36C26125Q0516 - Mohs Sources Sought.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* Mohs Micrographic Surgical Technician

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 95652

SOLICITATION NUMBER* 36C26125Q0516

RESPONSE DATE/TIME/ZONE 05-09-2025 10AM PACIFIC TIME, LOS ANGELES,

USA

ARCHIVE 30 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* Q504

NAICS CODE* 621511

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

Network Contracting Office (NCO) 21

POINT OF CONTACT*

Contracting Officer

Cynthia Diezel cynthia.diezel@va.gov

916-923-4567

PLACE OF PERFORMANCE

ADDRESS San Francisco VAMC

4150 Clement Ave

San Francisco, CA 95121

POSTAL CODE

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY.

No Solicitation is currently available.

All information contained in this Sources Sought Announcement is preliminary, as well as subject to modification, and is in no way binding on the Government. The Government will not pay for any information submitted in response to this request. The information requested will be used solely within the Department of Veterans Affairs to facilitate decision making and will not be disclosed outside of the Government. The determination of a procurement strategy, based upon the comments submitted in response to this Sources Sought Announcement, is solely within the discretion of the Government.

The applicable North American Industry Classification System (NAICS) Code is 621511, Medical Laboratories, and the small business size standard is $41.5 Million.

The Department of Veterans Affairs (VA) Network Contracting Office (NCO 21) is soliciting information from contractors that can provide Mohs Technician for the VA San Francisco Medical Center. A draft copy of the Statement of Work (SOW) is attached.

Brief Description of Services

See attached Draft SOW.

Capability Statement

All interested contractors must respond by email to Cynthia.diezel@va.gov before 10:00 A.M.

PST on May 9, 2025.

Please answer the following questions when responding:

1. What is your company’s Socioeconomic Status? (ex: small business, large business, SDVOSB, etc.)

a. If SDVOSB or VOSB, are you registered with the Small Business Administration?

Veteran Small Business Certification (sba.gov)

2. Provide Company’s legal name along with Unique Entity ID (SAM) number.

3. Primary point of contact, including phone number and e-mail address.

4. Capabilities Statement.

5. Describe experience in providing candidates for Mohs technicians.

6. List other Projects (Government and Commercial) that are similar in scope and size.

7. As this is a service acquisition, the Small Business Administration and the Federal Acquisition Regulation have a Limitations on Subcontracting requirement. For all small businesses, to include SDVOSB and VOSB, “At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.” See FAR 52.219-14 and FAR 52.219-27 available in full text at https://www.acquisition.gov/far/html/52_217_221.html

7a. Of the service actions listed above, which one(s) will your company perform as the prime contractor using its own personnel without subcontracting?

7b. With respect to the service actions listed above, which action(s) do you intend on subcontracting or using other than your company’s own personnel?

7c. Of those services that will be performed, approximately what percentage will be paid to the subcontractor(s)?

8. GSA Contract Number, if applicable.

9. Fill out the price estimate (5 Option Years) below.

*Failure to provide the information requested above (items 1-9) will be considered non-responsive and will not be considered a viable source.

RFQ number 36C26125Q0515 has been assigned and should be referenced on all correspondence regarding this announcement.

The Government will use this information when determining its business type decision.

This synopsis is not to be construed as a commitment by the Government and no contract will be awarded as a direct result of this Sources Sought announcement.

Notes: Contractors must have a current registration in the System for Award Management (SAM) at https://sam.gov/SAM/

SDVOSB and VOSB firms should be registered at the time of submission and verified at Veteran Small Business Certification (sba.gov)

CLIN Description Quantity Unit Unit Price Total Price

0001 Mohs Micrographic Surgery Technician In Accordance With Performance Work Statement.

Projected Period of Performance -Base Year 10/01/25 – 09/30/26

817 EA $ $

0002 Immunohistochemistry Staining

(IHC).

