S02 36C25721Q1108.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 72

36C25721Q1108 07-07-2021

Melanie Williams 210-694-6378 07-20-2021

1:00pm CDT

36C257

Department of Veterans Affairs

VISN17 Network Contracting Activity

5441 Babcock Road Ste. 302

San Antonio TX 78240

X 100

X

541380

$16.5 Million

N/A

X

George H. O'Brien VA Medical Center

SPS

300 Veterans Boulevard

Big Spring TX 79720

36C257

Department of Veterans Affairs

VISN17 Network Contracting Activity

5441 Babcock Road Ste. 302

San Antonio TX 78240

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Contractor shall provide water testing required on a monthly basis in accordance with the Statement of Work (SOW).

See CONTINUATION Page

X X

X 1

Shantelle Mayfield

36C25721Q1108

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INSTRUCTIONS TO OFFERORS

B.2 STATEMENT OF WORK

B.3 CONTRACT ADMINISTRATION DATA

B.4 PRICE/COST SCHEDULE

B.5 DELIVERY SCHEDULE

B.6 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.6 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION 2015-5269

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INSTRUCTIONS TO OFFERORS

Evaluation Factors for Award

This solicitation is issued as a Small Disabled Veteran Owned Small Business (SDVOSB) set-aside. The vendor must be registered for NAICS 541380 in SAM to be eligible for award.

Quotations due 7/23/2021 at 1:00 p.m. EST.

Point of Contact:

Melanie Williams Contract Specialist Network Contracting Office 17 (NCO 17) 5441 Babcock Road, Suite 302 San Antonio, TX 78240 Phone: 210-694-6378 Melanie.Williams5@va.gov

Late quotes or documentation will not be accepted. All questions, comments, or inquiries are to be submitted in writing to the Point of Contact, referenced above, prior to the closing of the solicitation.

I. Basis of Award

The Government intends to award a contract Brand Name or Equal resulting from this solicitation to the responsible offeror whose quote conforming to the solicitation meets or exceeds the requirement. The quotes will be evaluated based on the evaluation factors listed below. The technical acceptability will be evaluated on an "acceptable" or "unacceptable" basis.

All evaluation factors other than cost or price, when combined, are significantly more important than cost or price.

The following areas will be evaluated:

1. Technical Capability (acceptable/unacceptable)

2. Past Performance

3. Price

Factor 1: Technical Capabilities – The contractor shall provide a written statement addressing each of the following items. The written statement must describe each point and must provide enough detail to determine minimum qualifications.

a. Description of Specifications: Provide a listing of capabilities meeting the specifications contained within the Statement of Work (SOW)

Factor 2: Past Performance – Provide any past performance evaluations or past performance references for past work for the same type of work requested within the SOW.

Factor 3: Price – Contractor shall complete B.2 Price/Cost Schedule. The schedule may be altered, or an alternate schedule used where appropriate in order to express quote detail.

THE REMAINDER OF THIS PAGE IS INTENTINALLY LEFT BLANK

B.2 STATEMENT OF WORK

OBJECTIVE:

The West Texas VA Health Care System (WTVAHCS) Biomed Service is establishing a contracted Water Management Program Services for Sterile Processing Service (SPS) that includes monthly, quarterly, and annual testing cycles in accordance with the Association for the

Advancement of Medical Instrumentation (AAMI) TIR 34:2014-2017 and requirements for equipment operation according to the Instructions for Use (IFU).

SPS is located at the George H. O’Brien, Jr. VA Medical Center, 300 Veterans Boulevard, Big

Spring, TX 79720-5566.

The contractor shall develop a Water Management Program (WMP) for SPS water systems in alignment with VHA Directive 1116(2) Sterile Processing Services and AAMI TIR 34:

2014/(R)2017 Water for the Reprocessing of Medical Devices.

Water Management Program Operations for Sterile Processing Service should include meetings and maintenance documentation and advice on the water management program.

Provide remote support for the WMP. Provide, operate, and continue to customize the WMP using the web-based data management site. Provide training and records for a web-based data management site. The web-based data management system will also provide services 24/7, provide easy access to WMP- related reports, provide assistance with customized management dashboards, provide email or phone notification for any data outside of normal parameters, and provide data-collection via tablets or other hand-held devices.

Water testing will be conducted monthly, quarterly, and annually for a year. Vendor needs to include option for additional 4 years. Vendor will come to WTVAHCS Sterile Processing

Service to take water samples in secured areas. Utility and Critical water will be tested.

Reports will be supplied electronically and hard copy.

