06-SOW.docx

Great Plains Area Indian Health Service Statement of Work Acquisitions for Fort Thompson Optometry Project

C-1 Purpose:

To provide the award of Optometry Equipment with a firm-fixed price type contract for Fort Thompson Service Unit in Fort Thompson, SD.

C-2 Scope of Work:

The Contractor shall provide to the Great Plains Area Indian Health Service, hereafter referred to as the Government, with the Optometry Equipment described in this statement of work within 180 days of award contract.

Shipping Destination:

Fort Thompson Service Unit ATTN: Biomed 1323 BIA Route 4, Fort Thompson, SD 57339 Scheduled freight delivery should be between 8:00 AM and 5:00 PM Central Standard Time. Freight delivery should include lift-gate capability.

C-3 Equipment:

Acuity System Chart Specifications

· Screen: 21.5-inch or 22-inch high-resolution LED/LCD display.

· Memory: 512 MB RAM.

· Storage: 512 MB SSD.

· External Connections: 2 USB ports.

· Power Consumption: 120 VA.

Features and Capabilities

· Optotypes and Charts:

Offers a wide selection of optotypes (Letters, Numbers, Tumbling E, etc.) and test charts, including ETDRS, children's charts, clock fan, and astigmatism dots.

· Patient Education:

Includes anatomy photos and eye movies for patient education.

· Polarization:

Utilizes a unique polarization technique for 100% image separation and equal background color for both eyes.

· Stand-Alone: Can be operated as a standalone unit using a dedicated remote control.

· PC Integration: Can be controlled with PC-driven virtual remote control software

Tonometer Specs:

· Measuring Range: 7 to 60 mmHg

· Display: 5.7" LCD TFT monitor

· Printer: Integrated thermal printer

· Power Supply: 100-240 V, 50/60 Hz, 60-85 VA Features

· Non-Contact Measurement: Uses a soft puff of air to measure intraocular pressure (IOP) without contact or anesthetic.

· Automatic Operation: Features auto-tracking for easy positioning and initiates measurements automatically via the touchscreen.

· Intuitive User Interface: One-button touch screen operation makes it user-friendly.

· Patient Fixation: Integrated LEDs in the headrest help patients intuitively fixate on a target.

· Staff Operable: Designed to be used by practice staff as part of pre-test exams.

· Integrated Connectivity: Includes an optional VISUCONNECT 500 for network connectivity and EMR/PMS integration.

· Data Output: Results can be printed or exported via a serial interface.

· Patient Comfort: The soft puff of air and user-friendly operation make the process more comfortable for patients.

Auto Kerato-Refractometer Specs

· 5-in-1 Functions: Combines autorefractor, keratometer, visual acuity (VA) check, grid, and contrast tests.

· Subjective Testing: Performs subjective far and near testing.

· Rotary Prism Technology: Ensures high accuracy and consistent measurements.

· User-Friendly Design: Features a compact, ergonomic design and a bright 8.5-inch color touchscreen.

Measurement Ranges

· Sphere Range: -25D to +22D (0.12D/0.25D steps).

· Cylinder Range: 0D to ±10D (0.12D/0.25D steps).

· Axis Range: 0° to 180° (1°/5° steps).

· Minimum Pupil Diameter: Ø 2 mm.

Physical Specifications

· Power Supply: 100-240V AC, 50-60Hz.

Indirect Ophthalmoscope Specs

· Illumination: Convertible LED (4,000K) and traditional bulb (3,800K) options, or pure LED.

· Optics: New high-contrast optics for crisp, glare-free views.

· Magnification: Offers a high-magnification lens for increased detail.

· Design: Available in both wireless and wired formats, offering flexibility.

· Illumination: Convertible LED (4,000K) and traditional bulb (3,800K) options.

· Brightness: Up to 2,000 lux, with dimmable functionality.

· Aperture Control: Features a single-switch adjustable aperture.

· Weight: Approximately 520g (with battery).

· PD Range: 47mm to 75mm..

· Illumination: Long-lasting LED illumination.

· Optics: High-quality, precision-crafted lenses and mirrors.

