-NOV-23-2005 WED 02:35 PH Shutts and Bowen FAA NU, sUos0lesoe STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, : “AHICA No.: 2005008930 ; Retum Receipt Requested VS. 7002 2410 0001 4234 7203 . 7002 2410 0001 4234 7524 HEALTH ENVIRONMENT MEDICAL CENTER CORP., d/b/a HEALTH ENVIRONMENT MEDICAL CENTER CORP., Respondent. / i ADMINISTRATIVE COMPLAINT. The STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRA- TION (hereinafter “AFCA” or the “A gency”), by and through its undersigned counsel, hereby files and serves this ADMINISTRATIVE.COMPLAINT against Respondent, HEALTH ENVIRONMENT MEDICAL CENTER CORP., d/b/a HEALTH ENVIRONMENT MEDICAL CENTER CORP., pursuant to Sections 120.569, and 120.57, Florida Statutes (2005), and alleges: NATURE OF THE ACTION 1. This is an administrative action to revoke or suspend Respondent’s health care clinic license, number HCC 5760, and to impose administrative fines totaling TEN THOUSAND DOLLARS AND NO/100 (310,000.00) pursuant to Sections 400.9935 and 400.995, Florida Statutes (2005), for non-compliance with the Health Care Clinic Act. _NOV-23-2005 WED 02:36 PM Shutts and Bowen rAA NU, SU0o0 1} dooe ; JURISDICTION & VENUE 2. AHCA has jurisdiction pursuant to its regulatory authority under the Health Care Clinic Act (“Act”), Chapter 400, Part XII, Florida Statutes (2005). In the event that Respondent requests a formal hearing in the manner required by law and AHCA thereafter refers the case to the Division of Administrative Hearings (““DOAH ”, then DOAH will have jurisdiction pursuant to Sections 120.569 and 120.57, Florida Statutes (2005). 3, Venue for any formal hearing shall be determined pursuant to Rule 28- 106.207, Florida Administrative Code. ) 4. Tn the event Respondent requests an informal hearing (i.e., no dispute as to the underlying material facts), then the Agency will refer the matter to an informal hearing officer who will hear the matter as to any argument as to the application of the Jaw to the undisputed underlying facts pertaining to the suspension or revocation, and fines. PARTIES 5, AHICA is the regulatory agency responsible for the licensure of Florida health care clinics and for the implementation and enforcement of the Act, including in particular the licensure of non-exempt infusion clinics engaged in providing infusion therapy services to patients in a clinic setting (outpatient) rather than a hospital setting. 6. HEALTH ENVIRONMENT MEDICAL CENTER CORP., owns, operates and is doing business as HEALTH ENVIRONMENT MEDICAL CENTER CORP (“Respondent”), Respondent's principal business address js 358 Hast 6 Street Hialeah, nN . NOV-23-2005 WED 02:36 PH Shutts and Bowen FAK NO, 309301 dee FL 33010. Respondent's mailing address is 358 E. 6 Street Hialesh, FL 33010. The Clinic is located at 3750 West 16" Ave., Hialeah, Florida 33012. . 7, Atall times material to this proceeding Respondent has been engaged and is now enpaged in providing infusion therapy services to patients. Respondent is licensed to operate the Clinic under license number HCC 5766, issued to Respondent by the Agency on or about June 17, 2004. 8. At all times material hereto, Respondent was required to comply with the Act. "INFUSION THERAPY SERVICES 9, Many patients with HIV infection need intravenous (IV) therapy a at some point in the course of their treatment. While IV therapy generally is provided in hospital settings, in some circumstances it can be provided properly in an outpatient setting, either jn the home or in an outpatient infusion center such as Respondent's Clinic. 10. Intravenous therapy is the therapeutic infusion and/or injection of substances through the venous peripheral system, consisting of activity which includes: observing, initiating, monitoring, disoontisuing, maintaining, regulating, adjusting, documenting, planning, intervening and evaluating, as recognized by administrative rule in Florida. See Rule 64B9-12.002 (1), defining intravenous therapy. 11, Outpatient infusion therapy at infusion clinics includes administration of nutrition, antibiotic therapy, and fluid and electrolyte repletion. Such outpatient IV therapy has risks. Most notable are potential serious adverse effects of administered medications and the possibility of thrombosis and infection related to IV catheters. 