A.09.03__W81K02-18-Q-0014.pdf

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Blanket Purchase Agreement on Various FDA-Approved Invasive Surgical
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W81K02-18-Q-0014
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SEE ADDENDUM

(No Collect Calls)

W81K02-18-Q-0014 26-Mar-2018

b. TELEPHONE NUMBER

360-486-0708

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 22 Apr 2018

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81K029. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

ANGELA A. DEXTER

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

BPAMAMC201711

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FT SHAFTER HI 96858-5098

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE W68MX3 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

MADIGAN HEALTHCARE SYSTEM

MADIGAN HEALTHCARE SYSTEM

9040 FITZSIMMONS DR.

TACOMA WA 98431

TEL: FAX:

.FAX:

TEL: . SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

NAICS:

339113

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF65

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81K02-18-Q-0014

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Various FDA-Approved Invasive Surgical

FFP

Various FDA-Approved Invasive Surgical Implants and Surgical products including but not specifically limited to; AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Inflatable Penile Prosthesis, Spectra Concealable Penile Prosthesis, AMS 800 Urinary Control System, AdVance Male Sling System, Geistlich Bio- Oss, biocompatible porous bone mineral substitute, Geistlich Bio-Oss Collagen®, biocompatible bone mineral plus 10% collagen Geistlich Bio-Gide, biocompatible, resorbable bilayer collagen membrane, Geistlich Bio-Oss Pen®, biocompatible porous bone mineral substitute, Lamp Module Replacement MLX, Integra Surgical Illumination and Visualization System, Integra Neurosciences Meshed Bilayer Wound Matrix,Integra DuraGen Dural Graft Matrix,Integra NeuraGen Nerve Guide, Integra NeuraWrap Nerve Protector, Integra Reinforcement Matrix,Tornier DX Salto Talaris Total Ankle Prothesis Stryker Xia 3 Pedicle Screw System, Stryker Oasys Occipito-Cervico-Thoracic Posterior Spine Implant System, Stryker Escalate Laminoplasty Implant System, Stryker Aviator Anterior Cervical Plating System, Stryker Tritanium PL Posterior Lumbar Cage Implants, Stryker AVS Anchor-C Cervical Standalone Cage Implant System, Stryker Demineralized Bone Matrix, Stryker BIO Chips bone void fillers,Stryker VBOSS Vertebral Body Support Implant System consumable supplies, tools and accessories for patient specific needs basis on the surgeons requirement. The commercial price listing will be incorporated into the Master Blanket Purchase Agreement.

FOB: Destination

PURCHASE REQUEST NUMBER: BPAMAMC201711

NET AMT

SECTION SF 1449 - CONTINUATION

BPA Master Dollar Limit - $2,800,000.00 (for life of Agreement)

BPA Call Limit- $25,000.00 (if placed via Government Purchase Card) BPA Call Limit - $150,000.00(ordered through the Contracting Office)

Period of Perfomrance 15 May 2018 thru 14 May 2021

FSC Codes: 6515

SCOPE OF WORK

Blanket Purchase Agreement (BPA) Between Joint Base Lewis-McChord Health Contracting Cell (JBLM-HCC)

And

(1) AUTHORITY.

This agreement is established in accordance with FAR 13.303, Blanket Purchase Agreements (BPA) and Army Federal Acquisition Regulation Supplement (AFARS) Part 5113.303. It will be reviewed by the Contracting Officer at least once annually prior to the anniversary of the effective date, and revised to conform to all requirements of Statutes, Executive Orders, or the Federal Acquisition Regulation as updates occur. Any revisions will be incorporated by modification to this BPA and agreed upon by the Contracting officer and the Agreement Holders.

(2) DESCRIPTION OF AGREEMENT

The Agreement Holder shall provide Various FDA-Approved Invasive Surgical Implants and Surgical products including but not specifically limited to; AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Inflatable Penile Prosthesis, Spectra Concealable Penile Prosthesis, AMS 800 Urinary Control System, AdVance Male Sling System, Geistlich Bio-Oss, biocompatible porous bone mineral substitute, Geistlich Bio-Oss Collagen®, biocompatible bone mineral plus 10% collagen Geistlich Bio-Gide, biocompatible, resorbable bilayer collagen membrane, Geistlich Bio- Oss Pen®, biocompatible porous bone mineral substitute, Lamp Module Replacement MLX, Integra Surgical Illumination and Visualization System, Integra Neurosciences Meshed Bilayer Wound Matrix,Integra DuraGen Dural Graft Matrix,Integra NeuraGen Nerve Guide, Integra NeuraWrap Nerve Protector, Integra Reinforcement Matrix,Tornier DX Salto Talaris Total Ankle Prothesis Stryker Xia 3 Pedicle Screw System, Stryker Oasys Occipito-Cervico-Thoracic Posterior Spine Implant System, Stryker Escalate Laminoplasty Implant System, Stryker Aviator Anterior Cervical Plating System, Stryker Tritanium PL Posterior Lumbar Cage Implants, Stryker AVS Anchor-C Cervical Standalone Cage Implant System, Stryker Demineralized Bone Matrix, Stryker BIO Chips bone void fillers,Stryker VBOSS Vertebral Body Support Implant System consumable supplies, tools and accessories for patient specific needs basis on the surgeons requirement. The commercial price listing will be incorporated into the Master Blanket Purchase Agreement.

