The Issue The issue in this case is whether the Petitioner is entitled to receive a passing grade on the Physician Assistant licensure examination administered in June of 1998.
Findings Of Fact The Petitioner, Raul A. Gonzalez, sat for the Physician Assistant licensure examination administered in June of 1998. The Physician Assistant licensure examination is made up of three parts: (1) a general written examination; (2) a surgical specialty examination; and (3) a primary care specialty examination. In order to pass the overall examination and be eligible for licensure, an applicant must pass the general written examination and must also pass at least one of the two specialty examinations. The general written examination and both of the specialty examinations are all multiple-choice examinations. A scaled score of 600 is required to pass each of the three examinations. The following grades were assigned to the Petitioner's examinations: 595.50 on the primary care specialty examination; 554.50 on the surgery specialty examination; and 591.90 on the general written examination. On the basis of these grades, the Petitioner was advised that he had failed all three portions of the examination. In order to receive a passing grade on the overall examination, the Petitioner needs credit for correct answers to three additional questions on the general written portion of the examination, and either (a) credit for a correct answer to one additional question on the primary care specialty examination, or (b) credit for correct answers to ten additional questions on the surgery specialty examination. The Petitioner is entitled to credit for a correct answer to one additional question on the primary care specialty examination. With credit for the one additional correct answer, the Petitioner is entitled to a passing grade on the primary care specialty examination.2 The subject licensure examination was prepared and conducted in accordance with the standard testing and security procedures of the Department of Health. The post-examination review of the subject licensure examination was conducted in accordance with the standard examination review procedures of the Department of Health. There is no competent substantial evidence in the record of this case of any material defects or deficiencies in those procedures. There is no competent substantial evidence of any material departure from established procedures during the course of the preparation of the subject licensure examination, the administration of the examination, the grading of the examination, or the post-examination review of the examination. Except as noted above in paragraph 4, there is no competent substantial evidence in the record of this case of any error or omission in the scoring and grading of the Petitioner's answers on the subject licensure examination.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a final order be issued in this case concluding that the Petitioner is entitled to a passing grade on the primary care specialty examination; that the Petitioner failed the other two portions of the examination; and that the Petitioner is not entitled to the license he seeks. DONE AND ENTERED this 21st day of April, 1999, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 21st day of April, 1999.
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue The issues are as follows: (a) whether Respondent acted upon Petitioner’s application for renewal as an office surgery accrediting organization within the time frames established under Section 120.60(1), Florida Statutes; and (b) whether Respondent properly denied Petitioner’s application for renewal of its status as an approved physician office surgery accrediting organization.
Findings Of Fact Background In Florida, physicians who perform certain surgical procedures in their offices are required to register the office and have the office inspected by Respondent unless the office is accredited by a nationally recognized accrediting agency or an accrediting organization approved by Respondent. § 458.309(3), Fla. Stat. (2003); Fla. Admin. Code R. 64B8-9.0091. In order to avoid physician office inspection by Respondent, a physician must submit written documentation of a current office-accreditation survey by one of the nationally recognized or Board-approved accrediting organizations. Fla. Admin. Code R. 64B8-9.0091(2)(a) and 64B8-9.0091(3)(a). A physician is also required to submit a copy of a current accreditation survey within 30 days of accreditation of the office. Fla. Admin. Code R. 64B8-9.0091(3)(b). Florida Administrative Code Rules 64B8-9.0092(1)(b) and 64B8-9.0092(7) list the approved national and Board-approved accrediting organizations. Petitioner is the only Board-approved accrediting organization. Florida Administrative Code Rule 64B8-9.0092(1)(a) provides that "accredited" means that an office has achieved either "full" accreditation or "provisional" accreditation when the office is in "substantial compliance" with accrediting standards. Petitioner provided Respondent with a complete application for renewal as an office surgery accrediting agency on January 17, 2003. Florida Administrative Code Rule 64B8- 9.0092(5) specifies that such entities must apply for renewal every three years and shall submit their applications for renewal at least three months prior to the third anniversary of their initial approval. Petitioner conducted office surgery accreditation inspections for approximately three years prior to the final hearing in this matter. Physicians who conduct office surgery are required to comply with Florida Administrative Code Rule 64B8-9.009 regarding the Standard of Care for Office Surgery. Florida Administrative Code Rule 64B8-9.0091(2)(a) specifically provides that all nationally recognized and Board-approved accrediting organizations shall be held to the same surgery and anesthesia standards for Florida office surgery sites as adopted by rule. Petitioner's accreditation standards, as outlined in its original application for approval as an accrediting agency and its subsequent application for renewal, include the requirement that physicians comply with the standard of care rules for office surgery as outlined in Florida Administrative Code Rule 64B8-9.009. In fact, Petitioner asserts that its standards meet or exceed the requirements of Chapters 455 and 458, Florida Statutes (2003), and rules promulgated there under. Petitioner's accreditation standards should have remained the same throughout the three years preceding the submission of its renewal application. Petitioner did not file any changes or amendments to its accreditation standards prior to submitting its renewal application on January 17, 2003. Submission of Corrective Action Plans Throughout the first three years of its operation, Petitioner provided Respondent with copies of all the accreditation reports for the facilities it inspected and accredited as required by Florida Administrative Code Rule 64B8- 9.0092(4)(e). That same rule also required Petitioner to furnish Respondent copies of any corrective action plans within 30 days of receipt from the inspected physician office. Petitioner did not provide Respondent with any corrective action plans or any compliance information until after Petitioner filed its renewal application. Petitioner did not offer any corrective action plans as evidence during the hearing even though Petitioner found deficiencies (non- compliance with accreditation standards) in 24 of the 25 office inspection files entered as evidence by the Respondent in this hearing. The only materials submitted by Petitioner that address the deficiency corrections are copies of photographs, invoices, packing slips, order forms, and correspondence from the inspected offices, which are supposed to constitute evidence of subsequent compliance accreditation standards. Beth Sautner is Petitioner's Executive Secretary. Ms. Sautner's duties required her to submit the requisite accreditation materials to Respondent and to communicate with Respondent regarding such activities when needed. The greater weight of the evidence indicates that Respondent's staff never told Ms. Sautner to only send the facility inspection form and that submission of corrective action plans and compliance materials was unnecessary. Ms. Sautner knew that a rule required the submission of corrective action plans. Nevertheless, Petitioner never filed any petition seeking a waiver of such rule. Action on the Application Respondent considered Petitioner's renewal application on three separate occasions. It was first considered on February 8, 2003, in Orlando, Florida, at Respondent's regularly scheduled meeting. At that meeting Petitioner waived the 90-day provision in Section 120.60(1), Florida Statutes (2002), until after Respondent's August 2003 meeting. Respondent next considered Petitioner’s renewal application at a regularly scheduled meeting on June 7, 2003, in Miami, Florida. Finally, Respondent voted to deny the application at the August 2, 2003, meeting in Orlando, Florida. Respondent filed the Notice of Intent to Deny Petitioner's application for renewal as an office surgery accrediting organization on August 28, 2003. Accreditation Process Upon the request and payment of an accreditation fee, Petitioner arranges for the inspection of an office by an inspector. Inspection is required when the physician conducts level II office surgery lasting more than five minutes or level III office surgery. The inspectors are physicians affiliated with Petitioner who personally visit the facility to conduct the inspection. The inspectors use an inspection form when conducting the accreditation inspection. The form contains a pass or fail check-off space next to each statement reflecting an accreditation standard. The form contains comment sections following the standards and at the end provides for a pass or fail designation along with two additional sections. The inspectors use the final sections for outlining minor deficiencies to be corrected within 20 working days and for major deficiencies requiring a second inspection. The form has signature lines for the inspector and the physician being inspected. After completing the inspection, the inspector forwards the form to Ms. Sautner. Next, the inspector and Ms. Sautner review the form to determine what is needed in order to complete the process. The inspector tells Ms. Sautner what is needed and she attempts to collect the requisite compliance documentation from the inspected facility. The appropriate materials are then forwarded to Ms. Sautner who sends them to the inspector for a final accreditation determination. The final accreditation determination is always made by an inspector and never by Ms. Sautner. Once the final accreditation determination is made, Ms. Sautner orders an accreditation certificate from Scribes, Inc. Scribes, Inc. sends the certificate directly to the newly accredited facility. At times, Ms. Saunter orders the certificate in advance but places it on hold until she is notified that an accreditation determination has been made. Ms. Sautner usually contacts Scribes, Inc. by e-mail to request release (delivery) of the certificate. Scribes, Inc. then sends Petitioner a facsimile copy of the physician’s accreditation certificate. Petitioner accredits offices for three years. The accreditation period begins to run from the date of the original office inspection. The certificate that Petitioner issues through Scribes, Inc. contains a month and year which reflect the final month of the facility accreditation. Therefore, if a facility’s accreditation certificate has a May 2005 date, it reflects an accreditation from May 2002 through May 2005. This is true even when the physician did not document that his or her facility fully complied with Petitioner's accreditation standards until, in some cases, months after the initial inspection. After Petitioner requests Scribes, Inc. to send a certificate to a newly accredited facility, Petitioner sends a copy of the facility inspection form, the accreditation certificate, and a cover letter to Respondent. This documentation notifies Respondent that Petitioner has inspected the physician's office and that the office is entitled to recognition as an accredited facility. Throughout the hearing Petitioner's witnesses testified that physicians' offices were not accredited until they demonstrated that they had met all of the accreditation standards. The weight of the evidence indicates that Petitioner routinely accredited a facility retroactive to its inspection date. A review of every accreditation certificate in evidence shows that each facility’s period of accreditation starts the month Petitioner performed the inspection and ends three years later. This is true even when the inspection form reveals that the physician’s office did not fully comply with Petitioner's accreditation standards at the time of inspection and the physician did not demonstrate compliance until months after the initial inspection. Ms. Sautner's testimony adds support for the proposition that Petitioner gave physicians accreditation credit retroactively to the inspection date. She was responsible for notifying Scribes, Inc. to release accreditation certificates bearing specific months and years exactly three years after the date of the inspections, as opposed to three years after the date of compliance with standards. Petitioner's inspectors considered the inspection date to be the accreditation date. They knew the subsequently issued accreditation certificates would reflect compliance with accreditation standards for a period of time before the physicians actually demonstrated compliance. It is noteworthy that, upon completion of the inspections, Petitioner gave a "pass" or, in a couple of cases, a provisional pass, to every physician’s office that Petitioner inspected before it submitted its renewal application. This adds credence to the supposition that Petitioner considered the inspection date to be the date that a facility was entitled to accreditation, even though the physicians did not demonstrate compliance until some time after the inspection. It is clear that Petitioner was not routinely accrediting physicians' offices without requiring some evidence of demonstrated compliance with accreditation standards. Instead, Petitioner usually required the physicians to furnish some documentation showing compliance after an inspection revealed deficiencies but allowed the new period of accreditation to begin retroactively on the date of the inspection. The most persuasive evidence indicates that the date Petitioner completed the accreditation process occurred sometime after the inspection: (a) on the date Ms. Sautner authorized Scribes, Inc., to release the physician's accreditation certificate; or (b) the date that Scribes, Inc., faxed Ms. Sautner a copy of the accreditation certificate sent to the physician. Therefore, the information provided to Petitioner was inaccurate to the extent it reflected that physicians' offices were in full compliance as of their inspections date. Given the above, Respondent presented ample evidence which demonstrates that Petitioner's accreditation process was misleading. At the very least, Petitioner lacked sufficient quality assurance policies and procedures to ensure that physicians were not recognized as accredited before they were entitled to such recognition. Regardless of whether any physicians were actually performing surgery in their offices between the inspection dates and the dates of compliance, Petitioner's accreditation procedure created a false impression of the adequacy of the facilities that Petitioner inspected. This mischaracterization of the status would lend support for the acceptability of procedures performed in that setting when the physician was not entitled to that recognition, with potential consequences to the health and well being of the patients. Marwan Shaykh, M.D. Petitioner inspected Dr. Shaykh’s facility on May 30, 2002. The date that appears on his accreditation certificate is May 2005. Hence, his accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Shaykh’s office did not have the following required medications: adrenalin (expired), dextrose (expired), verapamil hydrochloride (expired), succinylcholine, and nitroglycerin. Petitioner also discovered that Dr. Shaykh’s office did not have the following required monitoring and/or emergency equipment: ambu bag and emergency power able to produce adequate power to run required equipment for a minimum of two hours. (hereinafter “emergency power”). After the inspection, Dr. Shaykh provided Petitioner a copy of an invoice from the Apothecary at Memorial. The invoice indicated that Dr. Shaykh ordered adrenalin (ephedrine), dextrose, verapamil hydrochloride, succinylcholine, and nitroglycerin (nitroquick) on July 2, 2002. The invoice was dated August 15, 2002. Dr. Shaykh also provided Petitioner a copy of an invoice from Physician Sales and Services, Inc. The invoice reflected that Dr. Shaykh ordered an ambu bag (resuscitator adult disp) on July 16, 2002. The invoice was dated July 16, 2002. Finally, Dr. Shaykh provided Petitioner a copy of a letter which read in part: Please find enclosed the copies of the anesthesia record where the EBL is recorded, the physician job description and a copy of the surgery log. In addition, invoices indicate the replacement of Dextrose 50 percent, Isuprel 1:5000, Verapamil 5mg/2ml, succinylcholine 20mg/ml to the crash cart and Administration sets (Micro drips) and Adult Resuscitator bag (Ambu Bag) to the surgery room. The letter appears to be a cover letter that accompanied the above-discussed invoices. The letter is undated and does not indicate when Petitioner received it. However, if it accompanied the medication invoice from the Apothecary, Dr. Shaykh must have sent it to Petitioner on or after August 15, 2002. Ms. Sautner ordered and placed a hold on Dr. Shaykh’s accreditation certificate on June 6, 2002. She released the hold on July 16, 2002. The certificate itself has a fax date of June 11, 2002. It appears that Scribes, Inc., faxed it to Petitioner on that date. Based on the foregoing, it is not clear whether the fax date on Dr. Shaykh’s certificate of June 11, 2002, or Ms. Sautner's stated release date of July 16, 2002, is the actual release date. Nevertheless, regardless of which date is the correct release date, it is apparent that Petitioner sent Dr. Shaykh an accreditation certificate before he documented compliance with Petitioner's accreditation standards because the Apothecary invoice was dated after both possible release dates. Karen Chapman, M.D. Petitioner inspected Dr. Chapman’s facility on April 6, 2002. The date that appears on her accreditation certificate is April 2005. Hence, her accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Chapman’s office did not have multiple (14) medications, one of which was inderal. Petitioner also discovered that Dr. Chapman’s office did not have a required ambu bag among other missing