SOW_IOLS.docx

Statement of Work

Statement of Work:

Background Phoenix Indian Medical Center (PIMC) provides surgical services to Native American/Alaskan Native patients throughout the Phoenix Service Unit, Phoenix, AZ. PIMC performs an estimated 450 cataract surgeries a year. One of the most common operations we perform here is for cataracts surgery in which a new intraocular cataract lens (IOL) is used to replace the diseased lens. These lenses are made in a variety of sizes and strengths so that the patient’s vision can be restored to as normal as possible.

Objective The objective of this contract is to ensure the ready availability of an adequate number of lenses of varying sizes and strengths and surgical supplies so that we can best serve our patient population. Many of our patients needing this operation come from reservations hours away from our facility. It is imperative that we have a steady, dependable supply of lenses so we can use the best lens on the patient the day of their scheduled surgery. It is impossible to preoperatively predict the appropriate size/strength with 100% accuracy and hence the need for the range to be available on the operative day.

The improvement we expect to see is significant. While we are requesting sizes from Diopter/power to range from 6.0 to 27.0, 90% of the lenses we use are between the size of 13.0 and 24.0. It is not uncommon to use four or five lenses of the same size on one operating day. In the past this meant on some days, the ophthalmologist was faced with having to use a less than optimal sized IOL or to reschedule the patient who may have traveled four hours to have the surgery done that day.

Requirements

The Contractor will provide a stock range of pre-loaded lenses (IOLs) and foldable multipiece posterior chamber lenses (IOLs). The pre-loaded (IOLs) range from 6.0 diopter to 27.0 diopter will meet our requirement.

PIMC will purchase lenses on an “As Needed Basis” to fulfill its patient’s requirements. PIMC will order the special order IOLs seven days before surgery and the COR will place order with contractor representative. As the IOLs are used and are replaced, the contractor will send the COR an invoice itemizing the cost of replacement.

For the frequently used pre-loaded (IOLs) sizes 12.0 through 17 diopter (11 diopter sizes) PIMC will order on an “As Needed Basis” 5-each pre-loaded, for the more common sizes 17.5 through 22.5 diopter (11 diopter sizes) PIMC will order on an “As Needed Basis” 10-each pre-loaded, and for the less commonly used lenses we shall stock 3 each 6.0

The Contractor will provide Toric IOLs to our patients to correct there astigmatism with cataract surgery. We estimate 30 Toric IOLs per year. These are used in elective surgeries and so these lenses will be ordered on an “As-Needed Basis” seven days or more before the date of surgery.

The Contractor will ensure quality assurance that no IOLs are found upon delivery to have been manufactured in an unusable state (fogged, irregular in shape or inhomogeneous in diopter).

The Contractor will be fully responsible for assuring delivery of adequate lenses as required above. The Contractor will be responsible for delivery of all cataract intraocular lenses and shall be sterile to meet all industry and regulatory FDA requirements.

Contractor not delivering the minimum shelf life of 12 months for the Intraocular Cataract Lenses (IOLs) supplies will be instructed to replace IOLs supplies and provide, at no cost to the Government, a shipping company to pick up and deliver back to the contractor.

Contractor will provide PIMC a web-based ordering system that provides reports for inventory management and capability to order par level IOLs and special order IOLs. If web-based ordering system is not available the Contractor shall provide best means to provide inventory management and ordering processes.

Minimum Qualifications Contractor shall have a minimum of 5 years of experience in production, delivery and support of intraocular cataract lenses (IOLs) supplies.

Delivery Delivery of all preloaded IOLs s required within 3 days after receipt of order (ARO) or sooner. Toric IOLs will be delivered within 7 days after receipt of order (ARO) or sooner.