“sauteed STATE OF FLOF aa De | Un AGENCY FOR HEALTH CARE ADMINISTRATION |") Q0JUN I PHIE5h | STATE OF FLORIDA, AGENCY FOR DIVISION OF HEALTH CARE ADMINISTRATION, ADMINISTRATIVE too . HEARIN Petitioner Vv. CASE NO.: 09-00-032-HOSP LAWNWOOD MEDICAL CENTER, INC., . 2Y §7/ d/bJa LAWNWOOD REGIONAL MEDICAL CENTER, OO Respondent. ADMINISTRATIVE COMPLAINT Petitioner, STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION (“Agency”) by and through the undersigned hereby issues this Administrative Complaint against Respondent, LAWNWOOD MEDICAL CENTER, INC. d/b/a LAWNWOOD REGIONAL MEDICAL CENTER (“LRMC’”), for violation of state hospital licensure law, and imposes administrative fines in the amount of $75,000. As grounds therefor, the Agency states: 1. The Agency has jurisdiction over LRMC and the enforcement of hospital licensure law and risk management law pursuant to Chapter 395, Florida Statutes and Rules 59A-3 and 59A-10, Florida Administrative Code. 2. LRMC is a hospital within the meaning of Sections 395.002(11) and (13), Florida Statutes, and Rule 59A-10.002(2), Florida Administrative Code. 3. The Agency conducted a site survey of LRMC on or about April 30, 1999, pursuant to Sections 395.0161 and 395.0197(15), Florida Statutes, and hereby determines that LRMC was in violation of numerous risk management Vo VU requirements pursuant to Section 395.0197, Florida Statutes, and Rule 59A-10, Florida Administrative Code. 4. The Agency conducted a follow-up site survey of LRMC on or about January 11, 2000, pursuant to Sections 395.0161 and 395.0197(15), Florida Statutes, and hereby determines that LRMC remains in violation of risk management requirements and is thus subject to fines, pursuant to Section 395.0197(12), Florida Statutes. a.) Hospital risk management violations 5. Hospitals are required to establish and maintain an interna! risk management program. Section 395.0197, Florida Statutes (1999); Rule 59A- 10.0055, Florida Administrative Code (1999). An essential component in an effective risk management program is the development of appropriate measures to minimize the risk of adverse incidents to patients, including the application of adequate corrective action to potentially hazardous situations. Section 395.0197(1)(b), Florida Statutes (1999); Rule 59A-10.0055(3)(b), Florida Administrative Code. 6. During the survey conducted on 4/30/99, the LRMC risk manager was unable to document plans of corrective action for adverse incidents involving 2 patients. Therefore, LRMC has violated Section 395.0197(1)(b), Florida Statutes, and Rule 59A-10.0055(3)(b), Florida Administrative Code. 7. During the follow-up survey conducted on 1/11/00, the LRMC risk manager was again unable to document plans of corrective action for adverse incidents involving an additional 2 patients. Therefore, LRMC has repeatedly Cae U violated Section 395.0197(1)(b), Florida Statutes, and Rule 59A-10.0055(3), Florida Administrative Code.’ 8. Hospital risk management programs are required to have a reporting system under which adverse incidents are reported to the risk manager or his designee within three business days. Section 395.0197(1)(d), Florida Statutes (1999); Rule 59A-10.0055(2), Florida Administrative Code (1999). 9. During the follow-up survey conducted on 1/11/00, the Agency found that the risk manager or his designee did not receive 112 of the 229 incidents logged within the third quarter of 1999 within the specified three business days. This problem was also cited in the hospital survey of 2/2/99. Therefore, LRMC has violated Section 395.0197(1)(d), Florida Statutes, and Rule 59A-10.0055(2), Florida Administrative Code, thereby subjecting itself to administrative fines. 10. Hospital adverse incident reports must contain: patient name, address, admission diagnosis, admission date, age and gender; a clear and concise description of the incident; physician recommendations as to medical treatments (if applicable); names of all witness or involved parties; name, signature, and position of the person completing the form; and, the time and date the report was completed. Rule 59A-10.0055(2), supra. 