36C24424Q1003.docx

36C24424Q1003

GENERAL INFORMATION

Network Contracting Office 4

1010 Delafield Road

POINT OF CONTACT*

Contract Specialist Jeff Mann jefferson.mann@va.gov 717-202-5456

PLACE OF PERFORMANCE

University Drive

Pittsburgh PA

ADDITIONAL INFORMATION

EMAIL DESCRIPTION

DESCRIPTION

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address 1010 Delafield Rd, Pittsburgh PA 15215

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 in conjunction with Part 13 of Federal Acquisition Regulation (FAR), as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This Solicitation is issued as a Request for Quote (RFQ), and the solicitation number is 36C24424Q1003.

This notice incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-06 effective 08/29/2024, and the Veterans Affairs Acquisition Regulations (VAAR). The complete text of any of the clauses and provisions may be accessed in full text at FAR | Acquisition.GOV.

This Solicitation is being competed as 100% SDVOSB. The NAICS Code is 811210-Electronic and Precision Equipment Repair and Maintenance and the Product Service Code (PSC) is J065 –Maint/Repair/Rebuild of Equipment- Medical, Dental, and Veterinary Equipment and Supplies, and the business size standard is $34 Million.

The Pittsburgh, PA Contracting Office is seeking Tape Removal, 2D Matrix Laser Etching, and Commissioning of 25,000 surgical instruments in Censitrac. The Statement of Work (SOW) is provided.

Service Contract Act Wage Determination No. 2015-4235 Rev 27 Dated 07/22/24, applies to this acquisition and will be incorporated into the resulting contract. A copy of the Wage Determination is included with this solicitation as an attachment.

Complete instructions for submitting a response to this solicitation and applicable provisions and clauses are found in “36C24424Q1003.” All offerors are advised to pay careful attention to the quote submission instructions as there are very specific instructions as what is required to be provided.

The period of performance (POP) is estimated to be 09/30/2024 – 05/01/2025.

Any award resulting from this solicitation will be issued on a Standard Form 1449.

NOTE: To receive an award resulting from this solicitation, offerors MUST be registered in the System for Award Management (SAM) database. Registration may be done online at: www.acquisition.gov or www.sam.gov.

Contractors are advised that any and all questions concerning this solicitation must be sent in writing via email to Jeff Mann at Jefferson.mann@va.gov. No questions will be answered after 09/13/2024 at 12:00pm ET.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the contract specialist, Jeff Mann at Jefferson.mann@va.gov

Point of Contact Jeff Mann Contract Specialist Services 3 (Medical Equipment Maintenance Services) Department of Veterans Affairs | Service Area Office East | Network Contracting Office 4 1700 S Lincoln Ave, Lebanon, PA 17042 Jefferson.mann@va.gov Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C244 Department of Veterans Affairs Network Contracting Office 4

1010 Delafield Road Pittsburgh PA 15215

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Service-Tape Removal, UDI Laser Mark - 2D data matrix code, and Commissioning to CensiTrac of up to 25,000 surgical instruments IAW Statement of Work Contract Period: Base POP Begin: 09-30-2024 POP End: 05-01-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies LOCAL STOCK NUMBER: Laser Etching

B.3 DELIVERY SCHEDULE

University Drive C Pittsburgh, PA 15240 1003

USA

Tonya.Johnson3@va.gov

36C24424Q1003

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B.4 STATEMENT OF WORK

STATEMENT OF WORK

NuTrace Laser Etching & Instrument Services VA Pittsburgh Healthcare System (VAPHS) Sterile Processing Service University Drive C Pittsburgh, PA 15240

1. Introduction:

Background: The VA Pittsburgh Healthcare System (VAPHS) Sterile Processing Services (SPS) requires the expertise of a contractor to provide laser etching and label services for the surgical instruments at VAPHS. This will increase accountability and improve the compliance status of our instruments in accordance with VHA Directive 1116 (1).

Performance period: The contractor must coordinate with the SPS Chief and the Program Point of Contact (POC) from contract award until the end of this project and all deliverables have been completed. Contractor on-site work hours will be Monday through Friday; 7:00 AM to 4:00 PM, excluding Federal Holidays; (Normal VAPHS Business Hours) unless otherwise coordinated with the SPS Chief. The contractor may be required to work outside the normal operating hours but shall not exceed a 40-hour work week. For work hours outside of normal business hours; approval will be coordinated and permitted at the discretion of the Sterile Processing Services (SPS) Chief.

