36C24925R0020.docx

VA

HANDBOOK

6500.6 APPENDIX C

MARCH

12,

GENERAL INFORMATION

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

POINT OF CONTACT*

Contract Specialist Jeannette Morphew jeannette.morphew@va.gov 6158676000 x20230

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

DESCRIPTION

This is a request for information to industry regarding eyeglass manufacturing. We are requesting industries input on the attached draft PWS. If you have any questions or guidance on clarifying the attached PWS, please provide your comments and input to jeannette.morphew@va.gov, carmen.hanczyk@va.gov, and john.mccomas@va.gov.

We also have the below questions for industry:

1. What does a typical Transition Plan (phase in new contractor and phasing out old contractor) look like when transitioning eyeglass manufacturers?

2. What does the typical transition period look like?

3. Would the new eyeglass manufacturer need to train the dispensing optician on their proprietary software or computer system that is going to be used by the eyeglass manufacturer?

4. If training is needed for dispensing optician, how many days and hours would it take to complete the training?

5. Is there available support if questions arise after the training period is complete?

Special Notice Special Notice The Government does not intend to respond to questions, comments, or feedback provided from industry upon the comment period closing. The Government will review and revise the PWS based on feedback and the final version of the documents will be provided upon the official solicitation being issued.

Special Notice

Performance Work Statement VISN 9 Prescription Eyeglass Manufacturing

1. SCOPE:

1.1 The Department of Veterans Affairs (VA) has an ongoing program to furnish medically necessary eyeglass fabrication for Veterans who are eligible for VA benefits and have been referred for eye care services.

1.1.1 The contractor will provide all labor, parts, tools, materials, equipment, transportation, and other items necessary for eyeglass manufacturing in accordance with (IAW) the terms and conditions of this contract, to include any terms and conditions defined in Purchase/Delivery Orders (POs/DOs) issued under this contract. The Contractor and subcontractors shall comply with all United States Government (USG) laws, regulations, policies, procedures, and guidelines in the performance of this PWS, unless otherwise stated. This contract will use the North American Industry Classification System (NAICS) code 339115.

1.2 BACKGROUND: The VA is committed to providing Veterans timely, accessible, and high-quality care. The solicitation is intended for use by different VA Health Care Systems (Medical Centers and Outpatient Clinics) located within VISN 9. Each VISN 9 VA Health Care System is responsible for ordering and payment for their site. A health care system-by-health care system breakdown is included in paragraph 1.3 VISN 9 Prosthetics Sensory Aid Service (PSAS) facility addresses and point of contract information. Contractor to provide eyeglasses according to the contract specifications for beneficiaries of the Department of Veterans Affairs Centers in VISN 9. VISN 9 estimated annual average of 128,374 pairs of eyeglasses to eligible veterans. Eyeglass lenses will be all types, to include but not limited to, single vision, bifocal, trifocal, oversized lenses, progressive, etc. Availability of multiple lenses will be required such as glass, polycarbonate, plastic, photochromatic, and tints. Style and variety of frames provided should meet the needs of our Veteran population with a balance of modern and classic styles. Veterans Affairs has a wide range of beneficiary ages; thus, a wide range of styles are required. Current and stylish, commercially available frames are required. Discontinued frames will not be acceptable.

1.3 VISN 9 Prosthetics Sensory Aid Service (PSAS) Facility Addresses And Point of Contract Information:

859-233-4511 ext3397

859-233-4511 ext3397

502-287-5257

502-287-5257

W 901-523-8990 ext 6149 C 901-431-9038

W 901-523-8990 ext 6149 C 901-431-9038

W 901-523-8990 ext 6149 C 901-431-9038

(mobile clinic in Bristol)

W 423-979-3600

W 423-979-3600

615-517-0357

615-517-0357

615-517-0357

615-517-0357

1.4 PERIOD OF PERFORMANCE:

Ordering Period : Year 5 (10/01/2030 – 09/30/2031)

Ordering Period : Year 6 (10/01/2031 – 9/30/2032)

Ordering Period : Year 7 (10/01/2032 – 09/30/2033)

1.5 LOCATION AND DAYS/TIME OF OPERATION:

1.5.1 LOCATION. VISN 9 locations listed in 1.3. VISN 9 PSAS Facility Addresses.

1.5.2 DAYS/TIME OF OPERATION. Prefer the minimum operation hours of Monday through Friday 8:00 am – 5:00 pm.

1.6 RECOGNIZED HOLIDAYS:

Any other day designated by the President as a national holiday. When one of the holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by US Government agencies.

