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
The Issue This proceeding was initiated when HRS proposed to deny San Marco's application for Certificate of Need No. 3304 for an ambulatory surgical center in Jacksonville, Duval County, Florida. San Marco filed a timely petition for formal hearing. Initially four intervenors were involved: Baptist, Memorial, Surgical Services of Jacksonville, Inc. and Medivision of Duval County, Inc. Surgical Services filed its Notice of Voluntary Dismissal on March 7, 1985, and Medivision withdrew on October 28, 1985. At the hearing, San Marco offered evidence through eight witnesses and 28 exhibits; HRS presented one witness and one exhibit; and the two intervenors presented nine witnesses and 26 exhibits. Certain exhibits, by stipulation of the parties, were entered as "Hearing Officer Exhibits." Those four exhibits included the state agency action plan, the petitioner's application for CON, a three-volume state health plan and the District IV health plan The primary issue is whether San Marco is entitled to Certificate of Need No. 3304 for an ambulatory surgical center which will include two operating rooms. During the course of the proceeding several ancillary issues developed; those issues are summarized here and are addressed in the body of this recommended order: In determining need for a free-standing ambulatory surgery center, is it appropriate to consider evidence of out- patient surgical services provided by hospitals? (Petitioner's Motion in Limine, T-9). Is the project proposed by San Marco an "ambulatory surgical center" as defined in subsection 381.493(3)(a), Florida Statutes? (Respondent's Motion to Dismiss, T-500). Should the intervenors, Baptist and Memorial be dismissed for failure to establish standing? (Petitioner's Motion for directed verdict, T-1182). The briefs, memoranda and proposed orders of the parties have been carefully considered in the preparation of this Recommended Order. A specific ruling on each proposed finding of fact is included in the Appendix attached hereto. On March 25, 1986, Petitioner filed a Motion for Restricted Reopening of Record. Basis for the motion is Medivision's withdrawal of its application for certificate of need. The motion is denied.
Findings Of Fact The Parties San Marco is a limited partnership. The owners are Stuart Yachnowitz, individual general partner and sole limited partner; Surgi-Centers of America, Inc., (SCA), a Florida corporation, corporate general partner; and Jacksonville Women's Health Organization, Inc., a Florida corporation, (JWHO), corporate general partner. The sole shareholders of SCA are Stuart Yachnowitz, his father, Joseph Yachnowitz and Susan Hill. The owners of JWHO are Joseph and Stuart Yachnowtiz. (T-47, 48, CON application pp. 20-23). San Marco intends to include local physicians in the ownership of the surgicenter. (CON application p. 40) The surgieenter will be managed by Y and S Management Corporation, the company now providing management services to JWHO. Y and S Management Corporation is owned by Joseph and Stuart Yachnowitz. Including JWHO, it manages eight licensed abortion clinics throughout the country as well as two free-standing ambulatory surgery centers (FSACs) which primarily perform abortions. Susan Hill, the chief operating officer for Y and S for the past ten years, prepared the CON application for the surgicenter. (T-47-49, 108-111). The building at 1561 San Marco Boulevard in Jacksonville, currently occupied by JWHO for its licensed outpatient abortion clinic, will be renovated and occupied by San Marco. The facility will be expanded from approximately 3000 square feet to 4700 square feet. Two operating rooms (ORs) will be added along with ancillary facilities necessary for licensure as an ambulatory surgical center. (Petitioner's Exhibit #1, CON application p. 4, T-52, 54, 55). Abortions will continue to be performed at the facility at an estimated rate of 168 procedures a month. (Petitioner's Exhibit #2, T-102, 103). Other surgical procedures will be added in the categories of gynecology, general surgery, and plastic surgery at the projected rate of 15 per month for the first month of operation to 90 per month after a little over a year's operation. The 90 additional procedures per month is anticipated to continue through the second year of operation. (Petitioner's Exhibit #2, CON application p. 40, T- 102, 103). San Marco anticipates drawing some patients for the additional procedures from its existing caseload and utilizing some physicians who currently practice at the abortion center. (T-62, 63, 101, 102, 247). Memorial is a not-for-profit acute care hospital, located in Duval County in close proximity to the San Marco facility. Since May 1985, Memorial has been providing outpatient surgery services in a dedicated outpatient facility adjacent to the acute care hospital. The same day surgery" facility contains two laser rooms and four operating rooms. (T-854, 913, 914). Baptist is a not-for-profit acute care general hospital also located within close proximity to the San Marco facility. It currently provides outpatient surgical services in twelve ORs and 3 cystoscopy rooms in its main facility. Sometime around August 1987, its new adjacent 17-story structure, The Pavillion, is anticipated to open. The fourth floor of that facility will be dedicated to outpatient surgery and will include four operating rooms and two cystoscopy rooms. (T-939, 984, 987, 988, 1045, 1047). HRS reviewed San Marco's application and determined that it should be denied on the following basis: "There appears to be an insufficient projected number of outpatient procedures to allow this facility to be viable." (State Agency Action Report, September 6, 1984). The State and Local Health Plans The 1985-1987 State Health Plan does not directly address the need for additional ambulatory surgical centers. It adopts as an objective that ". . . By 1989, 30 percent of all surgical operations should be performed on an outpatient basis." (Vol. II p. 81). It addresses ambulatory surgical centers as an alternative delivery system which lowers costs by substituting less costly services. (Vol. II p. 76). And, it outlines a brief history of the increase of ambulatory surgical centers in Florida during the decade of the 1980s. It acknowledges, "As in the case of hospitals, saturation of the marketplace for outpatient surgery has caused new entrants into the field to be more highly specialized in order to attract sufficient business. (Vol. II p. 27). HRS District IV includes Duval, Nassau, Baker, Clay, St. Johns, Flagler and Volusia counties. The 1985 District IV Local Health Plan adopts sub-area boundaries in planning for certain specialized services, including ambulatory surgery. Sub-area A is comprised of Baker, Nassau, Duval, Clay and St. Johns counties. (p. 112). In contrast to the State Health Plan, it makes specific recommendations: that sub-area boundaries should be used for planning purposes; that no additional units should be approved prior to the adoption of state rules; and that no ambulatory surgery units should be added to the district through 1986, when the agency will review the matter again. (p. 20). Utilizing 1983 data to base its projections and the need methodology of a challenged draft state rule, it concludes that Sub-area A has a surplus of 14 ambulatory surgical units. (p 143). Existing Like Facilities and Other Alternatives to the Proposed Service. Ambulatory surgery is typically performed in three types of facilities: general hospitals which mix inpatient and outpatient surgery in main operating rooms; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in adjacent buildings; and free-standing surgical centers which are unassociated physically or administratively with a hospital. (T. 387-390). Testimony in this proceeding was virtually unanimous as to the distinct disadvantages of serving surgical outpatients in a non-dedicated operating room setting. The mingling of' less ill or well outpatients with seriously ill inpatients increases the opportunity for contagion, heightens patient anxiety, deprives patients of access to their families, presents scheduling problems (including the bumping of outpatients in emergencies), and generally increases the cost of the service to the outpatient consumer. (T-386, 388-392, 1125- 1128). Both Baptist and Memorial have recognized the need for separate, dedicated operating rooms. The comparison of hospital-based dedicated ambulatory surgery rooms with free-standing ambulatory surgery rooms stirs somewhat more controversy. There are advantages and disadvantages to both. A hospital-based unit may or may not be more accessible to the physicians. While doctor's offices are often near hospitals, parking still is a problem. While some patients might prefer to avoid a hospital setting altogether, some are comforted by the proximity in the event of an emergency or decision to recuperate overnight. While costs are generally lower in a free-standing facility, there may be an advantage to having the expensive equipment immediately available in some cases (T-241-246, 392, 758-760,996, 1000-1001). If comparing non-dedicated ORs to free-standing ambulatory centers is comparing apples to oranges, then comparing hospital-based ambulatory centers to free-standing ambulatory centers is comparing red apples to green apples. Personal preferences often dictate the choice, but either one will make a pie. There exists no adopted rule governing methodology for determining need for ambulatory surgery centers. In this proceeding, each party presented its own methodology through an expert witness. Those methodologies are described as follows: Petitioner's Need Methodology Howard Fagin, PhD, was qualified as an expert in Health Planning and Health Economics without objection. (T-377) In his opinion there is a need for additional ambulatory surgery rooms. His opinion is based on a four-step process which includes: Analysis of the service area and population within that service area; Review of existing facilities providing comparable or related services; Examination of the utilization of those services within the existing facilities; and Analysis of the need for new health care facilities based upon population and need for new services in the area. 393, 394) Dr. Fagin identified Duval County as the primary service area, and Nassau, Baker, Clay and St. Johns counties as the secondary service area. The surrounding counties depend on Duval for their medical care in many cases. Together, the primary and secondary service areas comprise HRS District IV, Sub- area A (Local Health Plan, p. 112). Population figures are taken from those compiled and projected by the Executive Office of the Governor. (T.-396) For several reasons it is difficult to obtain data on out-patient surgical procedures in Florida. Out-patient surgery is a relatively new phenomenon; some hospitals do not separate in-patient from out-patient procedures in reporting; other hospitals count cases rather than procedures. (T-398) Dr. Fagin felt comfortable with data obtained from the state and from the N. E. Florida Health Planning Council, as adjusted with the use of data obtained from Baptist and Memorial for 1982, 1983, and 1984. (Petitioner's exhibits #11, 12 and 13) For 1984, he figured 31.1 percent of the surgical cases in Duval County were out-patient cases, with the trend increasing. (T-403) Petitioner's Exhibit #15 is the summary of Dr. Fagin's need analysis with two columns, one assuming an out-patient surgery rate of 35 percent of total surgeries, and the other assuming a rate of 40 percent. The number of available ambulatory surgery rooms (24) is based upon the availability of four rooms in one recently opened free-standing ambulatory center (AMI) and twenty other free-standing or dedicated (used only for out-patients) operating rooms in Duval County hospitals. The analysis assumes that the rooms will be operated five days a week, two hundred and fifty days a year (5 days x 52 weeks, minus 10 days for holidays and "down-time"). The figure of 960 cases per year, per room, is further derived from the assumptions the room will be operated 6 hours a day, an average case (including preparation, surgery, and cleanup) will take 1.25 hours, and the rooms will be utilized 80 percent of the time. In addition to the number of cases described to dedicated and free-standing rooms through that process, 3000 cases are presumed to be done each year in non-dedicated operating rooms. This figure is derived from rounding off the reported 3030 out-patient cases in non-dedicated units in 1983. The rationale for including those cases is that due to lack of sufficient free-standing units, the out-patient services must be provided in the regular hospital OR environment. The number of such cases, according to Dr. Fagin, should decrease as the number of free-standing units increases. (T. 414-415). Dr. Fagin's methodology applied to various hypothetical fact situations yields the following conclusions as to need for (+), or excess of (- ), free-standing ambulatory surgery operating rooms: Assuming a service area including all of HRS District IV, Sub-area A, 24 currently available rooms; and 960 cases per room per year: (Petitioner's Exhibit #15) 35 percent 40 percent + 6 rooms + 10 rooms Same assumptions as A, above: (intervenor`s Exhibit #16) 30 percent rate + 1 room Same assumptions as A, above, except limited to Duval County: (Intervenor Exhibit #17) 30 percent 35 percent 40 percent -4 rooms -1 room +2 rooms Same assumptions as A, above, except 31 existing rooms, instead of 24: (Intervenor Exhibit #18) 30 percent 35 percent 40 percent not calculated -2 rooms +3 rooms Same assumptions as A, above, except 31 existing rooms and service area limited to Duval County: (Intervenor Exhibit #19) 30 percent 35 percent 40 percent -11 rooms -8 rooms -5 rooms Same assumptions as A., above, except 1200 cases per room per year, instead of 960: (Intervenor Exhibit #20) 30 percent 35 percent 40 percent -4 rooms -1 room +3 rooms Same assumptions as A, above, except 1200 cases per room and 31 existing available rooms: (Intervenor Exhibit #21) 30 percent 35 percent 40 percent -11 rooms -8 rooms -4 rooms Same assumptions as A, above, except 1200 cases per room, 31 existing available rooms and Duval County only: (Intervenor Exhibit #22) 30 percent 35 percent 40 percent -15 rooms -13 rooms -10 rooms HRS Need Methodoloy Reid Jaffe, Medical Facilities Consultant for the Office of Community Medical