monitoring and/or emergency equipment. After the inspection, Dr. Chapman provided Petitioner copies of invoices from Southern Anesthesia + Surgical dated April 11, 2002, which reflected that Dr. Chapman ordered all the missing medications with the exception of inderal. Dr. Chapman also provided Petitioner a copy of undated correspondence which asserted that Karen Chapman ordered and received inderal 1mg/mL, on April 11, 2002. Both the Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal contain a fax strip across the top. The date on the fax strip indicates that Dr. Chapman sent the invoice copies and the inderal correspondence to Petitioner on February 12, 2003. Ms. Sautner was unable to provide an order or release date for Dr. Chapman’s accreditation certificate. However, the inspection file contained an accreditation certificate which had a fax date across the top of May 10, 2002. The Southern Anesthesia + Surgical invoice copies and the undated correspondence regarding the inderal were obviously faxed to FLACS over seven months after the accreditation certificate was sent to Dr. Chapman. Petitioner attempts to explain this discrepancy away by claiming that it had all compliance documentation prior to issuing accreditation but in some cases it could not find the documents when it conducted an audit in 2003. In those instances, Petitioner contacted the physicians and asked them to send the compliance materials again after the fact. Such an explanation is unacceptable because it does not explain why the compliance documentation was not in the file in the first place. Additionally, Petitioner has provided no documentation of compliance materials from Dr. Chapman disclosing whether she ever obtained a required ambu bag. Lucien Armand, M.D. Petitioner inspected Dr. Armand’s facility on June 8, 2001. The date that appears on his accreditation certificate is June 2004. Hence, his accreditation covers June 2001 through June 2004. During the inspection, Petitioner determined that Dr. Armand’s office did not have the following required medications: adrenalin (epinephrine) 1/10,000 dilution, calcium chloride, dextrose, dilantin (phenytoin), dopamine, and inderal (propranolol). After the inspection, Dr. Armand provided Petitioner on some unknown date a copy of an invoice from Medical III Pharmacy. The invoice reflected that on April 23, 2001, Dr. Armand ordered dilantin, dopamine, and inderal. The invoice was dated April 30, 2001. Dr. Armand also provided Petitioner, on some unknown date, unsigned correspondence indicating that he had “re- supplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal. Ms. Sautner placed Dr. Armand’s accreditation certificate on hold on June 22, 2001. The certificate had a fax date across the top of June 28, 2001. The above-referenced invoice from Medical III Pharmacy is of course not probative as to whether Dr. Armand obtained the missing crash cart medications after the inspection because the invoice indicates that the drugs were ordered before the inspection. Furthermore, Dr. Armand’s unsigned correspondence indicating that he had “resupplied” his emergency cabinet with adrenalin, calcium chloride, dextrose, dilantin, dopamine, and inderal is obviously problematic because it is unsigned and provides no objective proof of compliance. Scott Warren, M.D. Petitioner inspected Dr. Warren’s facility on April 11, 2001. The date that appears on his accreditation certificate is May 2004. Thus, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Warren’s office did not have required intubation forceps. After the inspection, Dr. Warren provided Petitioner a copy of an order receipt from an unknown pharmaceutical vendor. The order receipt reflected that, on an unknown date, Dr. Warren ordered adult and child sized McGill Forceps (a type of intubation forceps). The invoice was not dated but a fax strip across the top reveals that Dr. Warren's office faxed a copy of the receipt to Petitioner on July 11, 2001. Ms. Sautner placed a hold on Dr. Warren’s accreditation certificate on June 22, 2001. The certificate had a fax date across the top of June 29, 2001. The copy of the Magill Forceps receipt was faxed to Petitioner ten days after Petitioner released the accreditation certificate to Dr. Warren. Therefore, Petitioner could not have verified compliance prior to the awarding of accreditation. Furthermore, this discrepancy cannot be attributed to Petitioner's 2003 audit because the fax receipt date was approximately one and a half years prior to the audit. Juan Flores, M.D. Petitioner inspected Dr. Flores' facility on July 21, 2002. The date that appears on his accreditation certificate is July 2005. Accordingly, his accreditation covers July 2002 through July 2005. During the inspection, Petitioner determined that Dr. Flores’ office did not have inderal (propranolol) or nasal airways. Dr. Flores provided Petitioner correspondence dated July 30, 2002, from a Laura Leyva. The correspondence indicated that Dr. Flores’ facility had acquired the requisite nasal airways. On November 14, 2003, Petitioner received a fax copy of an invoice numbered 9927 from Prime Medical Care, Inc. The invoice dated July 15, 2002, documents Dr. Flores' acquisition of inderal. Dr. Flores’ accreditation certificate had a fax date of September 6, 2002, across its top. The Prime Medical Care, Inc., invoice copy was faxed to Petitioner on November 14, 2003, over a year after the accreditation certificate was sent to Dr. Flores. Petitioner again explains this discrepancy by raising the 2003 audit excuse. However, the explanation does not explain why the compliance documentation was not in the file in the first place. Mina Selub, M.D. Petitioner inspected Dr. Selub’s facility on May 17, 2002. The date that appears on her accreditation certificate is May 2005. Therefore, her accreditation covers May 2002 through May 2005. During the inspection, Petitioner determined that Dr. Selub’s office did not have heparin, nasal airways, and intubation forceps. Dr. Selub sent Petitioner a copy of a customer packing slip on an unknown date. The customer packing slip revealed that Dr. Selub ordered heparin from McKesson Medical Surgical on May 3, 2002. The packing slip had a handwritten note indicating that the heparin was received on June 1, 2002. Dr. Selub also submitted a copy of a second customer packing slip to Petitioner on an unknown date. The second customer packing slip revealed that Dr. Selub ordered Magill Forceps from McKesson Medical Surgical on May 13, 2002. The packing slip had a handwritten note indicating that Dr. Selub did not receive the forceps, which were reordered from Henry Schein. Petitioner never received any other documentation indicating that Dr. Selub actually ordered or received intubation forceps. Additionally, Dr. Selub also failed to provide any documentation of compliance with the nasal airway requirement. Ms. Sautner placed a hold on Dr. Selub’s accreditation certificate on June 6, 2002. She released the hold on July 12, 2002. The accreditation certificate has a July 15, 2002, fax date across the top. The above-referenced invoice for heparin from McKesson Medical Surgical indicates that the medication was ordered before the inspection. However, the hand written notation on that same invoice indicates that Dr. Selub's office received the heparin on June 1, 2002. The lack of any documentation regarding the ordering and/or receipt of the intubation forceps is more problematic. Apparently Petitioner issued Dr. Selub's office an accreditation certificate without obtaining further written verification of compliance with accreditation standards. Abelardo Acosta, M.D. Petitioner inspected Dr. Acosta’s facility on November 17, 2001. The date that appears on his accreditation certificate is November 2004. Hence, his accreditation covers November 2001 through November 2004. During the inspection, Petitioner determined that Dr. Acosta’s office did not have the following required medications: succinylcholine, magnesium sulfate, heparin, dopamine, inderal (propranolol), and dilantin (phenytoin). Petitioner also discovered that Dr. Acosta’s office did not have the following required monitoring and/or emergency equipment: tonsillar suction and nasal airways. After the inspection, Dr. Acosta provided Petitioner with the following documentation: (a) a copy of a packing slip from Southern Anesthesia + Surgical dated November 26, 2001, reflecting that Dr. Acosta ordered dopamine, succinylcholine, dilantin, magnesium sulfate, and heparin; (b) a copy of a statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta had ordered inderal (propranolol); (c) a copy of an invoice from Armstrong Medical Industries, Inc., with an order date of January 2, 2002, which reflected that Dr. Acosta ordered a suction unit; and (d) a copy of a packing slip from Physician Sales & Service dated December 3, 2001, reflecting that Dr. Acosta ordered numerous types of airways and a yankuar suction unit. Ms. Sautner placed a hold on Dr. Acosta’s accreditation certificate on December 5, 2001. She released the hold on December 12, 2001. The certificate has a December 12, 2001, fax date across the top. The statement from Southern Anesthesia + Surgical dated July 15, 2002, which reflected that Dr. Acosta ordered inderal, constitutes undisputed evidence that Petitioner did not verify Dr. Acosta’s full compliance with Petitioner's crash cart accreditation requirements prior to the awarding of actual accreditation on December 12, 2001. Charles Graper, M.D. (Level II Accreditation) Petitioner inspected Dr. Graper’s facility for level II accreditation on March 25, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Graper’s office did not have dextrose 50 percent, a required medication. Dr. Graper failed to provide Petitioner with any subsequent documentation to demonstrate compliance with accreditation standards regarding the need to have dextrose 50 percent as part of the office’s crash cart. Ms. Sautner released Dr. Graper’s accreditation certificate on April 4, 2001. The certificate has a April 19, 2001 fax date across the top. Petitioner failed to verify that Dr. Graper obtained dextrose 50 percent for his crash cart after his inspection for level II surgery and before the release of his accreditation certificate by Petitioner on April 4, 2001. Leigh Phillips, III, M.D. Petitioner inspected Dr. Phillips' facility for level II and III surgery on January 31, 2002. The date that appears on his accreditation certificate is January 2005. Hence, his accreditation covers January 2002 through January 2005. During the inspection, it was determined that Dr. Phillips' office did not have the following required medications: dextrose 50 percent and 36 ampules of dantrolene (missing 18). After the inspection, Dr. Phillips provided Petitioner a copy of an order acknowledgment form from Southern Anesthesia + Surgical dated February 7, 2002. The order acknowledgment form reflected that Dr. Phillips ordered dextrose 50 percent. Dr. Phillips' inspection file also contained a handwritten letter from Dr. Mel Propis dated January 31, 2003. The letter indicated that Dr. Propis had just returned from the office of Dr. Phillips and while there he had counted 36 ampules of dantrolene and the dextrose 50 percent in the crash cart. Ms. Sautner did not know the date that she advised Scribes, Inc., to release Dr. Phillip’s accreditation certificate. However, her records indicate that the certificate was faxed to her on February 19, 2002. Dr. Propis’ correspondence dated January 31, 2003, verifying Dr. Phillips' receipt of the requisite dantrolene was provided to Petitioner approximately 11 months after Petitioner received a copy of Dr. Phillips' accreditation certificate. Such constitutes further undisputed evidence that FLACS did not verify Dr. Phillips' full compliance with accreditation standards prior to awarding him accreditation. Brandon Kallman, M.D. and Francisco Prado, M.D. (combined inspection) Petitioner inspected Drs. Kallman and Prado’s facility on June 2, 2002. The date that appears on their accreditation certificates is June 2005. Hence, their accreditation covers June 2002 through June 2005. During the inspection, Petitioner determined that the physicians’ office did not have the following required medications: adrenalin (1:10,000 dilution), magnesium sulfate, heparin, dopamine, pronestyl (procainamide), and dilantin (phenytoin). Drs. Kallman and Prado provided Petitioner with a copy of a packing slip from Southern Anesthesia + Surgical dated July 12, 2002. The packing slip reveals that Drs. Kallman and Prado ordered the missing adrenalin (epinephrine), dopamine, pronestyl (procainamide), and dilantin (phenytoin). However, as evidenced by the fax strip across the top of the packing slip copy, the documentation was provided to Petitioner via fax transmission on July 22, 2002. Drs. Kallman and Prado also provided Petitioner with a copy of a packing slip from Henry Schein. The packing slip is dated July 18, 2002. The packing slip has a date of July 23, 2002, on the fax strip across the top. The packing slip in the record is illegible. Therefore, one cannot determine whether the packing slip served as documentation for receipt of the missing magnesium sulfate and heparin. Additionally, Drs. Kallman and Prado provided Petitioner with copies of an e-mail dated October 14, 2002, and multiple photos dated October 11, 2002. The photos depict the facility’s crash cart, its drawers, and the presence of dantrium. The original inspection form dated June 2, 2002, did not reveal any missing dantrium. Finally, Dr. Kallman provided one more document which purports to be some attempt at curing the deficiencies that were discovered during the inspection. The document in question is a short handwritten letter on Dr. Kallman’s letterhead signed by Dr. Kallman and dated July 16, 2002. The body of the letter reads as follows: Herewith are the documents requested. I will fax tomorrow a copy of Ms. Mad. Katz RN ACLS certification. Let this letter also reflect that we have ordered from Henry Schein the appropriate missing drugs for the crash cart. They are currently on back order. I will send a copy of the shipping slip upon arrival. Ms. Sautner released Drs. Kallman and Prado’s accreditation certificate on July 17, 2002. The certificate contains a July 23, 2002, fax date across the top. It may be that the illegible packing slip from Henry Schein verifies the receipt of magnesium sulfate and heparin by Drs. Kallman and Prado. Even so, the packing slip was dated July 18, 2002, one day after Ms. Sautner released the accreditation certificate on July 17, 2002. Additionally, the packing slip from Southern Anesthesia + Surgical was provided to Petitioner after the accreditation certificate release date. Needless to say, the e-mail and multiple photos are dated almost three months after the release of the accreditation certificate. The inspection file for Drs. Kallman and Prado is particularly problematic because the handwritten correspondence from Dr. Kallman put Petitioner on notice that he and Dr. Prado did not yet have the requisite drugs needed to meet the accreditation standards. Nevertheless, the very next day, with no further verification, Petitioner released the accreditation certificate. Dr. Luis Zarate, M.D. Petitioner inspected Dr. Zarate’s facility for level II and III office surgery on September 14, 2002. The date that appears on his accreditation certificate is September 2005. Hence, his accreditation covers September 2002 through September 2005. During the inspection, Petitioner determined that Dr. Zarate’s office did not have the required 36 ampules of dantrolene. Petitioner's inspection file for Dr. Zarate does not contain any documentation of ordering or receipt of dantrolene by Dr. Zarate or by anyone else on his behalf. Ms. Sautner did not have a release date for Dr. Zarate’s accreditation certificate. The certificate had an October 3, 2002, fax date. When Petitioner inspected Dr. Zarate, he was working in the same facility as Drs. Kallman and Prado. It is possible that the dantrolene photo contained in Drs. Kallman and Prado’s inspection file was meant to document Dr. Zarate’s compliance with the dantrolene requirement. Even if that is the case, Drs. Kallman and Prado's dantrolene photos were dated October 11, 2002, which means that the photos were taken after Petitioner released Dr. Zarate’s accreditation certificate. Dr. Andrew Weiss and Dr. Anthony Rogers Petitioner inspected Drs. Weiss and Rogers’ facility on December 6, 2001. However, the date that appears on their accreditation certificates is November 2004. Hence, their accreditation covers December 2001 through November 2004. During the inspection, Petitioner determined that the physicians’ office did not have two required medications: pronestyl (procainamide) and inderal (propranolol). Drs. Weiss and Rogers provided Petitioner with a copy of an invoice from Henry Schein dated February 6, 2003. The invoice reveals that Drs. Weiss and Rogers ordered the missing pronestyl (procainamide) and inderal (propranolol). The inspection file also contains a printed statement under the title “Andrew Weiss, M.D.” which states that “[a]ll ACLS approved drugs were present at the time of accreditation. Inspector found no deficiencies.” However, during the hearing, Ms. Sautner admitted that the statement was inaccurate and inserted into the file by error. Ms. Sautner placed a hold on the certificates for Drs. Weiss and Rogers on December 5, 2001 and December 10, 2001. She did not know the release dates of the certificates. The fax date on the certificates was December 12, 2001. The above-mentioned Henry Schein invoice dated February 6, 2003, is persuasive evidence that Drs. Weiss and Rogers ordered and received the requisite pronestyl (procainamide) and inderal (propranolol) over one year after Petitioner received a copy of Drs. Weiss and Rogers’ accreditation certificates. Such constitutes undisputed evidence that FLACS did not verify Drs. Weiss and Rogers’ full compliance with FLACS’s accreditation standards prior to awarding accreditation. Richard Edison, M.D. Petitioner inspected Dr. Edison’s facility on April 22, 2001. The date that appears on his accreditation certificate is April 2004. Thus, his accreditation covers April 2001 through April 2004. During the inspection, Petitioner determined that Dr. Edison’s office did not have the following required medications: adrenalin (1:10,000 dilution), succinylcholine, dilantin (phenytoin), and lanoxin (digoxin). Petitioner also discovered that Dr. Edison’s office did not have the following required monitoring and/or emergency equipment: intubation forceps. Dr. Edison’s inspection file contains a handwritten letter dated May 7, 2001, from Pam Rolm, R.N. Ms. Rolm wrote the letter on the letterhead for Dr. Edison’s facility, Cosmetic Surgery Center. The letter reads in part as follows: This letter is in response to request for information for certification. The following medications have been updated and the