1.7 CONTRACT DELIVERABLES: Contract deliverables are detailed throughout the PWS.

1.8 POINT OF CONTACT INFORMATION

1.8.1 CONTRACTOR. The contractor shall maintain a current letter designating primary or primary/alternate point of contacts (POCs) with contractual authority to be contacted for prompt contract administration. Any changes to the designated individual must be provided to the CO, in writing, NLT 15 calendar days after the proposed effective date of the change.

2. PERSONNEL

2.1 GOVERNMENT KEY PERSONNEL

VISN 9 facilities CORs are listed in section 1.3.

2.2 CONTRACTOR KEY PERSONNEL

The contractor shall provide the point of contact name, address, telephone number and email of individual(s) NLT two (2) business days after contract award and NLT 24 hours when a change of contractor personnel has occurred for the following:

1) Contract Manager - a contract manager and alternate, who shall be responsible for contract performance IAW the Performance Work Statement (PWS). The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

2) Customer Service/Product Support Information (who can be contacted for product information)

3) Financial Operations - primary and alternate POC responsible for billing/invoicing/payment

3. ORDERING, DELIVERY & INVOICING

3.1 ORDERS: Any supplies to be furnished under this contract shall be ordered by issuance of POs/DOs.

3.2 AUTHORIZED ORDERING AGENCIES: VISN 9 agencies listed in section 1.3 are authorized to place orders under the terms and conditions of this contract.

3.2.1 The Government will submit all available orders to the Contractor on a daily basis. These orders will be sent in the form of an Excel spreadsheet containing multiple orders to be paid by certified invoice. Batching of orders is not authorized by either party. Batching in this case means holding all orders to meet a minimum requirement by any or all parties. Orders received by Contractor on a daily basis shall be processed upon receipt. No fabrication of glasses shall begin prior to receiving a purchase order or Excel spreadsheet request from Prosthetics.

3.2.2 The contract will receive two excel files.

3.2.3 In the event that the VISN 9 agencies listed in section 1.3 are unable to the orders using the method described above the PSAS will use CPRS Prosthetics Eyeglass Consult/VA Form 10-2914, Prescription and Authorization for Eyeglasses, to place orders with the Contractor.

3.3 DELIVERY INFORMATION:

3.3.1 Delivery is Free On Board (FOB) delivery. destination to United States or its territories/possessions (American Samoa, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, etc.), the District of Columbia, and the Commonwealth of Puerto Rico.

3.3.2 Prior to delivery the contractor will verify that the eyeglasses match the appropriate prescription within applicable ANSI Z80 and ISO 12870/8624/7998 standards and tolerances.

3.3.3 Normal delivery is required within seven (7) to fourteen (14) (14) business days after receipt of order (ARO) Any eyeglasses not received within this time will be considered delinquent. When needed express deliveries shall be made within 3 business days after receipt of a delivery order. The Contractor shall accept express shipping on an occasional basis, but it is not intended to become a substitute for timely ordering. Government ordering should usually require normal delivery.

3.3.4 The eyeglass fabricator shall ship the eyeglasses to the Dispensing site or the Veteran’s residence address as indicated on the purchase/delivery order after receipt of the eyeglass dispensing and fabrication request.

3.3.5 Contractor will be responsible for all shipping/mailing costs. Deliveries will be shipped using a mail tracking system to identify location and proof of delivery. The contractor shall have a confirmation of delivery (i.e. UPS, FEDEX with tracking number, or USPS certified mail [no signature required]). In the event the Veteran requests delivery directly to his/her place of residence, the VA requires proof of delivery. Delivery procedures shall safeguard PHI and PII.

3.3.6 Prior to shipping, a tag is to be placed around the eyeglasses case with the Veterans last name and last four digits of the social security number. Packing slip shall also be marked with the Veterans last name and last four digits of the social security number. One copy of either a packing slip or invoice which provides the patient’s last name, first name and last four of social security number shall be enclosed in the shipment.

3.3.7 Shipments to the Veteran’s home will include a notification that fitting, and adjustments of their eyeglasses is preferred before the Veteran uses the eyeglasses.

3.3.9 The Contractor shall retain proof of delivery for the life of the contract and shall provide the information upon request from the VA for the contract period of performance. The proof of delivery should be retained for 1 year after the ordering period. The Government acceptance of all delivery orders shall take place at the delivery point.