12. The drugs used in infusion therapy, some of which have been used by Respondent, are dangerous if not administered carefully and properly as to each patient. NOV-23-20U9 WED Uc so rit onutis anda Gowen PAA NU. QUo90lauoc id 13. In an outpatient infusion clinic’setting, adverse events can be difficult to monitor and manage as to the clinic’s patients. ) 14. Bach infusion clinic must determine the suitability of individual patients for outpatient TV therapy. Patients who do not meet certain criteria are not good candidates for complex outpatient infusion therapy. Further, clinically unstable patients should not be considered for complex outpatient IV therapy. 15. ‘The relative cost of infusion therapy services is very expensive in comparison with most ather kinds of health care services provided in health care clinics generally. Such significant cost for infusion therapy services, as provided or rendered by infusion clinics as well as hospitals, is almost universally billed to Medicare, which is the case as to the infusion services provided by Respondent. 16. As to this relative cost of infusion therapy services, the cost of a single infusion given to an individual AIDS/HIV patient is often in the thousands of dollars, . even more than $10,000 for a single infusion session. The relatively high expense of infusion therapy services generally applies to services that have been and are being rendered by Respondent to its patients. Patients of infusion clinics, including the subject clinic, often receive mitltiple treatments or infusions ina single week, sometimes even twice in a single day, and such treatments often continue for many weeks, sometimes months. 17. Inshort, the nature and cost of infusion therapy services, especially as provided in an outpatient clinic setting, place a high degree of responsibility upon any clinic licensee with respect to assuring not only the health, safety and welfare of patients ’ of the clinic. - NOV-23-2005 WED 02:38 PH Shutks and Bowen FAA NQ, sUase lose roi THE FLORIDA HEALTH CARE CLINIC ACT AS DEA 18. The Act establishes the role and importance of an appointed medical director or clinic director in Florida health care clinics generally, and expressly requires that each licensed clinic must place its “clinic responsibilities” in the hands of its medical director or clinic director, who in turn must agree in writing to accept legal responsibility for certain specified activities, as follows: 400.9935 Clinic responsibilities.-- (1) Each clinic shall appoint a medical director or clinic director who shall agree in writing to accept legal responsibility for the following activities on behalf of the clinic. The medical director or the clinic director shall: : (a) Have signs identifying the medical director or clinic director posted in a conspicuous location within the clinic readily visible to all patients. (b) Ensure that all practitioners providing health care services or supplies ‘to patients maintain a current active and unencumbered Florida license. (c) Review any patient referral contracts or agreements executed by the clinic, ° : (d) Ensure that all health care practitioners at the clinic have active appropriate certification or licensure for the level of care being provided. (e) Serve as the clinic records owner as defined in section 456.057 (f) Ensure compliance with the recordkeeping, office surgery, and adverse incident reporting requirements of chapter 456, the respective practice acts, and rules.adopted under this part. (g) Conduct systematic reviews of clinic billings to ensure that the billings are not fraudulent or unlawful. Upon discovery of an unlawful charge, the medical director or clinic director shall take immediate corrective action, * * * * 19. §400.991(7)(a) of the Act expressly contemplates that aclinic’s medical or clinic director or similarly titled person shall be “responsible for the day-to-day operation of the licensed clinic... .” 