SPE2D1-15-R-0001_AMENDMENT_0003.pdf

SOLICITATION SPE2D1-15-R-0001 AMENDMENT 0003

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(1.) Attachment #3 is hereby removed and replaced in its entirety with Attachment #3 (v.2).

(2.) Attachment #6 is hereby removed and replaced in its entirety with Attachment #6 (v.2).

(3.) All instances of the term “Substantial Clinical Use” in section IX. (b.) Final Inspection/Acceptance, on pages 40 through 42, are hereby removed and replaced with the term “Clinical Use.”

(4.) Sections XI. (f.) SERVICE BULLETINS and XI. (g.) PRODUCT CORRECTION, REMOVAL OR RECALL; on pages 47 and 48 are hereby removed and replaced in their entirety with the following section (f.) and (g):

(f.) SERVICE BULLETINS

Service bulletin affecting safety, effectiveness, functionality, and/ or maintenance of equipment furnished under this contract shall be emailed to the receiving activity for the entire expected life of the product or a period of ten (10) years from the date of delivery, whichever is longer.

Service bulletins as well as any other special communications, such as, but not limited to, hazard alerts, safety notices, end-of-life notifications, and/or any other manufacturers’ letters shall be emailed to the Contracting Officer for the basic contract and all POC’s on any issued delivery orders. When applicable, this shall occur within FDA established timeframes from the date of a recall. Additionally, the following organizations shall be emailed:

For Center for Engineering & Occupational Safety and Health (CEOSH):

vhahtmrmdvisnnewissue@va.gov

For National Center for Patient Safety - vhancpsrecalls@va.gov

(g.) PRODUCT CORRECTION, REMOVAL OR RECALL

If any product awarded under this solicitation requires correction as defined by FDA, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required correction, 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. All the following offices and points of contact should emailed or mailed a notification:

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(1.) Chief, High Tech Medical Equipment (003A4C2), VA National Acquisition Center, P.O.

Box 76, Building 37, Hines, IL 60141.

(2.) Manager, Product Recall Office, National Center for Patient Safety, Veterans Health Administration, 24 Frank Lloyd Wright Drive, Lobby M, Ann Arbor, MI 48106 or vhancpsrecalls@va.gov

(3.) Biomedical Engineer, Center for Engineering & Occupational Safety and Health (CEOSH) (138F), Veterans Health Administration, 1 Jefferson Barracks Rd. Bldg. 65, St.

Louis, MO 63125 or vhahtmrmdvisnnewissue@va.gov.

(4.) Each individual VA Facility who purchased the product.

(5.) DLA Contracting Officer and Biomedical Engineer cited in the delivery order.

(6) DoD Service Recall POC and all facility POCs referenced in the DLA delivery order

b. The following information must be provided in each individual notification that is forwarded to all above offices and points of contact:

(1.) Complete item description and/or identification, the contract number and delivery order numbers

(2.) Reasons for modifications, removal or recall.

(3) Proposed offers for return for credit, replacement or corrective action shall be forwarded to the facility POC and Contracting Officer, for consideration by the Government.

c. The vendor will responsible for all costs associated with a recall.

d. The following additional information must be provided, in writing, to the above points of contact at the National Center for Patient Safety (NCPS) and the Center for Engineering & Occupational Safety and Health (CEOSH) regarding each individual notification that is forwarded to all above offices and points of contact:

(1.) Complete listing of ALL VA Facilities who purchased the product and the total number of affected product(s) at each facility.

(2.) National summary detailing the status of the actions being taken by the contractor or manufacturer regarding the product correction, removal, or recall at the affected VA Facilities.

(3.) Confirmation that all affected products were corrected, removed, or recalled at the affected VA Facilities and all expected actions were completed.

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(5.) The first sentence of Section X. (b.) SERVICE DURING WARRANTY, on page 44, is hereby removed and replaced in its entirety by the following:

The Contractor shall provide a minimum of a one-year warranty from the warranty effective date established by the Government at final acceptance that includes all parts, labor, preventive maintenance and adjustments necessary for normal operation of the equipment at a level meeting all requirements of the purchase description/salient characteristics/specifications.

(6.) Clause 52.203-5 Covenant Against Contingent Fees. (APR 1984) on page 13 is hereby removed.

(7.) Clause 52.215-2 Audit and Records – Negotiation (Oct 2010) Alternate I (MAR 2009) on page 13 is hereby removed.

(8.) Clause 52.212-9002 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS APPLICABLE TO DEFENSE

ACQUISITIONS OF COMMERCIAL ITEMS (NOV 2014) DLAD, on pages 16 through 21, is hereby removed and replaced with the following individual clauses:

FAR 52.203-3, Gratuities (APR 1984) (applies to both DLA and VA administered contracts)

DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials (SEP 2011)

DFARS 252.203-7003, Agency Office of the Inspector General (DEC 2012)

DFARS 252.203-7005, Representation Relating to Compensation of Former DoD Officials

(NOV 2011)

DFARS 252.204-7012, Safeguarding of Unclassified Controlled Technical Information (NOV 2013)

DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders (DEC 1991)

DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013)

DFARS 252.215-7008, Only One Offer (OCT 2013)

DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts) (OCT 2014) (Only applies to DLA administered contracts)

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DFARS 252.225-7020, Trade Agreements Certificate (JAN 2005)

DFARS 252.225-7021, Trade Agreements (OCT 2013)

DFARS 252.225-7027, Restriction on Contingent Fees for Foreign Military Sales (APR 2003)

DFARS 252.225-7028, Exclusionary Policies and Practices of Foreign Governments (APR 2003)

DFARS 252.227-7015, Technical Data -- Commercial Items (FEB 2014)

DFARS 252.227-7037, Validation of Restrictive Markings on Technical Data (JUN 2013), DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports

(JUN 2012)

DFARS 252.232-7010, Levies on Contract Payments (DEC 2006)

DFARS 252.243-7002, Requests for Equitable Adjustment (DEC 2012)

DFARS 252.244-7000, Subcontracts for Commercial Items (JUN 2013)

DFARS 252.246-7003, Notification of Potential Safety Issues (JUN 2013)

DFARS 252.247-7022, Representation of Extent of Transportation by Sea (AUG 1992)

DFARS 252.247-7023, Transportation of Supplies by Sea (APR 2014).

(9.) The following language is hereby added to the bottom of Section XIV. (c)(3)(iv) on page 55:

If authorized by the Government, the contractor may reuse existing materials.

(10.) The following is added to the bottom of section XIV. (c)(5)(ii) on page 56:

If specified in writing by the Government, the shielding type, thickness and placement in floor(s), wall(s) and/or ceiling(s) will be determined by a qualified Government physicist available at the site.

(11.) The following language is added to the bottom of section XV. on page 56 :

(b.) Additional Instructions for Completing Column BE in the Contract Price Book: Country-of-origin information shall be completed for all offered items. Items that are not being offered for

6 | P a g e individual ordering, but are part of a TAA compliant higher level end item shall be identified by placing “COMPONENT” in the price book field followed by the country-of-origin for the item.

(12.) Except as provided herein, all terms and conditions remain unchanged and in full force and effect. The original closing date is not extended.