PRESOL | 65 | Various Blanket Purchase Agreements (BPAs) on FDA approved Corneal Implants and Eye Tissue related products such as , DSAEK cut cornea, Whole sclera, Half sclera, and Quarter sclera for patient specific requirements

FBO DAILY ISSUE OF NOVEMBER 24, 2011 FBO #3652
SOLICITATION NOTICE

65 -- Various Blanket Purchase Agreements (BPAs) on FDA approved Corneal Implants and Eye Tissue related products such as , DSAEK cut cornea, Whole sclera, Half sclera, and Quarter sclera for patient specific requirements

Notice Date: 11/22/2011
Notice Type: Combined Synopsis/Solicitation
NAICS: 621991 — Blood and Organ Banks
Contracting Office: Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
ZIP Code: 98431-1110
Solicitation Number: W91YU0-12-T-0014
Response Due: 12/22/2011
Archive Date: 2/20/2012
Point of Contact: Angela Dexter, 253-968-4912
E-Mail Address: Western Regional Contracting Office
(angela.dexter@amedd.army.mil)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation W91YU0-12-T-0014 of Purchase Request BPAEYETISSUE321 is issued as a Request for Quote (RFQ). This request is for information and set up to process Various Blanket Purchase Agreements (BPAs) on FDA approved Corneal Implants and Eye Tissue related products such as, DSAEK cut cornea, Whole sclera, Half sclera, and Quarter sclera for patient specific requirements. The Primary delivery point will be to Irwin Army Community Hospital, Ft. Riley, Kansas. Additionally, we may include deliveries/calls to the following facilities, within the Western Region Medical Command, to include, but not limited to the following outlying facilities: Madigan Health Care System Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright AK, Evans Army Hospital, Fort Carson CO, Raymond W Bliss Army Health Center, Fort Huachuca AZ Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, Munson Army Health Center, Fort Leavenworth KS, William Beaumont Army Medical Center, El Paso TX, McAffee Army Health Clinic, White Sands Missile Range NM Weed Army Community Hospital, Fort Irwin, CA 92310 See attached Blanket Purchase Agreement Scope of Work. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-54. Simplified acquisition procedures will be followed. The NAICS Code being used is 621991 - Blood and Organ Banks, FSC Code is 6505 Drugs and Biologicals. Interested parties must register in the Central Contractor Registration (CCR), online at www.ccr.gov All responsible Contractors shall fill out the attached Blanket Purchase Agreement Scope of Work and provide price listing. The full text of a FAR provision or clause may be accessed electronically at www.farsite.hill.af.mil. The following provisions apply to this acquisition: 52.212-1 Instructions to Offerors-Commercial Items. 52.212-3 Offerors Representations and Certifications- Commercial Items. Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following clauses apply to this acquisition: 52.204-7 Central Contractor Registration, 52.212-4 Contract Terms and Conditions Commercial Items. 52.212-5 (DEV) Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items including subparagraphs: 52.222-3, Convict Labor, 52.222-19 Child Labor Cooperation With Authorities And Remedies, 52.222-21, Prohibition of Segregated Facilities 52-222-26, Equal Opportunity, 52.222-35 Equal Opportunity for Special Disabled Veterans, 52.222-36, Affirmative Action for Workers with Disabilities, 52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other eligible Veterans, 52.222-50 Combat Trafficking in Persons, 52.225-13 Restriction on Certain Foreign Purchases,52.232-18 availability of Funds, and 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration. 252.225-7001, Buy American Act and Balance of Payments Program, 252.225-7036, Buy American Free Trade Agreement Balance of Payments Program 252.232-7003, Electronic Submission of Payment Requests, 252.232-7010 Levies on Contract Payments, 252.247-7023, Transportation of Supplies by Sea 252.247-7023 Alt III, Transportation of Supplies by Sea. Clauses Incorporated by reference FAR 52.252-2 and DFAR 252.212-7001 (DEV), Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items, 52.203.3 Gratuities; 252.225-7001 Buy American Act and Balance of Payments Program; 252.232-7003 Electronic Submission of Payment Requests; 252.247-7023 Transportation of Supplies by Sea; Alternate III. WAWF Instructions (local clause available via e-mail request). Potential contractors must be registered in the Central Contractor Registry (CCR) to be eligible for award. The CCR internet web site is http://www.ccr.gov. Offers are due by 31 December 2011, 10:00 AM, LOCAL Pacific Standard Time. Submit offers via fax to (253) 968-4091 or email to angela.dexter@us.army.mil. ALL QUESTION NEED TO BE SUBMITTED VIA EMAIL. BLANKET PURCHASE AGREEMENT (BPA) Scope of Work Western Region Contracting Office Tacoma, WA 98431 (1) AUTHORITY This agreement is established in accordance with FAR 13.303, Blanket Purchase Agreements (BPA). 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 FDA-approved contractor shall provide Various Corneal Implants for patient specific requirements. Other items ordered may include, but not limited to: Corneal Implant Tissue or relate Eye Tissue products such as, DSAEK cut cornea, Whole sclera, Half sclera, and Quarter sclera. Primary delivery point will be to Irwin Army Community Hospital, Ft. Riley, Kansas. This agreement shall be in effect for a term of five (5) years. 