Wu 4575 3274 SONG NS SENDERS RECORD i STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION ==> On STATE OF FLORIDA, AGENCY FOR ~ Re HEALTH CARE ADMINISTRATION, Bae protest Petitioner, ; ee vs. AHCA NO; 02-01-01 16-RM LORENE PERONA, oO _ e = - fo) a) a ” 3G ~ = | A|- D3 HL Respondent. Petitioner, STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION (“Agency”), by and through its undersigned counsel, les this administrative complaint against Respondent, LORENE PERONA (‘RESPONDENT’), for violations of Chapter 395, Florida Statutes, governing risk management licensure. In support thereof, the Agency states the following: 1. Petitioner is the state agency charged with regulating the ractice of risk management pursuslit to Chapter 395, Florida Statutes, and Rule 59A-10, Florida Administrative Code. 2. RESPONDENT, is and has been at all times material hereto, a licensed Risk Manager in the State of Florida, having been issued license number 5501946 on certificate number 566 | 3. RESPONDENT's last known address is, P.O. Box 188, Fort Pierce, Florida 34954-0188. EXHIBIT 4. Atall times material hereto, RE! RESPONDENT was employed by Lawnwood Regional Medical Center (Lawnwood”), located at 1700 S. Qgr4 Street, Fort Pierce, Florida. 34950. The employer facility’s license number is 100246. 5s. The Agency conducted a risk management survey of Lawnwood on or about January 11, 2000 , 6. Pursuant to section 395,0197(5){a)(1), Florida Statutes, for purposes of reporting to the Agency, the term “adverse incident" means an event over which health care personnel could exercise control and which is associated in whole er in part with medical intervention, rather than the condition for which such intervention occurred, and which results in death. | 7. Pursuant to section 395.0197(5)(c), Florida Statutes, for purposes of reporting to the Agency, the term “adverse incident" means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather . than the condition. for which such intervention occurred, and which required the surgical’ repair “of damage ‘tesulting to a patient from 2 planned surgical procedure, where the damage was not a recognized . specific risk, as disclosed to the patient and documented through the informed consent process. 8. Risk Managers are required to report the following adverse incidents whether occurring in the licensed facility or arising from health ’ care prior to admission in the licensed facility to the agency within fifteen. (15) calendar days after their occurrence, pursuant to §2395.0197(8), Florida Statutes: a. The death of a patient g The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk , a5 disclosed to the patient and documented through the informed consent process. 9. The January 11, 2000 survey disclosed that patient W.A. was admitted through the emergency room for jaw, back and neck pain with a history of diabetes, congestive heart failure, coronary artery disease and a leaky heart valve. During an exploratory laparotomy to rule out rupture of an abdominal aortic aneurysm, W.A. expired. Postoperative diagnosis stated that the abdominal pain was most likely due to myocardial infarction and two xray summary reports indicate congestive heart failure. No abdominal aortic aneurysm was found during W.A.’s laparotomy. 10. The death of WA. was an: adverse event as defined by section 395.0197(5)(a)(1), Florida Statutes and was not reported to the Agency as required by section 395.0197(8)(a), Florida Statutes. 11. During the survey conducted on January 11, 2000, the Agency found another unreported incident which met the criteria of a reportable adverse event. Patient J.B.. underwent three different surgical procedures te correct complications of an infection of the sternum, J.B.'s infection was a postoperative noscomially acquired infection that arose asa result of having undergone coronary artery bypass grafts. The infection constituted an adverse event as defined by section 395.0197(5)(a)(6), Florida Statutes and was not reported to the Agency as mandated pursuant to section 395.0 197(8)(g), Florida Statutes. 12. Pursuant to Rule 59A-10.0055(3), Florida Administrative Code, the risk manager shall be. responsible for the regular and systematic reviewing of all incident reports including fifteen day incident reports for the purposes of identifying trends or patterns as fo time place or persons. , 13. The risk manager could not provide documentation of investigation, analysis, tracking and trending for the two patient incident investigations requested during the January 11, 2000 survey. Additionally, there was no tracking and trending of Infection Control issues, or physician performance issues into the risk management evaluation process that is supposed to be implemented in any patient Injury case. - 14, Based on review of risk management documents, incident reports, clinical records, facility documents and interview with the risk manager/designee and other key personnel, the Agency determined that RESPONDENT failed to regularly, eystematically review all incident 9S CEERI a reports to track and trend patterns as to time, place er persons, as required by Rule 59A-10.0055(3), Florida Administrative Code. 15. Through negligence, incompetence, or misconduct, RESPONDENT failed to report the above-mentioned adverse events to the Agency as required by §395.0197(8), Florida Statutes, and failed to track and trend adverse incident reports as required by Rule 59A-10.0055(8), Florida Administrative Code. 16. Based on the foregoing, RESPONDENT'S license to practice risk management is subject to discipline pursuant to §895.10975(1) & (2), Florida Statutes, for violation of §$95.0197(8)(a), Florida Statutes, and Rule 59A-10,0055(3), Florida Administrative Code. «17, The Agency intends to issue a final order that imposes one or more of the following penalties against Respondent's license: administrative fine not to exceed $2,500 for each count or separate offense; revocation; suspension; issuance of a reprimand; or probation for a period of time subject to such conditions as the Agency may specify. NOTICE Respondent is notified that she has a right to request an administrative hearing pursuant to Section 120.57, Florida Statutes, to he represented by counsel (at her own expense), to take testimony, to call or cross-examine wimesses, to have subpoenas and/or subpoenas duces tecum issued, and to present written evidence or argument if it requests a hearing. In order to obtain a formal proceeding under Section 120.57(1), Florida. Statutes, Respondent's request must state which issues of material fact are disputed. Failure to dispute material issues of fact in the request for a hearing, may be treated by the Agency as an election by Respondent for an informal proceeding under Section 120.57(2), Florida Statutes. All requests for hearing should be made to ‘the Agency for Health Care Administration, Attention: Sam Power, Agency Clerk, Senior Attorney, 2727 Mahan Drive, Mail Stop #3, Tallahassee, Florida 32308. RESPONDENT 15 FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 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. tesued thie Ti day of June. _, 2001. ‘ 53 luna Sith ‘Anna Polk, Manager Risk t Unit Agency for Health Care Administration Care & Health Quality 2727 Mahan Drive, Bldg. 1 Tallahassee, Florida 32308 —ee CERTIFICATE OF SERVICE 1 HEREBY CERTIFY that the original complaint was sent by U.S, Mail, Return Receipt Requested, to: Lorene Perona, P.O. Box 188, Fort Pierce, Florida 34954-6188 on this Ztday of _-) «<-.-¢ _, 2001. C Bo, LZ, \Y Mision Christine T, Messana, Esquire Office of the General Counsel Copies furnished to: Christine T. Messana Attorney Agency for Health Care Administration 2727 Mahan Drive Mail Stop #3 Tallahassee, Florida. 32308 — Elizabeth Dudek, Acting Deputy Secretary © Managed Care and Health Quality ‘ Agency for Health Care Administration 2727 Mahan Drive, Building 1 Tallahassee, Florida 32308-5403 Risk Management Unit Agency for Health Care Administration Managed Care & Health Quality 2727 Mahan Drive, Bldg. 1 Tallahassee, Florida 32308 Gloria Collins, Finance & Accounting

Docket for Case No: 01-002854PL