Loading...
CONTRACT 4433 Other CLOSED 44 3 3 I •c 9F LOS,� - . # A * ' ° ' . - tar k + `ZA,2 ^‘r-,z millir .4f. ,.14. k. --------t „. ,� i � . ..x. __ ______:.. c• [IFORo. AGREEMENT BY AND BETWEEN COUNTY OF LOS ANGELES AND EL SEGUNDO FIRE DEPARTMENT FOR CONTROLLED SUBSTANCES SUPPLY FOR PARAMEDIC PROVIDER AGENCIES AGREEMENT PROVISIONS 0 .11 TABLE OF CONTENTS PARAGRAPH TITLE PAGE RECITALS 1 1.0 APPLICABLE DOCUMENTS 3 2.0 DEFINITIONS 4 3.0 WORK 5 4.0 TERM OF AGREEMENT 5 5.0 AGREEMENT SUM 5 6.0 ADMINISTRATION OF AGREEMENT- COUNTY 6 6.1 COUNTY'S PROJECT DIRECTOR 7 6.2 COUNTY'S PROJECT MANAGER 7 6.3 COUNTY'S AGREEMENT PROJECT MONITOR 7 7.0 ADMINISTRATION OF AGREEMENT - CONTRACTOR 7 7.1 CONTRACTOR'S PROJECT MANAGER 7 7.2 CONFIDENTIALITY 8 8.0 STANDARD TERMS AND CONDITIONS 9 8.1 AMENDMENTS 9 8.2 ASSIGNMENT AND DELEGATION 9 8.3 AUTHORIZATION WARRANTY 10 8.4 BUDGET REDUCTIONS 10 8.5 COMPLAINTS (Intentionally Omitted) 11 8.6 COMPLIANCE WITH APPLICABLE LAW 11 8.7 COMPLIANCE WITH CIVIL RIGHTS LAWS .. 12 8.8 COMPLIANCE WITH THE COUNTY'S JURY SERVICE PROGRAM (Intentionally Omitted) 14 8.9 CONFLICT OF INTEREST (Intentionally Omitted) 14 8.10 CONSIDERATION OF HIRING COUNTY EMPLOYEES TARGETED FOR LAYOFF/OR RE-EMPLOYMENT LIST (Intentionally Omitted) 14 8.11 CONSIDERATION OF HIRING GAIN/GROW PROGRAM PARTICIPANTS (Intentionally Omitted) 14 8.12 CONTRACTOR RESPONSIBILITY AND DEBARMENT (Intentionally Omitted) 14 8.13 CONTRACTOR'S ACKNOWLEDGEMENT OF COUNTY'S COMMITMENT TO THE SAFELY SURRENDERED BABY LAW (Intentionally Omitted) 17 Controlled Substances Supply for Paramedic Provider Agencies Agreement Page i May 2013 4433 AGREEMENT PROVISIONS TABLE OF CONTENTS PARAGRAPH TITLE PAGE 8.14 CONTRACTOR'S WARRANTY OF ADHERENCE TO COUNTY'S CHILD SUPPORT COMPLIANCE PROGRAM (Intentionally Omitted).,,. 17 8.15 COUNTY'S QUALITY ASSURANCE PLAN 17 8.16 DAMAGE TO COUNTY FACILITIES, BUILDINGS OR GROUNDS (Intentionally Omitted) 17 8.17 EMPLOYMENT ELIGIBILITY VERIFICATION (Intentionally Omitted) 17 8.18 FACSIMILE REPRESENTATIONS 17 8.19 FAIR LABOR STANDARDS (Intentionally Omitted) 18 8.20 FORCE MAJEURE (Intentionally Omitted) 18 8.21 GOVERNING LAW, JURISDICTION, AND VENUE 18 8.22 INDEPENDENT CONTRACTOR STATUS 18 8.23 INDEMNIFICATION 19 8.24 GENERAL PROVISIONS FOR ALL INSURANCE COVERAGE 19 8.25 INSURANCE COVERAGE 25 8.26 LIQUIDATED DAMAGES (Intentionally Omitted) 25 8.27 MOST FAVORED PUBLIC ENTITY (Intentionally Omitted) 26 8.28 NON EXCLUSIVITY (Intentionally Omitted) 26 8.29 NOTICE OF DELAYS (Intentionally Omitted) 26 8.30 NOTICE OF DISPUTES AND DISPUTE RESOLUTION 26 8.31 NOTICE TO EMPLOYEES REGARDING THE FEDERAL EARNED INCOME CREDIT (Intentionally Omitted) 27 8.32 NOTICE TO EMPLOYEES REGARDING THE SAFELY SURRENDERED BABY LAW (Intentionally Omitted) 27 8.33 NOTICES 27 8.34 PROHIBITION AGAINST INDUCEMENT OR PERSUASION (Intentionally Omitted) 27 8.35 PUBLIC RECORDS ACT (Intentionally Omitted) 27 8.36 PUBLICITY (Intentionally Omitted) 27 8.37 RECORD RETENTION AND INSPECTION/AUDIT SETTLEMENT 27 8.38 RECYCLED BOND PAPER 29 8.39 SUBCONTRACTING (Intentionally Omitted) 29 Controlled Substances Supply for Paramedic Provider Agencies Agreement Page ii May 2013 AGREEMENT PROVISIONS TABLE OF CONTENTS PARAGRAPH TITLE PAGE • 8.40 TERMINATION FOR BREACH OF WARRANTY TO MAINTAIN COMPLIANCE WITH COUNTY'S CHILD SUPPORT COMPLIANCE PROGRAM (Intentionally Omitted) 29 8.41 TERMINATION FOR CONVENIENCE 29 • 8.42 TERMINATION FOR DEFAULT 29 8.43 TERMINATION FOR IMPROPER CONSIDERATION (Intentionally Omitted) 31 8.44 TERMINATION FOR INSOLVENCY (Intentionally Omitted) 31 8.45 TERMINATION FOR NON-ADHERENCE OF COUNTY LOBBYIST ORDINANCE (Intentionally Omitted) 31 8.46 TERMINATION FOR NON-APPROPRIATION OF FUNDS (Intentionally Omitted) 31 8.47 VALIDITY 31 8.48 WAIVER 31 8.49 WARRANTY AGAINST CONTINGENT FEES (Intentionally Omitted) 31 8.50 WARRANTY OF COMPLIANCE WITH COUNTY'S DEFAULTED PROPERTY TAX REDUCTION PROGRAM (Intentionally Omitted) 32 8.51 TERMINATION FOR BREACH OF WARRANTY TO MAINTAIN COMPLIANCE WITH COUNTY'S DEFAULTED PROPERTY TAX REDUCTION PROGRAM (Intentionally Omitted) 32 9.0 UNIQUE TERMS AND CONDITIONS 32 9.1 CONTRACTOR'S OBLIGATIONS AS A "BUSINESS ASSOCIATE" UNDER THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT of 1996 (HIPAA) AND THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) 32 9.2 NO REQUIREMENT TO TRANSPORT TO COUNTY FACILITIES 32 SIGNATURES 33 Controlled Substances Supply for Paramedic Provider Agencies Agreement Page iii May 2013 4433 AGREEMENT PROVISIONS TABLE OF CONTENTS EXHIBITS A STATEMENT OF WORK B PREHOSPITAL CARE MANUAL (REFERENCE NO. 702) B1 PREHOSPITAL CARE MANUAL (REFERENCE NO. 502) C CONTROLLED SUBSTANCES INVENTORY C1 CONTROLLED SUBSTANCES FEE SCHEDULE D CONTRACTOR'S EEO CERTIFICATION (Intentionally Omitted) E COUNTY'S ADMINISTRATION F CONTRACTOR'S ADMINISTRATION G1 CONTRACTOR ACKNOWLEDGEMENT AND CONFIDENTIALITY AGREEMENT H JURY SERVICE ORDINANCE (Intentionally Omitted) I SAFELY SURRENDERED BABY LAW (Intentionally Omitted) J NOVATION AFFILIATE PURCHASING PROGRAM AGREEMENT HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) AGREEMENT K CONTRACTOR'S OBLIGATIONS AS A "BUSINESS ASSOCIATE" UNDER THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) AND THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) Controlled Substances Supply for Paramedic Provider Agencies Agreement Page iv May 2013 4433 x R a AGREEMENT BETWEEN COUNTY OF LOS ANGELES AND EL SEGUNDO FIRE DEPARTMENT FOR CONTROLLED SUBSTANCES SUPPLY FOR PARAMEDIC PROVIDER AGENCIES This Agreement and Exhibits are made and entered into this day of , 201_ by and between the County of Los Angeles, hereinafter referred to as County and the El Segundo Fire Department, hereinafter referred to as Contractor. RECITALS WHEREAS, pursuant to the authority granted under the Emergency Medical Services and Prehospital Emergency Medical Care Personnel Act (California Health and Safety Code Division 2.5, Sections 1797, et sec{.), (hereafter "Act") County has established and maintains an Advanced Life Support (hereafter "ALS") system providing services utilizing Emergency Medical Technicians- Paramedics (hereafter "EMT-P"), or "paramedics") for the delivery of emergency medical care to the sick and injured at the scene of an emergency, during transport to a general acute care hospital, during interfacility transfer, while in the emergency department of a general hospital, until care responsibility is assumed by the regular staff of that hospital, and during training within the facilities of a participating general acute care hospital; and WHEREAS, pursuant to the Act, County has designated its Department of Health Services as the local Emergency Medical Services Agency (hereafter "EMS Agency"), and WHEREAS, the EMS Agency approves paramedic provider agencies, to render through licensed and accredited EMT-P personnel ALS-level patient care in accordance with policies and procedures established by the EMS Agency and the State EMS Authority; and WHEREAS, under Title 22, California Code of Regulations, Section 100145(c), the Medical Director of the local EMS Agency may approve policies and procedures allowing an EMT-P to administer medications identified in that Section, provided they are incorporated into the written policies and procedures of the EMS Agency; and Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 1 May 2013 4433 WHEREAS, the EMS Agency Medical Director has developed and approved the EMT-P Scope of Practice for Los Angeles County, which includes the administration of approved controlled drugs and use of medical devices; and WHEREAS, under the California Business and Professions Code, Chapter 9, • Section 4119, a pharmacy may furnish a dangerous drug or a dangerous device to an approved service provider within an emergency medical services system for storage in a secured emergency pharmaceutical supplies container, in accordance with the policies and procedures of the local emergency medical services agency; and WHEREAS, the California Business and Professions Code, Section 4380, restricts the resale of drugs acquired at preferentially low prices to the person's own use or when sold to a purchaser also eligible for those prices; WHEREAS, approved Controlled Substances cannot be obtained by a paramedic provider agency without the authorization of a physician; and WHEREAS, the EMS Agency Medical Director may accept responsibility for authorizing the procurement of approved Controlled Substances upon the request of a paramedic provider agency provided that the provider agency adheres to policies and procedures established by the EMS Agency and this Agreement is maintained in full force; and WHEREAS, Contractor is approved by the County of Los Angeles as an ALS provider of prehospital emergency medical services and is staffed with licensed and accredited EMT-Ps; and WHEREAS, Contractor desires the EMS Agency Medical Director to provide authorization for Contractor's procurement of approved Controlled Substances; and WHEREAS, Contractor has a quality assurance program that specifically addresses the procurement, transport, storage, administration, and monitoring of approved Controlled Substances which has been approved by the EMS Agency; and WHEREAS, Contractor and the EMS Agency Medical Director agree to cooperate to ensure appropriate handling and monitoring of approved Controlled Substances; and WHEREAS, the parties wish to cooperate with each other to efficiently and appropriately meet the needs of Los Angeles County EMS patients; and WHEREAS, this Agreement is not intended, and shall not be deemed, a written agreement between City and County (or the local EMS Agency) for the purpose of California Health and Safety Code Section 1797.201 and City does not waive Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 2 May 2013 4433 its "grandfather" status, if applicable, under California Health and Safety Code Section 1797.201; and WHEREAS, this Agreement is authorized by California Health and Safety Code Section 1797.252; Title 22, California Code of Regulations Sections 100144 and 100170; and California Government Code Section 26227; and WHEREAS, County-Operated Pharmacies are licensed to provide approved Controlled Substances and operate under the regulations of the State of California Department of Consumer Affairs Board of Pharmacy. NOW THEREFORE, in consideration of the mutual covenants contained herein, and for good and valuable consideration, the parties agree to the following: 1.0 APPLICABLE DOCUMENTS Exhibits A, B, B1, C, C1, D, E, F, G1, H, I, J and K are attached to and form a part of this Agreement. In the event of any conflict or inconsistency in the definition or interpretation of any word, responsibility, schedule, or the contents or description of any task, deliverable, goods, service, or other work, or otherwise between the base Agreement and the Exhibits, or between Exhibits, such conflict or inconsistency shall be resolved by giving precedence first to the Agreement and then to the Exhibits according to the following priority. Exhibits: 1.1 EXHIBIT A - Statement of Work 1.2 EXHIBIT B - Prehospital Care Manual (Reference No. 702) 1.3 EXHIBIT B1- Prehospital Care Manual (Reference No. 502) 1.4 EXHIBIT C - Controlled Substances Inventory 1.5 EXHIBIT C1-Controlled Substances Fee Schedule 1.6 EXHIBIT D - Contractor's EEO Certification (Intentionally Omitted) 1.7 EXHIBIT E - County's Administration 1.8 EXHIBIT F - Contractor's Administration 1.9 EXHIBIT G1-Contractor Acknowledgement and Confidentiality Agreement 1.10 EXHIBIT H - Jury Service Ordinance (Intentionally Omitted) 1.11 EXHIBIT I - Safely Surrendered Baby Law Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 3 May 2013 4433 1.12 EXHIBIT J - Novation Affiliate Purchasing Program Agreement Health Insurance Portability AND Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) Agreement 1.13 EXHIBIT K - Contractor's Obligations as a "Business Associate" Under the Health Insurance Portability AND Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) 2.0 DEFINITIONS The headings herein contained are for convenience and reference only and are not intended to define the scope of any provision thereof. The following words as used herein shall be construed to have the following meaning, unless otherwise apparent from the context in which they are used. 2.1 Agreement: Agreement executed between County and Contractor. It sets forth the terms and conditions for the issuance and performance of the Statement of Work, Exhibit A. - 2.2 Contractor: The duly incorporated City or other public entity that has entered into an agreement with the County to perform or execute the work covered by the Statement of Work. 2.3 Contractor Project Manager: The individual designated by the Contractor to administer the Agreement operations after the Agreement award. 2.4 Director: County's Director of Health Services, or his duly authorized designee. 2.5 County Agreement Project Monitor: Person with responsibility to oversee the day to day activities of this Agreement. Responsibility for inspections of any and all tasks, deliverables, goods, services and other work provided by the Contractor. 2.6 County Project Director: Person designated by County with authority for County on contractual or administrative matters relating to this Agreement that cannot be resolved by the County's Project Manager. 2.7 County Project Manager: Person designated by County's Project Director to manage the operations under this Agreement. 2.8 Day(s): Calendar day(s) unless otherwise specified. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 4 May 2013 41133 1 . 2.9 Fiscal Year: The twelve (12) month period beginning July 1st and ending the following June 30th. 3.0 WORK Pursuant to the provisions of this Agreement, the Contractor shall procure, transport, store, distribute, administer, and monitor approved Controlled Substances utilized by Contractor and other work identified in Exhibit B, the EMS Agency's "PREHOSPITAL CARE MANUAL REFERENCE NO. 702, CONTROLLED DRUGS CARRIED ON ALS UNITS", as set forth in Exhibit A, Statement of Work, for the purpose of continuing the delivery of ALS care in the field. 4.0 TERM OF AGREEMENT The term of this Agreement shall commence effective upon approval by the County's Board of Supervisors, and shall continue in full force and effect up to and including June 30, 2017, unless sooner cancelled or terminated as provided herein. This Agreement may thereafter be extended at the sole discretion of the Director of the Department of Health Services (DHS), or his designee (hereafter Director), for two (2) additional 1-year terms, through June 30, 2019, by providing written notice to the Contractor, in the form of an Amendment to this Agreement, prior to the end of the current term. 5.0 AGREEMENT SUM 5.1 During the term of this Agreement, Contractor's payment to County hereunder shall be for the issuance of approved Controlled Substances and other applicable fees as set forth in Exhibit C-1, Controlled Substances Fee Schedule, attached hereto and incorporated herein by reference. 5.2 Invoices and Payments 5.2.1 Contractor shall reimburse Health Services Finance (hereafter "HS Finance") for all fees billed for approved Controlled Substances specified in Exhibit C, Controlled Substances Inventory. HS Finance shall prepare invoices, which will include the charges owed to the County by the Contractor under the terms of this Agreement. 5.2.2 HS Finance's quarterly invoices shall be priced in accordance with Exhibit C-1, Controlled Substances Fee Schedule. These rates will be adjusted annually each July, 1 or based on changes of more than 100% in unit cost, random testing, or administrative expenses of supplying Contractors with approved Controlled Substances. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 5 May 2013 4433 5.2.3 HS Finance's quarterly invoices to Contractor will clearly reflect items issued and provide reasonable details of approved Controlled Substances. 5.2.4 HS Finance's quarterly invoices to Contractor will include, if applicable, any fines assessed against the County-operated hospital pharmacy by the California State Board of Pharmacy that are a direct result of noncompliance with State Law or a direct result of actions or omissions by the Contractor. 5.2.5 HS Finance's quarterly invoices to Contractor will include, if applicable, the cost of Controlled Substance testing if tampering or diversion by Contractor is suspected and confirmed after an investigation is conducted. Contractor will not be charged if tampering or diversion is not confirmed. 5.2.6 Contractor shall reimburse HS Finance within thirty (30) days of receipt of a complete and correct invoice. Reimbursement shall be sent to: DHS-Health Services Finance Fiscal Services 313 North Figueroa Street, Room 505 Los Angeles, CA 90012 5.2.7 HS Finance's quarterly invoices to Contractor will include, if applicable, a one-time restocking fee, as specified in Exhibit C-1, Controlled Substances Fee Schedule, for each lot of recalled approved Controlled Substances returned to the County-operated hospital pharmacy for resupply. 5.2.8 HS Finance's quarterly invoices to Contractor will include, if applicable, an ingredient cost, as specified in Exhibit C-1, Controlled Substances Fee Schedule, for each dose of expired approved Controlled Substances returned to the County-operated hospital pharmacy for resupply. 6.0 ADMINISTRATION OF AGREEMENT - COUNTY COUNTY ADMINISTRATION A listing of all County Administration referenced in the following sub- paragraphs are designated in Exhibit E, County's Administration. The County shall notify the Contractor in writing of any change in the names or addresses shown. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 6 May 2013 4433 , . 6.1 County's Project Director Responsibilities of the County's Project Director include: • ensuring that the objectives of this Agreement are met; and • providing direction to the Contractor in the areas relating to County policy, information requirements, and procedural requirements. 