STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2010002856 GULF COAST MEDICAL CENTER LEE MEMORIAL HEALTH SYSTEM, Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, State of Florida, Agency for Health Care Administration (hereinafter “the Agency”), by and through its undersigned counsel, and files this Administrative Complaint against the Respondent, GULF COAST MEDICAL CENTER LEE MEMORIAL HEALTH SYSTEM (hereinafter “the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2008), and alleges as follows: NATURE OF THE ACTION This is an action to impose an administrative fine against a hospital in the amount of ONE THOUSAND DOLLARS ($1,000.00) pursuant to Section 395.1065(2)(a), Florida Statutes (2008). JURISDICTION AND VENUE 1, The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2008). 2. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes (2008), Chapters 408, Part II, and 395, Part I, Florida Statutes (2008), and Filed August 19, 2010 11:34 AM Division of Administrative Hearings. Chapter 59A-3, Florida Administrative Code. 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the licensing and regulatory authority that oversees hospitals in Florida and enforces the applicable federal and state regulations, statutes and rules governing hospitals pursuant to Chapter 408, Part II, Florida Statutes (2008); Chapter 395, Part I, Florida Statutes (2008), and Chapter 59A-3, Florida Administrative Code. The Agency may deny, revoke, suspend a license, or impose an administrative fine, against a hospital, for the violation of any provision of Chapter 395, Part I, Florida Statutes (2008), or any rule adopted under this part. 5. The Respondent was issued a license by the Agency to operate a 349-bed hospital (License No. 4301) located at 13681 Doctor’s Way, Fort Myers, Florida 33912, and was at all times material required to comply with the applicable federal and state regulations, statutes and tules. COUNTI The Respondent Failed To Ensure The Quality Assessment And Performance Improvement Program Participated In Identifying And Reducing Adverse Incidents Pertaining To Patients Receiving Cardiac Monitoring In Violation Of Rules 59A-3.271(1)(a), And 59A- 3.271(b)(1)-(8), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, each hospital shall have a planned, systematic, hospital wide approach to the assessment, and improvement of its performance to enhance and improve the quality of health care provided to the public. Such a system shall be based on the mission and plans of the organization, the needs and expectations of the patients and staff, up-to-date sources of information, and the performance of the processes and their outcomes. Rule 59A-3.271(1)(a), Florida Administrative Code. Pursuant to Florida law, each system for quality improvement, which shall include utilization review, must be defined in writing, approved by the governing board, and enforced, and shall include: 1. A written delineation of responsibilities for key staff; 2. A policy for all privileged staff, whereby staff members do not initially review their own cases for quality improvement program purposes; 3. A confidentiality policy; 4, Written, measurable criteria and norms; 5. A description of the methods used for identifying problems; 6. A description of the methods used for assessing problems, determining priorities for investigation, and resolving problems; 7. A description of the methods for monitoring activities to assure that desired results are achieved and sustained; and 8. Documentation of the activities and results of the program. Rule 59A-3.271(6)(1)-(8), Florida Administrative Code. 8. On or about June 10, 2009, the Agency conducted a Complaint Survey (CCR# 2009006501) of the Respondent’s facility. 9. Based on interviews, and a review of Quality and Safety Management Council minutes, the facility failed to ensure the Quality Assessment and Performance Improvement program participated in identifying and reducing adverse incidents as they pertained to patients receiving cardiac monitoring. 10.‘ During an interview with the Lee Memorial Health System Medical Director and Chairperson of the Quality Assessment and Performance Improvement Program Committee on June 10, 2009 at 9:31 a.m., he stated the root cause analysis for the deaths on telemetry was not completed so it had not been reported to the committee. 11. During an interview with the facility System Director for Standards and Quality on June 10, 2009 at 10:08 a.m., she stated the root cause analysis for the two (2) incidents that occurred in telemetry were taking longer due to the second event on March 9, 2009 and were still in process. 12. The minutes of the Quality Assessment and Performance Improvement Program meetings for February, March and April 2009 were reviewed on June 10, 2009 at 4:49 p.m. with the Risk Manager. There was no documentation in the minutes the facility Quality and Safety Management Council/Quality Assessment and Performance Improvement program committees are aware or involved in developing a plan to prevent the death of patients involved in the cardiac monitoring process that occurred on February 12, 2009 and March 9, 2009. 13. The Agency may impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of Chapter 395, Part I, Florida Statutes (2008); Chapter 408, Part II, Florida Statutes (2008), or applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. Section 395.1065(2)(a), Florida Statutes (2008). 14. The Agency provided Respondent with a mandatory correction date of July 10, 2009. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, intends to impose an administrative fine against the Respondent in the amount of ONE THOUSAND DOLLARS ($1,000.00). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to grant the following relief: 1. Enter findings of fact and conclusions of Jaw in favor of the Agency as set forth above. 2. Impose an administrative fine in the amount of ONE THOUSAND DOLLARS ($1,000.00) against the Respondent. A 3. Order any other relief that the Court deems just and appropriate. Respectfully submitted this _444@, day of Haag + 2010. Caton Aap fo Assistant General Counsel Florida Bar No. 0355712 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Telephone: (239) 335-1253 NOTICE RESPONDENT IS NOTIFIED THAT IT/HE/SHE HAS A RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT/HE/SHE HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS. ALL REQUESTS FOR HEARING SHALL BE MADE AND DELIVERED TO THE ATTENTION OF: THE AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG #3, MS #3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 922-5873. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING 1S NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED BY THE AGENCY. Aan CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form has been served to: James Nathan, Chief Executive Officer, Gulf Coast Medical Center Lee Memorial Health System, 13681 Doctor's Way, Fort Myers, Florida 33912, by U.S. Certified Mail, Return Receipt No. 7009 1680 0001 8777 1059, on this YM day of Gay , 2010. Copies furnished to: CarPduley Tae, Assistant General Counsel Florida Bar No. 0355712 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Telephone: (239) 335-1253 James Nathan, Chief Executive Officer Gulf Coast Medical Center Lee Memorial Health System | 13681 Doctor’s Way | Fort Myers, Florida 33912 (U.S. Certified Mail) Mary Daley Jacobs, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C | Fort Myers, Florida 33901 (Interoftice Mail) Harold Williams, Field Office Manager Agency for Health Care Administration 2295 Victoria Avenue, Room 340A Fort Myers, Florida 33901 (Interoffice Mail)

Docket for Case No: 10-007954