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HomeMy WebLinkAbout2011-254 DSS - NC Baptist Hospital for Quantitative Interdisciplinary Evaluations~~4 ~:s-~. Contract # 68-1015 North Carolina Baptist Hospital Contract # 68-1015 Fiscal Year Begins July 1, 2011 Ends June 30, 2012 This contract is hereby entered into by and between the Orange County Department of Social Services (the "County") and North Carolina Baptist Hospital (the "Contractor") (referred to collectively as the "Parties"). The Contractor's federal tax identification number is 1. Contract Documents: This Contract consists of the following documents: (1) CONTRACT # 68-1015 (2) The General Terms and Conditions (Attachment A) (3) The Scope of Work, description of services, and rate (Attachment B) (4) Federal Certification Regarding Drug-Free Workplace (Attachment C) (5) Conflict of Interest (Attachment D) (6) No Overdue Taxes (Attachment E) (7) HIPPA Agreement (Attachment I) These documents constitute the entire agreement between the Parties and supersede all prior oral or written statements or agreements. 2. Precedence Among Contract Documents: In the event of a conflict between or among the terms of the Contract Documents, the terms in the Contract Document with the highest relative precedence shall prevail. The order of precedence shall be the order of documents as listed in Paragraph 1, above, with the first-listed document having the highest precedence and the last-listed document having the lowest precedence. If there are multiple Contract Amendments, the most recent amendment shall have the highest precedence and the oldest amendment shall have the lowest precedence. 3. Effective Period: This contract shall be effective on July 1, 2011 and shall terminate on June 30, 2012. This contract must be twelve months or less. 4. Contractor's Duties: The Contractor shall provide the services and in accordance with the approved rate as described in Attachment B, Scope of Work. 5. County's Duties: The County shall pay the Contractor in the manner and in the amounts specified in the Contract Documents. The total amount paid by the County to the Contractor under this contract shall not exceed $15,096.00. This amount consists of $15,096.00 in Federal funds (CFDA # 93.563) and State Funds, $0.00 in County funds; [ X ] a. There are no matching requirements from the Contractor, [ ] b. The Contractor's matching requirement is $ ,which shall consist of: [ ] In-kind [ ]Cash [ ]Cash and In-kind [ ]Cash and/or In-kind The contributions from the Contractor shall be sourced from non-federal funds. The total contract amount including any Contractor match shall not exceed $15,096.00. (General Terms and Conditions - O6I04) Page 1 of 19 Contract # 68-1015 North Carolina Baptist Hospital 6. Reporting Requirements: Contractor shall comply with audit requirements as described in N.C.G.S § 143C-6-23 OMB Circular A-133. 7. Payment Provisions: Payment shall be made in accordance with the Contract Documents as described in the Scope of Work, Attachment B. 8. Contract Administrators: All notices permitted or required to be given by one Party to the other and all questions about the contract from one Party to the other shall be addressed and delivered to the other Party's Contract Administrator. The name, post office address, street address, telephone number, fax number, and email address of the Parties' respective initial Contract Administrators are set out below. Either Party may change the name, post office address, street address, telephone number, fax number, or email address of its Contract Administrator by giving timely written notice to the other Party. For the County: IF DELIVERED BY US POSTAL SERVICE IF DELIVERED BY ANY OTHER MEANS Sharron Hinto Sharron Hinton Orange County DSS Orange County DSS P.O. Box 8181 113 Mayo Street Hillsborough, NC 27278 Hillsborough, NC 27278 919-245-2840 (P) 919-644-3005 (F) shinton ~%:co.oran ~e.nc.us For the Contractor: IF DELIVERED BY US POSTAL SERVICE IF DELIVERED BY ANY OTHER MEANS Jan Frye Hill, Rehab Program Coordinator Jan Frye Hill, Rehab Program Coordinator North Carolina Baptist Hospital North Carolina Baptist Hospital 131 Miller Street 131 Miller Street Winston-Salem, NC 27103 Winston-Salem, NC 27103 336-716-8404 (P) 336-716-8401 (F) jlrye(a,~wfubmc.edu (General Terms and Conditions - 06104) Page 2 of 19 Contract # 68-1015 North Carolina Baptist Hospital 9. Signature Warranty: The undersigned represent and warrant that they are authorized to bind their principals to the terms of this agreement. The Contractor and the County have executed this contract in duplicate originals, with one original being retained by each party. ~gnature 'Date ~i/, :vim.` / ?J.;-cG^~ir !~% /? Jan-~'~itt- ~/Siw •, ~/. ~GGri.Cf R 'nato .GG Printed Nam Title ©l~-I - ` ~S%: Signature Date Nancy Coston Director, Orange County DSS Printed Name Title This instrument has been pre-audited in the manner required by the Local Government Budget and Fiscal Control Act. /,~-~ 7-2s- ~i Signature of County Finance Officer Date This ~ot~tract h~een approved as to form and legal sufficiency. of C ll (General Terms and Conditions - 06104) Page 3 of 19 Contract # 68-1015 North Carolina Baptist Hospital ATTACHMENT A General Terms and Conditions Relationships of the Parties Independent Contractor: The Contractor is and shall be deemed to be an independent contractor in the performance of this contract and as such shall be wholly responsible for the work to be performed and for the supervision of its employees. The Contractor represents that it has, or shall secure at its own expense, all personnel required in performing the services under this agreement. Such employees shall not be employees of, or have any individual contractual relationship with the County. agreed that the enforcement of the terms and conditions of this contract, and all rights of action relating to such enforcement, shall be strictly reserved to the County and the named Contractor. Nothing contained in this document shall give or allow any claim or right of action whatsoever by any other third person. It is the express intention of the County and Contractor that any such person or entity, other than the County or the Contractor, receiving services or benefits under this contract shall be deemed an incidental beneficiary only. Subcontracting: The Contractor shall not subcontract any of the work contemplated under this contract without prior written approval from the County. Any approved subcontract shall be subject to all conditions of this contract. Only the subcontractors specified in the contract documents are to be considered approved upon award of the contract. The County shall not be obligated to pay for any work performed by any unapproved subcontractor. The Contractor shall be responsible for the performance of all of its subcontractors. Assignment: No assignment of the Contractor's obligations or the Contractor's right to receive payment hereunder shall be permitted. However, upon written request approved by the issuing purchasing authority, the County may: (a) Forward the Contractor's payment check(s) directly to any person or entity designated by the Contractor, or (b) Include any person or entity designated by Contractor as a joint payee on the Contractor's payment check(s). In no event shall such approval and action obligate the County to anyone other than the Contractor and the Contractor shall remain responsible for fulfillment of all contract obligations. Beneficiaries: Except as herein specifically provided otherwise, this contract shall inure to the benefit of and be binding upon the parties hereto and their respective successors. It is expressly understood and Indemnity and Insurance Indemnification: Each party agrees to indemnify and hold harmless the other party and any of their officers, agents and employees, from any claims of third parties arising out of any actor omission of that party in connection with the performance of this contract. Insurance: During the term of the contract, the Contractor at its sole cost and expense shall provide commercial insurance of such type and with such terms and limits as may be reasonably associated with the contract. As a minimum, the Contractor shall provide and maintain the following coverage and limits: (a) Worker's Compensation -The contractor shall provide and maintain Worker's Compensation Insurance as required by the laws of North Carolina, as well as employer's liability