Performance -Base Year 10/01/25 – 09/30/26

72 EA $ $

1001 Mohs Micrographic Surgery

Performance -Option Year 1 10/01/26 – 09/30/27

833 EA $ $

1002 Immunohistochemistry Staining

10/01/26 – 09/30/27

72 EA $ $

2001 Mohs Micrographic Surgery

Performance -Option Year 2

840 EA $ $

10/01/27 – 09/30/28

2002 Immunohistochemistry Staining

10/01/27 – 09/30/28

72 EA $ $

3001 Mohs Micrographic Surgery

10/01/26 – 09/30/27

840 EA $ $

3002 Immunohistochemistry Staining

10/01/27 – 09/30/28

72 EA $ $

4001 Mohs Micrographic Surgery

10/01/26 – 09/30/27

834 EA $ $

4002 Immunohistochemistry Staining

10/01/27 – 09/30/28

72 EA $ $

Total Estimated Price

Performance Work Statement for Dermatology Mohs Surgery Services

GENERAL:

The contractor shall provide a cryostat for Mohs technician use for processing specimens.

The Mohs Tech should arrive no later than 8:00am.

The Mohs Tech is responsible for maintaining the cryostat, setting up the work area, completing and maintaining the Mohs log, maintaining the appropriate paperwork for the tissue, marking and orienting the tissue correctly, embedding, cutting and staining the specimen so that usable sections can be analyzed by the Mohs surgeon, storing the tissue appropriately, observing and maintaining appropriate safety precautions, cleaning up the laboratory area after use, and Quality Assurance.

Mohs Tech will have no computer access at the SF VAMC. Mohs Tech will have access to patient name and last 4 of SSN. Mohs Tech will review and sign Dermatology Service Business Continuity Plan (BCP) and Emergency Response Plan (ERP).

Mohs Tech Minimum - Based on the number of lesions the VA is performing per day:

o Regardless of the caseload/# of lesions scheduled for the day, if one technician is sent, they must be able to handle 10-20 cases solo without compromising slide quality or wait time. Specifically, they must be able to produce slides within 30 minutes for simple cases and within 60-90 minutes for more complex cases, without the need for additional recuts of the tissue for processing errors. The ability to do so must be confirmed by two letters of recommendation from current companies that use the technician service.

day.

o If the VA is performing less than 5 lesions per day the contractor can invoice for a minimum of 5 lesions.

o The VA will pay the contractor based on the number of lesions and not the number of techs.

If IHC staining is required, the Contractor shall provide Immunochemistry stain (e.g. Mart-1, CK5) per patient lesion site for IHC materials and staining.

o The same requirements regarding caseload/#lesions and technician ability apply for days with IHC cases scheduled. If one technician is sent, they must be able to handle 10-20 cases solo, including the IHC cases, without compromising slide quality or wait time.

The need for additional technicians based on anticipated case size and patient safety is at the discretion of the VA Mohs Surgery Team and the contractor will be notified accordingly with 2 weeks’ notice.

PLACE OF PERFORMANCE:

Contractor shall furnish services at the VA Medical Center San Francisco 4150 Clement Street, San Francisco, CA. 94121.

AUTHORITY:

Title 38 USC 8153, Health Care Resources (HCR) sharing Authority

POLICY/HANDBOOKS:

VHA Directive 1101.12 MOHS MICROGRAPHIC SURGERY

a. Resources Needed for Mohs Operative Suite, MMS SharePoint

b. Required Resources for Mohs Laboratory, MMS SharePoint

c. Required MMS Operative Documentation, MMS SharePoint

d. Mohs Lab Slide Quality Control, MMS SharePoint,

e. Quarterly Proficiency Quality Control Form Cover Sheet, MMS SharePoint

f. Daily Tissue Staining Quality Control Form, MMS SharePoint

g. Staff Support Needed for Mohs Micrographic Surgery, MMS SharePoint, MOHS MICROGRAPHIC SURGERY SITE ACTIVATION

General Information. General Information about the Mohs Micrographic Surgery Site Activation Plan, MMS SharePoint

Checklist. Mohs Surgery Site Activation Checklist, MMS SharePoint

VHA MOHS SHAREPOINT:

https://dvagov.sharepoint.com/:f:/s/VACOVHAPS/10ppolrev/EjWufiO6mEJNk1jnEFXAcK YBUjubnTRyK_Ylcr_IHYIMTg?e=5U3SP3

VAMC SAN FRANCISCO DERMATOLOGY MOHS SURGERY POLICY AND PROCEDURE

TISSUE PROCESSING PROTOCOL FOR MOHS MICROGRAPHIC SURGERY

SCOPE:

Mohs surgery is performed using intraoperative frozen section slide evaluation to determine a clear margin for skin cancer, and these cases are routinely performed at the SFVA dermatology department. The frozen remnant of the final margin specimen is submitted to Pathology in 10% buffered formalin for permanent sections.