1. Project must begin within 1 month of award. No invoices will be submitted during the start-up period and the contractor shall make all necessary preparations during this time. Invoicing begins at the commencement of services and no reimbursement will be paid by the Government for efforts expended during the start-up period.

2. The project must be completed no later than 7 months after award.

Type of Contract: Firm Fixed Price

Delivery Location VA Pittsburgh Healthcare System (VAPHS), Sterile Processing Service (SPS) | University Drive C, Pittsburgh, PA 15240 | Sterile Processing Chief - Charlene Haynesworth (412-360-6615) charlene.haynesworth@va.gov

2. Scope: The VAPHS Sterile Processing Service requires a service for 25,000 surgical and clinical instruments to 1. remove all surgical instrument tape, 2. create a Unique Device Identification (UDI) with a 2D laser etched Matrix, 3. verify the UDI on currently etched equipment for readability, 4. input instrument information into data fields in Censitrac instrument tracking software and 5. provide training on Censitrac system to Sterile Processing Service (SPS) staff at VA Pittsburgh Health System.

The instruments cleaned and reprocessed by Sterile Processing Services (SPS) must be effectively traced via the Censitrac instrument tracking software system already in use by SPS.

When instruments are traced via Censitrac, items can be located/traced for utilization in patient care, inventory tracking, and repair purposes. A unique device identification UDI laser mark - 2D data matrix code is used to commission Reusable Medical Devices (RMD) in the Censitrac system. Contractor shall apply a UDI laser mark to any RMD that does not already have a compatible scannable 2D data matrix code. The contractor shall utilize the 2D matrix code to load pertinent information for each reusable medical device into the Censitrac system.

3. Tasks and Deliverables: Contractors must have the capability to meet ALL requirements of the following services without exceptions:

Contractor shall coordinate with SPS to determine the RMD requirements for each commissioning session.

Contractor shall coordinate with SPS to ensure appropriate staff are available to reprocess RMD that is opened and commissioned for the project, to prevent delays in patient care.

Tape Removal Surgical instrument tape is currently used to identify the service and owner for RMD. Contractor shall be responsible for the complete removal of instrument tape from all instrumentation at VAPHS prior to laser etching.

The contractor shall ensure the item immediately receives a Unique Device Identification (UDI) to ensure each item can be identified while retaining the service/owner information.

Ultrasonic devices may be utilized by contractor in the removal of instrument tape, however all ultrasonic devices must be inspected and approved by VA Pittsburgh Health System FMS and BioMed Departments prior to use.

2D Data Matrix Code Laser Etching: Instruments must be “commissioned” via laser etching at the same time tape is removed to eliminate errors associated with instrumentation lacking unique identifiers that provide owner/service information.

The contractor must provide laser etching that applies 2D Matrix Codes directly to 25000 surgical and clinic instruments that are not already etched at VA Pittsburgh Healthcare System. A Class 1 laser NuTrace Fiber Laser 1064nm 20W - NUX20 NG is available onsite for use by contractor certified in operating this equipment. Contractor must comply with the laser safety standards from the International Electrotechnical Commission (IEC) (VAPHS laser committee/facility policy, available upon request). Any laser etching that requires laser work that is greater than Class 1 must be performed by the contractor with contractor supplied laser.

Each individual instrument and instruments in surgical trays will be individually inspected and examined by the contractor to ensure the laser marks are visible and functional on the instruments. Existing instruments already marked will be reviewed by the contractor for accurate description and unnecessary duplicates will be eliminated. Any marks not being picked up and read by scanners will be removed by the contractor and reapplied.

For surgical instruments that are not a compatible material with laser etching, a Censitrac 2D data matrix sticker dot can be utilized. The sticker dots will be provided by the vendor. The vendor will ensure adequate sequence numbers are utilized.

SPS will provide location for contractor to perform laser etching and commissioning tasks.

SPS will provide space on-site for work involving class 1 laser etching.

Censitrac Data Entry: Commission instruments into the instrument tracking software (Censitrac). The contractor will ensure that all laser etched UDI markings are readable and correctly recognized by the Censitrac system. All information input into Censitrac will be complete and accurate at conclusion of the commissioning process.

SPS will provide local access to Censitrac for contractor.