Facilities, was qualified as an expert in health care planning with emphasis on certificate of need. (T-533) He explained the ambulatory surgical center need methodology as summarized in DHRS Exhibit #1. The Department typically uses a single county as its planning area for ambulatory surgery applications. (T-556). Therefore, the data is based on Duval County population and services provided by Duval County facilities. To obtain the volume of surgical procedures in Duval County hospitals, letters were written requesting the break-out for the period February 1984-January 1985. While the process is not an exact science, Mr. Jaffe feels that since the Department asks for the same type of information over a period of time, the anomalies in the figures will become obvious. (T-569). Based upon the returns to the questionnaire, the Duval total surgery rate, (out-patient and in-patient) was determined as 97.7 per 1000 population; the out- patient surgery rate was determined to be 30.2 per 1000 population. The July, 1987 population projection was 623,091. Need was projected at both 30 percent out-patient to total surgeries and 40 percent out-patient to total surgeries. The out-patient surgical potential (number of procedures) is derived from subtracting the hospital out-patient surgical volume from the projected number of procedures needed at a 30 percent and 40 percent rate. From that line was deducted the projected breakeven procedures for each of three free-standing ambulatory surgery centers in various stages of development in Duval County. The 30 percent rate yielded a bottom line of 5,922 excess procedures, and the 40 percent rate yielded a bottom line of 165 procedures remaining for some other facility to perform (unmet need). Since HRS considers the facility breakeven point to be considerably more than 165 procedures per year, it concludes that no additional facilities are required at this time. HRS did not explain its assumption that the rate of surgeries performed on an out-patient basis at hospitals would remain constant (30.2 per 1,000 population), while the overall percentage of out-patient surgeries to total surgeries would increase to 40 percent. (DHRS #1, T-569-576). Intervenor's Need Methodology Michael Swartz testified for Memorial and Baptist as an expert in health care planning and hospital administration. (T-704) He rejected the second-hand data utilized by both Petitioners' and HRS' experts. He devised a poll that was sent to all area hospitals and attempted to verify the responses through direct contacts and, in some instances, a walk-through of the facilities and review of hospital records. Information reported in State Agency Action reports was used for St. Luke's, since that one hospital failed to respond. (T- 704-707, 711-713). Like the other need methodology experts in this proceeding, Mr. Swartz relied on population projections from the Executive Office of the Governor. (T- 711). The geographical service area was considered Duval County, because that is what the state considers and in Mr. Swartz' opinion an ambulatory surgery center draws from a less than 30-minute driving period. (T-712). Mr. Swartz found in his data gathering that, while the number of surgeries per 1000 population has fluctuated only slightly, the mix of surgeries (in-patient to out-patient) has shown a dramatic increase in out-patient procedures. (Intervenor's Exhibit #5, T-722). After determining what he considered were the actual numbers of surgeries performed in 1983 and 1984, the actual number of operating rooms in Duval County, and the actual amount of time spent for each case, including clean-up, he determined that the bottom line showed a utilization rate of only 27.8 percent of existing surgical suites in Duval County in 1984. (Intervenor's Exhibit #6, T-729). Utilizing a fixed use rate of 103.3 surgery cases per thousand, Mr. Swartz projected an excess capacity of 109,214 cases in hospitals in 1986 and 1987, and an excess capacity for 19,279 cases in free-standing surgical centers (including AMI, Surgicare III and Medivision) in 1986 and 1987. (Intervenor's Exhibit #12 and #14, T-749, 750). The most fatal flaw in Mr. Swartz' ultimate conclusion, that there is a current and projected excess of surgery suites in Duval County, is that after his painstaking data-gathering process he lumped together all types of existing operating rooms and assumed they were all equally appropriate to handle in- patient and out-patient surgeries. This assumption is contrary to the weight of evidence in this proceeding. Of the three methodologies presented, I find Dr. Fagins most reasonable. It requires some adjustments, however, to conform to the evidence. Proceeding from Petitioner's Exhibit #15, I find the 40 percent out-patient surgery rate reasonable and consistent with credible expert testimony from all sides in this case. (Howard Fagin - T-413; Reid Jaffe - T-573; Rena Blackmer - T-106l; Carol Whittaker-T- 990: Eileen Fullernveider, T- 1125). Utilization of Subdistrict A as the service area is also 4 appropriate here. It is consistent with the District IV local health plan and recognizes the fact that Jacksonville draws from outlying counties for the sophisticated range of medical services it provides. (T-254, 255) while ordinarily free-standing surgery centers might be more neighborhood oriented and draw from a closer geographical area, it is noted that Duval is the only county in Subdistrict A with free-standing or dedicated operating rooms and for that reason patients could be expected to travel into Jacksonville. (Petitioner's Exhibit #14) The one-hour travel time addressed in the CON application, p. 226, would include some travel from the outlying counties. Reid Jaffe, the HRS expert, does not agree with the local health plan because it would be unlikely that a resident of a county that has a hospital or multiple hospitals in it and that have ambulatory surgical programs, to bypass those closer facilities just to go to Jacksonville." (T-554, 555). In the absence of dedicated ambulatory surgical programs, however, some patients very likely would travel to Jacksonville. The continued projection of 3000 cases in non-dedicated operating rooms is reasonable, since not all ambulatory surgery patients would travel to Jacksonville. Further, even when it completes its new ambulatory center, Baptist anticipates continuing to conduct approximately 2096 of its out-patient surgeries in the main ORs. (T-1063, 1064, 1085). Patient and physician loyalty would also account for some continued out-patient surgeries in those hospitals without dedicated ORs. The population projection for 1988 is appropriate, given a two-year planning horizon and the fact that the final hearing in this proceeding was continued until the end of 1985. The surgical rate of 102.94 per 1000 population is slightly higher than the 97.7 rate utilized by HRS but, just under the 103.3 rate utilized by Intervenor's expert, Howard Swartz. (Intervenor's Exhibit #14). Petitioner's Exhibit #15 understates the available ambulatory surgery rooms projected for 1988. A second free- standing ambulatory surgery center has been approved for Jacksonville and has completed its legal proceedings: Surgicare III, with 3 operating rooms. (T-562, Surgical Services of Jacksonville v. HRS, 479 So.2d 120, Affirmed 11/18/85). The record in this proceeding does not clearly reveal the status of a third surgical center, Medivision, with two rooms dedicated to opthomologieal surgery. Since that facility may still be in legal limbo, its rooms are not being counted. While Intervenor, Baptist, on cross examination posited a hypothetical application of Petitioner's methodology which included seven additional available rooms, no competent evidence followed up to substantiate any more than three additional beds. The available ambulatory surgery rooms factor in the methodology is therefore adjusted to 27. Petitioner's methodology also understates "available capacity" by understating the number of cases which could be handled per room, per year. While Dr. Fagin's methodology utilized 960 cases per room, per year, the weight of evidence and expert opinion established that at least 1300 cases per room, per year is a more realistic approximation. Intervenor's need expert, Michael Swartz, determined capacity based on ten available hours per day, five days a week, at 75 percent effici-ency (American College of Surgeons Standard) to be 2,077 cases per room, per year. (Intervenor's Exhibit #9, T-735- 737). The Hill-Burton standard utilized to determine the need for construction funds in the 1970's was 1200 cases per year, based upon data collected in the 1960s when the average time for a ease was 2 hours. (T-740, 741). Average time today is far less. (T-149, 240, 1064) Petitioner's own projected utilization assumes a capacity for 2 operating rooms, with evening and Saturday scheduling to be 300 procedures a month. (Petitioner's Exhibit #2). This translates into 1800 procedures per year, per-room. while recognizing that counting procedures rather than cases yields a higher number, San Marco never asserted that it anticipates performing two procedures for almost every case it handles. Yet this ratio is the only means of reconciling the difference between its expert's projection and that of its administrator. The above-described adjustment to Petitioner's need methodology results in the following adaptation of Petitioner's Exhibit #15: 40 percent Am. Surg. Subdistrict A 1988 Population Surgical Rate Total Surgery 861,120 102.94/1000 pop. 88,644 Ambulatory Surgery 35,457 Available Am. Surg. rooms 27 Available capacity (1300 cases) 35,100 Am. Surg. in Hospitals 3,000 Net Need Cases -2,643 Net Need Rooms - 2 Quality Of Care San Marco will occupy a building presently occupied by the Jacksonville Women's Health Organization, a licensed abortion clinic. If the certificate of need is granted, the existing building will be remodeled to provide two operating rooms and ancillary facilities required for licensure as an ambulatory surgical facility. HRS witness Reid Jaffe does not question the ability of the structure to meet requirements for licensure and does not question the ability of the proposed center to provide quality care. (T-584). The center will develop bylaws and protocols to maintain quality of care. To practice at the center, a physician must be licensed in Florida and must have privileges in good standing at a local hospital (T-59, 60). Jaroslav Fabian Hulke, M.D., was accepted as an expert in obstetrics and gynecology. He has had extensive experience in teaching and conducting out- patient surgery. (Petitioner's Exhibit #7). He has become personally familiar with Y & S Management's facilities and with their staff through his work at the center in Raleigh, North Carolina. He has also observed the facility in Jacksonville and assisted Susan Hill in developing the equipment list for the facilities. His high commendation of Miss Hill, her facilities and the planned equipment was without equivocation; his testimony as to the anticipated quality of care to be offered by this facility is most credible. (T-351, 353, 355). Anesthesia classifications range from I to IV depending on the condition of the patient. Class I and II are relatively healthy. The San Marco center will handle class I and II; some hospital out-patient units handle class III patients on a selected basis. (T-114, 141, 1120). Statistics on emergencies and deaths in free-standing ambulatory centers are not available now. The Free-standing Ambulatory Surgical Association (FASA) is in the process of gathering data. (T-1129, 1153, 1154). Depending on how they are run, equipped and staffed, the free-standing centers are considered extremely safe. (T-1128). Nothing in this proceeding would hint that the proposed administration, staffing or equipment for San Marco is less than high quality. Staffing By their Prehearing Stipulation filed on October 25, 1985, the parties agreed that there exists in Duval County an adequate labor pool of health manpower and management personnel to staff an ambulatory surgical facility. San Marco has the ability, experience and intention to obtain adequate, well- trained personnel to provide staffing for the proposed center. (T-72-75, 232- 236, 351-352). Physical and Economic Accessibility The parties have stipulated that the proposed facility is geographically available to all residents of Duval County. (Prehearing Stipulation, filed October 25, 1985). While the center will focus on the Duval County area, it also will likely draw from surrounding counties to a lesser degree. The existing abortion center already serves the wider area and as found in paragraph 12 above, no free-standing ambulatory center or dedicated out- patient ORs exist in Subdistrict A outside Duval County. For that reason, patients could be expected to drive as much as an hour to get to the facility. (CON application, p. 226). San Marco claims that it will serve 15 percent medicaid and 5 percent medicare patients. (CON application pp. 91-136). The Raleigh-Surgi-Center was used as a model since it is the one facility that receives medicaid reimbursement for non-abortion procedures. (T-89,160). However, while Medicaid does not reimburse for abortions, the State of North Carolina provides state funds and apparently those patients are computed in Raleigh's 21.6 percent figure. (T-89,90). The validity of the model is undermined by the fact that no such reimbursement occurs in Florida. (T-161). Even though the 20 percent Medicaid and Medicare projection is overstated, economic accessibility is enhanced by the willingness of the center to reduce fees for abortion procedures for otherwise Medicaid eligible patients by $50.00 or $60.00, which sum represents the management fee portion of the procedure cost. (T-158-160). More significantly, the projected standard fee for other than abortion procedures, $300.00 - 400.00, is substantially lower than fees at hospitals, including hospitals with separate ambulatory units. (T- 57, 81-82, 907, 1070, 1071, Petitioner's Exhibits #19, 20, 21, 22). Capital Costs and Financial Feasibility The total anticipated project cost for the proposed center is $246,000.00, including $80,000.00 for renovation of the building and approximately $133,000.00 for the purchase of equipment. (T-94-98, 172-173, 327). Capital is available for project start-up through the personal funds of millionaires, Stuart and Joseph Yachnowitz. (T-172). In its review of the application, HRS concluded: "There appears