Veterans Affairs



DEPARTMENT OF VETERANS AFFAIRS

DRAFT

STATEMENT OF WORK

ELECTROPHYSIOLOGY (EP) CATHETERS

FOR

DEPARTMENT OF VETERANS AFFAIRS

November 7, 2012

TABLE OF CONTENTS

1.0 BACKGROUND 4

2.0 APPLICABLE DOCUMENTS 4

3.0 SCOPE 5

4.0 OBJECTIVES 5

5.0 TASKS 5

5.1 CONSIGNMENT 5

5.1.1 EXTENT OF OBLIGATION 6

5.1.2 INITIAL STOCK LEVEL REQUIREMENT 6

5.1.3 FILLING STOCK LEVEL REQUIREMENT 6

5.1.4 CONTRACTOR’S INVENTORY MANAGEMENT REQUIREMENT 6

5.2 GOVERNMENT MANAGEMENT AND ADMINISTRATIVE RESPONSIBILITIES 7

5.3 GOVERNMENT INVENTORY MANAGEMENT 7

5.4 RETURNED CONSIGNMENT UNIT 7

5.5 CANCELLATION AND MODIFICATIONS 8

5.6 TITLE TO EP CATHETERS AND ASSOCIATED ACCESSORIES 8

5.7 STORAGE 8

5.8 LIABILITY 8

5.9 ACCOUNTING BY THE CONTRACTOR 8

5.10 ACCEPTANCE AND SALES 9

5.11 RETURNS 9

6.0 DELIVERY 9

7.0 GOVERNMENT FURNISHED PROPERTY 9

8.0 SECURITY REQUIREMENT 9

9.0 PLACE OF PERFORMANCE 10

9.1 ON-SITE WORK (GOVERNMENT SITE) 10

9.2 OFF-SITE WORK (CONTRACTOR SITE) 10

9.3 TRAVEL 10

10.0 PERIOD OF PERFORMANCE 10

10.1 FEDERAL HOLIDAYS 11

ADDENDUM 1: DEFINITIONS 12

ADDENDUM 2: ELECTROPHYSIOLOGY CATHETERS 13

STATEMENT OF WORK

FOR

ELECTROPHYSIOLOGY CATHETERS

1. BACKGROUND

This Statement of Work (SOW) defines the requirements to provide Electrophysiology (EP) Catheters and other associated accessories and lab supplies.

The Veterans Health Administration is home to the United States’ largest integrated health care system consisting of 152 medical centers, nearly 1,400 community-based outpatient clinics, community living centers, Vet Centers and Domiciliaries. Together these health care facilities and the more than 53,000 independent licensed health care practitioners who work within them provide comprehensive care to more than 8.3 million veterans each year.

This requirement is for the purchase of Cardiology Electrophysiology (EP) Catheters, sheaths and connectors. Electrophysiology is a medical branch related to the study of electrical activity within the heart. These catheters are slim, bendable or deflectable multi-electrode wires used in medical procedures, sheaths are tubes that are sometimes used to direct the catheters to specific areas in the heart and connectors connect the catheters to monitoring equipment.

The VA has a need for an enterprise-wide contractual vehicle that shall allow for the purchase of Cardiology EP Catheters and other EP Lab Accessories. This contractual vehicle shall provide the essential products required by physicians, and/or, other clinicians, to perform cardiac testing or procedures that require electronic monitoring of the heart.

The EP Catheters program has been initiated to design, develop, produce, and deploy an improved method of fulfilling the requirements under this SOW. The preferred method of acquiring these products is through the establishment of a consignment process as defined under Section 5.

2.0 APPLICABLE DOCUMENTS

The following documents are applicable to this Statement of Work and attached appendices to the extent specified herein.

1. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

2. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

3. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

4. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

5. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

6. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

7. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

8. National Institute Standards and Technology (NIST) Special Publications

9. VA Handbook 6500.6, “Contract Security,” March 12, 2010

3.0 SCOPE

The Contractor shall perform the following:

Furnish all labor, material, transportation, resources, and facilities to provide EP Catheters and associated Laboratory Accessories in accordance with Attachment 2 located at the end of this SOW. All items shall be delivered in accordance with the specified guidelines under each individual BPA Call or delivery order, depending on the type contractual vehicle awarded as a result of the solicitation under this requirement. Products provided shall be new and free from defect.

