sep/07

BBDA00/

116909
LUMENIS INC
10376
SELECTAII
LASER, ND:YAG, FREQUENCY-DOUBLED, OPHTHALMIC
OPHTHALMOLOGY OP
27/Sep/12

Base Year Cost:

Option Year Cost:

BBFA00/

0001/1001

119604
AMS USA
A1877
00108118 AURA XP
LASER, ND:YAG
OTOLARYNGOLOGY O/P
03/Dec/13

Base Year Cost:

Option Year Cost:

BBGA00/

0008/1008

067022
ASCLEPION LASER TECHNOLOGIES
1624
162400216
1624
LASER, ER:YAG, DERMATOLOGIC
PLASTIC SURGERY O/P
08/Jun/06

BBGA00/

066732
LUMENIS INC
00950236
LUMENSONE
LASER, RUBY, DERMATOLOGIC
PLASTIC SURGERY O/P
21/Jun/06

BBGA00/

100680
LUMENIS INC
01475913
064240701
LASER, CARBON DIOXIDE, SURGICAL/DERMATOLOGIC
PLASTIC SURGERY O/P
30/Sep/08

Base Year Cost:

Option Year Cost:

CAAA02/

0002/1002

129635
MILLENNIUM DENTAL TECHNOLOGIES INC
PERIOLASE MVP-7
PL172075
PERIOLSDRMVP7
LASER, ND:YAG, DENTAL
SP - DENTAL CLINIC
16/Mar/17

Base Year Cost:

Option Year Cost:

CONTRACTOR UNCLASSIFIED ACCESS

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.

ECMRA REQUIREMENT

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 [NAMED COMPONENT] 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://www.ecmra.mil .

(End of Text)

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN
INSPECT AT
INSPECT BY
ACCEPT AT
ACCEPT BY
0001
Destination
Government
Destination
Government
0002
Destination
Government
Destination
Government
0003
Destination
Government
Destination
Government
0004
Destination
Government
Destination
Government
0005
Destination
Government
Destination
Government
0006
Destination
Government
Destination
Government
0007
Destination
Government
Destination
Government
0008
Destination
Government
Destination
Government
0009
Destination
Government
Destination
Government
0010
Destination
Government
Destination
Government
1001
Destination
Government
Destination
Government
1002
Destination
Government
Destination
Government
1003
Destination
Government
Destination
Government
1004
Destination
Government
Destination
Government
1005
Destination
Government
Destination
Government
1006
Destination
Government
Destination
Government
1007
Destination
Government
Destination
Government
1008
Destination
Government
Destination
Government
1009
Destination
Government
Destination
Government
1010
Destination
Government
Destination
Government

CLAUSES INCORPORATED BY REFERENCE

52.246-4
Inspection Of Services--Fixed Price
AUG 1996
252.246-7000
Material Inspection And Receiving Report
MAR 2008

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN
DELIVERY DATE
QUANTITY
SHIP TO ADDRESS
DODAAC / CAGE
0001
POP 01-OCT-2018 TO

30-SEP-2019

N/A
NAVAL MEDICAL CENTER

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

0002
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

0003
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

0004
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

0005
01-NOV-2013
1
NAVAL MEDICAL CENTER

RECEIVING OFFICER, BLDG. 250

PORTSMOUTH VA 23708-2297

N00183

0006
01-NOV-2013
1
(SAME AS PREVIOUS LOCATION)

N00183

0007
POP 01-OCT-2018 TO

30-SEP-2019

N/A
NAVAL MEDICAL CENTER

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

0008
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

0009
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

0010
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1001
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1002
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1003
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1004
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1005
01-NOV-2013
1
NAVAL MEDICAL CENTER

RECEIVING OFFICER, BLDG. 250

PORTSMOUTH VA 23708-2297

N00183

1006
01-NOV-2013
1
(SAME AS PREVIOUS LOCATION)

N00183

1007
POP 01-OCT-2018 TO

30-SEP-2019

N/A
NAVAL MEDICAL CENTER

BIOMEDICAL ENGINEERING

54 LEWIS MINOR STREET

BLDG. 250

PORTSMOUTH VA 23708-2297

757-953-5336

N00183

1008
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1009
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

1010
POP 01-OCT-2018 TO

30-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

N00183

52.247-35
F.O.B. Destination, Within Consignee's Premises
APR 1984

NMCP DOCK HOURS

Naval Medical Center Portsmouth (NMCP) Receiving Dock Hours of Operation:

NMCP Receiving Dock is open Monday through Friday 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(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 System for Award Management 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).

(Contracting Officer: Insert applicable document type(s). Note: If a “Combo” document type is identified but not supportable by the Contractor's business systems, an “Invoice” (stand-alone) and “Receiving Report” (stand-alone) document type may be used instead.)

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

(Contracting Officer: Insert inspection and acceptance locations or “Not applicable”.)

(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* Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC____
Issue By DoDAAC____
Admin DoDAAC____
Inspect By DoDAAC____
Ship To Code____
Ship From Code____
Mark For Code____
Service Approver (DoDAAC)____
Service Acceptor (DoDAAC)____
Accept at Other DoDAAC____
LPO DoDAAC____
DCAA Auditor DoDAAC____
Other DoDAAC(s)____

(*Contracting Officer: Insert applicable DoDAAC information or “See schedule” if multiple ship to/acceptance locations apply, or “Not applicable.”)

(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.

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

(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.

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

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

(End of clause)

Section H - Special Contract Requirements

PRIVACY & SECURITY OF PHI

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…

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