to be an insufficient projected number of out- patient procedures to allow this facility to be viable." (State Agency Action Report, Hearing Officer Exhibit #1). At hearing, HRS witness Reid Jaffe testified that because of the co-mingling of revenues from the abortion center and the proposed ambulatory surgery center, the financial feasibility of the project could not be determined. (T. 588, 589). On the other hand, if the revenues are co-mingled and if the projections in the applicant's pro formas are accurate, then the facility ought to do better than break even. (T-600-601). Christopher Fogel, Petitioner's expert accountant, represents Y & S Management and the ten out-patient facilities owned by Joseph and Stuart Yachnowitz. (T-182, 183) His financial projections for the proposed facility are found in Petitioner's Exhibits #5 and #6. The first projection is based upon the fee of $300.00 per procedure, for one hour of OR time, and the second is based upon $400.00, for 1.3 hours of OR time. The projections presume the facility would continue to offer its existing services (abortions) at its current level and expand to 250, 500 or 1000 procedures per year. At the $300.00 per procedure level, the facility would begin to make money with 500 additional procedures a year. However, by adding back 50 percent of the management fees (profit in the fees available to the Yachnowitz') and adding back depreciation and amortization, a positive cash flow results without any additional procedures, and increases substantially for 250, 500 and 1000 procedures at both the $300.00 and $400.00 per procedure rate. (T-198-206). Given the worst case scenario (no additional procedures), the owners are losing money only for tax purposes, but are actually increasing cash flow through the legitimate tax deduction of a loss which is not a loss of cash. (T-206). H. Impact on Competition The introduction of a free-standing ambulatory center in Duval County had a positive dynamic effect on existing traditional providers of surgical care in Duval County. Prices were lowered and more hospitals began out-patient surgery programs of their own. While the changes in costs and methods of surgical services is also attributable to pressure and incentives from insurers, no one disputes that the competition from AMI (the one free-standing facility in Duval County that is currently operational) was healthy. (T-639, 640, 1132, 893-894, 1061, 996- 997, 239). HRS health care planning expert, Reid Jaffe is of the opinion that currently the four ORs at AMI, the two opthalomological ORs at Medivision, and the 3 general ORs of Surgicare III (approved but not yet opened) are sufficient competition to the hospitals and to each other (T-564- 565, 643). No one seriously contends that the addition of San Marco's 2 ORs would put an existing facility out of business. Memorial's Chief Financial Officer, Earl Winston Lloyd, expects his facility's new out-patient unit to continue to be profitable with or without San Marco. Memorial's out-patient facility has exceeded Memorial's expectations in its productivity and profitability (T. 871- 874). John Anderson, Chief Financial Officer at Baptist, is concerned that Baptist will lose at least 35 procedures per month which are currently being performed at Baptist by physicians who have indicated an interest in practicing at San Marco. (Intervenor's Exhibit #23, T-943-945). However, he doesn't know whether those same doctors are performing out-patient surgeries in other facilities or whether those surgeries might be the ones that are taken to San Marco. (T-976). Rena Blackmer, Director of Surgical Services at Baptist, testified that when competing out-patient units opened at A.M.I., Memorial and St. Lukes, she felt initially that Baptist was losing a share of the market, but there has not been a continuing adverse effect. (T-1062). In 1985, Memorial`s excess revenue over expenses was approximately $2.5 million, with gross patient revenues of $80-82 million. (T. 863, 864). In 1985, excess revenue over expenses for Baptist was approximately $10 million. A $4.6 million loss on refinancing a debt is not included in that total; however, the $4.6 million is a balance sheet entry which impacts the income statement and is not a cash item. (T-956, 957) Total operating revenue in 1985 was $96 million. (T-955) David Mobley M.D. is a plastic surgeon who has been medical director of the Jacksonville Womens Health Organization since 1976. He practices at Baptist Medical Center, and his name appears on Intervenor's Exhibit #23 as one of the doctors whose out-patient surgeries the hospital is concerned about losing to San Marco. Dr. Mobley performs in his private office approximately ten surgeries a week that he would like to transfer to San Marco. Among as those cases are performed in his office, he is reimbursed only the fee that he receives for the same procedure done in a hospital. He absorbs the cost for his operating room at his office, his staff and supplies. (T- 247, 248). For the patient or his insurer however, the cost for the procedure would be at least twice as much in a free-standing surgery center as in the physician's office. (T-268). San Marco: Abortion Clinic or Ambulatory Surgical Center? From all the evidence in this proceeding the uncontrovertible fact emerges that when and if it is approved, San Marco Surgi-Center will merge with the Jacksonville Women's Health Organization and the two entities will make up a single health care facility: the building is the same; the equipment is the same; the owners are primarily the same; the managers are the same; and for purposes of predicting financial success, the revenue and expenses of the two entities have been considered one and the same. San Marco projects that even after two years of operation as a surgical center, a majority of its procedures will remain abortions. (Petitioner's Exhibit #2). Abortions are accomplished in health care facilities through a variety of surgical techniques, the most common of which is dilation and evacuation (D & E). (T-346, 347). Even though D & E's are expected to predominate at the facility in terms of projected number of procedures (168 per month, compared to 90 other surgical procedures per month, by June 1988), the D & E's will not predominate either in gross revenue from fees or in the anticipated OR time. San Marco anticipates the average patient charge for surgeries other than abortions to be $400.00 per case and the average OR time to be 1.3 hours. (T-93, 149). The non-medicaid patient charge for a D & E is $185.00, and the time in the OR room is generally about twenty minutes. (T-148, 158). Taking the same month, June 1988, and multiplying the number of abortions first by fee, then by OR time, yields a total of $31,080 in fees and 55.4 hours in the OR room. The same process for the 90 other surgical procedures yields $36,000.00 in fees and 119.7 hours OR time.
Recommendation Based on the foregoing, it is recommended that Certificate of Need #3304 be denied. DONE and ORDERED this 2nd day of April, 1986, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of April, 1986. APPENDIX TO RECOMMENDED ORDER, CASE NO. 84-3712 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in substance in paragraph 3. Adopted in paragraph 1. Adopted in substance in paragraph 2. The surgical procedures are summarized by category in paragraph 3. Adopted in substance in paragraphs 2, 16 and 24. Rejected as cumulative and unnecessary. Adopted in substance in paragraphs 16 and 19. Adopted in substance in paragraphs 25 and 26. The statement of John Anderson's testimony is unnecessary, Rejected as cumulative and unnecessary. Adopted in substance in paragraph 26. Rejected as cumulative and unnecessary. Substantially adopted as summarized in paragraph 26. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in part in paragraph 23, otherwise rejected as unnecessary. Adopted in substance in paragraph 12 and 21. Adopted in substance in paragraph 12, 13 and 21. Adopted in substance in paragraph 13. Adopted in substance in paragraph 13. Adopted in substance in paragraph 4. Adopted in substance in paragraph 5. Adopted in part in paragraph 5, otherwise rejected as unnecessary. Rejected as irrelevant and unnecessary. Adopted in paragraph 20. Rejected as irrelevant. Rejected as explained in paragraph 22. Rejected as unnecessary. Policy memorandum #7 is addressed in Conclusion of Law No. 3; otherwise this is rejected as a finding of fact. Rejected as unnecessary. Rejected as repetitive. Adopted in substance in paragraph 24 and 26. Adopted in substance in paragraph 21. Adopted in paragraph 9. Rejected as cumulative. Adopted in paragraph 9, otherwise rejected as contrary to the weight of evidence or unnecessary. Adopted in part in paragraph 29, otherwise rejected as unnecessary. Adopted in substance in paragraph 28. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 28. Adopted in paragraph 28. Adopted in part in paragraph 28, otherwise rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 29 as to the profit of $10 million dollars, otherwise rejected as unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. As addressed in conclusions of law #10 and #11, the impact on Baptist was found to be minimal and insufficient to support "standing". Adopted in paragraph 10. Rejected as unnecessary. Rejected as unnecessary. Adopted in substance in paragraphs 10 and 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in substance in paragraph 11. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary, except as to the apples/oranges analogy, which is adopted in paragraph 9. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Rejected as cumulative and unnecessary. Adopted in paragraph 11. Adopted in paragraph 10, as to the characterization of Dr. Fagin's testimony. Otherwise, rejected as summary of testimony rather than findings of fact. The adoption of 40 percent as reasonable is found in paragraph 12. Rejected as contrary to the weight of the evidence. HRS Need Methodology is rejected in paragraph 10.(b) and paragraph 12 as being less reasonable than Petitioners' experts methodology. Rejected as essentially argument, rather than findings of fact. Rejected as contrary to the weight of evidence. Rejected as repetitive. Adopted in substance in paragraph 33 and Conclusion of Law #3. Rejected as argument unsupported by the weight of evidence. Rejected. See paragraph 7 for discussion of State Health Plan. Rejected as argument, rather than finding of fact. No paragraph of this number is found in Petitioner's Proposed Findings of Fact. Adopted in Conclusions of Law, paragraph 4. Rulings on Joint Proposed Findings of Fact Submitted by the Respondent and Intervenors. (Note, the numbers in the left column conform to the numbering of the joint proposed findings) 1. Adopted in substance in paragraph 1, 2 and 3. Adopted in paragraph 6. Adopted -In paragraph 4. Adopted in paragraph 5. 1. Adopted in paragraph 7. Adopted in paragraph 8. Rejected as irrelevant. Adopted in part in paragraph 8, otherwise rejected as unnecessary. Rejected as irrelevant. Adopted in substance in paragraph 10(b). Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Rejected as a re-statement of testimony, rather than finding of fact 10.c. Description of Mr. Swartz' methodology is provided in paragraph Rejected as irrelevant. Rejected as irrelevant. 13 - 21. Rejected as unnecessary. Adopted in substance in paragraph 10. Rejected as unnecessary. Rejected as contrary to the weight of evidence, except as reflected in paragraph 10. Adopted in part in paragraph 10.b., otherwise rejected as unnecessary. 25A. Adopted in part in paragraph 10, otherwise rejected as unsubstantiated by competent substantial evidence. Adopted in part in paragraph 10, otherwise rejected as unnecessary. Adopted in part in paragraph 22 and 23, otherwise rejected as unnecessary. 1. Adopted in substance in paragraph 31. Adopted in substance in paragraph 31. Rejected as contrary to the evidence by considering all uncontroverted testimony and evidence describing the facility. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Adopted in part in paragraph 32 and 33, otherwise rejected as irrelevant. Rejected as contrary to the weight of the evidence. Adopted in part in paragraph 31, 32 and 33, otherwise rejected as irrelevant. Rejected as irrelevant. Rejected as contrary to the weight of the evidence. 1. Rejected as unnecessary. Rejected as argument that is unnecessary or unsupported by competent substantial evidence. Adopted in substance in paragraph 27. 1. Rejected as cumulative. Rejected as cumulative. Rejected as unnecessary. Adopted in part in paragraph 4, 5 and 10, otherwise, rejected as unnecessary. Adopted in substance in paragraph 9. Adopted in substance in paragraph 9. Adopted in part in paragraph 4 and 5, otherwise rejected as unnecessary. Rejected as cumulative. Addressed in Conclusion of Law 6. 1. Adopted in paragraph 17. Rejected as irrelevant. Rejected as irrelevant. 1. Rejected as cumulative. 2. Rejected as mere re-statement of testimony rather than a finding of fact. 1. 1. 1. 1. Adopted in paragraph 20. Adopted in part in paragraph 24, otherwise rejected as irrelevant or contrary to the weight of evidence. Rejected as irrelevant. 1. Adopted in part in paragraph 26, otherwise rejected as irrelevant. Adopted in paragraph 24. Rejected as irrelevant. 1. Addressed in Conclusion of Law 4. 1. Addressed in Conclusion of Law 4. 1. Rejected as unnecessary argument. Adopted in part in paragraph 27, otherwise rejected as unnecessary. Rejected as the description of an exhibit and characterization of testimony. Adopted in part in paragraph 30, otherwise rejected as unnecessary. 1. Adopted in paragraph 24. COPIES FURNISHED: William J. Page, Jr., Secretary Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Steve Huss, Esquire General Counsel Department of HRS 1323 Winewood Blvd. Tallahassee, Florida 32301 Chris H. Bentley, Esquire William E. Williams, Esquire Jeannette Andrews, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Richard Power, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 Michael J. Dewberry, Esquire Christopher Hazelip, Esquire 1300 Gulf Life Drive Jacksonville, Florida 32207 Robert Meek, Esquire Post Office Box 240 Jacksonville, Florida 32201 =================================================================
The Issue The issue for determination is whether Respondent committed the offenses set forth in the corrected administrative complaint, and, if so, what action should be taken.