Information to be entered into Censitrac shall include:

· UDI

· Owner

· Location

· Name of Instrument

· Catalog Number; provided by VAPHS Logistics

· Serial numbers (as applicable); provided by VAPHS Logistics

· VHA tracking numbers (EE) (as applicable); provided by VAPHS Logistics

· The Nature of Instrument Use (i.e., individually peel packed or surgical tray identification)

· Each surgical set shall be weighed and weight information input.

· Per manufacturer’s instructions for use (MIFU); instrument set weights are required to ensure sterilizer loads are not overweighed and cycles are run appropriately. By adding the weight of all sets into Censitrac; the management software can ensure load weight limits are not exceeded and compliance standards are met. During the commissioning process of surgical sets, each set will be weighed by the contractor; and the contractor will input this information into the instrument tracking in accordance with the:

1. Association for the Advancement of Medical Instrumentation (ANSI)/(AAMI ST79): 2017 & 2020 (aami.org/standards)

2. VHA Directive 1116(1) which is the Management of Critical and Semi-Critical Reusable Medical Devices July 17, 2023 & June 13, 2024 (provided to vendor upon request) Complete Surgical Sets: During performance of laser etching and data input into Censitrac, the contractor shall identify any surgical instrument sets that are incomplete. Contractor will locate replacements for any missing instruments in the Operating Room Par Stock within the operating room suite at VA Pittsburgh to make as many complete surgical sets as possible from materials on site.

Sets will be complete with accurate weights at time of data input into Censitrac.

Count sheet revisions: Count sheet revisions and identifying any missing instruments from complete sets will aid in compliance with VHA Directive 1116(1) and will greatly increase traceability for these items.

Upon completion of all data entry into Censitrac system, VAPHS count sheets shall be updated and provided to SPS Chief.

Packaging Waste Management:

Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contractor shall fold metal and plastic banding, flatten and place in designated areas for trash.

4. On-site Training: At the conclusion of all tasks and deliverables, contractor shall provide a 2-day comprehensive training across all 3 shifts to SPS staff on the utilization of Censitrac System.

The training shall be on-site at the VA Pittsburgh Healthcare System University Drive location.

The training shall include at a minimum:

· Scanning 2D Laser Etched Matrix

· Inputting data into Censitrac system

· Updating/Revising information in Censitrac system

· Tracking data in Censitrac

Training must be coordinated by the contractor at least 2 weeks in advance with SPS Chief.

VAPHS SPS Shifts for contractor-initiated training will be as follows:

· 1st Shift 6:30am – 3:00pm Eastern Time

· 2nd Shift 2:30pm - 11:00pm Eastern Time

· 3rd Shift 10:30pm - 7:00am Eastern Time

5. Stakeholder Team BIOMED: Inspect and approve any contractor utilized ultrasonic devices LOGISTICS: Will provide RMD identification numbers, serial numbers, and VHA Tracking Numbers (EE) for Censitrac data entry FMS: Inspect and approve any contractor utilized ultrasonic devices.

VA Pittsburgh Healthcare System Sterile Processing Service staff: Will coordinate workspace for contractor, coordinate RMD requirement for commissioning sessions, provide local access to Censitrac system, and reprocess RMD after contract requirements completed.

Team Includes:

Sterile Processing Service (SPS) Chief: Charlene Haynesworth 412-360-6615 Charlene.Haynesworth@va.gov Biomed: Justin Wissinger 412-360-3765 vhapthbiomedicalengineering@va.gov FMS: Andrew Welbeck 412-360-6831 vhapthfmsmgrs-supvrs@med.va.gov Infection Prevention: Jody Feigel 412-360-1703 vhapthinfectionpreventiondepartment@va.gov Program Point of Contact (POC): Tonya Johnson, Executive Assistant, PCS 412-360-6077 Tonya.Johnson3@va.gov

6. Security

1. Have VA approved form of identification.

2. Contractor Personnel Security Requirements

3. Contractor may not have access to the VA network or any VA sensitive information under this contract.

4. Contractor owned computer instrument including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical instrument must be scanned by Biomed or OIT.

5. The contractor would be responsible for ensuring that they utilize the Symplr System as described below to remain in compliance with VAPHS policies and standards.

The contractor would be responsible for ensuring that they or any hired contractors working for the contractor shall utilize the Symplr System as described below to remain in compliance with VAPHS policies and standards.

