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Item C06County of Monroe <r BOARD OF COUNTY COMMISSIONERS � Mayor David Rice, District 4 IleOI1da Keys ��x t t 0. Mayor Pro Tem Sylvia J. Murphy, District 5 Danny L. Kolhage, District I P f,< George Neugent, District 2 a Heather Carruthers, District 3 County Commission Meeting March 21, 2018 Agenda Item Number: C.6 Agenda Item Summary #3959 BULK ITEM: Yes DEPARTMENT: Emergency Services TIME APPROXIMATE: STAFF CONTACT: Gary Boswell (305) 289 -6004 N/A AGENDA ITEM WORDING: Approval to sign a contract with OneBlood, Inc., for procurement, storage, and distribution of blood components required for air ambulance transportation to meet required Trauma Star medical protocols. ITEM BACKGROUND: OneBlood is located all over Florida, heavily saturated in South Florida, and they currently service all of the Hospitals in Monroe County and South Florida as well as most of the State. They physically pick up and deliver blood at no additional cost. They offer O neg blood and they are also the blood bank that does all the local blood drives for Monroe County. They also offer the lowest cost option. In accordance with Purchasing Policy, three vendors were evaluated for this service with OneBlood offering the lowest overall cost and best service options based on the needs for Monroe County. PREVIOUS RELEVANT BOCC ACTION: None CONTRACT /AGREEMENT CHANGES: N/A STAFF RECOMMENDATION: Approval DOCUMENTATION: Blood Vendors Memo (DRAFT) MCFR - Monroe County Blood and Blood Components Supply and Services Agreement - vl redline FINANCIAL IMPACT: Effective Date: 3/21/18 Expiration Date: 3/20/23 Total Dollar Value of Contract: Approximately $15,000 Total Cost to County: Approximately $15,000 Current Year Portion: $2,200.00 Budgeted: Yes Source of Funds: 101 - 11001- 530520 CPI: Indirect Costs: Estimated Ongoing Costs Not Included in above dollar amounts: Revenue Producing: Grant: County Match: Insurance Required: Additional Details: If yes, amount: Initial setup cost to be incurred in FYI is $2,200.00. This amount can be absorbed into the existing budget. Subsequent years will be budgeted according to usage and not expected to exceed $3,000 per year. 03/21/18 101 -11001 - MEDICAL AIR TRANSPORT Blood Supplies $2,200.00 REVIEWED BY: Gary Boswell Completed 03/02/2018 10:18 AM Pedro Mercado Completed 03/02/2018 3:32 PM James Callahan Completed 03/06/2018 1:35 PM Budget and Finance Completed 03/06/2018 2:26 PM Maria Slavik Completed 03/06/2018 2:32 PM Kathy Peters Completed 03/06/2018 2:51 PM Board of County Commissioners Pending 03/21/2018 9:00 AM t-lounty of Monroe yr. „d CA StYd�� The Florida Keys DATE: FEBRUARY 22, 2018 TO: TAMIKA HINES, FINANCE - PAYROLL ASSIS BOARD OF COUNTY COMMISSIONERS Mayor George Neugent, District 2 Mayor Pro Tern David Rice, District 4 Heather Carruthers, District 3 Danny L. Kolhage, District I Sylvia J. Murphy, District 5 TANT FROM: ANDREA THOMPSON, CAPTAIN, EMERGENCY SERVICES DEPARTMENT SUBJECT: BLOOD VENDORS I reached out to three blood bank services, these are the only ones I was able to locate in Florida. Suncoast Community Blood Center, LifeSouth Blood Center, OneBlood. Suncoast Community Blood Center is located in Sarasota and says they used to provide blood to Bayflight Tampa, because it's a local air ambulance program, they currently do not service our area or offer delivery services to our area. Life South Blood Center is located in Gainesville Florida. The hospitals they serve are all in the Jacksonville, and Gainesville Florida. They also service multiple air ambulance programs. I reached out to them and received a call back, however because they do not service any hospitals in our area or even South Florida area they only offer a FedEx option for the blood, which requires us to receive it via FedEx and then repackage the blood 14 days before the expiration date to avoid absorbing the cost of the blood and wasting it. I have concerns with the waste, cost and additional workload for this option, as well as the additional shipping costs every 28 days. I attached an email outlining the cost of their service including estimated cost of shipping. The estimated shipping cost would be about every 28 days and each way. ($40.00 x 13 times a year $520 a yr) They also will not supply O neg blood which is the blood type we prefer to carry (universal donor) OneBlood is located all over Florida, heavily saturated in South Florida, they currently service all of the Hospitals in Monroe County and South Florida as well as most of the State. They physically pick up and deliver blood at no additional cost. They offer O neg blood and they are also the blood bank that does all the local blood drives for Monroe County. They are also offer the lowest cost option. Thank you, k � { Andrea Thompson Captain of EMS & Trauma Star Monroe County Fire Rescue BLOOD AND BLOOD COMPONENTS SUPPLY AGREEMENT THIS BLOOD AND BLOOD COMPONENTS SUPPLY AGREEMENT (this " Agreement '), made and entered into as of 2 ',2018 and effective as of the Effective Date, as hereinafter defined, by and between ONEBLOOD, INC., a Florida not -for- profit corporation (as hereinafter defined, " OneBlood "), and MONROE COUNTY BOARD OF COUNTY COMMISSIONSERS, d/b /a MONROE COUNTY FIRE RESCUE (as hereinafter defined, "Coup '). WHEREAS, capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in Section 1 hereof; and WHEREAS, OneBlood is engaged in the procurement, storage, and distribution of Components and in providing certain related Services; and WHEREAS, County desires to procure its requirements of Components and certain Services from OneBlood; and WHEREAS, OneBlood desires to provide such Components and certain related Services to County, subject to the terms and conditions hereinafter set forth. NOW, THEREFORE, in consideration of the premises and the mutual covenants herein set forth and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows: 1. Definitions As used in this Agreement, the following capitalized terms shall have the respective meanings as follows: " AABB " shall mean AABB, formerly known as the American Association of Blood Banks, and any successor accrediting agency for blood banks. " Agreement ' shall mean this Blood and Blood Components Supply Agreement, together with all written amendments hereto hereafter executed and delivered by the parties in the manner contemplated hereby. "County" shall mean Monroe County Board of Commissioners d/b /a Monroe County Fire Rescue, located at the following locations (the "Locations "): Trauma Star Hangar Stock Island Fire Station #8 10100 Overseas Highway 5655 McDonald Ave Marathon, FL 33050 Key West, FL 33040 Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline Formatted: Underline W " Applicable Law shall have the meaning set forth in Subsection 11(a) of this Agreement. " Cause " shall mean cause adequate to support a party's termination of this Agreement, which shall consist of the other party's failure, after the applicable notice and cure period, to perform or observe any material covenant or obligation contained in this Agreement. " Components " shall mean transfusable human blood cellular and plasma