36C26119Q0998-001.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 78

36C26119Q0998 08-29-2019

Philip Caganap, Contract Specialist 925-372-2034 09-13-2019

5PM PDT

36C261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668

X

334516

1000 Employees

N/A

X

Department of Veterans Affairs Veterans Integrated Service Network 21 See Section B.2.9

VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668

FMS-VA-2(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Request for Quote (RFQ) to establish a VISN 21 Wide Blanket Purchase Agreement (BPA) for a Film Array laboratory test system as described within this RFQ and all attachments.

VA Contracting POC: Philip "Gabe" Caganap philip.caganap2@va.gov

Please review full RFQ, specifically Section E, for quote submission instructions.

See CONTINUATION Page

Brett Vegeto Contracting Officer

36C26119Q0998

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

B.2 DESCRIPTION OF AGREEMENT

B.3 STATEMENT OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

C.3 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

52.227-14 RIGHTS IN DATA—GENERAL (MAY 2014)

52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

SUPPLEMENTAL INSURANCE REQUIREMENTS

VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(JUL 2018)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS NOV 2018)

VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)

C.5 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

E.2 FAR 52.212-1 INSTRUCTIONS TO CONTRACTORS – COMMERCIAL ITEMS (TAILORED

FOR SAP)

E.3 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO CONTRACTORS – COMMERCIAL

ITEMS (TAILORED FOR SAP)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

52.233-2 SERVICE OF PROTEST (SEP 2006)

VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS

(OCT 2018)

E.6 52.214-21 DESCRIPTIVE LITERATURE (APR 2002)

E.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED

SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 BLANKET PURCHASE AGREEMENT (BPA) ADMINISTRATION DATA

1. BPA ADMINISTRATION: All BPA administration matters will be handled by the following individuals:

a. CONTRACTOR:

[Company Contact Person’s Name]:

[Company]:

[Street Address]:

[City, State, Zip]:

[Phone number]:

[Email address]:

[CAGE Number]:

[DUNS Number]:

b. GOVERNMENT:

Contracting Officer (CO): Brett Vegeto Department of Veterans Affairs Network Contracting Office (NCO) 21 Brett Vegeto@va.gov

Contract Specialist (CS): Philip "Gabe" Caganap

Network Contracting Office (NCO) 21 Philip.Caganap2@va.gov

2. OFFEROR REMITTANCE ADDRESS: See Section B.2.11 for details.

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

AMENDMENT NUMBER DATE

B.2 DESCRIPTION OF AGREEMENT

1. INTENT: In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition

Regulation (FAR) Part 12 – Acquisition of Commercial Items and FAR Part 13 – Simplified Acquisition Procedures, it is the intent of the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 21 to establish a Single Award BPA for a microbiology organism identification/susceptibility analyzer, service, training, reagents, and supplies to meet the requirement described within this solicitation.

2. TERMS OF AGREEMENT: This BPA shall have a five (5) year ordering period and will be reviewed at least annually to ensure the BPA terms are met, to assess current market conditions and to determine price reasonableness. Additional discounts maybe requested by NCO 21 at any time. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer, this BPA may be canceled with a thirty (30) days written notice to the Contractor by the Contracting Officer. The BPA shall not exceed sixty (60) months from the effective date of the BPA.

mailto:Brett%20Vegeto@va.gov mailto:Philip.Caganap2@va.gov

3. BPA PRICES: This BPA is a pricing agreement and does not obligate any funds. Pricing shall be established based on the estimated test quantities listed in Attachment B, Test Schedule and Volumes.

4. BPA ORDERS: The Government is obligated only to the extent of authorized BPA Delivery Orders

(DO) issued under the BPA by authorized individuals. DO’s shall be identified by the BPA Number, To Be Determined (TBD) and DO Number (TBD). DO’s may include options, if it is determined that options would be in the best interest of the Government. Any DO issued during the effective term of this BPA shall be completed by the Contractor within the time specified in the DO, including all option years. The Contractor shall accept the price, terms and conditions of an issued DO as long as they do not conflict with the terms set forth in the BPA.

The Government is obligated only to the extent of authorized purchases actually made under the BPA.

NOTICE TO CONTRACTORS: The awarded Contractor is advised that only the Contracting Officer, acting within the scope of the contract has the authority to make changes which affect the contract in terms of quality, quantity, price or delivery, unless otherwise specified within this solicitation. In the event the Contractor initiates any such change at the direction of any person other than the Contractor Officer, the change shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase of costs incurred as a result thereof.