20. The Act provides the Agency with the express authority to revoke a clinic license in two separate provisions within the Act, as follows: NQV-e3-cUU9 WED Ue so FM onulls and bowen PRA NU, 30050 ldgGe a. §400.9935 of the Act, regarding clinic responsibilities, authorizes the Agency to revoke the license of any clinic and states as follows: (7) The agency may fine, or suspend or revoke the license of, any clinic licensed under this part for operating in violation of the requirements of this part or the rules adopted by the agency. b. §400.995 ofthe Act, regarding Agency administrative penalties, states: (1) The agency may deny the application for a license renewal, revoke or suspend the license, and impose administrative fines of up ta $5,000 per violation for violations of the requirements of this part or rules of the agency. ‘ 91, As indicated in the preceding paragraph, in addition to authorizing the Agency to revoke or suspend a health care clinic license, Section 400.995(1), Florida Statues (2005), also authorizes the Agency to impose fines of up to FIVE THOUSAND AND NO/100 DOLLARS ($5000.00) per violation of Chapter 400, Part XIIL, Florida Statutes (2005). NON-COMPLIANCE WITH TBE ACT 22. On September 28, 2005, the Agency with its authorized personnel conducted — an unannounced onsite inspection (hersinafter referred to as the “survey”) of the subject clinic to determine compliance with the Act. On that date, the Agency’s surveyor and other members of the survey team observed and substantiated following facts: a. that Respondent has been licensed to operate for the period from June 17, 2004 to the present time; b. thal Respondent provided infusion therapy services dunng that period; c. that Respondent tendered charges for infusion therapy Bervices provided or ostensibly provided to its patients during that period, for which infusion therapy services or ostensible infusion therapy services Respondent sought reimbursement from third parties inchiding Medicare; and _ NOV-23-2005 WED 02:36 PH Shutts and Bowen TAA NU, gUoa0luv0c d. that Respondent, by and through its representatives present at the clinic at the time of the survey, knew ofits legal obligation to have a medical or clinic director who agreed in writing to accept and carry out the legal responsibilities of said clinic as delineated in §400.9935 of the Act; e. that the owner of the clinic, Mr. Arturo Garcia, stated to the surveyors and inspectors on September 28, 2005, that Dr. Julio Pino was the clinic’s medical director; { that Respondent was not able to produce a written agreement signed by Dr, Pino showing that he has accepted the responsibilities of being the medical director for the clinic pursuant to §400.9935(1) of the Act; g. that Respondent had instead a signed contract with Dr. Alphonso Ramirez, whose name was on the entry door and the Medical Director’s office as medical director pursuant to § 400.9935(1) and § 400.9935(1)(a) of the Act; | h. that Dr, Ramirez has not been working for this clinic for the past three months. j. that Dr. Julio Pino was interviewed by the surveyors and inspectors on September 28, 2005, and Dr, Pino stated that he would cease to be the clinic’s medical director after October 1, 2005; j. that Dr, Julio Pino stated that medical assistants, Angel Betancourt and Ammerys Garcia, have been preparing and administering infusion therapy medications to patients; neither Mr. Betancourt nor Ms. Garcia are qualified to give infusion therapy because neither one is a registered nurse or a licensed practical nurse. 23, The conduct and omissions of Respondent constitutes non-compliance with §400.9935(1) of the Act and warrants and legally justifies the revocation or suspension of Respondent’s subject license. 94. The facts indicate that individuals who are not qualified to do so have. been providing infusion therapy to the clinic’s patients, 25. Certain non-physician health care providers are authorized by law to perform intravenous therapy. See e.g., Chapter 6489-12, Florida Administrative Code (2005) is . NOV-23-2005 WED Q2:36 rl shutts ana Bowen TRA NY. sbosoledae 1 ' (authorizing licensed practical nurses ito perform intravenous therapy). However, the applicable statutory provision setting forth the duties and responsibilities a medical assistant may undertake under the direct supervision and responsibility of a licensed physician does not authorize medicallassjstanls to perform intravenous therapy. See, Section 458.3485, Florida Statutes (2005). ; CLAIM FOR RELIEF tL 1. Respondent’s medical director, Dr. Julio Pina, did not have a signed, written agreement evincing that he has decepted the Ipgal responsibilities of being the medical director for the clinic. Such failure is a violation of Section 400.9935(1), Florida Statutes (2005), subjecting the respondent to: (a) a fine of FIVE THOUSAND) AND NO/1N0 DOLLARS ($3,000.00), pursuant to Section 400.995(1), Florida Statues (2005), and/or (b) revocation or suspension ofithe Respondent's health care clinic license (HICC5760), pursuant to Sections 400.9935(7) and 400.995(1), Florida Statutes (2005). . 