products, all as more specifically described on Exhibit A attached hereto, and such other components, if any, as hereafter may be made available and mutually agreed to by the parties. " Confidential Information shall have the meaning set forth in Subsection 11(h) of this Agreement. " Effective Date shall mean the date on which this Agreement shall become effective and OneBlood shall commence providing Components to County hereunder, which shall be , --2-W-7 "FDA" shall mean the U.S. Food and Drug Administration, an agency of the U.S. government, together with any successor agency. " Federal Electronic Transactions Regulations shall mean the federal standards for electronic transactions contained in the Federal Electronic Transactions Regulations, 45 C.F.R. Parts 160 and 162, as amended. " Federal Health Care Programs shall mean the federal health care programs as defined in 42 U.S.C. Section 1320a- 7b(f), as amended. " Federal Privacy Regulations shall mean the federal privacy regulations contained in 45 C.F.R. Parts 160 and 164, as amended. " Federal Security Regulations shall mean the federal security standards contained in 45 C.F.R. Parts 160, 162 and 164, as amended. " Force Majeure shall mean labor disturbances, riots, fires, earthquakes, floods, storms, lightning, epidemics, pandemics, war, disorders, hostilities, expiration or confiscation of properties, failure of and delays by carriers, interference by civil or military authorities, whether legal or de facto, and whether purporting to act under some constitution, decree or law, or otherwise, acts of God, and all similar acts and occurrences beyond the reasonable control of a party. " shall mean the Comptroller General of the General Accounting Office of the United States. " shall mean hepatitis B virus. W " shall mean hepatitis C virus. " shall mean the Department of Health and Human Services of the United States " HIPAA " shall mean the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. § 1320d through d- 9, as amended. " HIPAA Requirements shall mean HIPAA and any current and future regulations promulgated thereunder including, without limitation the Federal Privacy Regulations, the Federal Security Regulations, and the Federal Electronic Transactions Regulations. " HITECH " shall mean the Health Information Technology for Economic and Clinical Health Act of 2009, as codified at 42 U.S.C. § 17931, as amended. "HIV" shall mean human immunodeficiency virus. " Individually Identifiable Health Information shall mean individually identifiable health information as defined in 42 U.S.C. Section 1320d(6), as amended. " Joint Commission shall mean the independent not - for -profit organization known as the "Joint Commission" that accredits and certifies more than 15,000 health care organizations and programs in the United States. The Joint Commission was formerly known as the Joint Commission on Accreditation of Healthcare Organizations. " OneBlood " shall mean OneBlood, Inc., a Florida not - for -profit corporation, exempt from federal income taxation pursuant to Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, together with its successors and permitted assigns, if any. " Protected Health Information shall mean protected health information, as defined in 45 C.F.R. Section 160.103, as amended. " Services " shall mean the basic services to be provided by OneBlood to County, as described in Section 2 of this Agreement and any additional services provided by OneBlood that may be more specifically set forth in one or more supplemental writings executed by OneBlood and County, which shall become part of this Agreement and subject to the terms hereof. " Standards " shall mean the relevant and applicable rules, regulations and guidelines governing the procuring, storage and preservation of the Components promulgated from time to time by the FDA Center for Biologics Evaluation and Review, the AABB and/or other regulatory agencies or other organizations. " Term " shall have the meaning set forth in Subsection 7(a) of this Agreement. W 2. Basic Supply and Services (a) Requirements Contract Subject to the limitations set forth in Subsection 2(b) hereof, during the Term County shall obtain its requirements of Components from OneBlood, and OneBlood shall supply County with its requirements of Components. Components will be supplied to County on an as- needed basis as such Components are requested by County and are available for delivery. During the Term County shall be precluded from obtaining Components from other suppliers; provided, however that County shall be permitted to obtain any Component from a source other than OneBlood in any instance when County requests such Component from OneBlood and OneBlood is unable to provide the same in a timely manner (i.e., by the time when County reasonably requires such Component). (b) Provision of Components Due to the unpredictable nature of the demands for Components, OneBlood is not able to guarantee County the availability of all or any portion of the Components to be supplied hereunder. OneBlood does agree, however, that (1) it will use its reasonable best efforts to supply all Components ordered by County in an expeditious fashion, and (2) at no time during the Term will OneBlood so conduct its operations that any other customer regularly receives preferential treatment in the allocation of Components. OneBlood has no reason to believe that, in the absence of special circumstances, it will be unable to provide any and all Components required by County in connection with its normal operations. (c) Components Supplied for Use at County Only The parties acknowledge that as of the date hereof, OneBlood's charges for Components are lower than the corresponding charges of most other blood suppliers in the United States. OneBlood also has obligations to supply Components at approximately the same charges to a number of other health care facilities in OneBlood's service area. OneBlood therefore requires, and County specifically agrees, that Components supplied by OneBlood will not be used at any location other than County Locations in Monroe County, FL. (d) Storage Until Components are used by County, County will provide appropriate temperature - controlled storage of such Components and otherwise comply with the Standards in all respects. County shall provide to OneBlood's Medical Director or his designee, upon request, reasonable access to the storage facilities and records maintained by County so that OneBlood can satisfy itself that all requirements for inspection and accreditation are being satisfied. (e) County Responsibilities County shall be responsible for controlling orders for Components by its physicians and other personnel, and OneBlood shall not be responsible for verifying orders from County physicians or controlling the use of Components by physicians. In addition, where applicable, County will be responsible for the proper labeling of request forms and patient specimens. (f) Returns County may return Components obtained from OneBlood and receive credit for the fees charged by OneBlood, as permitted under OneBlood's return policies in effect from time to