6.2 County's Project Manager The responsibilities of the County's Project Manager include: ■ meeting with the Contractor's Project Manager on an as-needed basis; and • inspecting any and all tasks, deliverables, goods, services, or other work provided by or on behalf of the Contractor. The County's Project Manager is not authorized to make any changes in any of the terms and conditions of this Agreement and is not authorized to further obligate County in any respect whatsoever. 6.3 County's Agreement Project Monitor The County's Project Monitor is responsible for overseeing the day- to-day administration of this Agreement. The Project Monitor reports to the County's Project Manager. 7.0 ADMINISTRATION OF AGREEMENT - CONTRACTOR 7.1 Contractor's Project Manager 7.1.1 The Contractor's Project Manager is designated in Exhibit F, Contractor's Administration. The Contractor shall notify the County in writing of any change in the name or address of the Contractor's Project Manager. 7.1.2 The Contractor's Project Manager shall be responsible for the Contractor's day-to-day activities as related to this Agreement and shall coordinate with County's Project Manager and County's Agreement Project Monitor on a regular basis. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 7 May 2013 443 .E 7i Confidentiality 7.2.1 Contractor shall maintain the confidentiality of all records and information in accordance with all applicable Federal, State and local laws, rules, regulations, ordinances, directives, guidelines, policies and procedures relating to confidentiality, including, without limitation, County policies concerning information technology security and the protection of confidential records and information. 7.2.2 Contractor shall indemnify, defend, and hold harmless County, its officers, employees, and agents, from and against any and all claims, demands, damages, liabilities, losses, costs and expenses, including, without limitation, defense costs and legal, accounting and other expert, consulting, or professional fees, arising from, connected with, or related to any failure by Contractor, its officers, employees, agents, or subcontractors, to comply with this Paragraph 7.2, as determined by County in its sole judgment. Any legal defense pursuant to Contractor's indemnification obligations under this Paragraph 7.2 shall be conducted by Contractor and performed by counsel selected by Contractor and approved by County. Notwithstanding the preceding sentence, County shall have the right to participate in any such defense at its sole cost and expense, except that in the event Contractor fails to provide County with a full and adequate defense, as determined by County in its sole judgment, County shall be entitled to retain its own counsel, including, without limitation, County Counsel, and reimbursement from Contractor for all such costs and expenses incurred by County in doing so. Contractor shall not have the right to enter into any settlement, agree to any injunction, or make any admission, in each case, on behalf of County without County's prior written approval. 7.2.3 Contractor shall inform all of its officers, employees, agents and subcontractors providing services hereunder of the confidentiality provisions of this Agreement. 7.2.4 Contractor shall sign and adhere to the provisions of the "Contractor Acknowledgement and Confidentiality Agreement", Exhibit G-1. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 8 May 2013 4433 Ra� 8.0 STANDARD TERMS AND CONDITIONS • 8.1 AMENDMENTS 8.1.1 For any change which affects the scope of work, term, any term or condition, or payment rates included under- this Agreement, an Amendment shall be prepared and executed by the Contractor and by Director or his designee. 8.1.2 The County's Board of Supervisors or Chief Executive Officer or designee may require the addition and/or change of certain terms and conditions in the Agreement during the term of this Agreement. The County reserves the right to add and/or change such provisions as required by the County's Board of Supervisors or Chief Executive Officer. To implement such changes, an Amendment to the Agreement shall be prepared and executed by the Contractor and by Director or his designee. 8.1.3 The Director or his/her designee may at his/her sole discretion, authorize extensions of time as defined in paragraph 4.0 - Term of Agreement. The Contractor agrees that such extensions of time shall not change any other term or condition of this Agreement during the period of such extensions. To implement an extension of time, an Amendment to the Agreement shall be prepared by the County and then executed by the Contractor and by Director or his designee. 8.1.4 The Director or his/her designee, may require, at his/her sole discretion, the addition and/or change of certain terms and conditions in the Agreement to conform to changes in federal or state law or regulation or County policy, during the term of this Agreement. The County reserves the unilateral right to add and/or change such provisions as required by law, regulation or County policy, without the need for Contractor's written consent, to preserve this Agreement's conformity and compliance to federal and state law or regulation or County policy as deemed necessary by the County's Board of Supervisors, County Counsel, the Chief Executive Officer or designee. 8.2 ASSIGNMENT AND DELEGATION 8.2.1 The Contractor shall not assign its rights or delegate its duties under this Agreement, or both, whether in whole or in part, without the prior written consent of County, in its discretion, and any attempted assignment or delegation Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 9 May 2013 4433 , without such consent shall be null and void. For purposes of this sub-paragraph, County consent shall require a written amendment to the Agreement, which is formally approved and executed by the parties. Any payments by the County to any approved delegate or assignee on any claim under this Agreement shall be deductible, at County's sole discretion, against the claims, which the Contractor may have against the County. 8.2.2 Shareholders, partners, members, or other equity holders of Contractor may transfer, sell, exchange, assign, or divest themselves of any interest they may have therein. However, in the event any such sale, transfer, exchange, assignment, or divestment is effected in such a way as to give majority control of Contractor to any person(s), corporation, partnership, or legal entity other than the majority controlling interest therein at the time of execution of the Agreement, such disposition is an assignment requiring the prior written consent of County in accordance with applicable provisions of this Agreement. 8.2.3 Any assumption, assignment, delegation, or takeover of any of the Contractor's duties, responsibilities, obligations, or performance of same by any entity other than the Contractor, whether through assignment, subcontract, delegation, merger, buyout, or any other mechanism, with or without consideration for any reason whatsoever without County's express prior written approval, shall be a material breach of the Agreement which may result in the termination of this Agreement. In the event of such termination, County shall be entitled to pursue the same remedies against Contractor as it could pursue in the event of default by Contractor. 8.3 AUTHORIZATION WARRANTY The Contractor represents and warrants that the person executing this Agreement for the Contractor is an authorized agent who has actual authority to bind the Contractor to each and every term, condition, and obligation of this Agreement and that all requirements of the Contractor have been fulfilled to provide such actual authority. 8.4 BUDGET REDUCTIONS In the event that the County's Board of Supervisors adopts, in any fiscal year, a County Budget which provides for reductions in the salaries and benefits paid to the majority of County employees and imposes similar reductions with respect to County Agreements, the Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 10 May 2013 4433 " County reserves the right to reduce its payment obligation under this Agreement correspondingly for that fiscal year and any subsequent fiscal year during the term of this Agreement (including any extensions), and the services to be provided by the Contractor under this Agreement shall also be reduced correspondingly. The County's notice to the Contractor regarding said reduction in payment obligation shall be provided within thirty (30) calendar days of the Board's approval of such actions. Except as set forth in the preceding sentence, the Contractor shall continue to provide all of the services set forth in this Agreement. 8.5 COMPLAINTS Intentionally Omitted 8.6 COMPLIANCE WITH APPLICABLE LAW 8.6.1 In the performance of this Agreement, Contractor and County shall comply with all applicable Federal, State and local laws, rules, regulations, ordinances, directives, guidelines, policies and procedures, and all provisions required thereby to be included in this Agreement are hereby incorporated herein by reference. 8.6.2 Contractor shall indemnify, defend, and hold harmless County, its officers, employees, and agents, from and against any and all claims, demands, damages, liabilities, losses, costs, and expenses, including, without limitation, defense costs and legal, accounting and other expert, consulting or professional fees, arising from, connected with, or related to any failure by Contractor, its officers, employees, agents, or subcontractors, to comply with any such laws, rules, regulations, ordinances, directives, guidelines, policies, or procedures, as determined by County in its sole judgment. Any legal defense pursuant to Contractor's indemnification obligations under this Paragraph 8.6 shall be conducted by Contractor and performed by counsel selected by Contractor and approved by County. Notwithstanding the preceding sentence, County shall have the right to participate in any such defense at its sole cost and expense, except that in the event Contractor fails to provide County with a full and adequate defense, as determined by County in its sole judgment, County shall be entitled to retain its own counsel, including, without limitation, County Counsel, and reimbursement from Contractor for all such costs and expenses incurred by County in doing so. Contractor shall not have the right to enter into any settlement, agree to any injunction or other equitable relief, Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 11 May 2013 4 4 3 3 : or make any admission, in each case, on behalf of County without County's prior written approval. 8.7 COMPLIANCE WITH CIVIL RIGHTS LAWS ANTI-DISCRIMINATION AND AFFIRMATIVE ACTION LAWS 8.7.1 The Contractor hereby assures that it will comply with Subchapter VI of the Civil Rights Act of 1964, 42 USC Sections 2000 (e) (1) through 2000 (e) (17); the Fair Employment & Housing Act, Government Code Section 12920-12922; and Affirmative Action in County Agreements, Chapter 4.32 of the Los Angeles County Code to the end that no person shall, on the grounds of race, color, religious creed, ancestry, national origin, sex, sexual orientation, age, physical or mental disability, medical condition, marital status, or political affiliation, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under this Agreement or under any project, program, or activity supported by this Agreement. 8.7.2 The Contractor certifies and agrees that all persons employed by it, its affiliates, subsidiaries, or holding companies are and shall be treated equally without regard to or because of race, color, religious creed, ancestry, national origin, sex, sexual orientation, age, physical or mental disability, medical condition, marital status, or political affiliation, in compliance-with all applicable Federal . and State anti-discrimination laws and regulations. 8.7.3 The Contractor shall take affirmative action to ensure that applicants are employed, and that employees are treated during employment, without regard to race, color, religious creed, ancestry, national origin, sex, sexual orientation, age, physical or mental disability, medical condition, marital status, or political affiliation, in compliance with all applicable Federal and State anti-discrimination laws and regulations. Such action shall include, but is not limited to: employment, upgrading, demotion, transfer, recruitment or recruitment advertising, layoff or termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship. 8.7.4 The Contractor certifies and agrees that it will deal with its subcontractors, bidders, or vendors without regard to or because of race, color, religious creed, ancestry, national origin, sex, sexual orientation, age, physical or mental disability, medical condition, marital status, or political affiliation. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 12 May 2013 44 \r 3 .p A o 8.7.5 The Contractor certifies and agrees that it, its affiliates, subsidiaries, or holding companies shall comply with all applicable Federal and State laws and regulations to the end that no person shall, on the grounds of race, color, religious creed, ancestry, national origin, sex, sexual orientation, age, physical or mental disability, medical condition, marital status, or political affiliation, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under this Agreement or under any project, program, or activity supported by this Agreement. 8.7.6 The Contractor shall allow County representatives access to the Contractor's employment records during regular business hours to verify compliance with the provisions of this sub-paragraph 8.8 when so requested by the County. 8.7.7 If the County finds that any provisions of this sub- paragraph 8.8 have been violated, such violation shall constitute a material breach of this Agreement upon which the County may terminate or suspend this Agreement. While the County reserves the right to determine independently that the anti-discrimination provisions of this Agreement have been violated, in addition, a determination by the California Fair Employment Practices Commission or the Federal Equal Employment Opportunity Commission that the Contractor has violated Federal or State anti- discrimination laws or regulations shall constitute a finding by the County that the Contractor has violated the anti- discrimination provisions of this Agreement. 8.7.8 The parties agree that in the event the Contractor violates any of the anti-discrimination provisions of this Agreement, the County shall, at its sole option, be entitled to the sum of Five Hundred Dollars ($500) for each such violation pursuant to California Civil Code Section 1671 as liquidated damages in lieu of terminating or suspending this Agreement. 8.7.9 Anti-discrimination in Services Contractor shall not discriminate in the provision of services hereunder because of race, color, religious creed, national origin, ethnic group identification, ancestry, age, sex, sexual orientation, medical condition, marital status, political affiliation, or physical or mental disability in accordance with requirements of Federal and State laws. For the purpose of this sub-paragraph, discrimination in the provision of services may include, but is not limited to, the following: Denying any person any service or benefit or the availability of a facility; providing any service or benefit to a person which is not equivalent or is provided in a non-equivalent Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 13 May 2013 .'• NIa manner or at a non-equivalent time, from that provided to others; subjecting any person to segregation or separate treatment in any manner related to the receipt of any service; restricting any person in any way in the enjoyment of any advantage or privilege enjoyed by others receiving any service or benefit; and treating any person differently from others in determining admission, enrollment quota, eligibility, membership, or any other requirements or conditions which persons must meet in order to be provided any service or benefit. Contractor shall take affirmative action to ensure that intended beneficiaries of this Agreement are provided services without regard to race, color, religious creed, national origin, ethnic group identification, ancestry, sex, sexual orientation, age, medical condition, marital status, political affiliation, physical or mental disability. 8.8 COMPLIANCE WITH THE COUNTY'S JURY SERVICE PROGRAM Intentionally Omitted 8.9 CONFLICT OF INTEREST Intentionally Omitted 8.10 CONSIDERATION OF HIRING COUNTY EMPLOYEES TARGETED FOR LAYOFF/OR RE-EMPLOYMENT LIST Intentionally Omitted 8.11 CONSIDERATION OF HIRING GAIN/GROW PROGRAM PARTICIPANTS Intentionally Omitted 8.12 CONTRACTOR RESPONSIBILITY AND DEBARMENT 8.12.1 Responsible Contractor A responsible Contractor is a Contractor who has demonstrated the attribute of trustworthiness, as well as quality, fitness, capacity and experience to satisfactorily perform the contract. It is the County's policy to conduct business only with responsible Contractors. 8.12.2 Chapter 2.202 of the County Code The Contractor is hereby notified that, in accordance with Chapter 2.202 of the County Code, if the County acquires information concerning the performance of the Contractor Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 14 May 2013 4433 on this or other contracts which indicates that the Contractor is not responsible, the County may, in addition to other remedies provided in the contract, debar the Contractor from bidding or proposing on, or being awarded, and/or performing work on County contracts for a specified • period of time, which generally will not exceed five years but may exceed five years or be permanent if warranted by the circumstances, and terminate any or all existing contracts the Contractor may have with the County. 