3.3.10 Individual claims by the Veteran of non-receipt of delivery may require the Contractor to respond to the VA with proof of shipment.

3.3.12 The Contractor shall be responsible for informing the CO/COR of any Government deficiencies such as missing information, illegible prescriptions and ambiguous authorization for eyeglasses, inability to reach the Government representative, payment delays or other issues.

3.4 INVOICE PROCESS OVERVIEW: The contractor shall send weekly billing statements in a digital format i.e. Excel, .csv, or other digital format to the VISN 9 Prosthetics Sensory Aid Service (PSAS) facility addresses and point of contract information listed in 1.3. These statements are a billing summary of each eyeglass order invoiced and shipped during the prior business week. The contractor shall submit invoices into their Tungsten Account Invoices for the Contract Line-Item Number (CLIN) shall be sent electronically to Invoice Processing Payment System (IPPS) VA Financial Service Center, Austin, TX.

3.4.1 INVOICE DOCUMENT: Invoices should include a detailed description of goods/services provided, associated costs, and verification that the goods or services have been delivered and accepted by VA representatives, where applicable. The contractor shall submit invoices into their Tungsten Account.

1) Contractor Name

2) Contractor invoice number: Invoice number that is connected to the consult and the pdf invoice.

3) Invoice date: Date eyeglasses were shipped.

4) Date of order

5) Date contractor shipped item(s)

6) Contract Number

7) Contract Delivery Order Number

8) Purchase Order number (9 digits)

9) Referring clinic (Station number for electronic invoices).

10) Name of Individual who placed the order.

11) Itemized list of item(s) and/or product(s) delivered.

12) Frame model name, lenses (specified - right and left), total prices with itemization.

13) Patient’s last name, first name and last four of social security number.

14) Certification statement: This certifies that the foregoing eyeglasses were shipped on date noted above and receipted by “insert mail carrier” (i.e., USPS, FedEx, UPS etc.), “Signature of company officer, title.”

15) Grand total of orders placed and total monetary value for the invoice period.

16) Put warranty date on invoice.

3.5 DISCREPANCY AND QUALITY ISSUES. The Contractor will bring any quality or discrepancy issues to the attention of the COR or CO within 24 hours of receipt of the issue. The contractor shall keep the COR or CO updated with changes in product characteristics specific to a product whenever changes occur. Only suitable substitutes (for both frames and lenses) will be accepted and must be preapproved by the VA. If eyeglasses received do not match the eyeglasses that were ordered (i.e. description, color, functionality) based on product information provided at time of award, the contractor shall replace the eyeglasses device within 3 business days include return shipment for the eyeglasses with discrepancies. The discrepancy report shall be sent electronically.

5.SPECIFIC TASKS

5.1 PRODUCT TECHNICAL REQUIREMENTS

5.1.1 STANDARD: All lenses and frames must meet the requirements under the Trade Agreement Act (TAA), as implemented by FAR Part 25.

5.2.1 SAMPLE KITS:

The contractor shall provide the required sample kits:

1) Upon contract award, the contractor shall provide a FREE VA approved frame kit and sample lens kit consisting of samples of each available size combination and color of each frame required under schedule of Items to allow for different eye sizes, bridge sizes, temples, colors, etc. of the most popular styles, available tint grades 1, 2 and 3 (solid or gradient).

2) The Contractor shall provide a wide selection of frames and lens types from which the Veterans can select.

3) The frame kits will consist of each eye size with multiple bridge sizes.

4) A minimum of one sample kit, display rack, and eyeglass tray shall be provided to each participating Optical Dispensing sites.

5) Sample frame and lens kits must be maintained and updated at no charge during the life of the contract.

6) Sample frame kits and lens kits shall be provided in working condition, free of major defects to the Dispensing sites. These sample kits will not be included in the inventory.

7) The contractor will contact the COR quarterly to make sure that the COR has each of the sample frames that are available or if replacements and/or substitutions need to be made.

8) Only suitable substitutes will be accepted upon VA approval.

9) The contractor will contact the COR quarterly to make sure that the CO/COR has a current “catalog” of the sample frames and lenses that are available or if replacements and/or substitutions need to be made.

10) Sample products submitted with solicitation offer will be evaluated on shape, finish, variety of color and quality (i.e. hinge placement and welds, flexibility, durability current fashion, rims, end pieces, bridge, screws, nose pads, pad arms and temple area).