The products are to support following outlying medical treatment facilities (MTF):

Madigan Army Medical Center Departments (MAMC), Joint Base Lewis McChord, WA

ALL PRODUCTS MUST BE FDA APPROVED, AND MEET THE SURGEON/PATIENT REQIREMENTS.

Master Blanket Purchase Agreements are being established to allow maximum flexibility and efficiency in the procurement of the provide Various FDA-Approved Invasive Surgical Implants and Surgical products including but not specifically limited to; AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Inflatable Penile Prosthesis, Spectra Concealable Penile Prosthesis, AMS 800 Urinary Control System, AdVance Male Sling System, Geistlich Bio-Oss, biocompatible porous bone mineral substitute, Geistlich Bio-Oss Collagen®, biocompatible bone mineral plus 10% collagen Geistlich Bio-Gide, biocompatible, resorbable bilayer collagen membrane, Geistlich Bio-Oss Pen®, biocompatible porous bone mineral substitute, Lamp Module Replacement MLX, Integra Surgical Illumination and Visualization System, Integra Neurosciences Meshed Bilayer Wound Matrix,Integra DuraGen Dural Graft Matrix,Integra NeuraGen Nerve Guide, Integra NeuraWrap Nerve Protector, Integra Reinforcement Matrix,Tornier DX Salto Talaris Total Ankle Prothesis Stryker Xia 3 Pedicle Screw System, Stryker Oasys Occipito-Cervico-Thoracic Posterior Spine Implant System, Stryker Escalate Laminoplasty Implant System, Stryker

Aviator Anterior Cervical Plating System, Stryker Tritanium PL Posterior Lumbar Cage Implants, Stryker AVS Anchor-C Cervical Standalone Cage Implant System, Stryker Demineralized Bone Matrix, Stryker BIO Chips bone void fillers,Stryker VBOSS Vertebral Body Support Implant System consumable supplies, tools and accessories for patient specific needs basis on the surgeons requirement for outlying medical treatment facilities (MTF).

A general competitive effort is made by the surgeon and attending team throughout the requirement review process which considers the applicability of products from various sources to determine the product that best meets the needs of the patient

a. All term and condition under this Blanket Purchase Agreement are in accordance with Department of Veteran Affairs , Strategic Acquisition Center contract number VA119-17-D-0014 (Other Implants, Surgical Products) under the current pricing listing.

b. This agreement shall be in effect for a term of five (5) years starting on or about 15 May 2018 thru 14 May 2021 or until the maximum value of the BPS is reached. The Agreement terms and conditions may be renegotiated annually prior to the anniversary of the effective date of the agreement. Either party may terminate this agreement by giving thirty (30) days written notice.

c. The approved price list submitted by the Agreement Holder, (to include all applicable discounts) is incorporated into this Agreement, and all BPA Calls shall utilize this pricing. Any updates or changes to the product catalogs or pricing must be approved by the Contracting Officer for incorporation into this Agreement. The Agreement Holder must allow thirty (30) days for the revised catalog to be incorporated into the Agreement.

d. The Government may place BPA CALLs to fund the estimated expenditures for the up to three months (90 days) one order and may place multiple BPA CALLs during the year for such limited periods. BPA CALLs will not cross fiscal years (except for required delivery time).

e. There is no travel cost allowance under this agreement by the government. It will be the sole responsibility of the contractor.

f. BPA calls may be issued by the Regional Health Contracting Office-Pacific (Provisional) Joint Base Lewis- McChord Health Contracting Cell(JBLM-HCC) locate at 673 Woodland Square Loop SE Suite 101, Lacey WA 98503 , or single calls or bulk funded calls not to exceed $150,000.00. In addition, designated Government Purchase Card (GPC) holders at the MTF may place single calls not to exceed $25,000.00.

JBLM-HCC will maintain administrative authority for this BPA.

(3) EXTENT OF OBLIGATION

a. This Blanket Purchase Agreement (BPA) does not obligate any funds and is not a binding contract.

The Government will be obligated only to the extent that authorized BPA calls are actually made under this agreement. The medical treatment facility (MTF) will order surgical spinal implants products, and other instrumental consumable related supplies for patient specific needs based on the surgical requirement, and will be responsible for payment of any obligation via Government Credit Card or DFAS Indy (GEFEBS) code HQ0490, for which invoicing is submitted into the into Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF.

Purchase Limitation:

BPA Call Limit- $25,000.00 (if placed via Government Purchase Card) BPA Call Limit - $150,000.00(ordered through the Contracting Office) BPA Master Dollar Limit - $2,800,000.00 (for life of Agreement)

(4) ORDERING PROCEDURES

ITEM NO SUPPLIES/SERVICES QTY U/I Unit Price

0001 2500 JOB $150,000.00

Various FDA-Approved Invasive Surgical Implants for patient specific needs basis on the surgeon’s requirement for Madigan Army Medical Center, Tacoma, WA.