coverage with minimum limits of $500,000.00, covering all of Contractor's employees who are engaged in any work under the contract. If any work is sublet, the Contractor shall require the subcontractor to provide the same coverage for any of his employees engaged in any work under the contract. (b) Commercial General Liability General Liability Coverage on a Comprehensive Broad Form on an occurrence basis in the minimum amount of $1,000,000.00 Combined Single Limit. (General Terms and Conditions - 06104) Page 4 of 19 Contract # 68-1015 North Carolina Baptist Hospital (Defense cost shall be in excess of the limit of liability.) (c) Automobile -Automobile Liability Insurance, to include liability coverage, covering all owned, hired and non-owned vehicles used in performance of the contract. The minimum combined single limit shall be $500,000.00 bodily injury and property damage; $500,000.00 uninsured/under insured motorist. Providing and maintaining adequate insurance coverage is a material obligation of the Contractor and is of the essence of this contract. The Contractor may meet its requirements of maintaining specified coverage and limits by demonstrating to the County that there is in force insurance with equivalent coverage and limits that will offer at least the same protection to the County. All such insurance shall meet all laws of the State of North Carolina. Such insurance coverage shall be obtained from companies that are authorized to provide such coverage and that are authorized by the Commissioner of Insurance to do business in North Carolina. The Contractor shall at all times comply with the terms of such insurance policies, and all requirements of the insurer under any such insurance policies, except as they may conflict with existing North Carolina laws or this contract. The limits of coverage under each insurance policy maintained by the Contractor shall not be interpreted as limiting the contractor's liability and obligations under the contract. Default and Termination Termination Without Cause: Either party may terminate this contract without cause by giving 30 days written notice to the other party. In that event, all finished or unfinished deliverable items prepared by the Contractor under this contract shall, at the option of the parties, become the Contractor's property and the Contractor shall be entitled to receive just and equitable compensation for any satisfactory work completed on such materials, minus any payment or compensation previously made. Termination for Cause: If, through any cause, either party shall fail to fulfill its obligations under this contract in a timely and proper manner, the terminating party shall have the right to terminate this contract by giving written notice to the breaching party and specifying the effective date thereof In that event, all finished or unfinished deliverable items prepared by the Contractor under this contract shall, at the option of the parties, become the Contractor's property and the Contractor shall be entitled to receive just and equitable compensation for any satisfactory work completed on such materials, minus any payment or compensation previously made. Notwithstanding the foregoing provision, the breaching party shall not be relieved of liability to the terminating party for damages sustained by the terminating party by virtue of the breaching party's breach of this agreement, and if the County is the terminating party, the County may withhold any payment due the Contractor for the purpose of setoff until such time as the exact amount of damages due the County from such breach can be determined. In case of default by the Contractor, without limiting any other remedies for breach available to it, the County may procure the contract services from other sources and hold the Contractor responsible for any excess cost occasioned thereby. The filing of a petition for bankruptcy by the Contractor shall be an act of default under this contract. Waiver of Default: Waiver by either party of any default or breach in compliance with the terms of this contract shall not be deemed a waiver of any subsequent default or breach and shall not be construed to be modification of the terms of this contract unless stated to be such in writing, signed by an authorized representative of the County and the Contractor and attached to the contract. Availability of Funds: The parties to this contract agree and understand that the payment of the sums specified in this contract is dependent and contingent upon and subject to the appropriation, allocation, and availability of funds for this purpose to the County. Force Majeure: Neither party shall be deemed to be in default of its obligations hereunder if and so long as it is prevented from performing such obligations by any act of war, hostile foreign action, nuclear explosion, riot, strikes, civil insurrection, earthquake, (General Terms and Conditions - 06/04) Page 5 of 19 Contract # 68-1015 North Carolina Baptist Hospital hurricane, tornado, or other catastrophic natural event or act of God. agreements and practices as the County may require to ensure compliance. Survival of Promises: All promises, requirements, terms, conditions, provisions, representations, guarantees, and warranties contained herein shall survive the contract expiration or termination date unless specifically provided otherwise herein, or unless superseded by applicable Federal or State statutes of limitation. Intellectual Property Rights Copyrights and Ownership of Deliverables: All deliverable items produced pursuant to this contract are the exclusive property of the County. The Contractor shall not assert a claim of copyright or other property interest in such deliverables. Federal Intellectual Property Bankruptcy Protection Act: The Parties agree that the County shall be entitled to all rights and benefits of the Federal Intellectual Property Bankruptcy Protection Act, Public Law 100-506, codified at 11 U.S.C. 365 (n) and any amendments thereto. Compliance with Applicable Laws Compliance with Laws: The Contractor shall comply with all laws, ordinances, codes, rules, regulations, and licensing requirements that are applicable to the conduct of its business, including those of federal, state, and local agencies having jurisdiction and/or authority. Equal Employment Opportunity: The Contractor shall comply with all federal and State laws relating to equal employment opportunity. Health Insurance Portability and Accountability Act (HIPAA): The Contractor agrees that, if the County determines that some or all of the activities within the scope of this contract are subject to the Health Insurance Portability and Accountability Act of 1996, P.L. 104-91, as amended ("HIPAA"), or its implementing regulations, it will comply with the HIPAA requirements and will execute such Confidentiality Confidentiality: Any information, data, instruments, documents, studies or reports given to or prepared or assembled by the Contractor under this agreement shall be kept as confidential and not divulged or made available to any individual or organization without the prior written approval of the County. The Contractor acknowledges that in receiving, storing, processing or otherwise dealing with any confidential information it will safeguard and not further disclose the information except as otherwise provided in this contract. Oversight Access to Persons and Records: The State Auditor shall have access to persons and records as a result of all contracts or grants entered into by State agencies or political subdivisions in accordance with General Statute 147-64.7. Additionally, as the State funding authority, the Department of Health and Human Services shall have access to persons and records as a result of all contracts or grants entered into by State agencies or political subdivisions. Record Retention: Records shall not be destroyed, purged or disposed of without the express written consent of the County. The Department of Health and Human Services' basic records retention policy requires all records to be retained for a minimum of three years following completion or termination of the contract. If the contract is subject to Federal policy and regulations, record retention will normally be longer than three years since records must be retained for a period of three years following submission of the final Federal Financial Status Report, if applicable, or three years following the submission ofa