S06-S-Oxygen RFQ- Question Responses-36C24721Q0140 (1).pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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

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

E. IMPORTANT:

is extended,

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

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

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

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

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 10

0001 0

Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799

Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799

To all Offerors/Bidders 36C24721Q0140

01-18-2021 X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: February 01, 2021 @ 15:00 EST

1. The purpose of this amendment to Solicitation 36C24721Q0140 is to provide responses to questions submitted and to change the North American Industry Classification System (NAICS)code.

2. The current NAICS is 532283. The NAICS will be changed to 325120 (Industrial Gas Manufacturing) with a size standard of 1,000 employees.

3. The Service code was W065 but will now be 6830 to coincide with the Commodity NAICS code.

4. Please see the attachment with the questions and responses posed to this solicitation.

5. The period for questions to this solicitation has been extended through Thursday January 21, 2021 @ 15:00 EST.

6. The quotation submission deadline for this solicitation has been extended until February 1, 2021 @ 15:00 CST.

Please referenced revised SOW with added text in red inserted in this modification.

Below are the received questions/comments from the RFQ. The highlighted green responses are the corrections/responses.

1. NAICS

misclassified 532283:

Home Health Equipment Rental When this SOW is NAICS 325120 furthermore any vendor looking for NAICS 325120 daily WOULD NOT SEE THIS MISCLASSIFIED NAICs

As referenced in Block 14 the NAICS will be changed to 325120.

1. Page 6 of 17 states:

5.6. Contractor shall provide for the following as outlined below:

1. Bulk Oxygen – Delivery weekly on Wednesday for the Ralph H. Johnson VA

Medical Center.

2. Emergency Delivery Fee – for a 12-month period.

3. Bulk Oxygen monthly portable tank rental.

4. Telemetry monthly rentals for main and reserve tank in order that Contractor and Government may always have constant awareness of levels in tanks and to provide a portal or website for the facility to have access to monitor and place orders as needed.

There was no question for this section and follow up request for more information as to the issue from the responding vendor resulted in no additional clarification.

2. Rhetorically, and respectfully, why would “HOME HEALTHCARE” involve filling a BULK

LOX Tank at the VAMC? Sound reasoning denotes this is not the case

This is what was requested by the station.

3. Please confirm the Sizes of the both the Main Tank and the Reserve Tanks

The tanks are a 3000G with a 900G backup oxygen tank

4. What is the current contract number please?

The current contract # is 36C24721P0015

5. Please confirm that the Prime Contractor SDVOB must be licensed (licensed in the Name of the SDVOB PRIME – as the accountable entity to the GOV) to distribute Medical Grade Oxygen, a prescription drug, in the state of SC NOTE:

5.1. The Medical-grade oxygen is classified as a drug and must meet USP specifications. Bulk oxygen tanks are classified as a drug delivery device, and all Contractors shall be registered with the Food and Drug Administration. This is not correct, under the SBA NMR consistent with the FDA only the manufacturer must have an FDA Number subject to FDA compliance/inspection. This is why the Prime Contractor must be licensed to distribute this prescription drug in the state of SC.

Only the manufacturer must have an FDA Number subject to FDA compliance/inspection. Under NAICS 325120 and Product Service Code (PSC) 6830 the SBA has a Waiver to the NMR.

Performance Work Statement Ralph H. Johnson VA Medical Center

Charleston, South Carolina Medical Grade Bulk Oxygen and Tank Rental Service

1. General

1.1. Services:

This requirement is for the leasing of bulk oxygen tanks and the purchase of compressed oxygen for the Ralph H. Johnson VA Medical Center (RHJVAMC) located in Charleston, South Carolina.

1.2. Period of Performance:

This is for a one-year base contract with the possibility of four one-year option periods. The base year period of performance is as follows and may be altered contingent upon date of award.

Base Year 01 April 2021 – 31 May 2022

Option Year 1 01 April 2022 – 31 May 2023

Option Year 2 01 April 2023 – 31 May 2024

Option Year 3 01 April 2024 – 31 May 2025

Option Year 4 01 April 2025 – 31 May 2026

1.3. Place Performance:

Ralph H. Johnson VA Medical Center 109 Bee Street Charleston, SC 29401

1.4. Background:

The RHJVAMC currently has a requirement for the distribution and supply of medical-grade liquid bulk oxygen and tank rental. The requirement is for estimated quantities which may change based on actual need to support patient care, historically, the facility has used quantities up to but has not exceeded the requested amounts.

The tanks are a 3000G with a 900G backup oxygen tank.

1.5. Acronyms and Definition:

• C&A – Certification and Accreditation

• CFR – Code of Federal Regulations

• CGMP – Current Good Manufacturing Practices

• COR – Contracting Officer’s Representative

• FDA – Food and Drug Administration

• ISO – Information Security Officer

• NFPA – National Fire Protection Association

• PII – Personally Identifiable Information

• PIV – Personal Identification Verification

• QASP – Quality Assurance Surveillance Plan

• U.S.P. – United States Pharmacopoeia

• VA – Veterans Affairs or Department of Veterans Affairs

• VHA – Veterans Health Administration

1.6. Publications:

• 21 CFR Part 201

• NFPA 55

• NFPA 99

• VA Handbook 6500.1

• VA Handbook 6500.6

• VHA Handbook 2005-028

• VHA Patient Safety Alert

2. Personnel

2.1. Key Personnel (Contractor and Government):

Name of Personnel Position / Title License/Certification/Experience Percentage of Work to Perform

3. Hours of Operation:

3.1. Business Hours

8:00 a.m. – 3:30 p.m., Monday through Friday, excluding Federal Holidays. Overtime is not authorized at this time.

