BPA_COMBINED_S_AND_S.docx

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Classification Code:

Contracting Office Address Regional Health Contracting Office - Central Fort Carson Health Contracting Cell 1650 Cochrane, Bldg 7500, Room 2510 Fort Carson, CO 80913-4604 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

The solicitation W91YU0-16-T-0039 is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 and Department of Defense FAR Supplement DPN 20151001.

The Regional Health Contracting Office – Central (RHCO-C), Fort Carson Health Contracting Cell, Fort Carson, CO intends to award a single Blanket Purchase Agreement (BPA) for a various consumable FDA approved Surgical Invasive Implants, Osteosynthesis Surgical Implants, Trauma Systems, Orthopedic Medical Devices for Extremity Procedures, Biologic Technologies, Neurosurgery, Oral Maxillofacial Surgery, Cardiothoracic Surgery and other instrument or related consumable supplies and accessories, and/or tools necessary for patient specific needs basis on the surgeons requirement, FDA approved vendors, both large and small businesses. Vendors should contact RHCO-C via email, if interested and provide a price list providing prices of the most favored customer. This solicitation is for Wright Medical Technology surgical implants.

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

If vendors are other than the Original Equipment Manufacturers (OEM), please provide evidence that there is an existing and ongoing business relationship that will allow distribution of the OEM products.

This solicitation and resultant master BPA is conducted as unrestricted under full and open competition using a primary NAICS code 339113, Surgical Appliance and Supplies Manufacturing and secondary NAICS code 339112, Surgical and Medical Instrument Manufacturing. The associated small business size standard is 500 employees. Simplified acquisition procedures found in FAR Part 13 will be followed. All responsible sources may submit an offer which shall be considered by the government.

All responsible Contractors shall provide price/product listing, which will be incorporated into the BPA.

The Place of Performance (Delivery Location) will vary depending on the location of need. The products are to support the following medical treatment facilities (MTF).

Evans Army Community Hospital, Fort Carson, CO Irwin Army Community Hospital, Fort Riley, KS William Beaumont Army Medical Center, El Paso, TX

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

a. FAR 52.212-1, “Instructions to Offerors–Commercial Items” (April, 2014) applies to this acquisition and the following addenda is provided. Addendum to 52.212-1:

INSTRUCTIONS TO QUOTERS

Submitting your quote. Submit your company’s written quote by email to the contract specialist specified in the Combined Synopsis/Solicitation of this Request For Quotes (RFQ). You may submit more than one quote. If you do, we will evaluate each separately.

Submission deadline. We must receive your quote at the email address specified in the Combined Synopsis/Solicitation by the deadline specified in the Combined Synopsis/Solicitation. We will not consider any quote that we receive after the deadline unless we receive it before we issue a purchase order and considering it will not delay our purchase. In case of an emergency that delays our operations and makes submission or receipt of your quote impossible, we will extend the deadline by one working day.

Terms and content of your quote. Your quote must be based on the terms of this RFQ. We might reject any quote that is not based on these terms in every respect. Your quote must contain all of the information described below.

Issuance of purchase order. Your quote should contain your best terms. The Contracting Officer may reject any or all quotes. After the evaluation of quotes, the Contracting Officer may negotiate final terms with one or more quoters of the Government’s choice before issuing a purchase order. The Contracting Officer will not negotiate with any quoters other than those of the Government’s choice and will not use the formal source selection procedures described in FAR Part 15.

The Contracting Officer may issue a purchase order to other than the quoter with the lowest price. We might issue multiple orders, purchasing various items or groups of items from different quoters. We might issue an order for less than the quantity on which your quote is based, at the quoted price, unless you tell us that you will not accept an order on that basis.

Information to be submitted. Put the following information on the first page of your quote: 1. the number of this RFQ; 2. your company name, address, DUNS number (see below) and telephone number; 3. your price and any discount terms; 4. acknowledgement of any amendments to this RFQ; and 5. a statement that you assent to all terms of this RFQ.

Beginning on the second page of your quote, provide the following information in the following order: 1. a detailed description of the product that you will provide; 2. the terms of any express warranty; 3. your payment address; 4. references to current or former customers who will attest to the quality of your product or service in the within the past three years, including (i) customer name, (ii) customer address, (iii) contract or purchase order numbers, (iv) persons to contact, and (v) telephone numbers.

