The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon allegations that he violated Sections 456.072(1)(bb), and 458.331(1)(t), Florida Statutes (2003), in the care and treatment of Patient H.J.?
Findings Of Fact Stipulated Facts Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME: 65565. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes. On or about July 21, 2003, the Respondent performed peritoneal dialysis catheter removal on Patient H.J. at Bay Medical Center (Bay Medical). Peritoneal dialysis is a technique that uses the patient's own body tissues inside of the abdominal cavity to act as a filter. On or about August 25, 2003, Patient H.J. presented with erythema (a redness of the skin resulting from inflammation) and induration (localized hardening of soft tissue of the body) in the area where the peritoneal dialysis catheter had been removed. On or about December 3, 2003, the Respondent performed exploratory surgery of Patient H.J.'s wound. Additional Facts Patient H.J. suffers from end-stage kidney failure, diabetes and heart disease. Dr. Ahmad Oussama Refai treated Patient H.J. for his kidney failure. Dr. Refai is a board- certified Nephrologist. Dr. Refai referred Patient H.J. for placement of a peritoneal dialysis catheter (catheter) to address the end-stage kidney failure. The catheter, as Dr. Refai describes it, was intended to remove the poisonous material in the blood of Patient H.J. By using the catheter clean fluid is introduced into the abdomen where it remains for a period of about four hours. The fluid introduced contains electrolytes put in the patient's blood stream. After the residence time for the fluid expires, the fluid is withdrawn through the catheter removing the harmful material. The patient, once instructed, is capable of performing the procedures described. The other option in performing this method of dialysis is to use a device that is employed at nighttime called a cycler, used while the patient is asleep and without the need for the patient to conduct the process. The patient's use of the catheter for dialysis is referred to as "home dialysis." Before Dr. Refai referred the patient to Respondent to place the catheter, the patient had been treated for his end- stage renal disease through a forearm AV graph to provide hemodialysis. That technique allows access to the patient's blood through a shunt, with the blood being run through a machine and cleansed and returned back to the patient. This procedure is done several times a week at out-patient centers, whereas the peritoneal dialysis is done daily by the patient or at night. On June 30, 2000, Respondent saw Patient H.J. and determined that the patient was a good candidate for the surgery necessary to place the catheter to perform peritoneal dialysis. On July 19, 2000, Respondent placed the catheter and peritoneal dialysis treatment was commenced. Following the placement the catheter was used by the patient as overseen by the Dr. Refai. As Dr. Refai describes it, the catheter is a silestic tube that has two cuffs. The cuff at the lower level sits on the fascia where it is secured and the other cuff is just under the skin or in the subcutaneous tissue. Dr. Refai describes the cuffs as fuzzy. The cuffs are expected to induce an inflammatory process promoting scarring so that the body forms tissue to hold the catheter in place. Dr. Refai calls this a bond. Dr. Refai explains that the other parts of the catheter are "slippery." It is the fuzzy part that holds the catheter in place. Petitioner's Exhibit No. 5 is an unused catheter similar in design to that placed in Patient H.J. On July 7, 2003, Respondent, Dr. Refai, and a Dr. Dean discussed Patient H.J. and the plan to remove the catheter that was no longer adequately performing the dialysis. On July 21, 2003, Respondent did surgery to remove the catheter from Patient H.J. On July 17, 2003, before Respondent did the surgery to remove the catheter, an explanation was made to Patient H.J. of the risks associated with the surgery as to bleeding, infection, MI stroke, death, and allergic reaction following removal of the catheter. Following the surgery Dr. Refai as the treating physician was aware that the wound associated with the surgery was not healing well and Dr. Refai sent Patient H.J. back to Respondent. Dr. Refai is familiar with the course of antibiotics prescribed for Patient H.J. to respond to the condition and the surgical exploration done by Respondent where a piece of cuff, as Dr. Refai describes it, was removed and the wound healed. December 3, 2003, was the date of the exploratory surgery. At that time, Patient H.J. was on hemo-dialysis and was being seen by Dr. Refai once a week. In Dr. Refai's opinion Patient H.J. was doing remarkably well, making allowances for his underlying condition (illnesses). At present Dr. Refai is aware that the patient is on the list to receive a kidney transplant. On August 1, 2003, Respondent saw Patient H.J. In his notes Respondent stated: His wounds look good. There is no evidence of infection. No fever or chills. He looks well. He is not taking any pain medicine. I am going to see him back in a month for a final visit. On August 25, 2003, Respondent saw Patient H.J. again. The Respondent's notes stated: His p.d. catheter removal site which was removed 4 weeks ago has some erythema and induration around it. I ultrasounded it here in the office and it looked like there was a little fluid. I anesthetized the area and opened it. There was no gross pus. I am going ahead and treat [sic] him with some Keflex and have him see Dr. Beaver on Friday as I am going to be out of town. This may come to a head and become an abscess. It may just be some cellulitis. I am not real sure why he would have cellulites as it certainly did not look like a hernia. I am going to have him see Dr. Beaver on Friday and make sure it is improving. On August 29, 2003, a note was made by Dr. Beaver concerning his visit with Patient H.J. In that note Dr. Beaver said: Patient of Dr. Kinsey. He was seen back for re-check. Apparently he was having some questionable cellulites around his p.d. cath today. He states that he is feeling much better. On examination, I see no redness at all and per the office assistance it has much improved. There is really not tender [sic]. It looks to me like it is improving. We will plan for him to see Dr. Kinsey back next week. On September 12, 2003, Respondent saw Patient H.J. and in the office note stated: The area in his left lower quadrant is completely healed. He is doing well. I am going to see him back in one month for a final visit. On September 16, 2003, Respondent saw Patient H.J. again and in the office note stated: He had some drainage from his previous p.d. catheter site. It does not appear to be infected. I am going to follow this area and see him in the office in a month. On September 30, 2003, Respondent saw Patient H.J. again and in the office note it states: He still has some drainage from the p.d. catheter exit site [sic] it was done about eight weeks ago. I told him that I would like to leave that along [sic] for at least three months and follow that. If it does not improve after three to four months then we may need to explore the wound but it may be a piece of suture that it [sic] trying to spit. We will see him back in the office in about 6 to 8 weeks. On November 11, 2003, Respondent saw Patient H.J. and noted: He is still draining from his p.d. catheter exit site. This has been 5 months. It is time to explore the wound. We will proceed to the operating room for exploration in the sinus tract. I suspect that there will be a piece of the catheter in the bottom of the wound. On December 1, 2003 Respondent saw