Findings Of Fact In the November 27, 1985 edition of The Florida Administrative Weekly, Volume 11, Number 48, the Board noticed Proposed Rules 21G-14.001(7) and 21G-14.005(1), Florida Administrative Code, which were timely challenged by petitioner and which provide as follows: 21G-14.001 Definitions. * * * (7) Office team approach - A methodology employed by a dentist in the administration of general anesthesia and parenteral conscious sedation whereby the dentist may use one or more qualified anesthetic auxiliaries who, working under the direct supervision of the dentists assist the dentist, and assist in emergency care of the patient. 21G-14.005 Application for Permit. (1) No dentist shall administer or super- vise the administration of general anesthesia, or parenteral conscious sedation in a dental office for dental patients, unless such dentist possesses a permit issued by the Board. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially. The cited statutory authority for these proposed rules includes Sections 466.004(3) and 466.017(3), Florida Statutes. Parenteral conscious sedation is defined by proposed Rule 210-14.001(6), which is not challenged in this case, as 21G-14.001 Definitions. * * * (6) Parenteral conscious sedation - A depressed level of consciousness produced by the parenteral administration of pharma- cologic substances, that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medications via all parenteral routes, that is: intravenous, intramuscular, subcutaneous, submucosal, or inhalation. A patient who is receiving parenteral conscious sedation will frequently slip in and out of consciousness, or a state of general anesthesia. General dentists do not receive adequate training in undergraduate dental school in the administration of general anesthesia and the treatment of medical emergencies which may result there from, and are not qualified to administer general anesthesia or treat resulting medical emergencies. The evidence is undisputed that a dentist who lacks the additional training in general anethesia and parenteral conscious sedation, which would be required under these rules, is not capable of competently and safely administering anesthesia or sedation himself, and does not possess the ability to competently assess all risks attendant to the administration of general anesthesia or parenteral conscious sedation. Additionally, such a dentist is not able to competently assess whether a patient is an acceptable risk for anesthesia or sedation, or to react to medical complications that may arise, such as respiratory obstruction and arrest, allergic or idiosyncratic reaction to drugs, cardiac arrest, miocardial infarction, seizures, and hypertensive crises. Since general dentists without further training in anesthesia are not qualified to administer general anesthesia in their dental office, or treat resulting medical emergencies, they are also not qualified to supervise the administration of general anesthesia in their office. The educational training received by undergraduate dentists in accredited dental schools in the United States and Canada offers only a brief didactic exposure to general anesthesia and parenteral conscious sedation of about 48 classroom hours. Clinical training is not offered. It is only at the graduate level of training, internship or residency programs that dental schools are required to offer training in dealing with medical emergencies. The general dentist does not maintain the equipment necessary to deal with medical emergencies and life threatening occurrences. Life threatening medical emergencies can develop while a patient is under general anesthesia, and a dentist administering or supervising the administration of general anesthesia must be able to deal with such emergencies. Undergraduate dental schools devote less than twenty-one hours in their entire program to the handling and treatment of medical emergencies and the evaluation of patients, and this does not prepare a general dentist without further training to deal with such emergencies. Certified registered nurse anesthetists (CRNA) are licensed by the Board of Nursing as advanced registered nurse practitioners. According to Nursing Board Rule 210-11.22, Florida Administrative Code, amended June 18, 1985: 210-11.22 Functions of the Advanced Registered Nurse. All categories of Advanced Registered Nurse Practitioner may perform functions listed in Section 464.012(3), F.S. The scope of practice for all categories of ARNPs shall include those functions which the ARNP has been educated to perform including the monitoring and altering of drug therapies, according to the established protocol and consistent with the practice setting. Specific activities which a CRNA may perform are enumerated in Section 464.012(4)(a), Florida Statutes (1984 Supplement). However, Section 464.012(3) specifies that these activities must be within the framework of an established protocol and that a licensed medical doctor, osteopathic physician or dentist shall maintain supervision for directing the specific course of medical treatment on any patient. Thus, a CPNA is not authorized to work independently on patients, but must operate within established protocols and under supervision. In order to become a CRNA, a registered nurse with at least one year's clinical experience in critical care nursing has to graduate from a two year accredited nurse anesthetist program comprised of approximately 425 contact hours, and also conduct 450 administrations of anesthesia consisting of 800 hours of actual anesthesia time. Thus, a CRNA has more training and experience in the administration of anesthesia than a general dentist receives in undergraduate dental school. The proposed rules in question were adopted to preclude a general dentist from employing a CRNA to administer anesthesia in his office unless he has received training beyond undergraduate dental school in anesthesia and has obtained