P02 - RFI Attachment B SOW Blood Gas.pdf

ATTACHMENT B - STATEMENT OF WORK

VISN 22 Point of Care (POC) Cost Per Test (CPT) Blanket Purchase Agreement (BPA)

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. SCOPE OF PROCUREMENT:

1.1.1. The desired reagents and consumables shall have the capability of performing the clinical parameters as defined within this statement of work. The reagents will be able to simultaneously perform the complete profile as described below 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).

1.1.2. Reagents and consumables shall be acquired at participating facilities within VISN 22. The following facilities are currently within VISN 22, and future facilities that fall under the authority of NCO 22, may be added or deleted to this agreement by exercising a supplemental agreement between the Government and the Contractor.

1.1.3. VISN 22 sites are : Greater Los Angeles, Long Beach, San Diego, Loma Linda, Albuquerque, Phoenix, Prescott and Tucson.

1.1.3.1. Participating facilities’ addresses:

VA Long Beach Healthcare System Warehouse Bldg 149 5901 East 7th Street Long Beach CA 90822-5201

Phoenix VA Healthcare System Campus Warehouse 650 E Indian School Road Phoenix AZ 85012-1839

Northern Arizona VA Healthcare System (Prescott)

500 HW 89N

Prescott AZ 86313-5001

Southern Arizona VA Healthcare System (Tucson) 3601 S 6th Ave Tucson AZ 85723-0001

May add additional VISN 22 sites if needed.

1.1.3.2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the Siemens RapidPoint and EPOC 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 date shall be clearly marked on reagent, 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 shall be forwarded to the designated individuals determined at contract award

1.1.4. 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.

1.2. DEFINITIONS:

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

1.2.2. 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.

SALIENT CHARACTERISTICS AND GENERAL REQUIREMENTS

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

1.3.1 The capability of performing analysis on 100% of the tests listed in Attachment A. (FDA Approved test menu required for initial award).

1.3.1.1 List Blood Gas and Co-ox testing

1.4 Reagents:

1.4.1 Obtain reagents and consumables that are 100% compatible with Siemens RapidPoint and EPOC instrumentations without modification for the performance of blood gas and co-oximetry testing of the following:

Material Number Material Descrip on

10310323 AQC CTL

10327073 Meas Cart BG-COOX 400

10341179 Wash Waste Cartridge

10316535 CMV CTL

10322638 Air Filter

10315772 Printer Paper

10309073 Luer Capillary

10492250 Proficiency Survey Quick Adapter

10329097 WASH/WASTE CART 4 PK

10491447 MCART LAC 250 TEST

10310472 LAMP ASSY RP405/500-CON

10309925 RAPID QC 1 CTL

10309926 RAPID QC 2 CTL

10309927 RAPID QC 3 CTL

10329817 Quick Adapter

10736515 EPOC BGEM Test Cards BUN 25 Tests

10736510 Eurotrol Gas - ISE Control Level 1 (10 x 2.5 mL) BUN

10736511 Eurotrol Gas - ISE Control Level 2 (10 x 2.5 mL) BUN

10736512 Eurotrol Gas - ISE Control Level 3 (10 x 2.5 mL) BUN

10736514 Eurotrol Calibra on Verifica on Fluid (4 Pack) BUN

10736359 Eurotrol EPOC Hct Control Level A (10 x 2.5 mL)

10736360 Eurotrol EPOC Hct Control Level C (10 x 2.5 mL)

10736514 Eurotrol EPOC Hct Linearity Verifica on Material

10736408 Martel Label Roll

10736384 Blunt Needles for QC transfer (50 Pack)

1.5 Period of Performance

1.5.1 This will be a Base-Plus 4-Option Year Firm-Fixed-Price contract.

1.5.1.1 Base Year 06/01/2026 – 05/31/2027

Option 1 06/01/2027 – 05/31/2028 Option 2 06/01/2028 – 05/31/2029 Option 3 06/01/2029 – 05/31/2030 Option 4 06/01/2030 – 05/31/2031

1.6 Equipment:

1.6.1 Obtain RAPIDPoint 500e or EPOC due to service expansion as needed.

1.7 MAINTENANCE AND OPERATION

1.7.1 Obtain service contract for Siemens RapidPoint and EPOC.

1.7.1.1 Service Contract for Siemens RapidPoint and EPOC.

1.7.1.1.1 Unlimited service visits Monday through Friday from 8:00 a.m. to 5:00 p.m. (local time).

1.7.1.1.2 Customer Support Center Specialists are available by phone 24 hours a day, 365 days a year to assist in troubleshooting.

1.7.1.1.3 All necessary warranted repair parts and the travel and labor to install parts.

1.7.1.1.4 Labor and preventive maintenance kits for preventative maintenance visit(s).

1.7.1.1.5 Response for emergency repairs within 24 hours of request Monday through Friday local time.

1.7.1.1.6 Remote access connectivity for problem identification, training, and monitoring.

1.7.1.1.7 A maximum labor charge for each service visit outside of contract coverage hours.

1.7.1.1.8 System repaired at customer site.

1.7.1.1.9 Preventative maintenance visits.

1.7.1.1.10 Factory authorized updated/modifications.

1.7.1.1.11 Staff must be Siemens trained and certified to work on Siemens instrumentation.

1.7.1.1.12 Staff must be Siemens certified to work on the Siemens RapidPoint and EPOC.

Site Instrument Model Serial Number

PRESCOTT EPOC (Reader) 54053

PRESCOTT EPOC (Reader) 54060

PRESCOTT EPOC (Reader) 54063

PRESCOTT EPOC (Reader) 54064

PRESCOTT EPOC (Reader) 54065

PHOENIX RAPIDPoint 500e 66132

PHOENIX RAPIDPoint 500e 66138

PHOENIX RAPIDPoint 500e 66278

TUCSON RAPIDPoint 500e 63256

TUCSON RAPIDPoint 500e 63258

TUCSON RAPIDPoint 500e 63259

TUCSON RAPIDPoint 500e 63260

TUCSON RAPIDPoint 500e 63261

TUCSON RAPIDPoint 500e 63262

TUCSON RAPIDPoint 500e 63264

TUCSON RAPIDPoint 500e 63265

LONG BEACH RAPIDPoint 500 45852

LONG BEACH RAPIDPoint 500 45862