RFQ 36C26025Q0194.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. UEI: EFT:

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. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

TBD

36C26025Q0194 02/11/2025

Peter Park 360-553-7631 03-05-2025

3:00PM PST

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd

Bldg.17, Suite B428

Vancouver WA 98661

X

334516

1,000 employees

NET 30

N/A

X

36C496

Department of Veterans Affairs

VISN 20 Containment Area

See SOW for all locations

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd

Dept of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

See CONTINUATION Page

The Department of Veterans Affairs, VISN20 VA NW Healthcare

Network desires to establish a single Blanket Purchase

Agreement (BPA) to provide the following services:

Laboratory urinalysis testing to include all the supplies and services in accordance with the Statement of Work

This is a five (5) year BPA with 4 Option Years.

See all the attachments for the BPA Price List and estimated testing annual volume

Please submit all the required documentation listed in

Section E.4 of this RFQ. An incomplete package would be considered a non-responsive quote and will not be evaluated.

Contracting POC: Peter.Park2@va.gov

See CONTINUATION Page

X X

James Harris

VA-VHA-RPOW-2024-0013

36C26025Q0194

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 STATEMENT OF WORK

B.2 PRICE/COST SCHEDULE

B.3 TERMS AND CONDITIONS

B.4 ADMINISTRATIVE DATA

B.5 PRICING DATA

B.6 OPTION TO EXTEND THE TERM OF THE BPA

B.7 OPTION TO EXTEND SERVICES

B.8 GENERAL SUPPLY ORDERS

B.9 AUTHORIZED LIMITS

B.10 OBLIGATION OF FUNDS

B.11 PERIOD OF PERFORMANCE

B.12 AUTHORIZED INDIVIDUALS

B.13 ORDER FORMAT

B.14 AUTHORIZED REPRESENTATIVES

B.15 FEDERAL HOLIDAYS

B.16 INVOICES

B.17 PRECEDENCE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 37

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENTS TO THIS RFQ

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 EVALUATION—SIMPLIFIED ACQUISITION PROCEDURES

E.4 EVALUATION

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

BPA FOR VISN 20 CPRR URINALYSIS TESTING

BPA LANGUAGE

The Government will award a CPRR BPA to a single Contractor for urinalysis testing. Contractor agrees to the following terms of the BPA exclusively with VISN 20 and awarded in the final BPA.

Under this agreement, the BPA holder shall provide CPRR Urinalysis Testing for all VISN20 medical facilities. The VHA facilities within VISN20 listed on this BPA are authorized to order any item listed on the Price/Cost Schedule at the listed price. No items may be ordered off this BPA unless they are listed on the Price/Cost Schedule. Additional, related items may be added without further competition to the Price/Cost Schedule with the award of a Modification by the administering Contracting Officer (CO). The administering CO is the only VHA employee authorized to Modify this BPA.

OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is only obligated to the extent of authorized Task Orders issued under this BPA.

PERIOD OF AGREEMENT

This BPA is effective from the date of award for a period of 5 years.

OPTION TO EXTEND THE TERM OF THE BPA

The Government may extend the term of this BPA for a period of up to twelve (12) months by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the

Government shall give the Contractor a preliminary written notice of its intent to extend at least 5 days before the BPA expires. The preliminary notice does not commit the Government to an extension.

PRICES AND TERMS

VISN20 has provided an estimated annual volume by test as reflected in Attachment A. Pricing is based on the AVERAGE annual test volume. The Government estimates the volumes as listed in “Attachment A” but does not guarantee volumes as listed; they are estimates ONLY and the

Government doesn’t guarantee that all listed stations will participate in the BPA.

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $825,000.00/per order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the

Agreement is set at $4,500,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary.

Authorization for individual Task Orders above the stated Task Order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

PRICE/COST SCHEDULE

See Attachment C – V20 BPA Price List

ORDER PLACEMENT

All properly warranted COs serving VISN20 are authorized to place orders under this BPA.

Task Orders will be placed against this BPA using Outlook Email Messages, Electronic Data

Interchange (EDI), FAX Internet portal, paper or oral communications.