Availability of Government Documents. If the descriptions in this RFQ of the products we want to buy refer to any Government specification, standard, or commercial item description, you may obtain a copy of any such documents from the places listed in Federal Acquisition Regulation 52.212-1, paragraph (i).

System for Award Management (SAM). Unless exempted by the Contracting Officer, you must register in SAM before we will issue a purchase order to you. If you do not register by the date set by the Contracting Officer, the Contracting Officer might issue the order to a different quoter. Once registered, you must remain registered throughout performance until final payment. Go tohttps://www.acquisition.gov for information on SAM registration and annual confirmation.

DUNS Number (Data Universal Numbering System Number). [This applies to all quotes if the solicitation requires that you be registered in the System for Award Management (SAM).] Place the annotation “DUNS” or “DUNS+4” next to your name and address on the first page of your quote followed by the DUNS or DUNS+4 number that identifies the quoter’s name and address.

If you do not have a DUNS number, contact Dun and Bradstreet to obtain one. If you are located within the United States, you may contact Dun and Bradstreet by calling 1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform.

If you are located outside the United States, you must contact the local Dun and Bradstreet office for a DUNS number. Tell Dun and Bradstreet that you are a quoter for a Government contract when contacting the local Dun and Bradstreet office.

The DUNS+4 is the DUNS number plus a 4-character suffix that you may use at your discretion to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts (see FAR Subpart 32.11) for your company.

All responsible Contractors shall provide price/product listing, which will be incorporated into the BPA.

Paragraph 52.212-1(c), Period for Acceptance of Offers. Replace with the following:

Government Minimum Acceptance Period. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless the Government specifies another time period in an addendum to the solicitation. The Government will not consider offers providing less than 90 calendar days for Government acceptance.

· Paragraphs 52.212-1 (d), (e), (h), (i) are deleted.

· Paragraph 52.212-1(m), Filing of Agency Protest. Add the following: 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 appeals or 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.

· Paragraph 52.212-1(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.

The provision at 52.212-2, Evaluation -- Commercial Items, applies to this acquisition. Price will be evaluated for reasonableness against the bidders price catalog. Price discounts are highly encouraged. Past performance will be evaluated as “pass” or “fail” or “neutral”. All bidders with Past Performance as “pass” or “neutral” will be considered for award. Prices of ten randomly selected part numbers will be evaluated for each proposal and the lowest evaluated price will receive the master BPA award. The government intends to award a contract without discussions with respective bidders. The government, however, reserves the right to conduct discussions if deemed in its best interest. Paragraphs (b) and (c) will be used and remain unchanged. (End of Addendum to 52.212-2)

(9) Offeror’s shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items Alt I (see attached), or a statement indicating that you have completed on-line at https://orca.bpn.gov/, with its offer.

FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (Dec 2014), applies to this acquisition and addenda to the clause is as follows: Addendum to paragraph 52.212-4(c): UNILATERAL MODIFICATIONS. The Government may make unilateral modifications considered administrative in nature. These include, but are not limited to, changes in the accounting and appropriation data, payment and issuing office addresses, and other corrections that have no effect on the terms and conditions of the contract.

(v) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found. (End of Addendum to 52.212-4)

1. FAR 52.233-2, Service of Protest

· The Contracting Officer’s address is:

Regional Health Contracting Office - Central 3551 Roger Brooke Drive, Bldg 1103 JBSA, Fort Sam Houston, TX 78234-4504

The following contract clauses/provisions apply to this acquisition:

· FAR 52.203-3, Gratuities (Apr 1984)

· FAR 52.203-6, Alternate I, Restrictions on Subcontractor Sales to the Government (Oct 1995)

· FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013)

· FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2015)

· FAR 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013)

· FAR 52.219-8, Utilization of Small Business Concerns (Oct 2014)

· FAR 52.219-28, Post-Award Small Business Program Rerepresentation (Jul 2013)

· FAR 52.222-3, Convict Labor (Jun 2003)

· FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014)

· FAR 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

· FAR 52.222-26, Equal Opportunity (Apr 2015)

· FAR 52.222-35, Equal Opportunity for Workers with Disabilities (Jul 2014)

· FAR 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)

· FAR 52.222-37, Employment Reports on Veterans (Jul 2014)

· FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

· FAR 52.222-50, Combating Trafficking in Persons (Mar 2015)

· FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011)

· FAR 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008)

· FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)

· FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

· DFARS 252.203-7000, Requirements Relating to Compensation of Former DOD Officials (Sep 2011)

· DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights (Sep 2013)

· DFARS 252.203-7005, Representation Relating to Compensation of Former DOD Officials (Nov 2011)

· DFARS 252.204-7008, Compliance with Safeguarding Covered Defense Information Controls (DEVIATION 2016-O0001)(Oct 2015)

· DFARS 252.204-7011, Alternative Line Item Structure (Sep 2011)

· DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting (DEVIATION 2016-O0001) (Oct 2015)

· DFARS 252.204-7015, Disclosure of Information to Litigation Support Contractors (Feb 2014)

· DFARS 252.213-7000, Notice to Prospective Suppliers on Use of Past Performance Information Retrieval System—Statistical Reporting in Past Performance Evaluations (Jun 2015)

· DFARS 252.222-7007, Representation Regarding Combating Trafficking in Persons (Jan 2015)

· DFARS 252.225-7000, Buy American—Balance Of Payments Program Certificate—Basic (Nov 2014)

· DFARS 252.225-7001, Buy American and Balance of Payments Program (Nov 2014)

· DFARS 252.225-7012, Preference for Certain Domestic Commodities (Feb 2013)

· DFARS 252.225-7050, Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism (OCT 2015)

· DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports (Jun 2012)

· DFARS 252.232-7006, Wide Area WorkFlow Payment Instructions (May 2013)

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

· DFARS 252.243-7002, Requests for Equitable Adjustment (Mar 1998)

· DFARS 252.244-7000, Subcontracts for Commercial Items and Commercial Components (Jun 2013)

· DFARS 252.203-7996, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (OCT 2015) (DEVIATION 2016-O0003)

· DFARS 252.209-7991, Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under Any Federal Law—Fiscal Year 2016 Appropriations (OCT 2015) (DEVIATION 2016-O0002)

· DFARS 252.203-7997, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (OCT 2015) (DEVIATION 2016-O0003)

1. FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Jul 2014) (Deviation 2013-O0019) The following subparagraphs of FAR 52.212-5 are applicable:

· Subparagraphs (b)(4), (b)(8), (b)(14)(ii), (b)(19), (b)(25), (b)(28 – 34), (b)(40), (b)(42), (b)(44)(iv), (b)(46), (b)(52) All offerors shall submit one copy of their price quote.

All quotations shall be sent to the Contracting Specialist via e-mail. Any questions or concerns regarding this solicitation should be submitted in writing via e-mail to the contract specialist:

This is an open-market combined synopsis/solicitation for product as defined herein. The government intends to award a master BPA as a result of this combined synopsis/ solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all offers must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Offeror shall list exception(s) and rationale for the exception(s).

Potential contractors must be registered in the System for Award Management (SAM), online at www.sam.gov to be eligible for award. The SAM internet web site is www.sam.gov.

Submission shall be received not later than November 30, 2015 at 10:00 a.m. Mountain Standard Time. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mail submissions are the only form of submission that will be accepted. Receipt will be verified by the date/time stamp on e-mail.

BLANKET PURCHASE AGREEMENT

Scope of Work

(1) AUTHORITY

This agreement is established in accordance with FAR 13.303, Blanket Purchase Agreements (BPA's), FAR 13.5, Test Program for Certain Commercial Items, and AFARS 5113.303-2 (S90), Use of Blanket Purchase Agreements. 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, and the Federal Acquisition Regulation as updates occur. Any revisions will be incorporated by modification to this BPA.

(2) DESCRIPTION OF AGREEMENT

a. The contractor shall provide various U.S. Food and Drug Administration (FDA) approved Surgical Invasive Implants, Osteosynthesis Surgical Implants, Trauma Systems, Orthopedic Medical Devices for Extremity Procedures, Biologic Technologies, Neurosurgery, Oral Maxillofacial Surgery, Cardiothoracic Surgery and other instrument or related consumable supplies and accessories, and/or tools necessary for patient specific needs basis on the surgeons requirement. The products are to support for the following medical treatment facilities (MTF).

