SOW-PWS for Dental Lab.docx

DRAFT PERFORMANCE WORK STATEMENT (PWS)

DENTAL LAB SERVICES

1. GENERAL

1.1. SERVICES REQUIRED: San Francisco VA Health Care System (SFVAHCS) requires contractor services to perform laboratory procedures that are required for the treatment of dental patients. These procedures include but are not limited to: all laboratory fabrication of complete dentures, removable partial dentures, fixed partial dentures and crowns, dental implant restorations, bleaching trays, surgical stents, mouth guards, and sleep apnea appliances. All outgoing dental cases (i.e., impressions, casts, prostheses and attachments) will be shipped to the Contractor via UPS and the Contractor will deliver the fabricated appliances via UPS, in a timely manner, to the 2 SFVAHCS divisions: San Francisco VA; VA Santa Rosa CBOC.

1.2. PLACE OF PERFORMANCE: The Contractor shall perform all laboratory work at the Contractor’s facility.

1.3. Lab cases will be shipped to and from the SFVAHCS San Francisco Dental Service, located at SFVA Medical Center 4150 Clement St San Francisco, CA 94121; VA Santa Rosa CBOC dental clinic, located at 3841 Brickway Blvd Santa Rosa, CA 95403. The new VA Santa Rosa CBOC is located at 2285 Challenger Way Santa Rosa, CA 95407. The dental clinic in Santa Rosa will be moving to this address.

1.4. AUTHORITY/POLICY/HANDBOOKS: Contractors and contractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

1.5. All standards related to prosthetic services shall be in agreement with the VA Central Dental Laboratory case requirements listed at http://vaww.infoshare.va.gov/sites/dental/PH/CDLWebsite.aspx.

1.6. DEFINITIONS/ACRONYMS:

COR- Contracting Officer’s Representative.

Dental Laboratory Services- Those laboratory procedures that are required for the treatment of dental patients. These would include, but not be limited to, all laboratory fabrication of complete dentures, removable partial dentures, fixed partial dentures and crowns, and dental implant prosthesis. Miscellaneous other procedures may include such items as bleaching trays, surgical stents, athletic mouth guards, and sleep apnea appliances.

Routine Handling- A dental laboratory work authorization that is usually performed and returned within specified timeframe.

Special Handling- Some circumstances may dictate the need for a dental order to be processed and returned within a shorter timeframe, such as a same-day or next day repair of a removable prosthesis. There may also be a circumstance where a patient needs to travel to the dental lab for custom shade matching/staining. For these reasons, it is important that the contracted dental lab be located in the San Francisco Bay Area.

Turnaround Time (TAT)- The length of elapsed time between pickup of the dental lab order by the Contractor and the receipt of the completed order by SFVAHCS Dental Service.

Working Day- Any 24-hour period of the administrative work week, which is Monday through Friday. Federal holidays occurring during the administrative work week, are not considered working days.

Using Service- Same as VA Dental Service.

SFVAHCS- San Francisco VA Health Care System.

VA Dental Service- Refers to the Dental Services located at the SFVAHCS San Francisco Division and Santa Rosa Division.

VISN 21- Veterans Integrated Service Network 21, comprising the network of VA facilities within the VA Sierra Pacific Network, including SFVAHCS.

2. CONTRACTOR QUALIFICATIONS

2.1. The Contractor shall demonstrate the use of procedures, techniques, and current technology that are equivalent to or exceed current industry standards.

2.2. The Contractor’s lab shall be certified by the National Association of Dental Laboratories. The Contractor shall provide a current copy of its National Association of Dental Laboratories certification.

2.3. 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.

2.4. Contractor Personnel: Contractor personnel performing the required work under this contract shall not be considered Government employees.

2.5. Changes in Subcontracted Dental Laboratories: The Contractor shall notify the Contracting Officer of any proposed changes in subcontracted dental laboratories used. Changes in subcontracted dental laboratories must have prior written approval by the Contracting Officer before any changes are implemented. The Contractor is responsible for any additional costs that are a result of any changes in subcontracted laboratories.

3. CONTRACTOR TASKS/RESPONSIBILITIES

3.1. The Contractor shall furnish all labor, shipping, materials, general dental laboratory tools, equipment, and supervision required to provide dental prosthesis to SFVAHCS between the work hours of 8:00am and 5:00pm, Monday through Friday.

3.2. Federal Holidays: The Contractor is not expected to work on Federal Holidays. The holidays are: New Year’s Day; Martin Luther King Jr.’s Birthday, President’s Day; Memorial Day; Juneteenth; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving Day; Christmas Day; and any other day officially declared by the President of the United States to be a federal holiday.