CRYOSTAT:

The cryostat temperature is at an optimum cutting temperature between -18*C to - 35*C. Check and log the temperature using an external thermometer. If out of range, notify a supervisor and document corrective action in the temperature log.

Make sure the handle is in locked position.

De-ice microtome as needed using isopropanol.

Oil all moving parts.

Secure the blade holder tightly.

Place the brushes, heat sink and lastly the disposable blade into the cryostat chamber.

PERSONAL PROTECTIVE EQUIPMENT:

Place gloves and a face mask with a shield near the work area so these are readily available while working with fresh tissue and for

SET UP:

Cover the work area with polyback drapes or any other non-porous covering to protect the counters.

Set up your tools in a safe and ergonomic manner.

Place your stains in the back of your work area. Make sure all reagent containers are marked with the appropriate reagent name.

Place your inks on one side and the cover slipping gear on the other.

Place the cutting board in the front closest to you and the scalpel just above the cutting board at 12 o’clock with the blade facing the cutting board.

Place chucks, embedding medium, slides, and a slide marking pen close to the cryostat.

Fill your cryac with liquid nitrogen following the LN2 Protocol using protective gear

(as stated in the LN2 protocol below) and place it close to the cryostat on an even surface.

Make sure the room/lab temperature lies within the accepted range of 68-82 degrees of Fahrenheit. If out of range, notify a supervisor and document corrective action in the temperature log.

LN2 PROTOCOL:

Liquid nitrogen is extremely cold and can result in burn injuries if exposed to bare skin.

Make sure that you wear eye protection (face shield or safety glasses) and loose fitting insulated gloves whenever you are handling liquid nitrogen.

With the cryac on a flat surface, slowly pour the LN2 into the container and be careful not to overfill the cryac. There is a line in the inside of the cryac that is approximately 1 inch from the top. This is the fill line according to cryac manufacturer.

Screw the lid of the cryac on so that it is finger tight making sure that the red gasket is in place when doing so.

MOHS LOG:

Fill in all the information as it becomes available.

There are 5 sections each day that need to be completed: Patient Log, Cryostat

Maintenance Log, Cryostat Temperature Log, Mohs Lab Room Temperature Log, and Stain Quality/Section Quality Control Log.

Review the Physician Profile and apply any special protocol noted on the profile to the workflow.

RECIVING THE SPECIMEN:

When picking up a specimen for frozen sectioning from the clinic, ask the surgeon for additional history that could be important in determining the diagnosis. It is useful to know the prior history of cancer, clinical differential diagnosis, or the question the frozen section seeks to answer (e.g., diagnostic tissue obtained, margins free of tumor etc). Ensure you have corresponding paperwork for any tissue. Make sure the orientation (12 o’clock) and the surgical marks correspond with the map whether it is drawn by the surgeons or the technician. Log all information needed in the Mohs log. Add accession number on the map if applicable.

MAPPING/RELAXING/INKING*:

Map out your work Use markings preferred by the surgeon Place the specimen on the prep board so that the 12’ orientation of the specimen matches the

12’ orientation of the prep board Divide the tissue into sections appropriate to fit on the slide There can only be one-site per slide Lay margins down using relaxing incisions Ink margins with permanent marking system and indicate appropriate colors on the map if not already performed by Mohs surgeon Number each piece of tissue

* The laboratory director will establish/document whether or not each Mohs technician is qualified to complete high complexity testing. If the Mohs technician is qualified, then testing will proceed as outlined in this protocol, if not, the Mohs surgeon will be responsible for grossing the tissue, i.e.

drawing the map for the Mohs surgery case, indicating which inks are used, and inking the tissue.

The surgeons would also be responsible for any other description of the tissue. Once this portion of the testing is complete, the Mohs technician can proceed to follow the protocol as outlined above.

EMBEDDING THE TISSUE:

Specimen is positioned on a slide about ¼ of an inch from the bottom.

Carefully place the slide on the bottom of the cryostat and leave it to freeze for 10-15 seconds.

Label chuck on the back side to ensure you know which chuck belongs to which patient for any re-cuts.

Place a chuck on the freeze bar and cover it with embedding medium.

Carefully pick up the slide and cover the tissue with embedding medium.

Invert the slide on top of the chuck and sandwich them together.

Spray it with liquid nitrogen or freezing spray pulsing the spray to give the cold a chance to penetrate to the depth of the tissue.