8.12.3 Non-responsible Contractor The County may debar a Contractor if the Board of Supervisors finds, in its discretion, that the Contractor has done any of the following: (1) violated a term of a contract with the County or a nonprofit corporation created by the County, (2) committed an act or omission which negatively reflects on the Contractor's quality, fitness or capacity to perform a contract with the County, any other public entity, or a nonprofit corporation created by the County, or engaged in a pattern or practice which negatively reflects on same, (3) committed an act or offense which indicates a lack of business integrity or business honesty, or (4) made or submitted a false claim against the County or any other public entity. 8.12.4 Contractor Hearing Board 1. If there is evidence that the Contractor may be subject to debarment, the Department will notify the Contractor in writing of the evidence which is the basis for the proposed debarment and will advise the Contractor of the scheduled date for a debarment hearing before the Contractor Hearing Board. 2. The Contractor Hearing Board will conduct a hearing where evidence on the proposed debarment is presented. The Contractor and/or the Contractor's representative shall be given an opportunity to submit evidence at that hearing. After the hearing, the Contractor Hearing Board shall prepare a tentative proposed decision, which shall contain a recommendation regarding whether the Contractor should be debarred, and, if so, the appropriate length of time of the debarment. The Contractor and the Department shall be provided an opportunity to object to the tentative proposed decision prior to its presentation to the Board of Supervisors. 3. After consideration of any objections, or if no objections are submitted, a record of the hearing, the proposed decision, and any other recommendation of the Contractor Hearing Board shall be presented to the Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 15 May 2013 4433 t.. � .. Board of Supervisors. The Board of Supervisors shall have the right to modify, deny, or adopt the proposed decision and recommendation of the Contractor Hearing Board. 4. If a Contractor has been debarred for a period longer than five (5) years, that Contractor may after the debarment has been in effect for at least five (5) years, submit a written request for review of the debarment determination to reduce the period of debarment or terminate the debarment. The County may, in its discretion, reduce the period of debarment or terminate the debarment if it finds that the Contractor has adequately demonstrated one or more of the following: (1) elimination of the grounds for which the debarment was imposed; (2) a bona fide change in ownership or management; (3) material evidence discovered after debarment was imposed; or (4) any other reason that is in the best interests of the County. 5. The Contractor Hearing Board will consider a request for review of a debarment determination only where (1) the Contractor has been debarred for a period longer than five (5) years; (2) the debarment has been in effect for at least five (5) years; and (3) the request is in writing, states one or more of the grounds for reduction of the debarment period or termination of the debarment, and includes supporting documentation. Upon receiving an appropriate request, the Contractor Hearing Board will provide notice of the hearing on the request. At the hearing, the Contractor Hearing Board shall conduct a hearing where evidence on the proposed reduction of debarment period or termination of debarment is presented. This hearing shall be conducted and the request for review decided by the Contractor Hearing Board pursuant to the same procedures as for a debarment hearing. 6. The Contractor Hearing Board's proposed decision shall contain a recommendation on the request to reduce the period of debarment or terminate the debarment. The Contractor Hearing Board shall present its proposed decision and recommendation to the Board of Supervisors. The Board of Supervisors shall have the right to modify, deny, or adopt the proposed decision and recommendation of the Contractor Hearing Board. 8.12.5 Subcontractors of Contractor These terms shall also apply to subcontractors of County Contractors. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 16 May 2013 , f . 1ti • • 8.13 CONTRACTOR'S ACKNOWLEDGEMENT OF COUNTY'S COMMITMENT TO THE SAFELY SURRENDERED BABY LAW Intentionally Omitted 8.14 CONTRACTOR'S WARRANTY OF ADHERENCE TO COUNTY'S CHILD SUPPORT COMPLIANCE PROGRAM Intentionally Omitted 8.15 COUNTY'S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor's performance under this Agreement on not less than an annual basis. Such evaluation will include assessing the Contractor's compliance with all Agreement terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Agreement in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Agreement or impose other penalties as specified in this Agreement. 8.16 DAMAGE TO COUNTY FACILITIES, BUILDINGS OR GROUNDS Intentionally Omitted 8.17 EMPLOYMENT ELIGIBILITY VERIFICATION Intentionally Omitted 8.18 FACSIMILE REPRESENTATIONS The County and the Contractor hereby agree to regard facsimile representations of original signatures of authorized officers of each party, when appearing in appropriate places on the Amendments prepared pursuant to sub-paragraph 8.1, and received via communications facilities, as legally sufficient evidence that such original signatures have been affixed to Amendments to this Agreement, such that the parties need not follow up facsimile transmissions of such documents with subsequent (non-facsimile) transmission of"original" versions of such documents. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 17 May 2013 4433 8.19 FAIR LABOR STANDARDS Intentionally Omitted 8.20 FORCE MAJEURE Intentionally Omitted 8.21 GOVERNING LAW, JURISDICTION, AND VENUE This Agreement shall be governed by, and construed in accordance with, the laws of the State of California. The Contractor agrees and consents to the exclusive jurisdiction of the courts of the State of California for all purposes regarding this Agreement and further agrees and consents that venue of any action brought hereunder shall be exclusively in the County of Los Angeles. 8.22 INDEPENDENT CONTRACTOR STATUS 8.22.1 This Agreement is by and between the County and the Contractor and is not intended, and shall not be construed, to create the relationship of agent, servant, employee, partnership, joint venture, or association, as between the County and the Contractor. The employees and agents of one party shall not be, or be construed to be, the employees or agents of the other party for any purpose whatsoever. 8.22.2 The Contractor shall be solely liable and responsible for providing to, or on behalf of, all persons performing work pursuant to this Agreement all compensation and benefits. The County shall have no liability or responsibility for the payment of any salaries, wages, unemployment benefits, disability benefits, Federal, State, or local taxes, or other compensation, benefits, or taxes for any personnel provided by or on behalf of the Contractor. 8.22.3 The Contractor understands and agrees that all persons performing work pursuant to this Agreement are, for purposes of Workers' Compensation liability, solely employees of the Contractor and not employees of the County. The Contractor shall be solely liable and responsible for furnishing any and all Workers' Compensation benefits to any person as a result of any injuries arising from or connected with any work performed by or on behalf of the Contractor pursuant to this Agreement. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 18 May 2013 4433 u, 8.22.4 The Contractor shall adhere to the provisions stated in sub- paragraph 7.2 - Confidentiality. 8.23 INDEMNIFICATION The Contractor shall indemnify, defend and hold harmless the County, its Special Districts, elected and appointed officers, employees, and agents from and against any and all liability, including but not limited to demands, claims, actions, fees, costs, and expenses (including attorney and expert witness fees), arising from or connected with the Contractor's acts and/or omissions arising from and/or relating to this Contract. 8.24 GENERAL PROVISIONS FOR ALL INSURANCE COVERAGE Without limiting Contractor's indemnification of County, and in the performance of this Agreement and until all of its obligations pursuant to this Agreement have been met, Contractor shall provide and maintain at its own expense insurance coverage satisfying the requirements specified in Sections 8.24 and 8.25 of this Agreement. These minimum insurance coverage terms, types and limits (the "Required Insurance") also are in addition to and separate from any other contractual obligation imposed upon Contractor pursuant to this Agreement. The County in no way warrants that the Required Insurance is sufficient to protect the Contractor for liabilities which may arise from or relate to this Agreement. 8.24.1 Evidence of Coverage and Notice to County • Certificate(s) of insurance coverage (Certificate) satisfactory to County, and a copy of an Additional Insured endorsement confirming County and its Agents (defined below) has been given Insured status under the Contractor's General Liability policy, shall be delivered to County at the address shown below and provided prior to commencing services under this Agreement. • Renewal Certificates shall be provided to County not less than 10 days prior to Contractor's policy expiration dates. The County reserves the right to obtain complete, certified copies of any required Contractor and/or Sub-Contractor insurance policies at any time. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 19 May 2013 4433 J . • Certificates shall identify all Required Insurance coverage types and limits specified herein, reference this Agreement by name or number, and be signed by an authorized representative of the insurer(s). The Insured party named on the Certificate shall match the name of the Contractor identified as the contracting party in this Agreement. Certificates shall provide the full name of each insurer providing coverage, its NAIC (National Association of Insurance Commissioners) identification number, its financial rating, the amounts of any policy deductibles or self-insured retentions exceeding Fifty Thousand Dollars ($50,000.00), and list any County required endorsement forms. • Neither the County's failure to obtain, nor the County's receipt of, or failure to object to a non-complying insurance certificate or endorsement, or any other insurance documentation or information provided by the Contractor, its insurance broker(s) and/or insurer(s), shall be construed as a waiver of any of the Required Insurance provisions. Certificates and copies of any required endorsements shall be sent to: County of Los Angeles Department of Health Services Contracts and Grants Division 313 Figueroa Street, 6th Floor-East Los Angeles, CA 90012 County of Los Angeles Department of Health Services Emergency Medical Services Agency 10100 Pioneer Boulevard, Suite 200 Santa Fe Springs, CA 90670 Attention: Administrative Services Contractor also shall promptly report to County any injury or property damage accident or incident, including any injury to a Contractor employee occurring on County property, and any loss, disappearance, destruction, misuse, or theft of County property, monies or securities entrusted to Contractor. Contractor also shall promptly notify County of any third party claim or suit filed against Contractor or any of its Sub-Contractors which arises from Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 20 May 2013 4433 u� . - or relates to this Agreement, and could result in the filing of a claim or lawsuit against Contractor and/or County. 8.24.2 Additional Insured Status and Scope of Coverage The County of Los Angeles, its Special Districts, Elected Officials, Officers, Agents, Employees and Volunteers (collectively County and its Agents) shall be provided additional insured status under Contractor's General Liability policy with respect to liability arising out of Contractor's ongoing and completed operations performed on behalf of the County. County and its Agents additional insured status shall apply with respect to liability and defense of suits arising out of the Contractor's acts or omissions, whether such liability is attributable to the Contractor or to the County. The full policy limits and scope of protection also shall apply to the County and its Agents as an additional insured, even if they exceed the County's minimum Required Insurance specifications herein. Use of an automatic additional insured endorsement form is acceptable providing it satisfies the Required Insurance provisions herein. 8.24.3 Cancellation of Insurance Except in the case of cancellation for non-payment of premium, Contractor's insurance policies shall provide, and Certificates shall specify, that County shall receive not less than thirty (30) days advance written notice by mail of any cancellation of the Required Insurance. Ten (10) days prior notice may be given to County in event of cancellation for non-payment of premium. 8.24.4 Failure to Maintain Insurance Contractor's failure to maintain or to provide acceptable evidence that it maintains the Required Insurance shall constitute a material breach of the Contract, upon which County immediately may withhold payments due to Contractor, and/or suspend or terminate this Agreement. County, at its sole discretion, may obtain damages from Contractor resulting from said breach. 8.24.5 Insurer Financial Ratings Coverage shall be placed with insurers acceptable to the County with A.M. Best ratings of not less than A:VII unless otherwise approved by County. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 21 May 2013 4433 8.24.6 Contractor's Insurance Shall Be Primary Contractor's insurance policies, with respect to any claims related to this Agreement, shall be primary with respect to all other sources of coverage available to Contractor. Any County maintained insurance or self-insurance coverage shall be in excess of and not contribute to any Contractor coverage. 8.24.7 Waivers of Subrogation To the fullest extent permitted by law, the Contractor hereby waives its rights and its insurer(s)' rights of recovery against County under all the Required Insurance for any loss arising from or relating to this Agreement. The Contractor shall require its insurers to execute any waiver of subrogation endorsements which may be necessary to effect such waiver. 8.24.8 Sub-Contractor Insurance Coverage Requirements Contractor shall include all Sub-Contractors as insureds under Contractor's own policies, or shall provide County with each Sub-Contractor's separate evidence of insurance coverage. Contractor shall be responsible for verifying each Sub-Contractor complies with the Required Insurance provisions herein, and shall require that each Sub- Contractor name the County and Contractor as additional insureds on the Sub-Contractor's General Liability policy. Contractor shall obtain County's prior review and approval of any Sub-Contractor request for modification of the Required Insurance. 8.24.9 Deductibles and Self-Insured Retentions (SIRs) Contractor's policies shall not obligate the County to pay any portion of any Contractor deductible or SIR. The County retains the right to require Contractor to reduce or eliminate policy deductibles and SIRs as respects the County, or to provide a bond guaranteeing Contractor's payment of all deductibles and SIRs, including all related claims investigation, administration and defense expenses. Such bond shall be executed by a corporate surety licensed to transact business in the State of California. 8.24.10 Claims Made Coverage Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 22 May 2013 4Li 33 . .� If any part of the Required Insurance is written on a claims made basis, any policy retroactive date shall precede the effective date of this Agreement. Contractor understands and agrees it shall maintain such coverage for a period of not less than three (3) years following Agreement expiration, termination or cancellation. 8.24.11 Application of Excess Liability Coverage Contractors may use a combination of primary, and excess insurance policies which provide coverage as broad as the underlying primary policies, to satisfy the Required Insurance provisions. 8.24.12 Separation of Insureds All liability policies shall provide cross-liability coverage as would be afforded by the standard ISO (Insurance Services Office, Inc.) separation of insureds provision with no insured versus insured exclusions or limitations. 8.24.13 Alternative Risk Financing Programs The County reserves the right to review, and then approve, Contractor use of self-insurance, risk retention groups, risk purchasing groups, pooling arrangements and captive insurance to satisfy the Required Insurance provisions. The County and its Agents shall be designated as an Additional Covered Party under any approved program. 8.24.14 County Review and Approval of Insurance Requirements The County reserves the right to review and adjust the Required Insurance provisions, conditioned upon County's determination of changes in risk exposures. 