Appendix A VA Information Security Requirements

· The contractor Personnel Security Requirements.

· Contractor must comply with VA Information Security requirements in order to obtain/maintain access to theVA network to include remote access.

· All remote access to the VA network must be via an approved site-to-site VPN connection or CAG.

· An ISA-MOU is required for a site-to-site connection.

· Contractor is not authorized to access any PHI/PII.

· If it applies, contractors needing access to the network must obtain PIV and local Censitrac access by notifying the SPS and Project COR.

The following language from VA Handbook 6500.6 is required in this contract:

Appendix C: Paragraphs #2a, b, d, e, #3a, b, d, e, f, h, j, k, #6(all), #7(all), #8, #9(all) Contractor employee(s) requiring computer access must sign and comply with Appendix D Contractor Rules of Behavior. (attached) Contractor must complete “VA Privacy and Information Security Awareness and Rules of Behavior” training prior to the performance of the contract and annually thereafter. Training must be completed in VA’s TMS system (https://www.tms.va.gov/).

Contractors must use the TMS Managed Self Enrollment method to complete the training in TMS.

The COR must ensure that all contractors are validated in the PIH domain. Proof of training completion must be verified and tracked by the COR.

Records Management Language for Contracts

· Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

· Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

· Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

· Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

· Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

· The Government Agency owns the rights to all data/records produced as part of this contract.

· The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

· Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

· No disposition of documents shall be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

· Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

· (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

6.0a. Vendor Requirement for Contractor PIV Badge / Fingerprinting Upon contract issuance, vendor/contractor staff will need to provide the following information to VAPHS SPS Chief or Project Manager/COR included in this contract to obtain a badge and for fingerprinting credentialing:

The following is the process is needed to start the process to obtain a badge and initiate fingerprinting for those vendor/contractor personnel requiring access to the VAPHS network.

Vendor provide the SPS Chief COR with the following:

1. Vendor must click the AI Scheduler Link to schedule their own fingerprinting/PIV appointments with the closest government local PIV office nearest to your city via the following link: AI Scheduler

a. USAccess Information Required below from Vendor/Contractor will begin the PIV process and Required Fingerprinting.

b. All fingerprints are now captured though USAccess Personal Identity Verification (PIV) system via the Enrollment process.

2. Vendor/Contractor First Name

3. Vendor Contractor Middle Name

4. Vendor/Contractor Last Name

5. Vendor/Contractor SSN

6. Vendor/Contractor Citizenship

7. Vendor/Contractor Birth Date

8. Vendor/Contractor Personal Email Address to receive notifications

9. Vendor/Contractor Other Email Address to receive notifications

10. Vendor/Contractor Work Email Address to receive notifications

11. Home Phone

12. Work Phone

13. Cell Phone

14. Agency/Company Name

15. Company Address

16. Tax ID

17. Type of Affiliation

VAPHS SPS Chief/ Project COR will receive and direct this information to appropriate VAPHS Service Line PIV Sponsor for USA Access Entry into USAccess system. This process is heavily reliant on vendor/contracting personnel and can take a minimum of 14 days to process.

For Internal VAPHS Use for Designated PIV Sponsor:

· Vendor/Contractor type will be [contractor]

· Vendor/Contractor status will be [future]

· Ensure to select WMC HROO PERSEC CONTRACTOR (VA08, 955C, 36001) from the drop-down menu so the SAC is forwarded to our team for adjudication.

· Tier 1 is the status.

6.0b. Office of Personnel Management Questionnaire for Non-Sensitive Positions SF85 Each vendor contractor POC assigned to perform duties at the VAPHS station referenced in this contract must gain access to perform network connectivity contractual obligations at the VA Pittsburgh Healthcare System.

To access the VA Pittsburgh Healthcare System network or system or VA sensitive information (e.g., system administrator privileged access to a VA system, to perform contractor processes that access or utilize VA sensitive information); VA security policies apply.

Vendor Contractor must meet the complete the requirements to meet the risk designation established by the determination chart below.

Important Note:

Each vendor contractor for the life of this contract designated to perform tasks in this contract to perform duties while connected to the VA Pittsburgh Healthcare System network (to connect to Censitrac); will be required to complete the Office of Personnel Management Questionnaire for Non-Sensitive Positions SF85 Process.