The periods of performance are:

Base Year: August 15, 2021 – August 14, 2022 Option Year One (1): August 15, 2021 – August 14, 2022 Option Year Two (2): August 15, 2021 – August 14, 2022 Option Year Three (3): August 15, 2021 – August 14, 2022 Option Year Four (4): August 15, 2021 – August 14, 2022

SPS requires water testing to occur in the morning (0800-1100) to ensure water testing does not interfere with SPS workflow or risk of workflow causing contaminated sample. Water samples should be performed using same criteria as AAMI TIR 34: 2017. Water samples should be collected from all water sources where a final rinse is completed according to AAMI TIR:34.

WTVAHCS requests re-testing or re-validation of non-conforming results.

Sampling locations for SPS Water as listed in below chart.

1. A total of 13 samples per month will be collected each month for the testing described above, with the inclusion of re-testing for non-conforming results:

Location / Room Critical / Utility Total

(Big Spring, Tx) Location-SPS

Decontamination Rm 214 Sites:

(1 washer/disinfector, 6 sinks, 2 water pistols, 1 De-Ionized tank site, and 2 water sprayers)

6/6 12

Outside City Water 1 1

Re-tests for non-conforming results

2 emergency re-tests for each non-conforming site.

As applicable.

2. SCHEDULE OF SUPPLIES:

a. Contractor shall supply all sampling supplies, containers, and paid postage shipping labels. Contractor will supply training as needed for emergency samples to be collected and shipped. Contractor shall supply all sampling supplies, containers, and paid postage shipping labels for required re-tests.

b. AAMI compliance with water quality Water Testing Requirements:

c. General Procedures for AAMI compliance with water quality:

i. The contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing. Containers must be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. Contractor required to provide trained staff to perform sample collections.

ii. VA requires minimum critical water testing in accordance with AAMI

TIR:34 standards. This may require testing on a monthly, quarterly, and annual basis plus 2 emergency re-tests for each non-conforming site if necessary. Endotoxins water testing may warrant additional testing upon new installation, modification, or repair of the Critical

Water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, ATP, or TOC.

3. Sample/Specimen Analysis and Reporting:

a. The testing laboratory processing the water samples for AAMI compliance with water quality must be certified by the Centers for Disease Control and Prevention (CDC) Environmental AAMI compliance with water quality Isolation Techniques Evaluation (ELITE) program as proficient at performing the culture of AAMI compliance with water quality from environmental samples.

i. The full 250 ml volume of potable water (utility) must be concentrated for routine quarterly testing. The testing laboratory must retain samples that test positive for AAMI compliance with water quality for 30 calendar days and must release them to the health care system if requested.

ii. Endotoxin testing must be in compliance with use of Limulus

Amoebocyte Lysate testing as listed in AAMI TIR 34: 2017.

Per Association for the Advancement of Medical Instrumentation (AAMI) TIR34:2014-

2.25 endotoxin: High-molecular-weight complex that is associated with the cell wall of Gram-negative bacteria, is pyrogenic in humans and specifically interacts with Limulus amoebocyte lysate (LAL). See also bacterial endotoxins test (BET) and pyrogen.

2.26 endotoxin unit (EU): Standard unit of measure for endotoxin activity initially established relative to the activity contained in 0.2 nanograms of the U.S. Reference Standard Endotoxin Lot EC-2 (United States Pharmacopeia [USP] standard reference material).

NOTE—FDA’s reference endotoxin EC-6, USP Lot G, and the World Health Organization’s primary international endotoxin standard (IS) are sublots of the same endotoxin preparation, making the EU and IU (International Unit) equal (Poole, et al., 1997).

b. The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body, such as Environmental Microbiology

Laboratory Accreditation Program (EMLAP), National Environmental

Laboratory Accreditation Program (NELAP), etc. Proof of certification must be provided before acceptance of contract.

c. Contractor required to provide all sample analysis reports via e-mail to identified Contracting Officer Representative (COR) and WTVAHCS Point of

Contact.

d. Contractor required shall provide water testing services no less than once per month and more frequent if necessary, to treat water or provide maintenance on equipment. Successive stops between testing shall not exceed 25 calendar days.

e. Contractor is required to make notification of any positive sampling results and notification will be made within 24 hours or next business day of making this determination. Confirmation of notification from WTVAHCS required complete notification process.

f. Contractor Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations and conditions, including the specific outlet temperature of water at the time the sample was collected, pH, biocide residual levels, method detection limits, and a description of test methodology. Sample reports need to be provided in a format that can be copied into the WTVAHCS, AAMI water quality sampling results reporting form. Sample analysis reports must be provided within 15 calendar days of the lab receiving the samples. If the 15th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

g. Required-The contractor shall have qualified technical support staff for consultation relative to proper water sample collection, testing, and interpretation of results.

h. Required- The collection of samples will be performed in full compliance with facility Personal Protective Equipment (PPE) practice and policy. Collection team will be escorted into SPS restricted access areas.

i. Reports must include reference material and include previous test results to note trend of water quality with visual aids/graphs. Reports and materials need to be both electronic and hard copy/paper.

j. Required-Assistance with interpretation of reports and creating effective plan of action consultation required.

