STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. ; Case No, 2010010829 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 TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) 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 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 (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) Jocated 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 rales. - - . - COUNT I The Respondent Failed To Ensure Hand Washing Techniques, As Well As Sanitation Of Equipment As It Pertains To Administering Direct Care To Patients Were Followed In Violation Of Rule 59A-3.250(1)(a)-(d), 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 establish an infection control program involving members of the organized medical staff, the nursing staff, other professional staff as appropriate, and administration. The program shall provide for: (a) The surveillance, prevention, and control of infections among patients and personnel; . _(b) The: establishment of a system for identifying, reporting, evaluating and maintaining records of infections; (c) Ongoing review and evaluation of all septic, isolation and sanitation techniques employed in the hospital; and (d) Development and coordination of training programs in infection control for all hospital personnel, Rule 59A-3.250(1)(a)-(d), Florida Administrative Code. 8. On or about September 13, 2010 through September 16, 2010, the Agency conducted a Licensure Survey at Respondent’s facility. 9, Based on observation, interview, and record review, the facility failed to ensure hand washing techniques, as well as sanitation of equipment as it pertains to administering direct care were followed. The facility failed to follow policy and procedures related to their Cardiac/Pulmonary Department. 10. On September 15, 2010 at 9:11 a.m. during an observation in the Intensive Care Unit of a patient during dialysis treatment the following occurred: Two (2) Intensive Care Unit nurses entered the room without donning any protective covering (which is a requirement during a patient being treated on dialysis), The nurses proceeded to work with the patient leaning over the patient, changing his/her gown, and fixing the patient's bed linen. Furthermore, there were no observations of either nurse washing or sanitizing their hands before they treated the patient or when the nurses left the room. On the same day at 9:40 a.m., an Electrocardiogram (EKG) technician entered the room and proceeded to administer an EKG on the patient without washing or sanitizing the leads of the machine, before proceeding with hooking the patient up to the machine. Furthermore, the technician was not observed donning any protective covering before entering the room or administering direct care to the patient. When the technician was asked why she did not use protective covering when working with the patient she replied, "I don't have to ‘use protective covering, the patient is not in isolation.” After the technician completed the EKG she was observed removing the leads, but was not observed washing or sanitizing her hands and did not sanitize the leads of the EXG machine. 11. . A review of the facility's policies and procedures as it pertains to Infection Prevention of Cardio-Pulmonary states the follow: Standard precautions include the following: Hand washing: "Hands are to be washed after touching blood, body, fluids, secretions, excretions, or other contaminated items, whether or not gloves are worn. Hands must be washed immediately after removal of gloves, between any patient contact and when otherwise indicated. This will prevent transmission of microorganisms. To prevent cross contamination of different body sites on the same patient, it may be necessary to wash hands between tasks, and procedures." 12. Arreview of the facility's policies for hand hygiene reveals the following: Health care personnel shall wash their hands to prevent the spread of infection and disease to other ‘personnel, patients and visitors: 1. Before beginning work. 2. Whenever hands are obviously soiled. 3. Before performing invasive procedures. _ A, Before handling medications. 5. Before touching or preparing food, 6. After having prolong contact with a patient, 7. After contact with patients on isolation. .15. After handling items potentially contaminated with any patient's blood, excretions or secretions. 13... On September 16, 2010 at 11:05 a.m., the Agency met with the administrator and Director of Nursing in regards to infection control issues in the dialysis treatment room, as well as the Intensive Care Unit. The Director of Nursing said the cardiac/pulmonary policies and procedures speak specifically to the cleaning of the leads as well as hand sanitation. 14. . 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 rules. Each day of violation constitutes a separate violation and is subject to a separate fine. Section 395.1065, Florida Statutes (2010). 15, 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 FIVE HUNDRED DOLLARS ($1,500.00). ‘ COUNT II The Respondent Failed To Ensure Implementation Of The Requirement That Soiled Linen Is Collected fn Such A Manner As To Minimize Microbial Dissemination Into The Environment As Approved In Policy And Procedure By The Infection Control Committee And Governing Body In Violation Of Rule 59A-3.250(3)(a)-(), Florida Administrative Code 16. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 17. Pursuant to Florida law, the policies and procedures devised by the infection control program shall be approved by the governing body, and shall contain at least the following: (a) Specific policies for the shelf life of all stored sterile items. (b) Specific policies and procedures related to occupational exposure to blood and body fluids. (c) Specific policies and procedures related to admixture and drug reconstitution, and to the manufacture of intravenous and irrigating fluids. (d) Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, Florida Administrative Code, May 1995, OSHA 29 CFR Part _ 1910.1030 Occupational Exposure to Blood Borne Pathogens Final Rule, July 1995, and the Department of Environmental Protection Code Chapter 62-712 on Biomedical Waste, May 1995. . (ce) Specific policies related to the selection, storage, handling, use and disposition of disposable items. (f) Specific policies related to decontamination and sterilization activities performed in central services and throughout the hospital, including a requirement that steam gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly. (g) Specific policies regarding the indications for universal precautions, body substance isolation, Centers for Disease Control isolation guidelines, or equivalent: and the types of isolation to be used for the prevention of the transmission of infectious diseases. (h) A requirement that soiled linen is collected in such a manner as to minimize microbial dissemination into the environment. (i) A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, Florida Administrative Code, be promptly and properly reported in accordance with the provisions of that rule. Rule 59A-3,250(3)(a)-(i), Florida Administrative Code. 18.° On or about September 13, 2010 through September 16, 2010, the Agency conducted a Licensure Survey at Respondent’s facility. 19. Based on observation, document review, and interview, the ‘facility failed to ensure implementation of the requirement that soiled linen is collected in such a manner as to minimize microbial dissemination into the environment as approved in policy and procedure by the Infection Control Committee and Governing Body. 20. During a tour of the facility on September 13, 2010 at 12:30 p.m., it was observed there was a large pile of linen on the floor against the wall in room 306-A. The patient was observed to be in the bed and a visitor was observed to be present at the bedside. It was also observed that an underpad was on the floor against the wall in room 307-A. A patient was observed to be in the bed. The linen on the floor in room 307-A was brought to the attention ofa random staff nurse. She stated, "They just changed him." The tour was continued and the linen on the floor was brought to the attention of the Unit's Clinical Coordinator. 21. Facility policy review included the Infection Control Policy "Standard and Extended Precautions" (IP-123) last revised July 2009. Under II E (Standard Precautions, Linen) the policy states: "Although soiled linen may be contaminated with pathogenic microorganisms, manner that avoids transfer of microorganisms to patients, personnel and environments." "Assume all linen is contaminated..." 22. 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 rules. Each day of violation constitutes a separate violation and is subject to a separate fine. Section 395.1065, Florida Statutes (2010). 23. 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: 1. 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 TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent. 3. Order any other relief that the Court deems just and appropriate. Respectfully submitted this Anal day of Araceae. 2010. i ra f, (A 4, Mary Daley , 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) 412-3630. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING 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 form 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 4060, 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 U.S. Certified Mail, Return Receipt No. 7002 2410 0006 5966 4053, on this teal day of. Laceraliete 2010. (patsy Ladies a kedias flary Daley Jacobs, 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 Copies furnished to: [ Joseph Clancy, Chief Executive Officer Mary Daley Jacobs, Assistant General Counsel Port Charlotte HMA, LLC Agency for Health Care Administration d/b/a Peace River Regional Medical Center Office of the General Counsel 2500 Harbor Boulevard 2295 Victoria Avenue, Room 346C Port Charlotte, Florida 33952 Fort Myers, Florida 33901 (USS. Certified Mail) (nteroffice Mail) CT Corporation System, Registered Agent for | Harold Williams, Field Office Manager Port Charlotte HMA, LLC Agency for Health Care Administration d/b/a Peace River Regional Medical Center 2295 Victoria Avenue, Room 340A 1200 South Pine Island Road Fort Myers, Florida 33901 | Plantation, Florida 33324 (Interoffice Mail) (U.S. Certified Mail) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, VS. Case No. 2010010829 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 ‘aust be returned by mail or by fax within twenty-one (21) days of the date you recéive 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 i 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. | 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 COMPLETE THIS SECTION ON DELIVERY ha ‘Agent * 0 Addresses oat iy (Pa . aan canes D, Is delivery atidress different from wf im Yes {f YES, enter delivery addrass below: DB No SENDER: COMPLETE THIS SECTION . @ Complete Items 1, 2, and 3, Also complete item 4 If Restricted Delivery Is desired. @ Print your name and address on the reverse so that we can raturn the card to you. § Attach thio card to the back of the mallptece; or on the front if space permits, “f, Article Addressed to; © O1O01 Joseeh Clancy C&O Peace River Regional Med Couker 2900 far ba (avievard haclo tle, Fr loride fart C , 83957 CQ insured Mall 1 ¢.0,0. qs 4, Restricted Delivery? (Extra Fee) ves * Nocona 7002 2410 O00b Stk 4053 (Transfer from service label) PS Form 3811, February 2004 Domestto Return Receipt 102695-02-M-1640 3. Service Type CI Gertited Mall 4) Express Malt CO Registered (2 Return Recelpt for Merchandise Rine, George R. From: Weaver, Amy Sent: Wednesday, February 23, 2011 3:03 PM To: Jacobs, Mary; Rine, George R. Ce: Shoop, Richard Subject: PORT CHARLOTTE HMA: 2010010876, 2010010829, 2010010754 Good Afternoon, When possible could you please send the NOI and Green Card for the case mentioned above? We received the EOR on 02/18. Thanks. Amy Leah Weaver Agency for Health Care Administration Office of the General Counsel Staff Assistant 2727 Mahan Drive, Building 3, MS 3 Tallahassee, FL 32308 Telephone: (850) 412-3689 Fax: (850) 921-0158 Email: weavera@ahca.myflorida.com

Docket for Case No: 11-001119

Orders for Case No: 11-001119