Patient H.J. for the pre-operative visit. At that time he noted: He is here for a pre-op for a wound exploration for his p.d. catheter removal site. He still has some granulation tissue there. I am going to plan to probe the area and evaluate where the sinus goes. On December 3, 2003, the surgery was conducted on Patient H.J. and Respondent noted: He underwent a left lower quadrant wound exploration. The p.d. catheter cuff was within the subcutaneous tissue and that is why his wound [sic] not close. This was removed and then the would [sic] was closed. He tolerated the procedure well. The various surgeries that have been discussed which were performed by Respondent took place at Bay Medical in Panama City, Florida. In the operative procedure report at the hospital related to the December 3, 2003 exploratory operation Respondent described a pre-operative diagnosis as: Non-healing wound, left lower quadrant of the abdomen. The post-operative diagnosis stated: Non-healing wound, left lower quadrant of the abdomen. Foreign body (peritoneal dialysis catheter cuff), left lower quadrant abdominal wound. The procedure performed was described as: Wound exploration and foreign body removal. The intra-operative findings related to the operation were: He was found to have a cuff of the catheter within the tissue. He had a small piece of p.d. catheter attached to it. The cuff had obviously broken. The catheter was broken with a cuff remaining in the subcu tissue. There was no intra-abdominal portion. In comparison, on July 21, 2003, in the operative/procedure report at Bay Medical through the description of the procedure to remove the catheter Respondent stated: . . . The previous incision in the left hypogastric area was anesthetized with local anesthetic and sharply incised. This was carried into the subcutaneous tissue and p.d.-catheter dissected and divided. The catheter was then pulled from the subcutaneous tissue at the exit site. The catheter was then delivered into the wound and abdominal wall cuff sharply incised and the catheter removed. The fascial edges were then reapproximated with 2 figure-of-eight0- vicryl sutures. On July 21, 2003, when Respondent removed the catheter from Patient H.J. no pathology was ordered. On December 3, 2003, following the exploratory surgery and retrieval of the catheter pathology was ordered. Daniel G. Dena was the pathologist at Bay Medical who addressed the specimen which was described by the pathologist as: "Tissue-p.d. catheter cuff" The anatomic diagnosis referred stated: "p.d. catheter cuff: plastic catheter, with attached fibro-fatty tissue at one end, showing acute and chronic inflammation." The macroscopic examination in the pathology report stated: "The specimen is labeled 'pd catheter cuff'. Received is a portion of plastic tubing measuring approximately 5 cm in length and up to 0.5 cm in diameter, with a cuff of soft tissue at one end measuring 2.5 cm in length and 1.2 cm in diameter." On July 26, 2004, in responding to the investigation that led to this prosecution Respondent stated in writing in relation to Patient H.J.: The original peritoneal dialysis catheter removal had gone uneventfully and I felt that both cuffs of the catheter had been removed in their entirety. But this was found not to be the case. I have placed a number of these catheters and removed a number as well and have not had this type of problem before. Visual inspection of the catheter on removal is routinely undertaken to ensure that the cuffs are removed and I felt that this had been completely removed but I was obviously mistaken. I am not sure if this was a defect in the catheter. Evaluation of the catheter and assurance of complete cuff removal would have probably prevented this process. I am certainly more cognizant of this being a problem in subsequent catheters that I have removed. At the original time of catheter removal the operative site appeared appropriate. At hearing Respondent offered additional explanation concerning the July 21, 2003 operation to remove the catheter from Patient H.J. and the exploratory surgery on December 3, 2003. As Respondent explained, in the July 21, 2003 surgery Respondent made a 3-to-4 cm incision about the belly button towards the middle of the abdomen through the skin, subcutaneous tissue, the fascial layer and muscle and peritoneal layer. The peritoneal layer is a semi-permeable membrane that waste products removed in the dialysis will cross. The catheter is placed into the abdomen. The catheter is 12 to 14 inches in length with a curlicue tail and holes in the end of the catheter that allows the fluids to be introduced and withdrawn from the abdomen. As Respondent explained the catheter has two cuffs, the smaller of which is designed for placement in the rectus muscle located along the inset part of the abdomen. The smaller cuff sits inside that muscle. Tissue attaches to that cuff to keep fluid from leaking out, to keep the catheter in place and to prevent bacteria from going down the outside of the catheter. There is a segment of the catheter between that cuff and a larger cuff which sits underneath the skin in the subcutaneous tissue. The tissue in that area attaches to the cuff and serves to hold the catheter in place. When removing the catheter on July 21, 2003, Respondent used an incision of about 3 cm and encountered the mid-portion of the catheter located between the two cuffs which was dissected down through the fascia and taken out with the portion in the abdomen being removed first. Before making the incision to remove the catheter, Respondent cut the portion of the catheter outside the body of Patient H.J. off, including the metal and plastic valves and other paraphernalia hanging out of the patient. The purpose of removing the catheter outside the patient's body was in the interest of protecting the surgical field from contamination to avoid wound infection. The part removed inside the patient initially was the intra-abdominal portion. The intra-abdominal portion of the catheter, including the cuff in that area was sharply removed. The cuff was 2 or 3 times the size that it would have been when first placed and the part around the cuff was cut to allow the catheter to be extracted. The area of the fascia was closed. Next Respondent addressed the subcutaneous portion of the catheter by following it out and sharply cutting the tissue around the catheter and the subcutaneous cuff with scissors to remove that portion which also had an ingrowth of scar and fibroblastic tissue. Once the portions of the catheter with the cuffs, had been removed Respondent looked to determine if he had both cuffs which appeared at that time as a wad of scar and tissue. Respondent then closed the wound. Respondent believed that he had removed the whole catheter, to include the cuffs. In fact the subcutaneous cuff was not entirely removed and another portion of the catheter remained in the patient following the July 21, 2003 surgery. Respondent's estimate of what had been left in the patient and removed on December 3, 2003, was about 2 cm of the subcutaneous cuff and then a portion of the balance of the catheter. In commenting on the difference between the pathology report and his visual assessment on December 3, 2003, Respondent remarked about "all the stuff" grown onto the cuff and catheter. He also said it had a lot of specimen, taken to mean the "stuff" attached to the cuff and catheter. Although in the operative notes from December 3, 2003, Respondent says the catheter broke, at hearing he stated that he did not know whether the catheter had been cut or broke during the July 21, 2003 procedure to remove the catheter. No independent tests were conducted to determine