Estimated quantities based on the patient needs by the surgeons

PRICING SET BY THE APPROVED PRICE LIST

FOB: Destination

Item Number Item Description Supplier Name

001320LX LAMP MODULE REPLACEMENT MLX PRICING SET BY THE APPROVED PRICE

001328 ULTRALITE MODULE, MARK II PRICING SET BY THE APPROVED PRICE

001388LX9

ULTRALITE PREMIUM HEADLIGHT CABLE, 9 FT, 275

cm PRICING SET BY THE APPROVED PRICE

00MLX MLX 300W XENON LIGHTSOURCE PRICING SET BY THE APPROVED PRICE

101269 CARB-EDGE METZ SCS 10 CVD PRICING SET BY THE APPROVED PRICE

1104BT

INTRACRANIAL PRESSURE / TEMPERATURE

MONITORING KIT PRICING SET BY THE APPROVED PRICE

1104HM MICRO VENTRICULAR BOLT ICP MONITORING KIT PRICING SET BY THE APPROVED PRICE

121231 CARB-BITE MICRO NH 8-1/2 SERR PRICING SET BY THE APPROVED PRICE

130225 COLLEGE PLIERS #317 PRICING SET BY THE APPROVED PRICE

140223 PETIT-POINT MIXTER FCPS 7-1/4 PRICING SET BY THE APPROVED PRICE

180100 TAYLOR PERC HAMMER SMALL SS PRICING SET BY THE APPROVED PRICE

20151 Geistlich Bio-Gide® 13x25 mm PRICING SET BY THE APPROVED PRICE

20152 Geistlich Bio-Gide® 25x25 mm PRICING SET BY THE APPROVED PRICE

20153 Geistlich Bio-Gide® 40x50 mm PRICING SET BY THE APPROVED PRICE

202050

DURASEAL DURAL SEALANT SYSTEM, 5ML US, BOX

OF 5 PRICING SET BY THE APPROVED PRICE

225450 HOHMANN RETR 10MM WIDE PRICING SET BY THE APPROVED PRICE

275500 HERCULES SUPERCUTTER 9IN PRICING SET BY THE APPROVED PRICE

275530 TC SIDE CUTTER 7-1/2IN PRICING SET BY THE APPROVED PRICE

305231 ALLIS-WILLAUER FCPS 11-1/4 PRICING SET BY THE APPROVED PRICE

33660112 CUTTING BLADE PRICING SET BY THE APPROVED PRICE

33661200MR 12MM LARGE ROUND ENDCAP PRICING SET BY THE APPROVED PRICE

33661200SR 12MM SMALL ROUND ENDCAP PRICING SET BY THE APPROVED PRICE

336612012 12 X 12MM CAGE PRICING SET BY THE APPROVED PRICE

336612040 12 X 40MM CAGE PRICING SET BY THE APPROVED PRICE

33661205SR 12MM SMALL ROUND ENDCAP 5 DEG PRICING SET BY THE APPROVED PRICE

48230000 XIA 3 TI BLOCKER PRICING SET BY THE APPROVED PRICE

482314030 XIA 3 TI PA SCREW DIA 4.0 X 30 MM PRICING SET BY THE APPROVED PRICE

482314035 XIA 3 TI PA SCREW DIA 4.0 X 35 MM PRICING SET BY THE APPROVED PRICE

482315030 XIA 3 TI PA SCREW DIA 5.0 X 30 MM PRICING SET BY THE APPROVED PRICE

482315035 XIA 3 TI PA SCREW DIA 5.0 X 35 MM PRICING SET BY THE APPROVED PRICE

482315535 XIA 3 TI PA SCREW DIA 5.5 X 35 MM PRICING SET BY THE APPROVED PRICE

482315545 XIA 3 TI PA SCREW DIA 5.5 X 45 MM PRICING SET BY THE APPROVED PRICE

482316540 XIA 3 TI PA SCREW DIA 6.5 X 40 MM PRICING SET BY THE APPROVED PRICE

482316545 XIA 3 TI PA SCREW DIA 6.5 X 45 MM PRICING SET BY THE APPROVED PRICE

482316550 XIA 3 TI PA SCREW DIA 6.5 X 50 MM PRICING SET BY THE APPROVED PRICE

482317540 XIA 3 TI PA SCREW DIA 7.5 X 40 MM PRICING SET BY THE APPROVED PRICE

48233150 XIA 3 TI ROD DIAM 6MM TI ALLOY L 150MM PRICING SET BY THE APPROVED PRICE

48238035 XIA 3 TI RAD ROD DIAM 6MM L 35MM PRICING SET BY THE APPROVED PRICE

48238040 XIA 3 TI RAD ROD DIAM 6MM L 40MM PRICING SET BY THE APPROVED PRICE

48238045 XIA 3 TI RAD ROD DIAM 6MM L 45MM PRICING SET BY THE APPROVED PRICE

48238050 XIA 3 TI RAD ROD DIAM 6MM L 50MM PRICING SET BY THE APPROVED PRICE

48238080 XIA 3 TI RAD ROD DIAM 6MM L 80MM PRICING SET BY THE APPROVED PRICE

48551000 OASYS BLOCKER PRICING SET BY THE APPROVED PRICE

48552040 ROD 3.5 X 40MM PRICING SET BY THE APPROVED PRICE

48552050 ROD 3.5 X 50MM PRICING SET BY THE APPROVED PRICE

48552060 ROD 3.5 X 60MM PRICING SET BY THE APPROVED PRICE

48558312 OASYS POLY SCREW NON BIASED DIA 3.5 x 12 PRICING SET BY THE APPROVED PRICE

48558314 OASYS POLY SCREW NON BIASED DIA 3.5 x 14 PRICING SET BY THE APPROVED PRICE