time; provided, that all of the requirements listed below are met: (1) The returned unit has not been entered or modified. W (2) The returned unit has documentation that, during County's custody, all rules and requirements of the FDA and the standards of the AABB have been met for the storage and handling of the unit. (3) The returned unit must be acceptable for re- issue, provided that the same unit was delivered to County in an acceptable condition for issue. (4) The expiration date for the returned unit does not exceed the following limits: Red Blood cells — ten (10) days or more from the date of return. Notwithstanding the foregoing, selected special order units of Components, including but not limited to the following, are NOT returnable for credit: (1) Washed or deglycerolized red blood cells; (2) Pooled blood components; (3) Split units; (4) Plasma products; (5) Thawed products; and (6) Reconstituted components. Any Component that is returnable for credit and re -issue is a resource of the regional community serviced by OneBlood, and any such units will be immediately released to OneBlood upon request to enable OneBlood to respond to an imminent transfusion need for that Component by another customer of OneBlood. Returns and fee credits are subject to the conditions and limitations contained herein or in OneBlood's return policies in effect from time to time. OneBlood may change its return policies from time to time by providing County thirty (30) days' prior written notice of any such change. 3. OneBlood's Charges As consideration for its providing Components under this Agreement, OneBlood shall be entitled to compensation as follows: (a) Charges (1) Upon the issuance to County of a Component or Service, County shall become obligated to pay OneBlood's charges with respect to such Component as specified in Subsection 3(b) or 3(c) hereof, as applicable. OneBlood may allow County to return unused Components, but only in strict compliance with OneBlood's return policies in effect from time to time. OneBlood shall have the power to change its return policies from time to time by providing County the same notice that County would be entitled to receive concerning an increase in OneBlood's charges under Subsection 3(b) of this Agreement. (2) OneBlood's charges shall be due from County irrespective of whether County can charge or collect from its patient or others for the Components or Services delivered. To the extent necessary for compliance with billing requirements of Medicare, Medicaid or other third party payors, OneBlood delegates and assigns to County W OneBlood's rights to bill County's patients for Components and Services provided to them by OneBlood under this Agreement; provided, that OneBlood shall retain the right to bill County's patients directly for consultations by OneBlood's physicians concerning matters such as transfusion reaction interpretations, antibody workup recommendations, etc., in circumstances where County is unable to bill for such physician services due to regulations of Medicare, Medicaid or other third party payors. (b) Charges for Components The initial level of OneBlood's charges for Components and certain services shall be as set forth in Exhibit A attached hereto. However, OneBlood's charges for any or all of such Components and such services, however may be adjusted by OneBlood upon thirty (30) days' prior written notice to County of the new charges applicable to such Components or services. (c) Charges for Additional Services. The level of charges for additional items and services (i.e., items or services other than Components or certain services referenced in Subsection 3(b) above) shall be as provided to County by OneBlood in writing from time to time. The parties acknowledge that County is not obligated to procure any additional items or additional services from OneBlood; provided, however, that County will not obtain any such additional item or service from any other provider for its Locations in Marathon, Florida and Key West, Florida except in the event that OneBlood is unable to provide such additional item or service. (d) Billing Policies: Interest on Overdue Amounts. During the Term OneBlood will bill County on the first day of each month for all charges incurred by County during the preceding month. All OneBlood charges are exclusive of any administrative fee charged by County to its patients or otherwise, and OneBlood shall have no input into the manner in which County prices any Component. When providing the monthly bill, OneBlood also shall provide County with the following: (1) a report summarizing County's use of all Components, by classification of each Component, during the preceding month; and (2) a report indicating the number of single units of Components provided to County during the preceding month. (e) Pavments. OneBlood shall submit to County invoices with supporting documentation acceptable to the Clerk. Acceptability to the Clerk is based on generally accented accounting principles and such laws, rules and regulations as may govem the Clerk's disbursal of funds. County shall nay in accordance with the Florida Local Govemment Prompt Payment Act: payment will be made after delivery and inspection by County and upon submission of invoice by One Blood. If OneBlood's invoice is past due more than sixty (60) days, OneBlood reserves the right to terminate this Agreement or suspend Services until payment is received. W (e) Sales Taxes 4 at a n-y tizAo a,,.-; t h e To.-.., sa tA*es s h a ll 7_0..,. applieable to Compettents or SerN4ees provided to County ander this Agreement, County shall be C oLinty, as a political subdivision of the state of Florida is exempt from sales taxes therefore Components or Services provided to County Linder this Agreement shall be exempt from sales taxes 4. Deliverv (a) Routine Delivery of Red Blood Cells and Plasma Components OneBlood will be responsible for one routine delivery per week (Monday, Wednesday or Friday), if required, for red blood cells and plasma Components to County. Such routine delivery for red blood cells and plasma Components shall be without charge to County. (b) Emergency Delivery of Components Emergency deliveries of Components to County (i.e., any delivery other than the routine deliveries contemplated by Subsection 4(a) above) will be accomplished by surface courier or commercial transport, whichever is quickest and safest, in OneBlood's discretion. Charges for such delivery shall be the responsibility of County. If an OneBlood courier is used for any such emergency delivery, then OneBlood's charge therefor shall be as set forth in Exhibit A; however, if a third -party courier is engaged by OneBlood for an emergency delivery, then the charge to County will be whatever OneBlood is required to pay to the third -party courier. (c) Delivery Within County After deliveries have been made to County in the manner contemplated by Subsections 4(a) and 4(b), the delivery of Components within County, to its customers or otherwise will be the sole responsibility of County. 