8.24.15 Contractor Self-Insurance Requirements The County will consider a Contractor's request to substitute a program of self—insurance as an alternative to commercial insurance upon review and approval of the following: • A formal declaration to be self-insured for the type and amount of coverage required in the agreement. This can be in the form of a corporate resolution or a certified statement from a corporate officer or an Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 23 May 2013 4 •) 7 "I authorized principal of the Contractor. The statement also must identify which required coverages are self- insured and which are commercially insured. Contractors who are self-insured for workers compensation must provide a copy of their "Certificate of Consent to Self-Insure" issued by the State. The Contractor must notify the County immediately of discontinuation or substantial change in the program. • A statement that the County is a protected party under the Contractor's self-insurance program. This statement must confirm that the Contractor's program will respond on a primary basis to any County commercial insurance or self-insurance programs to ensure that the County will be provided at least the same protection from liability and defense of lawsuits as would be provided by first dollar commercial insurance. • An agreement to notify the County immediately of any claim, judgment, settlement award, verdict or change in the Contractor's financial condition which would have a significant negative effect on the Contractor's self- insurance program. • An agreement to notify the County immediately of any claim, judgment, settlement, award or verdict under the Contractor's self-insurance program involving the County service agreement. • The name, title, address, and telephone number of the individual responsible for the administration of the Contractor's self-insurance program, as well as the name, address, and telephone number of the Contractor's claims administrator and legal counsel. • A current audited financial statement to be evaluated by the County to determine if the Contractor has adequate financial resources to respond to claims failing within the self-insured retention or self-insured program. Re- submission of such a statement is required not less than annually or more frequently at the County Project Manager's request. Failure to comply will result in withdrawal of County approval. The Contractor's proposed self-insurance program must be approved by the County prior to the effective date of the agreement. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 24 May 2013 4433 isia4 8.25 INSURANCE COVERAGE 8.25.1 Commercial General Liability insurance (providing scope of coverage equivalent to ISO policy form CG 00 01), naming County and its Agents as an additional insured, with • limits of not less than: General Aggregate: $2 million Products/Completed Operations Aggregate: $1 million Personal and Advertising Injury: $1 million Each Occurrence: $1 million 8.25.2 Automobile Liability insurance (providing scope of coverage equivalent to ISO policy form CA 00 01) with limits of not less than One Million Dollars ($1,000,000) for bodily injury and property damage, in combined or equivalent split limits, for each single accident. Insurance shall cover liability arising out of Contractor's use of autos pursuant to this Agreement, including owned, leased, hired, and/or non- owned autos, as each may be applicable. 8.25.3 Workers Compensation and Employers' Liability insurance or qualified self-insurance satisfying statutory requirements, which includes Employers' Liability coverage with limits of not less than One Million Dollars ($1,000,000) per accident. If Contractor will provide leased employees, or, is an employee leasing or temporary staffing firm or a professional employer organization (PEO), coverage also shall include an Alternate Employer Endorsement (providing scope of coverage equivalent to ISO policy form WC 00 03 01 A) naming the County as the Alternate Employer, and the endorsement form shall be modified to provide that County will receive not less than thirty (30) days advance written notice of cancellation of this coverage provision. If applicable to Contractor's operations, coverage also shall be arranged to satisfy the requirements of any federal workers or workmen's compensation law or any federal occupational disease law. 8.26 LIQUIDATED DAMAGES Intentionally Omitted Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 25 May 2013 433 . : 8.27 MOST FAVORED PUBLIC ENTITY Intentionally Omitted • 8.28 NON EXCLUSIVITY • • Intentionally Omitted 8.29 NOTICE OF DELAYS Intentionally Omitted 8.30 NOTICE OF DISPUTES AND DISPUTE RESOLUTION 8.30.1 The Contractor shall bring to the attention of the County's Project Manager and/or County's Project Director any dispute between the County and the Contractor regarding the performance of services as stated in this Agreement. If the County's Project Manager or County's Project Director is not able to resolve the dispute, the EMS Agency Medical Director, or designee shall resolve it. 8.30.2 The Contractor shall name specific individuals within the Contractor's agency, upon execution of this Agreement, who are authorized to assist the EMS Agency Medical Director with dispute resolution under this Agreement. 8.30.3 The Contractor shall respond to written requests of the EMS Agency Medical Director. for information regarding any perceived dispute within thirty (30) calendar days, unless otherwise mutually agreed, following receipt of such request. 8.30.4 Disputes perceived by the Contractor to have a system- wide impact should be referred directly to the EMS Agency. 8.30.5 As soon as reasonably possible, the Contractor shall report possible violations of the California Health and Safety Code Section 1798.200 by Contractor paramedics and EMT-Is directly to the EMS Agency Medical Director, as outlined in Reference No. 214, Base Hospital and Contractor Agency Reporting Responsibilities, of the EMS Agency's Prehospital Care Manual. The EMS Agency Medical Director is required to investigate any such allegations of violations. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 26 May 2013 O 8.31 NOTICE TO EMPLOYEES REGARDING THE FEDERAL EARNED INCOME CREDIT Intentionally Omitted 8.32 NOTICE TO EMPLOYEES REGARDING THE SAFELY SURRENDERED BABY LAW Intentionally Omitted 8.33 NOTICES All notices or demands required or permitted to be given or made under this Agreement shall be in writing and shall be hand delivered with signed receipt or mailed by first-class registered or certified mail, postage prepaid, addressed to the parties as identified in Exhibits E, County's Administration and F, Contractor's Administration. Addresses may be changed by either party giving ten (10) days' prior written notice thereof to the other party. The Medical Director or his designee shall have the authority to issue all notices or demands required or permitted by the County under this Agreement. 8.34 PROHIBITION AGAINST INDUCEMENT OR PERSUASION Intentionally Omitted 8.35 PUBLIC RECORDS ACT Intentionally Omitted 8.36 PUBLICITY Intentionally Omitted 8.37 RECORD RETENTION AND INSPECTION/AUDIT SETTLEMENT The Contractor shall maintain accurate and complete financial records of its activities and operations relating to this Agreement in accordance with generally accepted accounting principles. The Contractor shall also maintain accurate and complete employment and other records relating to its performance of this Agreement. The Contractor agrees that the County, or its authorized representatives, shall have access to and the right to examine, audit, excerpt, copy, or transcribe any pertinent transaction, activity, or record relating to this Agreement. All such material, including, but not limited to, all financial records, bank statements, cancelled checks or other proof of payment, timecards, sign-in/sign-out sheets and other time and employment records, and proprietary data and information, shall be kept and maintained by the Contractor and shall be made available Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 27 May 2013 4433 to the County during the term of this Agreement and for a period of five (5) years thereafter unless the County's written permission is given to dispose of any such material prior to such time. All such material shall be maintained by the Contractor at a location in Los Angeles County, provided that if any such material is located outside Los Angeles County, then, at the County's option, the Contractor shall pay the County for travel, per diem, and other costs incurred by the County to examine, audit, excerpt, copy, or transcribe such material at such other location. 8.37.1 In the event that an audit of the Contractor is conducted specifically regarding this Agreement by any Federal or State auditor, or by any auditor or accountant employed by the Contractor or otherwise, then the Contractor shall file a copy of such audit report with the County's Auditor-Controller within thirty (30) days of the Contractors receipt thereof, unless otherwise provided by applicable Federal or State law or under this Agreement. Subject to applicable law, the County shall make a reasonable effort to maintain the confidentiality of such audit report(s). 8.37.2 Failure on the part of the Contractor to comply with any of the provisions of this sub-paragraph 8.38 shall constitute a material breach of this Agreement upon which the County may terminate or suspend this Agreement. 8.37.3 If, at any time during the term of this Agreement or within five (5) years after the expiration or termination of this Agreement, representatives of the County conduct an audit of the Contractor regarding the work performed under this Agreement, and if such audit finds that the County's dollar liability for any such work is less than payments made by the County to the Contractor, then the difference shall be either: a) repaid by the Contractor to the County by cash payment upon demand or b) at the sole option of the County's Auditor-Controller, deducted from any amounts due to the Contractor from the County, whether under this Agreement or otherwise. If such audit finds that the County's dollar liability for such work is more than the payments made by the County to the Contractor, then the difference shall be paid to the Contractor by the County by cash payment, provided that in no event shall the County's maximum obligation for this Agreement exceed the funds appropriated by the County for the purpose of this Agreement. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 28 May 2013 4433 8.38 RECYCLED BOND PAPER Consistent with the Board of Supervisors' policy to reduce the amount of solid waste deposited at the County landfills, the Contractor agrees to use recycled-content paper to the maximum extent possible on this Agreement. 8.39 SUBCONTRACTING Intentionally Omitted 8.40 TERMINATION FOR BREACH OF WARRANTY TO MAINTAIN COMPLIANCE WITH COUNTY'S CHILD SUPPORT COMPLIANCE PROGRAM Intentionally Omitted 8.41 TERMINATION FOR CONVENIENCE 8.41.1 This Contract may be terminated, in whole or in part, from time to time, when such action is deemed by the County, in its sole discretion, to be in its best interest. Termination of work hereunder shall be effected by notice of termination to the Contractor specifying the extent to which performance of work is terminated and the date upon which such termination becomes effective. The date upon which such termination becomes effective shall be no less than thirty (30) days after the notice is sent. 8.41.2 After receipt of a notice of termination and except as otherwise directed by the County, the Contractor shall: • Stop work under this Contract on the date and to the extent specified in such notice, and • Complete performance of such part of the work as shall not have been terminated by such notice. 8.41.3 All material including books, records, documents, or other evidence bearing on the costs and expenses of the Contractor under this Contract shall be maintained by the Contractor in accordance with sub-paragraph 8.38, Record Retention AND Inspection/Audit Settlement. 8.42 TERMINATION FOR DEFAULT 8.42.1 The County may, by written notice to the Contractor, terminate the whole or any part of this Agreement, if, in the judgment of County's Project Director: Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 29 May 2013 4433 • If Contractor attempts to obtain any Controlled Substances not listed on Exhibit C, Controlled Substances Inventory, or procures approved Controlled Substances in quantities not approved by Medical • Director; or • If Contractor fails to comply with provisions of this Agreement or the policies and procedures contained in Exhibit B, Prehospital Care Manual (Reference No. 702); or • If Contractor fails to comply with any corrective actions required by the EMS Agency which are necessary to continue the procurement, transport, storage, distribution, administration, or monitoring of approved Controlled Substances; or • Contractor has materially breached this Agreement; or • Contractor fails to timely provide and/or satisfactorily perform any task, deliverable, service, or other work required either under this Agreement; or • Contractor fails to demonstrate a high probability of timely fulfillment of performance requirements under this Agreement, or of any obligations of this Agreement and in either case, fails to demonstrate convincing progress toward a cure within five (5) working days (or such longer period as the County may authorize in writing) after receipt of written notice from the County specifying such failure. 8.42.2 In the event that the County terminates this Agreement in whole or in part as provided in sub-paragraph 8.43.1, Contractor must have alternate means, approved by the EMS Agency, to purchase pharmaceuticals necessary to providing advanced life support services for its jurisdictional area. 8.42.3 If, after the County has given notice of termination under the provisions of this sub-paragraph 8.43, it is determined by the County that the Contractor was not in default under the provisions of this sub-paragraph 8.43, or that the default was excusable under the provisions of sub- paragraph 8.43.3, the rights and obligations of the parties shall be the same as if the notice of termination had been issued pursuant to sub-paragraph 8.42 - Termination for Convenience. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 30 May 2013 8.42.4 The rights and remedies of the County provided in this sub- paragraph 8.43 shall not be exclusive and are in addition to any other rights and remedies provided by law or under this Agreement. 8.43 TERMINATION FOR IMPROPER CONSIDERATION Intentionally Omitted 8.44 TERMINATION FOR INSOLVENCY Intentionally Omitted 8.45 TERMINATION FOR NON-ADHERENCE OF COUNTY LOBBYIST ORDINANCE Intentionally Omitted 8.46 TERMINATION FOR NON-APPROPRIATION OF FUNDS Intentionally Omitted 8.47 VALIDITY If any provision of this Agreement or the application thereof to any person or circumstance is held invalid, the remainder of this Agreement and the application of such provision to other persons or circumstances shall not be affected thereby. 8.48 WAIVER No waiver by the County of any breach of any provision of this Agreement shall constitute a waiver of any other breach or of such provision. Failure of the County to enforce at any time, or from time to time, any provision of this Agreement shall not be construed as a waiver thereof. The rights and remedies set forth in this sub- paragraph 8.49 shall not be exclusive and are in addition to any other rights and remedies provided by law or under this Agreement. 8.49 WARRANTY AGAINST CONTINGENT FEES Intentionally Omitted 8.50 WARRANTY OF COMPLIANCE WITH COUNTY'S DEFAULTED PROPERTY TAX REDUCTION PROGRAM Intentionally Omitted Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 31 May 2013 4433 . 8.51 TERMINATION FOR BREACH OF WARRANTY TO MAINTAIN COMPLIANCE WITH COUNTY'S DEFAULTED PROPERTY TAX REDUCTION PROGRAM Intentionally Omitted 9.0 UNIQUE TERMS AND CONDITIONS 9.1 CONTRACTOR'S OBLIGATIONS AS A "BUSINESS ASSOCIATE" UNDER HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) AND THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) The County is subject to the Administrative Simplification requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Under this Agreement, the Contractor provides services to the County and the Contractor receives, has access to, and/or creates Protected Health Information as defined in Exhibit K in order to provide those services. The County and the Contractor therefore agree to the terms of Exhibit K, Contractor's Obligations As a "Business Associate" Under Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) (Business Associate Agreement). 9.2 NO REQUIREMENT TO TRANSPORT TO COUNTY FACILITIES Nothing in this Agreement shall be 'interpreted to require or otherwise encourage contractors to transport patients to any County facility. Contractor shall comply with Exhibit B1, Reference No. 502, Patient Destination, of the EMS Agency's Prehospital Care Manual. Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 32 May 2013 4 L4 3 4 A v IN WITNESS WHEREOF, Contractor has executed this Contract, or caused it to be duly executed and the County of Los Angeles, by order of its Board of Supervisors has caused this Contract to be executed on its behalf by the Chair of said Board and attested by the Executive Officer-Clerk of the Board of Supervisors thereof, the day and year first above written. CONTRACTOR: El Segundo Fire Department By ILL ame Mjer COUNTY OF LOS ANGELES y M.D. rector APPROVED AS TO FORM BY THE OFFICE OF THE COUNTY COUNSEL V AS TO F M; CITY AT ORNEY JLLIAA !1421 City Clerk City of El Segundo Controlled Substances Supply for Paramedic Provider Agencies Agreement Page 33 May 2013 4433 1 i EXHIBIT A STATEMENT OF WORK FOR CONTROLLED SUBSTANCES SUPPLY FOR PARAMEDIC PROVIDER AGENCIES 44 33 TABLE OF CONTENTS SECTION TITLE PAGE 1.0 SCOPE OF WORK 1 - 2.0 COUNTY RESPONSIBILITIES 1 2.1 RESPONSIBILITIES OF THE EMERGENCY MEDICAL SERVICES (EMS) AGENCY 1 2.2 RESPONSIBILITIES OF THE COUNTY-OPERATED HOSPITAL 2 2.3 RESPONSIBILITIES OF THE OFFICE OF THE PHARMACY DIRECTOR2 3.0 CONTRACTOR RESPONSIBLITIES 3 3.1 CONTRACTOR RESPONSIBILITIES 3 3.2 AVAILABILITY OF PERSONNEL, FACILITIES, PROTOCOLS 4 3.3 MATERIALS AND EQUIPMENT 4 3.4 TRAINING 5 4.0 ADDITIONS AND/OR CHANGES IN AGREEMENT TERMS OR REIMBURSEMENT RATES 5 Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page i July 2012 443 EXHIBIT A STATEMENT OF WORK (SOW) 1.0 SCOPE OF WORK Since the mid 1990's, the EMS Agency has been responsible for the cost of approved Controlled Substances obtained from County-operated pharmacies by paramedic provider agencies. The Controlled Substances Supply for Paramedic Provider Agencies Agreement is intended to offset the EMS Agency's costs of dispensing approved Controlled Substances to contracted providers of Advanced Life Support (ALS) prehospital emergency medical services by licensed and accredited Emergency Medical Technicians-Paramedics (EMT-P). 