SOW Scope ENT.pdf

STATEMENT OF WORK

ENT SCOPES

SERVICE AND MAINTENANCE

1. Scope: The contractor shall provide all services, labor, parts, materials, and equipment necessary for the comprehensive service and maintenance of the government-owned surgical endoscopy equipment as listed in Appendix A, "Serviceable Equipment," at Naval Medical Center San Diego (NMCSD). The Contractor shall service and maintain the equipment to meet or exceed original equipment manufacturer (OEM) specifications, in accordance with all applicable US, State, and Local laws and regulations, US Navy regulations, and Joint Commission requirements. All services shall be performed at the Contractor's off-site certified repair facility.

2. Definitions:

• 2.1. Service and Maintenance: (a) any modification, adjustment, or replacement of parts on the equipment that corrects a malfunction and effectively brings the equipment into material conformity with its OEM technical specification; (b) any procedure or routine that, when observed, avoids a material adverse effect on the equipment's function; (c) any measures performed during repair that assure the continued safe operation of the equipment and return it to its designed efficiency and capacity; (d) the one-for-one replacement of a piece of equipment deemed beyond economical repair with a substitute of equal or greater value and technological capability.

• 2.2. Contracting Officer (KO): A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

• 2.3. Technical Representative (TR): A Government employee appointed by the KO (also referred to as COR) responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

3. Location:

The serviceable equipment is located at:

• Naval Medical Center San Diego

• 34800 Bob Wilson Drive, San Diego, CA 92134-5000

• Building 2, Second Floor, ENT Clinic

Primary coordination and shipping point of contact is:

• Biomedical Repair Division

• Building One, Ground Floor

4. Requirements:

4.1. General Performance Requirements:

• 4.1.1. The Contractor shall provide equipment maintenance services to include all unscheduled corrective repairs in accordance with OEM specifications. While this contract does not include on-site planned maintenance, the Contractor shall perform all necessary calibrations, adjustments, and preventative checks any time a piece of equipment is sent to its facility for service.

• 4.1.2. The Contractor may use third-party service vendors; however, these vendors must be approved in advance, in writing, by the KO and TR. A list of any intended sub-contractors must be submitted for approval prior to their use.

• 4.1.3. Ensure that only fully qualified engineers and/or technicians who have completed OEM or equivalent certified training schools for the specific equipment shall perform work under this contract. Upon request, the Contractor shall provide written assurance of their personnel's competency, including training certificates or credentials.

• 4.1.4. Test Equipment: Test equipment used to certify repairs shall have its calibration traceable to the National Institutes of Standards and Technology (NIST). Upon request, the Contractor shall provide a copy of the current calibration certification of any test equipment used on NMCSD equipment.

• 4.1.5. Field Service Reports (FSR): The Contractor shall furnish a written or electronic service report for every completed service event. All reports shall be submitted within 72 hours of the equipment's return to NMCSD and sent to usn.nmcsd-contractadministrator@health.mil. The report shall include, at a minimum:

1. Contractor Name

2. Technician's Name/ID

3. Date item was received at Contractor facility and date returned to NMCSD

4. ECN (if provided by Navy) and Serial Number of Equipment

5. A summary of the as-received condition and a detailed description of the work performed and parts replaced.

• Completed FSRs are required prior to acceptance of any invoice. It is highly recommended to attach a copy of the FSR to the Wide Area Workflow Invoice.

4.2. NMCSD Preventive and Uptime Requirements:

• 4.2.1. During any repair service, the Contractor shall perform all work necessary to minimize future corrective maintenance, including calibration, adjustment, lubrication, and testing required to maintain a safe environment of care and meet OEM specifications.

• 4.2.2. During service, the Contractor shall make repairs to the extent necessary to ensure a functional system that will efficiently serve its intended purpose.

• 4.2.3. Installation of system update changes to resolve specific product reliability problems shall be included. Hardware/software upgrades that solely enhance or add new product features are excluded.

• 4.2.4. While on-site Preventive Maintenance is not required, the Government reserves the right to send any piece of covered equipment to the Contractor for a full preventative check and service, at its discretion, a minimum of 1 time per year.

• 4.2.5. Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better for all equipment covered. Uptime is defined as any time the equipment is not in transit to/from the contractor or at the contractor's facility for repair.

• 4.2.6. Uptime Calculation: Uptime is calculated on a rolling 6-month basis.

