36C25521Q0289 Sources Sought Notice.pdf

Contract Opportunity Sources Sought Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Sources Sought Notice

Medivators Advantage Plus Endoscope Cleaning System

66048

36C25521Q0289

04-09-2021 4:00 pm CENTRAL TIME, CHICAGO, USA

N

339113

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

Jim Lewis james.lewis114fbb@va.gov

Cape Girardeau Health Care Center 711 South Mount Auburn Rd

Cape Girardeau MO

63703

USA

james.lewis114fbb@va.gov

This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following:

(a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide an Endoscope Cleaning System, for Veterans Health Administration, Poplar Bluff Health Care System, 711 South Mount Auburn Rd, Cape Girardeau, MO 63703.

Classification System (NAICS) code for this acquisition is 339113 (Surgical Appliance and Supplies Manufacturing) with a size standard of 750 Employees.

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act and VAAR 808.002 (Class Deviation), Priorities for use of Department of Veterans Affairs (VA).

However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open solicitation may be published.

POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING

INFORMATION IN THE RESPONSE:

1) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e. small/large), and DUNS Number.

2) Statement of Capability that demonstrates ability of providing the item in accordance with the attached Statement of Requirement (SOR) and past performance in providing this type of service. Include examples of prior completed Government contracts, references, and other related information.

This notice is to assist the NCO 15 in determining SOURCES ONLY.

This announcement is not a request for proposals or quotations. The

Government is not committed to award a contract pursuant to this announcement. The Government will not pay for any costs incurred in the preparation or submission of information in response to this announcement.

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov.

Any response to this source sought from Interested parties must be received NLT April 14, 2021. Attention: Jim Lewis, Contracting Specialist. Email: james.lewis114fbb@va.gov Phone: 913-946-1992 http://vip.vetbiz.gov/ mailto:james.lewis114fbb@va.gov

PERFORMANCE WORK STATEMENT – ENDOSCOPE CLEANING SYSTEM

I. GENERAL

1. Nature and/or Description of the Action Being Processed: This procurement is for purchase and installation of the procedure center flexible endoscope cleaning and processing system, forced-air endoscope drying cabinets, and associated accessories. This system MUST have pass-through capabilities. This will be a new firm-fixed price contract for the provision and installation of the system.

2. Description of Supplies/Services Required to Meet the Agency’s Needs:

a. (1) Medivators Advantage Plus pass-through dual flexible scope processing system.

b. (2) Medivators EndoDry pass-through flexible scope drying cabinets. Capacity of eight scopes in each cabinet.

c. (2) Medivators Scope Buddy Plus flexible endoscope pre-processing flushing devices.

d. (5) Medivators Cleanscope flexible endoscope transport carts.

e. All necessary software, and accessories required for operation.

f. Installation by Vendor.

g. Customer Support Contract.

h. Completion of installation between June 1, 2021 and October 6, 2021, dependent on construction schedule.

II. ENDOSCOPE REPROCESSOR

1. General Description of Performance Requirements and Features of the System:

The Medical Center seeks to purchase an Automated Endoscope Reprocessor (AER) with a pass-through design that physically separates clean and dirty reprocessing areas to reduce the risk of human error and cross-contamination, ensuring safe, patient-ready endoscopes for every procedure. The physical separation of the clean and dirty environments within an endoscope reprocessing area is a globally recognized infection prevention best practice that can decrease the risk of human error, distraction, and unintended lapses, which can result in the recontamination of reprocessed endoscopes. In accordance with the space configuration and basis of design the Medical Center requires a system utilizing a unidirectional workflow to improve department efficiency by supporting a consistent and repeatable reprocessing procedure for endoscopes, which helps reduce human error in endoscope reprocessing. The system must be capable of high-level disinfection of a wide variety of the most commonly used endoscopes.

