MIAMI-DADE COUNTY, FLORIDA Contract No. TBD



Scope of ServicesBackground2.1BackgroundThe County is soliciting proposals to provide a Forensic Toxicology Laboratory Program for the Miami-Dade Police Department (MDPD) and participating government agencies to include the Miami-Dade State Attorney’s Office (SAO), the Miami-Dade Public Defender’s Office (PDO). . The forensic/toxicology analysis performed for the MDPD also includes testing for other local law enforcement and government agencies with operations in Miami-Dade County. This includes agencies such as the Florida Highway Patrol, Florida Fish and Wildlife Conservative Commission, Miami-Dade County Municipalities, and local police agencies. Services shall be provided with reliability and security protocols as required by the judicial system. The samples to be analyzed will include blood and/or urine analyzed by the licensed laboratory for crimes such as rape and sexual assault cases, homicides, driving under the influence, and all criminal related investigations. In addition, expert witness and testimony services will be required by certified and licensed experienced toxicologists in depositions, hearings, and criminal trials arising from cases regarding the toxicological analyses and/or pharmacological effects of drugs and/or alcohol detected in case samples.It is anticipated that the annual sample volume will be approximately 600 urine samples to be analyzed for drugs and 500 blood samples to be analyzed for alcohol. A blood sample may also require analysis for drugs if the sample is at, or below, a certain blood alcohol threshold level, or if requested by the Assistant State Attorney or law enforcement. It is estimated that over 85% of urine samples will be positive for one or more drug categories with an additional 35% being positive for 4 or more drugs and/or metabolites and thirty five percent (35%) of blood samples will require confirmation and or quantification of one or more drug/metabolites.2.2QualificationsRequired QualificationsThe Contractor should be certified and accredited by the American Board of Forensic Toxicology (ABFT). This is a continuing condition of award, as the Contractor must maintain this minimum qualification throughout the duration of the contract. The laboratory director must have an education in toxicology, forensic science, and/or analytical science. In addition, must hold a Florida license as a laboratory director and be certified in toxicology.2.3REQUIREMENTS AND SERVICES TO BE PROVIDED The Scope of Services shall include the following: A.General The Contractor shall:Maintain and operate a facility that is properly equipped with the necessary instruments and equipment to provide the services stated herein. Additionally, the Contractor shall maintain security procedures and systems at the facility to ensure the integrity of the samples and testing. Establish and maintain protocols for sample handling, screening, and confirmation of drugs in blood and urine and chain-of-custody procedures. Make available at all times staff to provide expert testimony as analytical toxicology and pharmacology experts in depositions, hearings, and criminal trials.Ensure timely attendance of staff members who are called to depositions and/or court. The facility performing the services stipulated herein, should be located within a 2-hour driving distance from the County and state court systems in Miami-Dade County. Ensure the delivery of evidence expeditiously (no longer than 2-3 hours, if requested) to County and state court systems in Miami-Dade County. Be available via telephone and in person for extensive case consultations during normal laboratory hours and nights, weekends, and holidays. Contractor shall respond to the County within two hours of a telephone call or within three hours if responding in person. Provide laboratory services in support of the Drug Recognition Expert (DRE) program that includes general procedures and protocols established by National Highway Traffic Safety Administration and operated by the various police agencies in the CountyProvide other services related to the establishment of a forensic toxicology program, as may be requested by the County.B.Sample HandlingThe Contractor shall handle, test, and maintain samples in accordance with the following procedures: The Contractor will receive samples from the MDPD Property and Evidence Bureau twice each week or directly from law enforcement officers on an “as needed basis.” The Contractor must receive samples during routine and non-routine laboratory business hours. Samples will be labeled with case number bar codes by MDPD Property and Evidence Bureau and be accompanied by a properly completed external chain-of-custody. Provide Sample Accessioning: Samples received by the Contractor shall be assigned a unique identifying laboratory number within the laboratory's record keeping system. The Contractor’s number shall cross reference with the following