4.3. NMCSD Corrective Maintenance Requirements:

https://www.google.com/url?q=mailto%3Ausn.nmcsd-contractadministrator%40health.mil

• 4.3.1. The Contractor shall correct any inoperable condition in a timely manner by providing all necessary services at its off-site facility.

• 4.3.2. The Contractor shall provide all work necessary to restore the equipment to a properly serviceable/operating condition through adjustments, replacement parts, or complete overhaul as required.

• 4.3.3. Equipment improvements/modifications shall be made only upon BIOMED written approval and direction.

• 4.3.4. The Contractor shall notify BIOMED immediately upon receipt of any OEM safety recall notices pertaining to the covered equipment.

• 4.3.5. The original design and functional capabilities shall not be changed, modified, or altered without express written authorization from BIOMED.

• 4.3.6. The Contractor shall provide all suitable OEM-recommended repair equipment/tools required for the satisfactory execution of all repairs.

• 4.3.7. The Contractor shall furnish OEM-approved lubricants and lubricate wear points in accordance with OEM guidelines during any service event.

• 4.3.8. All replacement parts shall be new or OEM-certified refurbished parts that meet OEM specifications. The use of refurbished parts requires prior written approval from the TR for each instance. All replacement parts are warranted for the duration of the contract term.

4.4. End-User Requirements:

• 4.4.1. Service shall be performed on all devices submitted under this contract, regardless of the nature of the cause warranting service, excluding cases of overt abuse or negligence as determined by a joint review between the Contractor and TR.

• 4.4.2. Services shall be unlimited. There shall be no cap or limit on the number of repairs or replacements for any individual unit or for the facility.

• 4.4.3. The Contractor shall keep department personnel informed as to the repair status of equipment out for repair via a web portal or other communication method. The primary point of contact is:

Biomedical Repair Contracts team at 619-532-8017 or usn.nmcsd-contractadministrator@health.mil.

• 4.4.4. CATASTROPHIC DAMAGE CLAUSE: If equipment is received and deemed irreparably damaged (BER), the Contractor must provide a written report detailing the extensiveness of the damage and a technical assessment of the suspected cause before a replacement is issued.

4.5. Response Time:

• 4.5.1. The Contractor shall provide telephone consulting services 24 hours a day, 7 days a week.

During business hours (0800-1600 PST, M-F), the Contractor shall respond by telephone to any report of a malfunction within four (4) hours of notification.

5. Travel and Related Expenses: Not applicable, as all services are performed at the Contractor's off-site facility. All shipping and transportation costs are the responsibility of the Contractor.

6. Shipment: The contractor shall ship requested shipping materials to arrive at NMCSD within two (2) business days of the request. All shipping expenses/costs are included in the contract price.

7. Liability:

• 7.1. The Contractor shall not be liable for loss or delay due to causes beyond their reasonable control (force majeure).

• 7.2. NMCSD Employees will not perform maintenance or attempt repairs to equipment covered under this contract.

• 7.3. Insurance: The Contractor shall maintain general liability insurance of at least $500,000 per occurrence and property damage liability insurance of at least $500,000, meeting the requirements of

FAR 28.307-2.

8. Utilities, Facilities, and Equipment Access: Not applicable for on-site work. For the purposes of off-site repair, the Government will provide access to the equipment for shipping coordination.

9. Security and Safety Requirements: As all work is performed off-site, on-site security access requirements are not applicable to repair technicians. Any Contractor representative visiting the facility for logistical or administrative purposes must coordinate with NMCSD Security for access.

10. Compliance with Applicable Laws: The Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements.

11. Modifications to Contract: Only the KO has the authority to obligate the government in writing.

12. Invoicing: All invoicing shall be done in accordance with this SOW and the contract terms via Wide Area Workflow (WAWF).

13. NMCSD Points of Contact:

• Primary Technical/Shipping POC:

• Biomedical Repair Division, Tel: 619-532-8017, Email: usn.nmcsd-contractadministrator@health.mil

• Administrative Matters: Refer to the KO designated on the contract award document (SF 1449).

7229AA 3 HOPKINS II TELESCOPE 02,

2.7MM, 18CM

ENT Rigid Scopes

WD300 2 AIDA DOCUMENTATION

SYSTEM, 4K

ORl AIDA

WM200 2 ORl SMARTSCREEN FOR

WD300 AIDA BELLA

ORl AIDA

TH110 5 ASM,CAMERA HEAD,HX,1080P VID Cameras TH121 2 IMAGElS 4U RUBINA, OPALl

NIR/ICG

VID Cameras

TC201US 2 CCU, MODULAR, IMAGEl S

CONNECT II, US

VID CCU

TC301US 2 CCU,MODULAR,IMAGEl S X-

LINK,US

VID CCU

TC304US 2 CCU,MODULAR,4U-LI NK,US VID CCU

XUSM0030 2 27" 4K Monitor with 12G-SDI input VID Flat Panels

495ND 16 LIGHT CABLE, 3.5MM X 300CM.