Findings Of Fact At all times material hereto, Kenneth Douglas Glaeser (Respondent) was a licensed physician in the State of Florida, having been issued license number ME 0058606. Respondent's area of specialty is Emergency Medicine. On or about May 30, 1993, at approximately 9:45 p.m., Patient L. H., a 47 year old male, presented to the emergency room (ER) at Parkway Regional Medical Center (PRMC) in Miami, Florida complaining of chest pain. Patient L. H. and his wife were visiting his mother in Miami. At first, Patient L. H. believed he had heartburn, but it would not go away. His mother convinced him to go to the hospital. Patient L. H.'s wife and mother accompanied him to the hospital. His wife parked the vehicle while Patient L. H. and his mother entered the ER. Patient L. H.'s wife completed paperwork for the ER while the ER staff attended to her husband. Patient L. H.'s mother was with him. After completing the paperwork, approximately 10 minutes later, Patient L. H.'s wife joined Patient L. H. and his mother in the examining room. At the time, Respondent was the ER physician on duty at PRMC. Respondent was the only ER physician who attended to Patient L. H. Respondent has no independent recollection of Patient L. H. or what happened during Patient L. H.'s visit to the ER at PRMC. The first goal of an ER physician is to determine if the patient has a life-threatening condition, which, often times than not, involves excluding diagnoses. The second goal of an ER physician is to determine if the patient has a condition which can receive immediate treatment and to provide that immediate treatment whether the condition is life-threatening or not. Respondent obtained Patient L. H.'s history which included the type of pain, description of the pain, location of the pain, associated symptomatology, time frame of the pain (including onset), and past history. Respondent recorded, among other things, that Patient L. H. had chest pressure which radiated bilaterally to his shoulders and a numb left shoulder; that the pain lasted for approximately 10-15 minutes, subsided, and re-occurred 30 minutes later; that Patient L. H. had no shortness of breath, diaphoresis (sweating), nausea or vomiting, or palpitations; and that Patient L. H. had no cardiac history. Respondent's history of Patient L. H. was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent performed a physical examination on Patient L. H. The physical examination included taking vital signs and examination of the cardiovascular system, lungs, and pulses of the extremities. Respondent's physical examination was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent had laboratory work performed on Patient L. H. Respondent ordered SL (sublingual) nitroglycerine for Patient L. H. But, the nitroglycerine was not administered because Patient L. H. was not complaining of chest pains at the time. The ordering of the nitroglycerine and not administering it until chest pain developed was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent ordered diagnostic tests to be performed on Patient L. H. The tests included an electrocardiogram (EKG), a chest x-ray, and cardiac enzymes. Neither Patient L. H.'s wife nor his mother were present during the tests. ER physicians are trained to read EKGs. Generally, a cardiologist is not immediately available to the ER for the reading of EKGs. An ER physician looks for an injury pattern in the EKG, which would evidence an acute cardiac event. Most times, a cardiologist will over-read the EKG a day or two after the EKG is performed on a patient. Respondent's reading of Patient L. H.'s EKG did not show an injury pattern which would evidence an acute cardiac event. Respondent determined that Patient L. H.'s EKG was within normal limits. Even though an abnormality was demonstrated in the EKG, the abnormality could have been a false/positive reading. Respondent's reading of the EKG was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. A cardiologist over-read Patient L. H.'s EKG after he left PMRC. The cardiologist found a "definite abnormality." Respondent's reading of Patient L. H.'s chest x-ray indicated that it was within normal limits. Respondent's reading of the chest x-ray was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent's interpretation of the cardiac enzymes tests (CPK and LDH) indicated that they were within normal limits. If a heart is damaged, often times the enzymes contained in the heart cells will be released, and the cardiac enzymes tests would detect the enzymes. Respondent's interpretation of the cardiac enzymes tests was within that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. It is undisputed that based upon Patient L. H.'s history, the physical examination, the tests results, including diagnostic and laboratory results, a recommendation to Patient L. H. by Respondent for admission to PRMC was medically warranted. Admission would allow for monitoring and further evaluation. However, a patient has a right to refuse admission. Respondent discussed his findings with the doctor who was listed as Patient L. H.'s primary physician on the ER record. The primary physician was the private physician, a cardiologist, of Patient L. H.'s mother. The primary physician authorized Respondent to contact the physician on-call. Respondent discussed his findings and his concern with Patient L. H. Respondent recommended to Patient L. H. that he be admitted to PRMC. However, Patient L. H. did not wish to be admitted; he wanted to leave the hospital. Patient L. H. rejected Respondent's recommendation for admission to PRMC. 1/ Patient L. H.'s mother attempted to convince him to agree to admission and remain in the hospital, but he refused. It is undisputed that if a patient refuses admission, the physician should advise the patient of the risks involved and recommend admission. In Patient L. H.'s circumstances, it was medically warranted that Respondent advise Patient L. H. that, if he was not admitted, he could suffer a heart attack and die and recommended admission to Patient L. H. Taking the totality of the circumstances, an inference is drawn and a finding is made that Respondent advised Patient L. H. of the risks involved if he rejected admission and recommended to Patient L. H. that he be admitted. Respondent did not record in the ER record that he advised Patient L. H. of the risks involved in rejecting admission and recommended admission. ER physicians are not medically required to spell-out in the medical record what risks are discussed with a patient and that the patient left against medical advice. It is sufficient that the ER physician explains the risks to the patient. Respondent ordered a GI cocktail (Maalox, Donnatal, and viscous Lidocaine) for Patient L. H. 2/ The GI cocktail was not administered until approximately 12:15 a.m. on May 31, 1993. 3/ The ordering or not of the GI cocktail for or the time in which the GI cocktail was given to Patient L. H. has no effect on the standard of care that Respondent provided to Patient L. H. Respondent diagnosed Patient L. H.'s condition as atypical chest pain. This diagnosis essentially indicates that a number of different things may have been causing Patient L. H. to experience chest pain. Patient L. H. left PRMC on May 31, 1993, at approximately 12:20 a.m. against medial advice even though the ER record indicates that he was discharged. 4/ Before leaving PRMC, Patient L. H. was informed by Respondent to, among other things, follow-up with the primary physician and return to the ER if needed. Neither Patient L. H. nor his wife completed any discharge papers or received discharge instructions. It is not uncommon for a patient to be discharged from a hospital without completing discharge papers or receiving discharge instructions. However, hospitals attempt to prevent such occurrences. When a patient leaves PRMC against medical advice, the patient is requested to complete certain documentation. That documentation was not completed in the case of Patient L. H. However, the absence of the documentation is not considered to evidence that Respondent failed to advise Patient L. H. of the risks involved in rejecting admission and to recommend admission. On May 31, 1993, at approximately 8:45 a.m., Patient L. H. went into cardiac arrest at his mother's home. He was transported to the ER at PRMC by emergency vehicle, where he was pronounced dead. On June 1, 1993, Respondent entered an addendum to the ER notes of May 30 and 31, 1993. The addendum provided, among other things, that Patient L. H. was opposed to admission to PRMC and that, even when Respondent explained the risks to Patient L. H., he continued to oppose admission and wanted to leave. Furthermore, the addendum provided, among other things, that Respondent instructed Patient L. H. to return to the ER if the chest pain returns and to follow-up with the primary physician. An addendum to ER notes by an ER physician is not unusual and is an accepted practice. The Dade County Medical Examiner determined that Patient L. H.'s cause of death was occlusive coronary artery disease. Respondent's medical records justified the course of treatment of Patient L. H. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar ER physician as being acceptable under similar conditions and circumstances. Respondent is a defendant in a pending civil suit brought by Patient L. H.'s surviving spouse.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine dismiss the corrected administrative complaint. DONE AND ENTERED in this 27th day of January 1997 in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January 1997.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the application of Central Florida Surgical Ambulatory Center be DENIED. DONE and ORDERED this 27th day of March, 1985, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of March, 1985.
The Issue Whether disciplinary action should be taken against Respondent's license as a veterinarian based on alleged violations of Section 474.214, Florida Statutes (1997), as charged in the Administrative Complaints filed against Respondent in this proceeding. Count I of the Administrative Complaint in Case No. 00-2357 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances. Count II of the Administrative Complaint charged Respondent with a violation of Section 474.214(1)(ee), Florida Statutes (1997): failing to keep contemporaneously written medical records as prescribed by Rule 61G18-18.002(3), Florida Administrative Code. The Administrative Complaint in Case No. 00-2358 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances.