a permit from the Board. As expressed in the Purpose and Effect portion of the notice for these proposed rules: The effect of the proposed amendment will be further assurance that those dentists who are using anesthesia, and related forms of sedation, have met minimal standards designed to protect the public's health, safety and welfare . . . * * * The purpose of the proposed rules is to implement the provisions of Section 466.017 (3)(e), F.S., as enacted by the 1985 Florida Legislature. The rules are designed to insure that those dentists who utilize general anesthesia or parenteral conscious sedation in a dental office for dental patients on an outpatient basis meet certain minimum qualifications. It is the opinion of the Board that dentists who administer or supervise the administration of general anesthesia or parenteral conscious sedation on an outpatient basis must satisfy certain training, equipment, and staffing requirements prior to engaging in such activity. The effect of the proposed rules is the establishment of a permitting procedure, as well as the requirement that adverse occurrences resulting from the use of nitrous- oxide inhalation analgesia, parenteral conscious sedation, general anesthesia be reported. These new procedures and require- ments should enhance the protection of the public from-licensees who are otherwise not competent to use general anesthesia, parenteral conscious sedation, or nitrous- oxide inhalation analgesia. The Economic Impact Statement (EIS) accompanying these proposed rules states, in pertinent part that: The proposed amendment will have some economic impact upon those licensees who are currently authorized to use general anesthesia and parenteral sedation. Upon the effective date of these rules, these individuals will be required to pay a permit application fee as well as expend those funds necessary to bring their training, equipment, and staffing level up to the requirements of the proposed rules. The precise number of dentists to be affected by the proposals and the precise impact upon them, other than the permit application fee, is not known at this time. * * * The proposed rules should have an economic impact upon those dentists who currently admin- ister or supervise the administration of general anesthesia and parenteral conscious sedation. Although the proposed rules do not in any way affect a dentist's ability to utilize general anesthesia or parenteral conscious sedation in a hospital or other medical facility, the rules will require the dentist to obtain a permit and to maintain his office at certain equipment and staffing level. Aside from the permit appli- cation feed the precise economic impact upon those dentists who currently utilize general anesthesia or parenteral sedation is not known at this time. It is anticipated that any additional costs to the practitioner will be passed on to the consumer. The fact that patient costs might increase as a result of these proposed rules was supported by Petitioner's witnesses Ira Gunn and Barbara Quick, but neither witness offered any more detailed information about the economic impact of these proposed rules than is contained in the Economic Impact Statement. Further, Petitioner offered no evidence to show that the proposed rules would affect persons other than those referenced in the Economic Impact Statement. It has not been demonstrated that the Economic Impact Statement is either inadequate, misleading or inaccurate. The evidence in the record is insufficient to support a finding that Petitioner is a non-profit corporation registered in Florida and is composed of a majority of the licensed nurse anesthetists in Florida, that it is the only Florida association of general membership representing nurse anesthetists, or that many of its members will be substantially affected by these rules. There is no evidence of Petitioner's legal status, its purposes as reflected in any by-laws, its membership, or the number of members who will be substantially affected by the rules. Thus, Petitioner has not proven the allegations in its petition regarding its standing in this matter.
The Issue Whether Respondent, Dien Duong, violated the provisions of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, as specifically alleged in the Administrative Complaint, and, if so, what penalty would be appropriate.
Findings Of Fact Based upon observation of the witnesses and their demeanor while testifying, the documentary evidence received, and the entire record compiled herein, the following material and relevant facts are found: Petitioner, Department of Health, Board of Medicine, is the state agency charged with regulating the practice of physician's assistants pursuant to Chapters 455 and 458, Florida Statutes, and Section 20.43, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician's assistant in the state of Florida, having been issued license number PA 0003211 in 1997. Respondent received a Bachelor's Degree in Biology from Hope College, Holland, Michigan, in 1989 and thereafter received her physician's assistant degree from Western Michigan University in 1991, and became certified in Family Practice and in Surgery in Michigan upon graduation. Respondent has maintained her certification in Family Practice and in Surgery by successfully passing an examination every six years since 1991, in addition to taking a minimum of 100 hours of Continuing Medical Education (CME) courses each year. In 1997 Respondent began working at South Florida Baptist Hospital Emergency Department and has maintained her employment in that department as a physician's assistant. During the course of her employment, Respondent has gained extensive experience in the practice of assessing lacerations and repairing lacerations of all types. Respondent is highly respected by her employing physician, Dr. Charles Eaves, and by her supervising physicians in the emergency department of the hospital. Respondent has