5. PARTICIPATING FACILITIES: The following facilities currently within VISN 21, and future facilities that fall under the authority of NCO 21, may be added or deleted to this agreement with an exercise of a supplemental agreement between the Government and the Contractor.

VA Northern California Health Care System (VA NorCal) Valley Division (Mather) Sacramento VA Medical Center 10535 Hospital Way Mather, CA 95655 800-382-8387 / 916-843-7000

East Bay Division Martinez OPC 150 Muir Road Martinez, CA 94553 925-372-2000

VA Central California Health Care System (VA Fresno) 2615 E. Clinton Avenue Fresno, CA 93703-2223 559-225-6100

VA Palo Alto Health Care System (VA Palo Alto) Palo Alto Division 3801 Miranda Avenue Palo Alto, CA 94304-1207 650-493-5000 | 800-455-0057

Menlo Park Division 795 Willow Road Menlo Park, CA 94025- 650-614-9997

Livermore Division 4951 Arroyo Road Livermore, CA 94550-9650 925-373-4700

VA Sierra Nevada Health Care System (VA Reno) 975 Kirman Avenue Reno, NV 89502-0993 775-786-7200

VA Pacific Islands Health Care System (VA Honolulu) 459 Patterson Road Honolulu, HI 96819-1522 808-433-0600

VA San Francisco Health Care System (VA San Franscisco) 4150 Clement Street San Francisco, CA 94121 415-221-4810

VA Southern Nevada Health Care System (VA Las Vegas) 6900 North Pecos Road N. Las Vegas, NV 89086 702-791-9024

6. ORDERING METHOD: Designated primary facility Point of Contact’s (POCs) shall place orders against valid DO’s signed by the Contracting Officer. POCs may coordinate delivery quantities and schedule via Electronic Data Interchange (EDI), telephone, facsimile, email or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

7. BPA PROGRAM MANAGER: The Contractor shall provide a primary BPA Program Manager who shall be responsible for the performance of the work under the BPA. In addition, the Program Manager shall act as the main focal point of communication between the Contracting Officer and the Contractor.

The name of this person shall be designated in writing to the Contracting Officer. The Program Manager shall have full authority to act on behalf of the Contractor on all contractual/BPA matters relating to daily operation of the BPA.

Contact Name:

Contact Title:

Address:

Direct Phone No:

Alt. Phone No:

Fax No:

Email:

8. ORDERING CONTACTS: The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders. Additional tables may be inserted, if needed.

Contact Name:

Contact Title:

Address:

Direct Phone No:

Alt. Phone No:

Fax No:

Email:

9. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to:

VA Northern California Health Care System (VA NorCal)

Valley Division (Mather) Sacramento VA Medical Center 10535 Hospital Way Mather, CA 95655 800-382-8387 / 916-843-7000

East Bay Division Martinez OPC 150 Muir Road Martinez, CA 94553 925-372-2000

VA Central California Health Care System (VA Fresno) 2615 E. Clinton Avenue Fresno, CA 93703-2223 559-225-6100

VA Palo Alto Health Care System (VA Palo Alto) Palo Alto Division 3801 Miranda Avenue Palo Alto, CA 94304-1207 650-493-5000 | 800-455-0057

Menlo Park Division 795 Willow Road Menlo Park, CA 94025- 650-614-9997

Livermore Division 4951 Arroyo Road Livermore, CA 94550-9650 925-373-4700

VA Sierra Nevada Health Care System (VA Reno) 975 Kirman Avenue Reno, NV 89502-0993 775-786-7200

VA Pacific Islands Health Care System (VA Honolulu) 459 Patterson Road Honolulu, HI 96819-1522 808-433-0600

VA San Francisco Health Care System (VA San Franscisco) 4150 Clement Street San Francisco, CA 94121 415-221-4810

VA Southern Nevada Health Care System (VA Las Vegas) 6900 North Pecos Road N. Las Vegas, NV 89086 702-791-9024

The delivery location(s) is subject to change as required by the designated authority or authorized personnel at the receiving facility. The primary facility POC shall be required to notify the Contractor when delivery locations have been changed.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain: Contractor name, BPA number, DO number, VA obligation number, date of order, date of delivery, itemized list of products furnished, including product description and quantity shipped.