11)

5.2.2 LENSES: VA must approve the lens selection. All lenses shall be fabricated and provided in accordance with the standards set forth in the current edition of “American National Standards Institute (ANSI) Standard, Ophthalmic - Prescription Ophthalmic Lenses - Recommendations”, ANSI Z 80.1-2020 or latest edition. All ophthalmic lenses shall be in accordance with Food and Drug Administration (FDA) Regulation (2) Code of Federal Regulations, Part 3 and 4 for impact resistance, unless otherwise specified in the order. Glass ophthalmic lenses shall be chemically strengthened for impact resistance. All glass and plastic ophthalmic lenses shall be corrected curved lenses. All submitted lens types must include the name of the manufacturer. Only suitable substitutes will be accepted based on VA approval. The sample formulary provides an example of lens ranges. The VA requests the widest range of powers available.

1) Ophthalmic lenses with cylinder power of less than 1.5D may be fabricated in minus cylinder form. Plastic lenses will have scratch resistant coating.

2)

3) Single Vision Lenses: Lenses shall be available in glass, plastic, polycarbonate, Trivex or high index plastic. Construction of single vision lenses shall include spheres, plano-cylinders, and sphero-cylinders. Photochromatic lenses shall be available. Clear, framed lenses and oversized blanks shall be available at the price listed on the pricing schedule. All lenses shall be placed in frames unless otherwise requested.

4) Bifocal Lenses: Lenses shall be available in glass, plastic, polycarbonate, Trivex or high index plastic. Construction of bifocal lenses shall include spheres, plano-cylinders, and sphero-cylinders in all powers. Add +0.50 to + 6.00D. Clear, framed lenses and oversized blanks shall be available. The lens types shall include flattop, executive. round segments and progressive. Photochromatic lenses shall be available. For bifocal vision patients, suitable pieces of broken lenses can be used for fabricating blank/plano lenses. They must meet the ANZI Z 80.1 standard. Clear, framed lenses and oversized blanks shall be available. All lenses shall be placed in frames unless otherwise requested.

5) Trifocal Lenses: Lenses shall be available in glass, plastic, polycarbonate, Trivex or high index plastic. Construction of trifocal lenses shall include spheres, plano-cylinders, and sphero-cylinders in all powers. Add +1.50 to +4.50D, 50% intermediate power. The lens types shall include flattop, executive, round segments and progressive. Photochromatic lenses shall be available. For trifocal vision patients, suitable pieces of broken lenses can be used for fabricating blank/plano lenses. They must meet the ANZI Z 80.1 standard. Clear, framed lenses and oversized blanks shall be available and listed under the pricing schedule. All lenses shall be placed in frames unless otherwise requested.

6) Progressive Lenses: Lenses shall be available in glass, plastic, polycarbonate, Trivex or high index plastic. Progressive style shall be considered “soft” in design, meaning that the prescription for the eyeglasses may determine the most beneficial progressive style, design, or material used. Polycarbonate also needs to be available for progressive addition lenses (PAL) due to medical necessity. The requirements identify CR-39 Plastic progressives as the most ordered progressive. The offerors shall identify what progressive design lens type will be provided as the standard issue. If an authorized VA eye care provider requests a specific progressive lens type other than what is provided as first choice by the Contractor, the alternative shall be priced accordingly in the schedule of items and pricelists.

7) Special Lenses: The contractor shall provide any special lens design as directed by the authorized prescribing eye care provider with medical justification and concurrence from the referring VA facility. Special lenses shall be available in opaque, frosted or black, balanced lens, prismatic lens, cataract lens, aspheric lens, and slab off prism.

8) Oversized Lenses: The contractor shall make oversized (above 58mm) lenses available for all prescriptions at no additional cost to the government.

9) Prism Lenses: Contractor shall provide lenses in all frames and types.

10) Photochromatic lenses: Contractor will offer photochromatic lenses in all frames and all prescription types.

11) Anti-reflective Coating: Contractor will offer anti-reflective coating in all lens types, single and multi-focal.

12) Tints for all lens types to include Photo Grey Extra (PGX) and transitions as well as progressives shall be available. The Government reserves the right to ask for tint adjustments if deemed necessary based on VA Provider feedback. Both polarized and polarized transitional lenses shall be made available in gray and amber.

13) Anti-reflective lenses should be available in plastic, polycarbonate and Trivex for all available lenses.

