A1. Statement of Work Area dental lab services 11.2.26.docx

Statement of Work Bemidji Area Wide – Cass Lake and Red Lake Service Units Dental Laboratory Services Part 1: General Information A. Introduction The Bemidji Area Office Inidian health Services has two federal service units; Red Lake Hospital and Cass Lake IHS. Cass Lake and Red Lake function as not only clinics, but as Emergency departments and inpatient care units, serving the surrounding populations 24 hours a day 7 days a week. The service units serve as primary and emergency care for the populations. Along with medical care each service unit provides dental care to the Red Lake and Leech Lake population.

B. Background The Bemidji Area (BAO) IHS, Red Lake Service unit and Cass Lake Service unit have identified a need to procure commercial dental laboratory services to fabricate high-quality dental prosthetic appliances in support of restorative, prosthodontic, oral surgery, and specialty dental services.

The Contractor shall furnish all labor, materials, equipment, transportation, packaging, and technical expertise necessary to fabricate and deliver dental prosthetic appliances prescribed by licensed IHS dentists.

This is a base plus 4 option year contract

C. Scope The Contractor shall manufacture, repair, adjust, and remake dental prosthetic appliances using prescriptions submitted by licensed dentists of the Red Lake and Cass Lake Service Units.

The Contractor shall provide all necessary materials, fabrication, quality control, and shipping necessary to produce finished dental appliances ready for patient delivery.

The Contractor shall:

· Fabricate all appliances in accordance with written prescriptions.

· Utilize FDA-approved materials.

· Comply with all applicable FDA regulations governing dental laboratories.

· Maintain documented quality assurance procedures.

· Verify completeness of prescriptions before fabrication.

· Contact the ordering dentist within one business day regarding prescription discrepancies.

· Package all appliances to prevent shipping damage.

· Provide prepaid shipping labels when remakes are required due to laboratory error.

· Maintain production tracking for every case.

· Return appliances with work authorization documentation.

· Maintain HIPAA compliance for all patient information.

Services include fabrication of:

1. Premium Dentures

2. Economy Dentures

3. Premium Partials

4. Economy Partials

5. Interim Partials (2 clasps, 1-8 replacement teeth)

6. Interim Partials (no clasps, 1-3 replacement teeth)

7. Premium Flexible Partial

8. Economy Flexible Partial

9. Denture Relines

10. Acrylic Repair

11. Add Tooth to Partial or Denture

12. Repair of Frameworks / Clasps

13. Gold Crowns

14. Lithium Disilicate Crowns

15. Zirconia Crowns

16. Esthetic Zirconia Crowns

17. Lithium Disilicate Fused to Porcelain Crowns

18. PFM Crowns

19. Bi-Lateral Space Maintainers

20. TPA Space Maintainers

21. Bruxism Splints

22. Resin Based Partial with 2 Clasps

23. Gasket Retention Partials (Transitional Denture)

Estimated Annual Quantities

D. Applicable documents

· IGCE

· Market Research

· Acquisition planning

· COR Nomination form

Part 2: Technical requirements

1. Must be reachable by phone 8-3:30 Monday - Friday CT.

2. Tooth-colored crown flexural strengths (MPa) must be at least 1,100 (Zirconia), 650 (Esthetic Zirconia), and 350 (Lithium Disilicate). (MUST INCLUDE DOCUMENTATION OF FLEXURAL STRENGTHS IN MPa IN BID)

3. Gold crowns must be made up of at least 35% gold. (MUST INCLUDE INDENTALLOY STICKER OR EQUIVALENT IN BID)

4. PFM crowns must be made up of Argelite 71 alloy equivalent or better. (MUST INCLUDE INDENT ALLOY STICKER OR EQUIVALENT IN BID)

5. Partial frameworks must be made up of Vitalium 2000 Plus equivalent or better. (MUST INCLUDE INDENTALLOY STICKER OR EQUIVALENT IN BID)

6. Minimum guarantees for services / products (i.e. remakes at no cost): (MUST LIST ALL WARRANTEE INFO. IN BID)

i. Premium Dentures – 2 yrs. or more

ii. Economy Dentures – 1 yr. or more

iii. Partials – 2 years or more

iv. Crowns – 3 years or more

7. All materials used must be free of Nickel, Lead, & Beryllium. (DESIGNATE ON QUOTE SHEET)

8. All prostheses must be made / fabricated in the USA; Lab must not contract work out overseas. (DESIGNATE ON QUOTE SHEET)

9. All materials used must be FDA approved. (DESIGNATE ON QUOTE SHEET)

10. Flexible partials must be DuraFlex brand or equivalent. Must be able to add teeth or reline these flexible partials. (DESIGNATE ON QUOTE SHEET)

11. Quotes for removable services must include premium teeth (equivalent to IPN) unless the service requested is economy partial/denture or flipper. (DESIGNATE TEETH BRANDS ON QUOTE SHEET)

12. Must quote flat rate for all services including, but not limited to: shipping/handling, custom trays, denture teeth, infection control fees, alloy/metal charges, and custom trays for dentures and partials. (DESIGNATE ON QUOTE SHEET)

13. Must list brands of materials used. (DESIGNATE ON QUOTE SHEET)

14. Must provide all requested services. (DESIGNATE ON QUOTE SHEET)

15. Must provide plastic lab case shipping boxes (not corrugated cardboard). (DESIGNATE ON QUOTE SHEET)

16. Must be able to utilize the IHS Secure Data Transfer Email Service to ensure case photos are sent via encrypted email.