revised final Federal Financial Status Report. Also, if any litigation, claim, negotiation, audit, disallowance action, or other action involving this contract has been started before expiration of the three year retention period described above, the records must be retained until completion of the action and resolution of all issues which arise from it, or until the end of the (General Terms and Conditions - 06/04) Page 6 of 19 Contract # 68-1015 North Carolina Baptist Hospital regular three year period described above, whichever is later. contract or tort, relating to the validity, construction, interpretation, and enforcement shall be determined. Warranties and Certifications Date and Time Warranty: The Contractor warrants that the product(s) and service(s) furnished pursuant to this contract ("product" includes, without limitation, any piece of equipment, hardware, firmware, middleware, custom or commercial software, or internal components, subroutines, and interfaces therein) that perform any date and/or time data recognition function, calculation, or sequencing will support a four digit year format and will provide accurate date/time data and leap year calculations. This warranty shall survive the termination or expiration of this contract. Certification Regarding Collection of Taxes: G.S. 143-59.1 bars the Secretary of Administration from entering into contracts with vendors that meet one of the conditions of G.S. 105-164.8(b) and yet refuse to collect use taxes on sales of tangible personal property to purchasers in North Carolina. The conditions include: (a) maintenance of a retail establishment or office; (b) presence of representatives in the State that solicit sales or transact business on behalf of the vendor; and (c) systematic exploitation of the market by media- assisted, media-facilitated, ormedia-solicited means. The Contractor certifies that it and all of its affiliates (if any) collect all required taxes. Miscellaneous Choice of Law: The validity of this contract and any of its terms or provisions, as well as the rights and duties of the parties to this contract, are governed by the laws of North Carolina. The Contractor, by signing this contract, agrees and submits, solely for matters concerning this Contract, to the exclusive jurisdiction of the courts of North Carolina and agrees, solely for such purpose, that the exclusive venue for any legal proceedings shall be Orange County, North Carolina. The place of this contract and all transactions and agreements relating to it, and their situs and forum, shall be Orange County, North Carolina, where all matters, whether sounding in Amendment: This contract may not be amended orally or by performance. Any amendment must be made in written form and executed by duly authorized representatives of the County and the Contractor. Severability: In the event that a court of competent jurisdiction holds that a provision or requirement of this contract violates any applicable law, each such provision or requirement shall continue to be enforced to the extent it is not in violation of law or is not otherwise unenforceable and all other provisions and requirements of this contract shall remain in full force and effect. Headings: The Section and Paragraph headings in these General Terms and Conditions are not material parts of the agreement and should not be used to construe the meaning thereof. Time of the Essence: Time is of the essence in the performance of this contract. Key Personnel: The Contractor shall not replace any of the key personnel assigned to the performance of this contract without the prior written approval of the County. The term "key personnel" includes any and all persons identified as such in the contract documents and any other persons subsequently identified as key personnel by the written agreement of the parties. Care of Property: The Contractor agrees that it shall be responsible for the proper custody and care of any property furnished to it for use in connection with the performance of this contract and will reimburse the County for loss of, or damage to, such property. At the termination of this contract, the Contractor shall contact the County for instructions as to the disposition of such property and shall comply with these instructions. Travel Expenses: Reimbursement to the Contractor for travel mileage, meals, lodging and other travel expenses incurred in the performance of this contract (General Terms and Conditions - 06/04) Page 7 of 19 Contract # 68-1015 North Carolina Baptist Hospital shall not exceed the rates established in County policy. Sales/Use Tax Refunds: If eligible, the Contractor and all subcontractors shall: (a) ask the North Carolina Department of Revenue for a refund of all sales and use taxes paid by them in the performance ofthis contract, pursuant to G.S. 105-164.14; and (b) exclude all refundable sales and use taxes from all reportable expenditures before the expenses are entered in their reimbursement reports. Advertising: The Contractor shall not use the award of this contract as a part of any news release or commercial advertising. (General Terms and Conditions - 06!04) Page 8 of 19 Coniract ?! L8607fi- I Oh North Carolina Baptist (iospihtl Federal Tax Id. Contract # 68-1015 ATTACHMENT B -Scope of Work A. CONTRACTOR INFORMATION 1. Contractor Agency Name: North Carolina Baptist Hospital 2. If different from Contract Administrator Information in General Contract: Address Telephone Number: 336-716-8404 Fax Number: 336-716-8401 Email: ifrye(a;wjuh~ne.edu 3. Name of Program (s): Quantitative Interdisciplinary Evaluations (QIE) 4. Status: ( )Public (X) Private, Not for Profit OPrivate, For Profit 5. Contractor's Financial Reporting Year: July -June B. Explanation of Services to be provided and to whom (include SIS Service Code): Provider shall provide services to Contracting Agency in the following manner: Quantitative Interdisciplinary Evaluations (QIE) up to five (5) per month. Contractor will notify the County immediately of any no show and will consult with the Community Employment Case Manager andlor the Human Resource Placement Specialist in preparation for the QIE. There will be no no-show fee for not keeping an appointment. No appointments will be rescheduled for a patient who cancels within 24 hours more than 2 times, or for a patient that is a no show more than 1 time. Contractor will document the outcome of the QIE in a format acceptable to the Social Security Administration and /or other Service/Medical agency. Said documentation will be forwarded to the County within 5 business days of the QIE. Contractor agrees to meet with the participant and Community Employment Case Manager/Human Resource Placement Specialist at the end of the QIE to discuss findings and recommendations. County agrees to notify Contractor if patient agrees to follow-up appointments. Compensation: County agrees to compensate Contractor at the rate of $300.50 per hour. Total cost of this agreement shall not exceed fifteen thousand ninety-six dollars ($15,096.00). County agrees to give a 24-hour prior notification of any known cancellations. Invoice/Payment: Contractor shall submit an invoice to County by the fifth (5`h) business day of the month following provisions of the services. County shall provide payment to Contractor within two (2) weeks of receipt of the invoice. Contract-General (06/04) Page 9 of 19 C~~mtract'I L86076-108 Noith Carolina Ciaptist I lospital C. Rate per unit of Service (define the unit): 1. If Standard Fixed Rate, Maximum Allowable, (See Rates for Services Chart) $300.50/unit 2. Negotiated County Rate. D. Number of units to be provided: E. Details of Billing process and Time Frames; Contractor to bill Orange DSS once a month for the previous month's services. DSS will issue payment within two (2) weeks of receipt of the invoice. F. Area to be served/Delivery site(s): Orange County (Signature of C unty Authorized Person) 0`1-13~I1 (Date Submitted) (Signature of Contractor) 7 ~~ /i (Date Sub tted) Contract-General (06/04) Page 10 of 19 Contract '~+~ L8G076-108 Noah Carolina F3aptisf Hospital ATTACHMENT C CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS Orange County Department of Social Services I. By execution of this Agreement the Contractor certifies that it will provide adrug-free workplace by: A. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor's workplace and specifying the actions that will be taken against employees for violation of such prohibition; B. Establishing adrug-free awareness program to inform employees about: (1) The dangers of drug abuse in the workplace; (2) The Contractor's policy of maintaining a drug-free workplace; (3) Any available drug counseling, rehabilitation, and employee assistance programs; and (4) The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace; C. Making it a requirement that each employee be engaged in the performance of the agreement be given a copy of the statement required by paragraph (A); D. Notifying the employee in the statement required by paragraph (A) that, as a condition of employment under the agreement, the employee will: (1) Abide by the terms of the statement; and (2) Notify the employer of any criminal drug statute conviction for a violation occurring in the workplace no later than five days after such conviction; E. Notifying the County within ten days after receiving notice under subparagraph (D)(2) from an employee or otherwise receiving actual notice of such conviction; F. Taking one of the following actions, within 30 days of receiving notice under subparagraph (D)(2), with respect to any employee who is so convicted: (1) Taking appropriate personnel action against such an employee, up to and including termination; or (2) Requiring such employee to participate satisfactorily in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health, law enforcement, or other appropriate agency; and Making a good faith effort to continue to maintain adrug-free workplace through implementation of paragraphs (A), (B), (C), (D), (E), and (F). Contract-General (06/04) Page 11 of 19 Contract ~~t L86076-(08 Noi~kh Carolina t3aptist I lospital II. The site(s) for the performance of work done in connection with the specific agreement are listed below: (Street address) (City, county, state, zip code) (Street address) (City, county, state, zip code) Contractor will inform the County of any additional sites for performance of work under this agreement. False certification or violation of the certification shall be grounds for suspension of payment, suspension or termination of grants, or government-wide Federal suspension or debarment (Section 4 CFR Part 85, Section 85.615 and 86.620). S' atur Title /VG ~ ,~- Agency/Organization 7 i. i, Date (Certification signature should be same as Contract signature.) Contract-General (06/04) Page 12 of 19 Contract '# L86076-108 North Carolina Baptist I ospital ATTACHMENT D: CONFLICT OF INTEREST Conflict of Interest Defined: A conflict of interest is defined as an actual or perceived interest by a (staff member/Board member) in an action that results in, or has the appearance of resulting in, personal, organizational, or professional gain. A conflict of interest occurs when an employee/Board member has a direct or fiduciary interest in another relationship. A conflict of interest could include: - Ownership with a member of the Board of Directors/Trustees or an employee where one or the other has supervisory authority over the other or with a client who receives services. - Employment of or by a member of the Board of Directors/Trustees or an employee where one or the other has supervisory authority over the other or with a client who receives services. - Contractual relationship with a member of the Board of Directors/Trustees or an employee where one or the other has supervisory authority over the other or with a client who receives services. - Creditor or debtor to a member of the Board of Directors/Trustees or an employee where one or the other has supervisory authority over the other or with a client who receives services. - Consultative or consumer relationship with a member of the Board of Directors/Trustees or an employee where one or the other has supervisory authority over the other or with a client who receives services. The definition of conflict of interest includes any bias or the appearance of bias in adecision-making process that would reflect a dual role played by a member of the organization or group. An example, for instance, might involve a person who is an employee and a Board member, or a person who is an employee and who hires family members as consultants. Employee Responsibilities: It is in the interest of the organization, individual staff, and Board members to strengthen trust and confidence in each other, to expedite resolution of problems, to mitigate the effect and to minimize organizational and individual stress that can be caused by a conflict of interest. Employees are to avoid any conflict of interest, even the appearance of a conflict of interest. This organization serves the community as a whole rather than only serving a special interest group. The appearance of a conflict of interest can cause embarrassment to the organization and jeopardize the credibility of the organization. Any conflict of interest, potential conflict of interest, or the appearance of a conflict of interest is to be reported to your supervisor immediately. Employees are to maintain independence and objectivity with clients, the community, and organization. Employees are called to maintain a sense of fairness, civility, ethics and personal integrity even though law, regulation, or custom does not require them. Acceptance of Gifts: Employees, members of employee's immediate family, and members of the Board are prohibited from accepting gifts, money or gratuities from the following: a. Persons receiving benefits or services from the organization; b. Any person or organization performing or seeking to perform services under contract with the organization; and c. Persons who are otherwise in a position to benefit from the actions of any employee of the organization. Employees may, with the prior written approval of their supervisor, receive honoraria for lectures and other such activities while on personal days, compensatory time, annual leave, or leave without pay. If the employee is acting in any official capacity, honoraria received by an employee in connection with activities relating to employment with the organization are to be paid to the organization. Contract-General (06/04) Page 13 of 19 WFUBMC Infinet -Conflict of Interest Page I of 6 _... About Uf ~ Ev~rtts Calendar Help Drsk Hospital ~ Hume Rewurces I Vtwno birecmry ~ Sc heal +~,mnr~w~=a~~.~+wti~+~s,~Wn.~,~,.~, ~.n.~~,~.wu~uuu~m~„~r^ - ~.~~w~w..~w"aWL Quick Links > Home > Industry Policy > Conflict of Commitment and Research Policy > Industry Committee > Research Committee > Conflict of Interest FAQs > Central COI Office Contacts Have a question? Email tend ersot~wake health. ed u '~` Conflict of Interest Policy PPB-MC-50 Effective Date: 7/2010 WAKE FOREST BAPTIST HEALTH POLICY AND PROCEDURE BULLETIN Subject: Conflict of Interest with Industry Purpose of Policy The purpose of this policy is to establish rules for interactions with Industry and Industry representatives throughout Wake > InfiNet Home Forest University Baptist Medical Center and its component institutions, Wake Forest University Health Sciences and North > Wake Forest Baptist Extranet Carolina Baptist Hospital and their controlled affiliates. These institutions carry out a joint mission of patient care, education, > WFBMC Phone Directory research and community service, and are committed to ensuring that faculty, employees, students, trainees and volunteers strive for the highest degree of professional and ethical standards and integrity in carrying out this mission. Often, Wake Forest University Baptist Medical Center engages in effective and principled interactions and relationships with representatives of pharmaceutical, biotechnology, medical device, and hospital and research equipment supply companies in order to advance patient care, education, research, and community service. While many of these interactions and relationships may benefit the Medical Center, its individual members, patients and the community, they also have the potential to create actual and perceived conflicts of interest, as well as other adverse consequences. In addition, the federal Anti-Kickback laws prohibit knowingly receiving anything of value from vendors that induces a clinician to use or purchase products or services which are reimbursed by Government programs such as Medicare or Medicaid. Therefore, Wake Forest University Baptist Medical Genter has adopted the following policy to govern interactions and relationships with Industry, Statement and Scope of Policy It is the policy