2.0 RESPONSIBLITIES The County's and the Contractor's responsibilities are as follows: COUNTY 2.1 RESPONSIBILITIES OF THE EMERGENCY MEDICAL SERVICES (EMS AGENCY 2.1.1 Maintain policies and procedures consistent with State and County statutes, regulations, and standards for the procurement, transport, storage, distribution, administration, and monitoring of approved Controlled Substances, including narcotics. Current policies and procedures are reflected in Exhibit B, Prehospital Care Manual (Reference No. 702). Such policies shall be reviewed at least every three (3) years and revised as necessary to remain consistent with legal requirements. 2.1.2 Maintain a standardized inventory of approved controlled drugs carried on ALS Units ("Inventory") consistent with the paramedic scope of practice. Such Inventory shall be reviewed at least every three (3) years and revised as necessary to remain consistent with the paramedic scope of practice. 2.1.3 Assess compliance with the policies and procedures specific to procurement, transport, storage, distribution, administration and monitoring of approved Controlled Substances by performing periodic retrospective audits of records and by periodically observing the activity on a first-hand basis. Such observations may be performed on either an announced or unannounced basis. 2.1.4 With Contractor's Project Manager or their designee, review this Agreement on not less than an annual basis to ensure applicability to then current conditions, policies, procedures, and protocols specific to supply and resupply of approved Controlled Substances. Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page 1 July 2012 ; 433 a 2.1.5 Inform Contractor of manufacturer's recall of approved Controlled Substances dispensed, as applicable. 2.2 RESPONSIBILITIES OF THE COUNTY-OPERATED HOSPITAL PHARMACY 2.2.1 Maintain a consistent and adequate supply of approved Controlled Substances available to meet County dispensing requirements. • 2.2.2 Provide a mechanism for after-hours emergency dispensing of approved Controlled Substances. 2.2.3 Provide monthly report to the Office of the Department of Health Services (DHS) Pharmacy Director of approved Controlled Substances specified in Exhibit C, Controlled Substances Inventory, dispensed to Contractor. If applicable, said report will also include any fines assessed against the County by the California State Board of Pharmacy that are a direct result of noncompliance with State Law or a direct result of actions or omissions by the Contractor. 2.2.4 Provide accurate and timely data to the Office of the DHS Pharmacy Director for oversight and monitoring on a monthly basis. 2.2.5 Provide sixty (60) day, or earlier whenever practicable, advance written notice to the Contractor, Office of the DHS Pharmacy Director, and the EMS Agency of any operational changes that would affect the procurement of approved Controlled Substances, prior to implementation. 2.2.6 Maintain operation logs/tracking system with the capability to track approved Controlled Substances dispensed to Contractor and by individual unit. 2.2.7 Maintain system-wide data collection and the ability to provide data at the request of the EMS Agency or Contractor. 2.3 RESPONSIBILITIES OF THE OFFICE OF THE DHS PHARMACY DIRECTOR 2.3.1 Provide sixty (60) day, or earlier whenever practicable, advance written notice to Contractor, County-operated Hospital Pharmacy, and the EMS Agency of any operational changes that would affect the procurement of approved Controlled Substances, prior to implementation. 2.3.2 Notify the EMS Agency of manufacturer's recall of approved Controlled Substances, as applicable. 2.3.3 Provide accurate and timely data to HS Finance for invoice processing. Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page 2 July 2012 3.0 CONTRACTOR RESPONSIBILITIES 4 4 3 3 a . Contractor will administer the Agreement according to the Agreement, Paragraph 7.0, Administration of Agreement - Contractor. Specific duties shall include: 3.1 CONTRACTOR RESPONSIBILITIES • 3.1 .1 Adhere to policies and procedures consistent with State and County statutes, regulations, and standards for the procurement, transport, storage, distribution, administration, and monitoring of approved Controlled Substances, including narcotics. Current policies and procedures are reflected in Exhibit B Prehospital Care Manual (Reference No. 702). 3.1.2 Adhere to all policies and procedures of the EMS Agency as outlined in the EMS Agency's Prehospital Care Policy Manual pertaining to the supply and resupply of ALS units or other responding units providing prehospital medical care. 3.1.3 Procure, transport, store, administer and monitor only those approved Controlled Substances listed in Exhibit C, Controlled Substances Inventory, including any modifications thereto which may be implemented at a later date, to remain consistent with the paramedic scope of practice. 3.1.4 Maintain policies and procedures for the procurement, transport, storage, administration, and monitoring of approved Controlled Substances as defined herein. Such policies and procedures shall be submitted to the EMS Agency Medical Director for review and approval. Any subsequent changes to policies and procedures must be submitted to the EMS Agency for review and approval prior to implementation. 3.1.5 Implement and maintain a quality assurance program referencing approved Controlled Substances, which includes the mechanisms for overseeing the procurement, transport, storage, administration, and monitoring of approved Controlled Substances. 3.1.6 Permit the EMS Agency Medical Director or his designee(s) to make scheduled reviews of Contractor's policies and procedures and quality assurance program as it pertains to the procurement, transport, storage, administration, and monitoring of approved Controlled Substances, and, upon request, make available results of audits and investigations to the EMS Agency Medical Director or his designee(s) during the term of this Agreement. 3.1.7 Comply with periodic announced and unannounced site visits by County, State of California, or federal representatives to perform surveys and reviews to ensure compliance with State and federal laws and regulations and local policies pertinent to the procurement, storage, Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page 3 July 2012 4433 .. t. .i transport, administration, and monitoring of approved Controlled Substances. Monitoring may include testing of approved Controlled Substances. 3.1.8 Reimburse Los Angeles County DHS for any fines assessed against the County by the California State Board of Pharmacy, or other regulatory agencies, that are a direct result of actions or omissions by the Fire Department or the Fire Department's noncompliance with State Law. 3.1.9 Reimburse Los Angeles County DHS for the cost of Controlled Substance testing if tampering or diversion is suspected and confirmed after an investigation is conducted. Fire Department will not be charged if tampering or diversion is not confirmed. 3.1.10 Provide the EMS Agency Medical Director or his designee(s) with copies of all Contractor EMS records and logs associated with approved Controlled Substances in compliance with Exhibit B, Prehospital Care Manual (Reference No. 702). All such records and logs shall be retained at a location in Los Angeles County by Contractor for the minimum period of time required by law and by Exhibit B, Prehospital Care Manual (Reference No. 702). 3.1.11 Provide sixty (60) day, or earlier whenever practicable, advance written notice to the County-operated Hospital Pharmacy, Office of the DHS Pharmacy Director, and the EMS Agency of any operational changes that would affect the procurement of approved Controlled Substances. 3.1.12 Inspect inventory of approved Controlled Substances to ensure doses containing recalled lot numbers are immediately removed and disposed of in accordance with instructions provided once notification of manufacturer's recall is received from the EMS Agency. 3.1.13 Complete and submit Novation Affiliate Purchasing Program Agreement, Exhibit J of the Agreement, within thirty (30) days of agreement execution. 3.2 Availability of Personnel, Facilities, Protocols Contractor shall make its personnel, facilities, and medical protocols available to assist Director or his designee, or State representative(s), or both, to verify compliance with applicable standards and regulations and with the terms of this Agreement. 3.3 Materials and Equipment The purchase of all materials/equipment to provide the needed services is the responsibility of Contractor. Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page 4 July 2012 4433 3.4 Training 3.4.1 Contractor shall provide training programs for all new employees and • continuing in-service training for all employees handling approved Controlled Substances. All new employees shall review Ref. No. 702, Controlled Drugs Carried on ALS Units, and sign a statement that they have read and understood the policy. Signed statements must be.kept on file and made available to County staff upon request. 3.4.2 All employees involved in the handling and distribution of approved Controlled Substances shall be trained in their assigned tasks and in the safe handling of approved Controlled Substances. 4.0 ADDITIONS AND/OR CHANGES IN AGREEMENT TERMS OR REIMBURSEMENT RATES All changes must be made in accordance with sub-paragraph 8.1 Amendments of the Agreement. Exhibit A Statement of Work(Controlled Substances Supply for Paramedic Provider Agencies) Page 5 July 2012 4433 EXHIBIT B DEPARTMENT OF HEALTH SERVICES COUNTY OF LOS ANGELES (PARAMEDIC) SUBJECT: CONTROLLED DRUGS CARRIED ON ALS UNITS REFERENCE NO. 702 PURPOSE: To ensure accountability for all controlled drugs issued to ALS units. AUTHORITY: Health and Safety Code, Chapter 5. 1797.220 and 1798 California Business and Professions Code. Section 4005 and 4119(4)(5) DEA Regulations, Title 21, Code of Federal Regulations. Section 1300-1360 Controlled•Substances Act, 21 URIC 801-890 PRINCIPLES: 1. Effective controls and procedures are essential to guard against theft and diversion of controlled substances due to the risks associated with mishandling these drugs. 2, Controlled drugs will be restocked only with a full account of drugs administered, wasted, or lost. 3. Controlled drugs issued from County-operated pharmacies are intended for use within Los Angeles County except as otherwise specified in this policy. County-issued controlled drugs remain the property of Los Angeles County after being issued to paramedic provider agencies and when carried on ALS units. QUANTITIES OF CONTROLLED DRUGS TO BE CARRIED ON ALS UNITS; Morphine sulfate: 4mg unit dose, minimum amount 32mg not to exceed 60mg unless otherwise approved by the EMS Agency Medical Director. the Provider Agency Medical Director or as dictated by supply. Midazolam (Versed¢):5mg unit dose, minimum amount 20mg not to exceed 40mg unless otherwise approved by the EMS Agency Medical Director. the Provider Agency Medical Director, the Provider Agency Drug Authorizing Physician or as dictated by supply. POLICY: I. Provider Agencies May Obtain Controlled Drugs Through: A. A County operated hospital pharmacy utilizing the procedure outlined in this policy. B. A Provider Agency Medical Director who meets the qualifications of Reference No, 411. Provider Agency Medical Director, if they agree to authorize such procurement, or a Provider Agency Drug Authorizing Physician. EFFECTIVE: 1-7-98 PAGE 1 OF 6 REVISED: 08-01-10 SUPERSEDES: 07-1-09 ,;r r APPROVED: f LCCA I 'it f Director.;EMS Agency Medical Di - tar. EMS ;;ency SUBJECT: CONTROLLED DRUGS CARRIED ON ALS UNITS REFERENCE NO. 702 IL Controlled Drug Resupply Through a County Operated Hospital: A. County (EMS Agency) responsibilities: 1. Assign each provider agency that chooses to resupply controlled drugs through a County-operated hospital to one or more County facilities. 2. Supply each provider agency with a locked bag in which to store controlled drugs while in transit between the pharmacy and the provider agency. 3., Resupply controlled drugs on a one-for-one basis utilizing the procedure outlined in this policy. 4. Report the theft or loss of any controlled substances to the issuing pharmacy, whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them_ B Provider Agency Responsibilities: 1, Provider agency controlled drug policies and procedures shall be submitted to the EMS Agency for initial review and approval, a. Any subsequent changes to policies and procedures must be submitted to the EMS Agency for review and approval. 2, Provide the County pharmacists with the names and original signatures of individuals authorized to pick up and transport controlled drugs. a. Submit a single list of names (not copies of drivers` licenses or other ID cards)on departmental or company letterhead. b. Update the list annually. no later than June 30", and provide a copy to the EMS Agency. 3. Identify. in the provider agency's internal policy, one or more individuals responsible for the key to the controlled drug transit bag. The County pharmacist will maintain a second key at the pharmacy. 4. Ensure that the on-duty paramedic is responsible for the security of the drugs at all times. If the department uses a non-key system,such as a keypador padlock type, the internal controlled substance policy should indicate how the combination is kept secure. Ensure adequate security to guard against theft and diversion during controlled drug transport and distribution. Utilize County-issued controlled drugs outside of Los Angeles County only in the event of wildfires, disasters,terrorist responses or other unanticipated events. 6. Restock controlled drugs only from the assigned Department of Health Services (DHS) pharmacy to prevent intermingling of controlled drug stock. PAGE 2 OF 6 ,; SUBJECT: CONTROLLED DRUGS CARRIED ON ALS'UNITS REFERENCE NO. 702 C. Replacement Procedure for Controlled Drugs Administered in the Field: 1. Providers shall; a. Present the blue copy of the EMS Report Farm. or an EMS Agency approved electronic patient care record (ePCR)for each patient to • whom a controlled drug was administered. b. Present a photo identification (employee ID, driver's license, etc.)to verify identity at the pharmacy. • 2. Pharmacists shall: a. Stamp and initial the blue copy of the EMS Report Form (or an EMS Agency approved ePCR) utilizing the EMS Agency-issued stamp. b. Replace the controlled drugs utilizing the locked transport bag. c. Return the blue copy (or an EMS Agency approved ePCR)to provider agency personnel. D. Replacement Procedure for Missing. Broken. Lost or Expired Controlled Drugs: 1. Provider agencies shall: a. Complete Reference No. 702.1. Missing/Expired Controlled Drug Pharmacy Reporting Form, and maintain a copy in the provider agency's controlled drug file. b. Present the completed Reference No.702.1 to the issuing pharmacy along with the expired drug(s)for disposal in accordance with all applicable state and federal regulations. 2. Pharmacists shall: Replace the controlled drug following their facility's approved procedure. E. Replacement Procedure when the Blue Copy of the EMS Report Form (or the ePCR) is Missing: 1. Paramedics shall notify the on-duty captaim battalion chief or supervisor that the blue copy is missing. A written report summarizing the incident shall be submitted to the EMS Agency that: a. Describes what happened to the Blue Copy of the form (or the ePCR). b_ Is signed and dated by the reporting party,the on-duty captain or supervisor,the battalion chief or general manager. 2. The incident report and a copy of the EMS Report Form shall be forwarded to the paramedic coordinator or the individual responsible for controlled drug procurement. 3. The paramedic eaordinatoriresponsible individual shall review the documents and hand deliver copies to the EMS Agency, PAGE 3 OF 6 4433 • SUBJECT: CONTROLLED DRUGS CARRIED ON ALS UNITS REFERENCE NO. 702 4. EMS Agency staff shall review the documents and generate a letter to the provider agency's assigned County pharmacy authorizing replacement of the controlled drugs. The originacopy of the authorization,which expires in 14 days, is handed to the paramedic coordinator/responsible individual to carry to the pharmacy. III, Controlled Drug Replacement Through a Non-County Supplier: A. Provider agencies shall develop policies and procedures, approved by their Provider Agency Medical Director and/or Drug Authorizing Physician to ensure that all controlled drugs are obtained, maintained, and distributed in a secure manner consistent with local, state, and federal regulations. B. Such policies and procedures shall be submitted to the EMS Agency for review and approval unless the Provider Agency Medical Director/Drug Authorizing Physician wants to assume sole responsibility for procurement, storage and security of controlled substances. In that case,the Provider Agency Medical Director and Provider Agency Fire Chief(or CEO/President) shall submit Ref. No. 702.4, Provider Agency Medical Director Notification of Controlled Substance Program Implementation. IV. Controlled Drug Security A. Controlled drug security requirements apply to all provider agencies, whether drugs are ordered through the Provider Agency Medical Director, Drug Authorizing Physician or the EMS Agency Medical Director. B. Paramedics assigned to an advanced life support(ALS) unit shall be responsible for maintaining the correct controlled drug inventory and.security of the narcotic keys (or confidentiality of the keypad/padlock combination) for their assigned unit at all times. C. Controlled drugs shall not be stored in any location other than on ALS units unless authorized by the EMS Agency. Provider agencies authorized by the EMS Agency to store controlled drugs off the ALS unit shall specify in their internal policy the location, security, access and procedure for obtaining drugs from the controlled drug cache, D. Morphine and midazolam shall be secured on the ALS units under double lock. E. Daily Inventory Procedures 1. Controlled drugs shall be inventoried by two paramedics at least daily and anytime there is a change in personnel. 