information: MDPD Case number, arresting agency's Case number, Name of Arrested, and Court Case number, if available. The cross-referencing shall enable any of the identifying information to be used to find the case record. In addition, the Contractor laboratory's record shall contain the police agency and name of arresting officer and the date of arrest. The bar coded MDPD case number may be used as the unique laboratory number. The Contractor shall digitize all paperwork received in a case and maintain such in an electronic file to expedite transfer of information to the Miami-Dade SAO, Miami-Dade and submitting law enforcement officers.Chain-of-Custody: The Contractor shall maintain records of each person who has custody of a sample: including the date and time that the sample came into the individual's possession, the reason for his/her possession of the sample (storage, analysis, transport, etc.), and the date and time of transfer of the sample to secure storage or to another authorized individual. The chain-of-custody from receipt to final disposition shall be unbroken for all samples handled as a result of this Solicitation. The documentary record of the Chain-of-Custody shall be available for presentation in court or in deposition when requested by an Officer of the Court. Sample Storage: Original evidence containers and samples not being aliquoted for testing shall be maintained in secure refrigerated storage (less than 8 degrees Celsius). Samples shall be stored within their original containers and packaging material, if possible. Storage refrigerator(s) shall be organized such that samples can be located when necessary. The Contractor shall be responsible for storing for a minimum of four years all samples under appropriate refrigeration. The Contractor shall take custody of all current samples and store them appropriately. Security: The areas of the laboratory where samples are stored handled and analyzed and where records are stored shall be secure from unauthorized access. The security must be sufficient to ensure that no unauthorized person has the opportunity to tamper with the samples or records.Proper Disposal of Evidence/Samples:When analyses have been completed for each case and a final report has been issued (Report of Toxicology Results), the evidence shall be stored by the laboratory for long-term storage and for transport to Court when needed. The Contractor shall have digital imaging capabilities sufficient for forensic purposes to image the evidence in lieu of transporting biohazards to court. Samples shall be stored until the case is cleared by the Court and a “Disposal Notice” from the Miami-Dade SAO has been received by the laboratory. The Chain-of-Custody shall be maintained, including documentation of the evidence disposal. The Contractor shall subscribe to and participate in proficiency testing programs such as College of American Pathologist, California Association of Toxicology, and FDLE surveys and shall maintain satisfactory performance. Analysis The Contractor shall perform the following analyses: Blood Alcohol Analysis:Blood alcohol shall be measured by either a gas chromatographic (GC) or enzymatic (ADH=alcohol dehydrogenase) method as required by the Florida Department of Law Enforcement (FDLE) Rules (110-8 FAC). Headspace-dual column capillary GC is the preferred method because it enables the laboratory to test for volatile substances (inhalants) in addition to ethanol. Ethanol analysis shall be done in compliance with the FDLE regulations. Urine Drug Analysis: The Contractor shall screen for all of the common drugs in the categories below. In addition, the Contractor shall perform surveillance of the on-going drug use scene in and around Miami-Dade County and develop procedures for drugs that may appear.Those categories include, but are not limited to: Central Nervous System Depressants: Antihistamines, barbiturate class, benzodiazepine class, methaqualone, phenothiazines, carisoprodol/meprobamate, gamma-hydroxybutyric acid (GHB), zolpidem, zopiclone and zaleplon and related intoxicants Central Nervous System Stimulants: Cocaine, “amphetamines”, methamphetamine, methylphenidate, phentermine, metcathinone, tryptamines and related intoxicants Hallucinogens:LSD, Mescaline, Psilocybin, 3,4-Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA) Ecstasy, 3,4-Methylenedioxyethamphetamine (MDEA) Eve, 2,5dimethoxy-4-methylamphetamine (DOM), 2,4-dimethoxy-4bromophenethylamine (2-CB, "Nexus"), benzylpiperazines and related intoxicants. Dissociative Anesthetics: Phencyclidine (PCP), Ketamine, Dextromethorphan and PCP analogs and related intoxicantsNarcotic Analgesics: Opiates and Semi-synthetic Opiates: heroin, 6-acetylmorphine, morphine, codeine, hydromorphone, hydrocodone, oxymorphone and in addition, methadone, meperidine, propoxyphene, “fentanyls”, buprenorphine, tramadol, and related intoxicants. Metabolites, where appropriate, shall be included in analysis.Inhalants: Toluene, 1,1,1-trichloroethane, butane, freon, difluoroethane, chloroethane, nitrites and related intoxicantsCannabinoids?9- Tetrahydrocannabinol (THC), 11-CarboxyTHC It is well recognized that many chemicals capable of causing driver impairment may not fit into any one of the above categories. Therefore, the Contractor shall develop as comprehensive a toxicological testing program as possible in order to answer the question “Did alcohol, drugs or other intoxicant cause or contribute to the altered behavior or performance in the suspect?” The forensic toxicologists from the Contractor shall be technical experts on the most appropriate approach to driving-under-the-influence-of-drugs (DUID) testing and should exercise discretion to order further testing based on the preliminary results, positive or negative, or other relevant indicators such as those found in DRE reports. Many impairing chemicals may often be excreted in trace quantities or only as metabolites. The assay development must take into consideration the most appropriate target compounds.All drugs detected in screening procedures shall be confirmed by a second analysis using a method based upon a different chemical or physical property from the screening method and yielding unequivocal identification of the drug. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred methods for confirmation. A method used for screening shall provide sufficient sensitivity to detect the target analytes in the urine of individuals who are impaired by the drugs at the time of sample collection. Confirmatory procedures shall have greater sensitivity than those used for screening. If an active drug is excreted in urine during the acute phase of impairment, it should be the target of the confirmatory test. However, for drugs such as marijuana (THC) the confirmation should identify the appropriate metabolite(s). Blood Drug Analysis: Blood samples yielding alcohol readings below 0.15 g/dL or at the request of the Assistant State Attorney or submitting law enforcement officer shall be evaluated for drugs. The Contractor shall report such cases to the Miami-Dade SAO for review by the Assistant State Attorney. The Miami-Dade SAO shall be notified via telephone, FAX, or email of the toxicology results. Blood samples shall be screened for the drugs and drug classes as described in the Urine Drug Section (C.2.) and screening methods shall include immunoassay when applicable and chromatographic techniques. The procedures shall be sufficiently sensitive to detect parent drug and/or appropriate metabolite(s) within a blood sample collected during the course of investigation. Positive findings shall be confirmed by a second test yielding unequivocal identification. The parent drug and significant metabolites shall be quantified in blood or urine to provide information needed for interpretation on an as needed basis. Assay Sensitivity: Urine Screening shall offer maximum sensitivity consistent with the ability to confirm presumptive positives. The goal is to minimize false negative rate while limiting false positive screening results. Screening cut-offs must be consistent with current practices in the field of human performance forensic toxicology drug testing. The scope of screening should be continued as far as reasonable with respect to sample volume and court time constraints in an attempt to answer questions raised by the investigation.Whole Blood alcohol: Limits of detection and reporting are 0.01g/dLBlood drug screens: The Contractor shall be capable of detecting as wide a range of drugs as possible at concentrations known to be capable of causing impairment of driving skills. Screening cut-offs must be consistent with current practices in the field of Human Performance Forensic Toxicology drug testing. The scope of screening should be continued as far as reasonable with respect to sample volume and court time constraints in an attempt to answer questions raised by the investigation.Reporting The Contractor shall perform the following reporting: Provide the Miami-Dade SAO with a Report of Toxicology Results, at no cost; with one copy provided to the arresting or submitting officer, the DRE, if applicable, within twenty working (20) days after receipt of the evidence by the laboratory. The Report of Toxicology Results shall also be provided, at no cost, to the Miami-Dade PDO upon request. In addition, the Contractor, if requested to produce a “Litigation Package”, shall produce said package, charge the cost to the requester, and transmit any amount collected for the packages to the Board of County Commissioners via MDPD. Provide to the MDPD quarterly reports of the number of samples of blood and urine received, the number of blood samples analyzed for alcohol, for drugs, and for both and the number of urine samples analyzed for drugs, and the number of tests completed per case. The reports shall state the number of samples of each category not completed within 20 