The VA is also interested in identifying new technologies and equipment that may exist in the market place today, or may be upcoming or projected in the future. (See the paragraph entitled, “Technology Refresh”, below.

TECHNOLOGY REFRESH:

VA recognizes that this market is not static and we need to have access to state-of-the-art technology. New or modified items within the awarded product line may be added to or deleted from the contract by mutual agreement of both parties, the Contractor and the Government, at a later date in accordance with the paragraph Technology Refresh.

A. All Catheters, instruments, and accessories offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award will not be acceptable.

B. If upgrades of instruments, implants, or supplies become available after award of this contract, the contractor will submit the upgrades to the Contracting Officer for consideration and, if approved, substitute them for the awarded items per Item C below.

C. The contractor will provide to the contracting officer the following information:

(1) A list of specific awarded items which shall be updated.

(2) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved.

(3) Contractor will be responsible for supplying all training and additional requirement upgrades.

D. All new products that replace awarded items and released to the market during the term of the contract will be made available to the government at a discount price agreed to based on commercial sales practices disclosure. If pricing for new products is unacceptable, medical centers will continue to use current products on contract and contractor will be required to continue to supply the contracted item.

Offerors are encouraged to submit samples that meet or exceed the product specifications.

4.0 OBJECTIVES

The mission of the Department of Veterans Affairs (VA), VHA, is to honor America’s Veterans by providing exceptional health care that improves their health and well-being. In meeting these goals, the VHA strives to provide high quality, effective, and the appropriate tools and resources to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner.

5.0 TASKS

Contractor must provide EP Laboratory supplies (guides, guidelines, balloons, stents, specialty catheters) on consignment to all Department of Veterans Affairs, VA Medical Centers within the contiguous United States.

5.1 CONSIGNMENT

A consignment is an agreement between a consignee (a.k.a. Government) and consignor (a.k.a. Contractor) for the storage, transfer, sale, and use of a commodity. The consignee may take goods from the consignment stock for use subject to payment to the consignor agreeably to the terms bargained in the consignment agreement. The unsold goods will be returned by the consignee to the consignor.

Under the terms of the consignment, the Contractor must:

1. Maintain the same initial stock of consignment catheters and supplies requested in the initial inventory stock counts at all times.

2. Deliver electrophysiology supplies when needed.

3. Maintain complete deliveries every day.

4. Replacement time for each item(s) used shall be within 48 hours after receiving the order.

5. Review inventory every 2 months for utilization; and expiration date review.

All products will be approved by the FDA 510K process and labeled appropriately for EP Studies.

5.1.1 EXTENT OF OBLIGATION

This Consignment does not obligate any funds. The Government is obligated only for the item(s) that are used by the Government. At the end of the effective period of the agreement, unused (unopened and undamaged) items shall be returned to the Contractor without reimbursement or other expenses due from the Government. Delivery/Purchase orders will be issued for all unreturned products, including any lost, damaged, stolen or missing products, in order to obtain a replacement item.

The Contractor shall be paid only after item(s) are used by the Government. Contractor must ship products directly to the a designated Prime Vendor location identified under the applicable BPA Call or Delivery/Task Order in accordance with delivery schedule at no additional charge. A copy of the Delegation of Authority indicating VAMC authorized personnel to place orders against this arrangement will be provided by the Contracting Officer upon award of the proper contractual vehicle.

5.1.2 INITIAL STOCK LEVEL REQUIREMENT

The Contractor and the Contracting Officer or their duly authorized representatives shall mutually determine the final number of products and product mix initially stocked. Based on that determination, the Government shall issue to the Contractor an Order indicating products to be initially consigned. The Order shall include model, size, Ref or Catalogue number and quantities for the products to be consigned. The Products listed in the Schedule represent the maximum number of products that will be available for consignment. Maximum number of units available on consignment in any product combination equals what is stated in the Schedule by Product Category.

