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  1. 1. INTERSOCIETAL COMMISSION FOR THE ACCREDITATION OF NUCLEAR MEDICINE LABORATORIES (ICANL) NUCLEAR CARDIOLOGY & NUCLEAR MEDICINE 8840 Stanford Boulevard, Suite 4900, Columbia, Maryland 21045 (410) 872-0100 Fax (410) 872-0030 ACCREDITATION AGREEMENT (name of laboratory) (hereinafter the "Laboratory") located at (address) hereby requests accreditation by the Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories, Inc. (hereinafter "the ICANL") of its performance of nuclear medicine laboratory services. The Laboratory agrees to pay to the ICANL an application fee in the amount of $3500 for Comprehensive Nuclear Medicine Testing (Nuclear Medicine Testing and Nuclear Cardiology Testing and/or PET Testing); $3000 for Nuclear Cardiology Testing only; $3000 for Nuclear Medicine Testing only; or $3000 for PET Testing only. There is an additional $1000 per added site for laboratories meeting the multiple site exemption criteria and an additional $500 fee for laboratories applying for a mobile component. Additional fees for mobile services may be assessed based upon the size, complexity and geographic distribution. The Laboratory also acknowledges and hereby gives its consent to an on-site inspection of all facilities and procedures prior to receiving its final decision. The on-site visit will be conducted at a mutually agreed upon date and time following Laboratory notification. The fees for the site visit are included in the above mentioned application fees. The ICANL agrees to protect the confidentiality of all materials and information reviewed during the site visit. In exchange, the ICANL agrees to determine whether the Laboratory meets the ICANL's most recent Standards, as may be amended from time to time, for the performance of quality nuclear medicine testing. The ICANL agrees to evaluate the Laboratory by reviewing the Laboratory's completed application and site visit report and comparing the practices followed by the Laboratory to standards of practice independently developed and published by the ICANL. The ICANL will review the materials submitted to determine whether the Laboratory has demonstrated compliance with the ICANL's accreditation requirements. The ICANL reserves the right to determine the sufficiency of materials submitted. If the Laboratory fails to submit the documentation required for a complete application and/or fails to undergo the required site visit, accreditation will not be granted and the fee for processing the application will not be refunded. The ICANL agrees to preserve the confidential nature of all data and documents submitted related to the Laboratory’s application for accreditation and the site visit including, but not limited to, records that contain patient confidential and/or privileged information and quality review information, to the extent required by state and/or federal law, and as provided in the HIPAA Addendum, which is attached hereto and incorporated by reference. 10/2002 ICANL Accreditation Agreement
  2. 2. The Laboratory further grants the ICANL the right to report to third parties upon inquiry or in a directory to be published by the ICANL the status of the Laboratory with respect to accreditation, and when the Laboratory became accredited. If granted, accreditation will be valid for a period of three years from the date of decision (said decision date being the date of the ICANL Board of Directors meeting in which the Laboratory’s accreditation decision was made). If the Laboratory should undergo any change in its name, address, ownership, Medical Director, Technical Director or any material significant change in its operation, the Laboratory agrees that it shall notify the ICANL of such changes in writing within thirty (30) days. The ICANL, in its sole discretion, may require additional demonstration of compliance. If the ICANL finds that the Laboratory fails to comply with the published ICANL Essentials and Standards, the ICANL may revoke the Laboratory's accreditation. In the event accreditation is granted, the Laboratory agrees that the entity that owns the right to this accreditation is the corporation, partnership or business that owns and operates the Laboratory and that (organization) owns and operates this laboratory, with its main business address is at The application process requires good faith participation, including full accuracy of documents submitted. Any laboratory determined to have falsified documents faces loss of accreditation, suspension from the accreditation process and referral to appropriate state and federal government agencies. Falsification includes deletion or fabrication of data. The Laboratory is eligible to apply for or maintain accreditation only if it is in compliance with the ICANL policies and procedures. The Laboratory bears the burden of showing and maintaining compliance at all times. The ICANL may deny, revoke, or otherwise act upon accreditation or