Evans Army Community Hospital, Fort Carson, CO Irwin Army Community Hospital, Fort Riley, KS William Beaumont Army Medical Center, El Paso, TX

A Master Blanket Purchase Agreement is being established to allow maximum flexibility and efficiency in the procurement of the various FDA approved Surgical Invasive Implants, Osteosynthesis Surgical Implants, Trauma Systems, Orthopedic Medical Devices for Extremity Procedures, Biologic Technologies, Neurosurgery, Oral Maxillofacial Surgery, Cardiothoracic Surgery and other instrument or related consumable supplies and accessories, and/or tools necessary for patient specific needs basis on the surgeons requirement.

This agreement shall be in effect for a term of two years. Either party may terminate this agreement by giving thirty (30) days written notice.

b. The contractor’s submitted product catalog and pricing (TO INCLUDE ALL APPLICABLE DISCOUNTS) is incorporated into this Agreement, and all BPA Calls shall utilize this pricing. Discount pricing may vary from 0 percent to 50 percent depending on best customer pricing. Any updates or changes to the product catalogs or pricing must be approved by the Contracting Officer for incorporation into this Agreement. The contractor must allow thirty (30) days for the revised catalog to be incorporated into the Agreement.

c. The Government may place BPA Calls to fund the estimated expenditures for the entire year with one order, or may place multiple BPA Calls during the year for limited periods. BPA Calls will not cross fiscal years (except for required delivery time).

d. BPA calls will be issued by the Fort Carson Health Contracting Cell (FCHCC) located on Fort Carson, CO.

(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 facilities (MTFs) that orders Various Consumable FDA Surgical Invasive Implants, Osteosynthesis Surgical Implants, Trauma Systems, Orthopedic Medical Devices for Extremity Procedures, Biologic Technologies, Neurosurgery, Oral Maxillofacial Surgery, Cardiothoracic Surgery and other instrument consumable supplies and accessories, and/or tools necessary for patient specific needs will be responsible for payment of any obligation via DFAS Indy (GEFEBS).

b. Purchase Limitation:

BPA Call Limit: $150,000.00 but not to exceed $150,000.00 (if ordered through the Contracting Office) BPA Master Dollar Limit: $600,000.00 (for life of Agreement)

(4) ORDERING PROCEDURES

This contract uses a CLIN structure that allows the purchase of all items within the scope of the items covered by this BPA. The quantity and types of items needed for those medical treatments and emergencies vary over time based on patient needs. Each BPA Call will be funded to $150,000.00 and allow the facility to place telephonic orders for specific requirements/emergencies against that BPA Call until all funds are depleted. This also allows for procurement of new items as technology advances without the need to modify the contract to include them.

As requirements occur, medical treatment facilities (MTFs) will rotate contacting the various BPA holders for these products, and depending on the availability and delivery time of the products, will schedule deliveries accordingly.

Evans Army Community Hospital, Fort Carson, CO Irwin Army Community Hospital, Fort Riley, KS William Beaumont Army Medical Center, El Paso, TX

(5) Designated Individuals Authorized to Schedule Deliveries under the BPA

a. Each BPA Call paid by DFAS Indy 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 the designated appointed authorized individuals for calls.

c. Designated Individuals Authorized Responsibilities and Requirements (Requiring Activity):

1. The requiring activity is 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 Regional Health Contracting Office - Central (RHCO-C).

2. FCHCC issues a BPA Call and provides the contractor with the funded BPA Call document with a call number. The requiring activity shall use an authorized BPA holder 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. The requiring activity shall maintain a detailed log of delivery requests scheduled and decrement funding on their call each time a delivery request is scheduled. In minimum, for audit purposes, the log shall include delivery date, item number, nomenclature, quantity, $ amount, and BPA Call number.

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:

b. Upon use of the BPA holder’s product by the MTFs, the unit will send the BPA holder a confirmation document for acceptance of the product. The confirmation document will include the BPA and Call Number.

(7) SHIPPING

The Contractor shall ship directly to the Medical Treatment Facility address indicated in the ship to block of the BPA call for the medical treatment facilities (MTFs):

Evans Army Community Hospital, Fort Carson, CO Irwin Army Community Hospital, Fort Riley, KS William Beaumont Army Medical Center, El Paso (Fort Bliss), TX

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

Freight shall be inclusive to unit pricing and added to each invoice, if applicable.

The F.O.B. or Origin freight point is:___________________.

a. The contractors shall submit a separate invoice for each BPA Call. The invoice shall include the following information below:

The contractor shall submit invoice for Calls to the attention of the respective ordering individual who will verify material receipt and provide GPC information for payment purposes.