whether the catheter broke during the July 21, 2003 surgery or was cut by Respondent. Respondent does not precisely remember the appearance of the catheter, to include the cuffs, when examining it on July 21, 2003. But he believed that he had successfully removed the entire catheter. In his testimony Respondent describes the office visits subsequent to the July 21, 2003 surgery. When he saw Patient H.J. he observed cellulitis around the area of the incision which was treated with oral antibiotics and resolved. Respondent used ultrasound to determine whether fluid had collected in the area where he observed the cellulitis. No fluid collection was seen. Drainage was noticed around the exit site where the catheter came out of the skin, which ordinarily takes a month to six weeks to heal. Concerning the drainage around this exit site, Respondent expected the drainage to resolve within around five weeks unless there were a piece of suture or other kind of event keeping the site opened and draining. The wound site where the incision was made healed without incident. The exit site continued to drain. After a time Respondent concluded that the reason for the drainage was either an epithelilized sinus tract, a piece of suture, a piece of catheter, a piece of cuff, or a piece of dressing for the wound. Respondent waited a time before doing the exploratory surgery in view of the use of an absorbable suture in the July 21, 2003 surgery which would have dissolved over time, precluding the need to do the exploration. Respondent, given the problem with the drainage from Patient H.J. following the July 21, 2003 surgery to remove the catheter, does not believe that the failure to remove this fragment would have killed the patient or have caused a lot of problems, but it was bothersome enough that it was worth the effort to try and find it and get the patient healed. Respondent in dictating his post-operative note on December 3, 2003, thinks that the catheter had broken and continues to hold to that belief, although he recognizes that it may have been cut in the prior surgery. Concerning his practice at Bay Medical, Respondent did not routinely have an X-ray done for patients undergoing surgery without a more specific reason for ordering it. Nor did he order a pathology examination following surgery absent the need for specific information. Patient H.J. in his testimony described the level of pain following the July 21, 2003 surgery to remove the catheter as "a little pain." Expert Opinion Dr. Stanley P. Kococki is a general surgeon licensed in Florida. He is board-certified in general surgery. He has had experience placing and removing peritoneal dialysis catheters. He was qualified to offer expert opinion testimony concerning Respondent's treatment of Patient H.J., in particular, the surgery performed July 21, 2003. Dr. Kococki expressed the opinion that the Respondent fell below the standard of care in treating Patient H.J., in that Respondent failed to recognize that he had left a portion of the catheter in the patient, which Dr. Kococki describes as a retained foreign body and that this caused the patient to undergo a second unnecessary procedure, meaning that the second procedure would not have been necessary if the catheter had been removed completely in the first surgery. The failure to remove could possibly have caused serious problems for the patient, to include septicemia and death, according to Dr. Kococki. Dr. Kococki refers to the Respondent's obligation in removing the catheter, to make certain that the whole catheter was removed and that the wound properly healed beyond that point so that the patient would not experience problems. While recognizing that there are different techniques for removing the catheter from Patient H.J., Dr. Kococki took issue with the method employed by the Respondent. Dr. Kococki believes that there are other methods for avoiding the problem with infection than to cut the catheter outside the body. There was no description of the use of a hemostat or clamps to hold the retained part of the catheter once the outside segment had been cut, so that the remaining portion of the catheter would not be lost under the skin. In addition, by cutting the catheter in two places there was a chance of leaving a piece of the catheter in the patient. Dr. Kococki expressed the opinion that when you cut the catheter in several places you have to remember where the pieces of the catheter are left in the patient. Given other circumstances during the surgery that occupy the surgeon's mind, it can lead to leaving a piece of catheter behind. Dr. Kococki expressed the opinion that leaving the catheter behind was not in the best interest of the patient because it led to subsequent surgery and had the sinus tract closed over the foreign body would have caused a localized infection and abscess formation around that area and possibly allowed for the bacteria from the abscess to enter the patient's bloodstream causing sepsis, and abscess formation in other organs, possibly the abdominal cavity, with a possible rupture intra-abdominally causing the patient to have generalized peritonitis. That can be life threatening and ultimately lethal. It is more of a problem with the person that has end-stage renal failure, in that the patient has a weakened immune system and lessened prospects to fight off infection. Dr. Kococki relied upon the pathology report made after the December 3, 2003 surgery to accurately describe the size of the segment that was left in the patient. In order to ascertain what actually happened with the catheter Dr. Kococki believes that the company or an independent examining body would have to determine if the catheter was defective. Even in the instance where the catheter may have broken in the initial surgery to remove it on July 21, 2003, the onus is still on the surgeon removing the catheter to examine it to make certain it was removed intact. Dr. Kococki characterizes the catheter as commonly present and utilized in surgical procedures to place and remove peritoneal dialysis catheters. Dr. Kococki describes the catheter as a medical device, unlike a sponge, forceps, clamp or surgical needle. Dr. Kococki recognizes that the purpose of the catheter is to perform dialysis but the retained portion left after the initial surgery to remove the catheter does not have a medical purpose, in his judgment. Dr. Kococki describes the cuff in the field related to the abdominal wall as providing a seal to avoid bacteria. The cuff as he understands it has an antibiotic coating that will help fight off infection. The cuff reacts with the patient's body tissue to act as a sealant. To have avoided the problem of failing to account for a portion of the catheter during the initial surgery to remove it from Patient H.J., Dr. Kococki believes that the easiest thing to have done was while the patient was in the operating room send the catheter to a pathologist and have it measured for comparison against the known size of the catheter when first placed. A second safe-guard would be to use a portable X-ray of the abdominal cavity to make sure that there was no radiopaque material in the abdomen or subcutaneous tissue. The catheter has radiopaque material allowing this identification in Dr. Kococki's understanding. Dr. Kococki was not familiar with the procedures at Bay Medical where the catheter removal from Patient H.J. was performed. The bylaws of the institution do not require that the catheter be sent to pathology following removal. Dr. Thomas A. Gadacz testified in the interest of Respondent. He is licensed in several states. He is not licensed in Florida. He is an expert in the field of general surgery. He has placed