LGTH 9.8 FT

VID Light Cables

TL400 2 COLD LIGHT FOUNTAIN LED

LIGHT P

VID Light Sources

TP101 5 TELE PACK+ VID Telepack X

11101SKK2 1 7.5 FR. X 250MM RHINO-

LARYNGO SCOPE

ENT Flexible Fiber

11101RPK2 17 RHINO-LARYNGOSCOPE,

FLEX,11 FR. X 300

ENT Flexible Fiber

R11101RPK2 1 FIBERSCOPE, RHINO-LARYNGO. ENT Flexible Fiber

11101RP2 6 RHINO-LARYNGO-FIBERSCOPE

3.5 MM, 30 CM

ENT Flexible Fiber

11101HDK 7 HD VIDEO-RHINO-

LARYNGOSCOPE, 3.7MM

ENT Flexible Video

TC009 2 ADAPTOR,USB ACCESSORY VID Instrument

7229CA 2 HOPKINS II TELESCOPE 702,

2.7MM, 18CM

ENT Rigid Scopes

R7229BA 1 HOPKINS II TELESCOPE 302,

2.7MM, 18CM

ENT Rigid Scopes

10020ATA 3 TELESCOPE HOPKINS STRGHT

FORWARD

ENT Rigid Scopes

10324AA 5 TELESCOPE, HOPKINS,

STRAIGHT FORWARD

ENT Rigid Scopes

10017AA 4 TELESCOPE,HOPKINS

0',AUTOCLAV>

ENT Rigid Scopes

10018AA 5 TELESCOPE,HOPKINS

02,AUTOCLAVBLE

ENT Rigid Scopes

1218AA 2 TELE-OTOSCOPE W/HOPKINS

STRGHT

ENT Rigid Scopes

1230AA 2 TELESCOPE,HOPKINS STRAIGHT ENT Rigid Scopes

7220AA 1 TELESCOPE,HOPKINS,0°,3MM,

14CM

ENT Rigid Scopes

7220BA 3 TELESCOPE,HOPKINS,30°,3M

M, 14CM

ENT Rigid Scopes

7220CA 11 TELESCOPE,HOPKINS,70°,3M

M, 14CM

ENT Rigid Scopes

R7220AA 1 TELESCOPE,HOPKINS,0°,3MM,

14CM

ENT Rigid Scopes

R7220BA 2 TELESCOPE,HOPKINS,30°,3M

M, 14CM

ENT Rigid Scopes

8706CA 2 LARYNGOSCOPE-STROBO, W/ ENT Rigid Scopes

7230AA 5 TELESCOPE, HOPKINS II, 0', 4MM

DIAMETER

ENT Rigid Scopes

7230BA 1 TELESCOPE, HOPKINS 11,30',

4MM DIAMETER

ENT Rigid Scopes

7230BVA 3 TELESCOPE, HOPKINS II

FORWARD OBLIQUE

ENT Rigid Scopes

7230CVA 3 TELESCOPE, HOPKINS II

LATERAL, 70',

ENT Rigid Scopes

R7230AA 12 TELESCOPE, HOPKINS II, 0',

LENGTH 18 CM

ENT Rigid Scopes

R7230BA 4 TELESCOPE,HOPKINS II,

FORWARD-OBLIQUE,

ENT Rigid Scopes

R7230BVA 5 TELESCOPE, HOPKINS II

FORWARD OBLIQUE

ENT Rigid Scopes

R7230CVA 4 TELESCOPE, HOPKINS II

FORWARD OBLIQUE

ENT Rigid Scopes lO00SAA 4 HOPKINS II TELESCOPE o•, 4 MM ENT Rigid Scopes 1216AA 2 TELESCOPE, HOPKINS QQ, AUTOCLAVE ENT Rigid Scopes 1215AA 2 TELE-OTOSCOPE,HOPKINS,0',AUTO- ENT Rigid Scopes 8712AA 4 TELESCOPE,HOPKINS 11,0',AUTO- ENT Rigid Scopes