2. Furthermore, based upon the determination that two medical assistants were performing intravenous therasy, a type of therhpy that a medical assistant is not authorized to perform, the Agency determined that Julio Pina, M.D., the Respondent’s medical director, failed to ensure that all health care practitioners at the clinic have active appropriate certification or licensure for the level of care being provided. Such failure is aviolation of Section 400.9935(1){d), Blorida Statytes (2005), subjecting the respondent to: IV NOV-e3~cUU9 WED Ucrod rH onutts and Bowen PHA WU. JUJI0LOddEe (a) a fine of FIVE THOUSAND AND NO/100 DOLLARS ($5,000.00), pursuant to Section 400.995(1), Florida Statues (2005), and/or (b) revocation or suspension of the Respondent’s health care clinic license (HICC5760), pursuant to Sections 400,9935(7) and 400.995(1), Florida Statutes (2005). 3. The conduct and omisaions of Respondent as set forth herein constitute - non-compliance with and violations of Sections 400,9935(1) and 400.9935(1)(d) Florida. Statutes (2005). Such violations warrant and legally justify the following: (a) the imposition of a total fine of TEN THOUSAND AND NO/100 DOLLARS ($10,000.00) and/or in the alternative: . (b) the revocation or suspension of Respondent’s license to operate a health care clinic pursuant to Section 400.995(1), or alternatively Section 400.9935(7), Florida Statutes (2005). . ) WHEREBY, the Petitioner, State of Florida Agency for Health Care Administration requests the above-stated relief. Respectfully submitted this yay of November, 2005. Trin LawtoréRussell, Esq. Assistant General Counsel Agency for Health Care Administration _ 8350 N.W. 52 Terrace - #103 Miami, Florida 33166 305-470-6805 tt _ , NOV-23-2005 WED 02:36 PH Shubts and Bowen FAA NU, alasolodbe re oto cod TO yt NOTICE Bae BS Respondent is notified that it has a right to request an administrative hearing # Zz 2 pursuant to Sections 120.569 ‘and 120.57, Florida Statutes. Specific options for . idministrative review of the relief sought herein are set out in the attached Election of Rights form and explained in the attached Explanation of Rights form. All requests for hearing shall be made to the Agency for Health Care Administration and delivered to: ” Mr. Richard Shoop, Agency Clerk Agency for Health Care Administration Building #3, MSC #3 2.727 Mahan Drive Tallahassee, Florida 32308 Please also furnish a copy thereof to the above-named AHCA Assistant General Counsel who prepared and signed this Administrative Complaint (see address below signature). ; . ; RESPONDENT IS FURTHER NOTIFIED THAT THE AGENCY MUST RECEIVE A REQUEST FOR HEARING WITHIN 21 DAYS OF RECEIPT: OF THIS PLEADING BY RESPONDENT. FAILURE TO COMPLY WILL CONSTITUTE AN ADMISSION OF THE FACTS ALLEGED HEREIN AND RESULT IN ENTRY OF A FINAL ORDER BY THE AGENCY CONSISTENT WITH THE ACTIONS CONTEMPLATED BY THE AGENCY IN THIS PLEADING. _ Copies furnished to: Diane Lopez Castillo Field Office Manager Agency for Health Care Administration 8355 NW 53” Street, 1" Floor Miami, Florida 33166 — (interoffice Mail) Jean Lombardi ° Finance and Accounting Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) 10 0 je . NOV-23-2005 WED 02:37 PM shutts and Bowen NU, JUO00ldd0e Health Care Clinics Unit Program Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) CERTIFICATE OF SERVICE _ THEREBY CERTIFY that a true and correct copy of the foregoing was sent by U.S. Mail Certified Return Receipt Requested to Mr, Arturo Garcia, owner and registered. agent for Health Environment Medical Center, Corp., 358 East 6 Street, Hialeah, Florida 33010 and Health Environment Medical Center Corp.. 3750 W. 16" Avenue, Hialeah, Florida 33012 on this Thay of Rpuemben, a Lawton-Russell, Esquire Ww

Docket for Case No: 05-004522