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Agenda 01/15/2008 Item #16F 1 EXECUTIVE SUMMARY Recommendation to approve an Agreement between The Board of County Commissioners of Collier County and Zoll Medical Corporation for the purpose of conducting a retrospective analysis of cardiac arrcst data originally collected for quality assurance purposes by Collier County Emergency Mcdical Scrvices (EMS) for the pcriod October 1, 2003 through September 30, 2007. OBJECTIVE: That the Board of County Commissioners approves an Agreement with Zoll Medical Corporation to analyze cardiac arrest data which may ultimately be published or otherwise used by Zoll at the discretion.ofthe Collicr County Medical Director. ~ CONSIDERA nONS: Collier County EMS routinely collects cardiac an'est data for quality assurance purposes. Due to the County's very favorable outcomes, Zoll Medical Corporation has requested permission to study this data, subject to the Health Insurance Portability and Accountability Act of 1996 (HIPPA), along with limitations imposed by Collier County. The main objective of the study is to determine the effectiveness of the Collier County EMS cardiac arrest treatment protocol, which features pit-crew deployment of the AutoPulse (a machine which replaces manual compressions for CPR and is manufactured by 1,011), in achieving short- term patient survival. Patient age, gender. location of arrest, initial rhythm, witnessed aJTest. bystander CPR, EMS response time and AutoPulse deployment time will also be factored into the analyses. The Agreement provides Zoll access to the data. The County Medical Director has sole discretion to determine whether the data, as compiled and analyzed, may be published or otherwise used by 1,011. In addition, the County and Zol1 mutually agree that the resultant data may not be published without prior approval of an independent review board (lRB). Such IRB would be mutually selected by Zoll and the County. Should the County agree through the Medical Director that the data may be published; the County grants to Zoll the non-exclusive rights to the data, including the right to use the data worldwide for an unlimited number of times in perpetuity in any and all media. This means that the County may also use the data, if it desires. The County maintains right of action should use ofthis data is claimed to be defamatory or untrue. FISCAL IMPACT: There is no Fiscal Impact. Any cost associated with the study will be funded by Zoll Medical Corporation. GROWTH IMPACT: There is no Growth Management Impact resulting li'om this action. RECOMMENDATION: That the Board of County Commissioners approves the Agreement between Collier County and Zoll Medical Corporation to conduct a retrospective analysis of Collier County EMS cardiac arrest data for the period October I, 2003 through September 30. _ 2007; and authorize the Chairman tn execute said Agreement. Prepared bv: AJiie Bay, Operations Analyst Emergency Medical Services Depmiment Page 1 of I 1 2 ~1 .4 COLLIER COUNTY 3()p.r:-~D OF ':OUNTY COMMiSSIONERS Item Number: hiF1 Item Summary: ReC0l11tr".::n::JaT:8r: to 3~)iJl-O\!e an';greement belween T~e Board of County Commissioners of Collie, County and Zol! [\.,':ed:::31 Corporation for the purpose of conducting a retrospective ar~aly.:;i5 of C3i"j13C arrest dats o:-igina!ly coliected 'or quaiity a~,surance PuqJo:;es by Collier Counly ErT'f'rge!KY L~edic31 Services i:::rlfiS) for tne period October 1 ~002, through Se~)tembef ?,cJ 2007 Meeting Date: 1/: 5/2003900:;0 AM Prepared By Artie Bay Senior Administratrve Assistant Date Bureau of Emerg:m:::y Se:-v!:::f's ::MS 12/2.B':0::'7 5:03:11 PM Approved By Jeff Page ::[1,,1S Chi:::t Date Bureau of t:mcrsency ::::MS 12.'31/20G7 9:08 .L.fJi Services Approved By )cnnif0r t. 58,1:>: :;ii::c C:,S::-.i~:~,i;\t C:JLmty !,tU:'~"it')' :)?' r~ CC='.i:'^lc;! ,t.~(orn'?y' C(:<dr,t; ,""~;:jr:l'2Y GT;;~S ~ ,'2,';>:<CS~' 5.:2 A fill Approved By '-"3:1 :::. ::;L;;r;,,1SfS 5'_:~~<:<; 8r ::'n'Y,:Yc:\~)' ~:;;"''''I~,''S :::; .' ':t~': C;:;Uiltv :/,i'rii"OCr": 0:'"1::2 3:.Y,:;:'~; oj ~T'(,r ccc,'::::v ::,0:-\'1~-<; I,~' ::'_'Ck: t, _" ~y, Approved By :::,~:J:;;' C~,~j:C::~"'" ~',r::p:j~ati:-;';: '"'v <t" ,,::?'