PRESOL | 65 | Various Blanket Purchase Agreements for Radiopharmeutical (FDA) Appoved) Products for the Western Regional Medical Command Medical Treatment Facilities (MTF's)

FBO DAILY ISSUE OF FEBRUARY 12, 2011 FBO #3367
SOLICITATION NOTICE

65 -- Various Blanket Purchase Agreements for Radiopharmeutical (FDA) Appoved) Products for the Western Regional Medical Command Medical Treatment Facilities (MTF's)

Notice Date: 2/10/2011
Notice Type: Combined Synopsis/Solicitation
NAICS: 325412 — Pharmaceutical Preparation Manufacturing
Contracting Office: Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
ZIP Code: 98431-1110
Solicitation Number: W91YU0-11-T-0073
Response Due: 3/11/2011
Archive Date: 5/10/2011
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. BLANKET PURCHASE AGREEMENT ASFI INFORMATION BELOW: 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; request for quotes are being requested and a written solicitation will not be issued. This solicitation will be used to establish multiple Blanket Purchase Agreements. See attached Blanket Purchase Agreement Scope of Work. This solicitation W91YU0-11-T-0073 of Purchase Request YMERAD1019N161 is issued as a Request for Quote (RFQ). This is a request for quotes on Radiopharmaceutical (FDA Approved) such as Meta-Trace (FDB 91-20 MC), Sodium Fluoride (1-12 MCI) and Sodium Fluoride Calibration ((1-12MCI) Products (irradiated "tracers"); (for example, some of the tracers being solicited are used for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity). All tracers are ordered as patient specific, prescribed unit dose for a defined calibration date and time. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-48. Simplified Acquisition procedures will be followed. The NAICS Code is 325412, Pharmaceutical Preparation Manufacturing and the FSC Code is 6505 for Various Radiopharmaceutical (FDA Approved) Products. The following documents MUST be provided when submitting for a Blanket Purchase Agreement: a. Contractors shall provide the Material Safety Data Sheet (MSDS) on each product. b. Contractors' shall provide the pharmacy license number. c. Contractors' shall provide the radiopharmaceutical Washington state license number. Applicable references: 10 CFR 30: NRC license to provide radio-pharmacy services. 10 CFR 71 and 49 CFR 172, 177 and 178: NRC and DOT transportation of radioactive materials. For information: NRC Radio-Pharmacy license guidance document: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v13/r1/sr1556v13r1.pdf 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 listings or catalog of products. The full text of a FAR provision or clause may be accessed electronically at www.farsite.hill.af.mil (1) FAR provision 52.212-1 [Instructions to Offerors - Commercial Items] applies to this acquisition to include the following addenda: All quoters are cautioned that if selected for award, they must be registered with Central Contractor Registration (CCR) program. Confirmation of CCR registration will be validated prior to award; (2) 52.212-2 [Evaluation-Commercial Items] - Evaluation process: All quotations will be evaluated on a best value basis with the following criteria: Technical Capability and Price, with Technical Capability being significantly more important than Price; The following apply to this acquisition: FAR 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: FAR 52.204-7 Central Vendor Registration, 52.212-1 Instructions to Offerors- Commercial Item, 52.212-4 Contract Terms and Conditions Commercial Items; 52.212-5 Deviation Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. Addendum to 52.212-1 (Local Provision 5004), the following Addendum to FAR 52.212-4(c) (Local Clause 5003) (1) Unilateral Modifications: The Government may make unilateral modifications considered administrative in nature. (2) The Contracting Officer may unilaterally reduce and/or de-obligate any quantities not supplied/performed at the end of the contract period. Other FAR clauses included in the agreement: 52.223-3 Hazardous Material Identification and Material Safety Data; 52.252-2 Clauses Incorporated by Reference; 52.252-6 Authorized Deviations in Clauses. Clauses Incorporated by Reference; 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards; 52-211-6 Brand name or equal, 52.219-28 Post Award SB Program Representation; 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; 52.222-54 Employment Eligibility Verification; 52.225-13 Restriction on Certain Foreign Purchases; 52.232-18 Contractor Policy to Ban Text Messaging While Driving\; 52.232-33 Payment by Electronic Funds; 52-232-36 Payment by third party; 52.232-37 Multiple payment arrangements; 52.233-3 Protest After Award; 52.233-4 Applicable Law for Breach of Contract Claims; 52.242-13 Bankruptcy. The following DFARS clauses apply: 252.212-7001 Deviation, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items; 252-212-7000 Offeror Representations And Certifications-Commercial Item; 252.223-7006 Prohibition on Storage and Disposal of Toxic and Hazardous Materials; 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; 252.247-7023 with Alt III; 252.232-7010 Levies on Contract Payments; 252.211-7003 Item Identification and Valuation. 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 March 10:00 AM, LOCAL Pacific Standard Time. Submit offers via fax to (253) 968-4091 or email to angela.dexter@us.army.mil SCOPE OF WORK BLANKET PURCHASE AGREEMENT (BPA) Between Contractor And Madigan Healthcare System Military Treatment Facility (MTF) (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, or the Federal Acquisition Regulation as updates occur. Any revisions will be incorporated by modification to this BPA. (2) DESCRIPTION OF AGREEMENT a.The BPA holder shall provide Radiopharmaceutical (FDA Approved) such as Meta-Trace (FDB 91-20 MC), Sodium Fluoride (1-12 MCI) and Sodium Fluoride Calibration ((1-12MCI) products for the Departments of Radiology Nuclear Medicine Services at various Military Treatment Facilities (MTFs) located in the Western Region. These radiopharmaceutical doses are ordered for specific patient's treatment, at a specific time during the scheduled appointments at the hospital. Due to the very short shelf life of the radiopharmaceutical products, multiple deliveries may be required. 1.BPA holder shall provide the Material Safety Data Sheet (MSDS) on each product. 2. BPA holders shall provide the specific license number to manufacture, produce, and /or transfer for distribution of radiopharmaceuticals products 3. BPA holder shall provide the radiopharmaceutical Washington state license number (or applicable state license). b. The contractors' submitted product catalog and/or pricing (TO INCLUDE ALL APPLICABLE DISCOUNTS) is incorporated into this Agreement, and all BPA Calls will 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 BPA holder must allow thirty (30) days for the incorporation of a revised catalog to be incorporated into the Agreement This agreement shall be in effect for a term of five (5) years; starting on date of Award thru thru five years (dates to be determined at time of award). 