DELIVERY ORDER OVERSIGHT

Each ordering location will designate a Contracting Officer's Representative (COR) or POC (if dollar amounts warrant a COR, and subject to CO approval), who will be responsible for verifying contract compliance and certify invoices.

B.1 STATEMENT OF WORK

REQUIREMENT SPECIFICATIONS / STATEMENT OF WORK

1. SCOPE:

The Contractor shall provide Automated Clinical Laboratory Urinalysis testing for urine dipstick chemistries, urine microscopic analysis, and body fluid analysis (as applicable) to produce Cost

Per Reportable Results (CPRR) for the locations listed below. Installation and operational training will be provided by the Vendor at the Government’s facility. Vendor will provide Field Service

Support. Vendor will also supply Government with sufficient supplies, reagents, and training to execute the urinalysis analyzer in the performance of the testing listed for each site based on estimated patient results per month. Equipment will be defined by the facility.

Participating Locations:

• Alaska VA Healthcare System: 1201 North Muldoon Road, Anchorage, AK 99504

• Boise VA Medical Center: 500 West Fort Street. Boise, ID 83702

• Eugene Health Care Center: 3355 Chad Dr., Eugene, OR 97408

• VA Portland Health Care System: 3710 SW U.S. Veterans Hospital Road, Portland, OR

97239

• Roseburg VA Health Care System: 913 NW Garden Valley Blvd., Roseburg, OR 97471

• VA Southern Oregon Rehabilitation Center: 8495 Crater Lake Hwy., White City, OR

97503

• VA Puget Sound Health Care System - American Lake Division: 9600 Veterans Dr

Southwest, Tacoma, WA 98493

• VA Puget Sound Health Care System: 1660 S. Columbian Way, Seattle, WA 98108

• Mann-Grandstaff VA Medical Center: 4815 N. Assembly Street, Spokane, WA 99205

• Jonathan M. Wainwright Memorial VA Medical Center: 77 Wainwright Drive, Walla

Walla, WA 99362

Map and locations for Medical Centers and Clinics within the VISN 20 Northwest

Network can be found at the following link:

https://www.va.gov/directory/guide/region.asp?ID=1020.

2. GENERAL REQUIREMENTS:

A. Leased (Cost per Reportable Result) equipment.

B. All related consumables and supplies.

C. All necessary service to keep equipment in manufacturer's operating conditions, both preventive maintenance and emergency repairs.

D. Training for personnel operating equipment.

3. COST PER REPORTABLE RESULT CPRR:

Cost per Patient Reportable Result (CPRR): as defined in the Federal Supply Schedule FSC

Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, Vendor provided quality Controls, supplies, consumable/disposable items, parts, accessories, and any other item https://www.va.gov/directory/guide/region.asp?ID=1020 required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (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 shall provide delivery, installation and removal of equipment at no additional charge.

A. Parameters: The calculation for price and quantity of reagents in the annual list included in the contract as based on an estimated annual number of reportable results provided by the Government. The annual quantities of supplies shall be sufficient for testing as long as the reportable results are submitted in compliance with the following parameters:

a. Numbers of reportable results actually performed by the Government are within ten percent of the annual estimated reportable results as indicated by the annual supply list.

b. Use of the instrument(s) are in accordance with instrument usage information provided by Government (Primary, Back-up or Alternate).

c. Test volumes are determined by the Government.

d. No more than 10 percent repeats.

e. Two levels of quality control to be run as required by the manufacturer every test day.

f. Calibrators for periodic calibration checks and demand to validate systems following major repair or resolution of negative quality control trends.

B. Adjustments:

a. The Government and vendor will conduct ongoing reviews no less than annually to monitor contract performance against agreed upon efficiencies, operational assumptions, and product utilization (CPPR parameters).

b. The vendor will notify the Government when such reviews indicate an adjustment to the quarterly standing order shipments may be required. The Government will cooperate with the vendor in the conduct of the reviews.

c. Vendor, their personnel, and their sub vendors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and

Information system security as delineated in this contract.839.201 Contract Clause for Information and Technology Security.

