36C25018R0804-0004002.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE

OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

BY

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 11-14-2018 583-19-1-191-0001 None Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor

MI

48105 Y Department of Veterans Affair Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor

MI

48105 To all Offerors/Bidders

36C25018R0804 11-14-2018

X X X November 28, 2018 at 4:30 pm EST 583-3690160-191-824800-2632 010024843

The purpose of this amendment is to replace the SOW from the original RFQ. See page 2.

Please email updated proposals to Kellie.Konopinski@va.gov by 11/28/2018 at 4:30 pm.

Charles Lakin Contracting Officer

CONTINUATION PAGE

The following SOW will replace pages 6-17 of original RFP. See changes highlighted below.

PERFORMANCE WORK STATEMENT (PWS)

DENTAL LAB SERVICES

1. GENERAL: This is a non-personnel services contract to provide dental laboratory services to construct fixed and removable prostheses for eligible veteran beneficiaries. The Government will not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform dental laboratory services as defined in this Performance Work Statement except for those items specified as Government furnished property and services. The Contractor shall perform to the standards in this contract.

1.2 Background: The Richard L. Roudebush VAMC (RLRVAMC) provides health care services to veterans of the U.S. armed services. Part of the care provided to veterans involves providing dental prosthetics. While the RLRVAMC has a robust dental service, it requires outside services for dental prosthetics in order to meet the needs of the Veteran.

1.3 Objectives:

1. Provide transportation for pickup and delivery of dental prosthetic cases. Commercial shipping standard is that the contractor shall cover all shipping charges from the VA and back to the VA. Price of shipping shall be reflected in end item pricing.

1. For emergencies – onsite pick-up and delivery required for repairs and expedited intermediate fabrication items.

1. Provide all necessary dental lab supplies to construct prostheses

1. Construct prosthesis according to provider’s prescription and industry quality standards

1. Provide timely and accurate completion of dental lab cases:

4. Pick-up and delivery shall be between the hours of 8:00 a.m. – 4:00 p.m., Monday through Friday. Patient casework shall be identified with patient’s last name, last name of patient’s provider, and patient’s next appointment date.

4. The contractor shall meet the following turnaround times (includes shipping both ways if picked up by 1:00. If picked up after 1:00, the first day is the following day):

1. FCC- six (6) business days

1. PFM and Veneers- eight (8) business days

1. Ceramics/non-metallic crowns- ten (10) business days

1. Set-ups- five (5) business days

1. Denture finish- six (6) business days

1. Set-up/finish – seven (7) business days

1. Frameworks- eight (8) business days

1. Soft relines – four (4) business days

1. Provisional crowns- six (6) business days

1. Implant crowns for cementation of UCLA design- twelve (12) business days

1. Implant restorations (including custom abutments) – twelve (12) business days

1. Urgent and or Emergent repairs, relines, remakes, etc. – Six (6) to twenty-four (24) hours (same-day or up to the next-day on site pickup and delivery) on a case by case basis depending upon both the clinical need and the urgent/emergent nature thereof.

1. For any type of case that involves standard implant(s), the contractor may add one (1) business day to the required turnaround times. This includes implant cases that do not involve unusual & challenging orientation, occlusion, inter-arch relationships or unique esthetic demands.

For example:

1. A denture finish is shipped out Monday before 1:00 pm. You have six business days to have it back to the VA. The denture finish shall be back to the VA by the following Monday.

2. A soft reline is shipped out on Tuesday after 1:00 pm. You have five business days to have it back to the VA. The soft reline shall be back to the VA by the following Monday.

1. The contract will handle complex, full-mouth implant cases when required by the RLRVAMC

1. Make any necessary changes after the provider has reviewed the final product for quality if changes are ordered by the provider.

1. 5-year warranty required

1. Direct consultations shall be provided with an appropriate laboratory technician as follows below:

8. Consultations must be available during the dental clinic’s business hours (8:00 am – 4:30 pm) by phone on a case by case basis.

8. Two scheduled 1.5-hour consultations per month for the VA treatment planning and implant review boards in-person or using tele-dentistry

8. One 2-hour consultation for the monthly Resident Laboratory Case Review session in-person or using tele-dentistry

1. Continuous Education on laboratory techniques must be provided at least twice a year in-person or using tele-dentistry

1. All personnel working under this contract are required to follow standards of the FDA and ANSI. Documentation verifying this shall be provided with proposal.

1. Government requires that if turnaround times are not met, contractor shall use expedited shipping.

1.4 Scope:

Contractor shall provide both fixed and removable prosthetic services according with the specific list of dental lab services authorized under this contract (see estimated workload pricelist). Lab services shall be provided according to lab prescription by RLRVAMC dental provider and cases returned within specified timeframes. Contractor shall provide customized shade matching at Contractor’s site of business.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year Period and four (4) 1- year options. The estimated Period of Performance reads as follows:

1.6 General Information

1.6.1 Quality Control: The Contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. A proposed Quality Control Plan shall be submitted within 30 days after contract award. After acceptance of the quality control plan the Contractor shall receive the Contracting Officer’s acceptance in writing of any proposed change to his QC system.