4. Contractor shall provide water testing equipment – contractor shall provide submittals of water testing equipment or lab certification that they intend on using to carry out the requirements of this contract. Submittals will then be evaluated to ensure that equipment is appropriate and certified.

5. REQUIRED - Sampling for SPS water quality of Utility and Critical water:

a. Laboratory and Chemical Analysis:

i. Requirements for testing per TIR 34:

Water Quality Monitoring Table

ii. Requirements and Procedures for Sampling of SPS water lines for

CFU and Endotoxin: The contractor must be certified by the

Environmental Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic). The contractor shall utilize the Standard

Spread Plate Method 9215C using R2A agar. The contractor will provide an outline of their actual testing procedures. Proof of certification and outline of actual testing procedures must be provided before acceptance of the contract. Sampling results will report the

Characteristic Type of testing Sample site Suggested frequency of testing

Bacteria Heterotrophic plate count 1) (see

Annex D)

Reprocessing area, storage tanks

(if used), immediately downstream of water treatment process

Monthly

Endotoxins LAL test Reprocessing area, storage tanks

(if used), immediately downstream of water treatment process

On installation, modification, or repair of the Critical Water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, ATP, or

TOC

Total organic carbon

TOC test Reprocessing area Monthly pH pH meter

Colorimetric dipsticks

Reprocessing area

Reprocessing area

Monthly

Monthly

Water hardness

Determination of ppm CaCO3

Colorimetric dipsticks

All main water feedlines into the facility

Reprocessing area

Quarterly

Ionic contaminants

Specific tests for chloride, iron, copper, manganese

All main water feedlines into the facility number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml).

iii. Bacteria in water readings of less than 1CFU may be recorded as

<1CFU. Critical water quality readings greater than <9 cfu/ml or greater are required to be immediately less than 24 hours notified by both telephone and email to identified SPS staff designee.

iv. Required-Utility water with bacteria in water findings of <195 or greater will require immediate (<24 hours) notification by both telephone and email.

v. All readings greater than 1CFU/ML should be quantified in whole numbers...or greater than 500 may be recorded as <10 cfu/ml or >

500 cfu/ml.

vi. Required-Sampling will be tested for presence of Endotoxin and response of results expected in less than 24 hours. Testing should be conducted and resulted in less than 7 days. Parameters for LAL testing as listed in AAAMI TIR 34:2017.

b. Contractor shall provide all sample analysis reports via e-mail to the COR and the assigned Points of Contact within the WTVAHCS SPS within 7 calendar days including weekends and holidays of receiving the sample. If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

c. The contractor shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

d. The Contractor shall provide expertise to formulate effective plans of action to correct the water to safe, within parameters established.

6. REQUIRED-Contractor takes all responsibility of their staff while on WTVAHCS property.

Contractor staff will be escorted in all restricted areas of SPS. All Contractor staff will be required to wear full PPE, no exceptions.

7. Period of Performance: The period of performance of this contract shall consist of one

12-month base period with 4 option years. At the discretion of the Contracting Officer, the Government may exercise up to four 12-month option periods.

8. Place of Performance: Services will be performed at WTVAHCS, 300 Veterans Blvd, Big

Spring, Texas 79720.

9. The certification and accreditation (C & A) requirements do not apply, and a Security

Accreditation Package is not required.

10. Summary: The WTVAHCS Biomed Service is establishing a contracted water quality testing program for SPS on a monthly, quarterly, and annual testing cycle in accordance with AAMI TIR 34:2014-2017 and requirements for Steris equipment operation Instructions for Use.

11. Qualifications:

a. The Contractor services shall be performed by trained and qualified personnel and performed in accordance with manufacturer’s guidelines.

12. Contractor Furnished Material:

a. The Contractor shall furnish all supplies, labor, materials and equipment necessary for this service. No Government property will be provided.

b. Contractor responsible for clean-up and removal of all trash and debris created during installation or maintaining system.

c. Contractor responsible for any damage to property whether personal, private or government owned. Contractor responsible for actions of their workers.

d. Contractor to provide all safety equipment and PPE for their employees outside of the WTVAHCS SPS areas.

13. Work Hours: The following terms have the following meanings and are applicable to this contract:

14. Normal hours of coverage are Monday through Friday from 0800 to 1100, excluding federal holidays. All service/repairs will be performed during the hours of 0800 to 1100 unless requested or approved by COR or designee. WTVAHCS Infection Preventionist and/or Safety Officer will provide Risk Assessment and guidance for working in hospital areas that is required to be followed.