48560323 OASYS 2.5MM DRILL FOR 3.5MM SCREW PRICING SET BY THE APPROVED PRICE

48570114 ESCALATE 1.2 x 4MM DRILL BIT PRICING SET BY THE APPROVED PRICE

48570116 ESCALATE 1.2 X 6MM DRILL BIT PRICING SET BY THE APPROVED PRICE

48570118 ESCALATE 1.2 X 8MM DRILL BIT PRICING SET BY THE APPROVED PRICE

48570204 ESCALATE 2.0 X 4MM SELF DRILLING SCREW PRICING SET BY THE APPROVED PRICE

48570206 ESCALATE 2.0 X 6MM SELF DRILLING SCREW PRICING SET BY THE APPROVED PRICE

48570208 ESCALATE 2.0 X 8MM SELF DRILLING SCREW PRICING SET BY THE APPROVED PRICE

48570300 ESCALATE EXPANDABLE PLATE PRICING SET BY THE APPROVED PRICE

48770614 AVIATOR DRILL BITS 14MM PRICING SET BY THE APPROVED PRICE

48811112 AVIATOR ONE LEVEL PLATE SIZE 12 PRICING SET BY THE APPROVED PRICE

48811114 AVIATOR ONE LEVEL PLATE SIZE 14 PRICING SET BY THE APPROVED PRICE

48811226 AVIATOR TWO LEVEL PLATE SIZE 26 PRICING SET BY THE APPROVED PRICE

48811228 AVIATOR TWO LEVEL PLATE SIZE 28 PRICING SET BY THE APPROVED PRICE

48811342 AVIATOR THREE LEVEL PLATE SIZE 42 PRICING SET BY THE APPROVED PRICE

48811348 AVIATOR THREE LEVEL PLATE SIZE 48 PRICING SET BY THE APPROVED PRICE

48811351 AVIATOR THREE LEVEL PLATE SIZE 51 PRICING SET BY THE APPROVED PRICE

48811354 AVIATOR THREE LEVEL PLATE SIZE 54 PRICING SET BY THE APPROVED PRICE

48814010 AVIATOR VARIABLE SELF TAPPING SCREW 4X10MM PRICING SET BY THE APPROVED PRICE

48814012 AVIATOR VARIABLE SELF TAPPING SCREW 4X12MM PRICING SET BY THE APPROVED PRICE

48814014 AVIATOR VARIABLE SELF TAPPING SCREW 4X14MM PRICING SET BY THE APPROVED PRICE

48814016 AVIATOR VARIABLE SELF TAPPING SCREW 4X16MM PRICING SET BY THE APPROVED PRICE

48814512

AVIATOR VARIABLE SELF TAPPING SCREW

4.35X12MM PRICING SET BY THE APPROVED PRICE

48814514

AVIATOR VARIABLE SELF TAPPING SCREW

4.35X14MM PRICING SET BY THE APPROVED PRICE

48824010 AVIATOR VARIABLE SELF DRILLING SCREW 4X10MM PRICING SET BY THE APPROVED PRICE

48824012 AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM PRICING SET BY THE APPROVED PRICE

48824014 AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM PRICING SET BY THE APPROVED PRICE

48824016 AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM PRICING SET BY THE APPROVED PRICE

48834512 AVIATOR FIXED SELF TAPPING SCREW 4.35X12MM PRICING SET BY THE APPROVED PRICE

48834516 AVIATOR FIXED SELF TAPPING SCREW 4.35X16MM PRICING SET BY THE APPROVED PRICE

48950100 Tritanium PL 10mm x 23mm x0DEG - 9mm Posterior Lumbar Cage PRICING SET BY THE APPROVED PRICE

48950110 Tritanium PL 11mm x 23mm x0DEG - 9mm Posterior Lumbar Cage PRICING SET BY THE APPROVED PRICE

48951110 Tritanium PL 11mm x 23mm x0DEG - 11mm Posterior Lumbar Cage PRICING SET BY THE APPROVED PRICE

48952100 Tritanium PL 10mm x 28mm x0DEG - 9mm Posterior Lumbar Cage PRICING SET BY THE APPROVED PRICE

720066-01 AMS 800 ACCESSORY KIT, US PRICING SET BY THE APPROVED PRICE

720074-02 SPECTRA 12MMx16CM PRICING SET BY THE APPROVED PRICE

720074-03 SPECTRA 12MMx20CM PRICING SET BY THE APPROVED PRICE

720088-01 ADVANCE MALE TO SLING SYSTEM PRICING SET BY THE APPROVED PRICE

720185-01 CONCEAL IZ PRICING SET BY THE APPROVED PRICE

72400024 BALLOON FGS, 61-70 CM PRICING SET BY THE APPROVED PRICE

72400095 DEACTIVATION PKG FGS PRICING SET BY THE APPROVED PRICE

72401850 AMS 700 ACCESSORY KIT PRICING SET BY THE APPROVED PRICE

72403867 SKW DEEP SCROTAL RETRACT SYS PRICING SET BY THE APPROVED PRICE

72404127 CONTROL PUMP IZ PRICING SET BY THE APPROVED PRICE

72404130 OCCLUSIVE CUFF 4.0CM, IZ PRICING SET BY THE APPROVED PRICE

72404131 OCCLUSIVE CUFF 4.5CM, IZ PRICING SET BY THE APPROVED PRICE

72404132 OCCLUSIVE CUFF 5.0CM, IZ PRICING SET BY THE APPROVED PRICE

