Question to the Government with Replys Part 1.pdf

QUESTIONS TO THE GOVERNMENT WITH REPLY’S

W81K00-26-Q-A234

Question Reply

1. Approved Products - Does the Government require a specific manufacturer (e.g., BostonSight, AccuLens, Valley Contax, Art Optical, etc.), or will equivalent products that meet all Section C salient characteristics be considered acceptable? You do not need a specific contact lens manufacturer to successfully fit scleral lenses.

You can absolutely utilize equivalent products from different manufacturers. However, changing manufacturers will lead to a restart of the fitting process because of structural variations between brands, a clinician cannot simply order the new manufacturers lens using the old lens parameters. This will result in increased chair time, increase the workload for optometrist, and delayed visual rehabilitation negatively impacting vision readiness.

2. SmartSight HOA - Is SmartSight HOA a proprietary feature, or will equivalent higher-order aberration correction technologies be accepted if they meet the Government's performance requirements?

SmartSight HOA is a proprietary technology developed and owned exclusively by BostonSight. Equivalent high order aberration from other manufacturers can be accepted.

3. Hydra-PEG- Is Hydra-PEG coating required on every lens order or only when specifically requested under CLIN 0003?

No, a Tangible Hydra-PEG coating is not clinically or contractually required on every single scleral lens order. Not every patient needs Hydra-PEG. Patients with healthy tear films and no history of lens fogging or deposits can wear uncoated lenses perfectly well.

4. Lens Diameter - Are the listed lens diameters (16–17 mm and 18–19 mm) fixed requirements, or may clinically appropriate diameters within those ranges be provided based on patient fitting?

The listed lens diameters (16–17 mm and 18–19 mm) are not rigid, absolute parameters for every single patient. Rather, they represent standard target ranges meant to categorize the contract offerings.

Scleral lens fitting is highly specialized and customizable. A rigid, one-size-fits-all diameter requirement would violate the standard of medical care for irregular corneas

5. Estimated Quantities – Are the CLIN quantities annual estimates only or do they represent guaranteed minimum purchase quantities?

Not annual estimates, they help assess inventory and pre-purchase price quantities.

6. Ordering Process - Will orders be issued individually by patient, through blanket purchase releases, or in consolidated monthly orders?

Orders will be issued individually to save time on the fitting process.

Consolidated to monthly order will delay vision care.

7. Prescription Data - What patient fitting information and prescription parameters will accompany each order?

Lens brand, material, Base Curve, Diameter, Power, Coating, channels, Haptic measurement, patient name and DOB.

8. Delivery Location - Will all deliveries be made to Brooke Army Medical Center, or may deliveries be required at other Defense Health Agency facilities during contract performance?

All delivery will be made to Brooke Army Medical Center.

9. Delivery Time - What is the Government's expected delivery time for routine orders after receipt of a complete prescription?

Less than 1 week, for any initial order there is a warranty period for making any changes to the lens parameters. Delaying delivery time will hinder warranty period and once warranty period is expired, a new purchase will have to be ordered costing government more money.

10. Expedited Shipping - Does the two-day expedited shipping requirement apply to manufacturing and shipping combined, or only to transportation after the product has been manufactured?

2 day shipping applies to manufacturers and shipping combined.

11. Warranty - What warranty expectations does the Government have beyond the manufacturer's standard commercial warranty?

BostonSight provides a 90-day manufacturing warranty and a 120-day unlimited fit exchange period. Lenses can be exchanged an unlimited number of times for parameter adjustments (diameter, base curve, toric periphery, etc.) at no additional cost within 120 days) If a lens is defective in material or workmanship, it must be returned within 90 days of shipment in its original packaging for a free replacement. Due to the complexity of fitting a custom scleral lens, lens parameters will be adjusted to match the patient curvature eye.

12. Returns - What process should be followed for returns due to prescription changes, patient fitting issues, or ordering errors?

The only returns that need to be submitted are the manufacturer defects or errors from the manufacturer.

13. Acceptance - What inspection and acceptance procedures will the Government use upon delivery?

Packages are inspected to ensure the sterile saline vials or dry lens cases are completely sealed, untampered, and undamaged. Any sign of a broken seal or fluid leakage results in immediate rejection.Label Compliance: Labels are checked against the contract order to verify they clearly show the Patient’s Identifier/Case Number, Manufacturer Name, Power (diopters), Base Curve, Diameter, and Material Lot Number (for traceability). Surface Inspection: Lenses are placed under a slit-lamp microscope or magnifying loupe to inspect for manufacturing scratches, chips, edge defects, or surface bubbles in premium coatings.

14. Product Literature - Is manufacturer literature sufficient to demonstrate compliance with the salient characteristics, or does the Government require a separate compliance matrix?

Manufacturer literature is sufficient to demonstrate compliance with salient characteristics.

15. FDA Requirements - Are all proposed products required to be FDA-cleared or otherwise legally marketed in the United States?

Yes, FDA-cleared scleral lenses are specialized gas-permeable medical devices used for vision correction and ocular surface therapy for safety reasons.

16. Option Quantities - Are the option-year quantities expected to remain substantially the same as the base-year estimates.

Yes, however, payment will be made for actual items ordered, received and accepted by the Government.

17. Partial Shipments - Will partial shipments be accepted if a single order contains multiple CLIN items with different manufacturing lead times?

Yes

18. Technical Point of Contact - Is an Optometry Clinic technical representative available to answer clinical questions during contract performance?

Yes there is a technical representative available to answer clinical questions and troubleshooting for scleral lens fitting.

19. Ordering Method - Will orders be transmitted by email, electronic procurement system, GPC purchase, or another ordering method?

Orders will be submitted by electronic procurement system Wide Area Workflow (WAWF)

20. Invoicing - Does the Government require electronic invoicing through PIEE/WAWF, or another invoicing platform?

Yes government requires invoice for WAWF.

21. Does the Government anticipate significant fluctuations in annual ordering volumes during the Base or Option Years?

Yes the government will anticipate significant fluctuations in annual ordering volumes. JBSA is listed as 1 of 4 ocular trauma centers and will need to support medical contact lenses. JBSA optometry is expecting to see more referrals.

22. Are equivalent lens materials with comparable oxygen permeability (Dk values) acceptable if they satisfy all salient characteristics?

No, depending on the integrity of the cornea (Example: corneal transplant, corneal disease), some patients will need higher oxygen permeability materials than other patients, its standard of care.

23. Will the Government evaluate technical capability solely on compliance with the salient characteristics, or will additional consideration be given to product performance history, manufacturer experience, or clinical outcomes?

Government will be evaluated solely on compliance with the salient characteristics.

24. Does the Government expect the contractor to provide technical consultation on lens selection or fitting, or is the requirement limited to supplying products based on Government-issued prescriptions?

Yes, the contractor will provide technical consultation on lens selection and fitting since all fits are custom to every individual patient.

25. If a manufacturer discontinues a product during contract performance, what process should the contractor follow to propose an equivalent replacement?

Contractor should continue making the produce until the warranty period ends and/or contractor should reimburse initial lens cost to government since fitting process was not finalized.

26. Will we need staff on sight to evaluate patients?

Yes, trained clinicians (optometry provider/ optometry technician) should be there on site to evaluate the lens on the patient for safety.

Without evaluating in person, these lenses can cause harm if not appropriately fitted correctly.

27. How do we price adjust prescriptions? Because prescriptions often differ in price. Prices should be standardized for that contract year depending on material, coating, and any additional features.

28. Does the gov just want one set price for all prescriptions?

Yes, that would be ideal for both parties to standardize just one price per lens that includes all options (coating, HOA, etc).