Vendor contractor completing the SF85 for network access MUST return and maintain a favorable fingerprints and Office of Personnel Management Questionnaire for Non-Sensitive Positions SF85 outcome throughout the duration of the contract.

Functions associated with this contract are designated on the Position Designation Record at the VAPHS Healthcare System as follows:

Vendor Initiation of the SF85 - Personnel Security Screening Process Steps Vendor must go to the following link and complete the Contractor Request document.

Link to the document is as follows:

Regional Procurement Offices COR Contractor Onboarding serviced by WMC HROO PerSec Contractor Team (sharepoint.com)

Vendor/Contractor is Responsible Personal Identifiable Information

· Vendor/Contractor SSN

· Vendor/Contractor Gender

· Vendor/Contractor Last Name

· City of Birth

· Vendor Contractor Last Name

· Vendor/Contractor Middle Name

· Country of Citizenship

· County of Birth

· Date of Birth

· Marital Status

· Vendor/Contractor Birth Date

· Vendor/Contractor Citizenship

· Vendor/Contractor Personal Email Address to receive notifications

· Vendor/Contractor Other Email Address to receive notifications

· Vendor/Contractor Work Email Address to receive notifications

· Company Email Address

Vendor must also complete the contract information field as follows:

1. VA Contracting Officer Name & Email

2. COR Name and Email: Tonya Johnson (Tonya.Johnson3@va.gov)

3. Contract End Date (Including Options):

4. VISN & Station: VISN 4, 646

5. Purchase/Task Order or Contract Number

6. Contractor Position Description

7. Investigation Level: Tier 1

8. Contract Company Name (Subcontractor)

9. Contact POC Name & Phone:

10. Contractor POC Email

11. Contractor Officer/COR Signature

Once document is completed, vendor needs to be email to the following mail group:

VHAWMCPerSecContractor@va.gov If using a NON-VA email please password protect the document and send the password in a separate email.

WMC HROO PERSEC CONTRACTOR: Requests are reviewed and assigned timely, typically within 2 business days (depending on volume).

1. E-APP Initiation – within 5-7 business days of assignment.

2. E-APP Completion –Can take from 14-20 Business Days to complete.

Note: **Timelines are dependent upon all groups, Contracting, Vendor/Contractors, and Personnel Security hitting their benchmarks and completing their part of the onboarding process.

VHAWMC Vendor/Contractor POCs to check the status or to report any issues with completion of the above Contractor Request Form.

Your primary POC is the Personnel Security Professional who is assigned to your onboarding request.

· If you are unable to get a response within a reasonable timeframe, send all inquiries to VHAWMCPerSecContractor@va.gov first.

· Patrick Carrabine Patrick.Carrabine@va.gov Lead Personnel Security Specialist

· Erica Kordish Erica.Kordish@va.gov Lead Personnel Security Specialist

· David Wolff David.Wolff@va.gov Supervisory Personnel Security Specialist

References

1. VHA Handbook 0710 Personnel Security and Suitability Program

2. VA Directive 0710 Personnel Security and Suitability Program

3. VA Handbook 6500.6 Contract Security

4. VHACOPERSEC Advisory 23-01 VHA Personnel Vetting Program Standard Operating Procedures

5. USAccess Adjudication Guide

6. SharePoint: Regional Procurement Offices COR Contractor Onboarding serviced by WMC HROO PerSec Contractor Team (sharepoint.com)

7. SYMPLR Requirement for On-Site Appointments Contractor is responsible for obtaining Symplr access. All contractor staff or hired contractor contractors coming on-site must be in green light Symplr status when contractors are scheduled to be on-site.

The contractor must also have Symplr Credentialing approved badges and Censitrac access to complete this project.

Contractor must obtain Symplr access and all contractor staff coming on-site must be in green light Symplr status when contractors are scheduled to be on-site.

Symplr credentialing is required for any contracted staff that will be coming on-site at the VA Pittsburgh Healthcare System. The contractor would be responsible for ensuring that they utilize the Symplr System as described below in to remain in compliance with VAPHS policies and standards.

Contractor access to the VA Pittsburgh Healthcare System and sister locations are by appointment only and requires credentialing through our contractor credentialing partner Symplr.