of Wake Forest University Baptist Medical Center, including Wake Forest University Health Sciences and North Carolina Baptist Hospital, that interactions with Industry be free from improper influence by Industry, conducted so as to avoid or minimize actual or perceived conflicts of interest, and compliant with federal and state laws and regulations, including the Anti-Kickback law. This policy applies to all faculty, employees, students, trainees and volunteers of Wake Forest University Baptist Medical Center, Wake Forest University Health Sciences and North Carolina Baptist Hospital. For purposes of this policy, "Industry" is defined as all pharmaceutical manufacturers, and biotechnology, medical device, and hospital and research equipment supply Industry entities and their representatives, as well as any other vendor that provides goods or services for use in patient care, education or research. This policy also supplements existing WFUBMC, WFUHS and NCBH policies, including but not limited to' WFUHS Authorship Guidelines; WFUHS Policy on Conflicts of Interest and Disclosure; NCBH Policy on Conflicts of Interest; and WFUBMC Policies for Medical Service Representatives for Pharmaceutical Products and for Medical Service Representatives for Medical Devices and Products. In all cases where this policy is more restrictive than another WFUBMC, WFUHS or NCBH policy, this policy shall control, Procedures for the implementation and oversight of this policy shall be developed by the Conflict of Interest Oversight Committee with membership representing WFUBMC, WFUHS and NCBH. This policy incorporates the following types of interactions with Industry' I. Certified Gontinuing_Education (CGE) Activities and. Noncertfied Continuing Education (non-GCE) Acivties Ghost Writing.and Guest_Authorship II. News Releases and News Media Contact III. Committee Participation IV. Ind...ustry ~onso. red.Rese..a..rch V. Consulting and Speakers' Bureau Agreements VI. Payments for Attending Professional Meetings VII. Vendor Fairs http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 WFUBMC Infinet -Conflict of Interest Page 2 of 6 VIII. Personal Gifts from,Industry IX. Institutional Gifts from Industry X. Free Meals XI. Advertising Materials XII. Access o. f Medreal Serwce Representative. s (MSRs) XIII. Free Samples XIV. Free Services to Clinical Departments XV. Unless specified otherwise herein, penalties for violations of this policy will be imposed in accordance with applicable policies of WFUBMC, WFUHS and NCBH. Possible penalties may include: reimbursement to WFUBMC, WFUHS or NCBH for misused resources; formal reprimand for placement in employee or student file; ineligibility to participate in grant applications or on committees: or other disciplinary action up to and including termination of employment or dismissal from an educational or training program. Reports of suspected violations may be made to any of the individuals listed below, or anonymously through the WFUBMC hotline, Suspected violations will be referred to the following for investigation and sanctioning as appropriate: Students: Associate Dean for Student Services Staff: Human Resources Faculty: President of WFUP, WFUHS President and Dean of the School of Medicine, or Senior Associate Dean House Staff: President of WFUHS or Associate Dean for GME Policy Policy I. Certified Continuing Education (CCE) Activities and Noncertified Continuing Education (non- CCE) Activities Industry support of continuing education ("CE") can provide benefit to patients by ensuring that the most current, evidence- based medical information is provided to healthcare practitioners. In order to ensure that potential for bias is minimized and that CE programs are not a guise for marketing or off-label promotions, all CE events receiving Industry support or Industry sponsorship that are hosted, sponsored, or jointly sponsored by the Medical Center must comply with the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support of CME;_ Standards to Ensure the Independence of t;ME. Activties (or other similarly rigorous, applicable standards required by other health professions). whether or not CE credit is awarded for attendance at the event. All such agreements for Industry support must comply with the Wake Forest University School of Medicine ("WFUSM") Office of Continuing Medical Education ("CME") policies. Any such educational activity must be open on equal terms to all interested practitioners, and may not be limited to attendees selected by the company supporter(s). The same standards shall apply to Industry-supported non-CCE activities as apply to Industry-supported CCE activities. A Medical Center committee shall be established to review applications for Industry-supported non-CCE activities, and this committee will also manage logistics, including finances, of these programs. ~' RETURN TO TOP II. Ghost Writing and Guest Authorship Faculty, staff, and students may not be listed as authors on any materials ghostwritten by Industry representatives or someone acting on behalf of Industry. Faculty, staff, and students must always be responsible for the content of any publications or presentations, including slides. See also WFUHS Authorship Guidelines, Page IV-70 of Operations and Policy Manual, which provides guidance for scholarly publications. "~ RETURN TO TOP III. News Releases and News Media Contact It is the policy of Wake Forest University Baptist Medical Center to disclose any potential or actual conflict of interest (COI) related to an individual's financial interest in the sponsor of hislher research or in the ownership of a related entity or intellectual property, such as new or experimental drugs, devices or therapies, or of a start-up business. All such disclosures must comply with the policy on Conflict-of-Interest Procedure for. News Releases and News Media. Contact, http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 WFUBMC Infinet -Conflict of Interest (Communications, Marketing & Media (CM&M), January 2010). Page 3 of 6 RETURN TO TQP IV. Committee Participation WFUBMC, WFUHS and NCBH faculiy members and employees may serve on Medical Center committees that recommend purchases and utilization of pharmaceuticals or medical devices. In order to ensure that all actions of these Committees are free from the appearance of conflict of interest, each voting member of a Committee will annually complete a Disclosure of Potential Conflicts of Interest form. Additionally. Committee members are required to verbally update any new potentially conflicting relationships in open meeting prior to each vote during the year. Any voting member with an actual or potential conflict of interest shall recuse himself or herself from participation in voting events and similar decision-making processes when the decision or discussion may pose a conflict of interest. In addition, the Chair of a Committee may remove a member from the Committee in the event the Chair reasonably determines that the member cannot substantially contribute to and participate in the work of the Committee due the member's actual or potential conflict(s) of interest. RfTURff TO TOP V. Industry Sponsored Research Any WFUBMC, WFUHS or NCBH faculty member or employee acting as a Principal Investigator, Clinical Investigator (co- or sub-investigator), or othenaise conducting Industry-sponsored research in any way that could bias the design, conduct or implementation, management and reporting of research data, must comply with all institutional and federal requirements regarding management of conflicts of commitment and conflicts of interest. Specifically, each employee must comply with the "Overview and Summary of Conflict of Commitment and Gonflict oT Interest" Policy, revised in April, 2009, and as amended from time to time (WFt~M Organization and_Policies Handbook.IV,_pp,_46-5_5). RfTURff TO TOP VI. Consulting Agreements and Speakers' Bureaus Agreements For purposes of this policy consulting agreements are personal contracts between a faculty member or employee and a separate Industry Entity, and do not include Wake Forest University Baptist Medical Center, Wake Forest University Health Sciences, or North Carolina Baptist Hospital as a party to the consulting agreement. Nor does WFUBMC, WFUHS or NCBH provide review or insurance coverage for such contracts. Any faculty member or employee considering entering into a consulting arrangement may wish to seek the