and removed peritoneal dialysis catheters. Dr. Gadacz describes the catheter as a medical device. It has nothing in common with a sponge, forceps, clamp or surgical needle, in his opinion. As a surgeon Dr. Gadacz refers to sponges, forceps, clamps and surgical needles as items whose sole purpose is to assist during an operation, not intended to be left in the body. They are to facilitate an operation to provide exposure, to conduct the operation but they are not a therapeutic modality. By contrast the peritoneal dialysis catheter is used primarily for therapy by remaining in the patient for specified periods of time to treat the patient. Other aids in performing an operation are cotton balls called kitners, metal retractors and cannulas. Dr. Gadacz explains that the purpose of the cuffs related to the catheter is to react to the body so that tissue grows around them. The other part of the catheter made of Teflon is designed to be non-reactive. Dr. Gadacz is aware that catheters of the type under discussion have fractured or broken. Dr. Gadacz explained that the fracture of a cuff is not common. In his experience, in the instance where a segment broke in a catheter, Dr. Gadacz removed it. On the other hand the failure to remove the piece is not necessarily below the standard of care as Dr. Gadacz explains, "because some times this happens, and its, you don't know that that has happened." The possibility of knowing that the segment broke off is difficult. As Dr. Gadacz describes, it was impossible given the tract involved with the surgery here. The gross inspection of the catheter once removed from the patient is a process in which it is difficult to make certain that both cuffs are there because of the encrusting fibrous tissue found after removing the cuffs, causing the cuffs to no longer have the same appearance as when first placed. The visual inspection made of the catheter after removal would not necessarily reveal whether it was removed in its entirety, according to Dr. Gadacz. Dr. Gadacz is unfamiliar with surgeons who would use an X-ray after removal of the catheter to confirm that the entire catheter had been removed. Instead he defers to Respondent's operative note on December 3, 2003, where the Respondent says that the catheter had obviously broken to explain the failure to retrieve the catheter. Dr. Gadacz does not believe sending the catheter to pathology after it was removed on July 21, 2003, would necessarily have been useful because it would take familiarity on the part of the pathologist with that form of catheter to recognize that a part was missing. Dr. Gadacz recognizes that the fragment from the catheter left in Patient H.J. at the end of the initial surgery to remove the catheter is medically considered a foreign body because it was not part of the human body. Dr. Gadacz found nothing in the care provided by Respondent by to Patient H.J. after the July 21, 2003 surgery that was questionable. Dr. Gadacz did not find the technique Respondent used in removing the catheter on July 21, 2003, from the Patient H.J. to be below the standard of care. Generally Dr. Gadacz did not express the opinion that Respondent practiced below the standard of care. Dr. Gadacz explained that had the segment continued to be present in the patient there would have been a major risk of continuing infection and ultimately the patient could have developed a serious abscess in the subcutaneous tissue that could become life-threatening or nothing may have happened, and the segment may have been walled off by the patient's body. In determining the comparability of what is described in Section 456.072(1)(bb), Florida Statutes (2003), as "other paraphernalia," to those items listed within that section, "such as a sponge, clamp, forceps, surgical needle," that are "used in surgical examination, or other diagnostic procedures," reliance is made upon testimony from Dr. Gadacz. As a surgeon, the opinion by Dr. Kococki is rejected for reasons that will be explained in the conclusions of law. When considering whether Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, as envisioned by Section 458.331(1)(t), Florida Statutes (2003), with the specificity called for in that provision, Dr. Kococki is more compelling in his opinion that the fragment left in Patient H.J. should have been removed in the earlier operation whether it broke or was cut by Respondent. The notion that there are times when some portion of the catheter may have been left in the patient, as was the case here, with no consequences to the practitioner, as expressed by Dr. Gadacz is not persuasive. Disciplinary History The Respondent has no prior disciplinary history.
Recommendation Based upon the findings of fact, and conclusions of law, and the guidance set forth in Florida Administrative Code Rule 64B8- 8.001, it is RECOMMENDED: That a final order be entered finding that Respondent did not violate Section 456.072(1)(bb), Florida Statutes (2003); that Respondent did violate Section 458.331(1)(t), Florida Statutes (2003); placing Respondent on probation for two years; imposing an administrative fine in the amount of $2,500.00; requiring Respondent to perform 50 hours of community service; requiring the completion of 5 hours of continuing medical education on "risk management" and requiring him to present a one-hour lecture to a group of peers discussing retention of foreign bodies in surgeries and techniques to avoid the retention. DONE AND ENTERED this 14th day of February, 2006, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 14th day of February, 2006. COPIES FURNISHED: William F. Miller Ephraim D. Livingston Assistants General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether the Respondent committed the acts alleged in the administrative complaint contrary to Section 458.331(1)(t), Florida Statutes.
Findings Of Fact (Stipulated) The Respondent is and was at all times material to the allegations a licensed physician in Florida, holding license number ME 0050839 issued by the state. The Respondent was a board certified internist and board certified cardiologist practicing with Diagnostic Cardiology Associates at St. Vincent's Medical Center (St. Vincent's) at the time of the events which gave rise to these allegations. On or about June 25, 1988, W.V., referred to in the complaint as Patient #1, was admitted to St. Augustine General Hospital in St. Augustine, Florida. W.V. was a 68 year old male with a history of heart problems including four bypasses performed in 1977, a pacemaker implantation in 1979, chronic obstructive pulmonary disease, and prior prostate surgery. W.V. was determined to have had an acute myocardial infarction for which he was treated at St. Augustine General Hospital for five days. As W.V.'s condition improved, he was encouraged to walk at St. Augustine where he complained of chest pain and weakness. A echocardiogram showed segmental wall motion disturbance involving the posterior wall of the heart. A second electrocardiogram was performed which showed ventricular pacemaker rhythm and ST-T wave changes. On this basis, given his history and myocardial infarction, he was referred for a cardiac catheterization to St. Vincent's where his earlier heart surgeries had been performed. The patient was monitored during his hospitalization in St. Augustine, and did not show any signs of arrhythmias. On June 30, 1988, W.V. was transferred to St. Vincent's and received through the Emergency Room, where he was interviewed by the Respondent. After giving the Respondent a brief outline of his problems, W.V. was placed on a general medical floor for the evening, and scheduled for cardiac catheterization the following day. Cardiac catheterization