5. Delay Neither party shall be responsible for delays, failures or omissions hereunder due to Force Majeure or due to any other cause beyond such party's control that could not be overcome with the exercise of diligence or commercially reasonable efforts. The time for performance shall be deemed extended for a period equal to the duration of such event. This provision shall not excuse any delay in the payment of money. 6. Records OneBlood shall keep at its office accurate, full and complete books, records and accounts in respect of all Components provided to County hereunder. During the Term, OneBlood, upon reasonable request and at reasonable hours, shall make such books and records available for inspection by County personnel. All books and records maintained hereunder shall be maintained in accordance with the Standards and all other regulatory and accrediting agency requirements to which OneBlood and/or County is subject. 7. Term and Termination (a) Term The term of this Agreement (the " shall commence on the Effective Date and, unless sooner terminated in accordance with Subsection 7(b), shall extend until 11:59 p.m. on the calendar day immediately preceding the fifth anniversary of the Effective Date. Notwithstanding the foregoing, the parties shall review this Agreement from time to time as contemplated by AABB standard 4.2.1, and the parties may by written instrument amend this Agreement pursuant to Subsection 13(c) to incorporate any needed changes on which both OneBlood and County shall agree. W (b) Termination This Agreement may be terminated as follows: (1) Either party hereto may terminate this Agreement with or without Cause upon one hundred eighty (180) days' prior written notice to the other party; provided, that the parties may not terminate this Agreement without Cause until after the first anniversary of the Effective Date. In the event of such termination under this Subsection 7(b)(1), any and all charges outstanding at termination will be due and payable within thirty (30) days following the date of OneBlood's final invoice. (2) Either party hereto may terminate this Agreement for Cause that shall not have been cured within sixty (60) calendar days following the non - terminating party's receipt of written notice thereof specifying the Cause. In the event of such termination under this Subsection 7(b)(2), any and all charges outstanding at termination will be due and payable , A 4t i thiF,, (30 da f ll n the date o f n otzi a=te F4 44A € in accordance with Subsection 3(e) (3) This Agreement may be terminated immediately by either County or OneBlood if any license that OneBlood needs in order to provide Components in the manner contemplated hereby should be suspended or revoked, if either party shall fail to comply with a material requirement of Applicable Law as required by Subsection 11(a), or if OneBlood shall be in breach of Subsection 11(c). In the event of such termination under this Subsection 7(b)(3), any and all charges outstanding at termination will be due and payable within thirty (30) days following the date of OneBlood's final invoice. (c) Survival of Obligations All obligations of the parties for any period prior to termination or expiration of this Agreement that are intended to extend beyond the Term shall survive the termination of this Agreement, and any termination or expiration of this Agreement shall be without prejudice to any claims for damages or other rights against the other party that preceded or resulted from termination or expiration. 8. Disclaimer of Warranties PURSUANT TO SECTION 672.316(5), FLORIDA STATUTES THE PROCUREMENT, PROCESSING, STORAGE, DISTRIBUTION OR USE OF COMPONENTS IS DECLARED TO BE A SERVICE THAT DOES NOT CONSTITUTE A SALE OF A PRODUCT, WHETHER OR NOT ANY CONSIDERATION IS GIVEN THEREFOR, AND THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE SHALL NOT BE APPLICABLE. ONEBLOOD FURTHER DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, AS TO THE CONDITION OF COMPONENTS TO BE PROVIDED UNDER THIS AGREEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, ONEBLOOD SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. 9. Quality Assurance; Lookback (a) Quality Assurance OneBlood shall be responsible for and will maintain a quality assurance program to ensure the quality of the Components provided hereunder and its compliance with the rules and regulations to which it is subject. Without limiting the generality W of the foregoing, OneBlood agrees that all Components provided to County hereunder shall have been tested in accordance with the relevant requirements of the FDA and the AABB provided hereunder shall be in compliance with any accreditation requirements of the Joint Commission. OneBlood will promptly notify County when changes to the program have been made that could affect the safety of Components provided hereunder. (b) Lookback In compliance with the applicable rules of the FDA and/or the accrediting standards of the Joint Commission, OneBlood hereby agrees: (1) to notify County within seventy-two (72) hours after OneBlood determines that a donor of Components tests repeat reactive for conditions requiring donor lookback, but only if such donor made previous donations from which Components were sent to County that still could remain in available inventory; (2) to notify County promptly if OneBlood should discover that certain potentially infectious Components have been made available to County; (3) to notify County within three (3) calendar days after OneBlood determines that it has supplied Components collected from a donor who tested negative at the time of the donation but subsequently tested reactive for HIV, HBV, or HCV on a later donation, or subsequently is determined by OneBlood to be at increased risk for transmitting HIV, HBV or HCV; and (4) to notify County, within forty-five (45) days after the initial test, of the results of any supplemental screening test for HIV, HBV or HCV, or any other follow - up testing required by the FDA, to complete the notification above in Subsection 499(b)(3). The purpose of such notification is to enable County to take proper health and safety steps to minimize further spread of infection. OneBlood shall comply with its obligations under the rules referenced in subsection (b) above in a manner consistent with its reasonable interpretation of such rules. Notification will be made by telephone followed up by written notification to be sent or given in the manner contemplated by Subsection 13(d) of this Agreement. 