5.1.3 FILLING STOCK LEVEL REQUIREMENT

The contractor must maintain the same initial stock of catheters and supplies requested in the initial inventory stock counts in the consignment inventory at all times. Items removed due to expired dates must be replaced within 48 hours.

The contractor must be able to provide an uninterrupted source of supply for all of the items contracted for the entire duration of resulting contract period. The desired outcomes of the overall project under this acquisition is to enhance the clinicians ability to better plan and complete medical procedures in a more timely and efficient manner. The Contractor’s performance will be measured in terms of timeliness, delivery, and availability of supplies and products when needed and the level of quality products being provided by the contractor.

5.1.4 CONTRACTOR’S INVENTORY MANAGEMENT REQUIREMENT

The Contractor, in coordination with the Cardio Laboratory and/or PSAS and/or Office of Acquisition Logistics (OAL), must enter the Cardio premises, once every 2 Months basis, during normal business hours, where the EP Catheters and supplies, are stored for the purposed of inspecting and inventorying such items. Such visits shall be at the convenience of the Government.

The designated Clinical Technician will accompany the Contractor representative at all times during the review of consignment inventories.

The Contractor shall designate the same representative to administer inventory management of EP Catheters and supplies.

OAL shall maintain a jacket accountability file. This file shall be established and maintained showing all transactions and the total value of property on consignment at all times. This jacket accountability file (procurement file) will be kept and maintained in OAL and must include as a minimum:

a) Date of receipt of property;

b) Ownership of property;

c) Description: Model; Stock number

d) Quantity

e) Value of Property;

f) Agreement number;

g) Record of orders placed for property used during agreement period, and

h) Acknowledgment of receipt of unused products returned to owner.

The VA shall maintain the inventory showing all transactions and the total value of property on consignment at all times during the term of this agreement. The Contractor shall be allowed to have access to the consigned inventory upon advance notice to the Contracting Office or his/her representative.

5.2 GOVERNMENT MANAGEMENT AND ADMINISTRATIVE RESPONSIBILITIES

The Contracting Officers Representative (COR) for this contract will be designated under each individual call or order placed under this contractual vehicle. The COR will be responsible for providing direction and oversight to the contractor through the contractor representative or project manager, receiving and reviewing all required reports, and approving/disapproving/certifying invoices.

Contract administration responsibilities rest with the Contracting Officer (CO) designated by the SAC – Strategic Acquisition Center, Fredericksburg, VA.

5.3 GOVERNMENT INVENTORY MANAGEMENT

Government shall administer:

1) Full inventory of items/quantities reconciled by company and Clinical Technician performance of the inventory expiration date checks on the last week of every month; and will remove any items nearing expiration date.

3) Documentation of itemized inventory count sheet provided by the vendor. It must be signed by and contractor.

5.4 RETURNED CONSIGNMENT UNIT

Unopened and undamaged packages with original ship units may be returned for credit against the Consignment Stock Level. Unused items shall be returned to the Contractor in salable condition (unopened) and undamaged package with original ship units at the end of the effective period of the consignment without reimbursement or other expense due from the Government. Unused items shall be removed from the Government facility by the Contractor within 30 days, or upon other arrangements as deemed appropriated by the Contracting Officer, after written notification of the completion or cancellation of the consignment agreement. The Government shall be responsible for any lost, damaged, stolen, or missing products while in their possession.

5.5 CANCELLATION AND MODIFICATIONS

The Government following a thirty (30) calendar day’s written notice may cancel a consignment for an individual item, or an assortment of items, as specified in writing by the Contracting Officer, without additional cost to the Government, except of products ordered and accepted by VA. In coordination with the appropriate Government Representative (usually, the COR), the contractor must remove all unused products furnished for stock immediately upon expiration and/or termination of the contract vehicle. Upon the cancellation or expiration of a consignment, the Government shall reconcile all consignment stock units.

5.6 TITLE TO EP CATHETERS AND ASSOCIATED ACCESSORIES

The ownership of all items (catheters, balloons, wires, guide wires) furnished under the consignment agreement shall remain with the Contractor until such time as said item(s) is(are) used by the Government and vendor is in receipt of a proper BPA Call, or Delivery Order, as appropriate.

