SOW Pipette.docx

Statement of Work Pipette Calibration Instrument Overton Brooks VA Medical Center (OBVAMC)

1. CONTRACT TITLE

Pipette Calibration Instrument

2. BACKGROUND

A Pipette Calibration Instrument is used for maintaining quality and productivity, pipettes must be calibrated to ensure levels of accuracy and precision. They are calibrated biannually as required by Clinical Laboratory Improvement Amendment (CLIA) to provide verification of the analytical instruments used for patient specimen testing remain valid. 493.1255: Calibration and calibration verification procedures are required to substantiate the continued accuracy of the test system throughout the laboratory’s reportable range.

Calibration establishes the relationship between the analyte content and instrument measurement signal and the verification confirms the current calibration settings remain valid. If the calibration changes and/or fails to present acceptable data points during calibration, the pipette is cleaned following two consecutive attempts before recalibration. If an acceptable calibration is not obtained the pipette is retired and no longer available for use. The current instrument is no longer functional, has exceeded its life expectancy, and is past due for replacement.

3. SCOPE

The Pathology & Laboratory Medicine (P&LM) service requires a pipette calibration instrument which is utilized to calibrate the pipettes twice a year. The calibration is essential to maintain quality and productivity and to ensure high levels of accuracy and precision are maintained in specimen testing.

The purchase will consist of a pipette calibration instrument, portable computer, label printer, printer cassette, associated software, digital user guide, calibration kit with software activation code, startup QualAssure solutions, and a pipette calibration plastics kit.

The startup QualAssure solutions shall include: 1 QualAssure bulk kit with 50 blanks, 4 bottles of QualAssure 1, 2 bottles of QualAssure 2, and 1 bottle each of QualAssure 3, 4, 5, and 6.

The Pipette Calibration Plastics kit shall include: 50 aliquot containers, 50 transfer pipettes, and 1 aliquot container holder.

The selected vendor shall also provide on-site pipette calibration instrument installation and user training.

The selected vendor shall also provide a 1-year warranty including parts and labor.

4. SPECIFIC TASKS

4.1. CUSTOMER SERVICE

There shall be 24 hours / 7 days per week / 365 days per year phone support available for technical support.

4.2. INVOICE AND PAYMENT

Contractor shall invoice the Overton Brooks VA Medical Center monthly. Invoice shall be properly prepared and sent to the:

VA Financial Service Center P.O. Box 149971 Austin, Texas 78714-8971 Payments will be made in accordance with the Prompt Payment Act out of the Government annual appropriated funds obligated in an order which will be issued after the contract is awarded.

Note: Invoices that are not in compliance with the aforementioned requirements under this paragraph will be rejected for payments and required to be resubmitted.

4.3. PACKAGING AND INSPECTION

All deliveries will be inspected by lab personnel and if found to be defective, the contractor shall deliver new replacements immediately upon notification at no additional costs. All items will be packaged with adequate materials to ensure safe handling.

4.4. DELIVERY

Workstation shall be delivered to:

Overton Brooks VA Medical Center Attn: Warehouse 510 E. Stoner Ave Shreveport, LA 71101 All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain:

vendor’s name, purchase order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped.

Shipping terms: Vendor shall be responsible for shipping expenses.

4.5. INSTALLATION

The vendor will perform the installation and set-up, ensuring the instrument is in good working order and is ready for use.

4.6. TRAINING

The vendor will supply an operator’s manual as well as provide hands-on training for the new instrument to a subset of laboratory’s calibration team.

4.7. PRODUCT SUBSTITUTION

No product substitutions will be accepted without the prior approval of the Overton Brooks VA Medical Center’s Pathology and Laboratory Service (P&LMS) and the Contracting Officer. Any substitutions of product shall have the written approval of the VAMC Pathology & Laboratory Service and the Contracting Officer or his/her designee.

4.8. CHANGES / MODIFICATIONS

If any product awarded under this requirement requires modification, is removed, or recalled by the Contractor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the Contractor or manufacturer:

A. Notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following:

i. Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this Statement of Work.

ii. Reasons for modifications, removal or recall.

iii. Necessary instructions for return for credit, replacement or corrective action.

B. Provide the above information to all agencies and VA Facilities who purchased the product. The Contracting Officer Representative shall be provided a copy of the notification in ii. above, and a list of all agencies and/or VA facilities notified.

C. Contractor shall be responsible for any costs associated with the above.

Changes in the terms and conditions of this contract may be made only by written agreement of Overton Brooks VA Medical Center Pathology and Laboratory Service. Any and all modifications for changes in the prices, terms or conditions of this contract, shall be prepared for signature by the VA Contracting Officer.

4.9. RECALLED AND DEFECTIVE PRODUCTS

The Contractor shall immediately notify the Contracting Officer Representative of any recalls of product or other important product safety issues. The Contractor shall replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor shall be liable for the costs of processing recalls, i.e., administrative, and clinical services to replace recalled/defective products.

4.5. SITE CONDITIONS

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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

B. Business Hours: All work and delivery shall take place during clinical hours (Monday through Friday, 8:00 am to 4:30 pm (CST) excluding weekends and federal holidays).

C. Federal Holidays: New Year’s Day; Martin Luther King Jr.’s Birthday; President’s Day, Memorial Day, Juneteenth, Independence Day; Veteran’s Day; Labor Day; Columbus Day; Thanksgiving Day, and Christmas Day.

When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by the US government agencies.

D. Use of Cell Phones: The use of cellular phones is permitted within certain areas of the medical center. All contractors are required to ask either the Contracting Officer (CO) or the Contracting Officer’s Representative (COR) if there is doubt in the usage of cellular phones.

E. Smoke Free Facility: The Overton Brooks VA Medical Center is a smoke free facility. Smoking is prohibited inside any building and on the facility grounds. Violators shall be removed from the premises permanently.

4.6. PROTECTION OF PROPERTY

Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

5. PERFORMANCE MONITORING

The performance of the vendor will be monitored by the P&LMS Laboratory Information Manager based on the following criteria:

A. Ability of the vendor to consistently provide technical support of software in a timely manner.

B. Ability of the vendor to execute deliverables stated in scope and specific tasks.

6. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI)

No GFE/GFI shall be provided to the contractor.

7. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS

The vendor shall have the proprietary access codes associated with the requested instrumentation needed to perform service and maintenance on the administrator level.

IDENTIFICATION OF POTENTIAL CONFLICTS OF INTEREST (COI)

A determination has been made that COIs do not exist nor is there a potential for COIs prior to execution of this contract.

1.

2.

3.

4.

5.

6.

7.

8.

9.

9.1.

9.2.

8. RISK CONTROL

All employees, contractors, and visitors are required to abide by local infection control procedures.

9. PLACE OF PERFORMANCE

The system will continue to be used in the Pathology & Laboratory Medicine Service at the Overton Brooks VA Medical Center (OBVAMC) 510 E. Stoner Ave, Shreveport, LA 71101. Delivery and installation will be coordinated through the COR and/or the Laboratory Manager.

Laboratory Manager: Michael Salinas, 318-990-5482 Contract Officer Representative (COR): Jeanette Watson, 318-990-5569

12. PERIOD OF PERFORMANCE

Period of performance shall be Date of Award through one-year warranty.

The one-year warranty begins 10 days after the equipment is shipped from the contractor’s facility.