~ilJS- S" V;,~""~ '-'0,;';2::')," Lff Approved BJ' hJ,icn~',2: Smy'.;avFjki !l,ancg',;;i"nent r. C;u'jgst [.ir(;ctor :...:,,;],1:';> :;::\ur;L\' !~:;n8;::~r":'. C)ffic!_~ '':)f'i2e;:;'' iJ:.s;F;,;;t'n-J::n~ r.: ::>_::: 'n ~I""'?,)~::' 225 ,LLf; Approved B}' ,:0'llSS V. I',~,!d::i ,l~;n:' ',I." ,,,,,, _,:0' :'>:j2:J:;i:,(...I;;ty :::::rTlm'ssic);'<yS ~0uns jJ,;:: ,3:'1-:,: ::::3 L.i.1 -fil,....,//{',\ A (lpnrb'rpd\ r:','nnr1.\QSL l';Inl1';11.,!o/~,n 1'::; o/",()')()()Q\ 1 h nl.,()rrYf\.Il;;;:pl\.lTO/~,n;\ r.1:::"l\.ln ^ \ , I!O/')()()Q --- ,.-j AGREEMENT THIS AGREEMENT (hereinafter referred to as the "Agreement") is made and entered into on this 15 day of January, 2007, by and between ZOLL MEDICAL CORPORATION (hereafter, "lOLL"), a Massachusetts corporation, doing business at 269 Mill Road, Chelmsford, Massachusetts, 01824-4]05 and THE BOARD OF COUNTY COMMISSIONERS OF COLLIER COUNTY, FLORIDA, a political subdivision of the State of Florida (hereafter, "COUNTY"), located at 330] Tamiami Trail East, Naples, Florida 341 ] 2, as follows: For good and valuable consideration, receipt of which is hereby acknowledged, COUNTY hereby grants to lOLL, and their respective parents, subsidiaries and affiliates, licensees, successors and assigns, the right to acce~S5 patient data and information, subject to the Health Insurance Portability and Accountability Act of ]996 ("HIPAA") and any reasonable limitations imposed by COUNTY, for the purpose of conducting a retrospective analysis of cardiac arrest data that was originally collected for quality assurance purposes by COUNTY from October 1,2003 through September 30, 2007 (the "Data"), All Data may subsequently be published or otherwise used by lOLL in an abstract or manuscript under the terms of this Agreement if agreeable to COUNTY. COUNTY designates Dr. Robert Tober, COU]\;TY's Medical Director, to determine whether the Data as compiled and analyzed may be published or otberwise used by ZOLL. Dr. Tober at his sole discretion may refuse lOLL permission to publish the Data. All physical embodiments containing Data shall hereinafter be known as the "Materials." lOLL and COU:-:TY mutually agree that COUNTY will provide access to the Data and lOll will collect the Data at COUNTY's Bureau of Emergency Services located at 3301 E. TRmiami Trail. Naples, Florida 341 J 2, subject to any reasonable limitations imposed by Cul.NTY. lOLL agrees, at its solc expense, to pursue and receive approval of Materials by an independent private Internal Review Board (the "IRB") mutually selected by lOLL AND COUNTY prior to publication of Materials. The COUNTY and lOLL mutually agree that the Data may not be published without prior IRE approval. Should thc County agree through Dr, Tober that Materials may be published, COUNTY grants to 7.0ll the non-exclusive rights to the Materials including the right to use the data throughout the world, an unlimited number of times, in perpetuity in any and all media, now known or hereafter invented, and in connection with the Program or otherwise and for ~ .1 Df advertising, merchandising, and promotional purposes in connection therewith and all rights. The COUNTY shall have any right of action against ZOLL their respective parents, subsidiaries and affiliates, licensees, successors and assigns or any other party arising out of any use of said Materials, if such use is or claimed to be defamatory or untrue. ZOLL is not obligated to actually use the Materials or publish the Materials. The undersigned acknowledges on behalf of ZOLL rs~rescflts MS ')'al'ra1i't~t the undersigned has all rights and authority to enter into this agreement and to grant the rights granted hereunder. This is the entire agreement. No other authorization is necessary to enable ZOLL and COUNTY to use the Data and/or Materials for the purposes herein specified. IN WITNESS WHEREOF, the parties have caused these presents to be executed the date and year first above written. ATTEST: DWIGHT E. BROCK, CLERK Approval as to form and legal Sufficiency: - Jennifer A. Bclpedio Assistant County Attorney D7-EMG-00099/2 BOARD OF COUNTY COMMISSIONERS OF COLLIER COUNTY, FLORIDA By: JAMES COLETTA, CHAIRMAN ZOLL MEDICAL CORl'ORA TION JtQ~ lly: Gary Freeman VP Clinical Affairs 2