Manual Phoropter Refractor Specs Sphere (SPH) -19.00D ~ +16.75D (0.25D increments, or 0.12D increments when auxiliary ±0.12D lens used) (or, -29.00D ~ +26.75D (0.12D increments) (when optional ±10D lens used)) Cylinder (CYL) 0D ~ -6D (0.25D increments, or 0.12D increments when auxiliary ±0.12D lens used) (0D ~ -8D (0.12/0.25D increments) (when optional -2.00D lens used))

±0.50D (optional)

Spot Vision Screener

PRODUCT SPECIFICATIONS

Wireless Network 802.11 a/b/g/n Operating Temperatures 50°F to 104°F (+10°C to +40°C) Operating Humidity 30% to 75% relative humidity (non-condensing) MEASUREMENTS Spherical Equivalent Range: -7.50D to +7.50D in 0.25D increments Accuracy: -3.50D to 3.50D, ± 0.50D; -7.50D to < -3.50D, ± 1.00D; > 3.50D to 7.50D, ± 1.00D Cylindrical Range: -3.00D to +3.00D in 0.25D increments Accuracy: -1.50D to 1.50D, ± 0.50D; -3.00D to < -1.50D, ± 1.00D; > 1.50D to 3.00D, ± 1.00D Cylindrical Axis Range: 1 to 180 degrees in 1 degree increments Accuracy: ± 10 degrees (for cylinder values > 0.5D) Pupil Size 3.0 mm to 9.0 mm in 0.1 mm increments in ± cylinder* Accuracy: ± 0.4 mm Pupil Distance Range: 35 mm to 80 mm in 1 mm increments Accuracy: ± 1.5 mm Gaze Measurement 0 to 20 degrees in increments of 1 degree nasal, temporal, inferior and superior Accuracy: ± 1.5 degrees Time Per Measurement Second(s) Measuring Distance 3.3 ft ± 2 in (1 m ± 5 cm) Fixation Target Random visual pattern and audible sound Measurement Principal Optical reflex

Transilluminator Specifications Light Source: Fiber-optic, Halogen HPX lamp for true tissue color and cool, distal light.

Power Source: Compatible with 3.5V handles (Lithium Ion or Nicad) or a power transformer.

Sterilizability: The instrument heads are fully sterilizable via steam, water, gas, or solutions.

Features Cool, Distal Light: The fiber-optic system directs cool light to the examination site, enhancing patient comfort.

True Tissue Color: The Halogen HPX lamp provides accurate color representation of tissues.

Optional Cobalt Filter: A cobalt blue filter can be used for enhanced visualization during some examinations.

Versatile Design: Curved and straight designs are available, with the curved model particularly suited for viewing frontal and maxillary sinuses.

Direct Ophthalmoscope Specs Illumination: illumination provides high-quality, long-lasting light.

Apertures & Filters: Offers multiple apertures and filter combinations, including:

Small, large, fixation, and slit apertures Cobalt blue filter for corneal exams Red-free filter to enhance vessel visualization Polarizing filter to reduce reflections Lens System: A range of focusing lenses (e.g., -25 to +40 diopters) with diopter steps for sharp focus on the retina.

Optical System: Sealed optics keep out dust and dirt, ensuring long-term maintenance-free use. The coaxial system provides a shadow-free view of the fundus.

Comfort & Ergonomics: A rubber brow rest protects eyeglasses from scratching.

Power: Compatible with 3.5V power handles, including convertible NiCad and Lithium Ion options.

Retinoscope Specifications Light Source: Halogen HPX Lamp Power Source: Compatible with 3.5V power sources and handles Optical Quality: Produces bright, sharp, and clean streaks for accurate refraction Optics: Sealed optics keep lenses cleaner and protected from dust Advanced Features Focusing Sleeve: An external, continuous-rotation sleeve allows for comfortable and precise focusing adjustments Polarizing Filter: An optional crossed-linear polarizing filter reduces glare from trial lenses, improving visual clarity during refractions Streak/Spot Conversion: The device can be easily converted from a streak retinoscope to a spot retinoscope

Well Handle Specifications Voltage: 3.5 V Compatibility: Universal fit for all 3.5V instrument heads Construction: Durable, chrome-plated brass or engineering resin Grip: Smooth, non-abrasive, knurled finish for a no-slip grip Charging: Designed for charging in desk chargers, consoles, and well-chargers Durability: Metal head connectors for added strength Safety: Safety switch to prevent accidental battery draining Battery: NiCad battery included Weight: Heavier, as they are half the weight of traditional handles Runtime: Provides a standard runtime, with Li-Ion handles offering twice the on-time Battery: Lithium Ion battery Charging: May feature rapid charging options, including USB-C

Handheld Tonometer Specifications Measurement Range: 7 – 50 mmHg.

Accuracy: ±1.2 mmHg (for IOP ≤ 20 mmHg) and ±2.2 mmHg (for IOP > 20 mmHg).

Repeatability: < 8 % (coefficient of variation).

Power Supply: 4 x AA non-rechargeable batteries (1.5V alkaline LR6).

Connectivity: Bluetooth Low Energy (LE) for PC connection and Bluetooth Classic for printer connection.