Monthly Report:

The MTF’s designated appointed individual shall submit call usage report to the contracting officer; stewart.c.penrod.civ@mail.mil NLT the end of the month (30th). The monthly call 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.

Fort Carson Health Contracting Cell 1650 Cochrane Circle, Bldg 7500 Fort Carson, CO 80913-4604

b. INVOICES (DFAS Indy GEFEBS payments, CODE: HQ0490) The contractor shall be required to submit an invoice and receiving report (COMBO) in to the Army Electronic Invoicing system through invoice Receipt, Acceptance, and Property Transfer (iRAPT) for each BPA Call delivery. Within 30 days delivering an ordered product, the BPA holder shall submit a hard copy invoice to the outlying medical treatment facilities indicated in the ship to address block with the following information:

c. Contractors shall list the account number or provide a separate account for each MTF:

Evans Army Community Hospital (EACH) _____________________________ 7500 Cochran Circle Account Number Fort Carson, CO 80913

Fort Riley, KS 6642-5037

William Beaumont Army Medical Center (WBAMC) _________________________ 5005 North Piedras Street Account Number El Paso, TX 79920-5001

(8) PAYMENT METHOLOGY (invoicing, Receipt, Acceptance and Property Transfer) (iRAPT)

a. The contractor will be required to submit an invoice and receiving report (COMBO) into the Army Electronic Invoicing system through iRAPT for each BPA call delivery. Invoicing must show quantity amounts at 1$ each and will be subtracted from overall BPA Call order amount. (i.e. billing for $250.00 will show as 250 ea @ $1).

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. Contractor 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 18a of your purchase order/contract. 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

XX Invoice and Receiving Report (COMBO) ONCE THE iRAPT INVOICE IS SUBMITTED,NOTIFY THE POINT OF CONTACT, To be determined on each BPA Call

SO THE PAYMENT CAN BE PROCESSED

CAGE CODE:

PAYMENT OFFICE FISCAL STATION CODE: HQ0490

EMAIL POINTS OF CONTACT LISTING: (Use Group e-mail accounts if applicable)

INSPECTOR: To be determined on each BPA Call ACCEPTOR: To be determined on each BPA Call RECEIVING OFFICE POC: To be determined on each BPA Call CONTRACT ADMINISTRATOR/ SPECIALIST: To be determined on each BPA Call CONTRACTING OFFICER: To be determined on each BPA Call

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.

(9) CUSTOMER SERVICE

a. Contractor 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 Contractor.

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

Evans Army Community Hospital (EACH)

Name Phone Email

Irwin Army Community Hospital (IACH)

Name Phone Email

William Beaumont Army Medical Center (WBAMC)

Name Phone Email

The BPA holder’s Government Representative is:

Name Phone Email

The BPA holder’s Billing/Accounting Representative is:

Name Phone Email

(10) 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 contractor/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 Call number.

(11) PROMOTION

The contractor agrees it shall not advertise the use of this BPA in such a manner as to state or imply that MTFs endorses a product, project, or commercial product line.

NOTE: HIPPA –PHI clause is only applicable if representatives from the Contractor are involved in the actual surgeries being performed.

(12) HCAA Local Clause 5001 - 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 contractor, 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, Subcontractor, 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 USACHA (P)/Medical Command.

—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 subcontractors 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 under paragraph V (a) for their review, and for approval by the DHA Privacy Office. Upon request, the Business Associate shall provide the DHA Privacy Office with the final text of the notification letter sent to the affected individuals. If different groups of affected individuals receive different notification letters, then the Business Associate shall provide the text of the letter for each group. (PII shall not be included with the text of the letter(s) provided.) Copies of further correspondence with affected individuals need not be provided unless requested by the Privacy Office. The Business Associate’s notification to the individuals, at a minimum, shall include the following:

—The individual(s) must be advised of what specific data was involved. It is insufficient to simply state that PII has been lost. Where names, Social Security Numbers (SSNs) or truncated SSNs, and Dates of Birth (DOBs) are involved, it is critical to advise the individual that these data elements potentially have been breached.

—The individual(s) must be informed of the facts and circumstances surrounding the breach. The description should be sufficiently detailed so that the individual clearly understands how the breach occurred.

—The individual(s) must be informed of what protective actions the Business Associate is taking or the individual can take to mitigate against potential future harm.