Let chuck freeze for a few minutes with the heatsink on it.

CUTTING:

Be sure the cryostat handwheel is in the ‘lock’ position at all times, except when actually cutting the frozen section. Minimize the use of the pressurized cryofreeze to limit aerosolization.

Place the chuck in the ball joint and tighten the thumbscrew securely.

Bevel the chuck to remove excess medium.

Angle the chuck parallel to the blade.

Turn the advancement wheel until the tissue is in contact with the blade.

Face off the specimen until the skin edge and the depth are visualized.

Clean the blade of shavings and cut a section using constant and controlled speed.

Guide the specimen on top of the blade holder and pick up the specimen with a clean slide. If a treated slide is used make sure that the specimen is picked up on the right side of the slide.

Cut sections at 4-6 microns thick Label each slide with patient’s name, accession number, level and piece numbers.

Make sure you have at least 6 cuts to present to the surgeon.

Prepare an extra slide for Quality Control and present it to the surgeon with your first case to ensure stain quality and make sure the review of the slide is documented on the Quality Control Log.

The blade is changed on each Mohs day (Mohs is performed 1-2 x weekly). This is done more often if requested by the surgeon depending on the number of sections cut weekly.

STAINING AND COVERSLIPPING:

The slide containing the freshly cut frozen section is placed into a slide cradle, and placed sequentially into the following solutions, with intermittent dipping to ensure even staining:

a. Hematoxylin and Eosin Staining Regimen:

Solution Time Time 99.9% Isopropyl Alcohol 1 min.

Tap-H²O 30 sec.

Gills Hematoxylin 1-2 min.

Tap H²O 10 sec.

Tap H²O 10 sec.

Tap H²O 10 sec.

Tap H²O 30 sec.

Eosin Y 1 sec.

99.9% Isopropyl Alcohol 10 sec.

99.9% Isopropyl Alcohol 10 sec.

99.9% Isopropyl Alcohol 10 sec.

99.9% Isopropyl Alcohol 10 sec.

Place the slides in the slide holder for staining.

Withdraw the slide from the last alcohol bath and drain from excess alcohol. Apply a line of Clearium on the slide. Place a coverslip over the slide. Wipe the back of the slide and any excess medium that might push out on the sides.

Place the slides on a flat and take them to the doctor with the corresponding map.

REPORTING OF FROZEN SECTION RESULTS:

The diagnosis is documented on the Mohs map with the initials of the Mohs surgeon. After reporting the diagnosis, and confirming that no further cuts are necessary, the frozen residual tissue should be placed into a labeled container filled with 10% buffered formalin and submitted to pathology department for accessioning and permanent sections. The residual frozen tissue must be submitted for paraffin-embedding and preparation of histologic sections using labeled cassettes with alphabetical sequence.

PERMANENT SLIDE LABELING:

After slide has been read by the surgeon, label each slide with a paper label on the frosted end making sure it doesn’t cover any tissue.

Each slide should have the following information: (Date, Last Name, First Name, Site/Location, Stage and Specimen Section #, Accession #) Make sure all of the slides are accounted for.

Place the slides in cardboard slide holders and put in a place designated by the Mohs physician so that they can dry for 2 weeks (in Mohs lab Building 200, Module 3, room

GA-178A). At that time the office can safely store in permanent storage (Building 203, room 1C-13).

FROZEN SECTION STAIN MAINTENANCE:

All the reagents will be appropriately labeled. The solutions for staining of frozen sections will be changed at least once a week, or more often if necessary. This change will be recorded on the Cryostat Maintenance Log.

CLEAN UP:

After the surgeon has cleared all patients you will start the cleanup process.

Always first dispose of any sharps. All sharps including the disposable cryostat blade, scalpel blades, and used slides are disposed of in the sharps container.

The cryostat is cleaned by first taking out the blade holder and rinsing it with water and then finally with 99% alcohol before storing it.

Next the microtome and surrounding chamber is brushed clean of all shavings and the shavings are disposed in a biohazard container.

Outside of the cryostat is wiped down with a disinfectant.

When cryostat is defrosted the microtome and chamber are wiped down with the same disinfectant.

Pour reagents and wastewater into chemical waste container. This waste container will be emptied by Environmental Health & Safety at least every 2 weeks or more frequently if needed.

Throw away counter liners and wipe down counters.