Requirements:

a. At a minimum, the Endoscope Reprocessor shall:

i. Have hands-free operation and automatic cycle start for ease of operation

ii. Utilize dual asynchronous basins for fast and efficient endoscope throughput

iii. Be equipped with computerized cycle documentation and reporting for active monitoring and process verification

iv. Have minimal machine footprint saves space over comparable technologies

v. Provide continuous leak testing during cycle to disinfect leaky or damaged endoscopes prior to servicing

vi. Utilize an ergonomic design and large easy-loading basins support operator comfort

vii. Have remote diagnostics enable fast and efficient technical support and servicing, maximizing Reprocessor availability

viii. Provide a visual display of real-time cycle information

ix. Have barcode scanning for fast and accurate data entry (e.g., endoscope, operator, patient, and physician IDs) to facilitate cycle management and endoscope traceability

x. Include Installation

2. Site Specific:

a. Wall Preparation Basis-of-Design

i. Reprocessor must be compatible with a rough opening of 52-1/2” (1336 mm) wide x 79-3/4” (2025 mm) high

ii. Finished wall thickness of 4-1/2” (115 mm) to 7” (180 mm).

iii. Facility connections are made inside the wall. facility connections are divided into three groups:

1. Water/Air

2. Electrical/Networking

3. Ventilation

b. Floor Basis-of-Design

i. The floor must be level to allow for the proper leveling and sealing of the

Reprocessor

c. Water Supply Basis-of-Design

i. The water supply must be able to provide an on-demand water temperature of 95°F ± 4°F (35°C ± 2ºC)

ii. It is the responsibility of the facility to meet the water supply requirements. It is also the facility’s responsibility to install, maintain and troubleshoot the water supply system

iii. It is the responsibility of the facility to filter the incoming water to 1 micron

iv. If a mixing valve is used, then it must be a thermostatic mixing valve. One mixing valve per Reprocessor is required

v. Post thermostatic mixing valve the facility must include a thermometer followed by a bypass valve to a drain

vi. The incoming waterline must be a minimum of 1/2” (13 mm) ID providing a minimum flow rate of 2.6 GPM (10 l/min) (per machine) and a DYNAMIC water pressure between 40 to 87 PSI (3 to 6 bar) at the gauge before the Bypass Valve

d. Drain Basis-of-Design

i. The drain is located in the floor in the location indicated in the attached drawings

e. Air Supply Basis-of-Design

i. Facility must supply a 1/4” (6 mm) NPT female connection with a shutoff valve and pressure gauge located in the wall behind an access panel

ii. Facility supplied compressed air must meet these requirements:

1. 58 to 145 psi (4 to 10 bar)

2. The maximum demand of compressed air is 1.1 scfm (32 l/min ANR) filtered to 5 microns

3. The maximum dew point is 45°F (7°C)

4. The maximum oil concentration is 5 mg/m3

f. Electrical Supply Basis-of-Design

i. 120 VAC ± 10%, single phase, 60 Hz, 1200 watts per unit

ii. Facility must supply a GFI protected NEMA 5-15R outlet located in the wall behind an access panel per unit

iii. Power consumption: 180 watts at idle, 480 watts during a cycle in one basin, 720 watts during a cycle in both basins, and a nominal peak of 1200 watts per unit

g. Heat Load Basis-of-Design

i. Idle: 600 BTU/hr.

ii. Cycle (1 basin): 1600 BTU/hr.

iii. Cycle (2 basins): 2400 BTU/hr.

h. Ventilation Basis-of-Design

i. It is a health and safety requirement to have a minimum of 10 air changes per hour in the room

ii. Facility must supply a 4” (100 mm) round duct connection located in the wall behind an access panel.

1. A minimum of 25 cfm (12 l/s) at 0.25 inches (6 mm)-water (62 PA) static pressure is required to properly vent the reprocessing System.

i. Network Basis-of-Design

i. Facility is required to supply an RJ45 network connection receptacle located in the wall behind an access panel

ii. Reprocessing System is equipped with a PC running Windows 7 which will allow full networking along with the capability of remote diagnostics

j. Dimensions Basis-of-Design

i. Shipping Dimensions

1. Crate Dimensions: 85.5” (2172 mm) H x 69.5” (1766 mm) W x 44” (1118

mm) D

2. Crate Weight: 1100 lbs. (499 kgs)

ii. Reprocessor Dimensions

1. The physical dimensions are 51-1/2” (1306 mm) Wide x 78-3/4” (2000

mm) High x 31-1/4” (792 mm) Deep.

