The Issue Whether Respondent, USA Rehab and Chiropractic Center, Inc., should have a penalty and fine imposed against its license for alleged statutory and rule violations.
Findings Of Fact On August 23, 2013, Respondent submitted to Petitioner a Health Care Licensing Application (Application) using AHCA Recommended Form 3110-0013, August 2013. The Application was submitted for the purpose of renewing Respondent’s license to operate as a health care clinic. Personnel File and Background Screening Results Section nine of the Application seeks a listing of Respondent’s “licensed health care practitioners and all personnel who provide personal care services to clients or with access to client funds.” Employees that fall within this classification are required to submit to, and successfully pass, a Level 2 background screening. Respondent identified on the Application four individuals that fell within the designated category. Florida Administrative Code Rule 59A-33.012(1) directs that a “survey” will be conducted for “[a]pplications for renewal licenses.” This rule also provides that the survey process “is an onsite inspection and review of the health care clinic facility or administrative office, by authorized Agency employees to determine the health care clinic’s compliance with the minimum standards established by the Act, its statutory references and rules regulating the operation and licensure of health care clinics.” Vanessia Bulger was assigned to conduct the survey related to Respondent’s Application. On November 25, 2013, Ms. Bulger visited Respondent’s facility for the purpose of conducting the required survey. Ms. Bulger met with the owner of the facility, Mr. Lavaud Fevry. While meeting with Ms. Bulger, Mr. Fevry disclosed that after submitting his Application to the Agency, the health care clinic hired two additional employees who provided personal care services to the clinic’s clients. Ms. Bulger wrote the names of the two new employees on her copy of section nine of the Application and further identified these employees with the letters “C” and “D.” Employee “C” is Eugene Grazette and employee “D” is Dexter K. John. For employee “C,” Ms. Bulger wrote “Eugene Grazette – 8- 31-15 – NO BG” and for employee “D” she wrote “Dexter K. John 10- 17-09 BG.” Ms. Bulger testified that “NO BG” stands for “no background screening results.” The Administrative Complaint does not allege that employee “C” had not passed a Level 2 background screening at the time of the survey conducted by Ms. Bulger. Count I of the Administrative Complaint does allege, however, that Respondent failed to maintain a copy of the Level 2 background screening results in the personnel file for employee “C.” It is undisputed that employee “C,” during all times relevant hereto, possessed a valid health provider license that authorized him to deliver personal care services to Respondent’s clients. Additionally, the evidence also establishes that on September 18, 2013, approximately two months before the survey, Respondent, via electronic submission, requested a Level 2 background screening for employee “C.” Ms. Bulger, as part of the survey process, completed a “Heath [sic] Care Clinic Surveyor Worksheet & Facility Questionnaire.” Item nine of the questionnaire asks, “[i]s there a log of all natural persons required to be screened and who have been screened under Level 2 criteria?” In response to this question, Ms. Bulger wrote “NO - New Chiropractor – massage therapist not listed.” The questionnaire does not ask on any of its 10 pages whether a copy of the Level 2 background screening results is maintained in the personnel files of the employees of the clinic. At the time of the survey, employee “C’s” personnel file did not contain a copy of the results from his Level 2 background screening. Attestation Regarding Background Screening Section 10 of the Application is labeled “Affidavit.” Mr. Fevry provided the following attestation in support of the Application: I, Lavaud Fevry, hereby swear or affirm that the statements in this application are true and correct. As administrator or authorized representative of the above named provider/facility, I hereby attest that all employees required by law to undergo Level 2 background screening have met the minimum standards of sections 435.04, and 408.809(5), Florida Statutes (F.S.) or are awaiting screening results. Count I of the Administrative Complaint also alleges that when Mr. Fevry met with Ms. Bulger during the survey he informed her that: he had no affidavit or documentation that the employees, including the Medical Director, had . . . attest[ed] to meeting the requirements for qualifying for employment pursuant to Florida law and agreeing to inform the employer immediately if arrested for any of the disqualifying offenses while employed by the employer per chapter 435, Florida Statutes. The evidence establishes that Respondent’s employees had not completed the required attestations until after the survey. In December 2013 Respondent submitted a plan of correction to address problems related to employee attestations. Exactly 21 months prior to the survey that provides the basis for the instant dispute, Petitioner, on February 23, 2012, conducted a survey of Respondent’s clinic. As a part of this earlier survey, Respondent was also cited for failing to ensure that required staff completed attestations, subject to penalty of perjury, wherein they acknowledged meeting the requirements for employment and agreeing to immediately inform Respondent if arrested for a disqualifying offense. Verifying Florida Licenses Emmanuel Nau, M.D. has served as Respondent’s medical/clinic director since August 2009. Dr. Nau, at all times relevant