72404155 RESERVOIR, 65 ML, PC/IZ PRICING SET BY THE APPROVED PRICE

72404156 RESERVOIR, 100 ML, PC/IZ PRICING SET BY THE APPROVED PRICE

72404231 CX PRECONNECT MS 15CM PS, IZ PRICING SET BY THE APPROVED PRICE

72404232 CX PRECONNECT MS 18CM PS, IZ PRICING SET BY THE APPROVED PRICE

72404233 CX PRECONNECT MS 21CM PS, IZ PRICING SET BY THE APPROVED PRICE

72404251 LGX PRECONNECT MS 15CM PS, IZ PRICING SET BY THE APPROVED PRICE

72404252 LGX PRECONNECT MS 18CM PS, IZ PRICING SET BY THE APPROVED PRICE

77102050 SERV FEE BIO AVS CERV 0 DEG WITH PLUG 5MM PRICING SET BY THE APPROVED PRICE

77102054 SERV FEE BIO AVS CERV 4 DEG WITH PLUG 5MM PRICING SET BY THE APPROVED PRICE

77102060 SERV FEE BIO AVS CERV 0 DEG WITH PLUG 6MM PRICING SET BY THE APPROVED PRICE

77102064 SERV FEE BIO AVS CERV 4 DEG WITH PLUG 6MM PRICING SET BY THE APPROVED PRICE

77102070 SERV FEE BIO AVS CERV 0 DEG WITH PLUG 7MM PRICING SET BY THE APPROVED PRICE

77102080 SERV FEE BIO AVS CERV 0 DEG WITH PLUG 8MM PRICING SET BY THE APPROVED PRICE

7770205 SERV FEE BIO CHIPS CANC 5CC - 1-4 MM PRICING SET BY THE APPROVED PRICE

7770215 SERV FEE BIO CHIPS CANC 15CC - 1-4 MM PRICING SET BY THE APPROVED PRICE

7775001 SERV FEE BIO DBM PUTTY 1CC PRICING SET BY THE APPROVED PRICE

7775005 SERV FEE BIO DBM PUTTY 5CC PRICING SET BY THE APPROVED PRICE

7775010 SERV FEE BIO DBM PUTTY 10CC PRICING SET BY THE APPROVED PRICE

7775025 SERV FEE BIO DBM PUTTY 2.5CC PRICING SET BY THE APPROVED PRICE

90520US LED Headlight with Battery and AC/DC Power Supply PRICING SET BY THE APPROVED PRICE

90522 Lithium Ion Batteries, 2 each PRICING SET BY THE APPROVED PRICE

90542 LED Headband Replacement Pads, 10 per box PRICING SET BY THE APPROVED PRICE

AX2100BIF ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE PRICING SET BY THE APPROVED PRICE

BEA57240001943

OT 1200 STERIS AATHA FRACTURE TABLE WITH

DRIVE PKG PRICING SET BY THE APPROVED PRICE

DJ06012433112 WAR CAB PRE GLASS DUAL 24 IN. 120V EDL EDR PRICING SET BY THE APPROVED PRICE

DP1045 DuraGen Plus Dural Regeneration Matrix 4X5 1 PACK PRICING SET BY THE APPROVED PRICE

DWD060T DRILL BIT 1 X 3 MM length 220 mm PRICING SET BY THE APPROVED PRICE

E0980 RETRACTOR LID DESMARRES 0 PRICING SET BY THE APPROVED PRICE

E1793 US FCP FIX CASTRO .3 W/O PLTFM WD PRICING SET BY THE APPROVED PRICE

E1855 SHEPARD TYING FORCEPS STRAIGHT PRICING SET BY THE APPROVED PRICE

E4056 SPECULUM EYE LANCASTER 15mm PRICING SET BY THE APPROVED PRICE

E4065 A LIEBERMAN ADJUSTABLE SPEC ANG PRICING SET BY THE APPROVED PRICE

E4065AS LIEBERMAN ANGLED SPEC SOLID PRICING SET BY THE APPROVED PRICE

E4922 CAN BISHP-HRMN B-D HUB TIP OY PRICING SET BY THE APPROVED PRICE

E5108 DEPRES SCLERL SCHOCKET DBL END PRICING SET BY THE APPROVED PRICE

ET2009 FORCEP CAPSULORHEXIS MALONEY PRICING SET BY THE APPROVED PRICE

INS5HND CRANIAL KIT - NO DRUGS PRICING SET BY THE APPROVED PRICE

INS8401 AccuDrain with Anti-Reflux Valve PRICING SET BY THE APPROVED PRICE

INS8700 Integra External CSF Drainage Replacement Bags (5pk) PRICING SET BY THE APPROVED PRICE

INSHITH HITH KIT PRICING SET BY THE APPROVED PRICE

LG35 G5 DL LGT, N/CAM, S.CARDANIC PRICING SET BY THE APPROVED PRICE

LJU095T SALTO TAL. single use 11pins 1reamer LJU097/98/99, PRICING SET BY THE APPROVED PRICE

LJU200T SALTO TAL Talar Implant Sz 0 Right cement use only PRICING SET BY THE APPROVED PRICE

LJU202T SALTO TAL Talar Implant Sz 2 Right cement use only PRICING SET BY THE APPROVED PRICE

LJU210T SALTO TAL Talar Implant Sz 0 Left cement use only PRICING SET BY THE APPROVED PRICE

LJU211T SALTO TAL Talar Implant Sz 1 Left cement use only PRICING SET BY THE APPROVED PRICE