4. EQUIPMENT:

Vendor will provide Urinalysis Analyzer(s) for lease to meet VISN20 facilities usage needs.

A. Installation: The vendor shall deliver and install all rented or purchased equipment under this contract after an order is placed. Equipment shall be installed within 30 business days after receipt of order. Equipment shall not be considered installed until VA employee certifies that the equipment is properly functioning and has the necessary supplies to perform its required function.

a. The vendor shall maintain a record of installation to include: location, model number, serial number, and date of installation.

B. Removal: The vendor shall un-install and remove all rented equipment under this BPA from the requesting facility upon request. Equipment shall be removed within 30 days of request. Equipment shall be considered removed upon a VA employee certification that the equipment and all accessories have been taken by an employee of the vendor and there is no disruption and /or damage to the surrounding area.

a. The vendor shall maintain a record of removal to include: location, model number, serial number, and date of removal.

C. Equipment Requirements: Vendor shall provide Urinalysis systems that meet the following requirements:

a. Instrument shall include chemical analysis of urine (to include Bilirubin, Urobilinogen, pH, Specific Gravity, Glucose, Protein, Blood, Nitrites, Ketones and

Leukoesterase) without interference from urines with common abnormal colors

(red, orange, etc.).

b. Instrument shall also identify formed elements including but not limited to, red blood cells, white blood cells, epithelial cells (differentiating transitional, renal, and squamous) crystals, casts, bacteria, and yeast without the need to consistently verify with manual microscopy.

c. There must be a direct, automated specimen pathway between the chemistry urinalysis specimen sampling and testing and the microscopic urinalysis sampling and testing.

d. Equipment shall provide accurate test assay results for sample specimens up to the manufacturer's defined maximum tests per hour without excessive malfunctions, breakdowns, or service calls.

e. Instrumentation shall have auto reflex testing capability for specimens which require sediment analysis.

f. System shall have a minimum throughput of 60 samples per hour on the microscopic side.

g. The instrument shall have customer defined rule criteria to reduce the number of manual reviews and off-line testing required by the operator.

h. The system shall have the ability for auto-validation, should the facility choose to auto validate results.

i. Instrument shall auto-classify formed elements with limited review by the operator.

j. Microscopic analysis must be fully quantitative.

k. Microscopic analysis must have the ability for the instrument to identify cellular microscopic components and provide reviewable digital images.

l. Instrument must offer limited to no carryover from sample to sample to reduce interference.

m. Instrument must have the ability to continuously feed at least 300 chemistry strips without operator re-load.

n. Time from standby to operation processing samples is less than 3 minutes.

o. Time required for routine maintenance activities shall take less than 30 minutes daily and less than 30 minutes weekly/monthly.

p. All testing shall be FDA approved, including Body Fluids if available.

q. Current waste stream analysis and SDS (Safety Data Sheets) shall be provided to all locations.

r. Editable electronic copy in CLSI (Clinical and Laboratory Standards Institute) format of operating procedures shall be furnished with each instrument supplied to all participating facilities.

s. Testing shall include current laboratory assays, but the VA reserves the right to add additional tests to test menu.

t. Protocols in place for various degrees of urine turbidity.

u. A selection of instruments will be available based on volume, test menu needs and throughput requirements of each individual facility.

v. Instrument shall allow patient sample to be used for repeats or reruns on the same or different instrument.

w. All instruments must be new (non-refurbished) equipment.

x. Contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. (Note current VA security regulations require Windows based operating systems be Windows 10 or Higher).

y. Instruments that have the ability to have access to the internet must follow VA IT security policies. The internet access must be verified and adhered to before and during all internet access.

z. Contractor’s Software is required to be compatible and interface immediately upon award with governmental systems which include CPRS, VISTA, and

CERNER. Contractor must provide evidence with their solicitation response that their software is already accepted for use by VHA IT systems.

aa. All equipment shall come with any required accessories to perform normal duties, to include but not limited to, properly programmed printers and monitors, and

UPS.

bb. The analyzers will be VA Laboratory Information System (LIS) interfaceable, and the vendor will supply LIS specifications and assist with the interface connections.

cc. Operation of software uses minimal computer strokes to move from testing to reagent to data analysis or/and other screens.

dd. Size of instrumentation shall be no more than 65” W X 21” D. If stand is required, it is included in the contract at no additional cost.

ee. Upgrades shall be delivered and installed within 60 days of issuance to the commercial market.

ff. An operator's manual shall be furnished with each instrument supplied to VA and updates to manual shall be provided in a timely manner.

