36C24218Q0190-001.docx

A.4 SCOPE OF WORK

A.4.1 General The Government intends to award a firm fixed price requirements purchase order, to include four option years, for dental laboratory services listed, as described in section A.4.2, to support dental clinics located at the three VA New Jersey Healthcare System facilities. . The contractor shall furnish all personnel, equipment, tools, materials, supplies, and labor necessary to perform Removable Denture Laboratory Services for the New Jersey VA Healthcare System, in accordance with the terms and conditions herein. The quantities specified in the schedule are estimates only.

1. Location of Dental Clinics

· VA East Orange Medical Center – 385 Tremont Av, East Orange, New Jersey, 07018

· VA Lyons Campus – 151 Knollcroft Rd, Lyons, New Jersey 07939

· James J. Howard Clinic – 970 Rt. 70, Brick, New Jersey 08724

2. The contractor shall use procedures, techniques and current technology that are considered to be industry standards. The contractor shall provide items that meet the esthetic and functional requirements of the patient. The contractor shall be familiar with and utilize as applicable, mould guides by Trubyte Bio blend and with shade guides by Trubyte Bioform and the VITA 3D Tooth guide. High quality materials shall be utilized from ISO 9001/CE registered companies. Laboratory shall perform internal technical audits to ensure consistent, high quality, and timely restorations. The contractor shall provide a denture storage box for each completed denture case at no additional cost to the Government.

3. All work shall be performed by either a certified dental technician or a lab technician under the direct supervision of a certified dental technician.

4. The contractor shall provide certifications for all Certified Dental Laboratory Technicians that are assigned laboratory work from New Jersey VA Healthcare System before work commences. If uncertified technicians are being used the vendor shall provide proof of a formal in-house training program run by a certified dental technician. The contractor must comply with all FDA Regulations, ANSI Standards and “Buy American Act” policies in fabrication of all dental prostheses. All materials used for VA cases must be fabricated and assembled in the United States. If the vendor intends to use a sub-contractor for any portion of the performance of this purchase order, the sub-contractor shall be identified and the Contracting Officer shall be supplied with the sub-contractors certifications and in-house training documentation for approval. Sub-contractors shall not be used in the performance of this purchase order without prior approval from the Contracting Officer.

A.4.2 Dental Laboratory Services

1. The contractor shall provide the following dental laboratory services to the East Orange, Brick and Lyons Campuses of the New Jersey VA Healthcare System:

a) Complete Dentures (including custom trays, bite rims, articulation, set-up, process and finish)

b) Acrylic Partial Dentures with wrought wire clasps (including articulation)

c) Biomet 3i Flexible Partial Dentures (including custom trays, articulation, frameworks, bite rims, set-up, process and finish); Note: On occasion Zimmer/Biomet, Straumann, Nobel Biocare or Keystone formally known as Lifecore partials may be requested.

d) Precision and semi-precision attachments

e) Setups

f) Bleaching Trays (hard and soft)

g) Flippers

h) Maxillofacial Prostheses (Overdentures complete and partial; Obturator prostheses [surgical, temporary, postsurgical]; Surgical Stents; Palatal Lift prostheses; Speech Aid/Prostheses; Feeding Aid; Nasal Prostheses; Auricular Prostheses; Orbital Prostheses; Ocular Prostheses; Cranial Prostheses)

i) Complete and Partial Denture repair (repair of cast partial dentures will be completed using laser welding technique)

j) Complete and Partial Denture relines and rebases

k) Night Guards (Hard & Soft)

2. The contractor must identify the specific type of metal used in each prosthesis at the time of delivery.

3. The contractor shall provide a thorough infection control process for all incoming and outgoing cases. All completed cases must be disinfected before the product is returned to the East Orange, Lyons or Brick Campuses of the New Jersey VA Healthcare System.

4. Appropriate infection control practices for hand hygiene, standard precautions, conforming to recommendations of the Center of Disease Control and other appropriate authorities shall be maintained.

5. Contractor shall provide local repair and reline service with 24 hour turnaround of all denture repairs and relines/rebases.

6. The contractor shall provide, at no additional cost to the VA, professional case consultation with responsive and knowledgeable customer service.

7. The contractor shall provide personalized shipping, shipment tracking and/or pickup and delivery services to ensure that casework arrives on time and safely at no additional cost to the East Orange, Lyons and Brick VA Medical Centers. The contractor shall provide all packing and shipping materials for all three facilities at no additional cost.