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. Master Blanket Purchase Agreements are being established to allow maximum flexibility and efficiency in the procurement of the Various Corneal Implants products. Additionally, we may include deliveries/calls to the following facilities, within the Western Region Medical Command, to include, but not limited to the following outlying facilities: Madigan Health Care System Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright AK, Evans Army Hospital, Fort Carson CO, Raymond W Bliss Army Health Center, Fort Huachuca AZ Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, Munson Army Health Center, Fort Leavenworth KS, William Beaumont Army Medical Center, El Paso TX, McAffee Army Health Clinic, White Sands Missile Range NM Weed Army Community Hospital, Fort Irwin, CA 92310 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. 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 Western Regional Contracting Office (WRCO) located on Joint Base Lewis-McChord (JBLM) Tacoma, WA and the Contracting Office Cell located at William Beaumont Army Medical Center, Ft Bliss (El Paso), TX (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 outlying medical treatment facilities (MTFs) that orders Various Corneal Implants products will be responsible for payment of any obligation via Government Credit Card, or DFAS Indy (GEFEBS). b. Purchase Limitation: BPA Call Limit- $25,000.00 (if placed via Government Purchase Card) BPA Call Limit - $150,000.00(if ordered through the Contracting Office) BPA Master Dollar Limit=$2,000,000.00 (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 contract. 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 between $25,000.00 to $150,000.00 depending on payment method, and allow the facility to place telephonic orders for specific requirements/emergencies against that BPA CALL until the 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, outlying 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. Madigan Health Care System Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright, AK Evans Army Hospital, Fort Carson, CO Raymond W Bliss Army Health Center, Fort Huachuca, AZ Irwin Army Hospital, Fort Riley, KS Gen Leonard Wood Army Hospital, Fort Leonard Wood, MO Munson Army Health Center, Fort Leavenworth, KS William Beaumont Army Medical Center, El Paso (Fort Bliss), TX McAffee Army Health Clinic, White Sands Missile Range, NM Weed Army Community Hospital, Fort Irwin, CA (5) 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 appointed authorized ordering individuals for calls under payment terms by Government Credit Card. c. Each order under this agreement will be assigned a Call number or separate unique number by the Western Regional Contracting Office or the Ordering Officer using the Government Credit Card. Invoices shall reflect BPA number and Call number. Deliveries will be scheduled by, outlying medical treatment facilities (MTFs), and a call number will be associated with each delivery. 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 (purchase/call) order Number 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 b. Upon use of the BPA holder's product by outlying medical treatment facilities (MTFs), the unit will send the BPA holder a confirmation document for acceptance of the product. The confirmation document will include the BPA Number and BPA Call Number. (7) SHIPPING The Contractor shall ship directly to the Medical Treatment Facility address indicated in the ship to block of the BPA calls for the outlying medical treatment facilities (MTFs): Madigan Health Care System Departments (MAMC), Joint Base Lewis McChord, WA Bassett Army Community Hospital, Fort Wainwright, AK Evans Army Hospital, Fort Carson, CO Raymond W Bliss Army Health Center, Fort Huachuca, AZ Irwin Army Hospital, Fort Riley, KS Gen Leonard Wood Army Hospital, Fort Leonard Wood, MO Munson Army Health Center, Fort Leavenworth, KS William Beaumont Army Medical Center, El Paso (Fort Bliss), TX McAffee Army Health Clinic, White Sands Missile Range, NM Weed Army Community Hospital, Fort Irwin, CA Overnight Deliveries will be shipped via Federal Express or UPS Services on or around 10:30 am in the invent that 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: 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 Note: The contractor shall be responsible for any and all transaction service charges incurred for the acceptance of GPC payment. The contractor shall submit invoice for calls to the attention of the respective ordering individual who will verify material receipt and provide government purchase card (GPC) information for payment purposes. Monthly Report: The outlying medical treatment facilities (MTFs) shall submit monthly call reports to, no later than the 5th business day following the end of each. Western Regional Contracting Office ATTN: Simplified Acquisition Team 9902 Lincoln STR MAMC Annex Tacoma, WA 98431-1100 b. INVOICES (DFAS Indy GEFEBS payments) The contractor shall be required to submit an invoice and receiving report (COMBO) in to the Army Electronic Invoicing system through Wide Area Workflow (WAWF) 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: 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\ Monthly Report: The outlying medical treatment facilities (MTFs) shall maintain a usage report on each BPA call which must be submitted to the BPA Purchasing