5. UPTIME GUARANTEE/ PERFORMANCE PENALTY:

Vendor agrees that all equipment provided shall be operable and available for use no less than 98% of operational time per month. Each instrument at site shall be computed separately.

A. Operational time is 24 hours per day 7 days a week.

B. Downtime is defined as when the vendor is not able to produce clinically acceptable results on the system monitor and will be computed from the time the Government notified the hotline during normal working hours until the Field Service Engineer returns the instrument to the Government and the Government can produce acceptable clinical results. Scheduled maintenance is excluded from downtime.

6. METHOD VALIDATIONS:

A. Once the instrument has been installed according to the Vendor specifications at the

Government location the vendor will supply a Technical Representative to perform method validation studies during all equipment installations at all facilities.

B. The Method validations will be completed to include the necessary studies required for

Clinical Laboratory Information Act (CLIA), College of American Pathologist (CAP) and

Department of Veterans Affairs (VA) regulatory agencies and shall include precision, linearity and current system to new system correlations as well as establishment of normal and therapeutic ranges.

C. The VA will not accept equipment until it passes all validation testing. Validation testing will be conducted on the facilities primary and secondary testing methods.

D. The VA will provide all the samples necessary for the validation studies.

7. MAINTENANCE AND REPAIRS:

A. Vendor shall provide preventative and corrective maintenance per manufacturer's recommendation. This shall include software upgrades and parts and labor, to maintain all Urinalysis equipment and accessories. At a minimum, preventative maintenance shall be twice annually, beginning six (6) months after installation.

B. Vendor will furnish all transportation, equipment, tools and labor to accomplish the required maintenance.

C. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The Field Service representative will call to schedule onsite service within 2 hours of notification from Technical Assistance Hotline if necessary.

The vendor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification.

D. Telephone service support shall be available 24 hours/day,7days a week. Onsite Field

Service support shall be available Monday- Friday 8am- 4:30 pm (local time). Onsite repairs shall be initiated within 24 hours of first notification from Technical Hotline to

Field Service engineer.

E. Efforts shall be made by the vendor to minimize disruption to Governments and employees (i.e. reschedule if work interferes with normal operation, access equipment when convenient to the needs of the VA, etc.) Vendor shall maintain cleanliness of work area and minimize dust and contaminants to areas adjacent to the job site.

F. Vendor shall furnish a malfunction incident report to the installation upon completion of repair call within 2 business days after the completion of work. 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(s) of equipment.

d. Time spent for repair.

e. Description of malfunction and repair.

f. Proof of repair that included documentation of a sample run of quality control verifying acceptable performance.

G. Each instrument provided by the vendor shall maintain an uptime of 98% in each month of the term of the agreement. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, it is the responsibility of the vendor to immediately replace the broken laboratory equipment with new equipment at no additional cost to the Government. The responsibility for maintaining the equipment furnished in operating condition in accordance to manufacturer's instruction, shall solely be the responsibility of the vendor.

H. The contractor shall not leave a service call open pending verification that repairs are completed by the contractor's maintenance personnel. For each instrument provided, the vendor shall treat each notification for an emergency/repair service call form the

Government as a separate and new service call.

a. The following are guaranteed throughout the life of this contract:

b. Priority scheduling of requests for service.

c. Unlimited Emergency Service. No charges for labor, travel or any other related expenses.

d. Unlimited Parts. No charge for replacement parts which become marginal or defective due to normal use during agreement period.

e. Factory Authorized Product Updates and Modifications. Installed at no additional charge for improved product performance and reliability.

f. Factory trained and Authorized Service Engineers. Continual upgrading and certification of engineers in latest instrument technology.