11. During the survey conducted on 4/30/99, the Agency found that in a sample of 10 LRMC incident reports, 2 had no admitting diagnosis, 2 had no age of the patient, 2 had no gender of the patient, and 4 had no documentation of * The Agency is authorized pursuant to Section 395.0197(12), Florida Statutes, to fine the hospital for this violation, but declines to do so at this point in time. Woe UY physician recommendation. Therefore, LRMC has violated Rule 59A- 10.0055(2), Florida Administrative Code. 12. During the follow-up survey conducted on 1/11/00, the Agency found that in a sample of 20 LRMC incident reports, 5 had no admitting date, 2 had no admitting diagnosis, 3 had no age of the patient, 4 had no gender of the patient, and 5 had no documentation of physician being notified. Therefore, LRMC has . repeatedly violated Rule 59A-10.0055(2), Florida Administrative Code, thereby subjecting itself to administrative fines. | 13. Hospitals are required to report specified adverse incidents to the Agency within fifteen (15) days (“Code 15 Report’) of occurrence. Section 395.0197(8), Florida Statutes (1999); Rule 59A-10.0065, Florida Administrative Code (1999). Among the Code 15 adverse events that must be disclosed is the surgical repair of damage to a patient from a planned surgical procedure, where the damage is not a recognized specific risk as documented in the informed consent. Section 395.0197(8)(g), Florida Statutes (1999). 14. During the survey conducted on 4/30/99, the Agency found that an incident occurring on or about 2/8/99 at LRMC resulting in the death of the patient on 2/11/99, which meets the criteria of a Code 15 Report, had not been reported. Patient J.H. suffered hypoxic encephalopathy on 2/8/99 due to an unidentified problem with his ET tube on 2/7-2/8/99, which resulted in the patient’s death on 2/11/99. Therefore, LRMC has violated Section 395.0197(8)(g), Florida Statutes, and Rule 59A-10.0065, Florida Administrative Code. Uo. U 15. During the survey conducted on 4/30/99, the Agency found that an instance of surgical repair of damage on or about 4/5/99, sustained from nonemergency care to which the patient had not given informed consent, had not been reported. Patient A.H. suffered an acute pericardial tamponade during the insertion of a permanent pacemaker which required a pericardial window and chest tube for blood drainage. The medical record did not indicate disclosure of - the risk of pericardial tamponade, and accordingly meets the requirement for a Code 15 Report, which was not filed: Therefore, LRMC has violated Section 395.0197(8)(9), Florida Statutes, and Rule 59A-10.0065, Florida Administrative Code. | 16. During the follow-up survey conducted on 1/11/00, the Agency found that a series of instances of surgical treatment unrelated to the patient’s admiting diagnosis occurring on or about 9/29/99, 10/2/99 and 10/18/99, which meets the criteria.of a Code 15 Report, had not been reported. Patient J.B. was admitted for a quadruple coronary artery bypass graft and developed a nosocomial infection of the sternum requiring three separate surgical treatments and skin grafts. Therefore, LRMC has repeatedly violated Section 395.0197(8)(g), Florida Statutes, and Rule 59A-10.0065, Florida Administrative Code, thereby subjecting itself to administrative fines. 17. During the follow-up survey conducted on 1/11/00, the Agency found that a fourth event, a death occurring on or about 9/19/99 at LRMC, which meets" the criteria of a Code 15 Report, had not been reported. Patient W.A. was admitted through the emergency room for jaw and back pain with a history of a leaky heart valve. The patient underwent exploratory surgery to rule out a ruptured aortic aneurysm and expired due to a myocardial infarction. Therefore, LRMC has repeatedly violated Section 395.0197(8)(a), Florida Statutes, and _ Rule 59A-10.0065, Florida Administrative Code, thereby subjecting itself to administrative fines. 18. Risk managers are responsible for the systematic review of all adverse incidents to identify trends or patterns as to time, place, or persons. Section 395.0197(1), Florida Statutes (1999); Rule 59A-10.0055(3), Florida Administrative Code (1999). 19. During the survey conducted on 4/30/99, the Agency found that the LRMC risk manager failed to trend or pattern as to time, place, or person incidents involving 2 patients that met the Code 15 reporting criteria. Therefore, LRMC has violated Section 395.0197(1)(a), Florida Statutes, and Rule 59A- 10.0055(3), Florida Administrative Code. 20. During the follow-up survey conducted on 1/11/00, the Agency found that the LRMC risk manager again failed to trend or pattern as to time, place, or person incidents involving an additional 2 patients that met the Code 15 reporting criteria. Therefore, LRMC has repeatedly violated Section 395.0197(1)(a), Florida Statutes, and Rule 59A-10.0055(3), Florida Administrative Code.? 21. Risk managers are responsible for the development of recommendations for appropriate corrective actions and risk management ? The Agency is authorized pursuant to Section 395.0197(12), Florida Statutes, to fine the hospital for this violation, but declines to do so at this point in time. Uo, as) education and training. Section 395.0197(1)(b), Florida Statutes (1999); and Rule 59A-10.0055(3), Florida Administrative Code (1999). 