Symplr is a cost to each contractor, contractor representative or contractor requiring entry to:

VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

Each person entering campuses must obtain the required credentialing as advertised on the Symplr site. The link to the Symplr site is as follows: https://www.symplr.com

Contractor, contractor representatives or contractor contractors must login to the Symplr site:

· Create an account on the Symplr Site

· Select the plan pertaining to the contract requirements for the on-site visit at:

· VA Pittsburgh Healthcare System, University Drive C. Pittsburgh PA 15240

· Each person, contractor, contractor representative, contractor must pay for plan to begin the required credentialing on Symplr.

· Contractor, contractors, or contractor representatives must be in a green light status on Symplr to be permitted to proceed with on-site appointments. In the event a contractor is red lighted, a replacement contractor must be substituted and in a green light status or the appointment will be cancelled.

· All contractors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite.

· Contractors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

· Contractor shall have VA approved form of identification (Symplr Badge, Photo ID.)

Plan Costs to Contractor is as advertised on the Symplr Website for options listed below starting at $299 but may increase based on Symplr:

1. Clinical Contractors (entering patient care areas/direct patient involvement)

1. Service (Non-Clinical) Contractors

All contractors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite. Contractors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended.

a. All contractor employees and sub-contractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with The contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document– e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing The contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

8. INFLUENZA VACCINATION: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

1. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

1. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

1. Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

1. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

1. The contractor is required to submit annual certification in the form of a memorandum to the Designated Program Representative that all contract staff performing services at VA facilities are in compliance with VHA Directive 1192.

9. TUBERCULOSIS PREVENTION:

10. Mandatory Training for VA Contractor Personnel In order to be granted access to VA resources, you must first complete all of your assigned mandatory training. Required courses are accessed via the VA Talent Management System (TMS).

To access the TMS, you must first create a TMS user profile. Once you have crea ted a user profile, you will see the list of mandatory training and the date(s) by which it must be completed.

In order to access the TMS you must use one of the following browsers:

• Internet Explorer (7.0 to 11.0)

• Mozilla Firefox (3.6.x.x and above)

• Safari on Mac (6.0 and above)

• Google Chrome (23.0.x.x and above)

To ensure that the training courses operate correctly, your system must also have the following software installed and enabled:

• Flash player version 10.0.0 and above

• Adobe Reader 9.0 and above

You will be required to provide specific information about yourself as well as information related to the work you will be doing under this contract. Your contract Project Manager should have provided you with the following information:

1. The VA Location being supported.

2. The VA Contracting Officer’s Representative (COR) First Name, Last Name, Email Address, and Telephone Number.

3. The Name of the Contract.

4. The Contract Number.

5. The Contractor Project Manager

6. If you must complete HIPPA training.

The above information is required in order to create your profile. Make sure that you have it before starting the TMS User Profile creation process.

Step-by-step instructions for creating your TMS profile and then launching and completing the required training follow.

If You Need Assistance If you have any questions about the information to be provided or experience difficulties creating a profile or completing the mandatory training(s), contact the Enterprise Service Desk by going to the yourIT Services website or via phone at 1 (855) 673-4357.

A. Create Your TMS Profile

1. From one of the above browsers, access https://www.tms.va.gov/SecureAuth35/

2. Select the CREATE NEW USER button.

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Figure 1: VA TMS Login Screen with Arrow Pointing to the Create New User Button The first screen requires you to select the overall VA organization that you will be supporting.

Select either the Veterans Health Administration (VHA), Veterans Benefits Administration (VBA), National Cemetery Administration (NCA), Office of Information and Technology (OIT), or the VA Central Office (VACO) radio button.

Figure 2: VA Organization Screen Then select the NEXT button.

The next screen requires you to identify your enrollee type. The list of options is tied to the VA Organization. IF you selected VHA, this is the screen you should see:

Figure 3: VHA Enrollee Types IF you selected VBA, this is the screen you should see:

Figure 4: VBA Enrollee Types IF you selected NCA, this is the screen you should see:

Figure 5: NCA Enrollee Types IF you selected OIT or VACO, this is the screen you should see:

Figure 6: VACO and OIT Enrollee Types If you selected the incorrect organization, select the BACK button to return to the previous screen.

Select the CONTRACTOR radio button. Then select the NEXT button.

Figure 7: Contractor Radio Button Option

You must provide information related to MY ACCOUNT and MY JOB. All of the fields marked with an asterisk must be completed. Note: The Email Address that you enter here will be used as your Username to log into the system. Please ensure that the email address you use is one which you will be able access.