expired ones disposed of: 1) phenytoin, 2) Lanoxin, 3) succinycholine, and 4) Albuterol Inhaler. We have a McGill forceps in both anesthesia carts and an extra pair in the ORI medication cart. Dr. Edison’s inspection file also contains three invoices from Prime Medical Care, Inc. All three invoices have a fax strip across the top with a February 14, 2003, date and the sender name of Cosmetic Surgery Center. The first invoice dated December 11, 2000, indicates that Dr. Edison ordered ephedrine sulfate 50mg/ml. The second invoice dated October 30, 2001, indicates that Dr. Edison ordered lidocaine, heparin, verapamil, procainamide, and phenylephrine. The third invoice dated April 25, 2001, indicates that Dr. Edison ordered succinylcholine, albuterol inhaler, phenytoin, and digoxin. Ms. Sautner testified that she ordered and placed a hold on the certificate for Dr. Edison on May 4, 2001. She released the hold on May 10, 2001. The certificate has a May 22, 2001, fax date across the top. The above-referenced correspondence dated May 7, 2001, does not address whether Dr. Edison ordered/obtained the missing adrenalin (1:10,000 dilution). Additionally, the first invoice is dated four months prior to the inspection. The second invoice is dated months after Petitioner released the accreditation certificate. The third invoice is appropriately dated but does not show that Dr. Edison ever ordered/obtained the missing adrenalin (1:10,000 dilution). Accordingly, Petitioner released Dr. Edison’s accreditation certificate before he documented compliance with the requirements that he possess adrenalin (1:10,000 dilution) and intubation forceps. Dr. Alton Ingram, M.D. Petitioner inspected Dr. Ingram’s facility on April 28, 2002. The date that appears on his accreditation certificate is April 2005. Therefore, his accreditation covers April 2002 through April 2005. During the inspection, Petitioner determined that Dr. Ingram’s office did not have a required tonsillar suction unit with backup suction. Dr. Ingram’s inspection file contains a copy of a photograph of a tonsillar suction unit with a hand-written date of July 29, 2002. Ms. Sautner placed the certificate for Dr. Ingram on hold on June 6, 2002. She released the hold on July 19, 2002. The date on the certificate is not legible. The date on the photograph of the tonsillar suction unit is after Petitioner released the accreditation certificate. Petitioner accredited Dr. Ingram before he documented full compliance with accreditation standards. Mont Cartwright, M.D. (Heathrow Facility) Petitioner inspected Dr. Cartwright’s Heathrow facility on March 3, 2001. The date that appears on his accreditation certificate is March 2004. Thus, his accreditation covers March 2001 through March 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Heathrow office did not have the required dopamine, heparin, and inderal. In an undated letter, Dr. Cartwright’s staff advised Petitioner that Dr. Cartwright’s Heathrow facility had obtained the missing medications. Ms. Sautner released the hold on Dr. Cartwright’s accreditation certificate on April 4, 2001. The fax date on the certificate is April 19, 2001. Mont Cartwright, M.D. (Orlando Facility) Petitioner inspected Dr. Cartwright’s Orlando facility on May 13, 2001. The date that appears on his accreditation certificate is May 2004. Hence, his accreditation covers May 2001 through May 2004. During the inspection, Petitioner determined that Dr. Cartwright’s Orlando office did not have the required dilantin and heparin. Dr. Cartwright’s office staff sent Petitioner correspondence dated June 7, 2001. The letter claims that the “crash cart” in Dr. Cartwright’s Orlando facility had been “brought up to standards in accordance with compliance. ” Ms. Sautner testified that she released the hold on Dr. Cartwright’s accreditation certificate on June 22, 2001. The fax date on the certificate is June 28, 2001. Inadequate Quality Control Petitioner asserts that it has appropriate quality assurance programs and processes which Respondent reviewed without objection. Dr. R. Gregory Smith, one of Petitioner’s current co-directors for facility inspections, describes Petitioner's quality assurance program in the following manner: Right. We have regular board meetings. We go over the forms and changes and things like that. We talk to inspectors and say, you know, try to check all the boxes and that type of thing. Q. You basically go over your work again – A. Yes. – make sure everything is accurate? A. Right. Plus, I think the actual meeting with the Board of Medicine to iron out any issues is also quality assurance. Petitioner's renewal application included a two-page document titled, “Quality Improvement Plan.” The document can best be described as a description of the quality assurance exercises for physicians' offices. The document does not describe Petitioner's internal quality assurance program. Other than the above-quoted description provided by Dr. Smith, Petitioner failed to present any evidence that outlines Petitioner’s own quality assurance program. In fact, the manner in which Petitioner deals with its own errors indicates that Petitioner has inadequate quality assurance processes. In situations where an inspector fails to check yes or no on an item when conducting an inspection, Petitioner takes the position that an inspector is not to make any changes after the fact. Rather, Petitioner claims that it assumes the worse, treats the blank as a no answer, and asks the physician undergoing inspection to provide a letter of attestation, a packing slip, or some other material that documents compliance with the accrediting standard. Petitioner's inspection files reveal instances where Petitioner did not follow the above-referenced quality assurance policy. For example, the inspection form for Harold Reed, M.D., revealed no check under yes or no on page 3 under the crash cart medication succinylcholine. After the inspection, Dr. Reed did not provide Petitioner with any materials documenting compliance with the requirement to have succinylcholine on the facility's premises. It may be that the inspector made a clerical error during the inspection or he may have remembered seeing the medication in Dr. Reed's refrigerator after the inspection. In any event, Petitioner did not follow its alleged quality assurance policy of requiring the physician to show compliance after the inspection. Dr. Leonard Rubinstein’s inspection file presents another example of Petitioner's failure to follow its alleged quality assurance policies. The inspection form reveals no check under yes or no on page 3 under the crash cart medications lasix and magnesium sulfate and on page 4 under oximeter in the monitoring and emergency equipment section. After the inspection, Dr. Rubinstein did not provide Petitioner with any documentation showing the presence of the missing items. Petitioner did not attempt to determine whether the inspector had made a “clerical error” or whether Dr. Rubinstein procured the missing items. In other words, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Dr. Michael Freeman’s inspection file presents another example of Petitioner’s failure to follow its alleged quality assurance policies. Dr. Freeman’s inspection form reveals no check under yes or no on page 3 under the crash cart medication mazicon. The inspection file contains no deficiency documentation, and thus, does not address the mazicon issue. Again, Petitioner did not follow its own policy regarding the treatment of situations where the inspector fails to check no or yes on an inspection item. Conditions Posing a Potential Immediate Threat Dr. Hector Vila, Jr., a licensed Florida physician and an Assistant Professor of Anesthesiology and Oncology at the University of South Florida, H. Lee Moffitt Cancer Center, testified during the final hearing on the issue of whether any of the facilities inspected by Petitioner posed a potential immediate threat to patients due to the deficiencies discovered during the inspection. Dr. Vila has administered anesthesia in office surgery settings in the past and currently serves as an office surgery inspector for the Respondent. Dr. Vila is an expert in office surgery and anesthesia. His testimony regarding Petitioner's failure to report conditions posing a potential immediate threat to patients is persuasive. For example, the office of Marwan Shaykh, M.D, posed a potential immediate threat to patients because it did not have nitroglycerin and epinephrine (adrenalin) on the premises. Such medications are necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. It would be nearly impossible to resuscitate a patient without such items. Dr. Shaykh failed to provide documentation of compliance with the nitroglycerin and adrenalin requirement until August 15, 2002, or sometime thereafter. Dr. Shaykh demonstrated compliance approximately two months after Petitioner recognized Dr. Shaykh as being accredited. It is true that Dr. Shaykh’s office was located adjacent to a hospital. Therefore, it is possible that the same teams that respond to emergencies in the hospital could go to Dr. Shaykh's office if he needed them. It is also true that Dr. Shaykh performs in vitro fertilization procedures, which could be terminated in case of an emergency. However, after Petitioner recognizes Dr. Shaykh as being accredited, he could practice any type of medicine and perform any procedure as long as he is properly trained to do so. Furthermore, the office surgery accreditation rules do not provide any type of exemption based on the location of the physician’s office because to do so would undermine the reason for the rule. Office surgery facilities are not hospitals no matter how close to the hospital they may be located. If Dr. Shaykh felt that his close proximity to the hospital did not make compliance with the office surgery rules necessary, he should have filed a petition for waiver or variance from the relevant rules rather than ignore the need to have crucial resuscitative drugs in his crash cart. The office of Karen Chapman, M.D., posed a potential immediate threat to patients because it lacked 16 of the 22 medications required in an office surgery facility’s crash cart. The office also lacked an ambu bag, a piece of equipment used to resuscitate patients. Two of the 16 missing medications were the nitroglycerin and adrenalin, which are absolutely necessary to resuscitate a patient who may suffer a respiratory arrest due to either a surgical or anesthetic complication. The ambu bag is also used on patients under respiratory arrest and it is considered a crucial piece of equipment. Dr. Chapman’s office failed to provide documentation of compliance with the crash cart requirements until February 12, 2003. She did not demonstrate compliance until approximately nine months after she obtained her accreditation. Dr. Chapman may have informed Petitioner that she did not intend to open her new practice until she obtained accreditation. However, Dr. Chapman obtained her accreditation and presumably opened her practice almost nine months before she provided Petitioner with documentation of her compliance with the crash cart medication requirements. She never provided any materials documenting whether she obtained the required ambu bag.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent enter a final order denying Petitioner’s application for renewal as an office surgery accrediting agency. DONE AND ENTERED this 15th day of April, 2004, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD 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 15th day of April, 2004. COPIES FURNISHED: Alfred W. Clark, Esquire 117 South Gadsden Street, Suite 201 Post Office Box 623 Tallahassee, Florida 32302-0623 Edward A. Tellechea, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 Rosanna Catalano, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner is a hospital licensed by the State of Florida and is located in Jacksonville, Florida. Respondent, the affected state agency, as defined in Subsection 120.52(1), Florida Statutes, is responsible for the regulation of health care facilities, to include Petitioner. The Department also considers the question of provision of additional health care in the community through its certificate of need program. Intervenor has made application to provide ambulatory surgery in Duval County, Florida, through a freestanding surgery center. Jacksonville, Florida, is in Duval County. This case is part of a consolidated hearing process and is the companion matter to Saint Vincent's Medical Center, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp., d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-337 and Riverside Hospital, Petitioner v. State of Florida, Department of Health and Rehabilitative Services and Ambulatory Care - Duval Development Corp. d/b/a Jacksonville Surgical Center - Ambulatory Surgical Center, Respondents, D.O.A.H. Case No. 83-482. The first three days of the hearing were conducted on the dates alluded to in this order. That presentation was transcribed. In addition, deposition testimony was presented and accepted as part of the record in this matter. The campanion cases concern the propriety of the grant of a certificate of need to the Intervenor in this cause to allow construction and operation of a freestanding ambulatory surgery center which would be used for performing outpatient surgeries. At all times relevant to this case, Saint Vincent's had a department in which outpatient surgical procedures were performed and are expected to be performed in the future. With the advent of the establishment of the Intervenor's facility, that health care unit will be in competition with Petitioner in the realm of providing surgical procedures. As recently as 1975, Respondent knew that ambulatory surgery centers, such as that proposed by the Intervenor, would need permission to construct such a facility. This permission relates to the need to apply and receive a certificate of need from the Department. The authority for such regulation was pursuant to applicable provisions of Chapter 381, Florida Statutes. Notwithstanding this regulatory role to be fulfilled, Respondent did not undertake a program for enacting rules to consider the question of need for ambulatory surgical centers. This lack of rulemaking was primarily due to inactivity of applicants seeking ambulatory surgical center certificates of need. This circumstance changed in late 1982. In December, 1982, Respondent received approximately thirteen applications for ambulatory surgical center certificates of need, as contrasted with approximately ten applications over the prior three years. At the same time Respondent was in the throes of having to revamp its certificate of need review process related to the overall health industry, brought about by statutory changes which abolished health system agencies and created local health councils. In 1983, at the time of the hearings, Respondent had received 27 applications for ambulatory surgery centers. This glut of applications by would-be ambulatory surgical centers and the 1982 applications were examined without formal rules defining the need question, related to expected numbers of surgical procedures that might be conducted on an outpatient or ambulatory basis. The determination of this ratio of outpatient surgical procedures to inpatient surgical procedures is a vital part of the need question. 1/ Absent promulgated rules, Department officials began their attempt to ascertain the percentage comparison between outpatient and inpatient surgeries, as that item was involved in the establishment of a methodology for considering the need question. Based upon information provided by applicants for ambulatory surgery centers and its own research, Respondent concluded that anywhere from 18 to 40 percent of total surgeries could be expected to be outpatient surgeries. Having utilized a median projection related to population expectations in the certificate of need process, the Department decided to use a median projection for the expected percentage of outpatient surgery. Thus, 29 percent was selected as the percentage of outpatient surgeries in the total number of surgical procedures and that percentage was utilized in the computation of the number of expected outpatient surgical procedures. Utilization of this 29 percent factor in the computation of the number of procedures to be expected on an outpatient basis may be seen in Petitioner's Exhibit 2 and Respondent's Exhibit 1, application reviews. Once the Department decided to employ the 29 percent factor, it has consistently, on a statewide basis, utilized that factor in evaluating the question of the grant of certificates of need for ambulatory surgical center applicants. This has been done in more than one batch or cycle and was done in the instance of Intervenor's application which is at issue. Although the 29 percent factor is not the only determining element of the certificate of need process, it is an integral part of that process and can affect the outcome of the grant of the certificate, as has been the case in two instances alluded to in the course of the hearing. This policy choice by the agency is not emerging. It is not one of a series of approaches that have been experimented with in trying to arrive at a concluding agency position, prior to the formal adoption of a rule. This percentage factor has been the only number utilized in the review of all ambulatory surgery center applications commencing late 1982 to the time of final hearing in this action. This choice has not stood the test or scrutiny of the rulemaking process set forth in Section 120.54, Florida Statutes. Notwithstanding the stated willingness of the agency to modify its position when presented with a more credible method, that contingency or eventuality has not occurred and every applicant for ambulatory surgery center certificate of need has had its application measured against the 29 percent factor commencing December 1982, to the exclusion of other techniques suggested by applicants. In the face of the facts reported above and the record considered, and recognizing that the agency should be afforded an opportunity to establish a record basis for the utilization of the 29 percent factor, even if it were found to be an invalid rule, a decision was reached at the time of hearing on the question of the utilization of the 29 percent factor and whether it was a rule not duly promulgated. It was found that the 29 percent factor is an unpromulgated rule and could not stand as law without first being subject to an assessment of the quality of the record basis for the agency's policy choice. The argument related to this case may be found at pages 798 through 829 of the transcript. The ruling is announced at pages 829 through 832. Respondent subsequently presented additional evidence in support of its policy choice and that may be found in succeeding sections within the transcript. This written order memorializes the ruling announced at hearing.