RETENTION OF GLASS SLIDES:

The glass slides will be stored under appropriate conditions with minimum retention times as follows. All the Mohs surgery slides (located in building 203, room 1C-13), records (entered into patient electronic medical record and Mohs case log) and blocks (stored with pathology department) will be stored and retained for 10 years from the date of exam.

FROZEN SECTIONS COMPETENCY ASSESSMENT:

Initial certification and annual competency assessment for all Mohs technicians will be performed by Contractor and provided to SFVAHCS Dermatology Service

Records will be stored in Mohs Binder and on our SharePoint

HOURS OF OPERATION/SCHEDULING:

Patient Access/Timeliness of Scheduling:

The Contractor will ensure Mohs Tech(s) are present based on pre-determined schedule from 8:00am until all cases finished and dismissed by Mohs Attending. In rare circumstances cases can run quite long, we will stop and dismiss Mohs Tech(s) by 9pm at the latest. As this is an outpatient clinic, we do not operate on federal holidays.

Cancellations:

Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

CONTRACTOR RESPONSIBILITIES

The contractor is responsible for performance of ALL terms and conditions of the contract.

CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined.

Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards. The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

STANDARDS OF CARE:

The contractor personnel(s) care shall cover the range of Mohs Technician services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized TJC, VA and national standards as established by:

Mohs Micrographic Surgery (MMS) guidelines by the American Osteopathic Association (AOA) Board of Dermatology (AOBD) http://www.osteopathic.org/inside-aoa/accreditation/postdoctoral-training-approval/postdoctoral-training-standards/Documents/Basic-Standards-MOHS.pdf

The professional standards of the Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx

The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and;

The requirements contained in this PWS

MEDICAL RECORDS:

Authorities: Contractor’s personnel(s)providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C.

7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

HIPAA: Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility.

The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: (No , only name, last 4, diagnosis as needed for labeling/handling of slides

REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval

Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

Each Contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

Failure for the Contractor’s representative to respond to the evaluation within those sixty

(60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

GOVERNMENT RESPONSIBILITIES

Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

Name: TBD Address: TBD Phone: TBD Work Cell: TBD Email: TBD

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services;

consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

COR Responsibilities:

The COR for this contract is: Clarisse Mejia, Administrative Officer

4150 Clement Street SF.CA. 94121

Tel #: 415-849-5757

VA Email: Clarisse.mejia@va.gov

The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

The COR will maintain a record-keeping system of services by Clarisse Mejia. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices.

Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

All contract administration functions will be retained by the VA.

SPECIAL CONTRACT REQUIREMENTS

The Contractors’ facility shall meet all federal, state and local fire and life safety codes and must be accessible and convenient for wheelchair patients and other handicapped or disabled Veterans.

Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

The following are brief descriptions of required documents that must be submitted by Contractor:

upon award; weekly; monthly; quarterly’; annually, etc. identified throughout the PWS and is provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

What Submit as noted Submit To

Quality Control Plan: Description and reporting reflecting the contractor’s plan for meeting of contract requirements and performance standards

Upon proposal and as frequently as indicated in the performance standards.

Contracting Officer

BILLING:

Invoice requirements and supporting documentation: Payment to the Contractor shall be made monthly, in arrears, upon receipt of a properly prepared invoice. Payment for services will be at the rates specified in the Schedule of Supplies/Services. The Contractor shall submit invoices using CMS Uniform Billing (UB-04) forms covering the services performed under this contract. The invoices shall contain the following information: Invoice number, PO Number , Vendor Code, Invoice Date, Currency, Amount to Pay, Description, Quantity, Unit, Unit price. Delivery Note(Delivery Note and Payment Due)

Contract Number and Purchase Order Number (if applicable) Name of Beneficiary and last four digits of the Social Security Number Itemized statement of services rendered by CPT Code and Rates Total Price

VENDOR ELECTRONIC INVOICE SUBMISSION METHODS:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

Invoices will be electronically submitted to the Tungsten website at https://www.tungsten-network.com/us/support/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: https://www.tungsten-network.com/us/support/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

PAYMENTS IN FULL/NO BILLING VA BENEFICIARIES:

The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment.

The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered.

VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE

FOR INCLUSION IN CONTRACTS, AS APPROPRIATE

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. 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.

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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above- mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

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.

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 (see Section 4, Training, below). 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. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to):

removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.