2. The installed weight is 882 lbs. (400 kgs)

3. Deinstallation

a. N/A New construction

4. Compatibility

a. Must be compatible with the basis-of-Design detailed in the Activation Drawings and Shop Drawings

III. ENDOSCOPE STORAGE AND DRYING SYSTEM

A hands-free Endoscope drying and storage solution system utilizing instrument-grade air for direct channel drying. The system should be capable of storing scopes up to 31 days without an increase in microbial levels. System must have the capacity to digitally track endoscope storage, time, and location and have the capability to pair with the Automated Endoscope Reprocessor (WSH1).

Requirements:

a. At a minimum, the Endoscope Storage and Drying System shall:

i. Use dual filtered air to maintain positive cabinet pressure

ii. Have HEPA filtered and dehumidified air delivered to each scope channel

iii. Have clear toughened glass doors to allow easy scope recognition

iv. Use secure mounting for scope control section and lightguide plug

v. Offer full traceability

vi. Have extended storage time (up to 31 days) to cover holiday periods

vii. Have at least eight (8) endoscope trays with interlocks

viii. Be equipped with a barcode reader for consistent data entry, endoscope tracking and user authorization

ix. Have the ability to program a maximum storage time

x. Be equipped with an alarm in case of pressure or power loss

xi. Utilize Internal digital documentation of process parameters

xii. Have an integrated multi-lingual information and control panel

xiii. Be available in a pass-through configuration

xiv. Utilizes hands-free scope handling system for drying, storage, and transport

xv. Include installation

2. Site Specific Basis of Design: (Refer to Attached Drawings)

a. Air Supply

i. Quality: ISO 8573-1:2010 class 1.2.1

1. Particle Size: Incoming air filtered down to <1 micron in size.

2. Moisture Content: Pressure dew point (PDP) of -40°C or better required and no liquid water

3. Oil Content: < 0.01mg of oil per cubic meter of compressed air

(liquid, aerosol, or vapor oil)

ii. Pressure: The below pressures are required at the point of cabinet connection. Facility should consult with their Maintenance Department or their qualified air vendor to identify potential issues with the air supply

1. ENDODRY™ Cabinet for ADVANTAGE PLUS™ Endoscope Reprocessor: 58-145 psi (4-10 bar)

2. ENDODRY Cabinet for DSD EDGE™ Automated Endoscope Reprocessor: 72-145 psi (5-10 bar)

iii. Volume: The below volumes are required at the point of cabinet connection.

1. ADVANTAGE PLUS Endoscope Reprocessor/ENDODRY Cabinet: Minimum requirement of 4.2 scfm (120 l/min ANR) per cabinet

2. • DSD EDGE Automated Endoscope Reprocessor/ENDODRY Cabinet: Minimum requirement of 7 scfm (200 l/min ANR) per cabinet

iv. Flexible Air Hose: A 5-foot (1.5 Meter) line is included with each cabinet

1. One end will be pre-configured to connect to ENDODRY™ Drying

Cabinet

2. Open end will be ¼” or 6mm inner diameter and it is the responsibility of the facility to make that connection to their air supply line

b. Electrical Supply

i. 100-240 VAC ± 10%, single phase, 50/60 Hz, 15-amp circuit (120v), 10-amp circuit (230v)

ii. Power input: 75W

iii. A NEMA 5-15 power cord for the North America market and a CEE 7 power cord for the European market is included with the ENDODRY™ Storage and Drying System. The cord is approximately 6 feet (1.8 meters) in length