reaccredidation when the Laboratory is not in compliance with the ICANL published Essentials and Standards, policies or procedures. Nothing provided herein shall preclude administrative requests by ICANL for additional information to supplement or complete an application for accreditation or reaccredidation. In the event that the Laboratory meets the eligibility requirements and is granted accreditation by ICANL, the Laboratory hereby is granted a license to use certain ICANL logos and trademarks (hereinafter collectively referred to as the “Marks”). Provided, however, that at all times, the Laboratory shall use the Marks only as specifically authorized and in compliance with the then-current ICANL policies and procedures relating to the use of the Marks. Improper use of ICANL Marks and/or failure to abide by ICANL policies and procedures relating to the Marks may result in discipline, up to and including revocation of accreditation and/or permanent loss of eligibility for accreditation. It shall be the obligation of the Laboratory to keep up-to-date on ICANL policies and procedures. Page 2 10/2002
  3. 3. The Laboratory hereby agrees to hold harmless and indemnify the ICANL, its directors, officers, employees, agents, and sponsoring organizations for any and all damages, claims, judgments, losses, costs, and expenses, including attorney's fees, which may arise from or relate to this Accreditation Agreement or the Laboratory's participation in the accreditation process, including the ICANL's findings and recommendations as to the Laboratory's accreditation or lack thereof, publication of the accreditation status of the Laboratory, and actions that may be taken by any person as a result of the accreditation process or the Laboratory's status with respect to accreditation. The Laboratory hereby represents that it is a (circle one) corporation, general partnership, limited partnership, sole proprietorship or other (specify) In addition, the undersigned represents that he/she is (title) of the Laboratory and has been fully authorized by the Laboratory to enter into this Accreditation Agreement and that it shall constitute the formal, binding act of the Laboratory. Any controversies under this Agreement will be governed by and subject to the laws of the State of Maryland. This Agreement represents the entire agreement of the parties and supersedes any other understanding of the parties concerning the subject matter herein. There are no other representations, covenants, arrangements, or understandings, either written or oral, between the parties relating to the subject matter which are not fully expressed herein or have been relied upon in entering into this Agreement. In the event accreditation is granted, the name of the Laboratory appearing on the certificate and in any ICANL publication should be as follows: In the event accreditation is granted, the ICANL will post a link from the ICANL Web site to a Laboratory web site that appears as follows: Page 3 10/2002
  4. 4. The Laboratory hereby requests accreditation for: Nuclear cardiology - Myocardial perfusion imaging (MPI) Nuclear cardiology - Equilibrium radionuclide angiography (ERNA) Gastrointestinal system imaging Central nervous system imaging Endocrine system imaging Endocrine system non-imaging (RAI uptake) Skeletal system imaging Genitourinary system imaging Pulmonary system imaging Infection imaging Tumor imaging Hematopoietic, reticuloendothelial, lymphatic imaging Other cardiovascular imaging Nuclear medicine therapy Oncologic PET imaging Neurologic PET imaging Cardiac PET imaging The undersigned certifies that the attached completed application is an accurate, true and complete description of the nuclear medicine diagnostic services provided. (Must be signed by medical director or officer of the corporation.) THE ICANL: By: Name: Title: Date: _______________________ LABORATORY: WITNESS ATTEST: By: By: Name: Name: Title: Title: _____________________ Date: _______________________ Date: _____________________ Page 4 10/2002
  5. 5. INTERSOCIETAL COMMISSION FOR THE ACCREDITATION OF NUCLEAR MEDICINE LABORATORIES 8840 Stanford Boulevard, Suite 4900, Columbia, Maryland 21045 (410) 872-0100 Fax (410) 872-0030 HIPAA ADDENDUM For the purposes of this Addendum, the Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories shall be referred to as a Business Associate of Laboratories. As a “Business Associate” we agree to do the following: (a) Preserve the confidential nature of all data and documents submitted related to the Laboratory’s application for accreditation including, but not limited to, records that contain patient confidential and/or privileged information and quality review information, to the extent required by state and/or federal law. (b) Only use, disclose and maintain any individually identifiable health information, (hereinafter referred to as Protected Health Information (“PHI”) from Laboratory or any other party as a result of this