days. In addition, the report shall provide statistics on the number of positive screens for each drug and the percentage of those that confirmed positive, as well as the number of samples confirmed positive for two, three or more drugs and the identity of the drugs found in combination. Provide to the MDPD quarterly reports of the following activities to include the number of each:Depositions attended.Training activities and field exercises performed as part of their required service.Trials and hearings attended.Telephone consultations.Meetings attended with police agencies, Miami-Dade SAO, private defense attorneys, and Miami-Dade PDO.Expert TestimonyThe Contractor shall provide expert testimony.The Contractor’s laboratory personnel shall testify as expert witnesses in depositions, hearings, and criminal trials arising from cases processed as part of the services. Testimony may be required from analysts, supervisor(s), and/or the laboratory director regarding analytical procedures, data, and Chain-of-Custody and interpretation of toxicological results in light of the case. Expert testimony may be required of the Contractor regarding the pharmacological properties of drugs and alcohol. Such testimony may be solicited by the Contractor from experts outside of the Contractor's laboratory. Expert testimony provided by the Contractor shall not exceed the Rates of Compensation for Experts as established by the State Attorney and Public Defender, Eleventh Judicial Circuit of Florida (see Attachments 1 and 2). The expert witness must be qualified as an expert in forensic toxicology in the Courts of Florida. The Contractor shall provide expert testimony services with three (3) business days advance notice. However, the Contractor shall be prepared to provide expert testimony services on short notice based on the unforeseeable nature of the court system. The Contractor's expert witness services will only be required for criminal prosecution. Support and Continuing Education for State Attorney’s Office and Police Officer Training The Contractor shall provide assistance to the County in the initial training of new Assistant State Attorneys and Assistant Public Defenders, police officers, DRE officers in training and in the role and scope of the DUI laboratory and the effects of intoxicants on human performance and behavior. In addition, the laboratory staff shall provide on-going educational events to the Miami-Dade SAO, Miami-Dade PDO, law enforcement officers and others on an as needed basis, which often occurs during field exercises conducted at night and weekends. The Contractor shall perform additional toxicological testing of samples collected during such training to further the goals of the contract.APPENDIX BPAYMENT SCHEDULERates:The Contractor’s Annual Fixed Price for providing the services is stated in Appendix A, Scope of Services:Contract Term:Total Price Per TermJune 1, 2017 – May 31, 2022$Option to Renew Term:June 1, 2022 – May 31, 2027$APPENDIX CHIPAA BUSINESS ASSOCIATE ADDENDUMThis HIPAA Business Associate Addendum (“Addendum”) supplements and is made a part of the Agreement by and between the Miami-Dade County, Florida (“County”), and ___________. Business Associate ("Associate").RECITALSA.As part of the Agreement, it is necessary for the County to disclose certain information (“Information”) to Associate pursuant to the terms of the Agreement, some of which may constitute Protected Health Information ("PHI").B. County and Associate intend to protect the privacy and provide for the security of PHI, including but not limited to, PHI, disclosed to Associate pursuant to the Agreement in compliance with the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 ("HIPAA”) and regulations promulgated thereunder by the U.S. Department of Health and Human Services (the "HIPAA Regulations") and other applicable laws.C.The purpose of this Addendum is to satisfy certain standards and requirements of HIPAA and the HIPAA Regulations, including, but not limited to, Title 45, Sections 164.308(b), 164.314(a), 164.502(e) and 164.504(e) of the Code of Federal Regulations ("CFR'"), as the same may be amended from time to time.In consideration of the mutual promises below and the exchange of information pursuant to the Agreement, the parties agree as follows: Definitions. Terms used, but not otherwise defined, shall have the same meaning as those terms in 45 CFR Sections 160.103, 164.304 and 164.501.a."Business Associate" shall have the meaning given to such term under the HIPAA Regulations, including, but not limited to, 45 CFR Section 160.103.b.