Federal Holidays New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day Last Thursday in November Christmas Day December 25th

3.2. Work schedule

The Contractor shall be available during normal business hours of 8:00 a.m. – 3:30 p.m., Monday through Friday, excluding Federal Holidays to meet delivery requirements for non-emergent requests submitted by the Government.

4. Government Responsibilities:

4.1. A Contracting Officer Representative (COR) shall be designated and is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR’s specific responsibilities shall be provided to the Contractor at the time of contract award.

4.2. The Government shall ensure proper and timely submission of orders to allow Contractor to meet required delivery date. A list shall be provided to the Contractor of approved individuals who have authority to place orders against the awarded contract.

4.3. The Government shall provide a list of approved individuals who have the authority to receive and sign for the goods being delivered.

5. Contractor Performance Requirements and Responsibilities:

5.1. The Medical-grade oxygen is classified as a drug and must meet USP specifications. Bulk oxygen tanks are classified as a drug delivery device, only the manufacturer must have an FDA Number subject to FDA compliance/inspection.

The tanks are a 3000G with a 900G backup oxygen tank.

5.2. The quantities are estimates of the facility’s annual requirements. There is no express or implied guarantee that these quantities shall be purchased. Please note that contracts that include the installation of Contractor owned equipment shall include a sixty (60) day transition period at the beginning and end of the contract period.

5.3. Prior to first filling under this contract and yearly, Contractor shall perform in-service training for facility personnel, such as the COR and any other personnel deemed appropriate by the Service Line, to include the following facets for Contractor owned and Government owned systems:

• Refill procedure with documentation

• Preventative maintenance support requirements with documentation that may be needed from the

Medical Center systems

• Explanation and documentation of all the volume alarm and low pressure set points.

5.3.1. The Contractor shall provide written procedures and training for VA staff protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor shall provide 24/7 emergency contact name(s) and telephone number(s).

5.4. Prior to first filling, and annually thereafter, alarm set-point testing, risk assessment including an assessment of current infrastructure, and written verification shall be presented through the use of a qualified third party expert per NFPA 99, 2021 Edition (http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=99) for Contractor owned and Government owned systems. Any code deficiencies in the Medical Center’s existing system, as defined by NFPA 55, 2020 Edition (5), Chapter 9, “Bulk Oxygen Systems”, shall be identified by the Contractor. A detailed explanation of these deficiencies shall be presented in writing to the COR. Receipt of this written http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=99 http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=99 http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=50 explanation shall be signed for by the COR. An annual risk assessment shall be presented yearly in a formal document to the COR. The risk assessment shall only be conducted for the Medical Gas and Vacuum Systems related to the Medical Grade Bulk Oxygen and Tank Rental Service associated with this contract.

5.5. Prior to first filling for this contract, and annually thereafter, the Contractor shall verify, in writing, the accuracy of all gauges on Contractor owned tanks. If the gauge(s) are Government owned, Contractor shall provide, if requested after award, a written proposal with price to verify accuracy of the gauge(s).

The Government may choose to exercise this option at its desire.

5.6. Contractor shall provide for the following as outlined below:

5. Bulk Oxygen – Delivery weekly on Wednesday for the Ralph H. Johnson VA Medical Center.

6. Emergency Delivery Fee – for a 12-month period.

7. Bulk Oxygen monthly portable tank rental.

8. Telemetry monthly rentals for main and reserve tank in order that Contractor and Government may always have constant awareness of levels in tanks and to provide a portal or website for the facility to have access to monitor and place orders as needed.

9. The tanks are a 3000G with a 900G backup oxygen tank.

5.7. Contractor shall refer to delivery schedule (provided after award) which specifies order submission and delivery dates, to include alternate dates because of observed federal holidays.

6. Delivery of Medical Liquid Bulk Oxygen:

6.1. Bulk Oxygen is ordered by and delivered to the individual ordering facility. Specific information regarding any unique delivery requirements is included in the Price Schedule.

6.2. The Contractor shall deliver medical-grade liquid oxygen within the timeframe specified in the provided schedule. The timeframe identified may be either

10. The number of calendar days after receipt of the Government’s order.

11. The specific days of the week for delivery.

12. The specific time intervals between deliveries.

13. A specified reorder points.

14. Other specified ordering and delivery methods.

6.3. Upon award, delivery timeframe shall be discussed with site COR listed in the schedule, as sites shall have the option to establish an automatic delivery schedule. If the time frame for Contractor delivery is not identified in the facility requirements, the Contractor shall provide 24-hour notice prior to delivery or upon mutual agreement between the facility and Contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged.