Findings Of Fact Based on the evidence and testimony of the witnesses presented and the entire record in this proceeding, the following facts are found: At all times material, Respondent was a licensed veterinarian, having been issued license number VM 0003822. Facts relating to Case No. 00-2357 On or about March 5, 1998, Respondent performed a spay on "Midnight," a dog owned by Maryjane Greene and her husband. On or about March 8, 1998, "Midnight" expired at the Greene's home. When Mrs. Greene dropped off "Midnight," she was not sufficiently informed by Respondent about her option to have a pre-anesthesia lab work-up performed. There is no indication of an offer to perform a pre- anesthesia lab work-up, nor an indication that Mr. or Mrs. Greene declined such an offer, nor a consent form declining such a work-up, noted in the medical records kept by Respondent for "Midnight." It is a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the spay of "Midnight" included Xylzine (a.k.a. Rompun) a drug with a profound and potentially deleterious effect on the heart which may cause a first degree or second degree heart block. The anesthetic protocol used by Respondent during the spay of "Midnight" also included Ketamine, which is not approved for use in dogs. When used as an anesthetic protocol, it is considered an extra-label use of the drug. An extra-label use of a drug means that there have been no safety studies completed, and it cannot be adequately predicted what effects the medication will have on an animal on a consistent basis. There is no indication in Respondent's records for "Midnight" that Mrs. Greene was informed regarding the use of Ketamine in her dog's procedure. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug and not to have the client sign a consent form. Xylazine and Ketamine are both cardiac depressants. When used in combination they each make the other more of a cardiac depressant, thus requiring the administration of another drug, such as Atropine, to minimize the cardiac depressant effect. There is no indication in Respondent's medical records for "Midnight" that Atropine or any other drug was administered, other that the Xylazine and Ketamine. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xylazine and Ketamine was a deviation from the standard of care. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xyalzine and Ketamine played a substantial role in "Midnight's" demise. Upon picking up "Midnight," Mrs. Greene was given limited post-operative instructions. She was told not to give "Midnight" water until he could walk a straight line; not to give food until he could hold water down; only leash walks for 10 days; and no baths for 7-10 days. Respondent's post-operative discharge instructions given to Mrs. Greene did not comply with the standard of care in veterinary medicine. Facts relating to Case No. 00-2358 On or about August 25, 1998, Respondent performed surgery to remove a mass from the perineal area of "Snoopy," a nine-year-old obese Beagle belonging to Juan Ferras. There is no indication in Respondent's records for "Snoopy" that the surgery was performed due to an emergency, although the credible testimony indicated that it was an emergency. Given "Snoopy's" age (nine years) and weight (60 lbs.), it would be in the dog's best interest to perform a pre- anesthesia lab work-up, or to at least offer one to the owner. Respondent did not indicate in his medical records that he offered to perform a pre-anesthesia lab work-up on "Snoopy." In view of the emergency nature of the surgery, it was not a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the procedure on "Snoopy" included Ketamine, which is not approved for use in dogs. When used, it is considered an extra-label use of the drug. Ketamine should be used with extreme caution in dogs for which the veterinarian is unaware of the renal function or the liver function of the dog. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug, and not to have the client sign a consent form. There is no indication in Respondent's records for "Snoopy" that Juan Ferras was informed regarding the use of Ketamine in his dog's procedure. Upon picking up "Snoopy," Mr. Ferras was given limited post-operative instructions. Respondent's failure to give specific post-operative discharge instructions to Mr. Ferras constituted a deviation from the standard of care. After discharge, "Snoopy" began vomiting and was readmitted to Respondent's facility on or about August 27, 1998. On or about August 28, 1998, "Snoopy" expired at Respondent's facility. There is no indication in Respondent's records on "Snoopy" that upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, Juan Ferras refused to pay or was only willing to pay a small portion of any treatment rendered to "Snoopy." Because of this finding it is unnecessary to address whether refusal to pay a fee is an appropriate defense by Respondent. Upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, "Snoopy" was determined to be approximately 11 percent dehydrated and in a state of shock. In order to correct the dehydration and maintain "Snoopy," it would have been required to administer approximately 4300-4400 ccs of fluid. Respondent's records indicate that only 800 ccs of fluids were administered to "Snoopy." This left "Snoopy" with a tremendous deficit of fluids. Respondent's explanation as to the reason for the small amount of fluid shown on "Snoopy's" chart is not credible. Respondent's failure to administer the correct amount of fluids constitutes a deviation from the standard of care. Upon readmission to Respondent's clinic, Respondnet did not draw blood or perform any type of bloodwork on "Snoopy." Respondent's failure to draw blood or perform any type of bloodwork on "Snoopy" after being readmitted for dehydration and vomiting and shock constitutes a deviation from the standard of care. The fluids which were administered to "Snoopy" were administered sub-cutaneously. The failure to insert an IV catheter to administer the fluids, rather than administering them sub-cutaneously, constitutes a deviation from the standard of care. One way of re-hydrating a dehydrated patient is by weighing the dog and then adding enough fluids to get the patient to its normal weight. There is no indication in Respondent's records that "Snoopy" was weighed at the end of the day on or about August 27, 1998, or that "Snoopy" weighed approximately 60 pounds late in the day on or about August 27, 1998. Respondent's records for "Snoopy" contain a notation at 10:00 p.m. August 27, 1998, of "ADR" which means "ain't doing right." A patient whose records indicate "ADR" should be continuously monitored or transferred to an emergency facility. "Snoopy" was not monitored overnight and through the early hours of the next morning. Had Respondent taken appropriate steps with regards to fluid resuscitation upon "Snoopy's" readmission to Respondent's facility, "Snoopy's" chance of survival would have been much higher.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be render by the Board of Veterinary Medicine, as follows: Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statutes (1997), as alleged in Count I of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case NO. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(ee), Florida Statutes (1997), as alleged in Count II of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case No. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statues (1997), as alleged in the Administrative Complaint for DOAH Case No. 00-2358 (DBPR Case No. 98-21230). In light of these findings of guilt and aggravating circumstances, the following penalties are recommended: A thirty-day suspension of licensure. An administrative fine in the amount of four-thousand dollars ($4000.00). Assessing costs of investigation and prosecution, in the amount of $973.24 for Case No. 00-2357 and $684.29 for Case No. 00-2358. Five years of monitored probation upon such terms and conditions as the Board finds necessary and reasonable. DONE AND ENTERED this 19th day of December, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 19th day of December, 2000. COPIES FURNISHED: Walter H. Dornbusch, D.V.M. 1117 Malabar Road, Northeast Palm Bay, Florida 32907 Robert H. Hosay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-2202 Barbara D. Auger, General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Sherry Landrum, Director Board of Veterinary Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, 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 9th day of August, 2005.
Findings Of Fact The applicants, MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., are wholly owned subsidiaries of MediVision Inc., which maintains its corporate offices in Boston, Massachusetts. MediVision, Inc., was incorporated in January, 1984, to promote the development of outpatient eye surgery, in part through the development and operation of outpatient eye surgery centers. MediVision of Miami, Inc., and MediVision of Northern Dade County, Inc., will each be responsible for the development and operation of the projects proposed in their respective applications. MediVision, Inc., was organized by several individuals in response to a study conducted by Bain and Company, a strategic consulting firms as part of a consulting engagement in which those persons were involved. The study disclosed several demographic and health care delivery trends which prompted MediVision management to pursue the development of outpatient eye surgery centers. Those trends are: an overall movement of all types of surgery from an impatient to an outpatient setting; the increase in the nation's elderly population, and the fact that the likelihood of a person developing cataracts increases dramatically with age; the technological improvements in the provision of cataract surgery; the growth in the number of cataract surgeries performed nationally; and, a change in the manner in which Medicare reimburses a facility for outpatient surgery performed upon Medicare recipients. Medicare, since 1982, has reimbursed licensed freestanding ambulatory surgical facilities at a flat rate for the provision of such surgery, with no cost to the patient. For the same surgical procedures performed in a hospital outpatient setting, Medicare will reimburse the facility its costs of providing the surgery; the patient is responsible to pay the Medicare deductible and 20 percent co-insurance. Various subsidiaries of MediVision Inc., presently operate eight outpatient eye surgery centers nationwide; two are located in Florida. Other MediVision subsidiaries are developing three additional centers in Florida, pursuant to certificates of need issued by the Department of Health and Rehabilitative Services. Both parties employed the same quantitative need methodology. The methodology employs the following steps: acquire data regarding number of impatient and outpatient surgical procedures performed by existing providers; using this data, calculate current overall surgical use rate and outpatient surgical use rate for county; using the projected population for the year in question and the current use rate, calculate projected number of surgeries; multiply total projected surgeries by 40 percent to establish total outpatient surgery pool for year in question; subtract from result of step 4, all outpatient surgical procedures projected to be performed in hospitals and operating freestanding ambulatory surgery centers; subtract financial break-evens of all certificate of need approved freestanding outpatient surgery centers from this pool; and, after subtractions the number of surgical procedures remaining are compared to the break-evens of certificate of need applicant at issue. If the pool is larger than break-evens the condition is satisfied. If the pool is smaller than break-evens the condition is not satisfied. The quantitative methodology provides a reasonable approach to the evaluation of need for ambulatory surgical facilities. The basic methodology has been employed by the Department since 1982; in December, 1985, the Department began to employ a "40 percent outpatient factor" in implementing the policy. Accordingly, looking toward the planning horizon of 1988, the methodology projects that 40 percent of all surgeries in Dade County will be performed on an outpatient basis. The 40 percent outpatient factor is reasonable for use in these proceedings. The prevailing literature suggests that 40 percent of all surgeries can be expected to be performed on an outpatient basis. Within Florida, many counties are already performing in excess of 30 percent of all surgeries on an outpatient basis. Trends in health care delivery and reimbursements including the growth in pre-paid health care organizations, such as health maintenance organizations; professional review organizations, which monitor the appropriateness of hospital admissions; and Medicare reimbursement incentives will contribute to an increase in the percentage of surgeries performed in an outpatient setting. While employing the same quantitative need methodology, the parties' health planning experts arrived at different conclusions as to whether the methodology projects need for the facilities at issue in these proceedings. The differences in outcome are attributable to two issues: (1) the calculation of a base-year use rate; and (2) the calculation of "break-evens" for previously approved, but non-operational, ambulatory surgical facilities. Each expert relied upon the same basic data source in calculating a base-year surgical use rate, employing data collected by HRS and reported in the most current State Agency Action Report prepared by the Department relative to Dade County. Such Action Report (CON Action No. 4095) lacked complete data regarding the total number of surgeries performed in Dade County during the base-year (1984-5), in that six of the thirty-three acute care hospitals in Dade County failed to report. Because it is necessary to have complete data in order to establish an accurate base-year surgical use rate, Mark Druash who was engaged to undertake a need analysis by the applicants, referred to earlier State Agency Action Reports to acquire surgical procedure data for the six hospitals which had failed to report. Such documents are reliable data sources upon which to base a need analysis. In calculating a county's surgical use rate, health planners take into consideration the total population within the county. Accordingly, the total number of surgeries provided within the county must also be considered. In that six Dade County hospitals failed to report data and HRS' health planner did not acquire data relative to those facilities, the surgeries performed at those hospitals were not included in his calculation of a surgical use rate. If the total population of a county is considered in calculating a surgical use rate, but something less than the total number of surgeries is considered, the calculation results in an artificially deflated use rate. As the base-year use rate drives all of the remaining calculations in the quantitative methodology, an error in the calculation of the use rate will be carried through the entire methodology. The ultimate effect of a deflated use rate is to project a smaller number of surgical procedures, as compared to a use rate calculated upon complete data. HRS calculated a base-year surgical use rate for Dade County of 78.2 surgeries/1000 population. MediVision calculated a base-year surgical use rate of 92.8/1000 population. The variance in the use rates is attributable solely to the fact that Druash acquired and employed in his calculations surgical procedure data from all Dade County hospitals previously relied upon by HRS; while HRS relied upon incomplete data. In that Druash's calculations are based on a complete data based the surgical use rate of 92.8/1000 