STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2010010876 PORT CHARLOTTE HMA, LLC: | d/b/a PEACE RIVER REGIONAL MEDICAL CENTER, 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, PORT CHARLOTTE HMA, LLC d/b/a PEACE RIVER REGIONAL MEDICAL CENTER (hereinafter “the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2010), 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 (2010). JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2010). 2. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes (2010), Chapters 408, Part II, and 395, Part I, Florida Statutes (2010), and Filed March 3, 2011 8:00 AM Division of Administrative Hearings SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY ™ Complete items 1, 2, and 8. Also compfete » Slgpaturg tern 4 if Restrloted Delivery {s desired. x MK) | C1 Agent ™ Print your name and address on the reverse IN \ Addressee so that wa can return the card to you, @ Attach this card to the baok of the maliplece, or on the front If space permits, 1. Arlicls Addressed to: 7 6/00/00 76 Sa saph Clancy, CEO Peace Ruver Rme 280 harbor fovleyard Part Coarlotle, Flonde « r9e2 2. Aritole Number (itanstor trom sotvice label) 7002 2410 OO08 S5hh 395% PS Form 3811, February 2004 Domostle Returri Recelpt 102595-02-M-1540 SAF | eg by ( Printed Nama) G, Date of Delivery TL Vass. STEN a-[-1O D. Is delivery address different from item 17 CJ Yes it YES, enter delivery address below; 1 No 3. Service Type C] Certitied Mall (4 Express Mall C1 Registered © Return Recelpt for Merchandise T) insured Mall C1.6,0.0, 4, Restricted Delivery? (Extra Fee) O Yes 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 IJ, Florida Statutes (2010); Chapter 395, Part I, Florida Statutes (2010), 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 (2010), or any rule adopted under this part. 5. The Respondent was issued a license by the Agency to operate a 219-bed hospital (License No. 4340) located at 2500 Harbor Boulevard, Port Charlotte, Florida 33952, and was at all times material required to comply with the applicable federal and state regulations, statutes and rules. : COUNT I The Respondent Failed To Ensure Physicians Performing Surgery Using The Makoplasty Robotic Arm Were Credentialed To Perform The Procedure In Violation Of Rule 59A- 3.2085(3)(k), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7, Pursuant to Florida law, each Class I and Class II hospital, and each Class III hospital providing operative and other invasive procedures, shall be organized under written policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation and recording of treatment of the patient, All surgical department policies and procedures shall be available to the Agency for Health Care Administration, shall be reviewed annually, dated to indicate time of last review, revised as necessary, and enforced. These procedures shall require: Each hospital shall maintain a roster of physicians specifying the surgical privileges of each, shall review the roster annually and revise it as necessary. Rule 59A- 3.2085(3)(k), Florida Administrative Code. 8." Onor about September 13, 2010 through September 16, 2010, the Agency conducted a Complaint Survey (CCR# 2010008225) at Respondent’s facility. 9. Based on record reviews, credentialing files, and interviews, it was determined the facility failed to ensure the physicians performing surgery using the Makoplasty robotic arm were "credentialed to perform this procedure. (CCR# 2010008225) 10. A review of orthopedic patient surgery records from May 2010 to September 2010 revealed two (2) orthopedic surgeons were perfortning partial knee replacement surgeries using the Makoplasty robotic knee system procedure. The credentialing files for these two (2) surgeons were requested. On September 15, 2010 at 3:34 p.m., the facility submitted an undated memorandum from the Chairman, Credentials Committee and Chief of Staff with the following notation: "Please be advised the Makoplasty robot arm for single compartment knee replacement ‘is an extension of orthopedic privileges." A review of these files revealed there was no ~ documented evidence in their files to indicate an extension and/or expansion of privileges included this Makoplasty robotic knee system procedure had been approved/credentialed by the appropriate authority. 11. _ An interview on September 15, 2010 at 3:45 p.m. with the Chief Executive Officer, Chief Nursing Officer, and Medical Staff Services liaison confirmed this finding. 12. 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 (2010); Chapter 408, Part II, Florida Statutes (2010), or applicable tules. Each day of violation constitutes a separate violation and is subject to a separate fine. Section 395.1065, Florida Statutes (2010). 13. _. The Agency provided Respondent, with a mandatory correction date of October 16, 2010. . . 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: i. . Enter findings of fact and conclusions of law 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, 3. Order any other relief that the Court deems just and appropriate. Respectfully submitted this 9A, __ day of Measanltt, > 2010. tony Paley yg 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, j 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) 412-3630. THE RESPONDENT JS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING i IS 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. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights forin has been served to: CT Corporation System, Registered Agent for Port Charlotte HMA, LLC d/b/a Peace River Regional Medical Center, 1200 South Pine Island Road, Plantation, Florida’ 33324, by U.S. Certified Mail, Return Receipt No. 7002 2410 0006 5966 3964, and Joseph Clancy, Chief Executive Officer, Port Charlotte HMA, LLC d/b/a Peace River Regional Medical Center, 2500 Harbor Boulevard, Port Charlotte, Florida 33952, by US. Certified Mail, Return Receipt No. 7002 2410 0006 5966 3957, on this athh» day of Aecerenteedt. ', 2010. ans pced qf Mlary Daley Jaedbs, 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 ota Copies furnished to: Joseph Clancy, Chief Executive Officer Port Charlotte HMA, LLC d/b/a Peace River Regional Medical Center 2500 Harbor Boulevard Port Charlotte, Florida 33952 "| (US. 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 (Interoffice Mail) CT Corporation System, Registered Agent for Port Charlotte HMA, LLC d/b/a Peace River Regional Medical Center 1200 South Pine Island Road Plantation, Florida 33324 (U.S, Certified Mail) Harold Williams, Field Office Manager Agency for Health Care Administration 2295 Victoria Avenue, Room 340A Fort Myers, Florida 33901 (Interoffice Mail) . STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2010010876 PORT CHARLOTTE HMA, LLC d/b/a PEACE RIVER REGIONAL MEDICAL CENTER, Respondent. / ELECTION OF RIGHTS This Election of Rights form is attached to a proposed action by the Agency for Health Care Administration (AHCA). The title may be an Administrative Complaint, Notice of Intent to Impose a Late Fee, or Notice of Intent to Impose a Late Fine. Your Election of Rights must be returned by mail or by fax within twenty-one (21) days of the date you receive the attached Administrative Complaint, Notice of Intent to Impose a Late Fee, or Notice of Intent to Impose a Late Fine. If your Election of Rights with your elected Option is not received by AHCA within twenty-one (21) days from the date you received this notice of proposed action by AHCA, you will have given up your right to contest the Agency’s proposed action and a Final Order will be issued. Please use this form unless you, your attorney or your representative prefer to reply in accordance with Chapter 120, Florida Statutes (2010) and Rule 28, Florida Administrative Code. PLEASE RETURN YOUR ELECTION OF RIGHTS TO THIS ADDRESS: Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 Phone: 850-412-3630 Fax: 850-921-0158 PLEASE SELECT ONLY 1 OF THESE 3 OPTIONS OPTION ONE (1) I admit the allegations of fact and law contained in the Notice of Intent to Impose a Late Fine or Fee, or Administrative Complaint and I waive my right to object and to have a hearing, I understand that by giving up my right to a hearing, a Final Order will be issued that adopts the proposed agency action and imposes the penalty, fine or action. OPTION TWO (2) I admit the allegations of fact and law contained in the Notice of Intent to Impose a Late Fine or Fee, or Administrative Complaint, but I wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where I may submit testimony and written evidence to the Agency to show that the proposed administrative action is too severe or that the fine should be reduced. OPTION THREE (3)___—sd. dispute the allegations of fact and law contained in the Notice of Intent to Impose a Late Fee, the Notice of Intent to Impose a Late Fine, or Administrative Complaint, and J request a formal hearing (pursuant to Subsection 120.57(1), Florida Statutes) before an Administrative Law Judge appointed by the Division of Administrative Hearings. PLEASE NOTE: Choosing OPTION THREE (3) by itself is NOT sufficient to obtain a formal hearing. You also must file a written petition in order to obtain a formal hearing before the Division of Administrative Hearings under Section 120.57(1), Florida Statutes. It must be received by the Agency Clerk at the address above within 21 days of your receipt of this proposed administrative action. The request for formal hearing must conform to the requirements of Rule 28- 106.2015, Florida Administrative Code, which requires that it contain: 1. Your name, address, telephone number, and the name, address, and telephone number of your representative or lawyer, if any. 2. The file number of the proposed action. 3, A statement of when you received notice of the Agency’s proposed action. 4, A statement of all disputed issues of material fact. If there are none, you must state that there are none. Mediation under Section 120.573, Florida Statutes may be available in this matter if the Agency agrees. License Type: (Assisted Living Facility, Nursing Home, Medical Equipment, Other) Licensee Name: License Number: Contact Person: Name Title Address: Street and Number City State Zip Code Telephone No. Fax No. E-Mail (optional) I hereby certify that ] am duly authorized to submit this Notice of Election of Rights to the Agency for Health Care Administration on behalf of the above licensee. Signature: Date: Print Name: Title:

Docket for Case No: 11-001121