Federal Holidays observed by Veterans Health Administration are:

i. New Years' Day Labor Day

ii. Martin Luther King Day Columbus

Day

iii. Presidents' Day Veterans'

Day

iv. Memorial Day Thanksgiving

v. Independence Day Christmas Day

15. Security:

a. The certification and accreditation (C&A) do not apply.

b. The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

16. Identification, Parking, Smoking and VA Regulations:

a. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police

Service. The WTVAHCS will not validate or make reimbursements for parking violations to the Contractor under any conditions. Use of tobacco products is prohibited in VA property.

17. Possession of weapons, illegal drugs and alcohol is prohibited.

18. Points of Contact:

i. WTVAHCS: Reynaldo Quiroga, Biomed Chief, COR

Reynaldo.quiroga@va.gov, 432-263-7361 Ext. 5056

ii. WTVAHCS: Sintia Sheets, SPS Chief, SME

Sintia.sheets@va.gov, 432-263-7361 Ext. 7562

19. Additional Notes:

a. Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers. They will not have access to online resources belonging to the VA or the U.S. Government.

b. Privacy Officer: The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

mailto:Reynaldo.quiroga@va.gov mailto:Sintia.sheets@va.gov

B.3 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR: __________________________

ADDRESS: __________________________

Contractor Point of Contact (POC) for Contract: _______________________ Title: _______________________ Phone: _______________________ Email: _______________________

DUNS: ____________________ BUSINESS SIZE: ____________________

b. GOVERNMENT: Contracting Officer, 36C257 Shantelle Mayfield, 210-694-6330 Shantelle.mayfield@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road, Suite 302 San Antonio, TX 78240

Contract Specialist Melanie Williams, 210-694-6378 Melanie.Williams5@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road, Suite 302 San Antonio, TX 78240

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Monthly mailto:Melanie.Williams5@va.gov

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.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

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B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

12.00 MO ________________

Monthly Water Testing (to include Emergency Water Samples) in accordance with the Statement of Work (SOW) Contract Period: Base POP Begin: 08-15-2021 POP End: 08-14-2022

Monthly Water Testing (to include Emergency Water Samples) in accordance with the Statement of Work (SOW) Contract Period: Option 1 POP Begin: 08-15-2022 POP End: 08-14-2023

Monthly Water Testing (to include Emergency Water Samples) in accordance with the Statement of Work (SOW) Contract Period: Option 2 POP Begin: 08-15-2023 POP End: 08-14-2024

Monthly Water Testing (to include Emergency Water Samples) in accordance with the Statement of Work (SOW) Contract Period: Option 3 POP Begin: 08-15-2024 POP End: 08-14-2025

Monthly Water Testing (to include Emergency Water Samples) in accordance with the Statement of Work (SOW) Contract Period: Option 4 POP Begin: 08-15-2025 POP End: 08-14-2026

GRAND TOTAL ________________

B.5 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: George H. O'Brien Jr. VA Medical Center 300 Veterans Blvd.

Big Spring, TX 79720

USA

12.00 8/15/2021 - 7/14/2022

MARK

FOR:

Reynaldo Quiroga 432-263-7361 5056 reynaldo.quiroga@va.gov

1001 SHIP TO: George H. O'Brien Jr. VA Medical Center 300 Veterans Blvd.

12.00 8/15/2022 - 8/14/2023

MARK

FOR:

Reynaldo Quiroga 432-263-7361 x 5056

2001 SHIP TO: George H. O'Brien Jr. VA Medical

300 Veterans Blvd.

12.00 8/15/2023 - 8/14/2024

MARK

FOR:

Reynaldo Quiroga

3001 SHIP TO: George H. O'Brien Jr. VA Medical

300 Veterans Blvd.

12.00 8/15/2024 - 8/14/2025

MARK

FOR:

Reynaldo Quiroga

4001 SHIP TO: George H. O'Brien Jr. VA Medical

300 Veterans Blvd.

12.00 8/15/2025 - 8/14/2026

MARK

FOR:

Reynaldo Quiroga

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B.6 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. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that

VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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

Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable

Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart

C, information and system security categorization level designations in accordance with FIPS

199 and FIPS 200 with implementation of all baseline security controls commensurate with the

FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA

Information Security Program). During the development cycle a Privacy Impact Assessment

(PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration

(FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default

"program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST

Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal

Information Systems, VA Handbook 6500, Information Security Program and VA Handbook

6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records

Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of

1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a

SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the

VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A

Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally

Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification

Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the

PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program

Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal

(host-based or enclave based) firewall that is configured with a VA-approved configuration.

Software must be kept current, including all critical updates and patches. Owners of approved

OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA

Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The

ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the

COR 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.

b. 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.

c. With respect to unsecured protected health information, the business associate is…