17. Must follow lab Rx as written by DDS.

18. Must have minimal occlusal, internal, and interproximal adjustments for crowns and frameworks (less than 10 minutes spent on adjustments).

19. 5% or less remakes of crowns due to issues with occlusion, margins, contacts, fit, or shade discrepancies.

20. 5% or less remakes of dentures, partials, and flippers.

21. Wax rims must need less than 10% reduction / addition.

22. 5% or less of lab cases need additional, redundant appointments (2nd wax try-in or wax rim appointment, 2nd crown delivery appointment, etc.).

23. Esthetics must be rated "acceptable" or better by dentists through our quality assurance program.

24. Occlusion for all prosthesis must be rated "acceptable" or better by dentists through our quality assurance program.

25. Lab must meet all CDC guidelines for infection control.

26. Shall bill monthly via detailed itemized bill, identifying each individual prostheses as noted in the enclosed Dental Lab fee quote form.

27. Shall NOT bill hospital for laboratory fees already paid via patient or Tribal payment.

28. The contractor will comply with the maximum turnaround times for appliances

29. The contractor will ensure appropriate quality standards, inlcuding but not limited to:

· Accurate margins

· Proper occlusion

· Proper contacts

· Appropriate shade matching

· Anatomically correct morphology

· Accurate fit

· Proper polish and finish

· Absence of manufacturing defects Repairs or remakes resulting from laboratory error shall be performed at no additional cost.

30. Performance standards

31. Inspection and Acceptance The service units each reserve the right to inspect every appliance. Acceptance shall only occur after:

· Clinical Evaluation

· Verification of prescription compliance

· Fit

· Function

· Esthetics

· Material Verification

32. Billing

· Each site will have two accounts

· Each account will have an individual identification number assigned

· A monthly statement for all accounts is required no later than the 15th of each month

· Services rendered under this contract must not be duplicate billed

1. An account that allows for direct billing to the ordering service unit; Services rendered through this account:

a. Will be billed monthly

b. Will be invoiced to the government through the Invoice Processing Platform (IPP)

c. Will be invoiced upon completion of services

2. An account that allows for patient or Tribal payment; Services rendered under this account:

a. Will require payment prior to services rendered.

b. Will accept payment in the form of money order

33. Any appliances rejected for laboratory error shall be remade without additional cost.

Each Service unit will appoint a subject matter expert (SME) to provide acceptance or rejection for appliances.

All appliances will be shipped to the appropriate service unit. The Contractor shall:

· Pay return shipping on remakes due to laboratory error.

· Package all appliances securely.

· Use trackable shipping.

· Deliver Monday through Friday excluding Federal holidays.

34. Delivery Address

Red Lake Dental 24760 Hospital Drive Red Lake, MN 56671

Cass Lake Dental 425 7th St NW Cass Lake, MN 56633

35. Government furnished property The Government will provide:

· Dental prescriptions

· Impressions

· Bite registrations

· Shade information

· Implant information

· Clinical photographs when required

36. Vendor furnished property

a. The Contractor shall furnish all labor, materials, equipment, transportation, packaging, and technical expertise necessary to fabricate and deliver dental prosthetic appliances prescribed by licensed IHS dentists.

Part 3: Supporting Information A. Security The Contractor shall comply with:

· HIPAA

· Privacy Act of 1974

· HITECH Act

· IHS Privacy Policies

· Federal Information Security requirements for protected health information Patient information shall only be used for fabrication of prescribed appliances.

B. Place Of Perfomance

a. Contractor will perform all work in off-site FDA regulated laboratory and deliver completed work to the service units

b. All Appliances will be shipped to the ordering account’s associated address

C. Period of Performance

D. Special considerations The Contractor shall comply with:

· Federal Food, Drug, and Cosmetic Act

· FDA Dental Device Regulations

· OSHA Bloodborne Pathogens Standard

· HIPAA Privacy Rule

· HHS Security Requirements

· Applicable provisions of the Federal Acquisition Regulation (FAR)

· Applicable provisions of the Health Insurance Portability and Accountability Act (HIPAA)

· Current ANSI/ADA Specifications applicable to dental materials and laboratory fabrication

· Current National Association of Dental Laboratories (NADL) recommended practices

· Terms and service agreements must not include an indemnification clause, and the governing body must be United States federal.

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