A.09.03_W81K02-18-Q-0014-0001.pdf

W40M REGIONAL HEALTH CONTRACTING OF

US MEDCOM HCAA JBLM HCC

POC: ANGELA DEXTER

673 WOODLAND SQUARE LOOP SE, SUITE 101

LACEY WA 98503-1066

BPAMAMC201711

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

1.Amendment 0001 is to change the scope of w ork and the period of performance on the under this solicitation.

2. The date and time under this: Amendment 0001 has changed to 19 July 2018, at 10:00 am Local Time Pacific Time under this solicitation.

3. All other terms and conditions remain unchanged

1. CONTRACT ID CODE PAGE OF PAGES

J 1 21

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

16C. DATE SIGNED

BY 20-Jun-2018

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 W81K02-18-Q-0014

X 9B. DATED (SEE ITEM 11)

20-Jun-2018

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 X is extended, 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

20-Jun-2018

CODE

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FT SHAFTER HI 96858-5098

W81K02 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K02

FACILITY CODECODE

EMAIL:TEL:

1X

W81K02-18-Q-0014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 22-Apr-2018 10:00 AM to 19-Aug-2018 10:00 AM.

The solicitation issue date has changed from 26-Mar-2018 to 20-Jun-2018.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

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.

To:

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 surgeon evaluates implant products to determine those that will be best met the patient’s needs during surgery, and ensures that the products meet FDA requirements.

The following have been modified:

ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-1

W81K02-18-T-0050

Replace Paragraph 52.212-1(b) with the following:

INSTRUCTIONS FOR PREPARATION OF QUOTES:

Quoters shall submit signed and dated quotes to the office indicated in Block 9 of the Standard Form (SF) 1449, Solicitation/Contract/order for commercial Items, to arrive no later than the date and time specified in Block 8, SF 1449. The quoter shall have a title page identifying the quoter, the full address, phone/fax number, contacts (POCs) with email addresses, the solicitation number and its contents.

Acceptable Quote Submission:

Quotes shall be submitted via E-mail to: angela.a.dexter.civ@mail.mil

All submissions must clearly identify this notice and the name of the contract specialist on the first page or subject line. Submitters bear the burden of ensuring that the quote reaches the designated contracting office on time and should allow reasonable time for transmission to be completed. Large e-mail files may not transmit properly so it is advised to send large attachments in several separate e-mails. All pages of the transmission and attachments must reach the office before the deadline specified. Any part of the quote that arrives after the specified deadline will not be considered. The submitter bears the risk of non-receipt of quotes and should confirm by telephone that the quote was received. Contractor will be require to submit a price listing with the solicitation.

The surgeon evaluates implant products to determine those that will be best met the patient’s needs during surgery, and ensures that the products meet FDA requirements.

The point of contact for this requirement is Angela Dexter, Purchasing Agent at angela.a.dexter.civ@mail.mil

WRITTEN DOCUMENTATION: Quotes shall be prepared in three separate volumes as follows:

Factor 1– TECHNICAL Capability Factor 2 – PRESENT AND PAST PERFORMANCE Factor 3– PRICE

The quoter shall submit 1 copy of its entire quote. The submission of an incomplete quote may render the quote unacceptable and will not be considered.

WRITTEN DOCUMENTATION, shall include the following:

a. Request for Quotation. A copy of the Solicitation (SF 1449) with signatures of a corporate officer authorized to negotiate for the company. Include name of the company, phone, fax numbers, and email address(es).

b. Acknowledged and signed copies of amendment(s) if applicable. The number of copies required will be shown on the SF 30/amendment.

c. Completed copy of the Representations and Certifications at FAR 52.212-3, (Alternate I). If the quoter has completed the Representations and Certifications on the System for Award Management (SAM) at https://www.sam.gov, the quoter shall indicate such on their quote. The quoter shall also submit a completed copy of FAR 52.203-2, 52.209-2, 52.209-7, 52.209-11, 52.219-28, 52.222-22, 52.222-25; and DFARS 252.225- 7020, and 252.247-7022. Quoters may also complete annual representations and certifications electronically at https://sam.gov.

d. The quoter shall provide points of contact for administration of the contract during the quoter’s normal business hours and after normal business hours. The POC for other than normal business hours will be contacted only in the event of emergencies. Accordingly, the named individual(s) should possess sufficient corporate authority to effectively deal with emergency situations and the telephone number provided should be functioning at all times other than normal business hours. If there are different POCs for different conditions, such as weekdays, weekends, W81K02-14-Q-0014 holidays, etc., please furnish and explain:

(1) Quoter’s normal business hours/days:

(2) POC(s) during normal business hours:

(3) POC(s) for other than normal business hours:

FACTOR 1 TECHNICAL

a. To be considered for award, the quoter shall submit a detailed price list with the exact brand name, make, Model and part number of the product lines shown on of the solicitation. The products are determine by the by the patients’ physician/surgeon and determined by the physicians to be best suited to meet the medical, health and life-style needs of the specific patient for whom they are offeror in the commercial market.

b. Quoters shall provide evidence that they are an authorized distributor/reseller to provide the item(s) by submitting documentation from the manufacturer (if applicable). No prototypes, demonstration models, used or refurbished equipment will be considered.