All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m., unless specified otherwise. Standard orders shall be delivered within no more than four (4) working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions and may occur outside of working hours from 4:00 p.m. to 8:00 a.m. Under emergency occurrences, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, unless expedited shipping/delivery is approved by the primary facility POC, Contracting Officer or other authorized individual. The Contractor shall provide an emergency point of contact, if different from the standard points of contacts.

No product substitutions shall be made by Contractor without prior approval of the treating facilities primary POC. However, if substitution would further obligate the Government, the Contractor shall have approval of a warranted Contracting Officer.

10. PACKAGING: All supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

11. INVOICE AND PAYMENT: An itemized invoice shall be submitted at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. These invoices need not be supported by copies of delivery tickets. Invoices shall be submitted to WWW.TUNGSTEN-NETWORK.COM in accordance with FAR Part 52.232-34, Payment by Electronic Funds Transfer and Veterans Affairs Acquisition Regulation (VAAR) Part 852.232-72.

The following information shall be listed on all invoices submitted: (failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor)

a. Facility’s Name and address where service was provided

b. BPA Number (For Example: 36C26119A0001)

c. BPA Delivery Order Number (For Example: 36C26119J0001)

d. Obligation Number (For Example: 654-C97001)

e. Itemized list of products provided, to include quantity, unit price and extended price

f. Include the period of time that is being invoiced for in the invoice

g. BPA Holder’s Internal Contract number (if applicable)

h. Contractor company name, address, and phone number including a POC for concerns and questions, Invoices shall name a specific person, the phone number and email

In the event of an inconsistency between the terms and conditions of this BPA and the Contractor's invoice, the terms and conditions of this BPA will take precedence.

12. BPA REVIEW: The Contractor shall conduct a complete BPA review with the Contracting Officer/Contract Specialist, at least annually and as requested by the Contracting Officer/Contract Specialist, to ensure the BPA terms and conditions are being met, analyze and project item ordering trends, and discuss all other actions that are within the scope of this BPA.

B.3 STATEMENT OF WORK (SOW)

1. SCOPE OF PROCUREMENT:

a. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this Statement of Work (SOW), perform all the required tests described within this solicitation, and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

b. Equipment shall maintain, or preferably reduce the number of workstations and/or overall labor required to accomplish the required testing by each laboratory.

c. If a Contractor offers a family of analyzers, the VISN 21 technical evaluation panel shall determine if instrumentation proposed meets needs of using facility.

d. The Contractor shall provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. Expiration dates shall be clearly marked on reagents, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

e. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

2. DEFINITIONS:

a. Cost per Test (CPT) - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) five year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

b. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

3. TEST MENU: Refer to Attachment A for required test menu and estimated annual volumes.

4. GENERAL REQUIREMENTS:

a. Primary analyzer(s) – Base equipment offered shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. If a back-up analyzer is required, the back-up analyzer shall meet the technical functionality and the capabilities of the primary analyzer, to include additional analyzer(s) that meet the definition of a primary analyzer.

i. The instrument shall have capabilities of identifying organisms directly from blood culture specimens.

ii. The instrument shall include an FDA-approved broad library of gram positive, gram negative, anaerobic bacterial organisms as well as yeast and fungi to limit the amount of work needed on self-validation/verification studies.

iii. The instrument shall have bench side accessibility.

iv. The instrument shall be FDA 21 CFR Part 11 Compliant.

v. A preparatory apparatus and equipment shall be provided for specimen preparation, and there shall be an easy method for securely linking specimen information to each spot on the target slide.

vi. The instrument shall have capabilities of identifying organisms straight from blood culture specimens.

vii. The instrument shall be fully integrated with the antimicrobial susceptibility testing platform in place with automatic linking of organism ID to sensitivity.

Note to Contractor: A Matrix-Assisted Laser Desorption Ionization Time of Flight mass spectrometer (MALDI-TOF-MS) may be required as an additional, faster bacterial identification system. The device shall analyze material from microbial cultures to provide organism identification within minutes. Contractors shall provide pricing to add MALDI-TOF-MS that can be ordered under the BPA based on the future needs of VISN 21 facilities.

b. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for minimally aerobic, facultative, and fastidious microorganisms, yeast, and anaerobes.

c. Operational Features - The instrumentation offered shall have the following, at a minimum:

i. The capability of performing analysis on 100% of the test panels listed in Section d.

ii. Sufficient capacity and throughput to meet the volume and service demands as defined in

Attachment A.

iii. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling.

iv. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

(1) The accuracy of the barcode reading shall have less than a 1% failure rate.