Key Features No Anesthesia: Measurements do not require anesthetic drops.

Quick Measure: Reduces test time by capturing IOP with fewer individual measurements.

Wireless Connectivity: Allows for wireless printing and data transfer to a computer via Bluetooth.

Reliable Positioning: A visual indicator at the probe base confirms correct tonometer positioning before each measurement.

Auto Lensmeter Specifications Sphere Range: Typically measures from 0 to ±35D, with varying step resolutions (e.g., 0.01D, 0.06D, 0.12D, 0.25D).

Cylinder Range: Measures from 0 to ±10D.

Axis Range: Measures from 0° to 180°, with 1° step increments.

Add (Addition) Range: Measures from 0 to 10D.

Prism Range: Measures from 0 to 15Δ.

Lens Diameter: 20mm to 100mm.

Key Features UV Transmittance Measurement: Measures the ultraviolet light transmission of the lens, a crucial feature for sunglass and medical lenses.

Pupillary Distance (PD) Measurement: Automatically measures the distance between the optical centers of the lenses.

Multi-Focal Lens Detection: Advanced models can automatically detect and measure progressive, bifocal, and trifocal lenses.

Display: Features a 5.7-inch or larger color LCD touch screen with a graphical user interface for easy operation and visual representation of lens readings.

Automated Lens Detection: Sensors that automatically identify the type of lens being measured.

Hartmann Sensor: Utilizes advanced sensors with multiple measurement points for high precision.

Communication Features: Includes Bluetooth, Wi-Fi, and other wireless communication options for data transfer.

High-Speed Printer: Some models include an integrated printer with an auto-cutter for immediate documentation of lens measurements.

Contact Lens Measurement: Capabilities to measure contact lenses accurately.

C-4 Government Furnished Property, Facilities, and Services:

N/A

C-6 Period of Performance:

The period of performance will be 180 days from date of issuance.

C-7 SECURITY/ PRIVACY:

PRIVACY ACT NOTIFICATION (April 1984) The Contractor will be required to design, develop, or operate a system of records on individuals, to accomplish an agency function subject to the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 U.S.C 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties.

PRIVACY ACT (April 1984)

(a) The Contractor agrees to—

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies—

(i) The systems of records; and

(ii) The design, development, or operation work that the contractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a system of records on individuals that is subject to the Act; and

(3) Include this clause, including this paragraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a system of records.

(b) In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency.

(c)(1) “Operation of a system of records,” as used in this clause, means performance of any of the activities associated with maintaining the system of records, including the collection, use, and dissemination of records.

(2) “Record,” as used in this clause, means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and that contains the person’s name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint or voiceprint or a photograph.

(3) “System of records on individuals,” as used in this clause, means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

PRIVACY or SECURITY SAFEGUARDS (August 1996)

(a) The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

(b) To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

(c) If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

Privacy Act (December 18, 2015) The contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violation of the Act by the Contractor and/ or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a (i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/ she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement:

(a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and

(b) Specifies the disposition to be made of such records upon completion of contract performance.

CONFIDENTIAL INFORMATION

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: Patient Identifiable PHI/ PII, Networking Infrastructure

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: To protect records related solely to the internal personnel rules and practices of an agency.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

C-8 INDEMNIFICATION, LIABILITY, STATUTE OF LIMITATIONS:

Any provisions in the TOS related to indemnification and filing deadlines are hereby waived, and shall not apply except to the extent expressly authorized by law. Liability for any breach of the TOS as modified by this Amendment, or any claim arising from the TOS as modified by this Amendment, shall be determined under the Federal Tort Claims Act, or other governing federal authority. Federal Statute of Limitations provisions shall apply to any breach or claim.

C-9 GOVERNING LAW:

Any arbitration, mediation or similar dispute resolution provision in the TOS is hereby deleted. The TOS and this Amendment shall be governed by and interpreted and enforced in accordance with the laws of the United States of America without reference to conflict of laws. To the extent permitted by federal law, the laws of the State of [Company to insert name of state if one is mentioned in its TOS] (excluding [Company's state] choice of law rules) will apply in the absence of applicable federal law.

C-10 AUTHORITY:

0. No person other than the Contracting Officer has authority to bind the Government with respect to this contract.

0. No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

0. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

2. An understanding or agreement between the Contractor and anyone other than the Contracting Officer;

2. A purported modification or change order issued by anyone other than the Contracting Officer;

2. A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

2. An order, direction, consent, or permission from anyone other than the Contracting Officer to:

3. Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or

3. Expend hours in excess of a specified level of effort.