iv. GFI/RCD protected outlet located on the wall above the ENDODRY Storage and Drying System, see Floor & Wall Section

v. Medivators equipment must be on dedicated circuits

c. Networking

i. The ENDODRY Storage and Drying System is a networkable piece of equipment and has the capabilities to communicate to other Medivators technologies via a LAN interface (RJ45, 10/100 Mbit)

ii. A 6.5-foot (2 meter) cable is included with the cabinet

iii. A RJ45 wall mounted network jack located on the wall above the

ENDODRY Storage and Drying System, see Floor & Wall section

d. Dimensions

i. Shipping Dimensions

1. Crate Dimensions: H84”x W47”x D31”

2. Crate Weight: 583 lbs.

ii. Reprocessor Dimensions

1. Dimensions: H74.8” X W23.6” X D21.3”

2. Weight: 375 lbs. (170 kg)

3. Compatibility

Must be compatible with the Automated Endoscope Reprocessor

IV. ENDOSCOPE FLUSHING AID

Manual cleaning is the most important step in reprocessing endoscopes, ultimately helping to reduce the risk of Healthcare-associated infections. The Flushing Aid helps create a consistent, reliable, and safe means to flush endoscope channels. Manual cleaning is essential in removing bioburden and preparing the endoscope for high-level disinfection. Performing meticulous manual cleaning is of paramount importance and implies that it should have the same attention to quality control as high-level disinfection and sterilization.

Requirements:

a. At a minimum, the Endoscope Flushing Aid shall:

i. Have both automatic and manual modes to provide ease of use

ii. Be compatible with all major endoscope brands

iii. Help improve staff efficiency by simultaneously flushing multiple endoscope channels

iv. Provide an optional 24-Hour Multi-Use Pump Tube

v. Provide an optional 24-Hour Multi-Use Universal Hookup

vi. Provide an optional Auxiliary Detergent Out Tube (24-Hour Multi-Use)

vii. Provide an optional Detergent In Tube -Change with new detergent

2. Site Specific:

e. Electrical Requirements

i. 100 – 240 V, 50/60 Hz

f. Dimensions

i. 10.3 H x 7.5 W x 11.5 D (inches)

g. Weight

i. 10 lbs. (4.5 kg)

2. Deinstallation

a. N/A New construction

3. Compatibility

a. N/A

V. ENDOSCOPE TRANSPORT CART

Transport and Short-term Storage System to protect endoscopes and other delicate equipment by minimizing direct handling and reducing contact with airborne contaminants. Requires a design that creates a protective environment for each disinfected endoscope. Color-coded liners are preferred to immediately identify clean or contaminated equipment. Bacteria pose significant risk to endoscopes during transport and storage. Complete transport, drying and storage solution must be designed to protect valuable inventory, reduce cross contamination touchpoints, eliminate moisture in the endoscope channels and control humidity. Humidity or moisture in endoscope channels is known to aid bacterial growth.

2. Requirements:

a. At a minimum, the Endoscope Transport Cart shall:

i. Have trays fit perfectly into the cart top

ii. Provide protected short-term storage of clean scopes and equipment

iii. Have hard lids available for added protection when transporting outside department

iv. Have reusable trays that easily fit large endoscopes

v. Utilize a single-use sterile packed liner system to reduce the potential for cross-contamination

vi. Have locking caster wheels to make transport easy and smooth

vii. Meet ASGE Quality Assurance in Endoscopy Committee, 2011 and

SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes 2012

viii. Utilize a color-coded liner system to easily clean or contaminated equipment

3. Site Specific:

a. No infrastructure dependency, must fit and maneuver with the DECON Space

2023 identified in Procedure Activation Drawing (Attached)

4. Compatibility

a. Have reusable trays that easily fit large endoscopes

VI. MISCELLANOUS INFORMATION

1. Deinstallation

N/A New construction

2. Compatibility Must be compatible with the Automated Endoscope Reprocessor.

3. VA Medical Center Address:

John J. Pershing VA Medical Center 1500 North Westwood Blvd Poplar Bluff, MO 63901

4. Shipping Address:

TBD Upon Award of Warehouse Task Order Cape Girardeau, MO 63703

5. Facility Point of Contact:

TBD

6. VA Information and Information System Security/Privacy:

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY language FOR Inclusion into CONTRACTS

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.

ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS

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.

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.

VA INFORMATION CUSTODIAL Language

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).

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

SECURITY INCIDENT INVESTIGATION

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

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

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

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

LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $__37.50__ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

TRAINING

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

Successfully complete the appropriate VA privacy training and annually complete required privacy training (See below training); and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access

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

Failure to complete the mandatory annual training, 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.

7. ADDITIONAL Requirements

a. The COR is responsible for coordinating with the Police prior to contractor arrival to identify the names of contractor personnel so that Police can ensure sufficient number of contractor badges are available for issuance prior to beginning work. COR is also responsible for signing out and signing in temporary contractor badges.

b. The COR is also responsible for maintaining copies of signed Privacy training for all contractors according to RCS 10-1.

c. Any work performed outside of official VA business hours after hours will require escorts.

d. Escort duties for un-cleared contractors are strictly limited to government officials, specifically VA employees. At no time are contractors allowed to escort other contractors.

VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access or Use to VA Sensitive Information

The Department of Veterans Affairs, VA must comply with all applicable privacy and confidentiality statutes and regulations. One of the requirements in VA is to have all personnel trained annually on privacy requirements. “Privacy” represents what must be protected by VA in the collection, use, and disclosure of personal information whether the medium is electronic, paper or verbal.

This document satisfies the “basic” privacy training requirement for a contractor, volunteer, or other personnel only if the individual does not use or have access to any VA computer system such as Time and Attendance, PAID, CPRS, VistA Web, VA sensitive information or protected health information (PHI), whether paper or electronic. You will find this training outlines your roles and responsibility for protecting VA sensitive information (medical, financial, or educational) that you may incidentally or accidentally see or overhear.

If you have direct access to protected health information or access to a VA computer system where there is protected health information such as CPRS, VistA Web, you must take “Privacy and HIPAA Focused Training” (TMS 10203). “VA Privacy and Information Security Awareness and Rules of Behavior” (TMS 10176) is always required in order to use or gain access to a VA computer systems or VA sensitive information, whether or not protected health information is included. Both trainings are located within the VA Talent Management System (TMS): https://www.tms.va.gov

What is VA Sensitive Information/Data?

All Department information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes not only information that identifies an individual but also other information whose improper use or disclosure could adversely affect the https://www.tms.va.gov/ ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions.

What is Protected Health Information?

The HIPAA Privacy Rule defines protected health information as Individually Identifiable Health Information transmitted or maintained in any form or medium by a covered entity, such as VHA.

What is an “Incidental” Disclosure?

An incidental disclosure is one where an individual’s information may be disclosed incidentally even though appropriate safeguards are in place. Due to the nature of VA communications and practices, as well as the various environments in which Veterans receive healthcare or other services from VA, the potential exists for a Veteran’s protected health information or VA sensitive information to be disclosed incidentally.

For example:

You overhear a healthcare provider’s conversation with another provider or patient even when the conversation is taken place appropriately.

You may see limited Veteran information on sign-in sheets or white boards within a treating area of the facility.

Hearing a Veteran’s name being called out for an appointment or when the Veteran is being transported/escorted to and from an appointment.

Safeguards You Must Follow To Secure VA Sensitive Information:

Secure any VA sensitive information found in unsecured public areas (parking lot, trash can, or vacated area) until information can be given to your supervisor or Privacy Officer. You must report such incidents to your Privacy Officer timely.

Don’t take VA sensitive information off facilities grounds without VA permission unless the VA information is general public information, i.e., brochures/pamphlets.

Don’t take pictures using a personal camera without the permission from the Medical Center Director.