advice of an attorney retained at the faculty member's or employee's expense. The purpose of this policy on personal consulting is to ensure that the first commitment of the faculty or employee is to WFUBMC, WFUHS and NCBH, and that no conflict between a faculty member's or employee's employment exists when that faculty member or employee enters into a personal consulting relationship with an outside entity. Faculty members are pennitted to enter into consulting arrangements upon advance notification to the appropriate department chair and receipt of necessary approvals. Such notification shall specify the company the faculty member will be consulting with, the expected duration of the consulting, and the amount of money or other compensation the faculty member expects to earn or receive from the consulting. The department chair is responsible for maintaining documentation of all consulting arrangements for faculty members in his or her department for the duration of the consulting arrangement and for two years after the arrangement has terminated. Faculty members and staff may consult with Industry to provide scientific advice, provided any compensation for consulting services is reasonably related to specified services and is at fair market value; the arrangement is governed by written agreement specifying the service(s) to be provided; the consultant's duties are based on relevant expertise; the consultant is free to provide advice and services that reflect his or her expertise and judgment; and the arrangement complies with applicable Medical Center policies on conflicts of interest and commitment, The following paragraph (adapted to the particular agreement) should be included in any and all personal consulting agreements: The Entity acknowledges that Consultant's primary obligation is to WFUHS or NCBH. It is the intent of the http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 WFUBMC Infinet -Conflict of Interest Page 4 of 6 parties that efforts and specific responsibilities under this Agreement be separate and distinct from those duties performed for WFUHS or NCBH. In the event of any conflict between this Agreement and any terms of employment between the Consultant and WFUHS or NCBH, including work responsibilities and ownership of any resulting intellectual property, the terms and conditions of the Consultant's employment with WFUHS or NCBH will take precedence unless specific written arrangements have been made in advance between the Entity and WFUHS or NCBH In principle, faculty and staff may not participate in Industry sponsored Speakers' Bureaus and promotional speaking events. Faculty members may participate in extramural programs funded by unrestricted educational grants from industry, and may receive honoraria for these speaking engagements provided the content of the faculty member's presentation is his/her own and is not provided by the sponsor. For any presentation that an employee expects to receive compensation or support, the employee must disclose the name of the entity providing the support and the nature of it. This disclosure must be submitted in writing to the employee's Chair or supervisor for approval. Faculty members may fulfill speaking obligations to which they have committed themselves, provided such agreements precede the effective date of this policy and are completed by December 31, 2010. The phased implementation of this policy will be directed and monitored by the Conflict of Interest Oversight Committee. fi RETURN TO TOP VII. Payments for Attending Professional Meetings WFUBMC, WFUHS, and NCBH faculty and employees may attend Industry sponsored or supported educational meetings, lectures and conferences when such meetings, lectures and conferences are limited to objective scientific and educational information that promotes evidence-based medicine and scientific research. The following standards shall apply when attending Industry sponsored or supported educational meetings: A. Faculty and employees attending educational meetings may not accept any payments or reimbursements, either directly or indirectly, from Industry for costs and expenses related to the meeting, including registration fees, transportation, lodging, meats or other incidental expenses. In addition, payments or reimbursements may not be accepted for costs or expenses related to the cost of a spouse or other guest of the faculty or staff member attending the meeting. B. The main reason for attending the Industry sponsored or supported educational meetings should be to further the faculty member's or employee's knowledge on the subject(s) presented. Faculty and employees should ensure that such meetings are inclusive of and led by those who are qualified to present a program that is aimed at promoting evidenced-based medicine and scientific research, Meetings led by marketing representatives would not qualify as a legitimate educational meeting. C. Gifts may be accepted only in accordance with this policy. (See Section on Personal Gifts from Industry, below.) D. Faculty and employees may attend receptions and accept meals of modest value provided in connection with the educational meeting when provided or sponsored by Industry and when related to the educational meetings and available for all attendees. The receptions and meals should promote discussions among those attending the educational meeting, and should be incidental to the educational content of the meetings. Faculty and employees may not attend the reception and accept the meal if the faculty or employee will not be attending the educational component of the meeting. E. In principle, faculty and employees may not attend educational programs sponsored by Industry when such meetings are structured to improperly influence purchasing or prescribing decisions. F. Ii a faculty member or employee attends the meeting and participates as a presenter or speaker, acceptance of payments or reimbursements shall be in accordance with this policy. (See Section on Consulting and Speaker's Bureaus, above.) G. A faculty member or employee must complete the appropriate request form and obtain approval of hislher Chair or supervisor prior to attending an educational meeting, and such approval may be granted only in accordance with this policy. This policy is not intended to prohibit unrestricted educational grants provided by Industry. Departments may establish a departmental education fund where all such grants from Industry may be deposited. Awards from the departmental fund may not be made, conditioned upon or related to any pre-existing or future business relationship with any company that has contributed to the fund or any business or other decisions WFUHS, NCBH or WFUBMC has or may make relating to any such company or its products or services. In addition, the departmental fund may not be used to cover expenses for or related to attendance at an Industry organized meeting. Documentation of expenditures from the departmental fund and the purposes for such expenditures must be maintained by the department chair for as long as required by WFUBMC. fi RETURN Td TOP http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 WFUBMC Infinet -Conflict of Interest VIII. Vendor Fairs Page 5 of 6 Vendor fairs shall be prohibited at Wake Forest University Baptist Medical Center. A vendor fair is an event intended to promote drugs, devices, or other products to be prescribed for/used in the care of patients. This policy is not intended to preclude the NCBH Materials Management Department or the WFUHS Purchasing Department from coordinating vendor displays where several brands of medical devices or medical materials are displayed simultaneously for key decision makers to compare them in order make purchasing or standardization decisions. IX. Personal Gifts from Industry RETURN TO TOP Personal gifts Trom Industry may not be accepted by faculty, staff, students or volunteers. Examples of personal gifts include off-campus meals, pens, notepads, food baskets, flowers, gift cards, and entertainment, regardless of the value. Limited exceptions are permissible for items designed solely to educate patients, if individually valued at $100.00 or less. Examples include books related to healthcare such as The Premature Baby..B...o..o...k, diabetic cookbooks, general education booklets, and educational DVDs. Existing non-educational gifts branded with Industry logos must be removed from the Medical Center. X. Institutional