STATE OF FLORIDA 20" DEC 29 D AGENCY FOR HEALTH CARE ADMINISTRATION 234 AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, AHCA No.: 2004008174 Return Receipt Requested: Vv. 7003 1680 0006 9825 9868 7003 1680 0006 9825 9875 SOUTHEAST TISSUE ALLIANCE, INC. d/b/a SOUTHEAST TISSUE ALLIANCE, a | - INC. ij |. U oN ‘ c iv C. {Yo Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “AHCA”), and files this administrative complaint against Southeast Tissue Alliance, Inc. d/b/a Southeast Tissue Alliance, Inc. (hereinafter “Southeast Tissue Alliance, Inc.”) pursuant to 28-106.201, Florida Administration Code (2004) and Chapter 120, Florida Statutes and hereinafter alleges: NATURE OF ACTION 1. This is an action to impose an administrative fine in the amount of $1,000.00 pursuant to Section 483.221, Florida Statutes and Chapter 59A-1.012, Florida Administrative Code. JURISDICTION AND VENUE 2. This court has jurisdiction pursuant to Section 120.569 and 120.57, Florida Statutes and Chapter 28-106, Florida Administrative Code. 3. Venue lies in Alachua County, pursuant to 120.57, Florida Statutes and Chapter 28 Florida Administrative Code. PARTIES 4. AHCA is the enforcing authority with regard to clinical laboratories licensure pursuant to Chapter 483, Part I, Florida Statutes and Rule 59A-1, Florida Administrative Code. 5. Southeast Tissue Alliance, Inc. is an organ and tissue procurement facility located at 6241 N. W. 23 Street - Suite 400, Gainesville, Florida 32653 and is licensed under Chapter 483, Part I, Florida Statutes and Chapter 59A-1 Florida Administrative Code. Southeast Tissue Alliance, Inc. is licensed as an organ and tissue procurement facility under license number 6. Southeast Tissue Alliance, Inc. was at all times material hereto a licensed facility under the licensing authority of AHCA and was required to comply with all applicable rules and statutes. COUNT I SOUTHEAST TISSUE ALLIANCE, INC. RECOVERED TISSUE FROM DONORS WITHOUT WRITTEN OR ORAL CONSENT. RULE 59A-1.005(7) (b)1, FLORIDA ADMINISTRATIVE CODE RULE 59A-1.012 (1) (d), FLORIDA ADMINISTRATIVE CODE (INFORMED CONSENT) 6. AHCA re-alleges and incorporates (1) through (5) as if fully set forth herein. 7. An anonymous complaint was made alleging that SETA (Southeast Tissue Alliance, Inc.) had recovered tissues on 3/18/02 from a donor at Fort Walton Beach Medical Center, Fort Walton Beach, Florida without first obtaining a consent. Based on record review and interviews on the days of the investigation, the following findings were confirmed: 8. An interview was held with the Fort Walton Beach Medical Center Risk Manager on 8/26/02. The Risk Manager revealed that SETA had inadvertently retrieved tissue from a patient in the hospital morgue that had not consented to a tissue donation. A review of the alleged donor chart revealed a SETA "Corrective Action Request Form" confirming the incident and detailing the circumstances surrounding the event. An interview was then conducted on 8/30/02 with the Quality Assurance Manager and Vice President of Operations at Southeast Tissue Alliance, Gainesville, Florida. During interview and review of incident records at SETA, it was further confirmed by the agency that a recovery team had retrieved tissues from a donor at Fort Walton Beach Medical Center on 3/18/02 without documentation of a written or oral consent. SETA revised procedures for donor identification following the 3/18/02 incident to prevent a reoccurrence. 9. Another complaint investigation was conducted on January 26, 2004. Interview with the Director of Professional Regulations and Quality Assurance revealed that Southeast Tissue Alliance had retrieved tissues from cadavers without first obtaining consents for donation. On further interview with the director it was determined that SETA had conducted internal investigations into the incidents, CAR 02-016 and CAR 03-002. On review of these internal investigation reports, it was discovered that recovery staff had failed to verify donor identification prior to tissue recovery of donors on 6/14/02 and 3/14/03, thereby inadvertently retrieving tissue from cadavers that had not consented to donation of tissue. 10. Based on record review and staff interview on the day of investigation it was determined that the Agency Director failed to ensure technical staff had maintained comeetency for donor identification. 11. Failure of the Agency Director ensuring competency of all technical recovery staff in the identification of donors make the facility non-compliant as required by Ch. 59A- 1.005(1) (a)2.d., F.A.C. The findings include the following: 12. An interview with Southeast Tissue Alliance (SETA) Director of Professional Regulations and Quality Assurance revealed that SETA recovery technicians retrieved tissues from incorrect cadavers, on 6/14/02 and 3/14/03, by failing to properly identify the donors. 13. An interview with the Director of Professional Regulations and Quality Assurance revealed that SETA had conducted internal investigations into the incidents, CAR 02- 016 and CAR 03-002. On review of internal investigation of CAR 02-016, it was discovered that SETA had obtained consent for tissue donation from DRW Patient # 178769, at a hospital in Meibourne, Florida on 6/13/2002. On further review, it was revealed that a recovery team, including Recovery Tech 1 and Recovery Tech 2, were dispatched to the hospital on 6/14/02 to perform the recovery of Patient #178769. Recovery Tech 1 signed the demographic page verifying the identity of the donor, although he had not actually looked = at the identification. Recovery Tech 2 claimed that he looked at the body tag and believed it was the name of the person that consented for the donation and signed the demographic page verifying he had confirmed proper identification. However, when the body was checked by a hospital staff member and another SETA staff member, the body had three (3) identifying tags showing another name, DRW Patient #178780. Interview with the Director of Professional Regulations and Quality Assurance confirmed the findings of this investigation. 