LJU220T SALTO TAL Tibial Implant Sz 0 for cement use only PRICING SET BY THE APPROVED PRICE

LJU221T SALTO TAL Tibial Implant Sz 1 for cement use only PRICING SET BY THE APPROVED PRICE

LJU222T SALTO TAL Tibial Implant Sz 2 for cement use only PRICING SET BY THE APPROVED PRICE

LJU245T SALTO TAL PE insert Left Sz 1 8 mm thickness PRICING SET BY THE APPROVED PRICE

LJU256T SALTO TAL PE insert Right Sz 2 9 mm thickenss PRICING SET BY THE APPROVED PRICE

LJU408T SALTO TAL PE insert Right Sz 00 8 mm thickness PRICING SET BY THE APPROVED PRICE

LJU418T SALTO TAL PE insert Left Sz 00 8 mm thickness PRICING SET BY THE APPROVED PRICE

LV00006 SUSPENSION TUBE 9 INCH/225MM PRICING SET BY THE APPROVED PRICE

LY01 CONTROL PANEL ROUGH-IN BOX WITH MUD RING PRICING SET BY THE APPROVED PRICE

LY02 CONTROL PANEL RETROFIT KIT PRICING SET BY THE APPROVED PRICE

MCOREVISION1

Mammotome CoreVision® Digital Core Biopsy Radiography system (50mm x 100mm FOV) PRICING SET BY THE APPROVED PRICE

MCVRTRAY

** DISCONTINUED ** - Mammotome CoreVision revolve specimen tray PRICING SET BY THE APPROVED PRICE

MONPWR Monitor 18 V DC power adapter PRICING SET BY THE APPROVED PRICE

MWM4051

INTEGRA MESHED BILAYER WOUND MATRIX SIZE

4X5 PRICING SET BY THE APPROVED PRICE

MWM4101

INTEGRA MESHED BILAYER WOUND MATRIX SIZE

4X10 PRICING SET BY THE APPROVED PRICE

MWM8101

INTEGRA MESHED BILAYER WOUND MATRIX SIZE

8X10 PRICING SET BY THE APPROVED PRICE

N1705 93 CUT BLK HOUSE DELRIN 7X4X1CM PRICING SET BY THE APPROVED PRICE

N1705 P FCP ALLIGATOR & CRIMPER HOUSE PRICING SET BY THE APPROVED PRICE

N6930 SCISSORS METZENBAUM 7 IN LIGHT PRICING SET BY THE APPROVED PRICE

NEOCART1 Cart Storage Neoprobe Gds Transport (EA=1) PRICING SET BY THE APPROVED PRICE

NPA75

Cord Power Neoprobe AC Control Module Accessory Gamma Detection System (EA=1) PRICING SET BY THE APPROVED PRICE

NPB14A Neoprobe Bluetooth 14mm Angled Probe (EA=1) PRICING SET BY THE APPROVED PRICE

NPCU3

Neoprobe Gds Control Unit, Including Software (requires Power Cord - Sold Separately) (EA=1) PRICING SET BY THE APPROVED PRICE

NPE14

Collimator Radiosurgical External L14mm Mammotome

(EA=1) PRICING SET BY THE APPROVED PRICE

P0130 NEEDLE HLDR MAYO HEGAR 7.0 IN PRICING SET BY THE APPROVED PRICE

P0700 SCISSORS STRABISMUS CVD 4.5 IN PRICING SET BY THE APPROVED PRICE

P423 BARD PARKER KNIFE HNDL #3 5IN LENGTH PRICING SET BY THE APPROVED PRICE

P5066 SCISSOR KAYE DIS TUNG CAR 10CM PRICING SET BY THE APPROVED PRICE

PNG230 NeuraGen Nerve Guide 2mm ID x 3cm length PRICING SET BY THE APPROVED PRICE

PNG330 NeuraGen Nerve Guide 3mm ID x 3cm length PRICING SET BY THE APPROVED PRICE

R16702 KERRISON CVD UP 8IN 2MM PRICING SET BY THE APPROVED PRICE

S2050 1 FCP BIPOLAR 4 JEWELERS F/S2050 PRICING SET BY THE APPROVED PRICE

S2050 2 FCP BP 4-1/2IN CUSHING F/S2050 PRICING SET BY THE APPROVED PRICE

SAW5944T LARGE BONE BLADE 70 X 13MM, STRYKER 7 PRICING SET BY THE APPROVED PRICE

SAW5945T LARGE BONE BLADE, 85 X 21MM STRYKER 7 PRICING SET BY THE APPROVED PRICE

STAR1403 Marker Breast Biopsy Petite 14ga Mammostar (BX=10) PRICING SET BY THE APPROVED PRICE

The quantity and types of items needed for those medical treatments and emergencies vary over time based on patient needs. The products are to support following Outlying medical treatment facilities (MTF):

Madigan Army Medical Center Departments (MAMC), Joint Base Lewis McChord, WA

Fair opportunity among multiple BPA holders for the product class(es) incorporated into this BPA is provided at the MTF level. The surgeon/surgical team will determine the products that best meet the needs of the patient and will rotate orders among BPA holders for these products, based on the best fit determination, availability, and delivery time of the products, to meet the specific patient requirement and scheduled surgical dates.