Gifts from Industry RETURN TO TOP Gifts and loans to WFUBMC, WFUHS and NCBH of equipment, devices, supplies and similar items from Industry for use in education, research or clinical care must be consistent with institutional guidelines and procedures, including the sourcing of potential equipment prior to the acceptance of such gifts. The gift or loan transaction will be documented, and such gifts will be unrestricted in the sense that the donor-company will have no expectation of return benefit, or "quid pro quo". ~' RETURN TO TOP XI. Free Meals Effective July t, 2010, Industry supplied or supported food and drinks shall be prohibited at WFUBMC, WFUHS and NCBH. RETURN TO TOP XII. Advertising Materials Advertising materials (for example, print, radio, and television) designed to promote physician practices or clinical services that are funded directly or indirectly by Industry and include advertising for Industry or Industry products may not be purchased or accepted. Industry advertising and Industry advertising materials are prohibited at Wake Forest University Baptist Medical Center and at Medical Center programs. For purposes of this policy, Industry advertising does not include advertisements for clinical trials or Industry sponsored patient education materials such as those permitted under Section IX, Personal Gifts from Industry. RETURN TO TOP XIII. Access of Medical Service Representatives (MSRs) Industry access to the Medical Center occurs primarily through Medical Service Representatives (MSRs), including, but not limited to, pharmaceutical products MSRs and medical device MSRs. Pharmaceutical products MSRs are defined as vendors' representatives who promote pharmaceutical products antl provide information and services to health care http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 WFUBMC Infinet -Conflict of Interest Page 6 of 6 providers on behalf of manufacturers and suppliers. Medical device MSRs are defined as vendors' representatives who promote medical devices and products and provide information and services to health care providers and researchers on behalf of manufacturers and suppliers, but do not include health science associates or liaisons, who do not act in the capacity of MSRs. Faculty, staff, and student interactions with MSRs must comply with the Medical Center policies on MSR for Pharmaceutical Products and Medical Devices and Products. which require MSRs to properly register and prohibits their access to patient care areas. The Policy on Medical Devices and Products makes a limited exception for MSRs invited to provide in-service assistance regarding devices or equipment. MSRs providing in-service assistance must be accompanied by Medical Center staff or faculty at all times and patient consent for the MSRs attendance must be obtained. In these limited circumstances, an MSR may be allowed to offer technical advice to a surgical team regarding their equipment or devices but may not give advice concerning patient care. MSRs are restricted from manipulating their equipment or devices while in use on a patient and MSRs are not to touch patients at any time, nor may they scrub on any procedures. Exceptions to this restriction are extenuating circumstances (e.g., equipment malfunction) or specialized training (e.g., pacemaker representatives} under the direction of a Medical Genter physician and in accordance with the applicable departmental policy. MSRs must have an appointment with a specified individual in order to visit Medical Center staff or faculty. RETURN TO TOP XIV. Free Samples Individual Medical Center faculty, staff, students and trainees may not accept medications and pharmaceutical samples from Industry. Further, individual faculty, staff, trainees and students at the Medical Center may not accept medications and pharmaceutical samples from Industry representatives on behalf of the Medical Center. The only exceptions to this rule are that the NCBH Pharmacy may continue to accept pharmaceutical samples, as it has previously done, for select transplant and cardiology patients and that samples will be permitted when provided for patient education (for example education in the use of inhaled drugs for pediatric asthma). Should the elimination of medication samples negatively impact the quality of patient care within an individual clinic, the section or department may request an exception to this policy. Specific criteria will be established for such exceptions, and the request will be reviewed by the Medical Center Committee. A voucher system will be established for the distribution of pharmaceuticals to meet the needs of indigent and other selected patients at the medical Center. The Outpatient Prescription Drug Subcommittee shall develop the procedures for implementation of this policy, including a list of drugs that are acceptable for free distribution to indigent patients via the voucher system. '~ Rf.TURN TO TOP XV. Free Services to Clinical Departments Clinical departments may not accept free services provided by Industry representatives. Examples include Industry representatives obtaining insurance preauthorizationsfnr their drugs or devices, conducting coding audits, and appealing denied claims or reimbursing departments for denied claims. Exceptions may be appropriate if the primary purpose of the service is to benefit the patient, and the benefit to the clinical department is de minimus. For example, frequently providing a free service that is ordinarily performed by department staff is not acceptable. Requests for exceptions should be made to the WFUHS and NCBH Compliance Office as appropriate. RETURN TO TOP Comments or questions about the Conflict of Interest policy? Email us at AskUs(~wakehealth.edu. For technical questions or comments, contact the webmaster. Last updated.' March 23, 2011 http://infinet.wfubmc.edu/COI/COI_Policy.html 7/15/2011 Contract ~~~ ~H~o~~- i os Nord ('arolina Eiaptist Hospital NOTARIZED CONFLICT OF INTEREST POLICY State of North Carolina County of ~ I, ,Notary Public for said County and State, certify that l7Lt~~ ~~ ~e.(~Y~S personally appeared before me this day and acknowledged that he/she is /-G /Gf-Pih~itrfive of and by that authority duly given and as the act of the corporation, affirmed that the foregoing Conflict of Interest Policy was adopted by the Board of Directors in a meeting held /y-~ day of r ~i~_ ~~/ y. Sworn to and subscribed before me this ~ day ,o~O~~ i BE7TYE ~. SMtTH NOTARY PUBL,10 Forsyth County, North Carolina ' tty c;:~ Offici"a1 S~ea1 //'c'? '- ~~ Notary Public My Commission expires // '" ~ , 20/~/ Attached is the Conflict of Interest Policy for: LLa ,~ ~-vrGs~ ~,~~if of Corporation Official Contract-General (06/04) Page 14 of 19 Contract '~l~ L86076- t 08 Noiih Carolina I3aPtist I lospital ATTACHMENT E -OVERDUE TAXES Instructions: Grantee should complete this certification for all funds received. Entity should enter appropriate data in the yellow highlighted areas. The completed and signed form must be provided to the County Department of Social Services. Entity's Letterhead [Date of Certification (mmddyyyy)] i`c>: ()ranl;e ('t~ctnt~' C)cp~'t°tn~c°nt ts9°~;~~ci:ai'ticrtiaces Certification: /, /Vo/~lr Le~~-Lin. ~itr~jr3-~ f~f~~st l We certif that the - ~~ -'' "" '." "" ..r~~cres not have any overdue tax debts, as defined by Y ~:. N.C.G.S. 105-243.1, at the federal, State, or local level. We further understand that any person who makes a false statement in violation of N.C.G.S. 143C-6-23is guilty of a criminal offense punishable as provided by N.C.G.S.143C-10-1). Sworn Statement: [ being duly sworn, say that we are the Board Chair and [Title of the Second Authorizing Official], respectively, of [insert name of organization] of [City] in the State of [Name of State]; and that the foregoing certification is true, accurate and complete to the best of our knowledge and was ade and subscribed by us. We also acknowledge and understand that any misuse of State funds will be report to the appropriate authorities for further action. 7s-sa,~r !~..~G~iY.~s Sworn to and subscribed before me on the day of the date of said certification. My Commission Expires:ll ~ -l '~" (Notary Si~ature ETTYE J. SMITI Nara~r Pueuc Fonaytl~ County, Nor, MV Canmission Exoires Contract-General (06/04) Page 15 of 19 Contract # L8(i07fi-108 North Carolina F3aptist Etospital ATTACHMENT I ORANGE COUNTY DEPARTMENT OF SOCIAL SERVICES BUSINESS ASSOCIATE ADDENDUM This Agreement is made effective the 1st day of , 2011, by and between Orange County Dept. of Social Services ("Covered Entity") and North Carolina Baptist Hospital ("Business Associate") (collectively the "Parties"). 