hereto, held Florida Department of Health medical license number ME48249. Dr. Nau, as medical director for Respondent’s clinic, acknowledges that he has legal responsibility for the clinic as specified in section 400.9935, Florida Statutes. On the day of the license renewal survey, Ms. Bulger inquired of Dr. Nau as to whether, in his capacity as medical director, he was verifying that all practitioners at the clinic who were providing health care services or supplies to clinic patients had active, unencumbered Florida licenses. Dr. Nau, in response to the inquiry, admitted to Ms. Bulger that he had not verified the license status of the clinic’s practitioners. There was, however, no evidence indicating that Respondent’s practitioners did not actually possess active, unencumbered Florida licenses during the period in question. Additionally, no evidence was offered that Respondent had previously been cited for committing violations of this nature. In December 2013 Respondent submitted a plan of correction that was designed to shore up its system of verifying that its employees have active, unencumbered Florida licenses. Failure to Document “When” and “What” Ms. Bulger testified that during the survey, Respondent failed to produce, upon request, confirmation that Dr. Nau documented, for the two years prior to the survey, compliance of when and what action was taken relative to several of the functions, duties and clinic responsibilities enumerated in section 400.9935(1)(a)-(g), Florida Statutes. When Ms. Bulger, on the day of the survey, questioned Dr. Nau about the omissions, he admitted that he failed to document and to maintain for the previous two years, records demonstrating “compliance, when and what action” he took in regards to the performance of his functions, duties, and responsibilities as medical director for the clinic. Dr. Nau also admitted during the final hearing that he had not been listing in his reports all information related to the performance of his duties as medical director of Respondent’s clinic. No evidence was offered that Respondent had previously been cited for committing violations of this nature. In December 2013 Respondent submitted a plan of correction designed to ensure that clinic reports adequately address those matters required by statute and rule.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order finding that USA Rehab and Chiropractic Center, Inc., violated sections 400.991, 400.9935, 408.809, and 435.05(2), Florida Statutes. It is also recommended that the Agency suspend Respondent’s health care clinic license for 10 business days and impose against Respondent a fine in the amount of $3,500. Finally, it is recommended that Count III of the Administrative Complaint be dismissed. DONE AND ENTERED this 22nd day of April, 2015, in Tallahassee, Leon County, Florida. S LINZIE F. BOGAN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of April, 2015.
Findings Of Fact Based upon the record evidence, as well as the factual stipulations entered into by the parties, the following Findings of Fact are made: Respondent is now, and has been at all times material hereto, a licensed practical nurse in the State of Florida holding license number PN 0626161. At all times material hereto, Dr. Vladimir Rosenthal owned three clinics in Dade and Broward Counties at which he performed abortions. The clinics were located in Coral Gables (hereinafter referred to as the "Coral Gables clinic"), North Miami (hereinafter referred to as the "North Miami clinic") and Plantation (hereinafter referred to as the "Broward clinic"). All three clinics were licensed under Chapter 390, Florida Statutes. In September and October, 1989, Respondent was employed by Rosenthal and worked full-time as a licensed practical nurse in the North Miami clinic. During this period of time, she had no responsibilities with regard to the other two clinics owned by Rosenthal. Among Respondent's duties at the North Miami clinic during this time period was to prepare, under Rosenthal's direct supervision, packages of medications that Rosenthal gave to his patients, free of charge, to take home with them upon their discharge, a practice that Rosenthal has since discontinued. 6/ On September 30, 1989, the Department of Health and Rehabilitative Services (HRS) conducted an on-site inspection at the Coral Gables clinic. Respondent was not present at the clinic during the inspection. Nor were there any patients at the clinic at the time. Approximately 50 small manilla envelopes containing multiple doses of medications were found in a drawer of a desk in the clinic. The envelopes were labeled to the extent that they indicated the name of the drugs they contained, but they did not provide any information regarding the lot number, expiration date or the name of the manufacturer of the drugs. Carmen Penaloza, one of the clinic workers who was present during the inspection, was asked to demonstrate how these packages were prepared. Penaloza proceeded to take an empty manilla envelope like the ones that had been found in the desk drawer and fill it with medication that came from a large container. In performing this demonstration, she did not use gloves and her bare hands came in contact with the medication. Carlos Arias, a licensed pharmacist and one of the HRS employees who participated in the inspection, advised Penaloza that the technique she had employed was unsanitary and recommended that in the future she use a tray and spatula like pharmacists do to perform such a task. The HRS inspection also revealed that medical devices were being stored in a refrigerator that also contained food items. On October 26, 1989, HRS conducted an on-site inspection of the North Miami