14) U.V. tint/coat shall be standard with all lenses.

5.3.1 FRAMES: VA must approve the frame selection. All frames must meet the International Organization for Standardization (ISO) 12870: “Ophthalmic optics – Spectacle frames – Requirements and test methods”, ISO 7998: “Ophthalmic optics – Spectacle frames – Lists of equivalent terms and vocabulary” and ISO 8624: “Ophthalmic Optics – Spectacle frames – Measuring system and terminology” that was adopted by the Z80 Accredited Standards Committee for Ophthalmic Optics and replaces “American National Standard Requirements for Dress Ophthalmic Frames” ANSI Z80.5.

a) At a minimum the following frame mix needs to be part of the contractor’s frame selection under this award:

· twenty-five (25) men’s frames

· twenty-five (25) women’s frames

· fifteen (15) unisex frames each in varying temple length, eye and bridge sizes, and colors

· minimum of three titanium frames for men need to be part of the mix of metal frames.

· minimum of three titanium frames for women need to be part of the mix of metal frames.

· minimum of 5 hypoallergenic frames should be available for men.

· minimum of 5 hypoallergenic frames should be available for women.

· require flexible and non-flexible frame options.

· five-(5) safety frames (unisex)

· all frames shall have a one-year warranty.

b) Style and variety of frames provided should meet the needs of our Veteran population with a balance of modern and classic styles. Require current, stylish, commercially available frames.

c) Discontinued frames will not be acceptable.

d) Frame selection shall include men, women, unisex, and half-eye frames in assorted sizes and colors and shall include both plastic and metal frames. The metal frame selection shall include both spring hinged and adjustable nosepiece styles, and plastic frame selection shall include both spring hinged and non-spring hinged styles. There should be one man, one woman, and one unisex plastic frame with adjustable nosepieces for Veterans with allergic reactions to metal frames.

e) Minimum of five (5) large frame sizes (54mm-60mm), a minimum of three (3) frame sizes with short temple lengths (125mm or 130mm) and a frame selection variety for all age groups.

f) If there is a backorder on any frame style, the contractor must contact the CO/COR no later than 48 hours by email or telephone after receipt of order. The contractor will immediately offer the VA a substitute if the timeframe of delivery of the backorder warrants going with a substitute. If the contractor anticipates that a frame style will continue to be unavailable for an extended period of time, and if acceptable to the VA, the substitute may be made a part of the acceptable frame selection listing. A sample of the substitute frame should be sent to the Dispensary sites as a no charge addition to the sample frame kit if that frame was not already a part of the sample collection. The substituted frame should be at a comparable price point to the frame it replaces.

g) Available frames should be monitored for usage and frames that are not moving should be replaced at least quarterly. The replacement frame should be at a comparable price point to the frame it replaces.

h) If the manufacturer discontinues a frame during the contract period, the contractor shall provide the CO/COR with an approved substitute frame within two (2) working days. All frames offered by the contractor shall be listed in either Frame Facts or Individual Company Frame Catalogs and not include any discontinued models.

i) When fulfilling prescriptions, the contractor shall provide completely assembled eyeglass frames placed in standard alignment and include mounting of lenses.

j) Privately owned frames may be submitted to the contractor for new lenses. Charges for lenses only shall be in accordance with the pricing schedule. Contractor is responsible for replacing like frames in the event of loss/breakage of privately-owned frames at no cost to the VA or beneficiary.

k) Eyeglass case: One eyeglass case will be provided by the contractor with each pair of eyeglasses furnished as well as a cleaning cloth. Eyeglass cases shall be available in sliding style and snap style.

5.1.4 EYEGLASS CARE AND CLEANING: Contractor shall provide an insert with each order on how to care for and clean eyeglasses. Whether initial, previous, or on-going users; contractor at no cost shall provide educational information to the Veteran, regarding the care and cleaning of their eyeglasses. This information should include, but is not limited to, language such as: Do not lay your glasses face down on their lenses; Place glasses in a protective case when you are not wearing them; Use a lens cleaner designed for eyeglasses and a clean lens cloth or a soft clean 100% cotton cloth; Mild soap (without lotion) and lukewarm-to-cool water might also be used to clean the lenses and frame; Hold the eyeglasses by the eye frame with the thumb and forefinger of one hand. Use the other hand to gently buff the lenses in a circular motion. Do not press too hard on the lenses; Avoid using paper towels or your shirt tail to clean your lenses. Most clothing fabrics contain abrasive fibers that will scratch or smear the lenses.