5.7 STORAGE

The Government shall be responsible for storing the product; and for using the product as indicated by product labeling. The Government agrees that it shall be responsible for the following:

a. To pay all expenses incidental to the safekeeping of EP Catheter supplies; and use of the supplied hereunder;

b. To furnish proper storage and security for all item(s) supplied hereunder.

5.8 LIABILITY

The Government shall safeguard all EP Catheter supplies (guides, guidelines, balloons, specialty catheters) on consignment to it; and assumes full responsibility for any loss or damage to said Catheters, caused by negligence of officers, agents, or employees of the Government acting within the scope of their employment.

If an item is opened and damaged, or it cannot be re-sterilized, then it will be purchased by the appropriate VAMC facility. There will be no re-stocking fees of any kind incurred upon the VAMC. If an item is opened and is damaged or defective by the Contractor, the Contractor must replace the defective item, or items, at no charge to the Government.

5.9 ACCOUNTING BY THE CONTRACTOR

The Contractor must establish and maintain separate invoicing to identify all EP Catheters from the supplies (balloons, guidewires, etc…) used from VA Supply Processing and Distribution (SPD). The Contract will provide detail instructions of how to invoice to avoid confusion in the billing process.

5.10 ACCEPTANCE AND SALES

The Government shall take delivery of, and use when needed, EP Catheters and supplies consignment inventory from the Contractor. The government shall remit payment for the amount of used items in accordance with the invoice instructions provided under this Solicitation. The Contractor will submit separate invoices for Catheters and Supplies to the address listed in the section of the contract vehicle identifying Invoice and Payment instructions.

5.11 RETURNS

Unused items shall be returned to the Contractor at the end of the effective period of the consignment without reimbursement or other expense due from the Government. Unused items must be removed from the VA by the Contractor within thirty (30) days after written notification of the completion or cancellation of the consignment.

6.0 DELIVERY

The replacement time for each item(s) that is under consignment that is used by the Government shall be within 48 hours after receiving the order. As item(s) listed under Supplies/Services and Prices/Costs are used, an order will be placed by the Contracting Officer/Purchasing Agent with the Contractor within twenty-four (24) hours of its use, at the price listed in Supplies/Services and Prices/Costs.

Contractor shall deliver EP Catheter supplies per below performance threshold.

|Task |Performance Threshold |Method of Surveillance |

|Delivery of EP Catheter |100% of the time. |Direct observation, |

|Supplies | |inventory inspection. |

| |Contractor shall deliver replacement | |

| |supplies within 48 hours from the time | |

| |that purchase order was placed. | |

7.0 GOVERNMENT FURNISHED PROPERTY

There will be no Government-Furnished Property under this acquisition.

8.0 SECURITY REQUIREMENT

As a contractor of the Department of Veterans Affairs (VA), Contractors must safeguard the personal information that veterans and their families have entrusted to the Department. Sensitive information/data is any data and/or information the Contractor may obtain or learn as a result of the performance of the resulting contract. Therefore, the information shall not be removed, transmitted or shared to third parties. Sensitive information is all data that; if disclosed, could cause emotional or physical harm to an individual or to the institution.  

Contractor personnel must complete the annual General Privacy Awareness Training or VHA Privacy Training, as applicable, and submit a copy of the certificate of completion to the Contracting Officer. Contractor personnel must report any incident of misplaced and/or missing sensitive data/information to the Contracting Officer who will direct the case to the pertinent official’s. The Government may impose sanctions, up to and including the termination of the contract vehicle for violations to the applicable confidentiality and security statutes, policies and regulations. Contractor may be subject to civil and criminal penalties due to failure of compliance.

9.0 DESCRIPTION OF WORK PERFORMED

9.1 ON-SITE WORK (GOVERNMENT SITE)

Certain tasks under this SOW may be performed in VA facilities located throughout the United States. Work may also be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR), acting under the authority of the Contracting Officer. Such task may include, but not be limited to setup, install, calibration of equipment or product, and training. (Applicable only if place of performance might be accomplished at a Government facility (Onsite)).