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. BPA calls will be issued by the Western Regional Contracting office 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 Department of Radiology Nuclear Medicine Services located at each Military Treatment Facility, that ordered the radiopharmaceutical products, will be responsible for payment of any obligation via Government Credit Card b. Purchase Limitation: BPA Call Limit- $100,000.00 BPA Master Dollar Limit=$1,000,000.00 (for life of Agreement) (4) ORDERING PROCEDURES a. BPA holders will be awarded BPA Calls UP TO $100,000. As requirements occur, the Department of Radiology Nuclear Medicine Services will rotate the various BPA holders for these products, and depending on the availability and delivery time of the products, will schedule deliveries accordingly. (5) Individuals Authorized to Schedule Deliveries under the BPA a. Each BPA Call 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. Each order under this agreement will be assigned a Call number by the Western Regional Contracting Office. Invoices shall reflect BPA number and Call number. Deliveries will be scheduled by, Department of Radiology Nuclear Medicine Service, 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 deliveries shall contain the following information: a.Name of Supplier b.BPA Number c.Date of Surgery/Procedure d.Itemized list of supplies furnished (7) SHIPPING: A.All shipping shall be in accordance with the 49 CFR (Code of Federal Regulations, Transportation of Hazardous Waste Materiel's on Federal Highways regulation. United State Pharmacopeia (USP) 823 Regulatory issues for Radiopharmaceuticals for Positron Emission Tomography (PET) b. Under the Washington Administrative Code (WAC) all products shall be labeled as follows: (a) Standard radiation symbol; (b) the words "caution-radioactive material"; (c) the name of the radiopharmaceutical; (d) the amount of radioactive material contained, in millicuries or microcuries; (e) if a liquid, the volume in milliliters; (f) the requested calibration time for the amount of radioactivity contained; (g) expiration data, if applicable; and (h) specific concentration of radioactivity. The contractor shall ship directly to the following address: (or as stated on each individual BPA Call) Madigan Healthcare System Department of Radiology Nuclear Medicine Service Bldg 9040A (Receiving Section) Fitzsimmons Tacoma, WA 98431 All items are to be priced (inclusive of all fees, freight, etc.). In most cases, deliveries shall occur within 24 hours of the Department of Radiology Nuclear Medicine Services' patient scheduled appointment. All products shall be delivered at least one hour prior to any scheduled patient appointment or otherwise stated from the department. (8) INVOICES/PAYMENT: (Government- Wide Purchase Card (GPC). GPC is a Government -wide commercial purchase card provided by VISA for the purchase /payment of certain supplies and service. a. The BPA holder shall submit a separate invoice for each 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 BPA holder shall be responsible for any and all transaction service charges incurred for the acceptance of GPC payment. The BPA holder 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 Department of Radiology Nuclear Medicine Service shall submit a monthly call report to, Western Regional Contracting Office no later than the 5th business day following the end of each. b. BPA holders' shall l provide the account number for the military treatment facility (MTF): Madigan Healthcare System Departments (MAMC), _________________- Account number Bldg 9040A (Receiving Section) Fitzsimmons Tacoma, WA 98431 (9) CUSTOMER SERVICE The BPA holders' authorized Sales Representatives for the medical treatment facilities (MTF) are listed below: Madigan Healthcare System Departments (MAMC), _________________________ ________________________ _________________________ NamePhoneEmail _________________________ ________________________ _________________________ NamePhoneEmail The BPA holders' Government Representative is: _________________________ ________________________ _________________________ NamePhoneEmail The BPA holders' radiopharmaceutical products license number: ___________________________________ BPA holders' license number to manufacture, produce, and /or transfer for distribution of radiopharmaceutical products. ___________________________________ The BPA holders' Billing/Accounting Representative is: _________________________ ________________________ _________________________ NamePhoneEmail The BPA holder shall ensure that all customer service numbers are updated periodically to the MTF facility and the Contracting Office. (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 BPA holder/Sales Representative shall provide a replacement immediately if a deliverable is determined unsatisfactory in accordance with Medical Standards. Products purchased in a kit or set cannot be returned as individual components. 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. (11) PROMOTION The BPA holder agrees it shall not advertise the use of this BPA in such a manner as to state or imply that the medical treatment facilities endorse a product, project, or commercial product line. NOTE: HIPPA -PHI clause is only applicable if representatives from theBPA holder are involved in the actual surgeries being performed. (13) Health Insurance Portability and Accountability Act (6 May 10) Introduction 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 Associate 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. 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, 164.501 and 164.304. (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 agrees 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. (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 Associate 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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Place of Performance: Address: Western Regional Contracting Office ATTN: MCAA W BLDG 9902, 9902 Lincoln Street Tacoma WA; Zip Code: 98431-1110
Record: SN02377500-W 20110212/110210234545-a92cca18eec86bef444c54adf2da9b7e (fbodaily.com)
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65 -- Various Blanket Purchase Agreements for Radiopharmeutical (FDA) Appoved) Products for the Western Regional Medical Command Medical Treatment Facilities (MTF's)