Opthomology Zeiss PWS for Services final.docx

Department of Defense Defense Health Agency Performance Work Statement

Annual Service on Zeiss Equipment Naval Medical Center Camp Lejeune (NMCCL), NC Solicitation Number:

Version:

Date: 07 JUL 2026

PART 1

1.0 GENERAL INFORMATION

1.1. Description of Service/Introduction: The contractor shall provide full-service maintenance for Zeiss ophthalmology equipment located at Naval Medical Center Camp Lejeune (NMCCL), Building 100, and Building 15, Hadnot Point, Camp Lejeune, NC

1.2. Background: NMCCL utilizes Zeiss devices to support mission-essential ophthalmology examinations. A comprehensive maintenance program is required to ensure proper functioning, calibration, and reliability of this equipment. Previous maintenance contract for these devices expired. Bldg. 15 Hadnot Point Marine Corps Base Camp Lejeune.

1.3. Period of Performance (PoP):

Base: 01 December 2026 – 30 November 2027 Option 1: 01 December 2027 – 30 November 2028 Option 2: 01 December 2028 – 30 November 2029 Option 3: 01 December 2029 – 30 November 2030 Option 4: 01 December 2030 – 30 November 2031

1.4. Objectives: - Provide regularly scheduled preventative maintenance (PM) on all covered Zeiss MediTec equipment. Ensure timely onsite repair and return to service of any malfunctioning equipment. Perform required software updates in accordance with manufacturer guidance.

1.5. Scope: The contractor shall provide full-service maintenance for Zeiss MediTec equipment, including PMs, repair services, and software updates. Services shall be performed in accordance with the manufacturer’s recommendations and applicable medical equipment service standards.

1.6. Federal Regulations: The contractor shall adhere to all applicable FDA regulations for servicing and maintenance of medical devices, including 21 CFR Parts 210, 211, 820, and 1271.

1.7. Geographical Location: Bldg. 100 Naval Hospital Camp Lejeune and Bldg. 15 Hadnot Point

1.8. Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services.

1.8.1. Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.9. Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the Contracting Officer (CO) and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.10. Contractor Identification: Contractor personnel shall wear identification badges displaying their name and company. Contractors must check in and out through NMCCL Biomedical Equipment (BMET) prior to and upon completion of services.

1.10.1. The contractor shall report to Biomedical Repair NMCCL, phone number (910) 450-4945, before any services are performed under this contract.

1.10.2. After services are completed, the contractor shall report to Bio Medical Repair via Ophthalmology NMCCL before departure. FSRs shall be submitted within 10 days of service completion. FSRs shall be emailed to dha.lejeune.camp-lejeune-nmc.list.nmccl-bmet@health.mil

PART 2

2.0 SPECIFIC TASK

2.1. Task Headings: Maintenance and repair.

2.1.1 Preventative Maintenance (PM)

The contractor shall perform one annual PM per covered Zeiss MediTec device in accordance with the manufacturer’s recommendations. BMET will notify the contractor at least 30 days in advance for scheduling. PMs will be completed withing the scheduled month.

2.1.2 Repair Services

The contractor shall provide repair services for malfunctioning equipment, including troubleshooting, parts replacement, and comprehensive testing. The contractor shall provide a 10-business day onsite response time for repair requests, unless parts are on backorder. If repair parts are not immediately available, the contractor shall complete repairs within 10 additional business days

2.1.3. Service Calls and Base Access

Upon arrival, the contractor shall check in with BMET, obtain security clearance, and be escorted to Ophthalmology. All services must be fully completed and verified before departure.

To gain access to the base, contractor must have a REAL ID in accordance with Real ID Act of 2005.

2.1.4. Field Service Report: (FSR) After services are completed the contractor has up to 15 days to complete a field service report so that BioMed can close out the work order.

2.2. List of Pieces of Equipment

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

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

3.1. Services: The Government:

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

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

3.2. Utilities: The Government:

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

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below: Utility power 120V 50-60Hz AC

3.3. Materials: The Government:

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

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

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1. Services: The Contractor:

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

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

4.2. General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 2 of this PWS.

4.3. Secret Facility Clearance: The contractor shall possess and maintain a SECRET facility clearance from the Defense Security Service. The contractor’s employees, performing work in support of this contract shall have been granted a SECRET security clearance from the Defense Industrial Security Clearance Office. NOT APPLCABLE

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 2)

Performance Requirements Summary (PRS) # 1.

The contractor shall provide PM services to ensure 100% operability in accordance with manufacturer policy.

PRS # 3

The contractor shall submit Field Service Reports (FSRs) within 15 days of service completion.

PRS # 4

The contractor shall perform required software updates and verify functionality.

DHA PWS, FEB 2024

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