and its risks were explained to W.V., who signed the patient consent forms authorizing the procedure. On the morning of July 1, 1988, after examining the patient and finding no changes, the Respondent performed on W.V. a cardiac catheterization, which verified the recent acute myocardial infarction, the blockage of two of the bypasses, damage to the heart muscle serving the lungs, and high vascular resistance with severe pulmonary hypertension. The patient tolerated the procedure well and showed no signs of arrhythmias during or after the procedure. The test results indicated that he could not benefit from surgery or angioplasty. W.V.'s primary health threat was from congestive heart failure, a condition likened to drowning in one's own fluids. (Tx-129, line 1.) A patient suffering from congestive heart failure will call for assistance from the nursing staff, as one of the expert's phrased it, "he would have been crawling out the door on his hands and knees calling for the nurse." (See Dr. Gilmore, Tx-130, line 8.) Conversely, heart failure alone would not have caused the patient to have chest pains, unless the patient developed elevated pressures to the point where pulmonary hypotension caused chest pain. However, the chest pain in such a case is not caused by clogged arteries or an impending heart attack, but by build up of fluid in the lungs which causes the heart to work harder to pump the blood through the lungs. (Dr. Campbell, Tx- 107, line 16.) The Respondent's post-catheterization order initially directed that W.V. be moved to a monitored bed following the procedure. The purpose of monitoring a patient is to observe, document and ultimately treat cardiac rhythm disturbances. (Dr. Gilmore, Tx-117,line 6.) Approximately 75 percent of post- catheterization patients were placed on telemetric monitoring (monitoring or telemetry hereafter). Monitored beds existed on 3 East (eight monitored beds), 5 East (eight monitored beds), Coronary Care Unit (eight monitored beds), Intensive Care Unit (12 monitored beds), and open heart unit which, although monitored, would not take catheterization patients. Notwithstanding the number of monitored beds, the critical piece of equipment is the monitor because each room on a monitoring unit was set up to receive telemetry. The monitor is a small radio transmitter that relays information from leads attached to the patient to receivers in each room. The monitors are removed by patients upon discharge, thrown into the laundry, and into the trash. They also require repair. As a result, the actual number of monitors varied from the planned number of monitored beds. Upon completion of the catheterization, the catheterization nurse would advise the nurse in charge of placing patients that the cardiac catheterization patient was ready for admission to the hospital, and whether the doctor had ordered a monitored or unmonitored bed. If the doctor had ordered a monitored bed and one was not available, the placement nurse would ask the admitting physician whether the patient being admitted really needed monitoring given the critical number of monitored beds available and the necessity to poll the treating physicians of all the monitored patients to see if any could be taken off monitoring. Inferentially, the Respondent considered the status of his other patients who were being monitored. If the physician deemed the patient's need for monitoring critical, then the placement nurse would poll the physicians of all other monitored patients, and request that they reassess the needs of their patients on monitoring. (See Lipsky Deposition, Page 26) The unit which normally received post-catheterization patients, 5 East, had eight monitored beds and eight unmonitored beds which were used as "stepdown" beds for patients taken off monitoring so that the monitors could be changed, but the patient retained in the same bed. Not only were all the monitored beds occupied on 5 East, the post-catheterization unit, but that unit had almost a full census. (See Lipsky Deposition, Page 20 - Page 26) The hospital's procedures required cardiac catheterization patients to remain in the catheterization laboratory until a monitored bed was available if the doctor stated that the patient was to go to a monitored bed. The catheterization patient would be held in the catheterization laboratory where there was a shortage of nursing care until a bed was found. Contrary to the experts' testimony which presumed the authority of the Respondent to place the patient in a monitored bed, it was the placement nurse who placed the patient once the doctor ordered a monitored bed post-catheterization. No evidence was received regarding her authority to place patients requiring monitoring in the ICU or CICU. Typically, doctors reassessed their patients' need for monitoring during morning rounds, and those that were stable were removed from monitoring so the monitor became available for a more critical patient. (See Libsky deposition, Page 24, line 20) W.V. catheterization was completed at approximately 11:00 a.m., following morning rounds when a maximum number of monitors should have been available; however, no evidence was received when a monitor would have been available. Testimony revealed that the wait could be as long as two hours for a monitored bed. During that time, under hospital protocols, W.V. would have remained in the catheterization lab. Contrary to facts assumed by the Petitioner's experts, the Respondent's options for placing the patient were: to place the patient in an unmonitored bed on the cardiac floor, or to retain the patient in a monitored bed in the holding area where he would be monitored by the cardiac catheterization nurse until the patient placement nurse found a monitored bed. The Respondent did not retain the patient in the cardiac catheterization area because the nurses could not adequately monitor W.V. and perform their other duties. The Respondent did not place W.V. in the Cardiac Care Unit or the regular Intensive Care Unit to obtain monitoring because it was not his function to place the patient. The only way he could have placed W.V. in CICU or ICU would have been to change W.V.'s status to justify the overall intensive care of the patient. However, this would have been unsupportable if questioned given the patient's condition which was stable upon admission six days after the myocardial infarction, and remained stable after the procedure. See Dr. Edwards Depostion, Page 41, line 19 et seq. Staffing levels on 5 East at the time of W.V.'s hospitalization were one nurse to four or five patients. There were five nurses, a charge nurse, and nursing assistant, and 22 beds on the unit. (See Lipsky Deposition, Page 72, line 15.) The Hospital's Standing Order 01-009 provided that "The critical care nurse, in consultation with the charge nurse, may initiate the following (list of nursing interventions) and notify the physician as soon as possible in the event of an acute deterioration [of] patient status and in the absence of a physician." (See Burnsed Deposition, Page 112, line 4) The Hospital Standing Order 01-017 provided "Any changes in the patient's condition will be called to the attention of the attending physician and appropriate consulting physicians. The emergency standing orders may be initiated by the nursing staff, but the physician must be informed of their use." (See Burnsed Deposition, Page 113, line 10) The Respondent placed the patient on 5 East, the cardiac care floor, in an unmonitored bed at approximately 11:50 a.m., as indicated by the notation on the patient's chart "nonmonitored," which indicated a change from the initial orders. (See Cavin Deposition, Page 34, line 7 and Page 