clinic. Arias was among the various HRS employees who were on the inspection team. Diane Robie, a medical quality assurance investigator with the Department, accompanied the team members on their inspection. Approximately 30 envelopes containing medications were found during the inspection. They were similar to the packages that had been discovered the month before at the Coral Gables clinic. Respondent was at the clinic when the inspection was conducted. Penaloza was also there. No patients were present, however. Respondent was asked to demonstrate how the packages were prepared. Penaloza was nearby at the time the request was made. She saw Respondent nervously looking around and concluded that Respondent was unable to locate any sterile gloves to use. She therefore told Respondent where such gloves could be found. Respondent then donned the gloves, laid a clean piece of paper on top of the desk where she was situated, placed tablets from a large container onto the paper and pushed each tablet with a tongue blade into a small manilla envelope. 7/ The technique that Respondent used during her demonstration, while it may have been unconventional from the perspective of a pharmacist like Arias, nonetheless was antiseptic and therefore acceptable. Sometime during the inspection Respondent made a statement that led Robie to erroneously believe that Respondent was responsible for packaging medications, not just at the North Miami clinic, but at the Coral Gables clinic as well. A finding of probable cause was initially made in this case on May 14, 1990. An Administrative Complaint was thereafter issued and the matter was referred to the Division of Administrative Hearings. The Department received the following letter, dated September 4, 1990, from counsel for Respondent concerning settlement of the case: This will confirm our understanding that you will file a notice of dismissal with DOAH of the case now pending against my client and, providing the dismissal is confirmed as a final dismissal and closing order entered by the probable cause panel, that Ms. Echlov will agree not to seek fees against your agency under the Florida Equal Access to Justice Act. In the event the panel does not approve a final dismissal and instructs you to refile the case, neither party will be prejudiced by the present agreement and each party will retain all rights otherwise available to them, including my client's rights to seek fees should the case be refiled. If this does not reflect our understanding, please notify me at once. Otherwise, please fax me a copy of your notice of dismissal so that I can take the final hearing off my calendar. Thank you for your efforts to resolve this matter amicably. Counsel for Respondent sent to the Department, and the Department received, the following follow-up letter, dated November 6, 1990: You may recall that we reached an agreement in the above-referenced case providing for a voluntary dismissal on your part and promise on mine that my client would not seek attorney's fees under the Equal Access to Justice Act. You had to take the case back before the Probable Cause Panel and ask them to close it. In order that I can close my file and know that this matter is, in fact, concluded, please let me know whether you have taken the case back before the Probable Cause Panel and, if so, the outcome. If there are documents reflecting same, please, please send me a copy. If the case has not been taken back before the Panel, please let me know when this will be done. Thanks. I'll be looking forward to hearing from you. Counsel for Respondent sent to the Department, and the Department received, a third letter, dated January 14, 1991, the body of which read, as follows: It has now been over four months since we reached our "understanding" that DPR would dismiss the case pending before DOAH (which you did) and that my client would forego her right to seek fees under the EAJA, providing (to quote from my September 4, 1990 letter to you) "that the dismissal is confirmed as a final dismissal and a closing order [is] entered by the probable cause panel." The final part of the bargain has never been performed so far as I know (and, if it was performed, the action was illegal since I requested notification of the date when the matter would be presented to the panel so that I might attend or send a court reporter but never received any). I have not, of course, received any final order of dismissal from the probable cause panel. If, within ten days of the date of this letter, I have not received either: an order of closure from the probable cause panel, or the time, date and place when our agreement will be presented to the panel, I will consider that DPR is in breach of the agreement and pursue all remedies available to my client, including attorneys' fees. I look forward to hearing from you at your earliest convenience. The probable cause panel met a second time, at which it determined not to reconsider its initial finding of probable cause. 8/ Neither Respondent nor her attorney were notified of this second meeting of the probable cause panel. Following this meeting, an Amended Administrative Complaint was filed.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Nursing enter a final order (1) finding the evidence insufficient to establish that Respondent engaged in "unprofessional conduct," within the meaning of Section 464.018(1)(h), Florida Statutes, as charged in the Second Amended Administrative Complaint, and (2) dismissing said complaint in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 10th day of January, 1992. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of January, 1992.
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.