never been the subject of discipline or corrective action regarding her professional job performance as a physician's assistant. A physician's assistant is a licensed health care professional who works under the supervision of a doctor. Typical protocol between the supervising doctor and the physician's assistant is for the physician's assistant to inspect and evaluate the patient, examine the injury, prepare the patient for treatment, consult with the supervising doctor, and thereafter administer treatment to the injury approved by the doctor, followed by after-care instructions to the patient. Based upon the testimony of the experts, the protocol between experienced physician's assistants and their supervising doctors is based upon the doctor's respect and confidence in the physician's assistant's abilities, competence, experience and work history. In these mutual trust and respect working relationships, protocol typically permits the physician's assistant to work relatively autonomously. Without involvement of the supervising doctor, the physician's assistant examines emergency room injuries; they often treat the injured patient, and thereafter present the patient's case treatment and the patient's medical record to the supervising doctor for approval and, when recommended, signature for prescribed medication. The protocol between Respondent and her supervising physician, Dr. Diaz, at South Florida Baptist Hospital on May 8, 1998, was that of mutual trust. Patient D.Z. was a 33 year-old male who had fallen from a ladder and, while attempting to break his fall with his right hand, suffered a blunt, T-shaped, tear-like laceration injury to his right hand. The injury was on the palmar aspect in the area of the fifth metacarpal of the hand-bone that extended to the small finger; a complex laceration, described by doctors as a "sort of bust or blunt type," as opposed to a clean knife cut type, approximately 3/4 centimeter in depth. On May 8, 1998, D.Z. presented himself to the South Florida Baptist Hospital (Hospital) emergency room for treatment of his right hand laceration that extended to the subcutaneous level with subcutaneous tissue exposure. The Hospital's triage nurse, after completing preliminary patient information, directed D.Z. to First Care, that part of the hospital's emergency department where Respondent was working. Respondent, following protocol, examined D.Z.'s injured right hand and ordered x-rays to be taken. An x-ray was taken of D.Z.'s right hand and was reviewed by Respondent's supervising physician, Dr. Diaz, prior to treatment of the injury by Respondent. Dr. Diaz concluded that D.Z.'s x-ray was negative, with no broken bones or tendon involved. The medical records noted that D.Z. had the full range of motion of his fingers without numbness or tingling at that time. Respondent's treatment of D.Z. consisted of laying D.Z. on his back with his arm out to his side and using local anesthesia to numb the injured area. After numbing the hand, she infiltrated the wound with one percent plain Lidocaine, irrigated the wound with normal saline, and cleaned the wound with Betadine. She then debrided the tissue. Using sterile techniques, Respondent proceeded to suture the T-shaped laceration of D.Z.'s right hand. Because of the shape and depth of the laceration and because of the exposure of jagged-edge tears to the subcutaneous tissues, Respondent placed four subcutaneous sutures with 4.0 vicryl, an absorbable suture, in order to bring and keep the jagged-edged tears of D.Z.'s laceration together. For the type of wound suffered by D.Z., described as "bust-type-ripping-flesh tear," it is not possible to close a three or four centimeter wound with only surface sutures. Subcutaneous sutures are required for those wounds of this type and depth. For these reasons and acting appropriately within the scope of the practice of an experienced physician's assistant, Respondent determined to use subcutaneous sutures on D.Z., who is right-hand dominate. The experts who testified, Dr. Eaves, Dr. Solomon, Dr. Maddalon and Ms. Vergara, agreed that the process of using subcutaneous sutures helps to control bleeding, reduce tension within the laceration, and minimize potential "air pockets" within the wound, thereby promoting the healing process, and preventing potential, after-surgery, complications. In accord with protocol established between Dr. Diaz and Respondent, it was at the conclusion of her treatment care of D.Z. that she advised Dr. Diaz of her subcutaneous suture treatment and follow-up care plan. Respondent presented D.Z.'s record for his review, approval and signature. Dr. Diaz approved Respondent's subcutaneous suture treatment, her follow- up care plan of keeping the wound clean, taking the prescribed medication and having the sutures removed within a few days during his follow up a doctor of his choice. Dr. Diaz signed both the Emergency Room report and Respondent's suggested prescription medications for D.Z. On May 11, 1998, four days after his treatment and without obtaining and taking his prescription medications as instructed, D.Z. presented himself to Dr. Maddalon's office for a follow-up examination and evaluation of his injury. On May 14, 1998, Dr. Maddalon, who employed D.Z.'s mother as his office manager and had employed D.Z. for six years to clean his office and who had operated and treated D.Z.'s right hand for carpal tunnel syndrome some years earlier, examined D.Z.'s right hand following an earlier examination by his physician's assistant. On May 15, 1998, during exploratory surgery, Dr. Maddalon reopened the laceration of D.Z.'s right hand and observed that a subcutaneous suture had passed through the ulnar nerve and tied the ulnar digital nerve to the adjoining soft tissue. He removed the subcutaneous suture and removed the damaged part of the ulnar nerve. He then re-attached the exposed ends of the ulnar nerve. D.Z. recovered satisfactorily from