(2) Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

v. Equipment shall accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric, depending on the facility.

vi. Minimal daily, monthly, and periodic maintenance.

vii. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

d. Technical Features - The instrumentation shall be approved by the Food and Drug Administration (FDA) and shall have the following, at a minimum:

i. The capability of accurately and reliably identifying organisms directly from specimens including positive blood cultures, respiratory and stool.

ii. Positive blood cultures target organisms and antibiotic resistance genotypes should include:

a. Positive blood cultures

i. ☒Enterococcus

ii. ☒ Listeria monocytogenes

iii. ☒ K. oxytoca

iv. ☒ K. pneumoniae

v. ☒ Proteus

vi. ☒ S. marcescens

vii. ☒ C. albicans

viii. ☒ C. glabrata

ix. ☒ C. krusei

x. ☒ C. parapsilosis

xi. ☒ C. tropicalis

xii. ☒ S. aureus

xiii. ☒ S. agalactiae

xiv. ☒ S. pyogenes

xv. ☒ S. pneumoniae

xvi. ☒ E. baumannii

xvii. ☒ H. influenza

xviii. ☒ N. meningitidis

xix. ☒ P. aeruginosa

xx. ☒ E. cloacae complex

xxi. ☒ E. coli

xxii. ☒ mecA

xxiii. ☒ vanA/B

xxiv. ☒ SPC

iii. Respiratory specimen target organisms should include:

a. Respitory:

i. ☒ Adenovirus

ii. ☒ Coronavirus

iii. ☒ Influenza A and B

iv. ☒ Metapneumovirus

v. ☒ AParainfluenza

vi. ☒ RSV

vii. ☒ Rhinovirus/Enterovirus

viii. ☒Bordetella pertussis

ix. ☒ Chlamydophilia pneumonia

x. ☒ Mycoplama pneumonia

iv. Stool specimen target organisms should include:

a. Stool specimen:

i. ☒ Aeromonas

ii. ☒ Campylobacter

iii. ☒ C. difficile (ToxA/B)

iv. ☒ P. shigelloides

v. ☒ Salmonella

vi. ☒ Vibrio

vii. ☒ V. cholera

viii. ☒ Y.enterocolitica

ix. ☒ E. coli 0157

x. ☒ EAEC

xi. ☒ EPEC

xii. ☒ ETEC

xiii. ☒ STEC

xiv. ☒ EIEC

xv. ☒ Adenovirus

xvi. ☒ Astrovirus

xvii. ☒ Norovirus

xviii. ☒ Rotavirus

xix. ☒ Sapovirus

xx. ☒ Cryptosporidium

xxi. ☒ Cyclospora cayetanensis

v. The capability of detecting emerging antimicrobial resistance.

(1) MRSA (Methicillin Resistance Staphylococcus aureus, VRE (Vancomycin Resistant Entercoccus, ESBL (Extended Spectrum Beta Lactamase), KPC (Klebsiella pneumonia Carbapenemase), and others as they arise.

vi. Comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

vii. Software or equipment modifications as needed and, when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

(1) The platform shall be able to increase throughput by connecting the two machines together.

(2) The included middleware shall include, as a standard, the ability for continuous remote notification of critical events, and delayed processing steps.

(3) The included middleware shall be able to manage multiple instruments through a unified interface.

viii. Comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of quote.

ix. Built-in quality control program to regularly monitor system performance.

e. Data Management - The System shall have the following, at a minimum:

i. Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles, i.e. using conditional statements (if/then statements), that all search and retrieval of specific information (by patient, by organism, by antimicrobial agent, by specimen type, by MIC, etc)

(1) Conditional statements shall also allow for modification of reporting/not reporting selected antimicrobial agents by enabling/disabling suppression rules.

(2) Capability to connect to the VISTA interface.

a. The Contractor shall supply IT personnel support to implement a VISTA autoverification script from the supplied equipment middleware interface.

ii. Capability to record, store and print the following information:

(1) Required quality control and instrument maintenance information

(2) Patient demographic information and specimen results

(3) Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms (with the option of first-isolate antibiograms), organism trending report, phenotype occurrence report, etc.