The Issue The issues for determination are whether Respondent Lucien Armand, M.D., violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009(2) and (4), and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes (2006), as alleged in an Amended Administrative Complaint filed by the Department of Health before the Board of Medicine on June 20, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Lucien Armand, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 33997. Dr. Armand is board-certified in general surgery by the American Board of Surgery. Dr. Armand’s mailing address of record at all times relevant to this matter was 2071 Southwest 52nd Way, Plantation, Florida 33317. At the times relevant, Dr. Armand practiced medicine at 4100 South Hospital Drive, Suite 108, Plantation, Florida 33317. The office at which Dr. Armand practiced medicine was located very close to Plantation General Hospital (hereinafter referred to as “Plantation”). Dr. Armand has been the subject of three prior disciplinary matters arising out of five separate cases. Penalties were imposed in those three disciplinary matters. The Department summarized those disciplinary matters in paragraph 37 of its Proposed Recommended Order: In DPR Case Numbers 0019222, 0019123 and 0091224, Respondent was fined, received a reprimand, and was required to complete 30 hours of Continuing Medical Education (CME) in general vascular surgery and risk management within the surgical practice. In Case Number 94-10100, Respondent was required to submit to and comply with an evaluation at the University of Florida, to pay a fine, was reprimanded, was required to complete twenty hours of CME in general surgery in performing Laparoscopic Cholecystectomy, and was placed on Probation for two (2) years. In Case Number 1999- 58474, Respondent was restricted from performing Level II or above office surgery as defined in Rule 64B8-9.009(1)(d), Florida Administrative Code, until the Respondent demonstrated to the Board that he had successfully completed the University of Florida Comprehensive Assessment and Remedial Education Service (UF C.A.R.E.S.) course and complied with all recommendations, was reprimanded, was placed on probation for two (2) years, was required to attend the Florida Medical Association “Quality Medical Record Keeping for Health Care Practitioners” course, was required to perform 100 hours of community service, and was required to reimburse the Department for costs. Dr. Armand, who is 70 years of age, has been practicing medicine for 46 years. He has practiced medicine in Florida since 1979. During the eight months prior to the final hearing of this matter, Dr. Armand was working in South Sudan pursuant to contract with the United States State Department. October 6, 2006, Surgery on Patient W.C. On September 14, 2006, Patient W.C. presented to Dr. Armand and was diagnosed as having a slow-growing left inguinal hernia. Dr. Armand scheduled Patient W.C. for surgical repair of the inguinal hernia. The surgery was scheduled for October 6, 2006, at Dr. Armand’s office and, at the request of Patient W.C., under local sedation. At approximately 9:30 a.m., October 6, 2006, Patient W.C. arrived as scheduled at Dr. Armand’s office, accompanied by his wife and child. Patient W.C., who was not asked to execute any paperwork concerning the operation, was taken into a room where he was directed to lie down. There were two nurses in the room. Patient W.C. was given one shot of some form near the site of the procedure. This shot is the only medication he remembers receiving. He denied any recollection of having received medication intravenously, intramuscularly, or rectally. According to Dr. Armand, Patient W.C. was given “local anesthesia, Xylocaine 1% and ½% during the procedure and I gave some oral sedation, 10mg. of Valium, by mouth.” Page 171, Lines 19-21, Vol. II, Transcript of Final Hearing. At some point during the surgery, Patient W.C.’s intestines eviscerated, pushed themselves out through the hernia, making the hernia impossible to repair in the office. Due to the evisceration of Patient W.C.’s intestines, Dr. Armand eventually closed the incision and decided to transport Patient W.C. to Plantation to complete the procedure. Dr. Armand’s testimony that he closed and took patient W.C. to Plantation because Patient W.C. began “fidgeting” is not credited. While Patient W.C. did not have any clear recollection of the surgery while at Dr. Armand’s office, he did recall that “I was shaking myself and one of the nurses put something on my head and I went to sleep.” Page 40, Lines 20-22, Vol. I, Transcript of Final Hearing. Patient W.C. later indicated that “[o]ne of the ladies sprayed something on my face,” at which point Patient W.C. “went to sleep.” Page 41, Lines 23-24, and Page 42, Line 8, Vol. I, Transcript of Final Hearing. Patient W.C. did not remember anything else from this point in the surgery until he awoke at approximately 2:00 p.m., October 6, 2006, in a room at Plantation. Patient W.C. was transported to Plantation after he “fell asleep” by Dr. Armand. When Patient W.C. arrived at the Plantation emergency room, he was noted to be “sleepy” and, based upon Dr. Armand’s representation to the emergency room physician, Cornell Calinescu, M.D., was described as “somewhat sedated secondary to Valium and Clonidine.” Patient W. C. was also described by Dr. Calinescu and an emergency room nurse as able to speak. Upon admission to Plantation, Dr. Armand performed emergency surgery on Patient W.C. under general anesthesia, completing the procedure he had begun in his office. The surgery was completed without further complication. As noted above, Patient W.C. has no recollection of arriving at the Plantation emergency room, how he got to the hospital, or anything else that took place after falling asleep in Dr. Armand’s office, until he awoke in a hospital room later in the afternoon. Dr. Armand’s Medical Records for the October 6, 2006, Surgery. Dr. Armand’s office notes for Patient W.C. lack any documentation as to what took place in his office on October 6, 2006. Dr. Armand did not record the date of the procedure; the type of procedure performed; pre-operative care; any drugs that were prescribed, dispensed, and/or administered; the type and dosage of anesthetic sedation used; or post-operative care. Dr. Armand’s medical records for Patient W.C. also failed to include any informed consent for the procedure performed on October 6, 2006. As noted above, Dr. Armand did complete an operative report after the emergency surgery performed on Patient W.C. at Plantation. Office Surgery; Level of Anesthesia. Florida Administrative Code Rule 64B8-9.009 (hereinafter referred to as the “Office Surgery Rule”) prescribes standards for the performance of office surgery. In providing those standards, the Office Surgery Rule defines three levels of sedation and the conditions under which each level may be achieved and must be performed. Level II and Level III office surgery require registration of the physician’s office to perform. Dr. Armand’s office was not registered to perform Level II or Level III office surgery at the times relevant to this proceeding. Only the first and second levels of office surgery are relevant to this case. Florida Administrative Code Rule 64B8-9.009(3) describes the types of procedures appropriate for “Level I” office surgery, which Dr. Armand has argued he performed on Patient W.C., as follows: Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-inducted alteration of consciousness other than minimal pre- operative tranquilization of the patient. Liposuction involving the removal of less than 4000cc supernatant fat is permitted. Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopes, skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cysto-scopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints). . . . . 5. Chances of complication requiring hospitalization are remote. Florida Administrative Code Rule 64B8-9.009(4) describes the types of procedures appropriate for “Level II” office surgery, which the Department argues Dr. Armand utilized on Patient W.C., as follows: Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intra and post- operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat. Level II Office surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. [Emphasis added]. While the Department relies in part upon the language of Florida Administrative Code Rule 64B8-9.009(4) that “[s]uch procedures shall include, but not be limited to . . . hernia repair . . .” to support its argument that the procedure performed by Dr. Armand on Patient W.C. was in fact performed as Level II surgery, this reliance is misplaced. Regardless of the proper interpretation of this language of the Rule (whether it clearly puts physicians on notice that all hernia repair surgery must be conducted as Level II surgery or not), at best it establishes a proscription. Such a proscription, cannot, however, be relied upon to establish the “fact” that Level II surgery was performed or not. The question of whether Dr. Armand performed the procedure defined as “Level II” office surgery is the disputed issue of fact in this case. Resolving this factual dispute requires an ultimate factual determination, which involves the application of a legal standard (the Rule) to the historical facts (what Dr. Armand actually did) as found by the trier-of-fact based upon the evidence. The Rule is not evidence of what Dr. Armand did; rather it is the yardstick against which Dr. Armand’s conduct must be measured and, ultimately, judged. The evidence either way concerning the level of surgery performed by Dr. Armand consisted of his testimony denying that Level II surgery was performed, the testimony of Patient W.C. concerning his condition, the description of Patient W.C.’s condition by emergency room personnel, and the opinion of the Department’s expert witness, Christian Brikedal, M.D., as to the level of surgery. Dr. Armand’s denial that he performed Level II surgery was not convincing because it was inconsistent with the patient’s description of his condition on October 6, 2006, and the description of his condition by emergency room staff when arrived at Plantation. Patient W.C. had no recollection of going to the hospital or anything that transpired there until he awoke at about 2:00 p.m. the afternoon of October 6, 2006. Emergency room staff noted that Patient W.C. was able to talk when he arrived. These facts, convincingly proved, are more consistent with what constitutes Level II surgery: “the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining . . . the ability to respond purposefully to verbal command and/or tactile stimulation.” This finding is further supported by Dr. Brikedal opinion that Patient W.C.’s condition was consistent with having undergone Level II sedatopm. Dr. Brikedal, whose testimony was convincing and uncontroverted, was asked the following question and gave the following answer at Page 22, Lines 7-14, Vol. I, Transcript of Final Hearing: Q Assuming W.C. is going to testify that as soon as the complication occurred that he was put to sleep and didn’t wake up until he was in the hospital, are you able to reach any conclusions about the level of sedation that occurred? A He would have to have been given a sedative I.V. or I.M. to be that sleepy. This opinion, as to Patient W.C.’s condition on October 6, 2006, supports a finding that Patient W.C. was under Level II anesthesia while surgery was being performed in Dr. Armand’s office. Having found that Patient W.C. was under the level of sedation described in the definition of “Level II” office surgery, leads inescapably to the finding that Dr. Armand administered Level II sedation to Patient W.C. The foregoing finding is further supported by the portion of the Office Surgery Rule quoted, supra, in finding of fact 24. Dr. Brikedal explained during the hearing why it is “appropriate and necessary to do an inguinal hernia repair” as Level II surgery: “Sedation to the point that the patient’s comfortable so they’re able to or they’re not pushing against you, inhibiting you from performing this very safely.” Page 24, Lines 20-22, Vol. I, Transcript of Final Hearing. As a board- certified general surgeon who has previously registered and had his office accredited as an office at which Level II surgery could be performed, Dr. Armand must have been aware of why it is prudent to perform hernia repairs as Level II surgery. While Dr. Armand may have begun the surgery as Level I, when Patient W.C.’s intestines eviscerated, Dr. Armand must have realized that taking Patient W.C. to Level II sedation would give him a better opportunity to correct the problem. Unfortunately for Dr. Armand, it was too late. Office Surgery Rule Procedures. Florida Administrative Code Rule 64B8-9.009(2) prescribes requirements for conducting “office surgery,” taking into account of the level of sedation utilized during a procedure. The hernia repair performed by Dr. Armand on Patient W.C. constituted “surgery” as defined in Florida Administrative Code Rule 64B8-9.009(1). Performance of the surgery in Dr. Armand’s office constituted “office surgery” as those terms are defined in Florida Administrative Code Rule 64B8-9.009(1)(d). The “office surgery” performed by Dr. Armand on Patient W.C. failed to comply, as required, with all the requirements of Florida Administrative Code Rule 64B8-9.009(2), applicable to conducting Level II office surgery and, in some instances, Level I office surgery: Dr. Armand failed to “maintain complete records” of the surgical procedure as required by Florida Administrative Code Rule 64B8-9.003, or a written informed consent from the patient as required by Florida Administrative Code Rule 64B8- 9.009(2)(a)(applicable in part to Level I and Level II surgery); No log of Level II surgery was kept as required by Florida Administrative Code Rule 64B8-9.009(2)(c); No adverse incident report was filed as required by Florida Administrative Code Rule 64B8-9.009(2)(k). This portion of the rule requires that “[t]he surgeon shall report to the Department of Health any adverse incidents that occur within the office surgical setting. . . .” (Emphasis added). This requirement is separate from any requirement that a hospital report adverse incidents and the burden of reporting is put directly on the surgeon; and Dr. Armand did not have an established risk management program as required by Florida Administrative Code Rule 64B8- 9.009(2)(j). The Standard of Care. Dr. Birkedal provided an opinion to the Department and testified at the final hearing as to whether Dr. Armand’s treatment of Patient W.C. met the “level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers ” (Hereinafter referred to as the “Standard of Care”). In his original opinion dated December 22, 2007, Dr. Birkedal indicated that he did not believe that Dr. Armand’s care of Patient W.C. violated the Standard of Care. There were caveats or assumptions, however, which Dr. Birkedal recognized in his written opinion could change his opinion if not correct. In particular, at the time of his original opinion, Dr. Birkedalk had incorrectly assumed that the procedure performed on Patient W.C. was a Level I procedure. Dr. Birkedal recognized in his original opinion that, if his assumption were incorrect, that his opinion would change: “[i]f he did give an IV sedative, then he may have violated the standard of care if his office is not licensed to give IV sedatives.” At hearing, Dr. Birkedal was of the opinion that Dr. Armand had not simply performed Level I surgery and, therefore, opined that he had violated the Standard of Care because his office was not a properly licensed office surgery suite. Dr. Birkedal also offered other opinions at hearing concerning what he perceived were violations of the Standard of Care, but those “violations” were not alleged by the Department in the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Lucien Armand M.D., has violated Section 458.331(1)(v), Florida Statutes (2006); Section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-9.009 and Section 458.351, Florida Statutes (2006); Section 458.331(1)(m), Florida Statutes (2006); and Section 458.331(1)(t), Florida Statutes, to the extent found in this Recommended Order; and indefinitely suspending his license to practice medicine in Florida, but allowing him to continue to practice medicine outside the United States through his relationship with the United States Department of State after full disclosure of the Board’s final order to the United States Department of State. Should a medical license not be a condition of employment by the United States Department of State, his license should be revoked. DONE AND ENTERED this 17th day of June, 2009, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 17th day of June, 2009. COPIES FURNISHED: Diane Kiesling Assistant General Counsel Robert A. Milne Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Whether Proposed Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006, constitute an invalid exercise of delegated legislative authority?