8. TRAINING:

With the exception of specific training requirements stated herein, which shall have precedence; vendor shall provide "operator" training in accordance with the terms, conditions, and provisions of the vendor's existing Federal Supply Service Contract. Listed below are the training requirements:

A. The vendor shall provide, at no cost to the Government, On-site training and key operator training for at least 2 operators per instrument per site.

B. Provide initial in-depth training for two key operators at the facility and for each individual instrument provided. Provide annual training for one VA equipment operator, per each instrument, for the participating medical center.

C. Provide on-site vendor operator training for all personnel who will run instrument with training provided for all applicable shifts.

D. The Vendor shall have an on-going training program for Employees by the Technical

Service Representatives on any new products or updates on the product lines. All materials for training will be provided at no additional cost to the Government.

E. The vendor will provide competency assessment protocols for use at each site consistent with federal (CLIA) and CAP training requirements.

9. REAGENTS, CONTROLS AND SUPPLIES:

A. Routine reagents, controls and disposables (supplies) for Chemical and Microscopic

Urinalysis Testing shall be provided by the vendor and shall adhere to the following requirements.

B. Reagents including controls and disposables shall be identified prior to delivery.

Reagents including controls and disposables to be listed in a separate Table. The table should include annual reagent volumes, costs, and shipping charges for each quarterly standing order delivery.

C. Reagent manufacturer shelf life shall be no less than 12 months.

D. Reagents for the analyzer are marked for easy recognition by the operator and shall contain the appropriate facility Purchase Order number in the delivery address.

E. Vendor will supply a list of reagents, controls and disposables that will be shipped as part of the order.

F. Supplies will be shipped on a standing order schedule, agreed upon by the

Government and Vendor. All or part of a future quarterly Standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order.

G. Delivery shall be within four (4) business days of the prior agreed upon shipment date or it shall be considered late.

H. Vendor will provide sufficient reagents and supplies for performance of patient results for all VISN 20 sites. Consumables will be provided on demand as needed if the consumable allotments are insufficient to meet the needs of the facility.

I. Vendor shall supply all changes to the maintenance schedules that affect reagent or cleaning reagent volumes and shall be coordinated with the VA facility Point of

Contact to implement the changes in accordance with manufacturer's recommendations.

10. SPACE AVAILABILITY:

A. All proposed Urinalysis equipment must fit the existing space at each VISN 20 P&LMS facility's, without the need for renovation work. Small scale re-arrangement of furniture is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space.

(i.e., equipment size, weight, packaged size for delivery, electrical/voltage).

11. SPECIAL REQUIREMENTS:

In addition to the general requirements for the Urinalysis CPRR requirements stated above, the contractor shall meet the following special requirements:

A. Equipment shall have a fully established VA Veterans Health Information Systems and

Technology Architecture (VISTA) computer system and CERNER interface program via

Data Innovations Middleware, with all downloads/software necessary to transfer data into patient files in VA VISTA and CERNER computer systems via Data Innovations middleware, at no additional cost to VA.

B. Provide Bi-directional interface with Data Innovations and appropriate quality control analysis system and all components necessary to interface with VA VISTA and

CERNER computer system.

C. The Contractor shall provide an auto verification package through Data Innovations for validation utilizing the Instrument Manager which includes rules and technical support for the duration of this contract.

D. Contractor shall assist in the establishment, testing, deployment, and troubleshooting in the full capacity of the Middleware before implementation date.

E. The Contractor is responsible for verifying any software upgrades with the instrument during its life, will be compatible with Data Innovations middleware.

F. Contractor shall provide automated, walk-away Urinalysis Chemistry analyzer with peripherals with direct, automated sample pathway to an automated, walk-away

Microscopic Urinalysis analyzer with peripherals for sampling and testing.

G. Shall provide data backup.

H. Systems shall provide ease of use (uncomplicated menus), with minimal maintenance required.

I. Shall provide flexibility in test volumes.

J. Shall be easy to troubleshoot.

K. Provide extended expiration date of supplies.

L. Uninterruptible power supply (surge protection, battery backup) provided by vendor for all associated electrical instruments and ancillary components excluding printer.