FACTOR 2 – PRESENT AND PAST PERFORMANCE

The Government will evaluate each supplier’s present and past performance history in PPIRS-SR for the FSC and PSC of the supplies/services being purchased at the Government wide Past Performance Information Retrieval System PPIRS at www.ppirs.gov. The Government may also use information from its own records, information provided by the quoters or their customers, or from any other source it deems appropriate and consider them for present and past performance evaluation.

FACTOR 3: PRICE

a. Pricing for Requirements. The quoter shall submit proposed pricing for all items required for Various FDA-Approved Invasive Surgical Implants and Surgical products and meet the minimum requirements for all items on the item list.

b. Pricing shall be based on published catalog price lists and any discounts offered to the Government shall be as low as, or lower than, those charged to the contractors’ most favored customers for comparable quantities of similar items or services. Pricing will be included as an attachment to the BPA.

(m) Protests received at a level higher than the contracting officer will be referred to the contracting officer.

Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

(n) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and MEDCOM provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 for locations where full text can be obtained.

(End of Addendum to 52.212-1)

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 surgeon evaluates implant products to determine those that will be best met the patient’s needs during surgery, and ensures that the products meet FDA requirements.

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

Madigan Army Medical Center Departments (MAMC), Joint Base Lewis McChord, WA, Tripler Army Medical Center Departments (TAMC), Honolulu, HI

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. This agreement shall be in effect for a term of three (3) years starting on or about 1 August 2018 thru 31 July 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

Contractor shall provide 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

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, Tripler Army Medical Center Departments (TAMC), Honolulu, HI

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 Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable.

Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements immediately upon the Business Associate’s discovery of a possible breach.

(b) Government Reporting Provisions

The Business Associate shall report the breach within one hour of discovery to the Covered Entity and to the US Computer Emergency Readiness Team (US CERT) -the other parties as deemed appropriate by the Covered Entity.

The Business Associate is deemed to have discovered a breach as of the time a breach (suspected or confirmed) is known, or by exercising reasonable diligence would have been known, to any person (other than the person committing it) who is an employee, officer or other agent of the Business Associate.

The Business Associate shall submit the US-CERT report using the online form at https://forms.us-cert.gov/report/.

Before submission to US-CERT, the Business Associate shall save a copy of the on-line report. After submission, the Business Associate shall record the US-CERT Reporting Number. Although only limited information about the breach may be available as of the one hour deadline for submission, the Business Associate shall submit the US- CERT report by the deadline. The Business Associate shall e-mail updated information as it is obtained, following the instructions at http://www.us-cert.gov/pgp/email.html. The Business Associate shall provide a copy of the initial or updated US-CERT report to the -Covered Entity and the applicable Service-Level Privacy Office, if requested by either. Business Associate questions about US-CERT reporting shall be directed to the Covered Entity or Service- Level Privacy Office, not the US-CERT office.

The additional US Army and the US Army Medical Command (MEDCOM) reporting requirements are addressed in the PII Breach Reporting and Notification Policy. The latest version of this policy can be obtained from the Covered Entity or the MEDCOM Privacy Act/Freedom of Information Act (FOIA) Office at:

usarmy.jbsa.medcom.list.medcom-foia-users@mail.mil . If multiple beneficiaries are affected by a single event or related set of events, then a single reportable breach may be deemed to have occurred, depending on the circumstances. The Business Associate shall inform the Covered Entity as soon as possible if it believes that “single event” breach response is appropriate; the Covered Entity will determine how the Business Associate shall proceed and, if appropriate, consolidate separately reported breaches for purposes of Business Associate report updates, beneficiary notification, and mitigation.

When a Breach Report initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Business Associate shall submit a revised form or forms, stating the updated status and previous report date(s) and showing any revisions or additions in red text. Examples of updated information the Business Associate shall report include, but are not limited to: confirmation on the exact data elements involved, the root cause of the incident, and any mitigation actions to include, sanctions, training, incident containment, follow-up, etc. The Business Associate shall submit these report updates promptly after the new information becomes available. Prompt reporting of updates is required to allow the Covered Entity to make timely final determinations on any subsequent notifications or reports. The Business Associate shall provide updates to the same parties as required for the initial Breach Report. The Business Associate is responsible for reporting all information needed by the Covered Entity to make timely and accurate determinations on reports to HHS as required by the HHS Breach Rule and reports to the Defense Privacy and Civil Liberties Office as required by DoD Privacy Act Issuances.

In the event the Business Associate is uncertain on how to apply the above requirements, the Business Associate shall consult with the Covered Entity (or the Service-Level Privacy Office, which will consult with the DHA Privacy Office as appropriate) when determinations on applying the above requirements are needed.

(c) Individual Notification Provisions

If the DHA Privacy Office determines that individual notification is required, the Business Associate shall provide written notification to individuals affected by the breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities of the individuals are ascertained. The 10 day period begins when the Business Associate is able to determine the identities (including addresses) of the individuals whose records were impacted.

The Business Associate’s proposed notification to be issued to the affected individuals shall be submitted to the parties to which reports are submitted…