8. The contractor shall provide all packing and shipping materials at no additional cost to New Jersey VA Healthcare System.

9. The attached Quality Assessment of Dental Laboratory Procedures will be used to measure/assess the quality of the product produced (See attached document)

A.4.3 Service Turn-around Time

1. Pick-ups and deliveries shall be scheduled daily during regular business hours: 8:00 a.m. – 4:00 pm, Monday through Friday, excluding Federal Holidays(Federal Holidays shall be defined as New Year’s Day, Martin Luther King Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving and Christmas). Completed work shall be returned to Dental Service, the East Orange, Lyons or Brick Campuses of the New Jersey VA Healthcare System.

2. The New Jersey VA Healthcare System shall coordinate with the vendor to schedule a regular pick up time with the vendor.

3. The contractor shall adhere to the following turn-around requirements: All complete and partial denture steps shall be completed within five (5) working days of pickup. All work must meet the required Turn-Around Times.

Ten (10) Working Days:

a. Complete and Removable Partial Denture, processed Valplast Five (5) Working Days:

b. Complete and Removable Partial Denture, processed acrylic resin

c. Tooth Arrangements, Complete and Removable Partial Dentures

d. Custom Occlusal Guards

e. Diagnostic wax-up, five teeth or more Three (3) Working Days:

a. Diagnostic wax-up, four teeth or less

b. Tooth Rearrangements, Complete and Removable Partial Dentures

Forty-eight hours:

a. Complete and Removable Partial Denture, record bases and occlusion rims

b. Complete and Removable Partial Denture, record bases and occlusion rims, stabilized/processed

c. Transitional Removable Partial Denture, processed Twenty-four hours:

a. Complete and Removable Partial Denture acrylic resin repairs

b. Complete and Removable Partial Denture, tooth additions/repairs

c. Removable Partial Denture, clasp repair/replacement and wrought wire clasp retained by acrylic resin

d. Custom impression trays

e. Custom impression trays, altered case impression

f. Poured impressions

g. Articulation of cast

h. Cast duplications

i. Fluoride application tray

j. Complete and Removable Partial Denture, relines

k. Complete and Removable Partial Denture, rebase

4. Remakes shall be expedited with completion of all steps in half of the above specified working time.

A.4.4 New Jersey VA Healthcare System Requirements

1. New Jersey VA Healthcare System Dentists shall provide legible dental service prescriptions. New Jersey VA Healthcare System Dentists shall provide accurate impressions and bite registrations. If a prescription is not legible, nor clearly understood, the contractor shall contact VA’s Contracting Officer’s Representative (COR) to obtain a clear and legible prescription.

A.4.5 Corrective Actions

1. The contractor shall, at no additional expense to VA, re-make any dental prosthesis that is ill-fitting or structurally flawed due to contractor error. For example: excessive porosity in acrylic, distorted framework or inadequate adherence of denture teeth to acrylic. If prosthesis failure is due to contractor’s failure to adhere to prescription, remake is also done at contractor’s expense. If dentist provides inadequate or incomplete instructions, or the contractor advises the VA of a problem with the model or impression and is directed to use the model in question and a problem arises, the VA will bear the cost of remake.

2. If there is structural failure of the acrylic base, the partial framework (including clasps), or more than a single incidence of teeth debonding from acrylic base, the repair will be the responsibility of the contractor for a period of 12 months

A.4.6 Reporting

1. The Laboratory shall establish and maintain a log of patients treated under this contract including the patient’s name and last four numbers of their SSN, fees charged for each order, date received and date delivered. This log (or detailed invoice) will be submitted to the VA on a monthly basis.

A.4.7 Security requirements

1. A prohibition on unauthorized disclosure: “Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.” See VA handbook 6500.6, Appendix C, paragraph 3.a

2. A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COTR, the designated ISO, and Privacy Officer for the contract. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a

3. A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost or providing credit protection services to those individuals.” See VA handbook 6500.6, Appendix C, paragraph 7.a., 7d.

4. A requirement for annual security/privacy awareness training: “Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis wither: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA’s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA’s requirements, they will provide the COTR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in the VA’s contract have received their annual security/privacy training that meets VA’s requirements and the total number of employees trained, See VA Handbook 6500.6, Appendix C, paragraph9

5. A Requirement to sign VA’s Rules of Behavior: “Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shal sign on annual basis an acknowledgement that they have read understand, and agree to abide by VA’s Contractor Rules of Behavior which is attached to this contract.” See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If medical device vendor anticipates that the services under this contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA’s information and information systems.