(5) Individuals Authorized to Schedule Deliveries under the BPA

a. Each BPA call issued by a contracting office and paid through WAWF/iRAPT will identify the names of the individuals authorized to schedule deliveries under this Agreement. Only authorized Government employees who have been specifically named by the Contracting Officer may schedule deliveries under this agreement. STRICT COMPLIANCE WITH THIS STIPULATION IS IMPERATIVE.

b. The Contracting Officer will provide the BPA holder a written notification of individuals authorized to place calls under Government Credit Card payment terms.

c. The medical treatment facility designated individuals authorized responsibilities and requirements:

1. Are responsible for creating a GFEBS purchase request (PR) and routing the PR to Resource Management (RM) for funding. RM reviews the PR and conducts their L4 process to route the funded PR to Joint Base Lewis-McChord Health Contracting Cell (JBLM-HCC), NOTE – Funded PR cannot exceed $150,000.00 and must state payment by DFAS Indy in the funding line.

2. Shall use an authorized BPA GPC to schedule deliveries against the BPA Call up to $25,000 per delivery.

Deliveries will be scheduled by, outlying medical treatment facilities (MTFs), and a call number will be associated with each delivery. Invoices shall reflect BPA number and Call number.

3. Must submit a itemize price listing for each GFEBS purchase request (PR) for a BPA Call be issued. You are require to submit a itemize price listing with the GFEBS purchase request (PR) on the products you are anticipating of purchasing under that BPA Call. The products MUST match what is ordered off the price listing in the BPA Call.

4. When the BPA cardholder creates a GPC BPA order through U.S. Banks Access Online, the following general information blocks must be additionally filled out:

Under “Document #”, insert BPA Number, w/o dashes, e.g., W81K0212A1234

Under “Authorization Number”, insert BPA Call Number + your internal control number/ordering sequence, e.g., 0001-001

5. The Contracting Officer issues a BPA Call and provides the funded BPA Call document with a call number. The designate personal must us an authorized BPA Call to schedule deliveries. Deliveries will be scheduled by medical treatment facility (MTF), and a call number will be associated with each delivery. Invoices shall reflect BPA number and Call number.

6. Shall maintain a detailed log of delivery requests scheduled and decrement funding on their call each time a delivery request is scheduled. At a minimum, for audit purposes, the log shall include delivery date, item number, nomenclature, quantity, $ amount, and BPA Call number.

c. Monthly Report:

The medical treatment facility (MTF) designated appointed individual shall submit BPA Call itemized invoice usage report to their contracting officer monthly or upon expiration the BPA Call. The monthly call itemized invoice usage report shall list delivery date, item number, nomenclature, quantity $ amount, and BPA Call number for each delivery request scheduled against the BPA Call that month.

d. Orders will be placed telephonically to: _______________________ or _________________________ referencing Account Number: _____________________.

(6) DELIVERY TICKETS/PACKAGING

a. All packing lists (delivery tickets) shall contain the following information:

a. Name of Supplier

b. BPA Number/Call number

c. Date of Purchase

d. Delivery BPA/call) order Number (If the Contracting issue the BPA Call)

e. Itemized list of supplies furnished

f. Quantity, unit price, and extension of each item less applicable discounts, if applicable

g. Date of delivery or shipment

(7) SHIPPING

The Agreement Holder’s ship directly to the below medical treatment facility address indicated in the ship to block of the BPA calls for the medical treatment facility (MTF):

Overnight Deliveries will be shipped via Federal Express or UPS Services on or around 10:30 am in the event that immediate delivery is required.

a. The Agreement Holder shall submit a separate invoice for each BPA call. The invoice shall include the following information below:

a. Name of Supplier

b. BPA Number/Call number

c. Date of Purchase

d. Itemized list of supplies furnished

e. Quantity, unit price, and extension of each item less applicable discounts, if applicable

f. Date of delivery or shipment

The Agreement Holder shall submit invoices for BPA Calls in the Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF formerly known as WAWF).

(8) PAYMENT METHOLOGY (Government- Wide Purchase Card (GPC)

a. Agreement Holders that will be paid by Government credit card (GPC). The current Government credit card is VISA. All costs associated with the use of the credit card i.e. transaction fees, must be included in the price for the appropriate CLIN. See also FAR 52.232-36.

Invoices shall itemize implant products items used, showing the price for each product and the number utilized. If transportation charges are not included in the cost of the products, it must be prepaid and added to the invoice as a separate item. Invoice and credit card charges shall reflect the Blanket Purchase Agreement number and four digit call number.

Invoices need to be submitted to the outlying medical treatment facilities (MTF) addresses indicated in the ship to block of the BPA calls for the payment:

Credit card charges shall not be processed until the invoice has been certified and the cardholder has authorized payment. Payment amount MUST be based on actual surgery usage.

(9) PAYMENT METHOLOGY (Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF).

a. The Agreement Holder will be required to submit an invoice and receiving report (COMBO) into Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF for each BPA call delivery.

Invoicing must show quantity amounts at one, unit of issue will be JOB and will be subtracted from overall BPA call order amount. (i.e. billing for $150.00 will show as 150 Job @ $1). Subject to change based on USAHCA guidance

Instructions for submitting iRAPT invoices below:

Invoicing, Receipt, Acceptance and Property Transfer (iRAPT) – formerly known as WAWF iRAPT is the authorized method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically. Agreement Holder shall (i) register to use iRAPT at https://wawf.eb.mil and (ii) ensure an electronic business point of contract (POC) is designated in the System for Award Management at https://www.sam.gov within ten (10) calendar days after award of this contract/order.

iRAPT Instructions:

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) location listed in Block 15 of your call provided on the SF1155. Please have your purchase order/contract number ready when calling about payments.