10. Insurance Throughout the Term OneBlood and County shall each maintain at its own expense adequate levels of insurance. Without limiting the generality of the foregoing, OneBlood and County shall each procure and maintain in effect professional liability insurance with coverage of no less than $1,000,000 per occurrence and $3,000,000 annual aggregate. Each party shall, upon request, provide the other party with a certificate of insurance confirming such coverage and shall advise the other party promptly of the termination of such coverage or any material adverse modification of such coverage. If a party promptly notifies the other party that the notifying party is unable to purchase (other than at a cost that the notifying party reasonably considers prohibitive) the insurance required of the notifying party by this Agreement, then the other party shall have the right to terminate this Agreement upon ten (10) days' notice to the notifying party. If the second party shall have received any such notice and shall not have terminated this Agreement, neither the second party nor any insurer for the second party thereafter shall have any right to make a claim against the notifying party based solely upon its failure to provide the insurance coverage required of it under this Agreement. W 11. Compliance and Representations (a) Compliance with Applicable Law Both parties agree to comply with all applicable federal, state and local laws, statutes, regulations, codes, ordinances, rules and/or executive orders, as amended ( " Applicable LaAV '). In the event a party fails to comply with a material requirement of Applicable Law, the non - breaching party shall immediately notify the breaching party and the non - breaching party may immediately terminate this Agreement in accordance with Subsection 7(b)(3). (b) Regulatory Changes Each party reserves the right to modify this Agreement, upon thirty (30) days' prior written notice to other party in the event that a change to any Applicable Law, government or AABB policy or program, Joint Commission standard or standard of care is proposed or adopted, which affects Components, rates or obligations hereunder; provided, however, the parties acknowledge and agree that any modification of this Agreement, except for an adjustment of charges for Components pursuant to Subsection 3(b), a change to OneBlood's return policies, shall be set forth in a written amendment mutually agreed upon in accordance with Subsection 13(c). (c) Representations as to Federal Health Care Programs OneBlood represents and warrants to County that OneBlood (1) is not currently excluded, debarred, or otherwise ineligible to participate in Federal Health Care Programs; (2) is not a person who has been convicted of a criminal offense related to the provision of health care items or services but has not yet been excluded, debarred, or otherwise declared ineligible to participate in Federal Health Care Programs, and (3) is not, (A) to the best of its knowledge, under investigation, or (B) otherwise aware of any circumstances that, in either such case, reasonably could be expected to result in OneBlood's being excluded from participation in the Federal Health Care Programs. This shall be an ongoing representation and warranty during the Term, and OneBlood immediately shall notify County of any change in the status of this representation and warranty set forth in this Subsection 11(c). If OneBlood shall be in breach of this representation and warranty or if it otherwise should breach any of its obligations in this Subsection 11(c), County shall have the right to terminate this Agreement immediately in accordance with Subsection 7(b)(3). (d) HIPAA and HITECH Requirements Both parties agree to comply with any applicable HIPAA and HITECH Requirements. Without limiting the generality of the foregoing, the parties agree not to use or further disclose any Protected Health Information or Individually Identifiable Health Information in violation of any applicable HIPAA Requirements. To the extent that OneBlood is covered by the HIPAA Requirements, OneBlood will make its internal practices, books, and records relating to the use and disclosure of Protected Health Information available to HHS as required for determining compliance with the Federal Privacy Regulations. (e) Compliance with Applicable Laws and Standards OneBlood will ensure that the Services to be provided will be provided in accordance with: (1) the applicable standards, if any, of the Joint Commission; (2) the applicable standards of the FDA and the AABB; and (3) to the extent material, all other applicable federal, state, county and city laws, ordinances, codes, regulations, and rules governing the Services provided by OneBlood under this Agreement. OneBlood further agrees, to the extent necessary to permit County to receive reimbursement for Services rendered by OneBlood under this Agreement, to make available to the HHS, the GAO or 10 W their authorized representatives, the contract, and books, documents and records relating to the nature and extent of the costs hereunder for a period of four (4) years after the furnishing of Services under the Agreement. In addition, OneBlood hereby agrees that if Services hereunder involving a value or cost of $10,000 or more over a 12 -month period are to be provided to County by a subcontractor that is an affiliate of OneBlood, then OneBlood will cause such affiliated subcontractor, upon request, to make available to HHS, the GAO, or their authorized representatives the contract, books, documents, and records relating to the nature and extent of the costs thereunder for a period of four (4) years after the furnishing of Services thereunder. (f) Statement of Compliance OneBlood's quality system is defined, documented, implemented and maintained in compliance with current good manufacturing requirements and AABB standards. OneBlood is accredited by the AABB in donor center activities and in immunohematology reference laboratory activities, accredited by the Centers for Medicare & Medicaid Services (CMS), licensed by the State of Florida Agency for Health Care Administration (AHCA), and licensed and registered by the FDA. OneBlood's laboratory director approves all methods used by each laboratory; where applicable, FDA- licensed or approved test kits and reagents are used. Performance of testing and interpretation of results are in accordance with manufacturer's instructions. As required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) rules in 42 C.F.R. Part 493, all testing personnel are qualified and deemed competent to perform high complexity testing, and the laboratory participates in a proficiency testing program for each tested analyte. OneBlood has agreements in place for outsourced activities and monitors compliance with these agreements through supplier qualification audits. (g) Statement of Compliance with Bacterial Detection Requirements In compliance with AABB standard 5.1.5.1 for a method to detect bacteria in platelet components, all of OneBlood's platelets, pheresis and whole blood derived pre - pooled platelets are cultured using the Biomerieux BacT /Alert Microbial Detection System, an FDA- approved testing method. ( h) Confidential € -sus € of e gr € €me -nt, IN (h) Pudic Records Compliance. OneBlood must comply with Florida public records laws, inclldinz but not limited to Chapter 119, Florida Statutes and Section 24 of article I of the Constitution of Florida. The County and OneBlood shall allow and hermit reasonable access to, and inspection of, all documents, records, gapers, letters or other "public record" materials in its possession or under its control subject to the provisions of Chapter 119 Florida Statutes and made or received by the County and OneBlood in conjunction with this contract and related to contract 2erforrnance. The County shall have the right to