9.2 OFF-SITE WORK (CONTRACTOR SITE)

Task under this SOW shall be performed at Contractor facilities. Contractor is requested to identify Place of Performance, to include: plant name and location, in your proposal submission. (Applicable if place of performance is at a Contractor facility (Offsite)).

Note: TDY to a Government facility within the effort doesn’t change the Place of Performance to the Government Site.

9.3 TRAVEL

The Government does not anticipate travel under this effort; however, should the need for travel arise, individual travel requirements will be identified under each individual BPA Call, or delivery order. An example of when travel might be required would be to cover efforts associated with training and other setup needs as determined appropriate by the Contracting Officer, or his or her designated representative. All travel shall be authorized on an as needed basis only and must be approved by the Contracting Officer, or his or her designated representative, prior to the traveler traveling. (Applicable only if travel will be required.)

10.0 PERIOD OF PERFORMANCE

The period of performance shall be 12 months from date of award, with 4 options (48 months/4 years) for a total contract vehicle period of performance not to exceed 60 months.

The period of performance shall be as follows:

Base Year: January 1, 2013 – December 31, 2013

Option Period 1: January 1, 2014 – December 31, 2014

Option Period 2: January 1, 2015 – December 31, 2015

Option Period 3: January 1, 2016 – December 31, 2016

Option Period 4: January 1, 2017 – December 31, 2017

10.1 FEDERAL HOLIDAYS

There is ten (10) Federal holidays set by law (USC Title 5 Section 6103) that 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

ATTACHMENT - 1

ADDENDUM 1: DEFINITIONS

1. Consignment - an agreement for a specified period of time under which a vendor provides an item to the Department of Veterans Affairs, reimbursement for which is made only if and when use of the item is made by the Department of Veterans Affairs. Unused items are returned to the vendor at the end of the effective period of the agreement without reimbursement or other expense to the Government.

3. VAMC or VA: Veterans Affairs Medical Center or Veterans Affairs

4. OAL- Office of Acquisition and Logistics - VA Department that will EP Catheters and supplies. This department will handle day to day inventory management.

5. Contracting Officer (CO): The representative of the Government who has the authority to enter into, administer, terminate, modify, approve changes, or otherwise represent and bind the Government in all matters arising under or relating to this contract or agreement.

6. Contracting Officer’s Representative (COR): Individual(s) who furnishes guidance and advice or generally supervises the work performed under the agreement or contract. Designations will be in writing and will define the scope and limitation of the representative’s authority. Name, title, location, telephone number, will be provided when contract is awarded.

7. Contractor: Commercial business awarded agreement.

8. Quality Assurance: Those actions taken by the government to assure services meet the requirements of the Statement of Work (SOW).

1) Full inventory of items/quantities is reconciled by company; and Medical Instrument Technician (MIT)

2) Company is expected to deliver supplies on time specified by the Government; and responsible for moving used items and replace within 48 hours.

3) MIT performs inventory expiration date check on the last week of every month; and remove any items nearing expiration date.

9. Quality Control: Those actions taken by a contractor to control the performance of services so that they can meet the requirements of the Statement of Work (SOW).

ATTACHMENT – 2

ADDENDUM 2: ELECTROPHYSIOLOGY CATHETERS

Minimum Technical Requirements

1. Multi-pole, non-deflectable, diagnostic electrophysiology catheters

2. Multi-pole, deflectable, diagnostic electrophysiology catheters

3. Multi-pole non-irrigated radiofrequency ablation catheters

4. Multi-pole irrigated tip radiofrequency ablation catheters

5. Cryoablation catheters (equipment specific)

6. Intracardiac Ultrasound imaging catheters (equipment specific)

7. Nondeflectable electrophysiology catheter introducer sheaths

8. Deflectable electrophysiology catheter introducer sheaths

9. Trans-septal catheterization needles

10. 3D mapping electrodes and patches (equipment specific)

11. 3D mapping catheters (equipment specific)

STATEMENT OF INTENDED USE:

These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures.

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