2. The key to access controlled drugs shall be in the custody of the individual who performed the inventory. 3. The Daily Controlled Drug and Key Inventory Form, Reference No. 7012 or its equivalent, shall be co-signed with the names of the relinquishing and the receiving paramedic. Entries shall be in blue or black ink only. PAGE4OF6 e� 4, 3 X 4 SUBJECT: CONTROLLED DRUGS CARRIED ON ALS UNITS REFERENCE NO. 702 NOTE: Errors shall be corrected by drawing a single line through the incorrect wording; the writing underneath the single line must remain readable. The individual making the change should initial adjacent to their correction. Correction fluid or other erasure material is not permitted. 4. The Daily Controlled Drug and Key Inventory Form, Reference No. 702.2 or its equivalent, must be maintained by the provider agency for a minimum of three years. An entry shall be made on this form for each of the following situations: a, Change of shift. b. Any change to the narcotic inventory. c Any time there is a change of responsible personnel NOTE: Units authorized to participate in the 1:1 Staffing Program for Interfacility Transports are required to inventory controlled drugs at the end of the specified shift,when two paramedics are available to count and co-sign for the drugs. 5. Provider agencies that restock controlled drugs from County operated pharmacies shall forward copies of Reference No, 702.2, Monthly Controlled Drug Storage Inspection Form or its equivalent,to their assigned DHS pharmacy no later than the 30th of the following month. F. Loss of Controlled Substances 1, Issued by a County Operated Pharmacy a, Any loss of controlled substances or discrepancy in the controlled drug count is to be reported by the following business day to the Department of Health (OHS) pharmacy that supplied the drugs. The follow up paperwork shall be submitted within five business days. b. Any loss or discrepancy shall also be reported to the paramedic coordinator,the EMS Agency. and the Provider Agency Medical Director or other authorized physician. c. Any loss of controlled substances shall be documented on Reference No. 702.1, Missing/Expired Controlled Drug Pharmacy Reporting. Form, and shall initiate supervisory review at the involved provider agency. The original of the completed form will be presented to the DHS pharmacy that dispensed the drugs. d. If a provider agency's internal investigation into a controlled drug loss exceeds thirty days. the provider shall submit a status update to the issuing DHS pharmacy and the EMS Agency at the If day. PAGE 5 OF 6 41133 SUBJECT: CONTROLLED DRUGS CARRIED ON ALS UNITS REFERENCE NO. 702 2. Authorized by a Provider Agency Medical Director or Drug Authorizing Physician a Any loss or discrepancy shall be reported by the following business day to the paramedic coordinator, the EMS Agency. and the authorizing Provider Agency Medical Director or Drug Authorizing • Physician. b. Any significant loss, breakage or discrepancy in the count requires notification to the Drug Enforcement Administration, utilizing DEA Form 106 or electronically via the DEA web site, within one business day of discovery. c. Any loss shall initiate supervisory review at the involved provider agency. If a provider agency's internal investigation into a controlled drug loss exceeds 30 days, the provider shalt submit a status update to the Provider Agency Medical Director and the EMS Agency. V. Record Keeping A. All controlled drugs issued to a provider agency must be accounted for. The provider agency shall retain a copy of the EMS Report Form(or an ePCR)for each patient to whom a controlled drug was administered and maintain it with any completed Missing/Expired Controlled Drug Reporting Forms, drug orders, invoices or other associated documentation in a separate file for a minimum of three years. B. Each controlled drug Use must be documented on the EMS Report Form (or an ePCR). If the total amount of the drug is not administered, the remaining amount shall be wasted at the receiving facility. Wasted narcotics (partial or whole) must be documented in the"Narcotic Waste)Witness" section of the EMS Report Form or an ePCR). including the amount wasted and the witness at the receiving hospital's printed name and signature (registered nurse, physician. pharmacist). C. In addition to the local EMS Agency and the provider agency, controlled drug inventories and logs are subject to inspection by the issuing pharmacy, the California Board of Pharmacy, and agents of the Bureau of Narcotic Enforcement Administration of the Department of Justice, Federal Drug Enforcement Administration. CROSS REFERENCES: Prehospital Care Policy Manual:. Reference No. 410, Provider Agency Drug Authorizing Physician Reference No. 411, Provider Agency Medical Director Reference No. 606, Documentation of Prehospital Care Reference No. 701, Supply and Resupply of Designated EMS Provider Units/Vehicles Reference No. 702.1. Missing/Expired Controlled Drug Pharmacy Reporting Form Reference No. 702.2, Daily Controlled Drug and Key Inventory Form(Page 1 of 2) Monthly Drug Storage Inspection Form (Page 2 of 2) Reference No. 702.3. County Operated Pharmacy Contact Numbers for Reporting Loss of Controlled Drugs Reference No. 702.4, Provider Agency Medical Director Notification of Controlled Substance Program implementation PAGE 6 OF 6 4433 , . DEPARTMENT OF HEALTH SERVICES COUNTY OF LOS ANGELES SUBJECT: MISSING/EXPIRED CONTROLLED DRUG Reference No. 702.1 PHARMACY REPORTING FORM 1. Provider Agency Unit number 2. Request for exchange of EXPIRED drugs: Drug I #of syringes or equivalent Strength I Total mg. 1 Midazolam Morphine Sulfate 3. Request for replacement. Item is: (CIRCLE ONE)Missing/Broken Drug #of syringes or equivalent Strength I Total mg. Midazolam Morphine Sulfate � 4. Date and time narcotic and/or inventory form loss was discovered: I I Gg 5. Print name and title of individual(s)who discovered the narcotic or inventory form loss: 6, If missing, provide a brief description of the incident: 7. Print name/title of person completing this form Signature Date completed: 1_/ 8. Paramedic Coordinator's signature FOR PHARMACY USE ONLY Replaced: Midazolam #of syringes or equivalent: Total mg: Morphine Sulfate #of syringes or equivalent: Total mg: Pharmacist: Date: Time: Lost narcotic number: Revised 4-1-2010 4433 ■ � m f m © Z w . - 0 Z I < 2 7 I a . • A D ? . ■ ¥ y , 1 /6 0 2 W 7 - . I . . ± U - 0 / z E ' U ƒDJ 3 q a 2 D «q re\ = , u. 0 j ›- W u ix . 2 \ z q ` | , m 2 °k» -A t . - . Y / k2� . .- z 2~ I I./ / E� « _ Nt /33 2 1 I W .CG 2 / - W O �¥ , ƒ 0 , , m re 5 2 %af l- _I Z 0k - . . i 2 �/ ! 1 I < -1 k . . - , to • 0 0 3 u_ 0 W .. .. . . Q e _I ca EC . 2 U ' ' } u * 0 EL D 0 / / 0 f . , .. , . . W. 41433 • i 04 ca z 0 N N Z I Lu z � 1 1 U I Ce tol W. ua LL GU z 1 m at j p a b Ce Q U) ! TO as L Z < N y 4>• "r3 U •• Q ›, 0 16 SKIS C5 A m -0 N 7 cn V E Q)tu Cl) lo t.3 c c! '�C2 C U 8 -0 E� V1 N W p E 2 „0) N Alt LPL p p tit la W IX c 0 U UZI U - al N = > p w '' w' ° a c m C a. E c .5 m 2 t, Z to a Q iv va• c 3 { al m .9 � u .t, lu � >- 0 a} •c �, �, c °� Iii <Crt -I o co 7 c ( c: E —1 w Z F- 3' o U CD c m ¢ m E 1-7-'F- W LL o 4 Z Z 1- © c 4 0 cO si ci c z &5 c o s co U (/) c v c CO co c k ac T I` O fU w Y in o r Q. = p ° Q c v= it E c E W W 3 w0 n e -cn J- O W L? Q o E U) ro © 0 GO O. 0 r= c.j t T vi 0 ( < 0 ` ' z ce • 4433 DEPARTMENT OF HEALTH SERVICES COUNTY OF LOS ANGELES REFERENCE NO.702.3 SUBJECT: COUNTY-OPERATED PHARMACY CONTACT NUMBERS FOR REPORTING LOST CONTROLLED DRUGS • Harbor-UCLA Medical Center 1000 W. Carson Street Torrance, California 90502 Narcotic Pharmacist--(310)222-2357 LAC +USG Medical Center • 1200 N.State Street Los Angeles, California 90033 Narcotic Pharmacist—(323)226-6763 Olive View Medical Center 14445 Olive View Drive Sylmar, California 91342 Monday—Friday:8:00-16:30:(818)364-3225 Narcotic Pharmacist—(818) 364-3059 or(818) 364-1555 Ext.5956 or 6152 NOTE: Telephone reporting should be conducted during business hours. • • Revawed 3-29-10 *) q5 :0, DEPARTMENT OF HEALTH SERVICES COUNTY OF LOS ANGELES SUBJECT: PROVIDER AGENCY MEDICAL DIRECTOR NOTIFICATION OF CONTROLLED SUBSTANCE PROGRAM IMPLEMENTATION REFERENCE NO. 702.4 • am a physician licensed by the State of California to practice medicine, and authorized by the U.S. Department of Justice - Drug Enforcement Administration to purchase schedule II - IV controlled substances. My DEA registration number is . I have current knowledge of all Federal, State and County Regulations governing controlled substance procurement and administration and will assume total responsibility for the controlled substance "program" at , Fire Department/Approved ALS Provider Agency, including but not limited to, procurement, storage, control, safeguards, recordkeeping, disposal, and inventory. Physician Fire Chief/CEO/President Signature Signature Printed Name Printed Name Date Date Effective: 08-01-10 4 4 3 3 cat„,ii EXHIBIT C CONTROLLED SUBSTANCES INVENTORY Substance Unit Dose Maximum Quantity 1. Morphine Sulfate 4 mg 50 mg 2. Midazolam (Versed®) 5 mg 40 mg 4433 I EXHIBIT C-1 CONTROLLED SUBSTANCES SUPPLY FOR PARAMEDIC PROVIDER AGENCIES FEE SCHEDULE CONTROLLED SUBSTANCE DOSAGE COST.' Morphine Sulfate 4 mg unit $9 Midazolam (Versed®) 5 mg unit $9 Cost includes actual purchase price of the drug, plus additional incidental and administrative expenses incurred in procuring and dispensing the controlled substances. _ EXPIRED CONTROLLED SUBSTANCES CONTROLLED SUBSTANCE DOSAGE INGREDIENT COST Morphine Sulfate 4 mg unit Actual Cost Midazolam (Versed®) 5 mg unit Actual Cost RECALLED CONTROLLED SUBSTANCES Restocking Fee $9 Per Lot OTHER Tampering/Diversion Testing Fee Actual Cost_ Board of Pharmacy Fines Actual Cost Above fees may be adjusted annually each July 1, as stated in Paragraph 5.0, Agreement Sum, of the Agreement. 4433 t'., =:•• 155 North Wacker Drive 312 775 4100 main roTioii Chicago,Illinois 606 314580 fax The Supply Cotnpcny of VHA 3 UHC 1. Application Type: Novation Affiliate Purchasing Program Agreement An Affiliate is any entity that is sponsored by a UHC Member or Associate Member, and is making purchases independent of the UHC Member or Associate Member. 2. Identification Name of Affiliate Address of Affiliate Main Phone City State Zipcode 3. Primary Materials Management Contact at Affiliate First and Last Name Phone Address(if different from section 2) Fax City State ZIP Code E-mail First and Last Name of Primary Pharmacy Contact Phone Address(if different from section 2) Fax City State ZIP Code E-mail APP GPO Application Last Updated November 29,2011 Page 1 of 6 4 3 3 Chi North Bails Wacker brie 312 775 4100 main Nova 10�,� e�• Chicago,Illinois 60606 312 775 4580 fax The Supply Comps 7 VW+&UK 4. Facility Type Ambulatory Care Center/ Home Health Cam/ Long Term Cane! Non Careg€ving/Closed Rx Closed Rx Closed Rx Closed Rx Fitness Center Ambulatory Care Center _Home Health Care Nursing Home _Fpundation _Student Health Service _Home Infusion _Retirement Center laundry Oncology Center Hospice Skilled Nursing Facility Warehouse _Dialysis Center _Durable Medical Equipment Sub-Acute Facility Management Service _Surgery Center (non resaler) _Assisted Living Denial Pharmacy Diagnostic Imaging Center Physician/Practices Managed Care Plant Pharmacy Closed Outpatient - Closed Rx Closed Rx Pharmacy Retail _Immediate Care Center _Clinical or Medical Group Correctional Facility _Pharmacy Retail&Closed `Physician's Office _University Campus _Other,please specify You can add additional or alternate shipping locations(ASLs)as part of this application. An ASL is an entity in which the Member makes purchases on behalf of the ASL.This includes warehouses and entities that send purchase orders to the Participant to purchase on their behalf. To add additional shipping locations,attach spreadsheet containing the following information: • Facility name,address(including city,state,zip), phone,fax • Facility DEA number • Facility Type(from section above) • Material director/manager name,job title,phone,fax,email,and address(if different from facility address) • Pharmacy director/manager name,job title,phone,fax,email,and address(if different from facility address) 5. Group Purchasing Participation Information Participate in: Medical-Surgical &Pharmacy* MedSurg Start Date Pharmacy Start Date: ❑ Capital Equipment Start Date: Purchased Services Start Date: *For Pharmacy participation:DEA Number must be supplied in table below. Also requires the member to fill out a Pharmacy Program Participation Agreement. Standard Terms&Conditions may require 30-45 days notice to the suppliers to add a new participant to a purchasing agreement. APP GPO Application Last Updated November 29,2011 Page 2 of 6 4433 . , ,_ ��;.: 155 North Wacker Drive 312 775 4100 main � � ;•:•';. Chicago,Illinois 60606 312 775 4580 fax UHC Novation� The Supply Compary of YHA b(1HC 6. Distribution Declaration • Distribution Declaration(Please indicate Start Date and select one or none from each category) , Acute distributors can be selected if this facility is own ed/rrfanaged/controlled by sponsoring hospital. Medical-Surgical Distribution Pharmaceutical Distribution(Acute)** Laboratory Distribution (Acute) Start Date Start Date Start Date DF147fs Cardinal Healthcare —Cardinal Healthcare _Amerisource Bergen Medline Industries _Cardinal Drug Imaging Distribution —Owens&Minor McKesson Drug Start Date —'American Medical Depot 'Burlington Drug _Capital X-Ray 'Buffalo Hospital Supply _'Moms&Dickson _Evans-Sherratt Company _'Claflln Company _Jefferson Medical&Imaging,Inc. —'Kreiser Inc. Pharmacy Distribution(Non-Acute " _ *Midland Medical Supply Start Date ) _Merry Ray Medical Enterprise,LLC `'Midwest Medical Supply DEAF —NHD,Inc. 'N.S.law Food&Nutrition Distribution `Professional Hospital Supply (star cha••e one from cart group) Start Date 'Seneca medical _.Cardinal Healthcare(P.A) 'Shared Service Systems —McKesson Corp.(P,A) US Foodservice _Physician Sales&Services(P,A) Maintenance,Repair,Operation Besse Medical(P,A,L,H,HP) Distribution Medical-Surgical Distribution _CuraScript(P.A,L,H,HP) Start Date (Non-Acute) Seacoast Medical(P,A,L,H TM ,HP) Controlled Environmental Products Start Date —'Kinray.Inc (P.A.L,H.HP) Grainger industrial Supply Cardinal Healthcare(P,A) _Graybar Electrical Co.inc. _McKesson Corp,(P,A) Office Products Distribution _Physician Sales&Services(II,A) Smart Date Housekeeping Distribution _Gulf South Medical Supply(L,H.HP) —OffioeMax Start Date Medical Specialties(L,H,HP) Corporate Express Aetwork � Independence Medical(1,H.HP) _Network Services Home Healthcare Solutions(HP) Class or Trader P=Physielan,A-Ameuratery Care, Xpedx —Actives(P,A,L) L°LengTerm Care,H=dame Heallhcme,HP=HOrne —'Kreisers Inc.