unilaterally cancel this contract upon violation of this provision by the Oneblood. Failure of OneBlood to abide by the terms of this provision shall be deemed a material breach of this contract and the County may enforce the terms of this provision in the form of a court proceeding and shall, as a prevailing party, be entitled to reimbursement of all attorney's fees and costs associated with that proceeding. This provision shall survive any termination or expiration of the contract. OneBlood is encouraged to consult with its advisors about Florida Public Records Law in order to comp with this provision. Pursuant to F S 119 0701 and the terms and conditions of this contract OneBlood is required to: (1) Keep and maintain public records that would be required by the County to perform the service. (2) Upon receipt from the County's custodian of records, provide the County with a co py of the requested records or allow the records to be inspected or copied within a reasonable time at a cost that does not exceed the cost provided in this chapter or as otherwise provided by law. (J) Ensure that public records that are exe=t or confidential and exempt from public records disclosure requirements are not disclosed except as authorized by law for the duration of the contract teen and following completion of the contract if OneBlood does not transfer the records to the County. ( 4) Upon completion of the contract, transfer, at no cost, to the County all public records in possession of OneBlood or keep and maintain public records that would be required by 12 ow— R W the County to perform the service. If OneBlood transfers all public records to the County upon completion of the contract, OneBlood shall destroy any duplicate public records that are exempt or confidential and exempt from public records disclosure requirements. If OneBlood keens and maintains public records upon completion of the contract, OneBlood shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to the County, a on request from the County's custodian of records, in a format that is compatible with the information technology systems of the Count . (5) A request to inspect or coyy public records relating to a County contract must be made directly to the County, but if the County does not possess the requested records, the County shall immediately notify OneBlood of the request, and OneBlood must provide the records to the County or allow the records to be inspected or copied within a reasonable time. IF ONEBLOOD HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO ONEBLOOD'S DUTY TO PROVIDE PUBLIC. RECORDS RELATING TO THIS CONTRACT, CONTACT THE CUSTODI_AN OF PUBLIC RECORDS BRIAN BRADLEY AT (305) 292 -3470 12. No Joint Venture, Emplovment, or A2ency Relationship Nothing contained herein shall be construed to create a joint venture, employer /employee, or principal /agent relationship between County and OneBlood. It is specifically agreed that OneBlood is and at all times shall remain an independent contractor rendering services to County. In performing their duties, OneBlood personnel shall take direction only from OneBlood supervisors and not from the staff or administration of County. 13. Miscellaneous The following provisions shall govern this Agreement: (a) Requests All requests for Components or Services hereunder not specifically required by this Agreement or OneBlood's standard operating procedures to be in writing may be made orally or by telephone. Agreement: (b) Rules of Construction The following rules of construction shall govern this (1) Section and Subsection headings used in this Agreement are for convenience of reference only and in no way define, limit or describe the scope or intent of this Agreement or affect its provisions. (2) Whenever used herein, the singular shall include the plural, the plural the singular, and the use of any gender shall include all genders. (3) The parties shall be deemed to have participated equally in the preparation of this Agreement, and this Agreement shall not be construed more strictly against one party than against the other. 13 W (c) Entire Agreement; Modification of Agreement This Agreement represents the entire understanding and agreement between the parties with respect to the subject matter hereof, and supersedes all of the negotiations, understandings and representations (if any) made by and between such parties and all prior oral and written agreements between the parties (including their predecessor legal entities) with respect to the subject matter hereof. Without limiting the generality of the foregoing, as of the Effective Date this Agreement shall supersede any and all other existing agreements between OneBlood or any of its predecessor legal entities, on the one hand, and County or any of its predecessor legal entities, on the other hand. In the event of any discrepancy between the terms of this Agreement and the terms of any Business Associate Agreement that may be executed between the parties hereto, the terms of this Agreement shall control and supersede the terms of the Business Associate Agreement, except that both agreements shall be interpreted in a manner that enables the parties to comply with HIPAA and HITECH. None of the terms or provisions hereof may be amended, supplemented, waived or changed orally, but only by a writing signed by OneBlood and County and making specific reference to this Agreement; provided, that OneBlood may change its return policies, its charge levels in Exhibit A by providing notice to County as set forth herein; and provided, further, that the amendment of this Agreement to include an additional facility owned or controlled by County (and the resulting amendment of the definition of "County" in Section 1) shall also require the execution of a j oinder in this Agreement by such new facility's administration. (d) Notices Except as otherwise expressly provided in this Agreement, any notice or other communication required or permitted to be given hereunder shall be in writing and effective upon receipt. Such notices shall be personally delivered, sent by registered or certified U.S. mail, postage prepaid with return receipt requested, sent via a nationally recognized delivery service, or sent by facsimile or electronic mail with confirmation. Notices shall be addressed to the parties at the following addresses, but either party may change its notice address by providing written notice to the other in accordance with this Subsection. If to OneBlood: OneBlood, Inc. 8669 Commodity Circle Orlando, Florida 32819 Attn: John E. Murphy, Jr. Chief Financial & Administrative Officer Facsimile: (407) 248 -5095 E -mail: john.murphy@oneblood.org If to County: Attn: Facsimile: E -mail: (e) Invalid Provision The invalidity or unenforceability of any term or provision of this Agreement or the non - applicability of any such term or provision to any person or circumstance shall not impair or affect the remainder of this Agreement, and the remaining 14 W terms and provisions hereof shall not be invalidated, but shall remain in full force and effect and shall be construed as if such invalid, unenforceable or non - applicable provisions