(4) Sufficient memory to store patient information and test results with downloading capability to an external medium for long term storage of patient records and other information.

f. Hardware Features - The instrumentation shall have the following, at a minimum:

i. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

ii. An on-board monitor/screen that is easily readable.

iii. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

iv. An uninterruptible power supply with line conditioner for each instrument provided.

g. Support Features –

i. Commercial marketing. The equipment models being quoted shall be in current production as of the date this quote is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being quoted as new equipment.

Discontinued models that are only being made available as remanufactured equipment are not acceptable. Gray market equipment, supplies, reagents are not acceptable.

ii. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing.

iii. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and equivalent to a training program that the Contractor provides in the commercial market.

This shall include, but is not limited to, training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

iv. Service Requirements

(1) A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.

(2) Equipment repair service shall be provided on site during core business hours within 24 hours. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the Contractor will provide an emergent on-site repair service to be conducted outside routine business hours within 24 hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

(3) Equipment repair response time shall be no more than 2 hours.

(4) Preventative maintenance will be performed on all primary and back-up instrumentation and any incremental support equipment as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

(5) A malfunction incident report shall be furnished to each facility upon completion of each repair call. The report shall include, as a minimum, the following:

a. date and time notified

b. date and time of arrival

c. serial number, type and model number of equipment

d. time spent for repair, and

e. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

f. Each notification for an emergency repair service call shall be treated as a separate and new service call.

v. Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being quoted, i.e. new version of software, expanded database, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does includes replacing the original piece of equipment provided under the BPA if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

vi. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

vii. Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

viii. Characterization of waste. The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements.

Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

(1) The determination and description shall address the following:

a. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b. Waste ignitability (Reference 40 CFR §261.21)

c. Waste corrosivity (Reference 40 CFR §261.22)

d. Waste reactivity (Reference 40 CFR §261.23)

e. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

f. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33)

g. Solid Waste (Reference 40 CFR §261.2)

h. Exclusions (Reference 40 CFR §261.4)

(2) The Contractor shall provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

(3) The Contractor shall provide a description of all wastes that the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 shall be determined and documented. Any mercury containing reagents shall be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e.

mercury, thimerosol and formaldehyde) shall be developed and SDS sheets shall be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and shall be included with Contractor response:

a. Barium (Total)

b. Cadmium (Total)

c. Chromium (Total)

d. Copper (Total)

e. Cyanide (Total)

f. Lead (Total)

g. Mercury (Total)

h. Nickel (Total)

i. Silver (Total)

j. Zinc (Total)

k. Arsenic (Total)

l. Selenium (Total)

m. Tin (Total)

n. pH

o. Flash point (to higher than 200°F)

p. BOD; biochemical oxygen demand

(4) The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

ix. Implementation/transition timeframe. The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

(1) Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through [TBD] days.

During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

(2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed [TBD] days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

(3) At the end of [TBD] days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

h. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin after the installation date, equipment verification, and after the written acceptance by the VA that the equipment can perform the requirements stated within this solicitation. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

i. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

ii. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.)

iii. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

iv. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

v. The Government shall maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

vi. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the POC to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor.

Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

i. Government’s Responsibility - The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

j. Ownership of Equipment - Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

i. The Contractor will identify if removable media is required to perform their duties. The Clinical

Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason shall purge all patient sensitive information prior to departure from the facility.

ii. Prior to termination or completion of this BPA, the Contractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management 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 shall be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA.

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

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

a. Contractor shall accept the system without the drive;

b. VA’s initial medical device procurement includes a spare drive which shall be installed in place of the original drive at time of turn-in; or

c. VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase.

v. 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 Contractor shall have an existing BAA if the device being traded in has protected health 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 shall 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 BPA.

vi. 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 Information Security Officer (ISO) needs to maintain the documentation.

k. Installation - All contract work at the government sites is to be performed during regular business hours

8:00 am to 4:30 pm Pacific Standard Time, Monday through Friday. However, at the convenience of the government the COR may request any work that generates additional downtime for our customers be performed after-hours.

Any work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer’ Representative (COR). If required, the COR may designate the Contractor to work during holidays and weekends to resolve equipment failures affecting the end customer.

There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that the VA follows:

Under current definitions, four are set by date:

New Year's Day January 1 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

Installation under this SOW shall be performed at any of the facilities listed in Section B.2.5 and shall be coordinated with the designated COR and individual facility POC.

Travel - The Government anticipates local travel under this effort to perform UPS maintenance through the period of performance. Include estimated local travel costs in your firm-fixed price line items. These costs will not be directly reimbursed by the Government.

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S.