1.6.2 Quality Assurance: The Government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards shall be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Federal Holidays: The ten holidays observed by the Federal Government are listed below and in addition, any other day specifically declared by the President of the United States to be a national holiday. The Contractor is not required to provide dental lab services on these Federal holidays.

1.6.4 Hours of Operation: The Contractor is responsible for conducting business to provide reasonable coverage and to ensure timely fabrication and consultation for dental prostheses. For other than firm fixed price contracts, the Contractor shall not be reimbursed when the Government facility is closed for the reasons listed in 1.6.3 above. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. There are no standard business hours.

1.6.5 Security: The patient’s last name, dental provider’s last name, and date of the patient’s next appointment shall be used as an identifier both for the prescription and for billing purposes. No other personal patient identifiers shall be used.

1.6.6 Place of Performance: The work to be performed under this contract shall be performed at the Contractor’s facility.

1.6.7 Type of Contract: The Government anticipates awarding multiple contracts to the dental labs that meet or exceed the selection criteria.

1.6.8 Special Qualifications: National Association of Dental Laboratories (NADL) certification is desired, but not required. Contractor shall provide a current copy of the firm’s NADL certification if applicable.

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officer’s Representative (COR), and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.6.10 Contracting Officer Representative (COR): The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions; assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: No key personnel are specified as any lab awarded contract shall possess and maintain site certification. It is preferred that contractor’s lab be certified by the National Association of Dental Laboratories.

1.6.12 Organizational Conflict of Interest: Contractor and Subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

2. DEFINITIONS AND ACRONYMS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DEFINITIONS.

2.1.6 DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.7. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.8. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.9. QUALITY ASSURANCE (QA). The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.10. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of Contractor performance.

2.1.11. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.12. SUBCONTRACTOR. One that enters into a contract with a Prime Contractor. The Government does not have privity of contract with the Subcontractor.

2.1.13. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.14. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Materials: The Government will also provide all necessary impressions, and casts.

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Materials: The Contractor shall furnish all materials, supplies, and equipment necessary to meet the requirements under this PWS.

4.3. Equipment: The Contractor shall provide all the necessary equipment to meet the requirements under this PWS.

5. TASKS:

5.1. Basic Services. The Contractor shall provide services for dental laboratory services to fabricate fixed and/or removable prostheses following RLRVAMC dental provider’s prescription. If a lab prescription from the dental provider is not legible or not clearly understood, the Contractor shall contact the dental provider to obtain a legible prescription or for clarification of the requested procedure.

5.2. Provide the necessary materials for the fabrication of fixed and removable dental prostheses.

5.3. Provide pickup and delivery of prosthetic cases. Impressions, teeth, prescriptions, finished product, etc. will be picked up from and delivered to the RLRVAMC Dental clinic. Pick-up and delivery shall be between the hours of 8:00 a.m. – 4:00 p.m. Patient casework shall be identified with patient’s last name, dental provider’s last name, and date of patient’s next appointment.

5.4. All turnaround times are outlined above along with delivery times for all prosthetics picked up from RLRVAMC.

5.5. The Contractor shall offer professional case consultation and responsive and knowledgeable customer service. For fixed prostheses, contactor shall provide local custom shade matching services. Services to be provided at Contractor’s site of business.

5.6. The Contractor shall, at no additional expense to VA, re-make all dental items that are not correct or flawed due to Contractor error. For example, if a crown does not fit the die, it shall be considered flawed and unacceptable. The crown shall be remade at no additional expense to the Government. If the crown fits the die but not on the patient’s tooth, it shall be considered a flawed action of the Government and the remake shall be at VA’s expense. If, in the case of porcelain work, the porcelain shatters within twelve months of fabrication, it shall be considered a flawed product from the Contractor and remade at no additional expense to VA.

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor shall abide by all applicable regulations, publications, manuals, and local policies and procedures.

6.2. The Contractor shall comply with the regulations governing Food and Drug Administration (FDA) Quality System/Good Manufacturing Practices for products distributed in the United States dental laboratories. Additionally, the Contractor shall comply with standards by the American National Standards Institute (ANSI) in cooperation with the American Dental Association Department of Standards that require all materials used for fabrication of dental appliances meet the Standard Practices for Biological Evaluation of Dental Materials.

7. ESTIMATED YEARLY USAGE

8. ORDERING PROCEDURES

All dental prosthetic items listed are anticipated to be provided by different Contractors based on the individual patient needs, provider medical/dental opinion of what contractor’s device will work best, and delivery/turnaround time.