6. MANUFACTURER WARRANTY AND RECALL

6.1 FRAME AND LENS WARRANTY

6.1.1 The contractor warrants/guarantees the eyeglasses against defective materials and/or workmanship for a minimum of one year from the date of acceptance of the eyeglasses.

6.1.2 Manufacturer’s warranties of eyeglass components that extend beyond the minimum one-year period shall be expressed and enforced.

6.1.3 The contactor agrees to furnish without additional cost to the government, all labor and materials necessary to correct defects that were detected during the guarantee period. Should the prescription be incorrectly filled (fabrication error), the contractor agrees to make corrections at no additional cost to the Government. These conditions do not apply to adjustments incidental to the wearing of eyeglasses, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the contractor. If eyeglasses are returned to the contractor for correction of a problem due to contractor error (fabrication error), the corrected glasses shall be returned to the Optical Services Dispensary (OSD) location or sent to the Veteran within five (5) business days of receipt of the defective glasses.

6.1.5 Any adjustments (i.e., material defects, distortions, etc.), not able to be performed locally at the Optical Shop will be returned to the Fabrication lab contractor.

6.1.6 The contractor will be responsible for any loss of eyeglasses during shipping and will replace the eyeglasses within 3 business days after identification of loss.

6.2 LENS WARRANTY

6.2.1 The contractor warrants/guarantees the eyeglasses against defective materials (to include antireflective and other coatings) and/or workmanship for a minimum of one year from the date of acceptance of the eyeglasses.

6.2.2 Manufacturer’s warranties of eyeglass components that extend beyond the minimum one-year period shall be expressed and enforced.

6.2.3 The Fabrication lab contactor agrees to furnish without additional cost to the government, all labor and materials necessary to correct defects that were detected during the guarantee period. Should the prescription be incorrectly filled, the Fabrication lab contractor agrees to make corrections at no additional cost to the Government. These conditions do not apply to adjustments incidental to the wearing of eyeglasses, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the contractor. If eyeglasses are returned to the Fabrication lab contractor for correction of a problem due to contractor error, the corrected glasses shall be returned to the Optical Services Dispensary location or sent to the Veteran within five (5) business days of receipt of the defective glasses.

6.2.5 Any adjustments (i.e., material defects, distortions, etc.), not able to be performed locally will be returned to the Fabrication lab contractor.

6.2.6 The contractor will be responsible for any loss of eyeglasses during shipping and will replace the eyeglasses within 3 business days after identification of loss. The contractor will use the previous prescription order for replacement. A new prescription order will not be needed. ……

6.3 PRESCRIBING ERRORS:

6.3.1 Should the eyeglass prescription (Rx) be incorrectly filled; the contractor agrees to make corrections at no additional cost to the Government.

6.3.2 Errors made by the contractor in filling Rx’s will be corrected within five (5) business days after notification from either the VA or VA patient, whichever is soonest. These corrections will be made at no cost to the VA.

6.3.3 Prescribing errors made by the authorized VA Eye Care Provider and detected by the Contractor shall be called to the attention of the prescribing eye care provider within 24 hours of finding the error.

6.3.4 Delivery time shall commence with the date a corrected Rx is received by the contractor.

6.3.5 In the event replacement glasses are necessary, the VA will be responsible for cost and delivery of any replacement glasses required. Incorrect lenses/frames shall be returned once the correct lenses/frames are delivered.

6.4 RECALL: The Contractor shall immediately notify the CO/COR and all affected VA facilities in the event of a product recall, removal, required adjustments, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification include:

6.4.1 Complete item description and/or identification, order date and order numbers from customers and the contract number assigned as a result of an award on this solicitation.

6.4.2 Reasons for recall, removal, adjustment, or modification.

6.4.3 Instructions for return for credit, replacement or corrective action.

a) Notify the CO/COR in writing by the most expeditious manner possible within 3 business days. Provide a copy of the notification and a list of all VA facilities notified to VA PSAS and Contracting Officer.

b) A copy of the notification shall also be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

6.6 LOSS AND DAMAGE:

7. REPORTING:

7.1 REPORTS:

7.1.1 Activity Reports: The contractor shall provide to the CO/COR the following weekly reports broken down by month and Veteran’s home VA facility. They are required to be submitted no later than fifteen (15) business days following the end of each quarter during the fiscal year (e.g. Fiscal Year (FY) quarter 1 is from Oct 1 through Dec 31. Reports would be due by January 15.). All quarterly reports shall be presented by the Contractor at the Quarterly Quality Assurance Meetings. Any electronic communication that includes HIPAA protected information shall be done through FIPS 140-2 compliant e-mail, secure file transfer protocol or through direct interface such as HL7 or API.