were omitted. (f) Applicable Law and Binding Effect This Agreement shall be construed and enforced in accordance with the laws of the State of Florida applicable to agreements to be executed and performed wholly within said state. The parties further agree that in any dispute between them relating to this Agreement, exclusive jurisdiction shall be in the trial courts located within Orange County, Florida, any objections as to jurisdiction or venue in such court being expressly waived. (g) Attorneys' Fees If any litigation or controversy arises out of or in connection with this Agreement between the parties hereto, the prevailing party in such litigation or controversy shall be entitled to recover from the other party or parties all reasonable attorneys' fees, expenses and suit costs, including those associated with any appellate or post judgment collection proceeding. (h) Waiver No failure or delay on the part of either party in exercising any right or remedy under this Agreement shall operate as a waiver. No provision of this Agreement may be waived except specifically and in writing. (i) Assignment Neither party may assign this Agreement without first obtaining the prior written consent of the other party. 0) Survival Any provisions of this Agreement creating obligations extending beyond the term of this Agreement shall survive the expiration or termination of this Agreement, regardless of the reason for such termination. (k) No Use of Name Neither party will use the name of the other party, or of any of its employees, for promotional or advertising purposes without prior written permission from the other party. (1) No Referrals Required; Fair Market Value The parties expressly agree that nothing contained in this Agreement is intended or shall be construed as an inducement to refer or admit any patients to, or order any goods or services from the other party. Neither party will knowingly or intentionally conduct itself in a manner which violates any federal or state anti - kickback statute, the criminal and civil False Claims Act, any federal or state self - referral statute, federal law or regulation, or which could reasonably result in such a violation. All amounts paid under this Agreement are expressly intended to reflect and do reflect fair market value for services rendered. (m) OFCCP Compliance The parties shall abide by the requirements of the U.S. federal regulations set forth in 41 CFR §§ 60- 1.4(a), 60- 300.5(a) and 60- 741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity, or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. 15 (n) Counterparts This Agreement may be executed in any number of counterparts, each of which when so executed and delivered, shall be an original, but such counterparts shall together constitute but one and the same instrument. Signatures to this Agreement transmitted by facsimile transmission, by electronic mail in "portable document format" (.pdt) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, will have the same effect as physical delivery of the paper document bearing the original signature. (o) Adjudication of Disputes or Disagreements. County and OneBlood agree that all disputes and disagreements shall be attempted to be resolved by meet and confer sessions between representatives of each of the parties. If no resolution can be agreed upon within 30 days alter the first meet and confer session, the issue or issues shall be discussed at a public meeting of the Board of County Commissioners. If the issue or issues are still not resolved to the satisfaction of the parties, then any party shall have the right to seek such relief or remedy as may be provided by this Agreement or by Florida law. (p) Cooperation. In the event any administrative or legal proceeding is instituted against either party relating to the formation, execution, performance, or breach of this Agreement, County and OneBlood agree to participate, to the extent required by the other party in all proceedings, hearings, processes, meetings, and other activities related to the substance of this Agreement or provision of the services under this Agreement. County and OneBlood s pecifically agree that no party to this Agreement shall be required to enter into any arbitration proceedings related to this Agreement. (c Nondiscrimination. County and OneBlood agree that there will be no discrimination against any person, and it is expressly understood that upon a determination by a court of competent jurisdiction that discrimination has occurred, this Agreement automatically tenninates without any further action on the part of any party, effective the date of the court order. OneBlood agrees to comi2ly with all Federal and Florida statutes, and all local ordinances, as applicable, relating to nondiscrimination. These include but are not limited to: 1) Title VI of the Civil Rights Act of 1964 (PL 88 -352) which prohibits discrimination on the basis of race, color or national origin; 2) Title IX of the Education Amendment of 1972, as amended (20 USC ss. 1681- 1683 and 1685 -1686) which prohibits discrimination on the basis of sex; 3) Section 504 of the Rehabilitation Act of 1973, as amended (20 USC s.794), which prohibits discrimination on the basis of handicaps; 4) The Age Discrimination Act of 1975, as amended (42 USC ss. 6101 -6107) which prohibits discrimination on the basis of age: 5) The Dnig Abuse Office and Treatment Act of 1972 (PL 92 -255), as amended, relating to nondiscrimination on the basis of drug abuse; 6) The Comprehensive Alcohol Abuse and Alcoholism Prevention Treatment and Rehabilitation Act of 1970 (PL 91 -616), as amended, relating to nondiscrimination on the basis of alcohol abuse or alcoholism; 7) The Public Health Service Act of 1912, ss. 523 and 527 (42 USC ss. 690dd -3 and 290ee -3), as amended, relating to confidentiality of alcohol and dnig abuse patient records: 8) Title VIII of the Civil Rights Act of 1968 (42 USC s. et seq.), as amended, relating to nondiscrimination in the sale rental or fnanciu of housing; 9) The Americans with Disabilities Act of 1990 (42 USC s. 1201 Note), as maybe amended from time to time, relating to nondiscrimination on the basis of disability; 10) Monroe County Code Chapter 14, Article II, which prohibits discrimination on the basis of race, color, sex, religion, national origin, ancestry, sexual orientation, gender identity or expression, familial status or age; and 11) Any other nondiscrimination provisions in 16 ow— R anv Federal or state statutes which may aptly to the parties to, or the subject matter of, this Agreement. (r) Covenant of No Interest. County and OneBlood covenant that neither presently has any interest, and shall not acquire any interest, which would conflict in anv manner or degree with its 2erfonnance Linder this Agreement, and that the only interest of each is to perform and receive benefits as recited in this Agreement. (s) Code of Ethics. County agrees that officers and employees of the County recognize and will be required to comlly with the standards of conduct for public officers and employees as delineated in Section 112.313, Florida Statutes, regarding, but not