Dr. Maddalon's surgery with most but not all of the sensation returning to the little finger on his right hand. According to his deposition, and without a review of D.Z.'s medical records from South Florida Baptist Hospital emergency room prepared by Respondent, Dr. Maddalon opined that certain protocol should be followed in treating "blunt-tear" type hand injuries like that suffered by D.Z. Dr. Maddalon went on to stress, however, that in his opinion placing subcutaneous sutures in such an injury as D.Z.'s was not below the standard of care for a physician's assistant. Deborah Vergara, a physician's assistant at Town and Country Hospital, Tampa, Florida, qualified as an expert in physician's assistants' duties, responsibilities and protocol, and after reviewing D.Z.'s medical records, opined that the care provided D.Z. by Respondent during treatment on May 8, 1998, was appropriate for a patient with D.Z.'s type laceration and was not below the standard of care for a physician's assistant. Deborah Vergara further opined that a suture passing through the ulnar nerve, in and of itself, is not a breach of the standard of care, and she was not aware of any textbooks for physician's assistants that prohibited ever placing subcutaneous sutures in a laceration. Dr. Charles Eaves, D.O., an expert in emergency medicine and an expert in supervising physician's assistants and who also has been the supervising doctor of South Florida Baptist Hospital for the past three years, opined that Respondent's placing subcutaneous sutures in a palmar laceration was absolutely within the standard of care. Dr. Eaves further opined that Respondent's entries in D.Z.'s medical records were within the standard of care. Dr. Barry Solomon, Board Certified expert and employed by the Physician Health Care Alliance in Clearwater, Florida, after review of all of D.Z.'s medical records from South Florida Baptist Hospital, the Administrative Compliant filed in this case, Dr. Maddalon's deposition, and records from Brandon Regional Medical Center, gave his opinions in the following areas: Protocol of supervising physician and physician's assistants working in specific areas of medicine. According to Dr. Solomon, physician's assistants generally operate with relative autonomy, based upon the experience of the assistant and the confidence of the supervising physician. Physician's assistants see low acuity patients, leaving the physician to see high acuity patients. Physician's assistants do check with the physician on duty as they proceed through treating a patient, checking to make sure what they are going to do is appropriate and have the physician review and sign the chart as the patient is being made ready for discharge. Protocol for physician's assistants suturing palmar lacerations. Dr. Solomon opined that Respondent's conduct when presented with a patient with a palmar laceration in a subcutaneous area with an abnormal, complex laceration, and after assessment for nerve damage, tendon damage, bone injury, and after obtaining an x-ray which was reviewed by the emergency room physician at the time, and then proceeding to place a two- layer closure consisting of four subcutaneous sutures and eleven external sutures to close the wound, was within the standard of care of physician's assistant, in this case, the Respondent. Dr. Solomon further opined that there is nothing wrong with placing subcutaneous sutures in a hand laceration and there is always a risk, with a deep wound that nerves, blood vessels, arteries and veins could potentially be hit or sutured. This risk is a recognized complication when one places subcutaneous sutures in that (hand) part of the body. He concludes that Respondent practiced within the physician assistant's standard of care in her subcutaneous suture treatment of Patient D.Z.'s right hand. Petitioner has failed to provide the opinion of an expert that establishes a standard of care for an experienced physician's assistant; has failed to provide evidence of standard of care for maintaining medical records; and has failed to provide an expert opinion in support of the allegation that Respondent's treatment of D.Z.'s right hand laceration fell below a physician's assistant standard of care for treatment of hand lacerations. The testimony of Dr. Charles Eaves, Dr. Barry Solomon and Deborah Vergara is credible in establishing that Respondent, Dien Duong, actions were not violations of Subsection 548.331(1)(m) and 488.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty of violating Subsections 458.331(1)(m) and (t), Florida Statutes. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. FRED L. BUCKINE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of May, 2002.
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part II, and Chapter 400, Part X, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The parties have since entered into the attached Settlement Agreement, (Ex. 2). Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The facility’s Certificate of Exemption is deemed surrendered and is cancelled and of no further effect. 3. Each party shall bear its own costs and attorney’s fees. Any requests for administrative hearings are dismissed and the above-styled case is hereby closed. 4. In accordance with Florida law, the Respondent is responsible for retaining and appropriately distributing all client records within the timeframes prescribed in the authorizing statutes and applicable administrative code provisions. The Respondent is advised of Section 408.810, Florida Statutes. 