“Covered Entity” shall have the meaning given to such term under HIPAA and the HIPAA Regulations, including, but not limited to, 45 CFR Section 160.103."Protected Health Information" or "PHI" means any information, whether oral or recorded in any form or medium: (i) that relates to the past, present or future physical or mental 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; and (ii) that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual, and shall have the meaning given to such term under HIPAA and the HIPAA Regulations, including, but not limited to 45 CFR Section 1103. [45 CFR Parts 160, 162 and 164] “Electronic Protected Health Information” or “ePHI” means any information that is transmitted or maintained in electronic media: (i) that relates to the past, present or future physical or mental 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. and (ii) that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual, and shall have the meaning given to such term under HIPAA and the HIPAA Regulations, including, but not limited to 45 CFR Section 160.103. [45 CFR Parts 160, 162 and 164] “Electronic Media” shall have the meaning given to such term under HIPAA and the HIPAA Regulations, including but not limited to, 45 CFR Section 160.103. “Security incident” shall have the meaning given to such term under HIPAA and the HIPAA Regulations, including but not limited to, 45 CFR Section 164.304. 2.Obligations of Associate.a.Permitted Uses and Disclosures. Associate may use and/or disclose PHI received by Associate pursuant to the Agreement ("County’s PHI") solely in accordance with the specifications set forth in the Scope of Services, Appendix A. In the event of any conflict between this Addendum and Appendix A, this Addendum shall control. [45 CFR § 164.504(e)(2)(i)]b.Nondisclosure. Associate shall not use or further disclose County's PHI other than as permitted or required by law. [45 CFR § 164.504(e)(2)(ii)(A)]c.Safeguards. Associate shall use appropriate safeguards to prevent use or disclosure of County's PHI in a manner other than as provided in this Addendum. [45 CFR § 164.504(e)(2)(ii)(B)] Associate shall maintain a comprehensive written information security program that includes administrative, technical and physical safeguards appropriate to the size and complexity of the Associate's operations and the nature and scope of its activities. Appropriate safeguards used by Associate shall protect the confidentiality, integrity, and availability of the PHI and ePHI that is created, received, maintained, or transmitted on behalf of the County. [45 CFR § 164.314(a)(2)(i)(A)] County has at its sole discretion, the option to audit and inspect, the Associate’s safeguards at any time during the life of the Agreement, upon reasonable notice being given to Associate for production of documents and coordination of inspection(s). d.Reporting of Disclosures. Associate shall report to the County’s Project Manager, any use or disclosure of the County’s PHI in a manner other than as provided in this Addendum. [45 CFR § 164.504(e)(2)(ii)(c)] Associate shall report to the County through the County’s Project Manager, any security incident of which it becomes aware within forty-eight (48) hours of discovery of the incident. [45 CFR § 164.314(a)(2)(i)(C)] e.Associate's Agents. Associate agrees and shall ensure that any agents, including subcontractors, to whom it provides PHI received from (or created or received by Associate on behalf of) the County, agrees in writing to the same restrictions and conditions that apply to Associate with respect to such PHI and that such agents conduct their operations within the United States. Associate agrees and shall ensure that any agents, including subcontractors, to whom it provides ePHI received, created, maintained, or transmitted on behalf of the County, agrees in writing to implement reasonable and appropriate safeguards to protect the confidentiality, integrity, and availability of that ePHI. [45 CFR § 164.314(a)(2)(i)(B)] In no case may Associate’s Agents reside and operate outside of the United States. f.Documentation of Disclosures. Associate agrees to document disclosures of the County’s PHI and information related to such disclosures as would be required for the County to respond to a request by an individual for an accounting of disclosures of PHI. Associate agrees to provide the County or an individual, in a time and manner designated by the County, information collected in accordance with the Agreement, to permit the County to respond to such a request for an accounting. [45 CFR § 164.528]g.Availability of Information to County. Associate shall make available to the County such information as the County may require to fulfill the County’s obligations to provide access to, provide a copy of, and account for, disclosures of PHI pursuant to HIPAA and the HIPAA Regulations, including, but not limited to, 45 CFR Sections 164.524 and 164.528. [45 CFR § 164.504(e)(2)(ii)(E) and (G)]h.Amendment of PHI. Associate shall make the County’s PHI available to the County as may be required to fulfill the County’s obligations to amend PHI pursuant to HIPAA and the HIPAA Regulations, including, but not limited to, 45 CFR Section 164.526 and Associate shall, as directed by the County, incorporate any amendments to the County's PHI into copies of such PHI maintained by Associate, and in the time and manner designated by the County. [45 CFR § 164.504(e)(2)(ii)(F)]i.Internal Practices. Associate shall make its internal practices, books and records relating to the use and disclosure of the County’s PHI (or PHI created or received by Associate on behalf of the County) available to the County and to the Secretary of the U.S. Department of Health and Human Services in a time and manner designated by the County or the Secretary for purposes of determining Associate's compliance with HIPAA and the HIPAA Regulations. [45 CFR § 164.504(e)(2)(ii)(H) and 45 CFR Part 64, Subpart C.]j.Mitigation. Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Associate of a use or disclosure of the County’s PHI by Associate in violation of the requirements of this Addendum.k.Associate's Insurance. Associate agrees to maintain the insurance coverage provided in the Agreement. l.Notification of Breach. Associate shall notify the County within twenty-four (24) hours, and shall provide written notice no later than forty-eight (48) hours of any suspected or actual breach of security, intrusion or unauthorized disclosure of PHI and/or any actual or suspected disclosure of data in violation of any applicable federal or state laws or regulations. Associate shall take (i) prompt corrective action to cure any such deficiencies, and (ii) any action pertaining to such unauthorized disclosure required by applicable federal and state laws and regulations.m.Expenses. Any and all expenses incurred by Associate in compliance with the terms of this Addendum or in compliance with the HIPAA Regulations shall be borne by Associate. n. No Third Party Beneficiary. The provisions and covenants set forth in this Agreement are expressly entered into only by and between Associate and the County and are intended only for their benefit. Neither Associate nor the County intends to create or establish any third party beneficiary status or right (or the equivalent thereof) in any other third party nor shall any other third party have any right to enforce or enjoy any benefit created or established by the provisions and covenants in this Agreement.3. Audits, Inspection and Enforcement. From time to time, after reasonable notice, upon any breach of thisAddendum by Associate, the County may inspect the facilities, systems, books and records of Associate to monitor compliance with this Addendum. Associate shall promptly remedy any violation of this Addendum and shall certify the same to the County in writing. The fact that the County inspects, or fails to utilize its right to inspect, Associate’s facilities, systems, books, records, and procedures does not relieve Associate of its responsibility to comply with this Addendum, nor does the County's (i) failure to detect or (ii) detection, but failure to notify Associate or require Associate to remedy such breach, constitute acceptance of such practice or a waiver of the County's enforcement rights under this Addendum.4. Termination.a.Material Breach. A breach by Associate of any provision of this Addendum, shall constitute a material breach of the Agreement and shall provide grounds for immediate termination of the Agreement by the County. [45 CFR § 164.504(e)(3) and 45 CFR § 164.314(a)(2)(i)(D)]b.Termination for Cause - Reasonable Steps to Cure Breach. If the County recognizes a pattern of activity or practice of Associate that constitutes a material breach or violation of the Associate's obligations under the provisions of this Addendum and does not terminate the Agreement pursuant to Section 4a, above, the County may provide an opportunity for Associate to end the violation or cure the breach within five (5) days, or other cure period as may be specified in the Agreement. If Associate does not cure the breach or end the violation within the time period provided, the County may immediately terminate the Agreement. c.Judicial or Administrative Proceedings. The County may terminate the Agreement, effective immediately, if (i) Associate is named as a defendant in a criminal or administrative proceeding for a violation of HIPAA, or (ii) a finding or stipulation that Associate has violated any standard or requirement of the HIPAA Regulations (or other security or privacy law) is made in any administrative or civil proceeding.d.Effect of Termination. Upon termination of the Agreement for any reason, Associate shall return or destroy as directed by the County all PHI, including but not limited to ePHI, received from the County (or created or received by Associate on behalf of the County) that Associate still maintains in any form. This provision shall also apply to County PHI that is in the possession of subcontractors or agents of Associate. Associate shall retain no copies of such PHI or, if return or destruction is not feasible, Associate shall provide to the County notification of the conditions that make return or destruction infeasible, and