(P,A.H) Healll+cars Patient Specific Dental Distribution —•Nauenal Distribution&Contracting •Regional-see ineviduel launch packages for • Start Date • (P,A iI} �rdnd slates American Dental Cooperative DEA*Required —' The applications for the specific Novation distribution agreements referenced prior will be hand delivered by your Novation Service Delivery Account Executive. As a participant of UHC,each participant is eligible to access UHC's contract solutions agreements. There is no additional participation fee for this service. By signing this application,you acknowledge your understanding of the following information as it pertains to access of contracts negotiated by UHC Contract Solutions,Novation, and/or the Academic Medical Research Center Purchasing Program, APP GPO Application Last Updated November 29,2011 Page 3 of 6 4633 UHC 155 North Wacker Drive 312 775 4100 main • Chicago,Illinois 60606 312 775 4580 fax No-v51. ion..y • •• • ' The 4Ph1 Comm of VFW S Uric 7. Agreement This section applies to each Affiliate that has elected to participate in UHC's Group Purchasing Program(through UHC Contract Solutions,Novation and the Academic Medical Research Center Purchasing Program)and is intended to maintain UHC and Novation's compliance with both the Medicare Anti-Kickback Statute's GPO Safe Harbor(42 CFR 1001.952(j))and the Stark Law's GPO Exception(42 USC 1320-7b(3)(C)). By executing this purchasing profile form,Participant: • Authorizes UHC(and its agents,including Novation)to act as a group purchasing organization(GPO)on behalf of the Affiliate. • Understands and agrees that UHC will receive administrative fees("Fees")from suppliers and distributors("Vendors")based on Affiliate's purchases under UHC or Novation contracts ("Contracts")and may furnish certain administrative and promotional services to such Vendors. • Understands and agrees that except as noted herein, each Contract provides for Fees that are fixed at three percent or less of the purchase price of the goods or services covered by the Contract;and that with respect to Contracts providing for Fees that are not so fixed,Affiliate: (1)Will have access to a web-based report on the UHC Marketplace website indicating the Fees that UHC may receive from each Vendor under each such Contract("Fee Report"); and (2)Will have access to timely updates to the Fee Report("Fee Report Updates")for all such Contracts that are executed after the Fee Report is generated. • Understands and agrees that UHC shall provide the Affiliate's sponsoring Member with an annual report("Sales and Revenue Report") listing: (1)Affiliate's purchases under each Contract;and(2)the Fees received from Vendors based on such purchases,unless sponsoring Member directs UHC otherwise in writing. • Understands and agrees to a three(3)year term("Initial Term") of participation in the UHC/Novation group purchasing program,which shall automatically extend for additional 1- year terms("Renewal Terms"),unless Affiliate provides UHC ninety(90)days Notice of Termination from the group purchasing program. • Understands that the Fee Report,the Annual Sales and Revenue Report and all Fee Report Updates shall be automatically incorporated herein by reference. If Affiliate is considering purchasing under a Contract that is not listed on the Fee Report or a Fee Report Update,or if Affiliate otherwise needs any Fee or other information relating to any Contract,Affiliate may contact UHC's Vice President of Finance at 630/954-1700. Affiliate hereby authorizes UHC to send the Fee Report, all Fee Report Updates,and all annual Sales and Revenue Reports to Affiliate's Chief Financial Officer. Please note that to the extent Affiliate receives or earns discounts,rebates, incentives or any other price reductions(such as manufacturer incentives or patronage dividends)as a result of purchases made under UHC's Group Purchasing Program, Affiliate may have an obligation to disclose such price reductions(as part of the cost reporting process, for example)to federal or state health care programs or other payers. Affiliate understands and agrees to keep strictly confidential all UHC/Novation trade secrets, proprietary and other Confidential Information (especially pricing schedules),and shall not disclose such Confidential Information to any third party,and shall not use the Confidential Information for APP GPO Application Last Updated November 29,2011 Page 4 of 6 4433 • 155 North Wacker Drive 312 775 4100 main •'' Chica o,Illinois 60606 312 775 4580 fax Nova ion" The Supply Company of YHA&L$C any purpose other than group purchasing through UHC/Novation,without the prior written consent of Novation and UHC. "Confidential Information" includes,but is not limited to: the information of UHC, its member organizations("Members"),or Novation,LLC,("Novation"),encompassed in all technology,plans,designs,concepts,financial information, costs,pricing,spend and fee data, • computer programs,contract portfolios,videos,animation and designs;computer codes,including but not limited to, .NET,ASP,HTML, SQL,JAVA or JavaScript; formulas,websites, including UHC Marketplace,and equations; databases;customer information,vendors, business partners or suppliers; business and marketing plans or strategies; financial performance and projections;and all concepts, know-how,or ideas in or directly related to UHC's business,the business of its Members,and the business of Novation that have not previously been publicly released by duly authorized representatives of UHC, its Members,or Novation. UHC has instituted corporate policies and procedures for the business operations of its group purchasing business. Such policies may be updated from time to time and are hereby incorporated herein by reference. Affiliate acknowledges and agrees that it shall comply with all such policies, including but not limited to the Notice of Termination requirement,as well as those policies detailing certain consequences for an Affiliate who terminates participation in the UHC/Novation purchasing program. Contact the UHC Senior Vice President of Supply Chain for UHC's current policies at 630.954.1700. I very that, to the best of my knowledge, the above listed organization purchases pharmaceuticals within the meaning of the Nonprofit Institutions Act(NIA) as interpreted by the U.S. Supreme Court in Abbott Laboratories vs.Portland Retail Druggist Association, Inc., 425 US. 1 (1976). Information submitted by: Name Authorized Signature Title Date Name of Spoosoriayt Member or Associate Member Sponsor First Name Sponsor Last Name Sponsor Title Sponsor Phone Sponsor Fax Sponsor Email Sponsor Signature Date APP GPO Application Last Updated November 29,2011 Page 5 of 6 4433 -' 155 North Wacker Drive 312 775 4100 main �'••' Chicago,Illinois 60606 312 775 4580 fax NOWlion• " The Supply Compony of YHA 6UHC 8. Mailing/Fax Instructions Please return completed form to: Christine Santos,Membership Specialist UHC 155 North Wacker Drive Chicago,Illinois 60606 Phone:(312)775-4320 Fax: (312)775-4580 APP GPO Application Last Updated November 29,2011 Page 6 of 6 4433 ..:r,A CONTRACT FOR CONTROLLED SUBSTANCES SUPPLY FOR PARAMEDIC PROVIDER AGENCIES TABLE OF CONTENTS OF EXHIBITS STANDARD EXHIBITS A STATEMENT OF WORK B PREHOSPITAL CARE POLICY MANUAL (REFERENCE NO. 702) C CONTROLLED SUBSTANCES INVENTORY C-1 CONTROLLED SUBSTANCES PRICING SCHEDULE D PROVIDER'S EEO CERTIFICATION (Intentionally Omitted) E COUNTY'S ADMINISTRATION F PROVIDER'S ADMINISTRATION G-1 PROVIDER ACKNOWLEDGEMENT AND CONFIDENTIALITY AGREEMENT H JURY SERVICE ORDINANCE (Intentionally Omitted) I SAFELY SURRENDERED BABY LAW (Intentionally Omitted) UNIQUE EXHIBITS HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) AGREEMENT J PROVIDER'S OBLIGATIONS AS A "BUSINESS ASSOCIATE" UNDER THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) AND THE HEALTH INFORMATION AND TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT (HITECH) 1 '4J ) d EXHIBIT A 4_„4 3 3 ; mg EXHIBIT B 4433 , . EXHIBIT C 4433 4 EXHIBIT C-1 4433 EXHIBIT D PROVIDER'S EEO CERTIFICATION INTENTIONALLY OMITTED 4433 EXHIBIT E COUNTY'S ADMINISTRATION CONTRACT NO. COUNTY PROJECT DIRECTOR: Name: Title: Address: Telephone: Facsimile: E-Mail Address: COUNTY PROJECT MANAGER: Name: Title: Address: Telephone: Facsimile: E-Mail Address: COUNTY CONTRACT PROJECT MONITOR: Name: Title: Address: Telephone: Facsimile: E-Mail Address: ! 433 , , EXHIBIT F PROVIDER'S ADMINISTRATION PROVIDER'S NAME: CONTRACT NO: PROVIDER'S PROJECT MANAGER: Name: Title: Address: Telephone: Facsimile: E-Mail Address: PROVIDER'S AUTHORIZED OFFICIAL(S) Name: Title: Address: Telephone: Facsimile: E-Mail Address: Name: Title: Address: Telephone: Facsimile: E-Mail Address: Notices to Provider shall be sent to the following: Name: Title: Address: Telephone: Facsimile: E-Mail Address: 33 EXHIBIT G-1 PROVIDER ACKNOWLEDGEMENT AND CONFIDENTIALITY AGREEMENT PROVIDER NAME Contract No. GENERAL INFORMATION: The Provider referenced above has entered into a contract with the County of Los Angeles to provide certain services to the County. The County requires the Corporation to sign this Provider Acknowledgement and Confidentiality Agreement. PROVIDER ACKNOWLEDGEMENT: Provider understands and agrees that the Provider employees, consultants, Outsourced Vendors and independent providers (Provider's Staff) that will provide services in the above referenced agreement are Provider's sole responsibility. Provider understands and agrees that Providers Staff must rely exclusively upon Provider for payment of salary and any and all other benefits payable by virtue of Providers Staffs performance of work under the above-referenced contract. Provider understands and agrees that Providers Staff are not employees of the County of Los Angeles for any purpose whatsoever and that Providers Staff do not have and will not acquire any rights or benefits of any kind from the County of Los Angeles by virtue of my performance of work under the above-referenced contract. Provider understands and agrees that Providers Staff will not acquire any rights or benefits from the County of Los Angeles pursuant to any agreement between any person or entity and the County of Los Angeles. CONFIDENTIALITY AGREEMENT: Provider and Provider's Staff may be involved with work pertaining to services provided by the County of Los Angeles and, if so, Provider and Providers Staff may have access to confidential data and information pertaining to persons and/or entities receiving services from the County. In addition, Provider and Provider's Staff may also have access to proprietary information supplied by other vendors doing business with the County of Los Angeles. The County has a legal obligation to protect all such confidential data and information in its possession, especially data and information concerning health,criminal,and welfare recipient records. Provider and Providers Staff understand that if they are involved in County work, the County must ensure that Provider and Providers Staff, will protect the confidentiality of such data and information. Consequently, Provider must sign this Confidentiality Agreement as a condition of work to be provided by Provider's Staff for the County. Provider and Providers Staff hereby agrees that they will not divulge to any unauthorized person any data or information obtained while performing work pursuant to the above-referenced contract between Provider and the County of Los Angeles. Provider and Provider's Staff agree to forward all requests for the release of any data or information received to County's Project Manager. Provider and Providers Staff agree to keep confidential all health, criminal, and welfare recipient records and all data and information pertaining to persons and/or entities receiving services from the County, design concepts, algorithms, programs, formats, documentation, Provider proprietary information and all other original materials produced, created, or provided to Provider and Provider's Staff under the above-referenced contract. Provider and Providers Staff agree to protect these confidential materials against disclosure to other than Provider or County employees who have a need to know the information. Provider and Provider's Staff agree that if proprietary information supplied by other County vendors is provided to me during this employment, Provider and Providers Staff shall keep such information confidential. Provider and Providers Staff agree to report any and all violations of this agreement by Provider and Providers Staff and/or by any other person of whom Provider and Provider's Staff become aware. Provider and Providers Staff acknowledge that violation of this agreement may subject Provider and Providers Staff to civil and/or criminal action and that the County of Los Angeles may seek all possible legal redress. SIGNATURE: DATE: PRINTED NAME: POSITION: 33 71 I EXHIBIT H JURY SERVICE ORDINANCE INTENTIONALLY OMITTED Exhibits for Sample REP Agreement Jury Service Ordinance 08/26/10 4433 s ; Exhibit I SAFELY SURRENDERED BABY LAW INTENTIONALLY OMITTED .'.I tl� ..'' , A r. Exhibit J Page 1 of 11 AGREEMENT PROVIDER'S OBLIGATIONS AS A "BUSINESS ASSOCIATE" UNDER THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 AND THE HEALTH CARE INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT • (BUSINESS ASSOCIATE AGREEMENT) Under this Agreement, Provider ("Business Associate") provides services ("Services") to County ("Covered Entity") and Business Associate receives, has access to or creates Protected Health Information in order to provide those Services. Covered Entity is subject to the Administrative Simplification requirements of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 ("HIPAA"), and regulations promulgated thereunder, including the Standards for Privacy of Individually Identifiable Health Information ("Privacy Regulations") and the Health Insurance Reform: Security Standards ("the Security Regulations") at 45 Code of Federal Regulations (C.F.R.) Parts 160 and 164 (together, the "Privacy and Security Regulations"). The Privacy and Security Regulations require Covered Entity to enter into a contract with Business Associate ("Business Associate Agreement") in order to mandate certain protections for the privacy and security of Protected Health Information, and those Regulations prohibit the disclosure to or use of Protected Health Information by Business Associate if such a contract is not in place. Further, pursuant to the Health Information Technology for Economic and Clinical Health Act, Public Law 111-005, title XIII and title IV of Division B , ("HITECH Act"), effective February 17, 2010, certain provisions of the HIPAA Privacy and Security Regulations apply to Business Associates in the same manner as they apply to Covered Entity and such provisions must be incorporated into the Business Associate Agreement. This Business Associate Agreement and the following provisions are intended to protect the privacy and provide for the security of Protected Health Information disclosed to or used by Business Associate in compliance with HIPAA's Privacy and Security Regulations and the HITECH Act, as they now exist or may hereafter be amended. Therefore, the parties agree as follows: DEFINITIONS 1.1 "Breach" has the same meaning as the term "breach" in 45 C.F.R. § 164.402. 1.2 "Disclose" and "Disclosure" mean, with respect to Protected Health Information, the release, transfer, provision of access to, or divulging in any other manner of Protected Health Information outside Business Associate's internal operations or to other than its employees. 4433 > 4 Exhibit J Page 2 of 11 1.3 "Electronic Health Record" has the same meaning as the term "electronic health record" in the HITECH Act, 42 U.S.C. section 17921. Electronic Health Record means an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff. • 1.4 "Electronic Media" has the same meaning as the term "electronic media" in 45 C.F.R. § 160.103. Electronic Media means (1) Electronic storage media including memory devices in computers (hard drives) and any removable/transportable digital memory medium, such as magnetic tape or disk, optical disk, or digital memory card; or (2) Transmission media used to exchange information already in electronic storage media. Transmission media include, for example, the internet (wide-open), extranet (using internet technology to link a business with information accessible only to collaborating parties), leased lines, dial-up lines, private networks, and the physical movement of removable/transportable electronic storage media. Certain transmissions, including of paper, via facsimile, and of voice, via telephone, are not considered to be transmissions via electronic media, because the information being exchanged did not exist in electronic form before the transmission. The term "Electronic Media" draws no distinction between internal and external data, at rest (that is, in storage) as well as during transmission. 1.5 "Electronic Protected Health Information" has the same meaning as the term "electronic protected health information" in 45 C.F.R. § 160.103. Electronic Protected Health Information means Protected Health Information that is (i) transmitted by electronic media; (ii) maintained in electronic media. 1.6 "Individual" means the person who is the subject of Protected Health Information and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. § 164.502(g). 1.7 "Minimum Necessary" refers to the minimum necessary standard in 45 C.F.R. § 162.502 (b) as in effect or as amended. 1.8 "Privacy Rule" means the Standards for Privacy of Individually Identifiable Health Information at 45 Code of Federal Regulations (C.F.R.) Parts 160 and 164, also referred to as the Privacy Regulations. 1.9 "Protected Health Information" has the same meaning as the term "protected health information" in 45 C.F.R. § 160.103, limited to the information created or received by Business Associate from or on behalf of Covered Entity. Protected Health Information includes information that (i) relates to the past, present or future physical or mental health or condition of an Individual; the provision of health care to an Individual, or the past, present or future payment for the provision of health care to an Individual; (ii) identifies the Individual (or for which 4433 Exhibit J Page 3 of 11 there is a reasonable basis for believing that the information can be used to identify the Individual); and (iii) is received by Business Associate from or on behalf of Covered Entity, or is created by Business•Associate, or is made accessible to Business Associate by Covered Entity. "Protected Health Information" includes Electronic Health Information. • 1.10 "Required By Law" means a mandate contained in law that compels an entity to make a Use or Disclosure of Protected Health Information and that is enforceable in a court of law. Required by law includes, but is not limited to, court orders and court-ordered warrants; subpoenas or summons issued by a court, grand jury, a governmental or tribal inspector general, or any administrative body authorized to require the production of information; a civil or an authorized investigative demand; Medicare conditions of participation with respect to health care providers participating in the program; and statutes or regulations that require the production of information, including statutes or regulations that require such information if payment is sought under a government program providing benefits. 1.11 "Security Incident" means the attempted or successful unauthorized access, Use, Disclosure, modification, or destruction of information in, or interference with system operations of, an Information System which contains Electronic Protected Health Information. However, Security Incident does not include attempts to access an Information System when those attempts are not reasonably considered by Business Associate to constitute an actual threat to the Information System. 1.12 "Security Rule" means the Security Standards for the Protection of Electronic Health Information also referred to as the Security Regulations at 45 Code of Federal Regulations (C.F.R.) Part 160 and 164. • 1.13 "Services" has the same meaning as in the body of this Agreement. 1.14 "Unsecured Protected Health Information" has the same meaning as the term "unsecured protected health information" in 45 C.F.R. § 164.402. 1.15 "Use" or "Uses" mean, with respect to Protected Health Information, the sharing, employment, application, utilization, examination or analysis of such Information within Business Associate's internal operations. 