35, line 7 et seq.) There was no order that W.V. should not be resuscitated. The Respondent's standing orders called for the patient's vital signs, together with shortness of breath and chest pain, to be monitored every 15 minutes for four hours. This was done until 3:15 p.m., when the monitoring was reduced to every 30 minutes. The Respondent advised the cardiac catheterization nurse, Mary Cavin, who accompanied the patient to the floor, of his findings, to include evidence of a recent myocardial infarction, and the patient's response to the procedure. (See Cavin Deposition, Page 19-20) Ms. Cavin identified her handwriting on the charts describing the Respondent's findings. However, these notes do not mention the recent myocardial infarction. The referenced notes were not sufficiently identified to check in the patient's charts. W.V. was taken to 5 East by Mary Cavin. Ms. Cavin had worked in this area at St. Vincent's for three years. Cardiac catheterization nurses were described by one of the experts as being among the best trained nurses in the profession, who because they work with the medical staff continuously during the procedures, are aware of the physician's findings and the patient's status. They pass this information along to the floor nurses when they transport the patients back to the floor. Ms. Cavin did not remember specifically W.V., but testified in her deposition regarding her normal practice when delivering a patient. She advised the staff on 5 East how the patient did during the catheterization, and what the findings had been. However, as stated above, in Cavin's notes she did not mention the recent myocardial infarction, and it is unclear whether she mentioned this to the staff of 5 East. The record is unclear to whom Ms. Cavin reported W.V.'s condition; however, Ms. Burnsed received a report on W.V. when she came on duty from Carolyn Johnson, the nurse who had cared for W.V. on the preceding shift. Ms. Burnsed was advised by Ms. Johnson that W.V. was stable post-catheterization, that he had previous open heart surgery, and that one of his grafts was blocked, but "had good collateral circulation to that." Further, Johnson advised Burnsed that W.V.'s vital signs were good, and he had no problems. Johnson did not mention the recent myocardial infarction suffered by W.V. Although Ms. Burnsed could not specifically remember her actions, her general course of action was to do a complete assessment upon starting the shift, make sure her patients were all right and having no problems, and orient them about the call light and calling her. Her physical assessment of W.V. revealed an apical heart rate of 72, respiration 18, and blood pressure of 100/70. W.V.'s vital signs were monitored by the staff of 5 East every 15 minutes as ordered by the Respondent until 3:15 p.m., when this was reduced to every 30 minutes. At 5:00 p.m., the Respondent saw W.V., who had no complaints and was stable. Ms. Burnsed found W.V. up going to the bathroom at 5:30 p.m., and got him back into bed explaining that it was important that he stay in bed because of his incision for at least 24 hours. Ms. Burnsed checked W.V.'s incision, and found that it was not bleeding at that time. At 7:00 p.m., Ms. Burnsed administered Lasix to W.V., and W.V. asked for and was provided sleeping medication at 9:00 p.m., at which time, Ms. Burnsed took W.V.'s vital signs which were essentially unchanged and stable. At 9:20 p.m. the patient's charts reflect that he was complaining of mild shortness of breath (SOB), and pains in his chest. Pursuant to the Respondent's orders, Ms. Burnsed administered nitroglycerin, 150 grains times one, after checking his blood pressure to insure it was within limits for the administration of nitroglycerine, and oxygen via nasal cannula, two liters, pursuant to emergency orders. This relieved the patient's symptoms. Ms. Burnsed did not report to the Respondent that W.V. had suffered mild shortness of breath and chest pain because the nitroglycerin and oxygen relieved his symptoms. The decision to notify or not to notify the treating physician was described as a nursing judgment based upon the nurse's assessment of the patient's condition after being medicated and placed upon oxygen. (See Lipsky Deposition, Page 56, line 8 et seq.) Ms. Burnsed did not consider the patient's condition to have deteriorated given his response to the medication, and did not notify the Respondent. Subsequent to administering the nitroglycerin and oxygen, Ms. Burnsed spoke with W.V.'s wife on the telephone. It is intimated in the depositions that Mrs. W.V. called to advise that her husband had called complaining of shortness of breath and chest pains and an inability to get anyone to assist him; however, no evidence was submitted regarding the content of the conversation between Ms. Burnsed and Mrs. W.V. Five to ten minutes after speaking with W.V.'s wife, Ms. Burnsed returned to W.V.'s room, where she found him resting in bed without complaint. W.V. stated that he wanted to go to sleep. Ms. Burnsed did not remember checking his vital signs on this second visit, and it is most probable that she did not because he was trying to go to sleep. Ms. Burnsed checked W.V. at 10:10 p.m., and found he was not breathing, had no pulse, and was unresponsive. The Cardiac Resuscitation Team was called, and responded. Despite their efforts, W.V. was pronounced dead at 10:50 p.m. Although a partial autopsy was performed which confirmed the findings of the catheterization and the diagnosis of a recent myocardial infarction, the cause of death was not precisely determined. It was assumed by the experts that W.V. did not die of congestive heart failure because he would have complained more. Therefore, the experts concluded that his death was relatively sudden, most probably brought on by an arrhythmia or perhaps a stroke. There was a suggestion that the Respondent did not put W.V. on a monitor because he had a pacemaker. While patients with pacemakers are at no less risk of developing arrhythmias than patients without pacemakers, there was no evidence that this was a consideration of Respondent in placing the patient on a cardiac floor following cardiac catheterization. It was general practice to place cardiac catheterization patients who exhibited signs of cardiac pathology on telemetry for 24 hours following the procedure. The initial orders of the Respondent were consistent with this practice. Testimony was received from the Petitioner's experts was that the Respondent's care was substandard because he did not place the patient on monitoring as they would have done by placing the patient in the emergency room, or the intensive care unit, or the cardiac intensive care unit to obtain telemetry monitoring, or retain the patient in the cardiac catheterization area pending the availability of a monitored bed. Their assumptions regarding the doctor's authority were inconsistent with the procedure for placing patients at St. Vincent's which was the function of the placement nurse. The Petitioner's experts also testified that placing a patient on telemetry notified the nursing staff that the patient required special attention. The Respondent's witnesses were more credible in stating that placing a patient on telemetry was not the way to indicate to nursing staff that the patient required special attention. The testimony of Respondent's witnesses that intensive care personnel were not as well trained as personnel on the cardiac floor to deal with cardiac emergencies is not credible. Both groups of personnel, if not equally versed in cardiac care, are sufficiently skilled in steps to be taken in the event of a cardiac emergency that there would be no appreciable