14. A review of SETA internal investigation, CAR 03-002, revealed that SETA had obtained consent for tissue donation from DRW Patient # 202302, at a hospital in St. Augustine, Florida on 3/14/2003. On further review of the internal investigation, it was revealed that on 3/14/2003 a recovery team, consisting of Recovery Tech 3 and Recovery Tech 4 was dispatched to the hospital to perform the recovery of Patient #202302. Recovery Tech 3 located what he believed to be the donor by chart, which he stated had been placed under the donor's head. However, this could not be confirmed by the hospital, as the chart was found to be in the Medical Records. Recovery Tech 3 then contacted the Care Center to confirm the identity of the body and stated that the body had tags on the toe and wristband, and that the body bag had a tag on the zipper. He implied in his recorded ID confirmation that he had made positive identification from the donor ID tags. He then prepared the body for recovery without completing the donor identification section of the Donor Demographics form, which requires that two (2) witnesses verify and sign the donor identification. on completion of recovery and during reconstruction, Recovery Tech 3 noticed that the name on the toe tag was DRW Patient #202278, and not that of the correct donor. Recovery Tech 3 admitted afterward, he had assumed by the chart that he had the correct body and did not look at the information on the tags and bands on the body prior to recovery. Furthermore, Tech 4 did not confirm the donor ID or sign as a witness to the donor ID on the Donor Demographics form. Interview with the Director of Professional Regulations and Quality Assurance confirmed the findings of this investigation. 15. SETA has investigated each incident, revised procedures, and initiated training, however it has continued to occur. Within a twelve (12) month period, different SETA recovery members at three (3) separate locations failed to properly identify donors and inadvertently retrieved tissues from the incorrect cadavers. These successive violations represent a failure to ensure competency of Recovery Technicians to properly verify donor identification. 16. The director confirmed that tissues had been recovered without consent on 6/14/02 and 3/14/03. 17. These successive violations represent a failure to ensure competency of Recovery Technicians to properly verify donor identification. 18. Failure of this tissue bank to obtain informed consent and document this consent prior to recovering tissue could jeopardize the prospective donor or donor's next of kin by failing to give them sufficient opportunity to consider whether or not to agree to such donation, and thereby minimize the possibility of coercion or undue influence. 19. Based on the foregoing facts, Southeast Tissue Alliance, Inc. violated Rule 59A-1.005(7) (b)1, Florida Administrative Code and Rule 59A-1.012(1) (da), Florida Administrative Code which warrants an assessed fine of $1,000.00. PRAYER FOR RELIEF WHEREFORE, the Petitioner, State of Florida Agency for Health Care Administration requests the Court to order the following relief: 1. Enter a Judgment in favor of the Agency for Health Care Administration against Southeast Tissue Alliance, Inc. on Count I. 2. Assess against Southeast Tissue Alliance, Inc. an administrative fine of $1,000.00 for the violation as cited above in Count I. 3. Assess costs related to the investigation and prosecution of this matter, if the Court finds costs applicable. 4. Grant such other relief as this Court deems is just and proper. Respondent is notified that it has a right to request an administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statutes (2003). Specific options for administrative action are set out in the attached Election of Rights and explained in the attached Explanation of Rights. All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to the Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, MS #3, Tallahassee, Florida 32308. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO RECEIVE A REQUEST FOR A HEARING WITHIN TWENTY-ONE (21) DAYS OF RECEIPT OF THIS COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. Assfstant Geréral Counsel Agency for Health Care Administration 8350 N.W. 52 Terrace - #103 Miami, Florida 33166 305-470-6800 Copies furnished to: Karen Swann Field Office Manager Agency for Health Care Administration 921 N. Davis Street Building A - Suite 115 Jacksonville, Florida 32209 (U.S. Mail) Jean Lombardi Finance and Accounting Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) Home Care Unit Program Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) 10 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Certified Mail, Return Receipt Requested to Administrator, Southeast Tissue Alliance, Inc., 6241 N. W. 23 Street - Suite 400, Gainesville, Florida 32653; J. P. Ailstock, P.A., Registered Agent, 2615 N. W. 5 Place, Gainesville, Florida 32607 on this 32d day of OekE. 200. 7 nV Margarat |fulien// Esq. 11

Docket for Case No: 04-004636