Agent at the Western Regional Contracting Office or the William Beaumont Contracting Cell monthly. c. Contractors shall list the account number or provide a separate account for each outlying medical treatment facility (MTF): Madigan Army Medical Center Departments (MAMC), _________________- Account number Bldg 9040A (Receiving Section) Fitzsimmons Tacoma, WA 98431 Bassett Army Community Hospital, Fort Wainwright AK, _________________ Account number 1060 Gaffney Road #7400 Fort Wainwright, AK 99703-7400 Evans Army Hospital, Fort Carson CO, _____________________ Account number 7500 Cochran Circle Fort Carson, CO 80913-4604 Raymond W Bliss Army Health Center, Fort Huachuca AZ ____________________ Account number 45001 Winrow Drive Fort Huachuca, AZ 85613-7040 Irwin Army Hospital, Fort Riley KS, ___________________________ Account number 600 Caisson Hill Road Fort Riley, KS 6642-5037 Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, __________________ Account number 126 Missouri avenue Fort Leonard Wood, MO 65473-8952 Munson Army Health Center, Fort Leavenworth KS, ____________________ Account number 550 Pope Avenue Fort Leavenworth, KS 66027-2332 William Beaumont Army Medical Center, El Paso TX, __________________ Account number 5005 North Piedras Street El Paso, TX 79920-5001 McAffee Army Health Clinic, White Sands Missile Range NM ____________________ Account number Bldg 530 Rock Island Avenue White Sands Missile Range, NM 8802-5220 Weed Army Community Hospital, Fort Irwin, CA 92310, _____________________ Account number PBO/Material Receiving Point Bldg 178 Inner Loop Fort Irwin CA 92310-9986 (9) PAYMENT METHOLOGY (Government- Wide Purchase Card (GPC) a. Contractors 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 pharmaceuticals 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. b. PAYMENT METHOLOGY (WIDE AREA WORK FLOW) a. The contractor will be required to submit an invoice and receiving report (COMBO) into the Army Electronic Invoicing system through Wide Area Workflow (WAWF) 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 250ea @ $1). Instructions for submitting WAWF invoices below: ARMY ELECTRONIC INVOICING INSTRUCTIONS (FEB 2006) Contractor shall submit payment request using the following method(s) as mutually agreed to by the Contractor, the Contracting Officer, the contract administration office, and the payment office. __X_Wide Area Workflow (WAWF) (see instructions below) _____Web Invoicing System (WInS) (https://ecweb.dfas.mil) _____American National Standards Institute (ANSI) X.12 electronic data interchange (ESI) formats (http://www.dfas.mil/ecedi) _____Other (Please specify)_________________________________________________ DFAS -INDY VP GFEBS DODAAC: HQ0490 Phone number: 888-332-7366 or (317) 212-0300 OPTION 1 WAWF is the mandatory method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically. Contractor electing to use WAWF shall (i) register to use WAWF at https://wawf.eb.mil and (ii) ensure an electronic business point of contact (POC) is designated in the Central Contractor Registration site at http://www.ccr.gov within ten (10) calendar days after award of this contract/order. WAWF Instructions: Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) identified in Block 15 (Payment will be made by) of DD 1155 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 about the status of your payment. The following codes and information will be required to assure successful flow of WAWF documents. TYPE OF DOCUMENT - VENDOR WILL SUBMIT INVOICE INTO WAWF AS INDICATED BELOW: _____Commercial Item Financing _____Construction Invoice (Contractor Only) _____Invoice (Contractor Only) ___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 as 2-in-1 _____Performance Based Payment (Government Only) _____Progress Payment (Government Only) _____Cost Voucher (Government Only) _____Receiving Report (Government Only) _____Receiving Report with Unique Identification (UID) Data (Government Only) *UID is a new globally unique "part identifier" containing data elements used to track DoD parts through their life cycle. _____Summary Cost Voucher (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 LOCAL PROCESSING OFFICE DODAAC: NOT USED. IF REQUIRED BY WAWF ENTER DODAAC FROM SHIP TO ADDRESS OF DD 1155 PAYMENT OFFICE FISCAL STATION CODE: SEE BLOCK PAYMENT WILL BE MADE BY OF DD 1155 When submitting invoices via WAWF, the contractor 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: BPA ADMINISTRATOR: CONTRACTING OFFICER: 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. (10) 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: Madigan Healthcare System Departments (MAMC), Joint Base Lewis-McChord, _________________________ ________________________ _________________________ NamePhoneEmail Bassett Army Community Hospital, Fort Wainwright AK, _________________________ ________________________ _________________________ NamePhoneEmail Evans Army Hospital, Fort Carson CO, _________________________ ________________________ _________________________ NamePhoneEmail Raymond W Bliss Army Health Center, Fort Huachuca AZ _________________________ ________________________ _________________________ NamePhoneEmail Irwin Army Hospital, Fort Riley KS, _________________________ ________________________ _________________________ NamePhoneEmail Gen Leonard Wood Army Hospital, Fort Leonard Wood MO, _________________________ ________________________ _________________________ NamePhoneEmail Munson Army Health Center, Fort Leavenworth KS, _________________________ ________________________ _________________________ NamePhoneEmail William Beaumont Army Medical Center, El Paso TX, _________________________ ________________________ _________________________ NamePhoneEmail McAffee Army Health Clinic, White Sands Missile Range NM _________________________ ________________________ _________________________ NamePhoneEmail Weed Army Community Hospital, Fort Irwin, CA 92310, _________________________ ________________________ _________________________ NamePhoneEmail The BPA holder's Government Representative is: _________________________ ________________________ _________________________ NamePhoneEmail The BPA holder's Billing/Accounting Representative is: _________________________ ________________________ _________________________ NamePhoneEmail (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 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 and Government Purchase Card ordering account. (12) PROMOTION The contractor agrees it shall not advertise the use of this BPA in such a manner as to state or imply that outlying medical treatment facilities (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. (13) HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (6 May 10) In accordance with DoD 6025.18-R "Department of Defense Health Information Privacy Regulation," January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented. (a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R. Individual has the same meaning as the term "individual" in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g). Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. Protected Health Information has the same meaning as the term "protected health information" in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract. Electronic Protected Health Information has the same meaning as the term "electronic protected health information" in 45 CFR 160.103. Required by Law has the same meaning as the term "required by law" in 45 CFR 164.103. Secretary means the Secretary of the Department of Health and Human Services or his/her designee. Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C. Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501. b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law. (c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract. (d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract. (e) The Contractor shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm (f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware. (g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware. (h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information. (i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it. (j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524. (k) The Contractor shall make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government, and in the time and manner reasonably designated by the Government. (l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government's compliance with the Privacy Rule. (m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528. (n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government,information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528. General Use and Disclosure Provisions Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government. Specific Use and Disclosure Provisions (a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor. (b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached. (c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B). (d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1). Obligations of the Government Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions (a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520. (b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures. (c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522. Permissible Requests by the Government The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause. Termination (a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract. (b) Effect of Termination. (1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below (2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information. (3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information. Miscellaneous (a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02-R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required. (b) Survival. The respective rights and obligations of Business Associates under the "Effect of Termination" provision of this Clause shall survive the termination of this Contract. (c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule. (End of clause)
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(https://www.fbo.gov/spg/USA/MEDCOM/DADA13/W91YU0-12-T-0014/listing.html)
Place of Performance: Address: Western Regional Contracting Office ATTN: MCAA W BLDG 9902, 9902 Lincoln Street Tacoma WA; Zip Code: 98431-1110
Record: SN02627350-W 20111124/111122234402-a71623f93a03d933972aceae743ed30c (fbodaily.com)
Source: FedBizOpps Link to This Notice
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Loren Data's SAM Daily™

65 -- Various Blanket Purchase Agreements (BPAs) on FDA approved Corneal Implants and Eye Tissue related products such as , DSAEK cut cornea, Whole sclera, Half sclera, and Quarter sclera for patient specific requirements