Findings Of Fact Standing. The Petitioners, Medivision, Inc., and Tampa Surgi-Center, d/b/a Ambulatory Surgery Center, have standing to challenge the proposed rules at issue in these cases. See the affidavits of Larry Cyment and Donna McMillan. Intervenor, Florida Hospital Association, Inc., has standing to participate in these cases. See the affidavit of Pat Haines. The following Intervenors have established their standing to participate as intervenors in these cases through testimony or affidavit: Cataract Surgery Center, Cortez Foot Surgery Center, Ambulatory Surgery Center of Bradenton, Tampa Outpatient Surgical Facility, Naples Day Surgery, Ambulatory Surgical Center, Specialty Surgical Center and Tallahassee Single Day Surgery. Eye Surgery Center, The Eye Associates, FW Associates and Cordova Ambulatory Surgical Center have failed to prove their standing to participate in these cases. The Proposed Rules; Purpose and Adoption. The Health Care Cost Containment Board (hereinafter referred to as the "Board"), published Rules 10N-6.002, 10N-6.003, 10N-6.004, 10N-6.005 and 10N- 6.006 (hereinafter referred to as the "Proposed Rules"), in Volume 16, Number 12, of the Florida Administrative Weekly (March 23, 1990). The purpose of the Proposed Rules is to collect data concerning the provision of ambulatory surgery services in the State of Florida. Data collected by the Board will allow a comparison of patient charges and will create an additional bases for the analysis of trends in the health care field. In particular, data collection will promote the analysis of shifts in the provision of health care from inpatient to outpatient settings. Data concerning patient identity, geographic location, diagnosis, procedures performed and charges for services is required to be collected and submitted to the Board pursuant to the Proposed Rules. In June of 1989, the staff of the Board presented a study to the Board concerning the growth of ambulatory health care services. Staff recommended that the Board direct that steps be taken to explore the possibility of collecting ambulatory surgery data. The Board accepted the recommendation and appointed a Technical Advisory Panel. The Technical Advisory Panel appointed by the Board consisted of nine representatives of various interested groups. Two members were from freestanding ambulatory surgery centers and two members were from hospitals providing ambulatory surgery services. At meetings of the Technical Advisory Panel in July, August, September and October, 1989, the collection of ambulatory surgery services data was considered. The Technical Advisory Panel discussed collection costs, the type of data to be collected, implementation dates, legislative authority, methods of submitting data and the scope of data collection. The Board was made aware of the Technical Advisory Panel's efforts through minutes of the Panel's meetings and other materials provided to the Board. The collection of ambulatory surgery services data was considered by the Board at its October, November and December, 1989, meetings. The Proposed Rules were approved by the Board at its December, 1989, meeting. There is no statutory authority which specifically provides that data may be collected by the Board from "freestanding ambulatory surgical centers." The Board cited Section 407.03, Florida Statutes (1989), as the specific authority for the Proposed Rules. The Board cited Sections 407.003, 407.03 and 407.08, Florida Statutes (1989), as the laws implemented by the Proposed Rules. Scope of the Proposed Rules. Ambulatory surgery services are provided in a variety of settings: hospitals (e.g., acute care, psychiatric and rehabilitation), licensed freestanding ambulatory surgery centers, physician offices and other unlicensed health care facilities. The Proposed Rules provide that all licensed hospitals included in Groups 1 through 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual which provide outpatient surgery services and all licensed ambulatory surgery centers in Florida are required to collect and submit 45 data elements to the Board. Psychiatric hospitals and rehabilitation hospitals are not subject to the Proposed Rules. Physicians' offices and other unlicensed health care providers are also not subject to the Proposed Rules. The Proposed Rules are limited to licensed providers of ambulatory surgery services so that the Board's staff can insure that all members of the groups selected data actually collect and report data. The Board cannot insure that all unlicensed providers of ambulatory surgery services, such as physicians' offices, comply with the Proposed Rules. Therefore, if data was required to be collected and submitted by unlicensed providers, the data would be less reliable. The weight of the evidence failed to prove that the requirement of the Proposed Rules that only hospitals included in Groups 1 and 10 and Group 14 of the HCCCB Florida Hospital Uniform Reporting System Manual and licensed freestanding ambulatory surgery centers collect and submit data constitutes an invalid exercise of delegated legislative authority. Specific Data vs. Aggregate Data. The Proposed Rules require the collection and reporting of 45 specific data elements. Aggregate data concerning ambulatory surgery services could be obtained from insurance companies and used by the Board as an alternative to the more specific data required to be collected pursuant to the Proposed Rules. Aggregate data is a compilation of specific data. Aggregate data can be used to comply with the Board's statutorily required functions. If aggregate data is used, however, it is likely that reporting will be incomplete. Not all information is reported to insurance companies concerning outpatient activity. Therefore, aggregate data obtained from insurance companies would not cover 100% of ambulatory surgery services provided by reporting entities, resulting in the potential for presenting an incomplete or inaccurate picture of ambulatory surgery services. The recommendations and conclusions which can be reached from aggregate data are limited. Specific data allows more flexibility for research purposes. Specific data will assure greater accuracy and comparability of data. Recommendations and conclusions reached from specific data should be more accurate. In order to insure comparability of data, specific data concerning patients, geographic location, diagnoses, procedures and charges must be collected. The Board collected aggregate data concerning ambulatory surgery services through a special study. The Board collected the data from hospitals and, on a voluntary basis, from licensed ambulatory surgery centers. "Typical" charges for specified ambulatory surgery procedures was collected. This collection effort was flawed by the lack of specific data. The accuracy of the reports based upon the aggregate data was criticized publicly. The reports were even criticized by one of the witnesses called to testify by Intervenors, Cataract Surgery Center, et. al. The weight of the evidence failed to prove that the requirement of the Proposed Rules that specific data be collected and submitted instead of aggregate data constitutes an invalid exercise of delegated authority. Confidential Patient Data. Some of the data elements to be reported pursuant to the Proposed Rules constitute confidential patient information. Disclosure of confidential patient information is prohibited by Florida law. The Proposed Rules do not require or authorize disclosure of confidential patient information. The manner in which the data collected will be distributed has not yet been decided upon by the Board. The evidence failed to prove that the Board will not comply with prohibitions against disclosure of confidential patient information. The weight of the evidence failed to prove that the requirement of the Proposed Rules that confidential patient information be reported to the Board constitutes an invalid exercise of delegated authority. Computer Use. The Proposed Rules require that data be submitted by computer tape or computer diskette. Therefore, data will have to be input into a computer system. The Proposed Rules specify the format data must be in when submitted. Most of the language of the Proposed Rules is computer terminology. The terminology of the Proposed Rules will require some knowledge of computers to carry out the requirements of the Proposed Rules. The language of the Proposed Rules is intentionally designed to convey technical information. The general purpose and requirements of the Proposed Rules does not take any special knowledge to understand. Requiring the submission of data by electronic means is designed to assure the accuracy and confidentiality of the data. The requirement of the Proposed Rules that data be reported in computer form and the use of computer terminology does not constitute an invalid exercise of delegated legislative authority. Errors in the Proposed Rules. Proposed Rule 10N-6.002(2) defines "Ambulatory Surgery Services" as procedures "provided in a hospital in its dedicated ASC ..." [Emphasis added]. Instead of "ASC" the Board intended to use the terms "operating room." Proposed Rule 10N-6.005 contains a list of the data elements to be collected and reported to the Board. This Proposed Rule contains the following errors or unclear language: Item 20 is "Facility Fee - Pri. Proc." "Pri. Proc." is an abbreviation for primary procedure. Items 21-24, similar to Item 20, contains the abbreviation "Sec. Proc." instead of secondary procedure. Items 25-27 contain a reference to "Page 3". As published in the Florida Administrative Weekly, there is no page 3. Item 35, which deals with expected methods of payment, refers to "Comm. Ins. (incl. BCBS)." This reference is an abbreviation for commercial insurance (Blue Cross Blue Shield). Item 44, patient birth date, uses the abbreviation "MMYYYY." This abbreviation should be "MMDDYY." Proposed Rule 10N-6.006 refers to "Primary Diagnosis Code" and "Secondary Diagnosis Code." The Rule should refer to Primary and Secondary "Procedure" Code. The mistakes identified in findings of fact 38-40 are not significant enough to characterize the rule as vague. Nor are these mistakes sufficient enough to otherwise conclude that the Proposed Rules constitute an invalid exercise of delegated legislative authority. Economic Impact. The Economic Impact Statement (hereinafter referred to as the "EIS"), issued with the Proposed Rules provided the following concerning the economic impact of the Proposed Rules on the Board: ESTIMATE OF THE COST OF IMPLEMENTATION: The agency will be affected by the costs of rule promulgation and by the demands placed upon staff time to assure compliance with the rules and to analyze the data collected. Costs for these activities are estimated to be approximately $85,000 per year. The weight of the evidence failed to prove that this portion of the Board's EIS is unreasonable. The EIS provided the following concerning the economic impact of the Proposed Rules on persons affected by the Proposed Rules: ESTIMATE OF THE COST OF IMPLEMENTATION: Implementation by affected facilities will cost approximately $2.9 to $3.1 million. These funds will be used to develop the programs necessary to collect and submit the data required. On-going compliance will have a much less significant impact. . . . . ESTIMATE OF COST TO ALL PERSONS DIRECTLY AFFECTED BY THE RULE: The initial cost to Florida hospitals and freestanding ambulatory surgery centers (ASC) would be from approximately $2.9 to $3.1 million to develop the reporting system necessary to generate the necessary data elements. On-going annual cost to the hospitals and free standing ASCs would be substantially less after the first year's start-up procedures are adopted. . . . . The EIS is insufficient because it does not adequately discuss the costs (implementation and ongoing costs) to affected persons or the impact of the Proposed Rules on small business. The weight of the evidence proved that the Proposed Rules will have an economic impact on affected persons. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the implementation cost affected persons can be expected to incur as a result of the Proposed Rules. As indicated in the EIS, the Board's determination of the estimate of the economic impact on affected persons was based upon surveys the Board distributed to licensed ambulatory surgery centers, an estimate of costs that hospitals incurred in implementing the Board's detailed patient data collection rule, the Board staff's experience with computer costs (including the collection and entry of data) and consultation with a computer expert familiar with the Proposed Rules. The surveys relied upon by the Board were distributed to all licensed freestanding ambulatory surgery centers. A total of 91 surveys were distributed. The Board requested that the surveys be returned within one week. Forty-one responses to the surveys were received by the Board from licensed freestanding ambulatory surgery centers. The responses constitute hearsay. Findings of fact concerning whether the information contained in the responses is correct, therefore, have not been made. The responses to the surveys have, however, been relied upon to make findings of fact concerning what information the Board based its EIS on. The Board received the following pertinent responses to the surveys from licensed freestanding ambulatory surgery centers: (1) 26 of the responders use computers, 12 have no computer capacity and 3 have some computer capacity; 17 or 18 different software programs are in use; and, (3) the costs to implement the proposed collection of data ranged from $0 to $50,000.00. Twenty- six responders indicated that they did not know how long it would take for them to implement the proposed collection of data. The Board determined that the average implementation cost for licensed freestanding ambulatory surgery centers reported in the responses to its survey was $18,975.00 and that the average implementation time was 13 weeks. The Board rounded up the average cost reported to it in the surveys and estimated that the cost of implementing the Proposed Rules at licensed freestanding ambulatory surgery centers would be $20,000.00. Based upon the existence of 85 licensed facilities, the Board estimated the total implementation cost for licensed freestanding ambulatory surgery centers to be $1,700,000.00 ($20,000.00 x 85). The Board estimated that the maximum cost of implementing the Proposed Rules at affected hospitals would be $2.00 per patient record. This estimate was based upon the Board's estimate of the cost of hospital compliance with the Board's detailed patient discharge data rule. Based upon an estimate of 600,000 patient records a year which will have to processed as a result of the Proposed Rules, the Board estimated the total cost of implementation in affected hospitals to be $1,200,000.00. The Board concluded that the total minimum cost of implementing the Proposed Rules will be $2,900,000.00 ($1,700,000.00 cost for freestanding ambulatory surgery centers plus $1,200,000.00 cost for affected hospitals). The Board discussed the cost of implementing the Proposed Rules with J. Thomas Solano, an expert in computers. Mr. Solano estimated that the cost of modifying an existing computer system (small to mid-range computer) to comply with the Proposed Rules would be $4,000.00 to $10,000.00. The Board used the highest estimate, $10,000.00, and multiplied this cost by the number of affected persons (85 freestanding ambulatory surgery centers and 220 hospitals x $10,000.00). This resulted in a rounded-up estimated implementation cost of $3,100,000.00. The Board concluded that the total maximum cost of implementing the Proposed Rules will be $3,100,000.00. Some of the data to be collected and reported pursuant to the Proposed Rules is already being collected by affected persons. Therefore, the primary cost of complying with the Proposed Rules will be associated with modifying existing computer software and/or hardware. The cost of modifying an existing computer system can fluctuate widely. As a general rule, computer users with existing software must rely upon their existing software provider to make modifications. The cost of modifying software can, therefore, be much higher than Mr. Solano estimated. As an alternative to modifying existing systems, affected persons can acquire a freestanding personal computer and software which can be used to comply with the Proposed Rules. The cost of such an acquisition should be approximately $2,500.00 to $5,600.00. Intervenor, T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it will have to spend approximately $14,000.00 to $20,000.00 to implement the Proposed Rules. This estimate is based upon a letter purportedly from the Intervenor's computer company. The information contained in the letter is hearsay. The estimated implementation costs are, therefore, not supported by admissible evidence. The estimate, even if supported by competent substantial evidence, is within the Board's estimated implementation costs and, therefore, fail to prove that the Board's EIS is unreasonable or that the Board failed to fully consider the economic factors or impact. Intervenor, Cataract Surgery Center, estimated implementation costs of $1,900.00. This amount is limited to additional maintenance fees, supplies and personnel costs. Cataract Surgery Center believes there will no charge from its computer vendor to modify its software. Cataract's estimated costs are reasonable and within the Board's estimates. Ambulatory Surgical Center of Lake County (hereinafter referred to as "Lake"), does not own a computer. It uses the computer system of its physician owners. Lake considered more than one method of complying with the Proposed Rules. It considered buying a personal computer and estimated it would cost $5,000.00. This cost is consistent with the estimates of the Board. Lake also considered purchasing an integrated hardware and software package. It estimated that such a system would cost $40,000.00 to $50,000.00. The estimate is based upon hearsay. Even if the evidence concerning the cost of an integrated system is accepted as correct, the evidence fails to prove that such costs are necessary to comply with the Proposed Rules. The estimate for this system is based upon Lake's decision that it would perform other functions with the computer system, including storing management information and performing billing functions. These functions are not required in order to comply with the Proposed Rules. Lake currently treats approximately only 300 patients annually. The weight of the evidence failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the implementation cost which will be incurred by affected persons. The weight of the evidence also failed to prove that the inadequate treatment of implementation costs in the EIS was fully considered by the Board. Therefore, the treatment of implementation costs in the EIS constitutes harmless error. Although the primary costs to affected persons caused by the Proposed Rules will be associated with implementation of the Proposed Rules, there will also be certain costs associated with ongoing compliance with the Proposed Rules. There will be ongoing costs for the collection of data, entry of the data into a computer and reporting data to the Board. Ongoing costs caused by the Proposed Rules will be greater if an affected person with an existing computer system acquires a freestanding computer system instead of using the existing system. The Board's statement in the EIS concerning ongoing costs was not based upon information from affected persons. The statement concerning ongoing costs does not indicate what the ongoing costs of compliance with the Proposed Rules will be. It only indicates that it will be less than the initial implementation costs associated with the Proposed Rules. Although the weight of the evidence did not prove the estimated total amount of ongoing costs to affected persons from the Proposed Rules, the weight of the evidence failed to prove that ongoing costs will be greater than the estimated total amount of implementation costs. T.S.D.S., Inc., d/b/a Tallahassee Single Day Surgery Center, estimated that it would incur ongoing costs of approximately $6,000.00. This estimate is reasonable. Cataract Surgery Center estimated that it would incur ongoing costs of $41,600.00, or $20.00 per case, to comply with the Proposed Rules. Cataract Surgery Center's estimated costs include the following costs: reel purchase; handling; reel preparation; collection of billing data; process of sending information to the Board; clarification of errors; additional record production; and response to public inquiries. Cataract Surgery Center's estimated costs are not reasonable. The estimated time to comply with the Proposed Rules is excessive and some of the tasks, i.e., collection of billing data, are not required by the Proposed Rules. Cataract Surgery Center's conclusion that it may have an increase in maintenance fees is reasonable. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of the ongoing costs affected persons can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of ongoing costs in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated authority because of the ongoing cost which will be incurred by affected persons. The EIS contains a statement that the Proposed Rules should have no economic impact on small business. In reaching this conclusion the Board failed to take into account the legal definition of "small business" contained in Florida Statutes. The Board did, however, actually consider the impact the Proposed Rules would likely have on small ambulatory surgery centers subject to the Proposed Rules. The Board attempted to reduce the economic impact on small ambulatory surgery centers by allowing affected persons to file data on computer tape or on diskette. By allowing the use of diskettes for reporting data, the Board made it possible for affected persons to use personal computers to comply with the Proposed Rules. Delayed submission of some data elements was also allowed in order to reduce the impact on small facilities. It is unlikely that the Board would have made further modifications of the Proposed Rules had the legal definition of "small business" been considered. The weight of the evidence failed to prove what, if any, reasonable modifications should have been taken by the Board to accommodate any economic impact on small business. The weight of the evidence failed to prove whether any of the entities that participated in the proceeding were small businesses. Those entities, although meeting the definition of small business with regard to the number of employees they have and their net worth, failed to prove whether they are "independently owned and operated." See Section 288.703(1), Florida Statutes (1989). The weight of the evidence failed to prove if any person affected by the Proposed Rules is a small business. The weight of the evidence failed to prove that the Board did not fully consider the asserted economic factors and impact of small business which can be expected to incur as a result of the Proposed Rules. Therefore, the treatment of the impact on small business in the EIS was harmless error. The weight of the evidence also failed to prove that the Proposed Rules constitute an invalid exercise of delegated legislative authority because of the impact on small business. The Petitioners and Intervenors presented evidence concerning a number of actions which the Board did not take during its consideration of the economic impact and factors of the Proposed Rules and its preparation of the EIS. This evidence proved only that there were other steps which the Board could have taken during its preparation of the EIS. The Petitioners and Intervenors failed to prove, however, that the steps which the Board did take were not sufficient. The Petitioners and Intervenors therefore failed to prove that the steps which the Board did not take were required or necessary.
The Issue Whether Respondent, a medical doctor, in his treatment of Patient M.A., failed to keep legible medical records in violation of section 458.331(1)(m), Florida Statutes (2007); prescribed or administered inappropriate or excessive quantities of controlled substances in violation of section 458.331(1)(q), Florida Statutes (2007); committed medical malpractice by practicing below the standard of care in violation of section 458.331(1)(t), Florida Statutes (2007); failed to perform a statutory or legal obligation placed upon a licensed physician in violation of section 458.331(1)(g), Florida Statutes (2007); and violated any provision of chapter 458 or chapter 456, or any rules adopted pursuant thereto in violation of section 458.331(1)(nn), Florida Statutes (2007), as Petitioner alleges in the Third Amended Administrative Complaint; if so, whether (and what) disciplinary measures should be imposed.
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 that Paul M. Goldberg, M.D., violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Complaint; Dismissing Counts I-III of the Complaint; Imposing $20,000 in administrative fines; issuing a reprimand against Dr. Goldberg's medical license; requiring Dr. Goldberg to complete the "Laws and Rules" Course; suspending Dr. Goldberg's medical license until such time as Dr. Goldberg undergoes a "UF CARES" evaluation; and placing Dr. Goldberg's license on probation for three years under indirect supervision with 100 percent chart review of cosmetic surgery patients and 25 percent chart review of all other patients. DONE AND ENTERED this 4th day of March, 2015, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE 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 4th day of March, 2015.
Findings Of Fact Petitioner filed an application for certification as a physician assistant pursuant to Section 458.347(7)(b), Florida Statutes, a special avenue of certification as a physician assistant for graduates of foreign medical schools. In furtherance of that application, he appeared before the Physician Assistant Committee of the Board of Medicine. Subsequent to his appearance before that Committee, on August 13, 1992, Respondent sent Petitioner a letter which provides, in pertinent part, as follows: This is to advise that your application for issuance of a temporary certification with the requirement that prior to issuance of temporary certificate you submit within 30 days of date of appearance, a new corrected and complete application to be reviewed by the Board staff. Please complete the enclosed application. You will be required, as a condition to take the examination, 2 new personalized letters of recommendation, specifically recommending you as a physician assistant. The letter did not enclose an application form for Petitioner to complete. Respondent admits that the information in the letter was incorrect because it confused temporary certification with the requirements for examination. It is apparent that the letter is also incorrect because it fails to advise Petitioner if his application was being granted or denied; moreover, the wording of the letter makes no sense. By Order dated August 26, 1992, the Board of Medicine notified Petitioner that his application for temporary certification as a physician assistant was denied pursuant to the Committee's August 1 determination and the Board's August 9 determination that the length of time since Petitioner had last worked in the field of medicine or received significant medical education or training precluded him from being able to establish that he could practice as a physician assistant with reasonable skill and safety to the public. That Order further advised Petitioner, however, that the Board had granted Petitioner's application to sit for the certification examination pursuant to Section 458.347(7)(b), Florida Statutes, because Petitioner was eligible to take the examination to become certified as a physician assistant and that passage of the examination would serve to establish Petitioner's qualifications for practice. The Order specifically provided that the Board's permission for Petitioner to sit for the certification examination was "contingent upon and subsequent to receipt within 30 days" of Petitioner's appearance before the Physician Assistant Committee of (1) a complete and correct application and (2) two more letters of recommendation which specifically recommend Petitioner as a physician assistant. It would have been difficult for Petitioner to timely comply with the Order entered August 26 requiring him to file documents within 30 days of his August 1 appearance before the Committee. By letter dated August 31, 1992, Petitioner requested an extension of one week by which to obtain the second letter of recommendation due to the devastation produced by Hurricane Andrew and Petitioner's inability to communicate with the doctor who would sign it. Petitioner did, however, submit another application which was postmarked August 31, 1992, and received by Respondent early in September. At hearing, Respondent advised that it was waiving the 30-day deadline contained in the August 26, 1992, Order due to the intervention of Hurricane Andrew and because Respondent had not strictly enforced such deadlines as to other applicants. Rather, Respondent simply required that Petitioner comply with its Order within a reasonable period of time. By letter dated December 21, 1992, Respondent advised Petitioner that his application was incomplete because the Board had only received Petitioner's new application, one letter of recommendation, and Petitioner's request for an extension of time for submittal of the second letter. The letter further advised that the Board's staff's review of Petitioner's recent application had revealed some discrepancies requiring an explanation by Petitioner. The letter, therefore, advised Petitioner to submit one more recommendation letter, provide an explanation for six specified areas, and submit pages 8 and 9 of the application regarding Petitioner's clerkships. The letter further advised Petitioner that all information must be received by the Board no later than December 31, 1992. On January 20, 1993, Respondent received an undated letter from Petitioner referencing Respondent's December 21, 1992, letter which was received by Petitioner on December 30. Petitioner's letter enclosed the additional letter of recommendation requested by the Board, responded specifically to the six areas of inquiry, and enclosed pages 8 and 9 of the Board's application form. On January 20, 1993, the Board received a letter from Dr. Jose M. Bermudez, recommending Petitioner as a physician assistant. On January 28, 1993, the Board sent Petitioner a letter advising him that the Board had received the letter of recommendation from Dr. Bermudez and pages 8 and 9 of the application. That letter further provided as follows: However, the Physician Assistant Committee required you to submit a new complete and accurate application, and two (2) additional letters of recommendation which specifically recommend you as a physician assistant. Enclosed you will find a complete physician assistant application. Please fill the application out in its entirety and submit it to the Board of Medicine as soon as possible. In compliance with that request, Petitioner submitted yet another application for certification as a physician assistant, which was received by the Board on February 8, 1993. On February 24, 1993, the Board of Medicine entered its Order denying Petitioner's application for certification as a physician assistant. The Order recited that the denial was based upon the determination made by the Physician Assistant Committee on January 8 and by the Board on January 13 because Petitioner "failed to submit a new and complete and accurate application and one new personalized letter of recommendation within the time frame allotted by the Board." That Order does not mention Petitioner's application to sit for the certification examination, the issue pending before the Board, since the Board had already denied Petitioner's application for certification by Order entered August 26, 1992. That February Order also advised Petitioner of his right to request an administrative hearing regarding the Board's determination. On February 26, 1993, the Board's staff sent Petitioner a letter advising him that he had been certified by the Board to take the examination for licensure as a physician assistant to be administered in September, 1993. On March 10, 1993, the staff sent Petitioner a letter acknowledging Petitioner's "request for a hearing on the denial of your application for certification as a physician assistant," and advising Petitioner that the February letter advising him that he had been certified to take the examination for licensure as a physician assistant had been sent to Petitioner in error. A "corrected" letter was enclosed. That "corrected" letter dated March 10 advised Petitioner that the Board had preliminarily denied him certification to take the examination for licensure as a physician assistant. By letter dated March 18, 1993, the Board's staff sent an additional letter to Petitioner advising Petitioner as to the correct dates for the examination. In applying for temporary certification as a physician assistant and/or to sit for the certification examination, Petitioner has filed an additional application each time he has been instructed to do so by the Board or by the Board's staff and has submitted a letter explaining the information given in his applications each time that the Board's staff has requested that he do so. Petitioner has filed at least three such applications and has responded by letter to inquiries regarding the contents of his applications at least three times. Additionally, Petitioner has personally appeared before the Physician Assistant Committee on August 1, 1992, to be questioned regarding his qualifications. The Board has discovered some "discrepancies" or omissions in analyzing those various documents. Petitioner's August application states that the ending date for medical school, assumedly the date he received his degree, was February 25, 1965. That date appears in three places. Further, the copy of his diploma submitted to the Board reflects that date. Yet, the December 21, 1992, form from the Board to Petitioner advises him that he must explain his ending date for medical school. In response to that indication that he must provide different information, Petitioner's letter received by the Board on January 20, 1993, states that the ending date for medical school was February 29, 1962. At hearing, Petitioner explained that he attempted to differentiate between the date he completed classes and the date he completed all requirements, including internships, in order to receive his diploma. The information contained in Petitioner's application is correct. The August application contains an answer in the negative to question numbered 9 asking Petitioner if he is or has ever been emotionally or mentally ill. Although Petitioner's subsequent February 1993 application contains no answer to that question, the Board did not have before it the February application when it decided in January to deny Petitioner's application. Even so, Petitioner had no intention to be incomplete or inaccurate when he failed to answer that question on the February application. In his August application Petitioner does not list the completion of any social service work in either section inquiring about post-graduate training or practice employment. In an application that Petitioner filed in 1985 requesting licensure as a physician, Petitioner had specifically detailed the social service work performed by him as part of his medical school training. In that application he listed the dates as January 1, 1963 to December 31, 1963. The letter Petitioner wrote to the Board in response to its December 1992 request for a better explanation states that his social service work was done between March 1, 1963 and September 30, 1963. There is no dispute regarding whether Petitioner did in fact complete his social service work requirement as part of his education in order to receive his diploma, and it is clear that such work was done in 1963. Although there is a discrepancy regarding which months during 1963 he did his social work, the discrepancy as to the months during which Petitioner did something 30 years ago does not make his application inaccurate. In fact, the August application may be more accurate than the 1985 application form. The August application required Petitioner to list in chronological order from the date of graduation to the present all practice experience and/or employment. Petitioner advised that from February 28, 1970, to April 30, 1976, he was in private practice in Nicaragua. The Board's December 1992 letter asked for clarification because a prior application indicated additional activity. Petitioner's response letter advised that he was also in pediatric practice at the General Hospital of Managua from 1970 to 1972. His 1985 application did not mention the pediatric practice at General Hospital. At final hearing, Petitioner explained that he was in private practice at the same time that he practiced at the clinic in the hospital. Petitioner's 1985 and February 1993 applications, although not the subject of this proceeding, also contained some minor discrepancies regarding Petitioner's employment experience. For example, one shows Petitioner beginning his employment with the Nicaraguan Red Cross on May 1, 1976, and the other shows Petitioner's employment beginning on