Pare See gee ST OEE Oe octal. 7l0b 4S75 1294 2049 L4a0 SENDERS RECORD . AGENCY FOR NLTH Cane ADMINISTRATION )| ~ 2 iene STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, > . “Yt / gaa = — Petitioner, Sea oo TT ats © rm vs. AHCA NO: 02- 01-81 E20-RNE i MERN HENRY, “2 ey . Respondent. Oe wal! JUN 2 0 200) ADMINISTRATIVE COMPLAINT a! at, Petitioner, STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION (“Agency”), by and through its undersigned counsel, files this administrative complaint against Respondent, MERN HENRY (“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 practice of risk management pursuant to Chapter 395, Florida Statutes, and Rule 59-10, 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 5500723 on certificate number 748. 3. RESPONDENT's last known address is, 8008 Plantation Lakes Drive, Port Saint Lucie, Florida 34986. EXHIBIT A Bate t 4. At all times material hereto, RESPONDENT was employed by Lawnwood Regional Medical Center (“Lawnwood”), located at 1700 S. 23rd Street, Fort Pierce, Florida 34950. The employer facility’s license number is 100246. ) 5. The Agency conducted a risk management survey of Lawnwood on or about February 2, 1999, 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 or 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 resulting to a patient from a “oe 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 t the following adverse incidents whether occurring in the licensed facility or arising from health NEE I care prior to admission in the licensed facility to the agency within fifteen (15) calendar days after their occurrence, pursuant to §395.0197(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 , as disclosed to the patient and documented through the informed consent process. 9, The February 2, 1999 survey disclosed that patient A.G.'s pacemaker battery was weak and that the pacemaker was not capturing. There was no documentation of physician notification of the problem. A.G. was noted to be short of breath with periods of confusion and an unsteady gait. Despite being on fall precautions, A.G.'s bed alarm was turned off. A.G. was found slumped over the toilet dead. 10. A.G.'s death 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 February 2, 1999 survey the Agency found other unreported incidents that met the criterion of reportable adverse events. Patient G.C. had to return to eurgery for surgical repair to the left pneumothorax for bleeding bronchial artery. The surgical repair was subsequent to having @ left thoracotomy and left pneumonectomy performed earlier that day and was not listed as one of the specific complications of the procedure in the operative consent. oe A ee AS ENO ee ete P 12. G.C.'s surgical repair was an adverse event as defined by section 395.0197(5}(c), Florida Statutes, and was not reported to the Agency as required by section 395.0197(8)(g), Florida Statutes. 13. 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 to time place or persons. 14. The risk manager could not provide documentation of investigation, analysis, tracking and trending for the two above- mentioned adverse events requested during the February 2, 1999 survey. Additionally, no analysis was performed on the adverse incidents to identify relevant trends or patterns, including: nursing, medical practice and technique, communication, staffing and equipment issues. supposed to be implemented in any patient injury case. 15. Based on review of incident reports and surveyor investigation, ; the _Agency determined that RESPONDENT failed to regularly, eystematically review all incident reports to track and trend patterns as to time, place or persons, as required by Rule 59A- 10. 008513), Florida Administrative Code. 16. ‘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(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 be represented by counsel (at her own expense), to take testimony, to call or cross-examine witnesses, 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 IS 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. 2 Issued this 72 day ot Chane. , 2001. e - foe) CLK) 2 o . fe =o Anna Polk, Manager ne Risk Management Unit on Agency for Health Care Administration Managed Care & Health Quality 2727 Mahan Drive, Bldg. 1 Tallahassee, Florida 32308 CERTIFICATE OF SERVICE 1 HEREBY CERTIFY that the original complaint was sent by U.S. Mail, Return Receipt Requested, to: Mern Henry, 8008 Plantation Lakes Drive, Port Saint Lucie, Florida 34986 on this (Ukliay of Suna, 2001. Christine T. Messana, Esquire Office of the General Counsel