difference in the care provided. Placing the patient in the regular intensive care unit or the cardiac intensive care unit would have required changing the patient's medical status be changed, and there was no change in the patient's condition which would have warranted the change. The patient was extremely ill upon admission, and his prognosis was very poor. W.V. was going to die because of his cardiac condition and chronic pulmonary congestion unless he had a stroke. His condition was irreversible in the opinions of the various experts; however, he would have been released the day following the catherization and treated medically for his problems. The Petitioner's experts opined that the Respondent's decision not to place W.V. in a monitored bed was substandard care because they felt that there was an ethical duty to monitor the patient in the absence of orders directing that efforts not be made to resuscitate notwithstanding the dismal chances for success. Their opinion assumed the Respondent could direct the placement of the patient in a monitored bed on a specific unit within a relatively short period of time because of all the monitored beds in the hospital. The Respondent's experts opined that the decision not to monitor W.V. was within the acceptable standards of medical care by physicians under similar circumstances, i.e., retain the patient in the catherization laboratory where nursing care would have been inadequate pending availability of a monitored bed for up to two hours. Their opinion considered the circumstances at St. Vincent's, and is deemed more credible.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the charges against the Respondent be dismissed. DONE and ENTERED this 2nd day of June, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1995. APPENDIX The parties filed proposed findings of fact which were read and considered. The following states which of those findings were adopted, and which were rejected and why: Petitioner's Recommended Order Findings Paragraph 1-3 Paragraph 1-3. Paragraph 4 Paragraph 5. Paragraph 5 Paragraph 3. Paragraph 6 Paragraph 6. Paragraph 7 While true, this finding is unnecessary to a consideration of the issues. Paragraph 8 Paragraph 7. Paragraph 9 Paragraph 9. Paragraph 10 Paragraph 32. Paragraph 11 Subsumed in Paragraph 37. Paragraph 12 Subsumed in Paragraph 38,39. Paragraph 13 Rejected as contrary to more credible evidence. Paragraph 14 If arrythmias were undetected, they would have been irrelevant to consideration of the patient's condition. Paragraph 15 Subsumed in Paragraph 9. Paragraph 16 Paragraph 46. Paragraph 17 Subsumed in Paragraph 9. Paragraph 18 Contrary to more credible evidence; See Parag 48. Paragraph 19 Rejected at Paragraph 43. Paragraph 20 Rejected at Paragraph 40. Paragraph 21 Rejected as contrary to more credible evidence; See Paragraph 12. Paragraph 22 Accurately states the expert's credentials, but is not relevant to consideration of the issues. Paragraph 23 Rejected as contrary to more credible evidence; See Paragraphs 42 and 47. Paragraph 24 Subsumed in Paragraphs 9,12,47-49. Paragraph 25 Rejected at Paragraph 16. Paragraph 26 See comments to Paragraph 22. Paragraph 27 See comments to Paragraph 23. Paragraph 28 While the may have been a national standard of care, there was not a national set of circumstances which impact the issue of whether the Respondent adhered to the appropriate standard of care. Paragraph 29 Subsumed in Paragraph 47. Paragraph 30 Subsumed in Paragraph 24. Paragraph 31 Subsumed in Paragraph 9. Respondent's Recommended Order Findings Paragraph 1 Paragraph 4,5. Paragraph 2,3 Paragraph 6. Paragraph 4 Paragraph 6,4. Paragraph 5 Paragraph 9. Paragraph 6 Rejected as contrary to most credible evidence; See Paragraphs 12-14. Paragraph 7-10 Subsumed in Paragraphs 17-19. Paragraph 11 Accurate; however, the patient was stable upon admission. Paragraph 12 Subsumed in Paragraph 46. Paragraph 13 Paragraph 46. Paragraph 14 Paragraph 24. Paragraph 15 Subsumed in Paragraph 25-28. Paragraph 16 Paragraph 24. Paragraph 17 Paragraph 31. Paragraph 18 Subsumed in Paragraph 33. Paragraph 19 Paragraph 37. Paragraph 20 Subsumed in Paragraph 46. Paragraph 21 Paragraph 38,48. COPIES FURNISHED: Hugh R. Brown, Esq. Agency for Health Care Administration 1940 N. Monroe St. Tallahassee, FL 32399-0792 Michael J. Obringer, Esq. Osborne, McNatt, Shaw, et al One Enterprise Center 225 Water St., Ste. 400 Jacksonville, FL 32202-5147 Marm Harris, M.D. Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue in these cases is whether certain rules proposed by the Agency for Health Care Administration (AHCA) related to adult interventional cardiovascular services are an invalid exercise of delegated legislative authority.
Findings Of Fact By stipulation of the parties, all Petitioners and Intervenors in these cases are acute care hospitals licensed in Florida pursuant to Chapter 395, Florida Statutes; are substantially affected by the proposed rules at issue in these cases; and have standing to participate in this proceeding. AHCA is the state agency responsible for licensure of hospitals pursuant to Chapter 395, Florida Statutes, and responsible for promulgation of the proposed rules at issue in these cases. This dispute specifically involves proposed rules related to the licensure of adult cardiovascular services in Florida hospitals. Such services include percutaneous cardiac intervention (PCI), also referred to as percutaneous transluminal coronary angioplasty (PCTA). PCI involves the insertion of a device placed into an artery and directed to the site of a coronary artery blockage. The device is used to compress or remove the blockage material and restore arterial blood flow to heart tissue. A mechanism called a "stent" may be left in place at the site of the former blockage to reduce the potential for re-blockage ("restenosis") of the artery. The procedure is performed in a cardiac catheterization laboratory ("cath lab"). PCI that is performed on an emergency basis to open an arterial blockage causing myocardial infarction (heart attack) is referred to as "primary" or "emergent" PCI. PCI performed to resolve symptoms of coronary artery disease manifesting in presentations other than through myocardial infarction is referred to as "elective" PCI. Previous law restricted PCI services to those hospitals with onsite cardiac surgery (commonly referred to as "open heart" surgery). Hospitals are required to obtain a Certificate of Need (CON) from AHCA to operate a cardiac surgery program. Accordingly, in order to offer PCI services, a hospital was required to obtain a cardiac surgery program CON from AHCA. As cardiac catheterization procedures have become more widely available and physician training and experience have increased, the relative safety of the procedures has improved. The volume of open heart cardiac surgery has declined as the patient outcomes for non-surgical coronary artery disease treatments have improved, yet Florida hospitals seeking to provide PCI were still operating under the CON-based restrictions. There is an ongoing debate within the medical community related to the issue of whether non-emergent patients should receive PCI services at hospitals which lack cardiac surgery programs. The historic rationale for restricting the availability of elective PCI procedures to hospitals where onsite cardiac surgery was also available was related to the possibility that an unsuccessful PCI would require immediate resolution through surgery. The evidence establishes that PCI-related events requiring immediate access to onsite cardiac surgery have become less frequent, at least in part due to increased training and experience of practitioners, as