5. In accordance with Florida law, the Respondent is responsible for any refunds that may have to be made to the clients. Filed December 24, 2014 3:10 PM Division of Aadniinistrative Hearings 6. The Respondent is given notice of Florida law regarding unlicensed activity. The Respondent is advised of Section 408.804 and Section 408.812, Florida Statutes. The Respondent should also consult the applicable authorizing statutes and administrative code provisions. The Respondent is notified that the cancellation of an Agency license may have ramifications potentially affecting accrediting, third party billing including but not limited to the Florida Medicaid program, and private contracts. ORDERED at Tallahassee, Florida, on this 7D day of Le cop ple-en 2014. MOS where Elizabeth Dudek, Secretary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and core oes Final es was served on the below-named persons by the method designated on this LE lay of Z 2 Ly , 2014. Richard J. Sax Agency Cler Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 Jan Mills Thomas Jones, Unit Manager Facilities Intake Unit Licensure Unit Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Katrina Derico-Harris Arlene Mayo—Davis, Field Office Manager Medicaid Accounts Receivable Local Field Office Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Shawn McCauley Daniel A. Johnson, Senior Attorney Medicaid Contract Management Office of the General Counsel Agency for Health Care Administration Agency for Health Care Administration (Electronic Mail) (Electronic Mail) Division of Administrative Hearings Dagmar Llaudy, Esquire (Electronic Mail) Law Office of Dagmar Llaudy, P.A. 814 Ponce De Leon Blvd, Suite 513 Coral Gables, Florida 33134 (U.S. Mail) NOTICE OF FLORIDA LAW 408.804 License required; display.-- (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. 408.812 Unlicensed activity. -- (1) A person or entity may not offer or advertise services that require licensure as defined by this part, authorizing statutes, or applicable rules to the public without obtaining a valid license from the agency. A licenseholder may not advertise or hold out to the public that he or she holds a license for other than that for which he or she actually holds the license. (2) The operation or maintenance of an unlicensed provider or the performance of any services that require licensure without proper licensure is a violation of this part and authorizing statutes. Unlicensed activity constitutes harm that materially affects the health, safety, and welfare of clients. The agency or any state attorney may, in addition to other remedies provided in this part, bring an action for an injunction to restrain such violation, or to enjoin the future operation or maintenance of the unlicensed provider or the performance of any services in violation of this part and authorizing statutes, until compliance with this part, authorizing statutes, and agency rules has been demonstrated to the satisfaction of the agency. (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (4) Any person or entity that fails to cease operation after agency notification may be fined $1,000 for each day of noncompliance. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. (6) In addition to granting injunctive relief pursuant to subsection (2), if the agency determines that a person or entity is operating or maintaining a provider without obtaining a license and determines that a condition exists that poses a threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the same actions and fines imposed against a licensee as specified in this part, authorizing statutes, and agency rules. (7) Any person aware of the operation of an unlicensed provider must report that provider to the agency. STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA No.: 2014008789 Exemption No.: HCC10956 MAGIC HANDS REHABILITATION CENTER, INC., Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW, the Petitioner, State of Florida, Agency for Health Care Administration (“the Agency”), by and through its undersigned counsel, and files this Administrative Complaint ‘ against the Respondent, Magic Hands Rehabilitation Center, Inc. (“the Respondent”), pursuant to Section 120.569 and 120.57, Florida Statutes (2014), and alleges: NATURE OF THE ACTION This is an action to revoke the Respondent’s health care clinic Certificate of Exemption. PARTIES 1. The Agency is the state agency that oversees the licensure and regulation of _ health care clinics in Florida pursuant to Chapters 408, Part Il, and 400, Part X, Florida Statutes (2014); and Chapter 59A-33, Florida Administrative Code. “The Legislature finds that the regulation of health care clinics must be strengthened to prevent significant cost and harm to consumers. The purpose of this part is to provide for the licensure, establishment, and enforcement of basic standards for health care clinics and to provide administrative oversight by the Agency for Health Care Administration.” § 400.990(2), Fla. Stat. (2014). 2. The Respondent applied for and was issued a Certificate of Exemption to operate a health care clinic located at 7392 NW 35" Terrace, Unit 310, Miami, Florida 33122. FYHIRIT 1 Certificate of Exemption from Licensure for Health Care Clinics 3. Under Florida law, “clinic” means an entity where health care services are provided to individuals and which tenders charges for reimbursement for such services, including a mobile clinic and a portable equipment provider. Fla. Stat. § 400.9905(4) (2014). 4. Under Florida law, the term “clinic” does not apply to a sole proprietorship, group practice, partnership, or corporation that provides health care services by licensed health care practitioners under chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, chapter 490, chapter 491, or part I, part III, part X, part XIII, or part XIV of chapter 468, or s. 464.012, and that is wholly owned by one or more licensed health care practitioners, or the licensed health care practitioners set forth in this paragraph and the spouse, parent, child, or sibling of a licensed health care practitioner if one of the owners who is a licensed health care practitioner is supervising the business activities and is legally responsible for the entity's compliance with all federal and state laws. However, a health care practitioner may not supervise services beyond the scope of the practitioner's license, except that, for the purposes of this part, a clinic owned bya licensee in s. 456.053(3)(b) which provides only services authorized pursuant to s. 456.053(3)(b) may be supervised by a licensee specified in s. 456.053(3)(b). Fla. Stat. § 400.9905(4)(g) (2014). Such an entity may claim to be exempt from licensure and may be eligible for a Certificate of Exemption from the Agency. 