May 31, 1976. The parties do not dispute that Petitioner in fact practiced with the Nicaraguan Red Cross during that time period. In further response to the question requiring Petitioner to list all of his practice experience or employment, Petitioner did not list his activities from September 10, 1984, and thereafter. The Board's December 21, 1992, letter to him requested that he account for all his activities for the time period of January 1, 1984, and thereafter. In his response he did not identify those activities except to say that during that time period he was living in Miami. The detailed information had been provided to the Board in response to a letter to Petitioner from the Board dated March 8, 1992, in conjunction with his original application for certification as a physician assistant, although he did not again provide that information when he was ordered by the Board to file a new application. In Petitioner's August application, he listed no ending date regarding his private practice begun on January 1, 1984 in Managua, Nicaragua. Petitioner's 1985 physician license application showed that that employment ended September 10, 1984, whereas his February application showed that practice to have ended on September 15, 1984. Such a discrepancy is not material to Petitioner's application or eligibility. The application form contains a section regarding clerkships and requests that each clerkship be specified. In the August application Petitioner did not specify his four individual clerkships. After being asked pursuant to the Board's staff's December 1992 letter to resubmit pages 8 and 9 as to his clerkships, Petitioner did so by referring to them as a group rather than breaking them down individually. He did the same in the February 1993 application. The parties do not dispute that Petitioner performed the required clerkships. It is unclear how many letters recommending him as a physician assistant Petitioner has submitted to the Board. Petitioner referenced his submittal of photocopies of the "last two" letters of recommendation, the originals of which had previously been submitted to the Board, in a letter that Petitioner sent the Board in March of 1992. In correspondence from the Board to Petitioner in May of 1992 reference is made to the requirement that Petitioner submit another letter of recommendation because the Board did not have the original of that letter in its file. When the Board's staff instructed Petitioner to appear before the Physician Assistant Committee on August 1, 1992, the absence of necessary letters of recommendation was not one of the reasons given. The Board's August 26, 1992, Order requests "two more letters", which indicates that letters had been previously submitted. The staff's December 21, 1992, communication to Petitioner acknowledges receipt of one additional letter but requests another, which request was complied with at least by the submittal of the letter from Dr. Bermudez received by the Board on January 20, 1993. Petitioner applied to be certified as a physician assistant and the Board determined that he was eligible to take the examination. Thereafter, through a series of mistakes and correct acts, the Board's staff requested Petitioner on a number of occasions to file additional applications which he did. When the Board's staff asked for clarification he responded in writing and by telephone call, and the Board agrees that it has telephone slips in Petitioner's file. Each time the Board's staff asked for different information than had been given in Petitioner's previous application(s), Petitioner provided more and/or different information. There is no suggestion that Petitioner attempted to provide inaccurate or false information, and it is found that Petitioner provided correct and complete information to the best of his ability. Petitioner's mistakes are certainly no greater than the mistakes made by the Board's staff in sending Petitioner conflicting instructions, conflicting correspondence, and one letter that did not make any sense.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered permitting Petitioner to sit for the physician assistant examination to be administered during September of 1993. DONE and ENTERED this 12th day of July, 1993, at Tallahassee, Florida. LINDA M. RIGOT 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 12th day of July, 1993. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 93-1550 Respondent's proposed findings of fact numbered 1-10 have been adopted in substance in this Recommended Order. Respondent's proposed finding of fact numbered 11 has been rejected as not being supported by the weight of the evidence in this cause. COPIES FURNISHED: Catherine Lannon, Esquire Department of Legal Affairs The Capitol PL-01 Tallahassee, Florida 32399-1050 Enrique Rueda Arguello 9409 Fountainbleau Boulevard, Apt. #101 Miami, Florida 33172 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue in this case is whether the challenged portions of the proposed amendments set forth in the Fourth Notice of Change for Rule 64B8-9.009, Florida Administrative Code (FAC), published in the Florida Administrative Weekly on February 18, 2000, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Background Rule 64B8-9.009, Florida Administrative Code, is the Board's Rule governing the standards of care for office surgery. The Rule was first adopted on February 1, 1994 as a Rule 61F6- 27.009, Florida Administrative Code. It was transferred to Rule 59R-0.009, Florida Administrative Code, and was amended on May 17, 1994; September 8, 1994; and November 15, 1994, and then was finally transferred to Rule 64B8-9.009, Florida Administrative Code. In February of 1998, the Board directed its Surgical Care Committee to evaluate Rule 64B8-9.009 and to make recommendations for any modifications or amendments to the Rule. The 1998 Florida Legislature also addressed the issue of office- based surgery and provided that the Board may "establish by rule standards of practice and standards of care for particular practice settings . . . " including office-surgery environments. As discussed below, hearings were conducted by the Board and its Surgical Care Committee to consider changes to the office surgery rule. The Parties R. Gregory Smith, M.D., Charles Graper, D.D.S., M.D. and Florida Academy of Cosmetic Surgery Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Smith practices cosmetic surgery, plastic surgery, and oralmaxillofacial surgery in his office. Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery and a degree in medicine. Approximately 30 percent of FACS members use general anesthesia (Level III) in their office surgery procedures. At least one representative of FACS has attended each public rulemaking hearing relating to proposed Rule 64B8-9.009, Florida Administrative Code. FACS actively participated in the rulemaking process, expressing concerns relating to transfer agreements, hospital privileges, and the requirement for an anesthesiologist in Level III surgery. FACS' purposes include addressing adverse outcomes in the field of cosmetic surgery and implementing recommended approaches to improve patient safety. Petitioner Charles E. Graper, D.D.S., M.D., is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Graper received his doctorate in dental surgery from Emory University in 1971, his medical degree from Hahnemann University Medical School in 1983, and received one year of post-graduate training in general surgery at Orlando Regional Medical Center. Graper is Board-certified by the American Board of Oral and Maxillofacial Surgery, Board- certified in general cosmetic surgery, Board-eligible in general plastic surgery, and is a Fellow of the American College of Surgeons. Graper performs in his office cosmetic surgery, functional surgery, and surgery below the head and neck which would not be authorized by his dental license. Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. Graper has experience in performing Level III office surgery using general anesthesia. The Board of Medicine The Board of Medicine (Board) regulates the practice of medicine in Florida, and is the agency that adopted the rule at issue. The Florida Society of Plastic Surgeons, Inc., Florida Chapter, American College of Surgeons and Florida Society of Dermatologists The FSPS, FCACS, and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. As licensed physicians (M.D.s), members of FSPS, FCACS, and FDS are subject to the regulations promulgated by the Board of Medicine. A substantial number of physician members of the FSPS, the FCACS, and the FSD perform office surgery and are affected by the proposed amendments to Rule 64B8-9.009, Florida Administrative Code. FSPS is a Florida not-for-profit corporation whose 270 members are board-certified plastic surgeons (of the approximately 375 such physicians statewide) licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSPS was created and exists for the purposes of promoting plastic surgery as a science and profession. FSPS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members, and has participated throughout the rulemaking process with respect to Florida Administrative Code Rule 64B8-9.009. FCACS is a Florida not-for-profit corporation whose 1400 members are surgeons licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FCACS was created and exists for the purposes of promoting surgery as a science and profession. FCACS regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including Petitioner Graper, routinely perform office surgery. FSD is a Florida not-for-profit corporation whose 462 members are board-certified dermatologists licensed in the State of Florida pursuant to Chapter 458, Florida Statutes. FSD was created and exists for the purposes of promoting surgery as a science and profession. FSD regularly participates in legislative efforts, rulemaking proceedings, and litigation on behalf of its members. Members of the Association, including David Allyn, M.D., and Diane Calderone, M.D., routinely perform office surgery. The Florida Society of Anesthesiologists, Inc., Florida Hospital Association, Inc. and Association of Community Hospitals and Health systems The FSA is a not-for-profit professional membership organization representing approximately 2,000 anesthesiologists in Florida. FSA members practice in educational institutions, hospitals, ambulatory surgical centers, and physicians' offices. The purpose of the FSA is to provide its members information about anesthesiology and to inform the public about issues related to anesthesiology. The FHA and the ACHHS are nonprofit trade associations which represent over 200 hospitals and health systems. FHA and ACHHS represent member hospitals and health systems on common interests before the branches of government, particularly with respect to regulations that impact the members. The Florida Nurses Association (FNA) The Florida Nurses Association is a professional association of approximately 7,500 nurses licensed in the state of Florida, including approximately 1,700 advanced registered nurse practitioner (ARNP) members and a substantial number of CRNAs. Among its many purposes, the FNA represents the legal, legislative, and professional practice interests of the members. The Florida Association of Nurse Anesthetists Petitioner, Florida Association of Nurse Anesthetists (FANA), is a non-profit corporation and professional organization made up of more than 1,600 certified registered nurse anesthetists practicing throughout Florida, many of whom currently provide anesthesia for surgery performed in physicians' offices. As a part of its mission, FANA advocates its members' interests in legal, legislative, and professional practice issues. Rule Challenges by FSA and the Hospitals On July 8, 1999, the FSA filed a Petition for Administrative Determination of Invalidity of Proposed Rule challenging portions of the proposed amendments to Rule 64B- 8.9009 as set forth in the Second Notice of Change. The FSA's Rule challenge was assigned DOAH Case No. 99-2974RP. Also on July 8, 1999, the Hospitals filed a petition for Administrative Determination of the Invalidity of Proposed Rules challenging portions of the proposed amendments to Rule 64B8-9.009 as set forth in the Second Notice of Change. The Hospitals' Rule challenge was assigned DOAH Case No. 99-2975RP. The Board conducted a third public hearing on the proposed Rule amendments on August 7, 1999. The Board published a Third Notice of Change to the proposed Rule amendments in the August 20, 1999, issue of the Florida Administrative Weekly. None of the changes in the Third Notice of Change related to provisions that were in litigation. On January 12, 2000, the Board, the FSA, and the FSPS filed a Joint Stipulation on provisions of Rule 64B8-9.009, Florida Administrative Code (Joint Stipulation) in DOAH Case No. 99-2974RP. The Joint Stipulation released from FSA's Rule challenge, Case No. 99-2974RP, the majority of the proposed amendments to Rule 64B8-9.009 and reserved only the proposed amendments to Subsections (1)(e) and (6)(b)1.a. of Rule 64B8- 9.009 for challenge. On January 26, 2000, the Hospitals filed a Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(b)1. and 2. and (6)(b)1.a. and b. In light of the filing of the Joint Stipulation in DOAH Case No. 99-2974RP, and the filing of the Notice of Partial Voluntary Dismissal in DOAH Case No. 99-2975RP, the proposed amendments to Rule 64B8-9.009 were no longer subject to challenge, with the exception of the proposed changes to Subsections (1)(e), (2)(e), (2)(f), (2)(I), (4)(b)1., (4)(b)2., (6)(b)1.a. and (6)(b)1.b. Accordingly, on January 28, 2000, the Board filed the proposed amendments to Rule 64B8-9.009 that were no longer subject to challenge with the Department of State for Adoption. The Board subsequently conducted an additional public meeting and published a fourth notice of change relating to the proposed amendments to Rule 64B8-9.009 still subject to challenge by the FSA and the Hospitals. These changes included the withdrawal of the proposed amendments to Subsection (4)(b)1. which would have changed "transfer agreement" to "transfer protocol." During this public meeting, the Board was informed that those parts of the Rule no longer being challenged had been filed with the Department of State. On January 28, 2000, the Board filed all of its proposed amendments to Rule 64B8-0.009, with the exception of the amendments to Subsections (1)(e), (2)(e), (2)(f), (2)(i), (4)(b)1. and 2., and (6)(b)1.a-b, for adoption with the Florida Secretary of State. The proposed amendments filed for adoption on January 28, 2000, became effective February 17, 2000. The Board voted to modify some of the proposed amendments to Rule 64B8-9.009 still subject to challenge at its public meeting on February 5, 2000. The FSA filed a Notice of Voluntary Dismissal of its Rule challenge in DOAH Case No. 99-2974RP on February 7, 2000. DOAH case No. 99-2974RP was closed on February 8, 2000. The Hospitals filed a Notice of Voluntary Dismissal of their Rule challenge in DOAH Case No. 99-2975RP on March 9, 2000, and the case was closed on March 10, 2000. The Fourth Notice of Change was published in the February 18, 2000, issue of the Florida Administrative Weekly noticing the changes to proposed amendments to Rule 64B8-9.009 voted on by the Board at its February 5, 2000, meeting. On February 25, 2000, the FACS, Graper, and Smith filed a Petition for an Administrative Determination of the Invalidity of a Proposed Rule challenging the Board's proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. This petition was assigned DOAH Case No. 00-0951RP. On March 8, 2000, the FACS, Graper, and Smith filed an Amended Petition for an Administrative Determination of the Invalidity of a Proposed Rule in DOAH Case No. 00-0951RP challenging the Board's proposed withdrawal of the proposed changes to Subsection (4)(b)1. of Rule 64B8-9.009 and the proposed changes to Subsection (6)(b)1.a. of Rule 64B8-9.009 as published in the Fourth Notice of Change. The Board held a public hearing on April 8, 2000, in Orlando, Florida, and received testimony concerning the Fourth Notice of Change. At the conclusion of the hearing, the Board voted to adjourn without making any changes in the Fourth Notice of Change. On April 17, 2000, the FANA filed its petition challenging the Board's Fourth Notice of Change. The FANA's petition was assigned DOAH Case No. 00-1622RP. DOAH Case Nos. 00-0951RP and 00-1622RP were consolidated by Order of the Administrative Law Judge issued May 4, 2000. The Fourth Notice of Change states that "[t]he proposed changes to Subsection (4)(b)1., shall be withdrawn." With respect to Subsection (6)(b)1.a. of Rule 64B8- 9.009, the Fourth Notice of Change states: Proposed Subsection (6)(b)1.a. shall be changed to read, (b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia. Petitioners have challenged the Fourth Notice of Change on the following grounds: (1) the requirement that an anesthesiologist be present for all Level III surgeries in physicians' offices will increase the cost and limit surgical procedures and practice opportunities of Petitioners resulting in a substantial adverse financial impact on Petitioners and patients; (2) the Fourth Notice of Change exceeds the Board of Medicine's rulemaking authority by attempting to regulate nurse anesthetists; (3) the Fourth Notice of Change conflicts with existing statutes governing the practice of nurse anesthetists; (4) the rule is arbitrary and capricious and is not supported by competent evidence and is inconsistent with the law and policies of the federal government and of 49 states; (5) the Fourth Notice of Change is not supported by competent substantial evidence and would not have any measurable effect on patient safety; (6) the Rule was improperly adopted; and (7) that the Fourth Notice of Change conflicted with the existing requirement to provide a choice of anesthesia providers. Each of these arguments is addressed below. Final Order in DOAH Case No. 00-1058RX The Final Order in DOAH Case No. 00-1058RX invalidated certain existing Rule requirements related to transfer agreements and hospital staff privileges as a precondition for certain office surgeries. Specifically, that Final Order invalidated Subsection (4)(b) of Rule 64B8-9.009, which required a transfer agreement for any physician performing Level II office surgery who did not have staff privileges to perform the same procedure at a licensed hospital. In addition, the Final Order invalidated Subsection (6)(b) of Rule 64B8-9.009 which required a physician performing Level III office surgery to have hospital staff privileges for the procedure performed in an out-patient setting. As grounds for invalidating the staff privileges requirement, the Administrative Law Judge determined that the Board lacked specific