Figure 8: MY ACCOUNT INFORMATION Screen

Make sure that your PASSWORD complies with the requirements listed on the screen and that the re-entered password is identical.

Your password must comply with all of the following:

• Length must be 12 to 20 characters

• MUST contain: Lowercase letters (a through z) Uppercase letters (A though Z) Numerals (0 through 9) Non-alphanumeric characters to include ! @ # $ % ^ & * _ + = ? , . / ‘ [ ] { }

• Cannot include more than two repeated characters in a row

• Cannot include your User Name

• Cannot include your first or last names

Make sure to read the Privacy Act Notice regarding use of SSNs.

Figure 9: TMS Privacy Act Notice

After completing the MY ACCOUNT INFORMATION fields, you must complete the MY JOB INFORMATION fields. As indicated earlier, you should have received this information from your Project Manager. If you do not have this information, please reach out to your Project Manager as you will not be able to create your TMS User Profile without it.

Figure 10: MY JOB INFORMATION Screen

8. Once all of the required fields have been completed, select the SUBMIT button.

9. If there were any errors identified after selecting SUBMIT, you must fix those and then select SUBMIT again. Keep making corrections until you succeed.

10. Once any errors have been corrected, you should see the Congratulations screen. At this point you should make note of your TMS Username (which will be the Email Address that you entered).

Figure 11: Congratulations Screen After 20 minutes have passed, please return to https://www.tms.va.gov/SecureAuth35/ and enter your Username and click Submit. You will be able to send a one-time Passcode to your Email Address.

Figure 12: TMS 2.0 Login Screen

Once your Passcode arrives, enter it using your keyboard, or the on-screen number pad, and click Submit.

Figure 13: Enter Passcode Screen

You are now asked to select and provide answers to two security questions. These will be used if you need to reset your TMS password.

Figure 14: Set Security Questions Screen After selecting your questions and entering your answers, select the SAVE button.

At this point, you have now created your TMS User Profile. Now, you must complete all of the mandatory training courses assigned to you.

B. Launch and Complete Mandatory Training Follow these steps to launch and complete all of your assigned training.

1. Your TMS home screen displays. It lists the mandatory training you must complete and the date by which completion must occur.

While you may complete the course(s) at a later time, it is strongly recommended to complete one or both at the time of TMS profile creation.

2. Hover your mouse over one of the course titles listed on your TMS Home screen. Brief information pertinent to this course displays.

Figure 16: Course Information Pop-up on Mouse Hover

Select the START COURSE link.

The course windows launch in another browser window. You will see the Online Course Structure screen that is immediately followed by the initial screen of the selected course Follow the instructions on each of the course screens to complete all modules of the mandatory training course(s).

For the VA Privacy and Information Security Awareness and Rules of Behavior course, you must acknowledge and accept the Contractor Rules of Behavior that is the last Module of this course.

Figure 27: Contractor Rules of Behavior Acknowledgement

Once a course has been completed, select the HOME link located at the top left of the screen to return to your TMS Home screen.

Figure 18: Snapshot of the Home Link

Once all of the mandatory training has been completed, you will see the Learning Status Pod display information stating that the work is completed.

Figure 19: Example of the Learning Status Pod

6. While the completion of the mandatory training is recorded in the TMS, you must also print a Certificate(s) of Completion. To do this, you must select the Learning Status Pod to access the Completed Work screen.

Figure 20: Completed Work Screen All of the courses that you have completed and the date when they were completed display on this screen.

Hover the mouse over the course title for which a completion certificate is to beprinted to display the Completed Course pop-up window.

Figure 21: Completed Course Pop-Up

Select the PRINT CERTIFICATE link. A message indicating the information is being generated.

Figure 22: Generating Certificate of Completion Message Screen Once the necessary information has been gathered, another browser window opens and displays a PDF of the Completion Certificate.

Figure 23: Example of Certificate of Completion PDF

You may save this to your local drive and/or print the certificate to a local printer. Follow the instructions provided by your Project Manager to either save it, print it, or do both.

Once you have printed and/or saved your certificate(s), you may log out of theTMS. Select the SIGN OUT link located in the upper right portion of your TMSHome screen.

Figure 24: Snapshot of the Sign Out Link

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SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor 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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and 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.

c. 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.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor 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 or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor 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/subcontractor'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 contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met.