7.1.2 ORDER REPORTING: The contractor shall provide a report of all orders fulfilled to the CO and COR weekly. This report shall detail orders received and orders filled. It shall include order received date, order acknowledged date, shipped date, and shipped to location. The report should also indicate invoice dates and when invoice was paid. This report shall also include a detail of LINs ordered each month, so the VISN can track usage/spend rates.

a) Usage data: Procurement dollars spent on:

i. Eyeglasses by type according to the CLIN structure

ii. Number of glasses filled per VISN/VA facility by fiscal year.

b) Timeliness Report: Measure turnaround times from point of initial order to the shipment of eyeglasses. These reports should look at aggregate data showing trends:

i. Average in-lab process time.

ii. Average work in progress

iii. Fabrication accuracy rate- Accuracy of Spectacle Fabrication List (in accordance with ANSI Z80.1 and ISO 12870/8624/7998 Standards)

c) Initial Customer Satisfaction Rate

d) Return Categories

1. Number of eyeglasses returned due to lab error.

i. Remake report also to include reasons such as but not limited to:

· Remake report also to include reasons such as “due to doctor prescribing change” or non-adapt to PAL, seg height remakes, etc.

· Non-adapt to PAL.

· Segment height remakes

ii. Breakage/spoilage rate

2. Optician Error 3.Shipping Company Error

2. Warranty

3. Discretionary

4. Discretionary

f) Number of eyeglasses returned due to defective materials

i. Frame – by manufacturer, make, model, frame material (metal, plastic, combination), frame style (men’s, women’s, unisex)

ii. Lens – by manufacturer, lens type (single vision, bifocal, trifocal, progressive, photochromic, special, etc.), lens material (glass, plastic, polycarbonate, Trivex or high index plastic)

iii. Coating – by manufacturer, type (anti-reflective, scratch resistant, , tint, etc.)

7.1.2 Patient Satisfaction Survey: The Contractor shall submit to the COR a report on patient satisfaction. The report will be based on the patient satisfaction survey issued to the VA patients. The report will consist of VA customers only. The report will include the following information:

a) Veterans’ satisfaction with the quality of the product

b) Timeliness of delivery

c) Customer service received in the case they must contact you for service.

d) Outline of any specific issues/problems for that month along with their solutions to correct any issues.

e) The report will include individual responses, accumulative report for responses for each question and a graph of the % of positive and negatives for each question. The surveys will be conducted randomly for 20 Veterans or 5% of the orders for each month, whichever is greater.

f) The VA reserves the right to conduct separate satisfaction surveys to verify results.

7.2 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP):

Contractor shall have an on-going quality control program designed to monitor and evaluate the quality and appropriateness of patient care, resolve identified problems and pursue opportunities to improve patient care objectively and systematically. The written plan shall delineate the objective of the quality assurance activities, scope of the activities, activities for monitoring and evaluation, methods of implementation of the monitoring and evaluation activities, methods for reporting results, mechanisms for taking follow-up action and responsibilities of staff for each activity of the quality assurance program. The objectives, scope, organization, and effectiveness of the quality assurance plan shall be evaluated at least annually and revised as necessary.

7.2.1 The Contractor shall present their Quarterly Quality Assurance Measures/Data/Outcomes at Quarterly Quality Assurance Meetings. Members include the Contractor’s contract manager, contract administrator, Contracting Officer Representative (COR) and other Government personnel as deemed necessary. The contractor may request a meeting with the contracting officer when the contractor believes such a meeting is necessary. Contracting personnel shall record minutes of any such meetings, publish the minutes and provide a copy to the contractor.

8. CUSTOMER SERVICE/SUPPORT

The Contractor shall provide a toll-free telephone number for customer inquiries and shall designate an employee as a VA customer service person to maintain the account and rapidly resolve any identified problems. Contractor shall develop a customer service survey form to be completed by the Veteran. This shall be part of the Contractor's Quality Assurance Program.

9. CONTRACT SECURITY

9.1 GENERAL. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

9.2 VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

9.3 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems. The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property.