3.3. The Contractor shall provide the following services:

3.3.1. Fabricate complete dentures and removable partial dentures, including the following steps:

a. Box and pour preliminary and final impressions.

b. Prepare master stone casts.

c. Fabricate custom impression trays.

d. Fabricate base plates and wax rims.

e. Mount casts on semi-adjustable articulator.

f. Removable partial denture frameworks will be made from chrome cobalt alloy (Vitallium).

g. Set Ivoclar Blueline teeth (unless otherwise specified in lab prescription) in wax for denture try-in.

h. Flask and process dentures.

i. Patient’s name and last four digits of their SSN will be processed into the prosthesis.

j. All removable prostheses will be processed in Lucitone 199 unless otherwise specified in lab prescription.

k. Break out and finish dentures for delivery.

3.3.2. Fabricate crowns and fixed bridges that use metal alloys (i.e., PFM and cast gold), including the following steps:

a. Pour and prepare casts for fabricating crowns.

b. Mount casts on a semi-adjustable articulator.

c. Wax crowns.

d. Invest and cast wax patterns.

e. Noble or High noble alloys will be used unless otherwise specified in lab prescription.

f. Breakout, adjust and polish cast crowns for delivery.

g. Include stickers of alloy used in case returning to SFVAHCS.

3.3.3. Fabricate Ceramic Crowns and Fixed Bridges including the following steps:

a. Pour and prepare casts for fabricating crowns.

b. Mount casts on a semi-adjustable articulator.

c. Wax crowns.

d. Invest and cast wax patterns.

e. Breakout, adjust and polish cast copings.

f. Apply porcelain, finish and polish for delivery.

g. Pick-up and delivery from the facility.

OR

a. Receive digital scan or perform digital scan of working cast.

b. Digitally mark margins.

c. Digitally design crown or bridge contour.

d. Mill or press final restoration.

e. Check and adjust contours, contacts, and occlusion.

f. Crystalize, sinter, stain, and glaze final restoration.

g. Check and adjust contours, contacts, and occlusion.

h. Pick-up and delivery from facility.

3.3.4. The Contractor shall provide all packing and shipping materials, personalized shipping, shipment tracking and/or pickup and delivery services to ensure that casework arrives on time and safely to SFVAHCS: San Francisco and Santa Rosa Divisions.

3.3.5. Describe the method of referral, records management procedures, scheduling, and or documentation procedures: The Contractor shall receive cases via UPS. Each case will be tracked by a dental lab prescription and a UPS tracking number. Pick-up and delivery shall be between the hours of 8:00 a.m.– 4:30 p.m. Patient casework will be identified with the last name and last four digits of the patient’s security number. The lab prescription shall include the date of the follow-up appointment for the Veteran.

3.3.6. The Contractor shall comply with Occupational Safety and Health Administration (OSHA) regulations.

3.3.7. The Contractor shall comply with the Health Insurance Portability and Accountability Act (HIPAA).

3.3.8. The Contractor shall meet or exceed VA standards and The Joint Commission standards for constructing dental prostheses.

3.4. Quality Control Plan (QCP): The Contractor shall develop and maintain an effective Quality Control Plan (QCP) which details how they will monitor their work to ensure they are meeting all of the requirements of the contract. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s QCP is the means by which the Contractor assures that their work complies with the requirements of the contract. The QCP shall be submitted in written form with an electronic copy to the COR for review within thirty (30) calendar days of the contract award. The COR or designated representative will review the QCP and return it to the Contractor if changes are required. If any changes are required, the Contractor has five (5) working days to complete the changes and resubmit the QCP. If any future changes are needed, the Contractor has five (5) working days to submit the agreed upon changes.

3.4.1. To ensure that both parties have an equal understanding of the services to be provided by the Contractor, the following quality assurance guidelines are to be incorporated:

a. Services were received within the designated timeframe.

b. Services were delayed no more than twice in a 30-day period.

c. Performance problem occurred: ill-fitting denture or prosthesis was remade within 30 days.

d. Description of problem conveyed to Contractor by the Dental Service provider.

e. The Contractor was verbally informed and corrected the problem within the agreed upon turnaround times between SFVAHCS and the Contractor, plus one day.

f. Informed problem in writing and contractor corrected within a reasonable timeframe.

g. What actions were necessary: remake/adjustments– minor or major.

h. Three or more patient delays caused within a 30-day period shall result in a disincentive.

3.4.2. Quality Control Inspection Procedures for Crown and Bridge:

a. Read and ensure all of the following items correlate: work ticket, physician preferences, prescription, patient name, case pan number, dated wanted.

b. Identify tooth number with physician’s prescription.

c. Check shade with shade guide.

d. Check margins on die under magnification; ensure margins are closed.

e. Inspect all surfaces for: black spots; fractures; bubbles in porcelain; and rough textures.

f. Check anatomy and contours of crown and bridge: buccal and lingual contour in relation to adjacent teeth; marginal ridges in proper height to adjacent and opposing teeth; proper embrasures; proper length of anteriors; and proper emergence profile.

g. Check occlusion, group function, and lateral excursions.

h. Check contacts on solid model. Verify contacts for adequate contact and for proper form.

i. Check work ticket for any specific physician preferences.

j. Check to ensure that the inside of crown is sanded, free of glaze and is opaque.

k. All transfer copings and specified margin dies boxes with outgoing crowns and bridges.

l. Verify product codes on work invoice for: alloy; wrong codes; wrong quantity; and missing codes. Mark bottom of crown box with pan number.

m. Check all model work for cleanliness.