5. Under Florida law, a facility becomes a “clinic” when it does not qualify for an exemption, provides health care services to individuals and bills third party payers for those services. F.A.C. 59A-33.006(4). Facts 6. On December 19, 2013, Respondent was issued a Certificate of Exemption from licensure, number HCC10956, based upon Respondent identifying itself as solely owned by 2 Peter J. Maffetone, a licensed health care practitioner. 7. On August 22, 2014, Peter J. Maffetone gave testimony during a recorded sworn statement. 8. On that date, under oath, Peter J. Maffetone testified that he does not now, nor has he ever owned or had a financial interest in Respondent, Magic Hands Rehabilitation Center, Inc. 9. Respondent does not qualify for a Certificate of Exemption due to the fact that Peter J. Maffetone does not possess ownership. Sanction 10. Under Florida Law, any person or entity providing health care services which is not a clinic, as defined under Section 400.9905, may voluntarily apply for a certificate of exemption from licensure under its exempt status with the agency on a form that sets forth its name or names and addresses, a statement of the reasons why it cannot be defined as a clinic, and other information deemed necessary by the agency. § 400.9935(6), Fla. Stat. (2014). 11, Under Florida Law, the applicant for a certificate of exemption must affirm, without reservation, the exemption sought pursuant to Section 400.9905(4), F.S., and the qualifying requirements for obtaining and maintaining an exempt status; the current existence of applicable exemption-qualifying health care practitioner licenses; qualified ownership, qualified certifications or registration of the facility or owners; federal employer identification number; services provided; proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; plus other satisfactory proof required by form adopted by this rule. F.A.C. 59A-33.006(6). 12. Under Florida Law, facilities that claim an exemption, either by filing an application for a certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times the facility is in operation. F.A.C. 59A-33.006(2). 13. Under Florida Law, when a change to the exempt status occurs to an exempt facility or entity that causes it to no longer qualify for an exemption, any exempt status claimed or reflected in a certificate of exemption ceases on the date the facility or entity no longer qualifies for a certificate of exemption. In such case, the health care clinic must file with the Agency a license application under the Act within 5 days of becoming a health care clinic and shall be subject to all provisions of the Act applicable to unlicensed health care clinics. Failure to timely file an application for licensure within 5 days of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under the Act. F.A.C. 59A-33.006(3). 14. As demonstrated by the facts outlined herein, Respondent no longer qualifies for a Certificate of Exemption pursuant to § 400.9905(4)(g), Fla. Stat. (2014). 15. Therefore, Respondent is now required to be licensed as a clinic pursuant to F.A.C. 59A-33.006 and Chapters 408, Part II, and 400, Part X, Fla. Stat, 16. Under Section 400.995, Florida Statutes, in addition to the requirements of Part II of Chapter 408, the Agency may deny the application for a license renewal, revoke and suspend the license, and impose administrative fines of up to $5,000 per violation for violations of the requirements of this part or rules of the agency. § 400.995(1), Fla. Stat. (2014). Each day of continuing violation after the date fixed for termination of the violation, as ordered by the agency, constitutes an additional, separate, and distinct violation. § 400.995(2), Fla. Stat. (2014). 17. Under Section 400.9915(2), Florida Statutes, in addition to any administrative fines imposed pursuant to this part or Part IT of Chapter 408, the Agency may assess a fee equal to the cost of conducting a complaint investigation. § 400.9915(2), Fla. Stat. (2014). WHEREFORE, the Agency seeks to revoke the Respondent's health care clinic Certificate of Exemption. CLAIM FOR RELIEF The Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks a final order that: A. Makes findings of fact and conclusions of law in favor of the Agency as set forth above. B. Imposing the sanctions and relief as set forth above. Gj RESPECTFULLY SUBMITTED on this / / day of September, 2014. Florida Bar No. 0091175 Office pt the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 Telephone: (850) 412-3658 Facsimile: (850) 922-6484 Daniel. Johnson@ahca.myflorida.com
The Issue The ultimate issue to be resolved in this proceeding is whether the SSDB's proposal to construct a freestanding ambulatory surgery center in Volusia County, Florida, should be approved or denied. SSDB and the Department contend that the proposal meets statutory criteria and comports with the Department's rules. SSDB and the Department contend that there is a need for the facility and that SSDB is fully competent to construct and operate the facility. OBMH and HHMC contend that there is no need for the proposed facility, that the facility is not likely to be an economically viable venture, that the facility would injure existing businesses, and that the application should be denied because SSDB did not file a letter of intent with the local health council in a timely manner.
