= VATE OF FLORIDA By om AGENCY FOR HEALTH CARE ADMINISTRATION Acer ieee CLERK 1 SEP ws ‘fh! P isp Case NO. 20 pales Petitioner, DOAH NO. “' 16 2685°! an Ve RENDITION NO.: AHCA-07- ONS. -S-OLC CENTRAL FLORIDA RESEARCH, INC., vs. STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Respondent. a FINAL ORDER Having reviewed the Notice of Intent to Limit Licensure (NOI) dated May 18, 2007, attached hereto and incorporated herein (Ex. 1) and all other matters of record, the Agency for Health Care Administration (“Agency”) has entered into a Settlement Agreement (Ex. 2) with the parties to these proceedings, and being otherwise well advised in the premises, finds and concludes as follows: ORDERED: 1. The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Agreement. 2. Petitioner’s petition for formal administrative proceedings is hereby dismissed. 3. Each party shall bear its own costs and attorney’s fees. 4. The above-styled case is hereby closed. DONE and ORDERED this 26 day of Sot , 2007, in Tallahassee, Leon County, Florida. Sn A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Doug Lockwood, Esq. Honorable T. Kent Wetherell, IT Peterson & Meyers, P.A. Div. of Administrative Hearings 141 - 5" Street, N.W. The DeSoto Bldg. P.O. Drawer 7608 1230 Apalachee Parkway Winter Haven, Florida 33881 Tallahassee, Florida 32399-3060 (U. S. Mail) (Interoffice Mail) Jan Mills Elizabeth Dudek Agency for Health Care Admin. Deputy Secretary 2727 Mahan Drive, Bldg #3, MS #3 | Agency for Health Care Admin. Tallahassee, Florida 32308 2727 Mahan Drive, Bldg #1, MS #9 (Interoffice Mail) Tallahassee, Florida 32308 Interoffice Mail Thomas J. Walsh II, Esq. Agency for Health Care Admin. 525 Mirror Lake Drive N., #330G St. Petersburg, Florida 33701 (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this the DP aay of “2007. Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 922-5873 @o.SEP. 13. 200 Ts: 2:25PMoreecPETERSONAMYERS ACA GENERAL COUNSEL —NO. 99013 STATE OF FLORIDA _ DIVISION OF ADMINISTRATIVE HEARINGS CENTRAL FLORIDA RESEARCH, INC., Petitioner, DOAH Noe. 07-2685 vs. CASENo. 2007005425 STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Respondent. TRE! FP, 2/)asa7 Respondent, State of Florida, Agency for Health Care Administration (hereinafler the “Agency”), through its undersigned representatives, and Petitioner, Central Florida Research, Inc. (hereinafter “Petitioner”), pursuant to Section 120,57(4), Florida Statutes, each individually, a “party,” collectively as “partics,” hereby enter into this Settlement Agreement (“Agreement”) and agree ag follows: WHEREAS, the Petitioner is a clinical laboratory which filed an application seeking licensure to perform the Borrelia Direct Burgdorferi Fluorescent Antigen with Enumeration and Quantification by Flow Cytometry test (“Borrelia Antigen test”); and 99 SEP.13: 2007, 2: 25?ManggePETERSONMYERS aca cenera. couse. _—«N0. 9903. gf. 3/Tavar WHEREAS, the Agency bas jurisdiction by virtue of being the regulatory and licensing - authority over Petitioner, pursuant to Chapters 408, Part TI and 483, Part f, Florida Statutes and Chapter 59A-7, Florida Administrative Code; and ‘WHEREAS, the Agency served the Petitioner with a Notice of Intent to Limit Licensure; and WHEREAS, Petitioner requested a formal administrative proceedin gby filinga Petition for” Administrative Hearing; and WHEREAS, the parties have negotiated and agreed that the best inforests of all the portles: will be served by 2 settlement of this proceeding; and NOW THEREFORE, in consideration of the mutual promises and recitals hercin, the parties intending to be legally bound, agree as follows: 1. All recitals herein are true and correct and ate expressly incorporated herein. 2, Both parties agree that the “whereas” olausos incorporated herein are binding findings of the parties. 3. Upon full execution of this Agreement: (A) Petitioner agrees to waive apy and all appeals and proceedings tc which it may be entitled including, but not linsfted to, an informal proceeding under Subsection 120,57), Florida Statutes, a formal proceeding under Subsection 120.57(1), Florida Statutes, appeals under Section 120.68, Florida Statutes; and declaratory and all writs of relief in any court or quasi-court of competent jurisdiction; and agrees to waive compliance with the foun of the Final Order (findings of fact and conclusions of law) to which it may be entitled, provided, Oa SEP. 13. 209%. 