shall continue to extend the protections of this Addendum to such information, and limit further use or disclosure of such PHI to those purposes that make the return or destruction of such PHI infeasible. [45 CFR § 164.504(e)(2)(ii)(I)]5.Indemnification. Associate shall indemnify and hold harmless the County and its officers, employees, trustees, agents, and instrumentalities (the indemnified parties) from any and all liability, losses or damages, including attorneys’ fees and costs of defense, which the County or its officers, trustees, employees, agents or instrumentalities may incur as a result of claims, demands, suits, causes of actions or proceedings of any kind or nature arising out of, relating to, or resulting from the performance of this Addendum by Associate or its employees, agents, servants, partners, principals, or subcontractors. Associate shall pay all claims and losses in connection therewith and shall investigate and defend all claims, suits, or actions of any kind or nature in the name of any of the indemnified parties, where applicable, including appellate proceedings, and shall pay all costs, judgments, and attorney’s fees which may issue thereon. Associate expressly understands and agrees that any insurance protection required by this Addendum, or otherwise provided by Associate, shall in no way limit the responsibility to indemnify, keep and save harmless and defend the indemnified parties as herein provided. This paragraph shall survive the termination of the Agreement.6.Limitation of Liability. Nothing in this Addendum shall be construed to affect or limit the County’s sovereign immunity as set forth in Florida Statutes, Section 768.28.7.Amendment. Amendment to Comply with Law. The parties acknowledge that state and federal laws relating to the security and privacy of PHI, including electronic data, are rapidly evolving and that amendment of this Addendum may be required to provide for procedures to ensure compliance with such developments. The parties specifically agree to take such action as is necessary to implement the standards and requirements of HIPAA, the HIPAA Regulations and other applicable laws relating to the security or confidentiality of PHI. The parties understand and agree that the County must receive satisfactory written assurance from Associate that Associate will adequately safeguard all PHI that it receives or creates pursuant to this Agreement. Upon the County's request, Associate agrees to promptly enter into an amendment to the Agreement embodying written assurances consistent with the standards and requirements of HIPAA, the HIPAA Regulations or other applicable laws. The County, in addition to any other remedies including specific performance, may terminate the Agreement upon five [5] days’ written notice in the event Associate does not enter into said amendment to the Agreement providing assurances regarding the safeguarding of PHI that the County, in its sole discretion, deems sufficient to satisfy the standards and requirements of HIPAA and the HIPAA Regulations. Notwithstanding Associate’s failure to enter into an amendment, Associate shall comply with all provisions of the HIPAA laws.Amendment of Appendix C.? In addition to amendments described in 7a above, Appendix C may otherwise be modified or amended by written mutual agreement of the parties without amendment of the remainder of this Agreement.”8.Assistance in Litigation or Administrative Proceedings. Associate shall make itself, and any subcontractors, employees or agents assisting Associate in the performance of its obligations under this Agreement, available to the County at the County’s convenience upon reasonable notice, at no cost to the County, to testify as witnesses, for document production, or otherwise, in the event of litigation or administrative proceedings being commenced against the County, its trustees, officers, agents or employees based upon claimed violation of HIPAA, the HIPAA Regulations or other laws relating to security and privacy, except where Associate or its subcontractor, employee or agent is a named adverse party.9. Effect on Agreement. Except as specifically required to implement the purposes of this Addendum, or to the extent inconsistent with this Addendum, all other terms of the Agreement shall remain in force and effect. In the event of any conflict between this Addendum and Agreement, this Addendum shall control. 10.Interpretation. This Addendum and the Agreement shall be interpreted as broadly as necessary to implement and comply with HIPAA, the HIPAA Regulations and applicable Florida laws. The parties agree that any ambiguity in this Addendum shall be resolved in favor of a meaning that complies and is consistent with HIPAA and the HIPAA Regulations.11.Jurisdiction. Any litigation between the parties regarding the terms of this Addendum shall take place in Miami-Dade County, Florida. ................
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