statutory authority to mandate hospital privileges, thereby exceeding its grant of rulemaking authority. The Final Order further determined that the requirement for hospital privileges was arbitrary, deferred credentialing to individual hospitals, and was not supported by competent substantial evidence. During the prior hearing, the parties did not present specific argument related to, nor did the Final Order consider the proposed changes to the staff privileges requirement set forth in the Fourth Notice of Change due to the separate Rule challenge proceedings. The Proposed Rule Regarding Competency Demonstration Notwithstanding, Subsection 4 of the Fourth Notice of Change proposes to change Subsection (6)(b)1.a. of Rule 64B8- 9.009 to include alternatives to hospital staff privileges as a manner of demonstrating sufficient education, training and competency to perform Level III surgery in an office setting. The proposed change provides that a surgeon who seeks to provide Level III surgery in an office setting can demonstrate training as follows: The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Board of Medical Specialties or any other Board approved by the Board of Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training, and experience. (emphasis added) The proposed Rule at issue in this proceeding continues to provide for the same mechanism of hospital privileges, previously invalidated. The provision remains invalid for the reasons articulated in the previous Final Order. However, the proposed Rule also provides office surgeons with two alternative methods for objectively demonstrating sufficient training and competency through certification by a recognized medical specialty board or through direct demonstration to the Board of Medicine. That provision of the proposed Rule, provides significant flexibility and meaningful options to physicians seeking to perform office surgery. The Board demonstrated that the options are an appropriate approach for the Board to utilize in exercising its delegated regulatory authority and responsibility to adopt education and training standards for the office setting. The Petitioners adequately challenged the provisions and the Board proved the validity of the proposed alternatives by a preponderance of the evidence. Increased Costs Petitioners contend that the anesthesiologist requirement in the Fourth Notice of Change violates Section 120.52(8)(g), Florida Statutes, by imposing regulatory costs on the regulated person which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives. Petitioners offered credible evidence indicating that the hourly rates charged by anesthesiologists range from 50 to 100 percent higher than the hourly rates charged by CRNAs for similar procedures. Respondent and Intervenor, FSA, on the other hand, demonstrated that hourly rates varied from market to market within Florida and in a few cases, rates for anesthesiologists were approximately the same as for CRNAs. The evidence is clear, however, that the charges for an anesthesiologist are significantly higher than those for CRNAs for similar procedures. Anesthesiologists possess broader expertise, education, and training. As a result, requiring an anesthesiologist for Level III office surgeries will increase the total cost of a typical in-office plastic or cosmetic surgery procedure between five and ten percent. Furthermore, the evidence demonstrated that although some surgeons periodically use anesthesiologists during Level III office surgery for a variety of reasons, including availability, complexity of procedure, current health of patient and contractual agreements, most surgeons utilize CRNAs due to the considerable cost savings. Petitioners also claimed that the Rule would create a monopoly in the provision of in-office anesthesia for anesthesiologists and would force hundreds of CRNAs out of office practice. The Fourth Notice of Change applies to Level III surgeries, so it is reasonable to conclude that the need for CRNAs to participate in the performance of Level III surgeries under the supervision of an anesthesiologist will be obviated. Their assistance is unnecessary and cost prohibitive. And although nurse anesthetists would still be permitted to provide Level II anesthesia in the office setting under the supervision of the operating surgeon, the proposed Rule imposes a significant increase in the cost of Level III surgeries and severely decreases competition. Rulemaking Authority and Conflicting Law Petitioners mistakenly contend that the proposed anesthesiologists requirement exceeds the scope of the Board of Medicine's rulemaking authority and conflicts with existing law. The authority for the Fourth Notice of Change is contained in part in Section 458.33(1)(v), Florida Statutes, which states in pertinent part: The Board may establish by rule standards of practice and standards of care for particular practice settings, including but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manual in order to establish grounds for disciplining doctors. Specifically, Petitioners allege that the Fourth Notice of Change constitutes an impermissible attempt by the Board of Medicine to regulate nurse anesthetists and conflicts with Chapter 464, Florida Statutes, which permits nurse anesthetists to practice under the supervision of any physician, osteopath, or dentist. The parties have stipulated that Florida-certified registered nurse anesthetists are licensed only by the Florida Board of Nursing and are subject to discipline only by the Florida Board of Nursing. In mandating that office surgeons use an anesthesiologist during in-office Level III surgery, the proposed Rule does not directly regulate any nurse or certified registered nurse anesthetist and does not subject the CRNA to any discipline by the Board of Medicine or by the Board of Nursing. Thus, the Rule on its face does not conflict with the delegated legislative authority to the Board of Medicine for rulemaking in Section 458.331(1)(v). Federal Law, Scientific Evidence, Arbitrary and Capricious, Competent Substantial Evidence Petitioners contend that the Fourth Notice of Change requiring an anesthesiologist be present during Level III surgery is inconsistent with the laws and policies of the federal government and 49 states, contrary to the overwhelming weight of scientific evidence, arbitrary and capricious, and not supported by competent substantial evidence. There is no evidence that the Fourth Notice of Change is inconsistent with the laws and policies of the federal government. There is no federal law or rule which prohibits any state from establishing its own rules governing the rights of various practitioners to administer or supervise the administration of anesthesia in any particular setting. Federal government regulations defer to state law on this subject unless a state establishes a lower standard of care. While it is insignificant whether any other state currently requires an anesthesiologist to be present for the administration or supervision of general anesthesia in an office setting, some states have considered such requirements, including Pennsylvania and New Jersey. With respect to the scientific evidence presented by the parties, it is clear that there is a lack of competent and substantial evidence to demonstrate an increased level of safety for general anesthesia patients who undergo surgery under the care of an anesthesiologist as opposed to a CRNA. CRNAs are advanced registered nurse practitioners. In addition to their nursing training, CRNAs must have at least one year of experience in a critical care setting (such as working in a hospital intensive care unit) prior to beginning their two- to-three year master's level anesthesia training. Nurse anesthetists typically are trained side by side with physician anesthesia residents, use the same textbooks, and are taught by the same instructors. Unlike physician anesthesiologists who receive a general medical-surgical license that may not require any level of training or expertise in the administration of anesthesia, CRNAs must pass a national certifying examination in anesthesia as a condition of state licensure. In addition, CRNAs must complete 40 hours of continuing anesthesia education every two years, and must be recertified every two years to retain their state license. The evidence suggests that the safety of office surgery is comparable to that of hospitals and ambulatory surgery centers. Moreover, under the existing Rule, the office surgeon and patient determine the most appropriate anesthesia provider and setting based on the individual patient's needs. The direct testimony and scientific evidence indicate no significant difference in patient outcomes based on whether anesthesia is administered by an anesthesiologist or CRNA. Hence, Florida law and the existing standard of care in Florida permits a surgeon to supervise a CRNA in the office setting. Nearly forty percent of the 1600 CRNA members of FANA provide anesthesia in physicians' offices. Furthermore, the evidence indicates that anesthesiologist supervision of CRNAs in hospitals is extremely inconsistent. "Supervision" as defined by various hospitals requires the anesthesiologists to be within five to thirty minutes of the hospital. Anesthesiologists are often absent for extended periods and typically "supervise" several operating rooms simultaneously. In fact, Federal Medicare regulations permit an anesthesiologist to receive payment for the "medical direction" of as many as four CRNAs at the same time. Moreover, several smaller and often rural hospitals and ambulatory surgical centers in Florida do not have anesthesiologists on staff. CRNAs provide the anesthesia services in those venues. Dr. David Mackey, an anesthesiologist, testified that he had reviewed information on 28 deaths related to office surgery which occurred between 1987 and 1999. Dr. Mackey concluded that there have been nine deaths resulting from office surgery in the past 12 years in which anesthesia was a cause of death. However, Dr. Mackey was able to confirm that a CRNA provided the anesthesia in only two of the nine cases. Office surgeons and related professional societies agree that an office-based surgeon may safely supervise a CRNA. Currently, there are three national accrediting organizations that may accredit office surgery facilities: Joint Commission on Accreditation for Ambulatory Healthcare Organizations; American Association for Accreditation of Ambulatory Surgery Facilities; and Accreditation Association for Ambulatory Health Care. Rule 64B8-9.0091, Florida Administrative Code. None of these accrediting organizations requires that CRNAs be supervised by an anesthesiologist. No other state currently requires anesthesiologist supervision of CRNAs in an office setting. In fact, Florida's Joint Committee of the Boards of Nursing and Medicine identify specific medical acts that may be performed by ARNPs, and the level of physician supervision required for such acts. Section 464.003(a)(c), Florida Statutes. The Joint Committee does not require anesthesiologist supervision of CRNAs in any setting. The U.S. Armed Forces do not require anesthesiologist supervision of CRNAs in any practice setting. And the American Society of Anesthesiologists' has published its own "Recommended Scope of Practice for Nurse Anesthetists" which provides for CRNAs to administer anesthesia under the supervision of the operating surgeon. Studies of Anesthesia Outcomes and Medical Error Michael B. Pine, M.D., a Board-certified cardiologist, former chief of cardiology at Cincinnati Medical school, and a former professor of medicine at Harvard Medical School and two other medical schools, testified as an expert in healthcare quality assessment and improvement. Dr. Pine has served as a healthcare quality assessment and improvement consultant to the JCAHO, the Health Care Financing Administration (HCFA), the American Medical Association (AMA), the American Osteopathic Association, the Hospital Research and Educational Trust of the American Hospital Association, the American Association of Oral and Maxillofacial Surgeons, the American Association of Nurse Anesthetists, Blue Cross/Blue Shield, and Anthem, among others. Dr. Pine characterized his career transition from clinician to consultant as moving from "dealing with diseased individuals to dealing with diseased organizations to help them assess their problems in delivering health care and help them improve and get better." Dr. Pine assisted in the development of clinical indicators for JCAHO, including indicators in anesthesia care. He has worked with the federal Health Care Financing Administration (HCFA) to measure hospital mortality and adjust for patient severity as an indicator of hospital quality. Dr. Pine's consulting experience includes evaluating outcome data for individual practitioners, groups of providers, and whole systems. Dr. Pine testified that the classic study in anesthesia mortality was a 1950's study by Beecher and Todd of 600,000 anesthetic administrations which were followed by about 8,000 deaths, 325 of which were ultimately determined to be anesthetic related. The study reflects an anesthesia mortality rate of about 1:2,500. In the Beecher and Todd study, nurse anesthetists performed twice as many cases as anesthesiologists, but the number of deaths involving nurse anesthetists was virtually the same as the number of deaths involving anesthesiologists. Beecher and Todd initially hypothesized that the greater mortality rate for anesthesiologists could be explained by the severity of illness of the patients seen by anesthesiologists rather than nurse anesthetists, but after correcting for the difference in severity of illness, they discovered the nurse anesthetists had actually treated patients who were slightly more sick. Beecher and Todd were unable to explain why physician anesthesiologists, who anesthetized only half as many patients as nurse anesthetists, were involved in an equal number of deaths. Dr. Pine testified that a later study, the Bechtoldt, measured outcomes associated with two million anesthetics in North Carolina between 1969 and 1976. The mortality rate was approximately 1:24,000; a mortality rate ten times better than the rate reflected in the Beecher and Todd study 20 years earlier. The Bechtoldt study compared the outcomes of anesthesiologists working alone, nurse anesthetists working alone, and CRNAs and anesthesiologists working together, the surgeon or dentist administering anesthesia him/herself, and deaths in which no provider could be identified. Bechtoldt concluded that: When we calculated the incidence of anesthetic related deaths for each group which administered the anesthetic, we found that the incidence among the three major groups - the CRNA, the anesthesiologist, and the combination of both - to be rather similar. Although the CRNA working alone accounted for about half the anesthesia- related deaths, the CRNA working alone also accounted for about half the anesthetics administered. A 1980 study by Forrest of 17 hospitals and about 10,0000 patents was one of the first studies to make a formal adjustment for the sickness severity of the patients. Using conservative statistical methods, Forrest concluded that "there were no significant differences in outcomes" between the hospitals that predominately used anesthesiologists and the hospitals that predominately used nurse anesthetists. Anesthesia safety continued to improve as indicated by a British study in the early 1980's, that used a procedure similar to that used by Beecher and Todd in the 1950's. The British study looked at 485,000 surgeries in which anesthesia was provided. There were 4000 deaths, only 3 of which were determined to be anesthetic related, reflecting an anesthesia mortality rate of 1:185,000. The Institute of Medicine report entitled "To Err is Human," published in 1999, reflects an even better anesthesia mortality rate of 1:200,000 to 1:300,000 cases. The Institute of Medicine report states: The gains in anesthesia are very impressive and were accomplished through a variety of mechanisms including improved monitoring techniques, the development and widespread adoption of practice guidelines and other systemic approaches to improving errors . . . . the success of anesthesia, was accomplished through a combination of technological changes, new monitoring equipment, standardization of existing equipment, information-based strategies including the development and adoption of guidelines and standards, application of human factors to improve performance such as the use of simulators for training, formation of the Anesthesia Patient Safety Foundation to bring together stakeholders form different disciplines, physicians, nurses, manufacturers, to create a focus for action and having a leader who would serve as a champion for the cause. Dr. Pine also addressed the recent study regarding anesthesia by Silber published in June 2000. This study examined 7,665 deaths following 217,000 hospital procedures for which medical bills were submitted to HCFA for Medicare reimbursement. The study attempted to characterize the type of anesthesia provider based on whether an anesthesiologist submitted a bill for providing anesthesia or supervising the anesthesia. The study assumed that a CRNA administered the anesthesia if either the CRNA billed for it, or if no bill was located. Moreover, instead of reviewing deaths that occurred within 48 hours after the surgery, the study counted all deaths which occurred within 30 days following surgery, and ignored any non-anesthesia related complications and deaths which were included in the 7,665 death toll. Conversely, the 7,665 deaths in 217,000 procedures produce a mortality rate of 1:28, nearly 100 times greater than the mortality rate in the 1950 Beecher and Todd study, and nearly 10,000 times what the 1999 Institute of Medicine study reflected as the anesthetic mortality rate. The greatly inflated and inconsistent death rate is highly questionable and provides little scientific support for the Board's proposed rule. With respect to Petitioners' argument relating to arbitrary and capricious mandate, the proposed Rule would not permit office-based surgeons to provide a choice of anesthesia provider for Level III office surgeries, since only one anesthesia provider is necessary or justified for Level III office surgery, and the proposed rule mandates the participation of an anesthesiologist. It is unreasonable and not economically feasible for the surgeon or the patient to pay for an anesthesiologist and a CRNA for the same procedure. Based on the current Rule's "choice of anesthesia provider" requirement in subsection (2)(b) of the existing Rule, the proposed anesthesiologist mandate for Level III surgery is inconsistent, confusing and illogical to the reasonable person.