1.16 Terms used, but not otherwise defined in this Business Associate Agreement shall have the same meaning as those terms in the HIPAA Regulations and HITECH Act. OBLIGATIONS OF BUSINESS ASSOCIATE 2.1 Permitted Uses and Disclosures of Protected Health Information. Business Associate: 1L 33 4 Exhibit J Page 4 of 11 (a) shall Use and Disclose Protected Health Information only as necessary to perform the Services, and as provided in Sections 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10, 4.3 and 5.2 of this Agreement; (b) shall Disclose Protected Health Information to Covered Entity upon request; • (c) may, as necessary for the proper management and administration of its business or to carry out its legal responsibilities: (i) Use Protected Health Information; and (ii) Disclose Protected Health Information if the Disclosure is Required by Law. Business Associate shall not Use or Disclose Protected Health Information for any other purpose or in any manner that would constitute a violation of the Privacy Regulations or the HITECH Act if so Used or Disclosed by Covered Entity. 2.2 Prohibited Uses and Disclosures of Protected Health Information. Business Associate: (a) shall not Use or Disclose Protected Health Information for fundraising or marketing purposes. (b) shall not disclose Protected Health Information to a health plan for payment or health care relates. (c) shall not directly or indirectly receive payment in exchange for Protected Health Information, except with the prior written consent of Covered Entity and as permitted by the HITECH Act. This prohibition shall not affect payment by Covered Entity to Business Associate. Covered Entity shall not provide such written consent except upon express approval of the departmental privacy officer and only to the extent permitted by law, including HIPAA and the HITECH Act. 2.3 Adequate Safeguards for Protected Health Information. Business Associate: (a) shall implement and maintain appropriate safeguards to prevent the Use or Disclosure of Protected Health Information in any manner other than as permitted by this Business Associate Agreement. Business Associate agrees to limit the Use and Disclosure of Protected Health Information to the Minimum Necessary in accordance with the Privacy Regulation's minimum necessary standard as in effect or as amended. 4433 Exhibit J Page 5 of 11 (b) as to Electronic Protected Health Information, shall implement and maintain administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of Electronic Protected Health Information; effective February 17, 2010, said safeguards shall be in accordance with 45 C.F.R. Sections 164.308, 164.310, and 164.312, and shall comply with the Security Rule's policies and procedure and documentation requirements. 2.4 Reporting Non-Permitted Use or Disclosure and Security Incidents and Breaches of Unsecured Protected Health Information. Business Associate (a) shall report to Covered Entity each Use or Disclosure of Protected Health Information that is made by Business Associate, its employees, representatives, Agents, subcontractors, or other parties under Business Associate's control with access to Protected Health Information but which is not specifically permitted by this Business Associate Agreement or otherwise required by law. (b) shall report to Covered Entity each Security Incident of which Business Associate becomes aware. (c) shall notify Covered Entity of each Breach by Business Associate, its employees, representatives, agents or subcontractors of Unsecured Protected Health Information that is known to Business Associate or, by exercising reasonable diligence, would have been known to Business Associate. Business Associate shall be deemed to have knowledge of a Breach of Unsecured Protected Health Information if the Breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the Breach, who is an employee, officer, or other agent of the Business Associate as determined in accordance with the federal common law of agency. 2.4.1 Immediate Telephonic Report. Except as provided in Section 2.4.3, notification shall be made immediately upon discovery of the non- permitted Use or Disclosure of Protected Health Information, Security Incident or Breach of Unsecured Protected Health Information by telephone call to [To Be Determined], telephone number 1(800) XXX- XXXX. 2.4.2 Written Report. Except as provided in Section 2.4.3, the initial telephonic notification shall be followed by written notification made without unreasonable delay and in no event later than three (3) business days from the date of discovery of the non-permitted Use or Disclosure of Protected Health Information, Security Incident, or Breach by the Business Associate to the Chief Privacy Officer at: 4433 3 Exhibit J Page 6 of 11 Chief Privacy Officer Kenneth Hahn Hall of Administration 500 West Temple Street Suite 525 Los Angeles, California 90012 HIPAA @auditor.lacounty.gov - (213) 974-2166 (a) The notification required by section 2.4 shall include, to the extent possible, the identification of each Individual whose Unsecured Protected Health Information has been, or is reasonably believed by the Business Associate to have been, accessed, acquired, Used, or Disclosed; and (b) The notification required by section 2.4 shall include, to the extent possible, all information required to provide notification to the Individual under 45 C.F.R. 164.404(c), including: (i) A brief description of what happened, including the date of the Breach and the date of the discovery of the Breach, if known; (ii) A description of the types of Unsecured Protected Health Information that were involved in the Breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); • (iii) Any other details necessary to conduct an assessment of whether there is a risk of harm to the Individual; (iv) Any steps Business Associate believes that the Individual could take to protect him or herself from potential harm resulting from the breach; (v) A brief description of what Business Associate is doing to investigate the Breach, to mitigate harm to the Individual, and to protect against any further Breaches; and (vi) The name and contact information for the person most knowledge regarding the facts and circumstances of the Breach. If Business Associate is not able to provide the information specified in section 2.3.2 (a) or (b) at the time of the notification required by section 2.4.2, Business Associate 4433 Exhibit J Page 7 of 11 shall provide such information promptly thereafter as such information becomes available. 2.4.3 Request for Delay by Law Enforcement. Business Associate may delay the notification required by section 2.4 if a law enforcement official states to Business Associate that notification would impede a criminal investigation or cause damage to national security. If the law enforcement official's statement is in writing and specifies the time for which a delay is required, Business Associate shall delay notification, notice, or posting for the time period specified by the official; if the statement is made orally, Business Associate shall document the statement, including the identity of the official making the statement, and delay notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described in paragraph (a) of this section is submitted during that time. 2.5 Mitigation of Harmful Effect. 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 Business Associate Agreement. 2.6 Breach Notification. Business Associate shall, to the extent Covered Entity determines that there has been a Breach of Unsecured Protected Health Information, provide Breach notification for each and every Breach of Unsecured Protected Health Information by Business Associate, its employees, representatives, agents or subcontractors, in a manner that permits Covered Entity to comply with its obligations under Subpart D, Notification in the Case of Breach of Unsecured PHI, of the Privacy and Security Regulations, including: (a) Notifying each Individual whose Unsecured Protected Health Information has been, or is reasonably believed to have been, accessed, acquired, Used, or Disclosed as a result of such Breach; (b) The notification required by paragraph (a) of this Section 2.6 shall include, to the extent possible: (i) A brief description of what happened, including the date of the Breach and the date of the discovery of the Breach, if known; (ii) A description of the types of Unsecured Protected Health Information that were involved in the Breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); (iii) Any steps the Individual should take to protect him or herself from potential harm resulting from the Breach; 4433 ,i , Exhibit J Page 8 of 11 (iv) A brief description of what Business Associate is doing to investigate the Breach, to mitigate harm to individuals, and to protect against any further Breaches; and (v) Contact procedures for Individual(s) to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address. (vi) The notification required by paragraph (a) of this section shall be written in plain language Covered Entity, in its sole discretion, may elect to provide the notification required by this Section 2.6, and Business Associate shall reimburse Covered Entity any and all costs incurred by Covered Entity, including costs of notification, internet posting, or media publication, as a result of Business Associate's Breach of Unsecured Protected Health Information. 2.7 Availability of Internal Practices, Books and Records to Government Agencies. Business Associate agrees to make its internal practices, books and records relating to the Use and Disclosure of Protected Health Information available to the Secretary of the federal Department of Health and Human Services for purposes of determining Covered Entity's compliance with the Privacy and Security Regulations. Business Associate shall immediately notify Covered Entity of any requests made by the Secretary and provide Covered Entity with copies of any documents produced in response to such request. 2.8 Access to Protected Health Information. Business.Associate shall, to the extent Covered Entity determines that any Protected Health Information constitutes a "designated record set" as defined by 45 C.F.R. § 164.501, make the Protected Health Information specified by Covered Entity available to the Individual(s) identified by Covered Entity as being entitled to access and copy that Protected Health Information. Business Associate shall provide such access for inspection of that Protected Health Information within two (2) business days after receipt of request from Covered Entity. Business Associate shall provide copies of that Protected Health Information within five (5) business days after receipt of request from Covered Entity. If Business Associate maintains an Electronic Health Record, Business Associate shall provide such information in electronic format to enable Covered Entity to fulfill its obligations under the HITECH Act. 2.9 Amendment of Protected Health Information. Business Associate shall, to the extent Covered Entity determines that any Protected Health Information constitutes a "designated record set" as defined by 45 C.F.R., § 164.501, make any amendments to Protected Health Information that are requested by Covered Entity. Business Associate shall make such amendment within ten (10) business 4433 Exhibit J Page 9 of 11 days after receipt of request from Covered Entity in order for Covered Entity to meet the requirements under 45 C.F.R. § 164.526. 2.10 Accounting of Disclosures. Upon Covered Entity's request, Business Associate shall provide to Covered Entity an accounting of each Disclosure of Protected Health Information made by Business Associate or its employees, agents, representatives or subcontractors, in order to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 C.F.R. § 164.528 and/or the HITECH Act which requires an Accounting of Disclosures of Protected Health Information maintained in an Electronic Health Record for treatment, payment, and health care operations. [Optional, to be used when all Uses and Disclosures permitted in order to perform the Services will be for the Covered Entity's payment or health care operations activities: However, Business Associate is not required to provide an Accounting of Disclosures that are necessary to perform the Services because such Disclosures are for either payment or health care operations purposes, or both.] Any accounting provided by Business Associate under this Section 2.10 shall include: (a) the date of the Disclosure; (b) the name, and address if known, of the entity or person who received the Protected Health Information; (c) a brief description of the Protected Health Information disclosed; and (d) a brief statement of the purpose of the Disclosure. For each Disclosure that could require an accounting under this Section 2.10, Business Associate shall document the information specified in (a) through (d), above, and shall securely maintain the information for six (6) years from the date of the Disclosure. Business Associate shall provide to Covered Entity, within ten (10) business days after receipt of request from Covered Entity, information collected in accordance with this Section 2.10 to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 C.F.R. § 164.528. If Business Associate maintains an Electronic Health Record, Business Associate shall provide such information in electronic format to enable Covered Entity to fulfill its obligations under the HITECH Act. 2.11 Indemnification. Business Associate shall indemnify, defend, and hold harmless Covered Entity, including its elected and appointed officers, employees, and agents, from and against any and all liability, including but not limited to demands, claims, actions, fees, costs, penalties and fines (including regulatory penalties and/or fines), and expenses (including attorney and expert witness fees), arising from or connected with Business Associate's acts and/or omissions arising from and/or relating to this Business Associate Agreement; Business Associate's obligations under this provision extend to compliance and/or enforcement actions and/or activities, whether formal. or informal, of Secretary of 4 4 3 3 3 a A II Exhibit J Page 10 of 11 the federal Department of Health and Human Services and/or Office for Civil Rights. 3.0 OBLIGATION OF COVERED ENTITY 3.1 Obligation of Covered Entity. Covered Entity shall notify Business Associate of any current or future restrictions or limitations on the use of Protected Health Information that would affect Business Associate's performance of the Services, and Business Associate shall thereafter restrict or limit its own uses and disclosures accordingly. 4.0 TERM AND TERMINATION 4.1 Term. The term of this Business Associate Agreement shall be the same as the term of this Agreement. Business Associate's obligations under Sections 2.1 (as modified by Section 4.2), 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10, 4.3 and 5.2 shall survive the termination or expiration of this Agreement. 4.2 Termination for Cause. In addition to and notwithstanding the termination provisions set forth in this Agreement, upon either party's knowledge of a material breach by the other party, the party with knowledge of the other party's breach shall: (a) Provide an opportunity for the breaching party to cure the breach or end the violation and terminate this Agreement if the breaching party does not cure the breach or end the violation within the time specified by the non-breaching party; • (b) Immediately terminate this Agreement if a party has breached a material term of this Agreement and cure is not possible; or (c) If neither termination nor cure is feasible, report the violation to the Secretary of the federal Department of Health and Human Services. 4.3 Disposition of Protected Health Information Upon Termination or Expiration. (a) Except as provided in paragraph (b) of this section, upon termination for any reason or expiration of this Agreement, 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. (b) In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall A4 3 3 ewe! Exhibit J Page 11 of 11 provide to Covered Entity notification of the conditions that make infeasible. If return or destruction is infeasible, Business Associate shall extend the protections of this Business Associate 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. 5.0 MISCELLANEOUS 5.1 No Third Party Beneficiaries. Nothing in this Business Associate Agreement shall confer upon any person other than the parties and their respective successors or assigns, any rights, remedies, obligations, or liabilities whatsoever. 5.2 Use of Subcontractors and Agents. Business Associate shall require each of its agents and subcontractors that receive Protected Health Information from Business Associate, or create Protected Health Information for Business Associate, on behalf of Covered Entity, to execute a written agreement obligating the agent or subcontractor to comply with all the terms of this Business Associate Agreement. 5.3 Relationship to Services Agreement Provisions. In the event that a provision of this Business Associate Agreement is contrary to another provision of this Agreement, the provision of this Business Associate Agreement shall control. Otherwise, this Business Associate Agreement shall be construed under, and in accordance with, the terms of this Agreement. 5.4 Regulatory References. A reference in this Business Associate Agreement to a section in the Privacy or Security Regulations means the section as in effect or as amended. 5.5 Interpretation. Any ambiguity in this Business Associate Agreement shall be resolved in favor of a meaning that permits Covered Entity to comply with the Privacy and Security Regulations. 5.6 Amendment. The parties agree to take such action as is necessary to amend this Business Associate Agreement from time to time as is necessary for Covered Entity to comply with the requirements of the Privacy and Security Regulations and other privacy laws governing Protected Health Information