Findings Of Fact SSDB is a corporation that is a wholly owned subsidiary of Surgical Inc. Eighty percent of the stock of Surgical Services, Inc., is owned by American Medical International, Inc., a large, multinational health care corporation which owns and operates hospitals and other health care services. American Medical International is the third largest health care provider in the United States. The remaining 20 percent of Surgical Services, Inc., stock is owned by Randall L. Phillips, the company's president. SSDB is proposing to construct and operate a freestanding ambulatory surgery center in Daytona Beach, Volusia County, Florida. The service area for the proposed facility would be Volusia County. This facility would house four operating rooms and would be designed to handle all types of surgical procedures that can be performed on an outpatient basis. SSDB has entered into a contract to purchase land that provides a suitable site for the facility. It is located at the intersection of Clyde Morris Boulevard and Mason Avenue in Daytona Beach. The contract price for the property is $270,000. In addition to the cost of land acquisition, the preopening costs of the project would total $2,080,000. That amount would cover legal and accounting fees, architectural and engineering fees, a site survey, consulting fees, construction costs, movable equipment costs, and other engineering expenses. The preopening cost estimates are less than the $2,500,000 estimated in the original Certificate of Need application. The reduction is attributable to cost efficiencies primarily in selection and purchase of equipment. The costs estimated by SSDB are adequate to cover all preopening expenses and to provide an adequate facility. Financial support for the facility will be provided by American Medical International. This will include an equity contribution, a loan, and all necessary working capital. American Medical International has committed to provide financing adequate to construct and operate the facility. American Medical International has the financial resources to fulfill this commitment. The facility proposed by SSDB would be 15,500 square feet in size. The design is adequate for the proposed use and satisfies applicable health care facility standards and state and federal laws. The equipment proposed for the facility is sufficient to allow the handling of anticipated types of procedures. The facility will be open to all physicians qualified to perform the types of surgery that can be tone within an ambulatory setting. The facility will accept Medicare patients. The facility will admit any patient scheduled by surgeons, and ability to pay will not be a criterion for admission. SSDB has developed a marketing program to attract physicians and patients to the facility. SSDB has proposed adequate staffing for its facility and will be able to fulfill its staff requirements. SSDB is fully competent, given its backing by American Medical International, to construct and operate the proposed facility. OBMH is a Florida nonprofit corporation. It operates a 205-bed hospital in Volusia County, Florida, and renders medical services to residents of Volusia County and surrounding areas. OBMH presently renders ambulatory surgical services on an outpatient basis in connection with its surgery department. MEMO is a special taxing district. It operates a 345-bed hospital in Volusia County, Florida, and services residents of Volusia County and surrounding areas. HEM has a same-day surgery program and renders ambulatory surgical services through this procam on an outpatient basis. Ambulatory surgical services can be performed either in a hospital- based setting such as operated by OBMH and HHMC, or in a freestanding facility such as proposed by SSDB. HHMC presently has 12 general-purpose operating rooms. The HHMC same-day surgery program utilizes these rooms, but has a separate admitting area and waiting room that is utilized for inpatient surgery cases. OBMH has four general-purpose operating rooms. Outpatient or ambulatory surgeries are regularly performed in these rooms. There are presently 41 general-purpose operating rooms in Volusia County's eight hospitals. Outpatient or ambulatory surgical procedures are performed in these rooms. The Florida Health Care Plan is a health maintenance organization located in Volusia County. It has three operating rooms here inpatient or ambulatory surgery procedures are performed for members of the organization. The Neuman Dye Institute is a freestanding ambulatory surgical center licensed by the Department. It is located in DeLand, Volusia County, Florida. It has two operating rooms which are used for treatment of eye disorders. Approximately 15 percent of the surgeries performed in hospitals in Volusia County during the year August 1, 1982, through July 31, 1983, were done on an outpatient basis. The total number of surgical procedures performed in Volusia County has increased only slightly during the past three years. The number of impatient procedures has decreased, while the number of outpatient procedures has increased rather dramatically. This increase reflects a national trend which increasingly favors ambulatory or outpatient surgeries. It is likely that the number of outpatient cases as a percentage of total surgeries will continue to increase in Volusia County. The 15 percent figure for outpatient surgeries relates only to those procedures conducted in a hospital setting. It does not include procedures performed at the health maintenance organization, the Neuman Eye Institute, or in physicians offices. One major source of patients for ambulatory surgery programs is elective plastic surgery procedures. Two of the plastic surgeons who practice in Volusia County have their own operating rooms where ambulatory surgical procedures can be conducted. These physicians are not likely to use a separate, freestanding facility. The remaining plastic surgeons in Volusia County have utilized the same-day surgery facility at HHMC and have expressed satisfaction with that program. Existing