1. BACKGROUND a. Covered Entity and Business Associate are parties to contract number 68-1015 (the "Contract"), whereby Business Associate agrees to perform certain services for or on behalf of Covered Entity. b. Covered Entity is an organizational unit of Surry County (the "County") that has been designated in whole or in part by the County as a health care component for purposes of the HIPAA Privacy Rule. c. The relationship between Covered Entity and Business Associate is such that the Parties believe Business Associate is or may be a "business associate" within the meaning of the HIPAA Privacy Rule. d. The Parties enter into this Business Associate Addendum to the Contract with the intention of complying with the HIPAA Privacy Rule provision that a covered entity may disclose protected health information to a business associate, and may allow a business associate to create or receive protected heath information on its behalf, if the covered entity obtains satisfactory assurances that the business associate will appropriately safeguard the information. 2. DEFINITIONS Unless some other meaning is clearly indicated by the context, the following terms shall have the following meaning in this Agreement: a. "HIPAA" means the Administrative Simplification Provisions, Sections 261 through 264, of the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191. b. "Individual" shall have the same meaning as the term "individual" in 45 CFR160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g). c. "Privacy Rule" shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. d. "Protected Health Information" shall have the same meaning as the term "protected health information" in 45 CFR 160.103, limited to the information created or received by Business Associate from or on behalf of Covered Entity. e. "Required By Law" shall have the same meaning as the term "required by law" in 45 CFR 164.103. f. Unless otherwise defined in this Agreement, terms used herein shall have the same meaning as those terms have in the Privacy Rule.\ 3. OBLIGATIONS OF BUSINESS ASSOCIATE a. Business Associate agrees to not use or disclose Protected Health Information other than as permitted or required by this Agreement or as Required By Law. b. Business Associate agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Agreement. Contract-General (06/04) Page 16 of 19 Contract ~/E~ L8(i07(i-IOR North Carolina E3aptist I lospital c. Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of Protected Health Information by Business Associate in violation of the requirements of this Agreement. d. Business Associate agrees to report to Covered Entity any use or disclosure of the Protected Health Information not provided for by this Agreement of which it becomes aware. e. Business Associate agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity agrees to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such information. f. Business Associate agrees to provide access, at the request of Covered Entity, to Protected Health Information in a Designated Record Set to Covered Entity or, as directed by Covered Entity, to an Individual in order to meet the requirements under 45 CFR 164.524. g. Business Associate agrees, at the request of the Covered Entity, to make any amendment(s) to Protected Health Information in a Designated Record Set that the Covered Entity directs or agrees to pursuant to 45 CFR 164.526. h. Unless otherwise prohibited by law, Business Associate agrees to make internal practices, books, and records, including policies and procedures and Protected Health Information, relating to the use and disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity, available to the Covered Entity, for purposes of determining Covered Entity's compliance with the Privacy Rule. i. Business Associate agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528, and to provide this information to Covered Entity or an Individual to permit such a response. 4. PERMITTED USES AND DISCLOSURES a. Except as otherwise limited in this Agreement or by other applicable law or agreement, if the Contract permits, Business Associate may use or disclose Protected Health Information to perform functions, activities, or services for, or on behalf of, Covered Entity as specified in the Contract, provided that such use or disclosure: 1) would not violate the Privacy Rule if done by Covered Entity; or 2) would not violate the minimum necessary policies and procedures of the Covered Entity. b. Except as otherwise limited in this Agreement or by other applicable law or agreements, if the Contract permits, Business Associate may use Protected Health Information as necessary for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. c. Except as otherwise limited in this Agreement or by other applicable law or agreements, if the Contract permits, Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that: l) disclosures are Required By Law; or 2) Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and will be 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 Business Contract-General (06/04) Page 17 of 19 Contract a~ L86076-108 North Carolina baptist Ilospital Associate of any instances of which it is aware in which the confidentiality ofthe information has been breached. d. Except as otherwise limited in this Agreement or by other applicable law or agreements, if the Contract permits, Business Associate may use Protected Health Information to provide data aggregation services to Covered Entity as permitted by 45 CFR 164.504(e)(2)(i)(B). e. Notwithstanding the foregoing provisions, Business Associate may not use or disclose Protected Health Information if the use or disclosure would violate any term of the Contract or other applicable law or agreements. S. TERM AND TERMINATION a. Term. This Agreement shall be effective as of the effective date stated above and shall terminate when the Contract terminates. b. Termination for Cause. Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity may, at its option: 1) Provide an opportunity for Business Associate to cure the breach or end the violation, and terminate this Agreement and services provided by Business Associate, to the extent permissible by law, if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity; 2) Immediately terminate this Agreement and services provided by Business Associate, to the extent permissible by law; or 3) If neither termination nor cure is feasible, report the violation to the Secretary as provided in the Privacy Rule. c. Effect of Termination. 1) Except as provided in paragraph (2) of this section or in the Contract or by other applicable law or agreements, upon termination of this Agreement and services provided by Business Associate, for any reason, Business Associate shall return or destroy all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies of the Protected Health Information. 2) In the event that Business Associate determines that returning or destroying the Protected Health Information is not feasible, Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction not feasible. Business Associate shall extend the protections of this Agreement 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 Business Associate maintains such Protected Health Information. 6. GENERAL TERMS AND CONDITIONS a. This Agreement amends and is part of the Contract. b. Except as provided in this Agreement, all terms and conditions of the Contract shall remain in force and shall apply to this Agreement as if set forth fully herein. Contract-General (06/04) Page 18 of 19 C<:mtract #t L8(i07fi-108 Ncn11~ ('arolina E3aptist hospital c. In the event of a conflict in terms between this Agreement and the Contract, the interpretation that is in accordance with the Privacy Rule shall prevail. In the event that a conflict then remains, the Contract terms shall prevail so long as they are in accordance with the Privacy Rule. d. A breach of this Agreement by Business Associate shall be considered sufficient basis for Covered Entity to terminate the Contract for cause. ORANGE COUNTY DEPARTMENT OF SOCIAL SERVICES By: (/~ BUSINESS ASSOCIATE Corporation Name (if applicable): ~~~1 By: thor ed signature/date ,? /i~~/ Print name/title G /. •~-~ ~.r~ Contract-General (06/04) Page 19 of 19