population is found to be more accurate and reliable than the rate of 78.2/1000 population calculated by HRS from incomplete data. The parties differ in their calculation of "break- evens for previously approved, but not yet operational, ambulatory surgical facilities. The break-even calculation is an integral part of the quantitative need methodology. The purpose of subtracting from the available outpatient surgical pool the "break-evens" of approved, but not yet operational ambulatory surgical facilities is to assure that there exists need for the project proposed adequate to allow both such project and previously approved facilities to operate in a financially viable manner. The "break-even" approach is also intended to promote competition; rather than assuming that all of the procedures projected by a facility will be performed in such facility; the approach allocates to the facility only that number of procedures it needs to generate sufficient revenues to cover its expenses. Druash who participated in the development of the quantitative methodology during his tenure with HRS, testified that the "break-even" approach was selected because it would promote competition among providers by approving enough applicants so that they would be "hungry" for the residual surgeries projected by the methodology. The purpose of calculating a financial break-even is to ascertain at what point a project's cash flow will equal its expenditures. The generally accepted method for calculating a financial break-even requires that fixed costs be separated from variable costs. The concept of variable costs is the basis for the computation of a break-even. Fixed costs are those which remain constant regardless of the volume of business conducted by an entity; variable costs are those that change directly with volume. In the operation of an ambulatory surgical facility, virtually all expenses related to medical supplies are variable. If no patients are treated, no medical supplies are needed, and no expenses are incurred. If 100 patients are treated, 100 units of medical supplies are needed, with resultant expense. Certain expenses involved in the operation of an ambulatory surgical center are totally fixed, such as debt service and property taxes. All other expenses are variable to some degree e.g. salaries, utilities, and maintenance. Depreciation and amortization of property and equipment are not considered as expenses in a break-even analysis, as those items do not represent cash expenditures. As mere accounting recognitions of prior investment, depreciation and amortization should not be included in a calculation of a cash flow break-even. HRS' methodology for calculating financial break-evens for ambulatory surgical procedures treats all expenses as fixed, and includes amortization and depreciation among those expenses. By HRS' admissions the Department, "in lieu of attempting to determine what is fixed and what is variable . . . will use a somewhat more crude method". Where a financial break-even is calculated treating all costs as fixed, the resulting break-even number is artificially inflated. By the Department's reckoning, the effect of treating all expenses as fixed is to "add a cushion" to its approvals of prior applications. HRS' expert acknowledged, however, that differentiating between fixed and variable costs in performing a financial break-even analysis is the "preferred methods no question". Lovell Jones, a certified public accountant and expert in health care finance, performed revised break-even analyses for previously approved, but not yet operational, ambulatory surgical facilities. Jones first acquired expense and revenue data from the certificate of need applications submitted by previously approved applicants. Then, treating only medical supplies as variable expenses, and excluding amortization and depreciation from the list of fixed expenses, he calculated the actual financial break-even of each approved, but not yet operational, facility. Jones' analysis finds the collective break- even of all previously approved, but not yet operational, facilities to be 17,996 procedures, whereas the Department's "crude" analysis results in a collective break-even of 25,736. Jones' method of calculating break-even, which was agreed to be technically correct by both parties, is more accurate and reliable than the method employed by the Department. Using the agreed-upon quantitative methodology, the surgical use rate calculated by Druash, and the break-even numbers calculated by Jones, there is projected to exist in 1988 a pool of 5006 outpatient surgical procedures that could be provided by the applicants in these proceedings. Subtracting the break-even numbers of the two proposed facilities, there will exist a residual pool of greater than 3600 procedures. Accordingly, there exists a quantitative need for the two proposed facilities. Furthers the residual pool of greater than 3600 procedures represents an adequate "cushion" to satisfy the concerns of HRS that previously approved facilities be given the opportunity to operate in a financially viable manner. The proposed facilities will improve access to services for both Medicare and indigent patients. Medicare patients receiving surgery at the facilities will be treated free of cost, with the Medicare program having full responsibility for payment. All other patients will be treated at the facilities regardless of ability to pay. The proposed facilities will promote competition in that management intends the charges to commercial patients to be less than the prevailing charges in the community. Where an ambulatory surgical facility enters a market, hospital charges for similar services tend to decrease. The proposed facilities will promote cost containment, as it is more costly to render care in a hospital outpatient department than in a freestanding ambulatory surgical facility. Hospital outpatient departments, which are reimbursed by Medicare for their costs of providing services, do not have the same incentive to reduce costs as do freestanding ambulatory surgery facilities, which are reimbursed at a predetermined flat rate for the provision of services. Accordingly, Medicare has encouraged the use of freestanding ambulatory surgical facilities by incurring all responsibility for payments at no cost to Medicare recipients. The Department's sole concern regarding the financial feasibility of the proposed facilities arises out of its position that there exists no need for the facilities. Accordingly, the Department questions whether the facilities will enjoy utilization sufficient to generate the revenues necessary to their viable operation. In that need for the facilities has been found to exist, it follows that the facilities will be able to generate adequate numbers of surgeries to achieve break-even in their second years of operation. Several other factors indicate that the facilities will experience utilization sufficient to achieve break-even in their second years of operation: The marketing and community education activities proposed by the applicants will encourage utilization. In its existing surgical facility in Orlando, MediVision, Inc., has undertaken similar activities, which have resulted in substantial surgical referrals to the facility; There exists a residual pool of approximately 5,000,000 untreated cataracts nationally; Medicare reimbursement policies which allow Medicare recipients to receive treatment at licensed freestanding ambulatory surgical centers at no cost to the recipient will encourage utilization of the proposed facilities; The applicants' pricing structure, for both Medicare and commercial patients, will encourage utilization of the proposed facilities; and Two local ophthalmology group practices have expressed strong interest in performing surgery at the proposed facilities. Each group presently performs in excess of 1000 surgeries annually, which volume is greater than the break-even volume necessary to be achieved at each facility.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Lawn it is RECOMMENDED that a Final Order be entered approving the applications of Petitioners to establish and operate freestanding ophthalmic ambulatory surgical centers in Dade County, Florida. DONE and RECOMMENDED this 6th day of June, 1986, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of June, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Robert A. Weiss, Esquire The Perkins House, Suite 101 118 North Gadsden Street Tallahassee, Florida 32301 Richard A. Patterson, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 =================================================================
The Issue The issue for consideration in this hearing is whether Petitioner meets the academic requirements for licensure as a registered nurse in Florida.
Findings Of Fact At all times pertinent to the issues herein, Respondent, Board of Nursing, has been the state agency responsible for the licensing of registered and licensed practical nurses in Florida and the regulation of the nursing profession in this state. On November 25, 1998, while residing in France, Petitioner, Pascal Canesse, filled out an application for nursing licensure (DH Form 1204. 8/98), seeking licensure by examination as a registered nurse in Florida which he submitted in January 1999. Prior to the hearing, the parties stipulated, and it is found, that: Petitioner attended the nursing program at Institute Formation en Soins Infirmiers (the Institute) in France from 1993 - 1995, The Official Transcript submitted by the Institute does not list classroom instruction or clinical practice in obstetrics. The Training Sessions, or clinical practice, portion of the Official Transcript submitted by the Institute includes a breakdown of 350 hours of surgery training that includes the following subject areas: emergency polyvalent intensive care digestive surgery and urology The Form B submitted by the Institute states that Petitioner had 600 hours of classroom instruction and 490 hours of clinical practice in surgical nursing. The Training Sessions, or clinical practice, portion of the Official Transcript submitted by the Institute lists a total of 1,715 hours of training. The theoretical Assessment portion of the Official Transcript submitted by the Institute does not include the number of hours of instruction but breaks down the training to include nursing care to patients in the following categories: psychosis patients patients with breathing problems patients with ENT-stomatology- dermamtology troubles patients with endocrinous troubles patients with digestive troubles patients with troubles of the nutriment duct pediatrics and child psychiatry elderly patients with neuropsychiatry troubes elderly patients patients with nervous system troubles patients in emergencies-intensive care-blood transfusions patients with hematology/urology/nephrology troubles In answer to question 6 on his application, Petitioner stated that he completed 40 hours of training in obstetrical nursing under the categories listed on the transcript. The Form B - Transcript of Nursing Education in a Foreign Country submitted by the Institute and relating to Petitioner reflects that he received 40 hours of classroom instruction in obstetrical nursing. No hours of clinical practical in obstetrical nursing are reflected. In correspondence to the Board dated June 10, 1999, Petitioner set forth his explanation of the discrepancies in the application, Form B, and his transcript. Petitioner contends that when he filled out his application and the supporting documentation therefor, he listed 525 hours of clinical medical nursing practice and 490 hours of clinical surgical nursing practice. While he reflected 40 hours of instruction in obstetric nursing, he failed to indicate any obstetric clinical practice. He claims the number of hours claimed as being in medical/surgical area comprises the number of hours in both, including obstetrics. His failure to enter any clinical practice in the obstetrics area was the result of a combination of that discipline with medical/surgical training as is done in France. This reflects clinical hours only. His claim of 40 hours training is for classroom work in obstetrics only. It is not combined with surgery. It would have been much clearer if he had marked down the course he took rather than just the hours taken. A review of the Official Transcript provided by the Institute to be submitted to the Florida authorities in support of Petitioner’s application clearly fails to specifically indicate any obstetrical training. The "Addendum to Transcript" dated May 4, 1999, reflects 70 hours of obstetric classroom in addition to two weeks' clinical obstetrics experience. This is different from the surgical nursing that had been combined with surgical nursing on the Form B originally submitted. Other documentation from the Institute, a letter dated June 25, 1999, indicates that two "weeks" is equivalent to 70 hours. That same letter notes that much of the training in France is hospital-based with a significant amount of training being clinical in nature with a heavy emphasis in surgery. The French authorities claim that those surgical hours are comprehensive, and it is in that curriculum that the students receive clinical and classroom obstetrics training, with the clinical portion being a full two weeks - that is, "a minimum of 70 hours." Petitioner also introduced a syllabus for the module in the Institute’s nursing training program which relates to gynecology. This reflects the areas covered and includes a significant amount of information apparently related to obstetrics and childbirth. The syllabus reflects an extensive amount of clinical instruction over the three years of nursing training. However, again, the supporting documentation does not clearly quantify that portion of the training which deals with obstetrics, nor does it show where the training is integrated into the surgical nursing training as claimed by Petitioner. Petitioner was unable to convincingly recall at which point in the three-year training program he took the required clinical obstetrics training. At one point, in his deposition, he claimed it was integrated in his emergency medicine training. At hearing, however, he claimed it was integrated with medical surgical training. The fact that the obstetrical clinic may have been integrated with another service is not, of itself, disqualifying. The Board of Nursing accepts integrated nursing training, under certain conditions. When course integration is claimed, however, the Board requires the submission of a detailed course outline that delineates where the specific course content, here, obstetrics, is presented. Further, the Board considers the integration of obstetrics with emergency surgery as inappropriate because the basic nature of the disciplines is not the same. While one is reactive, the other is pro-active. No doubt, Petitioner was exposed to an obstetrics curriculum which included both classroom and clinical instruction. From the state of the evidence presented, however, it is impossible to determine the breadth and content of this exposure. According to Ms. Jacobsen, the Board’s nursing education director, staff which reviewed Petitioner’s application was concerned over the unexplained inconsistency in the supporting documentation submitted therewith. None of the information on the various submitted documentation matched. On its Notice of Educational Deficiencies dated May 20, 1999, it was suggested that Petitioner have his school write a letter explaining the discrepancy. The Institute’s letter of June 25, 1999 asserts that the required clinical training was provided, but does not define with any particularity at which point in the training the obstetrics discipline is treated. It appears to be integrated into the surgical clinical training, but from the state of the documentation presented, the particulars cannot be determined.