6.4. If for any reason the Contractor is unable to delivery at the agreed upon day or time, the Contractor shall provide 24-hour notice to the COR, so that the facility can initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 5, 2004 (https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279) and VHA Directive 2005-028 (https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279) dated June 24, 2005 all deliveries shall be monitored by a qualified and trained technical representative that shall be designated by each facility. Contractor shall be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution.

https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279 https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279

6.5. Tanks(s) shall be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the delegated COR.

6.6. At the time of each delivery, Contractor shall provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the facility representative supervising the delivery.

6.7. Emergency delivery shall be provided within twenty-four (24) hours after receipt of Government notification. Contractor shall respond to the facility by either telephone or email within one (1) hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak. Failure of the Contractor to remain current with agreed delivery schedule and requirements does not constitute an “emergency” for purposes of charging an emergency delivery fee.

7. Quality Assurance Specifications and Requirements:

7.1. All medical gas manufacturers and fillers of medical gases shall be registered with FDA as drug manufacturers. All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA’s Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA’s labeling regulations (21 CFR Part 201 -https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201).

7.2. Liquid bulk oxygen delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.).

7.3. Material Safety Data Sheets shall be provided to the facility upon request.

7.4. A copy of all inspection reports shall be provided to the delegated COR upon the completion of any Contractor owned or Government owned bulk oxygen system inspections that are required by regulation.

7.5. Provide reports to the facility such as usage in a timely manner. Reports may be issued based on time periods.

7.6. All Contractor-owned equipment shall be maintained or repaired in accordance with NFPA 55:

Compressed Gases and Cryogenic Fluids Code, 20020 and FDA’s Current Good Manufacturing Practices (CGMP) Regulations (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm).

8. Contractor-Owned Equipment:

8.1. The facilities listed in the schedule as having Contractor owned tanks shall have the Contractor provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Through the duration of the contract, the Contractor shall be liable for the integrity, suitability, and safety of Contractor owned tank(s) that shall insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the using facilities. Manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility’s gas system shall be furnished by the Contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201 https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

8.2. All equipment and materials required to perform on the contract (other than what is specifically listed in paragraph 10, Government-Furnished Property) shall be provided by the Contractor. Contractor owned equipment shall be installed, inspected and maintained by the Contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contract’s monthly equipment rental fee for the applicable facility.) Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The Contractor shall be provided reasonable access to the bulk oxygen systems for this purpose.

9. Installation of Contractor-Owned Equipment:

9.1. Unless otherwise directed by the using facility, Contractor owned equipment shall be installed by the first day of the period of performance (directed by Contracting Officer) and shall be connected to the medical gas system on that date; provided that the Contractor shall be allowed a maximum of sixty (60) calendar days after receipt of notice of award to complete installation.

9.1.1. If the Contractor’s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the Contractor and shall be removed upon termination of the contract when directed by the ordering facility and in full cooperation with the succeeding Contractor to avoid interruption of gas supply.

9.2. No guarantee is given or implied that data included in the schedule regarding Contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required Contractor owned tanks and appurtenances. Contractor is strongly encouraged to visit the facility sites prior to commencement of service and take steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work. Failure to do so shall not relieve you from the responsibility of estimating properly the difficulty and cost of successfully performing the work.

10. Government-Owned Cylinders

10.1. Individual Agency Ownership of Cylinders: Government owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either Government-owned or Contractor-owned, without authorization of the Contracting Officer Representative (COR) at the ordering agency.

11. Invoices

11.1. Contractor 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:

• VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party Contractor, Tungsten Network (Formerly OB10), to transition Contractors from paper to electronic invoice submission. Please go to this website http://www.tungsten-network.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

• A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

11.2. Contractor e-Invoice Set-Up Information:

http://www.tungsten-network.com/us/en/veterans-affairs-us/ http://www.tungsten-network.com/us/en/veterans-affairs-us/ http://www.x12.org/

Please contact OB10 at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or OB10, please contact the FSC at the phone number or email address listed below:

• OB10 e-Invoice Setup Information: 1-877-489-6135

• OB10 e-Invoice email: VA.Registration@ob10.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

11.3. A properly prepared invoice shall contain:

• Invoice Number and Date services were provided

• Contractor’s Name and Address

• Accurate Purchase Order Number

• Description of Supply or Service provided

• Total amount due

12. Special Contract Requirements

PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A-

INFORMATION SECURITY AND PRIVACY CHECKLIST:

• “The C&A requirements do not apply and a Security Accreditation Package is not required.”

• Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the Contractor

• There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services

12.1. Minimum Statutory Requirements

12.1.1. Prohibition on unauthorized disclosure: 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). See VA Handbook 6500.6, Appendix C, paragraph 3.a.

12.1.2. Requirement for data breach notification: Upon discovery 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, the Contractor/subcontractor shall immediately and simultaneously notify the COTR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a

12.1.3. Requirement to pay liquidated damages in the event of a 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.

http://VA.Registration@ob10.com http://vafsccshd@va.gov

12.1.4. 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.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

(7) The likelihood that the sensitive personal information shall 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 6500.6 Handbook, Contract Security, 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.