22. During the survey conducted on 4/30/99, the Agency found that the LRMC risk manager was unable to document corrective action plans, education or training concerning incidents involving 2 patients that met the Code 15 reporting criteria. Therefore, LRMC has violated Section 395.0197(1)(b), Florida - Statutes, and Rule 59A-10.0055(3), Florida Administrative Code. 23. During the follow-up survey conducted on 1/11/00, the Agency found that the LRMC risk manager was again unable to document corrective action plans, education or training concerning incidents involving an additional 2 patients that met the Code 15 reporting criteria. Therefore, LRMC has repeatedly violated Section 395.0197(1)(b), Florida Statutes, and Rule 59A- 10.0055(3), Florida Administrative Code.° b.) Fines for violation of hospital risk management law 24. The Agency hereby assesses an administrative fine against LRMC for intentional and willful failure to accomplish reporting of adverse incidents to the risk manager within three business days as determined in the 1/11/00 follow-up survey in violation of Section 395.0197(1)(d), Florida Statutes, and Rule 59A- 10.0055(2), Florida Administrative Code, of $25,000, pursuant to Section 395.0197(12), Florida Statutes. 25. The Agency hereby assesses an administrative fine against LRMC for a repeated intentional and willful failure to include all required elements on ° The Agency is authorized pursuant to Section 395.0197(12), Florida Statutes, to fine the hospital for this violation, but declines to do so at this point in time. 7 adverse incident reports as determined by the 1/11/00 follow-up survey in violation of Rule 59A-10.0055(2), Florida Administrative Code, of $25,000, ~ pursuant to Section 395.0197(12), Florida Statutes. 26. The Agency hereby assesses an administrative fine against LRMC for a repeated intentional and willful failure to submit Code 15 Reports regarding adverse incidents occurring on or about 9/19/99, 9/29/99, 10/2/99, and 10/18/99 - as determined by the 1/11/00 follow-up survey, in violation of Sections 395.0197(8), Florida Statutes, and Rule 59A-10.0065, Florida Administrative Code, of $25,000, pursuant to Section 395.0197(12), Florida Statutes. 27. Therefore, the total of administrative fines from the above-specified violations of hospital risk management law assessed against LRMC amounts to $75,000. . c.) Rights to A Hearing 28. LRMC has a right to request an administrative hearing pursuant to Section 120.57, Florida Statutes, to be represented by counsel, to take testimony, to call or cross-examine witnesses, and to have argument if a hearing is requested. In order to obtain a formal proceeding under Section 120.57(1), Florida Statutes, LRMC’s request for a formal hearing must set forth with specificity disputed issues of material fact. Failure to so set forth such disputed issues of material fact may be treated by the Agency as an election of an informal proceeding pursuant to Section 120.57(2), Florida Statutes. LRMC has a right to request mediation pursuant to Section 120.573, Florida Statutes. Choosing mediation will not affect LRMC’s right to an administrative hearing. A request for hearing shall be filed with: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Tallahassee, Florida 32308-5403, Attention: Sam Powers, Agency Clerk, General Counsel's Office, with a copy to Anna Polk, Agency for Health Care Administration, 2727 Mahan Drive, Building #1, Tallahassee, Florida 32308-5403. LRMC should include a copy of this administrative complaint with any request for hearing. . 29. If LRMC does not contest the matters asserted in this administrative | complaint, the amount of the total fine should be remitted by check or money order payable to: Agency for Health Care Administration, 2727 Mahan Drive, Building #1, Tallahassee, Florida 32308-5403, Attention: Anna Polk. 30. Failure to pay the fine or request an informal or formal hearing within twenty one (21) days of receipt of this complaint will result in an admission of the facts alleged herein and an entry of a final order based upon such facts by the Agency. ISSUED this_/0%_ day of Mek, 2000. AGENCY FOR HEALTH CARE Deputy Director . State of Florida Agency for Health Care Administration 2727 Mahan Drive Ft. Knox Executive Center Ill Tallahassee, Florida 32308-5403 CERTIFICATE OF SERVICE | hereby certify that this Administrative Complaint was sent by U.S. Certified Mail Return Receipt Requested to: Mr. Thomas Pentz President and Chief Executive Officer Lawnwood Regional Medical Center 1700 South 23” Street Ft. Pierce, Florida 34954-0188 / this / ry ores = € S. Thomas, Esquire 10

Docket for Case No: 00-002487