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law it is recommended that Petitioner’s application to sit for examination for licensure as a registered nurse in Florida be denied until he provides sufficient explanation of the clinical training he received in obstetrical nursing or proof of completion of the required training at an alternative approved site. DONE AND ENTERED this 28th day of April, 2000, in Tallahassee, Leon County, Florida. ARNOLD H. POLLOCK 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) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 2000. COPIES FURNISHED: Doris A. Bunnell, Esquire 608 15th Street, West Bradenton, Florida 34205 Lee Ann Gustafson, Esquire Office of the Attorney General Department of Legal affairs The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050 William Large, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Ruth Stiehl, Executive Director Board of Nursing Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue in this case is whether the challenged portions of Rule 64B8-9.009, Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact In 1994, Respondent, Florida Board of Medicine promulgated Rule 61F6-27.16, Florida Administrative Code. The Rule was later renumbered twice before being referenced as 64B8- 9.009, Florida Administrative Code. In 1998, the Florida Legislature provided that 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 manuals in order to establish grounds for disciplining doctors." Section 458.331(1)(v), Florida Statutes. On March 13, 1998, Respondent published in the Florida Administrative Weekly (FAW) a Notice of Proposed Rule-making concerning the Rule, followed by the first meeting of Respondent's Surgical Care Committee with respect to potential amendments to the Rule. After additional meetings, all of which were properly noticed in the FAW, the Surgical Care Committee presented its recommended amendments to the Rule to the full Board of Medicine from December 4-6, 1998. The full Board did not accept the Surgical Care Committee's recommendation completely, but rather voted to alter the proposed amendments. These latter amendments were approved by the Board at its January 6, 1999, conference call. On April 11, 1999 and June 3, 1999, the Board held additional public hearings, leading the Board to publish two Notices of Change, the second of which was published on June 18, 1999. Among the amendments contained in Rule 64B8-9.009 as proposed on June 18, 1999, was a deletion of Section (4)(b) which required those physicians not having staff privileges to perform the same procedure as that being performed in the office to have a "transfer agreement" with a licensed hospital within reasonable proximity. The Board considered replacing this mandate with a "transfer protocol." The June 18, 1999, version also considered a change to Section (6)(b)1., thereby permitting certain physicians to perform Level III surgery without hospital staff privileges and eliminating the mandated presence of a physician anesthesiologist. On July 8, 1999, the Florida Society of Anesthesiologists (FSA) and the Florida Hospital Association, et al. (FHA) filed separate rule challenges seeking to invalidate the proposed Rule (DOAH Case Nos. 99-2974RP and 99-2975RP, respectively). On August 7, 1999, the Board of Medicine held an additional public hearing, where further amendments were made to the Rule, none of which materially affected the above sections. A third Notice of Change was published on August 20, 1999, reflecting these amendments approved on August 7, 1999, by the Board. During the Fall of 1999, the incoming Chairman of the Board of Medicine, Dr. George El-Bahri, held several private settlement negotiations with the parties to the various rule challenges. Nevertheless, as of the Board's December 4, 1999, meeting, no settlement had been reached in either challenge, and the Board voted unanimously to proceed with the rule challenge litigation and make no further changes to the proposed amendments. This course of action was confirmed by the Board during its January 2000 conference call. Following the Board's January conference call, the parties to the pending litigation agreed to "submit to the Department of State for codification" those sections of the proposed amendments which were not at issue in the litigation. As a result, the Board, FSA, and FSPS entered into a joint stipulation on January 26, 2000. The FHA filed a Partial Voluntary Dismissal on January 28, 2000, dismissing their challenge to all proposed amendments to Rule 64B8-9.009, except with respect to Subsections (2)(e), (2)(f), (2)(i), (4)(g)1. and 2.; and (6)(b)1a. and 6., which are not at issue in this case. On January 28, 2000, the Board properly filed with the Department of State, portions of the proposed amendments which were no longer subject to the pending litigation, with the rule in its current form becoming effective on February 17, 2000. Because any proposed amendments relating to transfer protocols and Level III staff privileges were withdrawn and no longer being considered, they were not filed for adoption on January 28, 2000. Those existing sections remained unchanged in the rule and were renumbered by the Department of State. Petitioners challenge each of the approved amendments to Rule 64B8-9.009 which became effective on February 17, 2000, alleging that the provisions of the existing rule are an invalid exercise of delegated Legislative authority under Section 120.52(8), Florida Statutes. Specifically, Petitioners challenge the following Subsections of Rule 64B8-9.009. Subsection (1)(a) which provides that the rule covers "any elective procedures for aesthetic, reconstructive, or cosmetic purposes;" Subsection (2) which Petitioners allege imposes costly record-keeping requirements; c. Subsections (2)(d), (3), (4), (5), and (6) which Petitioners allege limit the types and durations of aesthetic reconstructive and cosmetic procedures which may be performed in Petitioners' office surgical suites; Subsections (4)(e) and (6)(e) which Petitioners allege impose costly equipment requirements; Subsections (4)(f), (5)(b)2., and (6)(f) which Petitioners allege impose costly personnel requirements; Subsections (3), (4), (5), and (6) which Petitioners allege establish levels of surgery unrelated to any rational classification scheme. Petitioners further challenge Subsection (3)(b) and (4)(b) of Rule 64B8-9.009 relating to transfer agreements and staff privileges as they existed prior to February 17, 2000, which contain the exact same language in Subsections (4)(b) and (6)(b) of the current version of the Rule. PARTIES Petitioner R. Gregory Smith, M.D., is a licensed medical doctor practicing in Ponte Vedra Beach, Florida. Petitioner Smith practices cosmetic surgery, plastic surgery, and oral-maxillofacial surgery in his office. Petitioner Smith has a dental degree from Ohio State University College of Dentistry, a residency in oral and maxillofacial surgery, a degree in medicine from the University of Florida College of Medicine, residency at the University of Florida with an internship in general surgery, and served as a faculty member at the University of Florida College of Dentistry in the Department of Oral and Maxillofacial Surgery at Shands Hospital Jacksonville. After specialty training in cosmetic surgery, Petitioner Smith opened his private practice in 1991. Petitioner Smith performs various surgical procedures in his office, including hair transplantation, cosmetic eyelid surgery, functional eyelid surgery, cosmetic and functional nasal surgery, face, neck, and forehead lifts, tumor reconstruction, liposuction, abdominoplasties, breast implants, and breast reductions. Petitioner Smith is also President of the Florida Academy of Cosmetic Surgery, Inc. (Academy). Petitioner Academy is an organization of multispecialty physicians who perform both cosmetic and functional surgery in their offices. Functional surgery means surgery being performed as part of a disease process or correcting some deformity and is generally not done for purely cosmetic reasons. Petitioner Charles E. Graper, D.D.S., M.D., FACS, is a Florida licensed medical doctor and dentist practicing in Gainesville, Florida. Petitioner 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. Petitioner 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 (FACS). Petitioner 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. Petitioner Graper has been practicing cosmetic surgery for 20 years and has been teaching cosmetic surgery for 15 years. The Board The Board regulates the practice of medicine in Florida, and is the agency that adopted the Rule at issue. It is comprised of 15 members appointed by Florida's Governor and confirmed by the Florida Senate. The FSPS and the FSD The FSPS and the FSD are comprised of Florida physicians who practice in the areas of plastic surgery and dermatology. The FSA 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 particular to anesthesiology. The Hospitals The Florida Hospital Association, Inc. (FHA) and the Association of Community Hospitals and Health Systems (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. Rule Adoption Procedures 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)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. Liz Cloud is the bureau chief for the Department of State's Bureau of Administrative Code (BAC). Ms. Cloud serves as the filing officer for rules and regulations filed by agencies, all laws passed by the legislature and any advertisements for publication in the Florida Administrative Weekly. She oversees the publishing of the Florida Administrative Weekly and the Florida Administrative Code and has served in that position since 1977. The BAC has rule-making requirements which agencies must follow in order to file a rule for adoption. When the BAC receives a rule that is filed for adoption, specific documents must be included, or the agency is required to resubmit a corrected rule packet. The BAC verifies that the certification from the Joint Administration Procedures Commission has been received and that all the required time frames have been met. BAC checks to ensure the rule is filed within the 90-day limit in Section 120.54(3)(e), Florida Statutes, and determines if there is a challenge to the rule. The BAC receives a weekly computer printout from JAPC on which Cloud's staff relies to determine if there are outstanding rule challenges to a rule being filed for adoption. The BAC's role in the rule-making process is not merely ministerial. If, for example, an agency files a rule on which the 90-day time limit has run, the BAC rejects the rule and does not file it for adoption. Nancy Murphy is a research associate at the Office of the Attorney General. With regard to rules and rule promulgation, Ms. Murphy drafts the documents necessary for rule- making, including notices of rule development, notices of rule- making, supporting documents that have to be supplied to JAPC and any documents that have to be prepared for adoption of rule. Prior to filing a rule for adoption, Ms. Murphy verifies that the time frames are correct and she has all the documents that are required for adoption, including the certificate, the additional statement, and the correct copy of the rule text and coded copy, which is the underlined and struck- through version of the rule. Ms. Murphy also determines whether the rule is subject to challenge before it is filed, and if JAPC has received a written response to all correspondence. Ms. Murphy was responsible for filing the amendments to Rule 64B8-0.009 for adoption. In determining which portions of the rule could be filed and which remained under challenge, she reviewed the Joint Stipulation and the Hospitals' Notice of Partial Voluntary Dismissal in DOAH Case Nos. 99-2974 and 99- 2975. Ms. Murphy redrafted and renumbered the proposed amendments to Rule 64B8-9.009 to be filed for adoption, excluding the sections that were still under challenge, after consultation from Ms. Cloud's office. Ms. Murphy also met with Vicky Macintosh at the BAC to review the Rule section-by-section before filing. Ms. Murphy provided a copy of the Joint Stipulation and Notice of Partial Voluntary Dismissal to establish the provisions of the Rule still under challenge. Murphy also consulted with JAPC prior to filing the amendments to Rule 64B8-9.009 for adoption. The BAC's standard operating procedure with regard to a rule challenge that challenges only a portion of a proposed rule is to accept for filing the unchallenged portions of the rule. This procedure has been strictly followed in the past, and approved by the BAC's counsel. Pursuant to that policy, the BAC permitted the Board to file for adoption those portions of Rule 64B8-9.009 not subject to challenge on January 28, 2000. The BAC received a certification from JAPC that permitted the filing of Rule 64B8-9.009 pursuant to Section 120.54(3), Florida Statutes. Based upon the evidence presented, it is concluded that, although the Board had considered amendments to Sections (3)(b) and (4)(b) involving transfer agreements and Level III staff privilege requirements, they were withdrawn and no longer subject to the pending litigation in DOAH Case Nos 99-2974 and 99-2975 after the Board agreed to make no change. Petitioners have not met their burden of proving that the Board materially failed to follow the rule-making procedures and requirements of Chapter 120, Florida Statutes. Record-Keeping Requirements: Subsection (2) Petitioners presented no evidence with regard to the record-keeping requirements or the cost of the record-keeping requirements imposed by Rule 64B8-9.009(2). Accordingly, Petitioners have not met their burden of proof in challenging this subsection of the rule. Limitation on Types and Duration of Procedures: Subsections (2)(d), (3), (4), (5), and (6) Subsection (2)(d) of Rule 64B8-9.009 states: In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000 cc supernatant fat may be removed by liposuction in the office setting. A maximum of 50 mg/kg of Lidocaine can be injected in the office setting. Petitioners claim that a limitation of 4000 cc on liposuction is arbitrary and unreasonable since a physician cannot accurately estimate the amount of fat to be taken out. Notwithstanding, Petitioners' witnesses acknowledged that the risk of a liposuction procedure is heightened as the volume of fat removed and the level of anesthesia increase. Petitioners' Exhibit 8, a journal article entitled "Does the Location of the Surgery of the Specialty of the Physician Affect Malpractice Claims in Liposuction?" supports this view. It states: "Large-volume liposuction (over 4000 cc) is inherently risky, but it also involves more aggressive anesthesia, adding to its danger. Risk management for liposuction should stress smaller liposuction procedures using local anesthesia, with minimal sedation." Petitioners' Exhibit 8 also includes the "2000 Guidelines for Liposuction Surgery" of the American Academy of Cosmetic Surgery. Those guidelines recommend volumes of up to 4000 cc of supernatant fat removal in the routine liposuction process. The Board received extensive testimony and information regarding the limitation of removal of tissue in office-based surgery as part of its rule-making process. In setting the volume limit for liposuction, the Board considered the amount of material removed, the Lidocane dosage required, and fluid replaced. The Board considered testimony supporting no limit on liposuction volume, and testimony supporting limitations on volumes as low as 2000 cc. The Board determined that the consensus among experts around the country is that 4000 cc is the appropriate ceiling to ensure the safety of patients undergoing liposuction procedures in the office environment. This conclusion is reasonable and amply supported by the rule-making record. Petitioners presented no evidence at hearing regarding other limitations on types or duration of procedures relating to Subsections (3), (4), (5), or (6) of Rule 64B8-9.009. