W81K00-17-T-0426-P00001.pdf

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

POC: ANTHONY D. BROWNER

36000 DARNELL LOOP

FORT HOOD TX 76544

0011017155

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

A. The purpose of this Amendment is threefold: 1.) Add reference to include FAR Part 13 Procedures. 2.) Change total BPA Limit from $11M to $7M. 3.) Change total Call Limit from $600,000 to $350,000.

B. See Summary of Changes.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 4

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 15-Sep-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K00-17-T-0426

X 9B. DATED (SEE ITEM 11)

13-Sep-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Sep-2017

CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K00-17-T-0426

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

STATEMENT OF OBJECTIVES

The Regional Health Contracting Office - Central has a requirement various neuro stimulators implants and supplies. When ordered, the item must pass a Technical Inspection performed by the regional healthcare facility’s surgeon prior to being accepted for use by the Government. The date/time of the procedure and case number will be provided to the vendor upon placement of an order. An order number shall be provided to the vendor by the Ordering Officer.

The government intends to award up to three (3) Blanket Purchase

Agreements (BPA) to offers that are determined technically acceptable and offer a fair and reasonable price. BPA(s) will be established under Federal Acquisition Regulation (FAR) Part 12 and 13. BPA(s) issued as a result of this solicitation will have a single bulk call limit of up to $350,000.00 for a 6 months delivery period, with a maximum overall BPA limit of $7,000,000.00.

BPA calls/orders will be based on patient need and physician preference. The

Medical Treatment Facility (MTF) will schedule deliveries against the bulk call as needed based on a case by case basis.

Offerors are reminded that, in the event they receive a BPA, calls/orders are not guaranteed. Funds are not obligated on the BPA, but only on any issued calls/orders.

The anticipated period of performance is 1 October 2017 through 30 September

2022. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113

– Surgical Appliance and Supplies Manufacturing, Size Standard: 750. This procurement is being conducted as a full and open competition.

Medical Treatment Facilities requiring neuro stimulators and supplies are listed below:

1) San Antonio Military Medical Center, Fort Sam Houston, TX

2) Carl R. Darnall Army Medical Center, Fort Hood, TX

3) Munson Army Health Center, Fort Leavenworth, KS

4) General Leonard Wood Army Community Hospital, Fort Leonard Wood, MO

5) Bayne-Jones Army Community Hospital, Fort Polk, LA

6) Irwin Army Community Hospital, Fort Riley, KS

7) Reynolds Army Community Hospital, Fort Sill, OK

8) Weed Army Community Hospital, Fort Irwin, CA

9) Raymond W. Bliss Army Health Center, Fort Huachuca, AZ

10) Evans Army Community Hospital, Fort Carson, CO

11) William Beaumont Army Medical Center, Fort Bliss, TX

NOTE 1: The terms “offer” and “offeror” should be interpreted to mean the same as

“quote” and “quoter” wherever they appear in the solicitation.

NOTE 2: A price list template is included as Attachment III. Offerors may submit their own format, but should include as a minimum the headings/categories listed on the template.

SCOPE

The following points represent the Government’s requirements for neuro stimulators and supplies.

Devices should be able to manage spinal pain through an implantable pulse generator and be able to stimulate specific nerves of the spinal cord and be surgically placed under the skin to send mild electric currents to the spinal cord in an effort to block pain messages from reaching the brain.

Delivery Terms: Neuro stimulator and any instrumentation shall be available 48 hours prior to surgical procedure and if any instrumentation is used that instrument must be picked up within 48 hours after procedure.

A. SPECIFIC REQUIREMENTS: The requirements for the neuro stimulators are:

1. Offered Products must be

- FDA and TAA compliant. Must be able to provide Spinal Cord Stimulation solutions.

-Must be able to manage pain through an implantable pulse generator (IPG).

-Must be able to stimulate specific nerves of the spinal cord.

-This items shall be rechargeable, but this not a discriminator.

-Must offer proven pain control.

-Must offer multiple sources of stimulation.

2. Must be able to provide clinical training (in-services) for surgeons and staff. An example of required training would consist of receiving training on the use of any new neuro stimulator or supply item based on the original equipment manufacturers instruction for use (IFU). (Offeror shall provide detailed information for any clinical training provided for offered products.)

3. Contractor shall provide procedures in the event of a recall for implants and supplies offered. If any product is recalled the contractor shall provide the dates of recall, a description of the preparations recalled, and the reasons for the recall. The contractor shall provide the corrective and preventive actions put into place for the recalls.

(Offeror shall provide a detailed description of recall procedures for all offered products.)

4. Contractor shall provide a monthly report (summary) of all supplies invoiced under the BPA. Information contained in the report shall include; Name of supplier, BPA number, Date of purchase, Purchase or case number, Itemized list of supplies furnished, Quantity, unit price, extension of each item, less applicable discounts, Date of delivery or shipment.

A. NEURO-STIMULATOR SUPPLY LIST

Attachment II – Cross Reference Product Matrix includes a sample list of neuro stimulators and supplies required. Vendors are encouraged to provide a comprehensive price list which includes all offered neuro stimulators as it relates to this requirement. Attachment III provides a template for vendor product and price listing.

The following have been deleted:

ADDENDUM 52.212-1

52.212-2 Evaluation - Commercial Items OCT 2014

(End of Summary of Changes)