Any protected health information overheard or seen in VA should not be discussed or shared with anyone who does not have a need to know the information in the performance of their official job duties, this includes spouses, employers or colleagues.

Do not share VA access cards, keys, or codes to enter the facility.

Immediately report lost or stolen Personal Identity Verification (PIV) or Veteran Health Identification Cards (VHIC), any VA keys or keypad lock codes to your supervisor or VA police.

Do not use a VA computer using another VA employee’s access and password.

Do not ask another VA employee to access your own protected health information. You must request this information in writing from the Release of Information section at your facility.

What are the Six Privacy Laws and Statutes Governing VA?

Freedom of Information Act (FOIA) compels disclosure of reasonably described VA records or a reasonably segregated portion of the records to any person upon written request unless one or more of the nine exemptions apply.

Privacy Act of 1974 provides for the confidentiality of personal information about a living individual who is a United States citizen or an alien lawfully admitted to U.S. and whose information is retrieved by the individual’s name or other unique identifier, e.g. Social Security Number.

Health Insurance Portability and Accountability Act (HIPAA) provides for the improvement of the efficiency and effectiveness of health care systems by encouraging the development of health information systems through the establishment of standards and requirements for the electronic transmission, privacy, and security of certain health information.

38 U.S.C. 5701 provides for the confidentiality of all VA patient and claimant information, with special protection for their names and home addresses.

38 U.S.C. 7332 provides for the confidentiality of drug abuse, alcoholism and alcohol abuse, infection with the human immunodeficiency virus (HIV) and sickle cell anemia medical records and health information.

38 U.S.C. 5705 provides for the confidentiality of designated medical-quality assurance documents.

What are the Privacy Rules Concerning Use and Disclosure?

You are not authorized to use or disclose protected health information. In general, VHA personnel may only use information for purposes of treatment, payment or healthcare operations when they have a need-to-know in the course of their official job duties.

VHA may only disclose protected health information upon written request by the individual who is the subject of the information or as authorized by law.

How is Privacy Enforced?

There are both civil and criminal penalties, including monetary penalties that may be imposed if a privacy violation has taken place.

Any willful negligent or intentional violation of an individual’s privacy by VA personnel, contract staff, volunteers, or others may result in such corrective action as deemed appropriate by VA including the potential loss of employment, contract, or volunteer status.

Know your VA/VHA Privacy Officer and Information Security Officer. These are the individuals to whom you can report any potential violation of protected health information or VA sensitive information, or any other concerns regarding privacy of VA sensitive information.

YOU ARE RESPONSIBLE FOR PROTECTING THE CONFIDENTIAL INFORMATION OF OUR VETERANS

Employee (Print Name) Date

Employee Signature

Print Name of Contract Agency, if contractor

Print Name of VHA Department/Supervisor/Local COR

PROVIDE A COPY OF THIS FORM TO YOUR SUPERVISOR/LOCAL COR

FOR DATA ENTRY INTO TALENT MANAGEMENT SYSTEM

---End---

RECORDS MANAGEMENT OBLIGATIONS

1. APPLICABILITY

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

2. DEFINITIONS

“Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

a. includes Department of Veterans Affairs, Veterans Health Administration records.

b. does not include personal materials.

c. applies to records created, received, or maintained by Contractors pursuant to their Department of Veterans Affairs, Veterans Health Administration contract.

d. may include deliverables and documentation associated with deliverables.

3. REQUIREMENTS

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. John J. Pershing VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of John J. Pershing VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to John J.

Pershing VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to John J. Pershing VA Medical Center’s control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and John J. Pershing VA Medical Center’s guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with John J. Pershing VA Medical Center’s policy.

h. The Contractor shall not create or maintain any records containing any non-public John J. Pershing VA Medical Center’s information that are not specifically tied to or authorized by the contract.

i. The 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 from public disclosure by an exemption to the Freedom of Information Act.

j. The John J. Pershing VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which John J. Pershing VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

4. FLOWDOWN OF REQUIREMENTS TO SUBCONTRACTORS

a. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.