3.4.3 Quality Control Inspection Procedures for Removable:

3.5. Work Guarantee: The Contractor shall provide an On-Time Delivery Guarantee; guaranteed turnaround times; and remakes at no additional cost to the Government when the Contractor’s products are flawed or defective.

4. PERIOD OF PERFORMANCE (POP)

4.1. Five (5) – one (1) year order periods, total of five (5) years. The POP will depend on the date of award.

4.2. The Contractor shall not perform work beyond the POP unless there is written authorization by the CO. Any work performed without prior authorization will be performed by the Contractor at no additional cost to the Government.

5. GOVERNMENT FURNISHED EQUIPMENT (GFP)

5.1. SFVAHCS will provide all necessary impressions, casts, and implant prosthetic parts for all cases submitted to the Contractor.

6. CONTRACTOR FURNISHED EQUIPMENT/PROPERTY

6.1. Unless specified otherwise in this solicitation, the Contractor shall furnish all supplies, equipment, facilities, and services required to perform work required.

6.2. The Contractor shall use high quality raw materials. All items shall be manufactured in the United States.

7. OTHER ADMINISTRATIVE RESPONSIBILITIES

7.1. Invoices: Invoices will be paid in arrears monthly. Invoices must include at minimum, the following information: date of invoice; vendor name; contract number, purchase order number, services provided, and the period of service. Under no circumstances shall the Contractor commence with any additional services without the written approval of the CO. Any additional services performed without this approval will be at the Contractor’s expense.

7.2. The Contractor shall be paid for actual services provided by Contractor personnel. The Contractor will not be paid for “availability” or “on-call” services unless otherwise provided herein.

7.3. Travel Costs: Unless otherwise specified in this solicitation, the Contractor shall include in its price, all labor, travel costs and its expenses, materials, tools, supplies, equipment, and other expenses necessary to perform this requirement.

7.4. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity or quality of performance of this contract.

7.5. Contracting Officer Representative (COR): The COR will be appointed and delegated by the Contracting Officer. A letter of designation will state 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. The Contractor will receive a copy of the Delegation Letter from the Contracting Officer. The COR shall be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

8. SECURITY REQUIREMENTS

8.1.1. A background check is required for the Contractor’s employees IF the Contractor’s employee requires access to areas within the VA such as offices, clinics, patient rooms, and other restricted areas. No employee shall be permitted to perform work or access non-public areas without a background check and written clearance by VA Police.

8.1.2. The position sensitivity has been designated as Low Risk.

8.1.3. The level of background investigation commensurate with the required level of access is Special Agreement Check (SAC) – Fingerprint Only. Fingerprinting will be done at a VA facility designated at the time of award. The VA will bear the cost of the initial SAC. The Contractor shall bear the cost of any subsequent SACs. The SAC shall be initiated five (5) days prior to entry on duty for Contractor personnel. The Contractor shall submit for its employee proof of a negative tuberculosis test within five (5) days of contract award to the Contracting Officer.

8.1.3. Privacy Training: The Contractor may be required to take on-site Privacy Training and any other training identified by SFVAHCS.

8.1.4. Access to VA Information and VA Information Systems: The Contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

8.1.5. All contractors, third-party servicers, and associates working with VA information are subject to the same investigative 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

8.1.6. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

8.1.7. The contractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor’s employ. The Contracting Officer must also be notified immediately by the contractor prior to an unfriendly termination.

8.1.8. VA Information Custodial Language:

a. 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 shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor’s rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor electronic storage media for restoration in case any electronic equipment or data used by the contractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

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 other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor is in receipt of a court order or other requests for the above mentioned information, that contractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

8.1.9. SECURITY INCIDENT INVESTIGATION

a. 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. The contractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract 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 has access.

b. To the extent known by the contractor, the contractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

8.1.10. Liquidated Damages for Data Breach:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract.

b. The contractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) Date of occurrence;

(b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

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

9.2. The QASP will be provided to the Contractor within fifteen (15) days after award of contract. The COR will monitor Contractor performance. Documentation of services performed will be reviewed prior to certifying payment. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

10. INVOICING/PAYMENT

10.1. The vendor shall submit a copy of the invoice prior to commencement of the training program to the COR prior to submitting it to DFAS Austin. The COR will verify the invoice and authenticate the invoice via Online Certification System (OLCS). This is the VA’s process and procedure for submitting invoices for payment.