You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/money/vendor . Your purchase order/contract number or invoice number will be required to inquire status of your payment.

DFAS POC: Vendor Pay (DFAS-INDY VP GFEBS), CODE: HQ0490

8899 E 56TH STREET

INDIANAPOLIS IN

Phone: 888-332-7366 OPTION 1 OR (317) 212-0300

The following codes and information will be required to assure successful flow of iRAPT documents.

Foreign Vendors will submit banking information in the Comments Tab of the iRAPT invoice.

TYPE OF DOCUMENT [X the appropriate block]

___ Invoice (Agreement Holder Only)

_____Invoice and Receiving Report (COMBO) 410. X__Invoice and Receiving Report (COMBO) **ONCE

THE WAWF INVOICE IS SUBMITTED, NOTIFY THE POINT OF CONTACT AT THE OUTLYING

MEDICAL FACILITES SO THE PAYMENT CAN BE PROCESSED IMMEDIATELY.

____ Invoice ___ Invoice as 2-in-1 (Services Only)

___ Receiving Report (Government Only)

CAGE CODE: SEE BLOCK 9 OF DD 1155

ISSUE BY DODAAC: SEE BLOCK 6 OF DD 1155

ADMIN BY DODAAC: SEE BLOCK 7 OF DD 1155

INSPECT BY DODAAC: SEE BLOCK 6 OF DD 1155

ACCEPT BY DODAAC: SEE BLOCK 6 OF DD 1155

SHIP TO DODAAC: SEE BLOCK 6 OF DD 1155

PAYMENT OFFICE FISCAL STATION CODE: SEE BLOCK PAYMENT WILL BE MADE BY OF DD 1155

When submitting invoices via (IRAPT), the Agreement Holder shall ensure that the Receiver and the Acceptor are notified that an invoice is pending by initially loading their email addresses in the record for the contract and selecting them for notification each time an invoice is submitted. Email addresses for the following positions will be provided apart from this clause at the time distribution of the contract is made:

INSPECTOR:

ACCEPTOR:

RECEIVING OFFICE POC:

ADMINISTRATOR: CONTRACTING OFFICER:

PRIMARY ALT CONTACT:

For more information contact: SEE ISSUE BLOCK 6 OF DD 1155 FOR THE CONTRACT SPECIALIST AND

BLOCK 24 OF DD 1155 FOR THE CONTRACTING OFFICER/ORDER OFFICER.

Any modification requests must be in writing and submitted to: ADMIN DODAAC.

10. CUSTOMER SERVICE

a. Agreement Holder shall ensure that all local or toll free customer service numbers are updated periodically to each know Government point of contact and the Contracting Office. In addition, Contactors shall assign an account manager to the order to ensure customer satisfaction. BPA call orders can be fax or via email to Agreement Holder.

b. The Agreement Holder shall provide authorized Sales Representatives for each outlying medical treatment facilities (MTF) are listed below:

Madigan Army Medical Center Departments (MAMC), Account number: ____________________ Tacoma, WA 98431

Bassett Army Community Hospital, Fort Wainwright AK, Account number: ____________________ 1060 Gaffney Road #7400 Fort Wainwright, AK 99703-7400

c. The Agreement Holder shall provide authorized Sales Representatives for each medical treatment facility (MTF) as listed below:

Madigan Healthcare System Departments (MAMC), Joint Base Lewis-McChord, Name Phone Email

The BPA holder’s Government Representative is:

Name Phone Email

The BPA holder’s Billing/Accounting Representative is:

Name Phone Email

The Agreement Holder shall ensure that all customer service numbers are updated periodically to the outlying MTF facility and the Contracting Office.

(11) WARRANTY PROVISIONS/RETURNS

Return Policy: Due to the nature of the Medical Products being procured under this agreement, the BPA HOLDER shall ensure that all deliverables are in compliance with Medical and FDA Regulations. The Agreement Holder/Sales Representative shall provide a replacement immediately if a deliverable is determined unsatisfactory in accordance with Medical Standards. A return evaluation number must be obtained prior to returning any product and should be used on the shipping label and on any correspondence in the package. All returned products shall be credited to the applicable account number and bpa call number.

(12) PROMOTION

The Agreement Holder agrees it shall not advertise the use of this BPA in such a manner as to state or imply that the medical treatment facility (MTF) endorse a product, project, or commercial product line.

NOTE: HIPPA –PHI clause is only applicable if representatives from the Agreement Holder are present during the actual surgeries being performed.

(13) Non-DHA HIPAA BAA (7 July 2014)

Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD Agreement Holder, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, SubAgreement Holder, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of Business Associate signatory to this BAA].

—Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this

BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean [insert name of MHS component signatory to this BAA].

—DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate

(NCRMD).

—DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

—DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

—HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

—HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566- 5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

—Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

(d) In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively), as applicable, the Business Associate shall ensure that any sub Agreement Holders that create, receive, maintain, or transmit PHI on behalf of the Business Associate agree to the same restrictions, conditions, and requirements that apply to the Business Associate with respect to such PHI.

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45

CFR 164.524.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526.

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45

CFR 164.528.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may only use or disclose PHI as necessary to perform the services set forth in the Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by the Agreement or directed by the Covered Entity.

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

(d) Except as otherwise limited in the Agreement, the Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in the Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

If the DHA…

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