limited to, solicitation or acceptance of gifts, doing business with one's agency; unauthorized compensation: misuse of public position, conflicting employment or contractual relationship; and disclosure or use of certain information. (t) No Solicitation/Payment. The County and OneBlood warrant that, in respect to itself, it has neither employed nor retained any company or person, other than a bona fide employee working solely for it, to solicit or secure this Agreement and that it has not Maid or agreed to pay any person, company, corporation, individual, or firm, other than a bona fide employee working solely for it, any fee, commission, percentage, gift, or other consideration contingent upon or resulting from the award or making of this Agreement For the breach or violation of the provision, OneBlood agrees that the County shall have the right to terminate this Agreement without liability and, at its discretion, to offset from monies owed, or otherwise recover, the full amount of such fee, commission, percentage, gift, or consideration. ( ii) Non - Waiver of Immunity. Notwithstanding the provisions of Sec. 768.28, Florida Statutes, the participation of the County and the Contractor in this Agreement and the acquisition of any commercial liability insurance coverage, self - insurance coverage, or local government liability insurance pool coverage shall not be deemed a waiver of immunity to the extent of liability coverage, nor shall any contract entered into by the County be required to contain any provision for waiver. (v) Privileges and Immunities. All of the privileges and immunities from liability, exemptions from laws, ordinances, and rules and pensions and relief, disability, workers' compensation, and other benefits which a12121 to the activity of officers, anents, or employees of anv public agents or employees of the County, when performing their respective functions Linder this Agreement within the territorial limits of the County shall a121l to the same degree and extent to the performance of such functions and duties of such officers, agents, volunteers, or employees outside the territorial limits of the County. (w) Non - Delegation of Constitutional or Statutory Duties. This Agreement is not intended to, nor shall it be construed as, relieving any participating entity from any obligation or responsibility imposed upon the entity by law except to the extent of actual and timely performance thereof by any participating entity, in which case the performance may be offered in satisfaction of the obligation or responsibility. Further, this Agreement is not intended to, nor shall 17 ow— R it be construed as, authorizinz the delegation of the constitutional or statutory duties of the County, except to the extent permitted by the Florida constitution, state statute, and case law. (x) Non - Reliance by Non - Parties. No person or entity shall be entitled to rely upon the terms, or any of them, of this Agreement to enforce or attempt to enforce any third -party claim or entitlement to or benefit of anv service or grogram contemplated hereunder, and the County and OneBlood agree that neither the County nor OneBlood or any went, officer, or employee of either shall have the authority to inform, counsel, or otherwise indicate that any particular individual or group of individuals, entity or entities, have entitlements or benefits under this Agreement separate and apart, inferior to, or superior to the community in general or for the ourposes contemplated in this Agreement. No Personal Liabilitv. No covenant or agreement contained herein shall be deemed to be a covenant or agreement of any member, officer, went or employee of Monroe County in his or her individual capacity, and no member, officer, went or employee of Monroe County shall be liable personally on this Agreement or be subject to any personal liability or accountability by reason of the execution of this Agreement. (z) it Indemnification/Hold Harmless. Notwithstanding any minimum insurance requirements prescribed elsewhere in this agreement, OneBlood shall defend, indemnify and hold the County and the County's elected and appointed officers and employees harmless from and against G) any claims, actions or causes of action, (ii) any litigation, administrative proceedings, appellate proceedings, or other proceedings relatin( to any type of injury (including death), loss, damage, fine, penalty or business interruption, and (iii) any costs or expenses that may be asserted against, initiated with respect to, or sustained by, any indemnified party by reason of, or in connection with, (_A) any activity of OneBlood or any of its employees, agents, contractors or other invitees durum the term of this Agreement, (B) the negligence or willed misconduct of OneBlood or any of its emgloyees, agents, sub- contractors or other invitees, or (C) OneBlood's default in respect of any of the obligations that it undertakes under the terms of this Agreement, except to the extent the claims, actions, causes of action, litigation, proceedings, costs or xpenses arise from the intentional or sole ne(,Ainent acts or omissions of the County any of its emoloS ees, agents, contractors or invitees (other than Contractor). Insofar as the claims, actions, causes of action, litigation, proceedings, costs or expenses relate to events or circumstances that occur during the term of this Agreement, this section will survive the expiration of the term of this Agreement or any earlier termination of this Agreement. (Signatures appear on the following page) 18 ow— R IN WITNESS WHEREOF, the parties hereto, acting through their officers or representatives thereunto duly authorized, have executed and delivered this Agreement as of the day and year first above written. "ONEBLOOD" ONEBLOOD, INC., a Florida not - for -profit corporation "COUNTY" Formatted: Strikethrough Formatted: Strikethrough Formatted: Strikethrough RIN M John E. Murphy, Jr. Chief Financial and Administrative Officer Print Name: Title: (SEAL BOARD OF BOUNTY COMMISSIONERS — Formatted: No underline, Font color: Red ATTEST: KEVIN MADOK CLERK OF MONROE COUNTY FLORIDA By By Deputy Clerk Mavor /Chairperson Formatted: No underline, Font color: Red w EXHIBIT LIST FOR BLOOD AND BLOOD COMPONENTS SUPPLY AND SERVICES AGREEMENT Exhibit A Identity and Initial Charges for Components and Certain Services 20 w EXHIBIT A Identity and Initial Charges for Components and Certain Services OneBlood Fee List Effective August 15, 2016 Item # Item Description Fee 20201 Red Blood Cells Leukoreduced $223.00 23400 Plasma (Liquid) 56.00 51004 Non- Crossmatch Set Up 42.00 51201 ABO Group & Rh Type 31.00 51355 Transportation Fees - Priority Shipment Services Area — 06 195.00 ➢ Hialeah Distribution Hub to Trauma Star Hangar in Marathon, FL 51356 Transportation Fees - Priority Shipment Services Area — 07 265.00 ➢ Hialeah Distribution Hub to Stock Island Fire Station #8 in Key West, FL A -1 W BLOOD AND BLOOD COMPONENTS SUPPLY AND SERVICES AGREEMENT Dated as of 2018 By and Between ONEBLOOD, INC. (" OneBlood ") and MONROE COUNTY BOARD OF COMMISSIONERS d/b /a MONROE COUNTY FIRE RESCUE ( "County ") WMACTIVE 7206968.1