Agreement in the performance of Business Associate’s obligations hereunder, to properly manage and administrate its business or in compliance with federal and state law, rules and regulations. The parties contemplate under this Agreement that Business Associate may use and disclose the protected information during or assisting in the performance of one or more of the identified activities or services in the Agreement: I. DUTIES AND OBLIGATIONS: Business Associate agrees to do the following: (1) Request the minimum necessary PHI for any uses or disclosures required by subparagraph (a). (2) Use appropriate safeguards to prevent use or disclosure of PHI other than those specified hereunder. (3) Report to a Laboratory any use or disclosure of the health information not provided for hereunder. (4) Obtain permission to disclose PHI to a subcontractor. (5) Require and ensure that its agent, including a subcontractor, to whom it provides PHI received from, or created or received by, or on behalf of Laboratory, maintain the confidentiality of such health information, report any disclosure or breach of confidentiality to Business Associate and agree to be bound by the same restrictions and conditions that apply, to Business Associates with respect to the health information. Page 5 10/2002
  6. 6. (6) Make any received PHI available if requested by the applicable patient for amendment(s). (7) Make available, if requested by Laboratory, PHI in order to provide an accounting of all disclosures of patient information. In doing so, Business Associate agrees to implement appropriate procedures and methods to allow it to track and maintain a log of any of its disclosures of PHI that are required to be accounted for pursuant to the Privacy Standards. Within ten (10) business days notice, by Laboratory to Business Associate that it has received a request for any accounting of disclosures, Business Associate shall make available to Laboratory such information as is in its possession and is required as to make the accounting required by 45 C.F.R. §164.528. (8) Make its internal practices, books, and records relating to the use and disclosure of PHI available if requested by the Secretary of the Department of Human Services to evaluate compliance with the applicable laws, rules, and regulations. (9) Recognize that the Laboratory owns the verbal, written and/or electronic form of the PHI for all patients related to this Agreement. 10) Maintain any PHI it receives from Laboratory in compliance with Laboratory’s policies and procedures and all applicable federal and state laws, rules and regulations and allow Laboratory access to the PHI it possesses as needed to provide patient care and to comply with all applicable federal and state laws, rules, and regulations. II. TERMINATION: The following procedures set forth in this Agreement shall govern the termination of this Agreement: 1) Laboratory may immediately terminate this Agreement for cause upon the knowledge of a material breach of confidentiality by Business Associate. 2) Any for cause termination shall be effective only after Laboratory has provided reasonable written notice of the potential “cause” to Business Associate of the material breach of any term or condition of this provision. 3) In the event of the termination of agreement, Business Associate agrees to return any health information and copies or destroy such information and copies. If for any reason, such health information cannot be returned or destroyed, then all obligations of Business Associate regarding such information shall survive the termination of the Agreement indefinitely or until such information is returned to the covered entity or destroyed. Under no circumstances, shall Business Associate be considered owner of the PHI used or disclosed by or to Business Associate pursuant to the terms of this agreement. III. THIRD PARTY RIGHTS: The terms of this Addendum are not intended, nor should they be construed, to grant any rights to any other parties other than Business Associate and Laboratory.
  7. 7. IV. INDEMNIFICATION: Business Associate shall indemnify Laboratory for any and all claims, inquiries, costs or damages, including but not limited to any monetary penalties, incurred by Laboratory arising from a violation by Business Associate of its obligations under this Addendum. In the event that Business Associate receives a subpoena, court or administrative order, or other discovery request or mandate for release of PHI, Laboratory shall have the right to control Business Associate’s response to such request. Business Associate shall notify Laboratory within two (2) business days of receipt of such request. V. REMEDIES: No remedy conferred upon any party by this Agreement is intended to be exclusive or any other remedy, and each and every such remedy shall be cumulative and shall be in addition to any other remedy given hereunder or now or hereafter existing in law or in equity. Page 7 10/2002