facilities in Volusia County are adequate to accommodate the anticipated growth and the number of outpatient or ambulatory surgeries that will be performed during the next three years in Volusia County. Hospital surgical facilities in Volusia County are significantly underutilized at present. Existing facilities have the capacity to accommodate a more dramatic increase in total surgical procedures and in outpatient surgical procedures than is anticipated over the next three years. Given the existence of the hospital facilities, the Neuman Eye Institute, the health maintenance organization, and operating rooms located in physicians' offices, adequate facilities exist to accommodate the increased demand for outpatient surgeries that is anticipated in Volusia County. SSDB is proposing to offer its services to the public during the first year of operation for an average charge of $490 per procedure. The cost would increase to $540 for the second year. The average per-case cost for outpatient surgeries at HHMC is $393. The average per-case cost at OBMH is $439. Given the fact that one case can Involve multiple procedures, it is evident that existing facilities in Volusia County are charging less for ambulatory surgical services than SSDB proposes to charge. While some increases in present charges are likely, given general trends, it is not likely that HHMC or OBMH will charge as much for outpatient surgical procedures as SSDB proposes to charge. It has been asserted that HHMC's charges for outpatient surgeries are inadequate to cover HHMC's costs and that the charges are being kept low artificially. The evidence is to the contrary. HHMC's charges for outpatient surgeries are adequate to meet the facility's expenses. The facility proposed by SSDB does not present any cost savings to patients. Services at the proposed facility would be more expensive than the same services at existing facilities in Volusia County. Freestanding surgical centers have generally presented some advantages to physicians no consumers. In many places, outpatient surgeries are difficult to schedule in a hospital setting because they are susceptible of being bumped by surgeries that are considered more urgent. Furthermore, in many locations, physicians have had difficulty scheduling their outpatient surgeries in blocks of cases so that they can perform them more efficiently. Those problems have not occurred in Volusia County. Physicians who regularly perform outpatient surgeries in hospitals in Volusia County have been able to schedule their cases in blocks and have experienced no difficulties with bumping. SSDB has projected that its proposed facility would experience an acceptable loss during its first year of operation, but that it would show a net profit during its second and third years of operation. These estimates are based upon projections that 2,160 procedures would be performed at the facility at an average rate per procedure of $490 during the first year and 2,640 procedures at an average rate of $540 during the second year. These projections are unrealistic. The projections contemplate that approximately one-third of all outpatient surgeries in Volusia County would be performed at the proposed facility. The projections also contemplate a very dramatic increase in the number of outpatient surgeries and that more than 60 percent of the increased outpatient procedures would be done at the proposed facility. While it is likely that the number of outpatient surgeries performed in Volusia County and elsewhere will continue to increase as a percentage of total surgeries and that eventually as much as 30 percent of all surgeries performed in Volusia County will be done on an outpatient basis, the increase is not-likely to occur in a single year. Even if It did, it is unlikely that local physicians and consumers cold so dramatically reject present facilities as SSDB projects. Indeed, there is no evidence from which it could be concluded that there is any dissatisfaction on the part of physicians or consumers in Volusia County with present facilities. The evidence is to the contrary. A second reason why the projections are inaccurate is that in making the projections SSDB ignored the existence of the Neuman Eye Institute, the health maintenance organization, and operating rooms that have been established in physicians' offices. A third reason is that SSDB proposes to provide services at a higher cost than at existing facilities. A fourth reason is that SSDB has underestimated the proportion of Medicaid and Medicare cases that are likely to be performed at the facility at a cost that is less than the average cost per procedure proposed by SSDB. It is unlikely that SSDB could operate at a profit during its first three years of operation. At the time that SSDB filed its letter of intent and application with the Department of Health and Rehabilitative Services, there was no local health council in existence Volusia County, Florida. SSDB did not file a copy of its letter of intent or application with the local health council and would have had no place to file it if it attempted to do so.
Recommendation That a final order be entered by the Department of Health and Rehabilitative Services denying the Application for Certificate of Need filed by Surgical Services of Daytona Beach, Inc. RECOMMENDED this 31st day of October, 1983, in Tallahassee, Florida G. STEVEN PFEIFFER Assistant Director Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of October, 1983. COPIES FURNISHED: Fred Baggett, Esq. Michael J. Cherniga, Esq. Post Office Drawer 1838 Tallahassee, Florida 32302 Jay Adams, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Richard B. Orfinger, Esq. 619 North Grandview Avenue Daytona Beach, Florida 32018 Harold C Hubka, Esq. Post Office Box 5488 Daytona Beach, Florida 32018 Mr. David Pingree, Secretary Department of Health and Rehabilitative Services Winewood Boulevard Tallahassee, Florida 32301