M. Provide a water system, if required.

N. If a printer is required to produce patient or QC reports, one shall be provided per system and replaced if broken.

12. CESSATION OF TESTING:

If, for any reason, Contractor ceases testing of any urinalysis assays, the Contractor must notify the VA Contracting Office and Laboratories, 60 calendar days prior to the change.

Until a new solicitation can be issued, or the problem resolved, the Contractor shall be held liable for all costs if performance is ceased, as the lab facility may have to resort to outsourcing the tests in order to continue patient care.

13. THE VENDOR WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER

REPORTABLE RESULT PROGRAM REAGENTS, CONTROLS AND SUPPLIES:

A. Routine reagents and disposables.

B. Reagents including controls and disposables to be listed in separate Table.

C. Vendor will supply a list of reagents, controls and disposables that will be shipped as part of the agreement.

D. Supplies will be shipped on a standing order schedule, agreed upon by Government and

Vendor. All or part of a future quarterly Standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order.

E. Vendor will provide sufficient reagents and supplies for performance of patient results for all VISN 20 sites.

F. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission (TJC).

G. Changes in maintenance schedules that affect reagent or cleaning reagent volumes will be approved by the Vendor in accordance with manufacturer's recommendations.

H. Additional reagents, if required, will be provided by the vendor at no additional charge.

14. THE GOVERNMENT WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER

REPORTABLE RESULT PROGRAM:

A. CPPR Periodic payments: Refer to Attachment A for volumes.

Test Description Estimated Volume Per Year Price per reportable.

B. During the agreement the Government will report by the 10th of each month, to the vendor in writing or electronically, the number of reportable results generated in the previous month.

C. The vendor will invoice the Government based on the report of reportable tests.

D. Laboratory Manager or designee will act as Contracting Officer Representative (COTR) for this contract.

15. SECURITY:

A. Returning leased equipment constitutes a risk. VA employees must sanitize VA sensitive information residing on leased equipment before releasing that equipment from direct VA control, or the media will not be returned upon termination of the contract.

B. Per VISN 20 VA Information Security Policies, no hard drives or computer disks containing VA patient information will be removed from VA facilities. At the time of turn-in or removal due to failure, the VA facility will remove all sensitive data from information systems storage devices or render the data from these systems unreadable. No Federal

Information Processing equipment will be discontinued from rental/lease or exchange without compliance with this require.

C. Contract personnel will not have direct access to a VA system or VA sensitive information. All work/maintenance will be accomplished by VA Laboratory personnel as an intermediary.

D. If contract leased/purchased equipment contains sensitive information (PII/PHI) to be directly uploaded to/downloaded from VA systems, a MOU/ISA shall be established between the vendor and VA. Unidirectional, deidentified data from contract leased/purchased equipment to the VA network shall be protected in accordance with established VA security policy.

16. QUALITY ASSURANCE MONITORING:

A. The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance thresholds briefly describe the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

17. INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

A. 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.

B. 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.

TASK SECTION

REQUIRED SERVICE

(Performance Requirements)

SUBSTANDARD

(Performance Standards)

ACCEPTABLE QUALITY LEVEL (AQL)

METHOD OF

SURVEILLANCE

(Quality Assurance)

1 #7C-D

Technical Assistance Center available by phone 24hrs per day, 7 days a week. Maximum call back response time of 2 hours for emergencies.

Technical Assistance not available or not responding within 2 hours of call

2% - Deviation allowable VA POC

2 #7d Repair response time within 24 hours

Repair response time greater than 24 hours.

2% - Deviation allowable VA POC

3 #7g Equipment operational 98% of the time per unit.

Equipment operational for less than 98% of the time per unit.

If any individual piece of equipment reflects a downtime of 5% or greater of the normal working days in one calendar month, it is the responsibility of the vendor to immediately replace the broken laboratory equipment with new equipment at no additional cost to the

Government

VA POC

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.

C. 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.

D. 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:

i. 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:

ii. The Systems of Records (SOR); and

iii. 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.

i. "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.

ii. "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.

iii. "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 10 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 10 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.

E.