2: 25PMozsqoPETERSONTMVERS AHCA GENERAL COUNSEL KO. 9903 gh. 4/hayaz however, that no agreement herein shall be deamed a waiver by either party of its tight to Judicial enforcement of this Agreement (B) The Agency shall issue to Petitioner a clinica} laboratory license which includes licensure to perform tbe Borrelia Antigen test. Said license shall be effective as of February 19, 2007. (C) Petitioner agrees 10 perform a validation study of the Borrelia Antigen test for submission to the Ageney with Petitioner's application for licensure renewal. ‘(D) Tho parties agree that this validation study will bc performed by Petitioner in good faith, without regard to outcome and in compliance with scientifically recognized standards, (E) Specifically the parties agree that the validation study will include, ata tuinimum, the following components: 1. Pertinent demographic information (including but not limited to regional data and pertinent patient symptoms and clinical diagnostic data); 2. A sample size of a minimum of 100 samples, 3. ‘Negative controls: 4 Positive controls; 5. Test subject preparation methodology; 6. Complete and detailed procedures for performing the assay; 7. Source and verification of standards as available, including quatity control and procedures; 8, Calculations of results; 9 Assay interferences and limitations (cross-reactivity); 10. Copies of pertinent literature; 11. A description of the mechanism that will be utilized to verify the accuracy and reliability of test results on an ongoing basis; 12, Patient summary; 9958.13, 2007), 2:25PMazegoP ETERSONMYERS ANCA GENERAL counseL —«NO. 9903. P. 5/75ve7 13. Utilization of the Wampole Pre Vue and Wester Blot tests pursuant to accepted scientific and industry standards for comparison of results; and 14. Utilization of Polymerase Chain Reaction (PCR) testing for verification of the Antigen test. (F) _ The results of the validation study, in conjunction with all relevant Federal and State standards ond Petitioner's compliance with this agreement shall he considered by the Agency when Petitioner's application for recertification is reviewed, Petitioner will transmit the validation study to the Respondent upon completion of the study by the Petiligner, Upon oceepranee by ATICA of the validation study, Petitioncr’s obligations under this Agreement regarding the study shall be completed. (G) During the time period that the Petitioner is conducting the validation study the Petitioner agrees to inchade a notification to all patients that submil a sample which will be included in the study that, “Data collected from this test may be used in an ongoing study of this testing protocol,” 4. Venue for any ection brought to enforce the terms of this Agreement or the Final Ordor entered pursuant hereto shall Jie in Circuit Court in Loon County, Florida. 5. Upon full execution ofthis Agreement and receipt ofa license es more fully described in paragraph thrée (3)(B), above, Pctitioncr’s Pctitloa for Administrative Ucaring shall be decmed dismissed and the Agency shall enter a Final Order adopting and incorporating the terms of this Agreement and closing the above-styled case. . 6. The parties agree that this agreement does not affect, impede or compromise Petitioner’s duty to comply with all Federal and State laws to which it is subject. a9,5EP. 13. 20023 2: 25 PMommgePETERSONTMYERS AHCA GENERAL COUNSEL NO. 9903 FP 5/Le say 7. Each party shall bear its own costs and attorney’s foes. 8. This Agreement shall become effective on the date upon which itis fully executed by all the parties, 9. The parties hereby mutually release cach other, their emmployces, agents, officers, directors, related or resulting arganizations, ils successors or transferees, attorneys, heirs, and executors or administrators from all claims, demands, actions, causes of action, suits. damages, losses, and expenses, of any and every nature whatsoever, arising out of ar in any way relaled te thes tater, 10. This Agreement is binding upon all parties herein and those identified in paragraph nine (9) of this Agreoment. {l. Inthe event that Petitioner is a Medicaid provider this settlement does not prevent the Agency from seeking Medicaid overpayments related to the subject issues or from imposing any sanctions pursuant to Rule 59G-9.070, Florida Administrative Code. 12, The undersigned have read and understand this Agreement and have the authority to bind their respective principals to it. 13. This Agteomont contains and incorporates the entire understandings and agreements of the parties, 14. This Agrecmont supersedes any prior oral or written agrcements between the partes 15. This Agreement may not be amended except in writing. 16, All parties agree that a facsimile signature suffices for an original signature. 17. The following representatives hereby acknowledge that they ate duly authorized to enter into this Agreement. SER. 13.2007 _2:26PHepoy-PETERSONHMYERS 2639560839 180. 9903gqe°- 7,/7-aa4 17. The following representatives hereby acknowledge that they are duly authorized to entex into this Agreement. Deputy S¢ Central Florida Research, Ine. pemory for Health ake Administration 245 North Seminole Avenue 9727 Mahan Drive, Bldg #1 Lake Alfred, Florida 33850 Tallahassee, Florida 32308 DATED: _ 7 [20/27 DATED: tobuar aig Florida Bar No 96598 Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 DATED: Agency for Health Care Administration Pereeson & Meyers, PA. 525 Mirror Lake Drive 141-5" Street, N.W. Suite 3306 P.O. Drawer 7608 St, Petersburg, Florida 33701 Winter Haven, Florida 3383) Attomey for Petitioner patep: 7//#/O

Docket for Case No: 07-002685