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Equipment Requirements: Subsections (4)(e) and (6)(e) Petitioners presented no evidence at hearing regarding the equipment requirements of subsection (4)(e) of Rule 64B8- 9.009, or the cost thereof. Accordingly, they have not met their burden of proof with respect to these provisions. With regard to Subsection (6)(e) of Rule 64B8-9.009, the only evidence presented by Petitioners at hearing related to the requirement that at least 36 ampules of Dantrolene be available on-site at a physician's office where Level III Office Surgery is being performed. Petitioners claim that the requirement in subsection (6)(e) for 36 ampules of Dantrolene is unreasonable. The cost of 36 ampules of Dantrolene can be as much as $2,000.00 and the shelf-life of Dantrolene is approximately one to two years. The evidence presented at hearing indicated that the manufacturer of Dantrolene will replace it for free if the shelf- life expires, and therefore, shelf-life of Dantrolene is not an economic consideration. The manufacturer of Dantrolene advises that 36 ampules of Dantrolene are necessary to ensure that a patient suffering from malignant hypothermia can be saved. The more persuasive evidence supports the Board's decision to impose a requirement consistent with this recommendation. Personnel Requirements: Subsections (4)(f), (5)(b)2., and (6)(f) Petitioners presented insufficient evidence regarding the cost of additional personnel required by Subsections (4)(f), (5)(b)2, or (6)(f) of the existing Rule. Accordingly, Petitioners have not met their burden of proof with respect to their challenge to these provisions. Petitioners did, however, present some general testimony with regard to Subsection (4)(f) of Rule 64B8-9.009. The evidence was insufficient, however, to prove that Subsection (4)(f) is invalid. That Subsection states: Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in Rule 64B8-30.012(b)(6), Florida Administrative Code, or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advance Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. Petitioners have not presented any persuasive evidence that this requirement is vague, arbitrary, or unreasonable. Evidence was presented that during meetings of the FACS, Dr. Anthony Rogers has held courses in conscious sedation to train non-anesthesiologist physicians to be providers of anesthesia for Level II Office Surgery. Dr. Rogers testified that he does not instruct surgeons on administering anesthesia to patients upon which the surgeons are performing surgery. Rather, he trains the surgeons to serve as anesthesia providers for other surgeons as well as providing them with a better understanding of "what's happening on the other side of the table." The training given by Dr. Rogers consists of approximately six to eight hours of staged administration of anesthesia and discussion of hypothetical scenarios. The training does not involve the actual administration of anesthesia by the physicians-in-training. Physicians attending Dr. Rogers' training course are not required to be certified in Advance Cardiac Life Support. No examination is administered as part of Dr. Rogers' training course, and no certification is issued for completion. Even assuming that some FACS members have completed Dr. Rogers' course, the requirement in Subsection (4)(f) for assistance by a qualified anesthesia provider has not been shown to be unreasonable. Levels of Surgery: Subsections (4), (5), and (6) Petitioners contend that the definitions of the various levels of surgeries provided in the Rule are impermissibly vague. Subsection (4) of Rule 64B8-9.009 defines Level I Office Surgery to include: Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in Level I Office Surgery. Subsection (5) of Rule 64B8-9.009 defines Level II Office Surgery 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, hemmorroidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000 cc 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 reflect withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Subsection (6) of Rule 64B8-9.009 defines Level III office surgery as follows: Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II office surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or Major Conduction anesthesia. The definitions of the three levels of office surgery are based on definitions developed by the American Society of Anesthesiologists and have been adopted in substantially similar form in other states. The American Society of Anesthesiologists is recognized as a group of specialists in anesthesia. Petitioners acknowledged the expertise of the American Society of Anesthesiologists in developing definitions of levels of office surgery. Petitioners argued that the classifications of levels of surgery in the Rule are irrational and vague because it is virtually impossible to differentiate between the various levels of surgery as defined in the Rule. However, the more persuasive evidence establishes that classifications were reasonably based on accepted medical standards. In discussing the potential for a particular patient to drift between what has been defined as Level II anesthesia and Level III, Petitioners' witness, Dr. Rogers testified that medicine itself is vague in this area because there is no machine to tell you if a patient is unconscious. He suggested that anesthesia is a continuum and there is no clear way to define levels of surgery. Dr. Carl Lentz, Board-certified plastic surgeon, supported the Rule's classification scheme. In his opinion, the differences between Levels II and III are clearly understood. When preparing for surgery, a surgeon develops an anesthesia plan. The procedures are distinctly different for each level. If, during surgery, a patient temporarily crosses the line of consciousness, which is apparent if the patient is appropriately monitored, actions to reverse the level can be taken quickly. According to Lentz, if a surgeon does not determine, prior to surgery, the level of anesthesia to be provided, the surgeon should not be performing the surgery. Petitioners complain that the terms "appropriate," "adequate," and "unpleasant" are vague. Although the Petition identifies no other specific terms that are vague, during the hearing, Dr. Graper suggested that numerous other terms contained in Rule 64B8-9.009 are vague, including, "preoperative," "medication," "minimal," "tranquilization,," "anesthesia," "local," "drug-induced," "consciousness," "sedation," "intravenously," "intra-operative," "monitoring," "necessary," "procedures," "hernia repair"," "reduction of simple fractures," "large joint dislocation," "colonoscopy," "tolerate," "cardiorespiratory function," and "ability to respond purposefully." His testimony related to vagueness was unpersuasive and not supported by the evidence. After reviewing the rule and considering the evidence, it is concluded that the Rule requirements are not unacceptably vague. The terms "adequate," "appropriate" and "purposeful" have standard meanings in the field of medicine. Likewise, the remaining medical terms in the rule are not unacceptably vague. Transfer Agreements and Staff Privileges: Subsections (4)(b) and (6)(b) Petitioners contend that the transfer agreement and staff privilege requirements found in the rule are vague, fail to establish adequate standards for agency decisions, vest unbridled discretion in the agency, enlarge modify and contravene the law, are arbitrary and capricious and not supported by competent substantial evidence. According to Subsection 455.517(4)(a), Florida Statutes, neither the Department of Health, nor the Board of Medicine may take any action: . . . that tends to create or maintain an economic condition that unreasonably restricts competition, except as provided by law. However, Subsection 458.331(1)(v), Florida Statutes, provides that the Board of Medicine may establish rule standards of practice for office surgery settings, including transfer agreements, in order for the Board to determine whether a licensed doctor, subject to discipline, has practiced beyond the scope of the law or beyond his competency level. Subsection (4)(b) of Rule 64B8-9.009, relating to Level II Office Surgery, states: Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. Subsection (6)(b) of Rule 64B8-9.009, relating to Level III Office Surgery, states; Hospital Staff Privileges Required. The physician must have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. There is no transfer agreement or hospital privileges requirement for Level I Office Surgery. Historically, surgeries were typically performed in hospitals, and a large body of regulation has developed to ensure patient safety. As many types of surgeries moved into ambulatory surgical centers, a new body of regulation was developed to ensure health and safety in that setting. Over the past few years, surgeons have increasingly been performing many types of surgeries in office settings with varying degrees of regulation. Among the regulations ensuring safety in hospitals are requirements for an organized medical staff, and staff-developed rules to set criteria for appointment to the staff and delineation of staff privileges. These rules promote quality of care by providing a review of the qualifications of staff physicians. Decisions regarding medical staff privileges are a function of the medical staff of a hospital with support and final approval by the Board of Trustees. Often, national standards and demonstrated competence provide a guide in making medical staff privilege decisions. The medical staff credentialing process is a well-established, but at times, subjective mechanism for evaluating the qualifications of a physician. A transfer agreement is a contract between a hospital and an office surgeon, providing for the transfer and acceptance of a patient in an emergency situation. There is no law or regulation which requires a hospital to enter into a transfer agreement with any physician. In addition, there is neither specific nor consistent criteria for the contents of a transfer agreement. Some agreements are very detailed contracts and others are general. During the rule-making process, the Board received testimony regarding surgeons performing Level II as well as Level III Office Surgeries and the requirement of staff privileges and transfer agreements. The Board's stated purpose for the Rule requiring a physician to enter into a transfer agreement is to ensure that steps are taken in advance to care for a patient who experiences a complication during surgery which exceeds the level of care that can be provided in a given facility. However, there is no reliable evidence that transfer agreements improve the quality of patient care. In the rare event an emergency occurs in the office surgery setting, the emergency 911 is called and the patient is delivered to the hospital. The absence of a transfer agreement between the hospital and office surgeon does not delay or impede the patient's admission to the hospital and access to appropriate medical care. Under Florida law, a hospital is required to accept and care for a patient who requires emergency medical attention. At the hearing, Petitioners provided significant testimony demonstrating they have been unable to obtain staff privileges and transfer agreements from certain hospitals. The determination of whether to grant staff privileges and/or a transfer agreement is solely the hospital's decision. And the evidence demonstrated that the determination doesn't always depend on the qualifications and reputation of the physician and the resources and circumstances of the hospital. It is undisputed that hospital privileges and transfer agreements may be denied (or revoked) for reasons other than physician competence. The standards for obtaining privileges vary from hospital to hospital. In fact, during the rule-making proceeding, the Board initially approved a change in Level III office surgery to remove the requirement that the surgeon have staff privileges, and recognized that: Hospital staff privileges may be denied for reasons other than competency, and that other documented training is comparable demonstration of competency. Factors other than physician competence enter into the decision of whether hospital privileges or transfer agreements may be approved. For example, turf battles at hospitals and personality conflicts among physicians at hospitals have been considered. Moreover, some physicians have refused to proctor other physicians as a part of the credentialling process. In fact, in some hospitals, competing physicians vote upon the approval or denial of the application of an office surgeon's request for hospital privileges. The evidence further showed that a physician's staff privileges can be approved by the medical staff but denied by the board of the competing hospital. Physician competence to perform Level II office surgery procedures is determined by Subsection (4)(d) of the Rule, "Training Required." Under this provision, in order to perform Level II surgery, the surgeon must either have staff privileges for the same procedure, or must be able to document satisfactory completion of training, or must document comparable background training or experience. Nevertheless, a competent office physician who possesses the "training required" to perform an office surgery procedure is precluded unless the physician has received either a transfer agreement or hospital privileges for that procedure. The inability of a qualified office surgeon to secure a transfer agreement or hospital privileges will have a drastic impact on the physician's ability to perform office surgery. The physician's office surgery will be limited to Level I office surgery. The Rule's requirements for either a transfer agreement or hospital privileges for Level II surgeries and hospital privileges for Level III surgeries unreasonably enable a competing hospital to unilaterally refuse a transfer agreement and privileges to a qualified office surgeon for reasons unrelated to physician competence. It has the direct effect of terminating a physician's Level II and Level III office surgery practice, without regard to the fact that the physician otherwise meets the "training required" elements of the Rule. It is inconsistent, provides no objective, non-competitive based criteria evaluation and tends to create and maintain an economic condition that unreasonably restricts competition which is inconsistent with and contravenes Section 455.507, Florida Statutes. Barbara Dame (Dame), who is a risk management consultant provided further support. She testified that over the last two years, many of her very qualified physician clients have had applications for transfer agreements summarily denied. Ms. Dame does not get involved in obtaining hospital staff privileges for her clients. Conversely, Bill Bell, General Counsel for the FHA, testified that the Rule requirement for physicians performing office-based surgery to have transfer agreements has existed for a few years and he is not aware of any problems physicians have had obtaining such agreements. The evidence to the contrary is more compelling. Transfer agreements can be a tool for some hospitals to control competition for surgery sites. Office surgery sites compete with hospitals for patients. Dr. Brent Amey is the Vice President of St. Joseph's Baptist Health Care, and has been an emergency room physician since 1974. He is aware of instances involving "economic credentialing", and the denial of transfer agreements and staff privileges unrelated to competence, although not at hospitals with which he has been associated.