well as an increased technical ability to resolve some events, such as arterial ruptures or perforations, within the cath lab. Nonetheless, there is also evidence that the outcomes of cardiac catheterization procedures performed in hospitals with onsite cardiac surgery may be superior to those performed in hospitals where onsite cardiac surgery is not available. In 2004, the Florida Legislature adopted two bills that, insofar as are relevant to this proceeding, had an impact on the regulatory process related to adult interventional cardiovascular services. The effect of the legislation was to shift the regulation of PCI programs away from CON-based restrictions and towards a licensing process. Both bills established a two-level classification of hospitals providing adult interventional cardiology services. House Bill 329 limited the provision of PCI at hospitals without onsite cardiac surgery to emergent patients and provided, in relevant part, as follows: In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult primary percutaneous cardiac intervention for emergent patients without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis supplied) Senate Bill 182 did not limit PCI services on the basis of onsite cardiac surgery availability and provided, in relevant part, as follows: Section 2. Notwithstanding conflicting provisions in House Bill 329, Section 408.0361, Florida Statutes, is amended to read: * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. (Emphasis added) Both the House Bill and the Senate Bill were signed into law. The legislation was codified as Section 408.0361, Florida Statutes (2004), which provided, in relevant part, as follows: 408.0361 Cardiology services and burn unit licensure.-- * * * In establishing rules for adult interventional cardiology services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. Extensive evidence was offered at the hearing to support both sides of the debate regarding the appropriateness of performing elective PCI in hospitals without onsite cardiac surgery, and it is clear that the debate continues. However, the evidence establishes that the Florida Legislature specifically chose not to restrict non-emergent PCI to Florida hospitals with onsite cardiac surgery units and has determined that properly-licensed Florida hospitals may provide PCI services without regard to the availability of on-site cardiac surgery. It is reasonable to assume that had the Legislature intended to restrict provision of adult PCI in hospitals without cardiac surgery programs to emergent patients, the "notwithstanding" language contained in Senate Bill 182 would not have been adopted. There is no credible evidence that the Legislature was unaware of the continuing debate within the cardiology community at the time the legislation was adopted in 2004. The Legislature has acknowledged the distinction between emergent and elective PCI as indicated by Subsection 408.036(3)(o), Florida Statutes (2008), which provides under certain circumstances that a hospital without an approved "open heart surgery program" can obtain an exemption from CON requirements and provide emergent PCI services to "patients presenting with emergency myocardial infarctions." It is reasonable to assume that had the codification of the 2004 legislation been incorrect, the Florida Legislature would have subsequently amended the statute to reinstate the restriction. In fact, the Legislature has revised the referenced statute without substantively altering the relevant language establishing the two-level licensure designation. Section 408.0361, Florida Statutes (2008), the current statute directing AHCA to adopt the rules at issue in this proceeding, provides, in relevant part, as follows: 408.0361 Cardiovascular services and burn unit licensure.-- Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency that establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules shall ensure that such programs: Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services. Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety. Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies. Demonstrate a plan to provide services to Medicaid and charity care patients. Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency that establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit. Such rules shall consider, at a minimum, staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure period and fees, and enforcement of minimum standards. The certificate-of-need rules for adult cardiovascular services and burn units in effect on June 30, 2004, are authorized pursuant to this subsection and shall remain in effect and shall be enforceable by the agency until the licensure rules are adopted. Existing providers and any provider with a notice of intent to grant a certificate of need or a final order of the agency granting a certificate of need for adult cardiovascular services or burn units shall be considered grandfathered and receive a license for their programs effective on the effective date of this act. The grandfathered licensure shall be for at least 3 years or until July 1, 2008, whichever is longer, but shall be required to meet licensure standards applicable to existing programs for every subsequent licensure period. In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for: Establishment of two hospital program licensure levels: a Level I program authorizing the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program authorizing the performance of percutaneous cardiac intervention with onsite cardiac surgery. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, it has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, it has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease. Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies. Demonstration of a plan to provide services to Medicaid and charity care patients. In order to ensure continuity of available services, the holder of a certificate of need for a newly licensed hospital that meets the requirements of this subsection may apply for and shall be granted Level I program status regardless of whether rules relating to Level I programs have been adopted. To qualify for a Level I program under this subsection, a hospital seeking a Level I program must be a newly licensed hospital established pursuant to a certificate of need in a physical location previously licensed and operated as a hospital, the former hospital must have provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations for the most recent 12- month period as reported to the agency, and the newly licensed hospital must have a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes. A hospital meeting the requirements of this subsection may apply for certification of Level I program status before taking possession of the physical location of the former hospital, and the effective date of Level I program status shall be concurrent with the effective date of the newly issued hospital license. (5)(a) The agency shall establish a technical advisory panel to develop procedures and standards for measuring outcomes of adult cardiovascular services. Members of the panel shall include representatives of the Florida Hospital Association, the Florida Society of Thoracic and Cardiovascular Surgeons, the Florida Chapter of the American College of Cardiology, and the Florida Chapter of the American Heart Association and others with experience in statistics and outcome measurement. Based on recommendations from the panel, the agency shall develop and adopt rules for the adult cardiovascular services that include at least the following: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. Hospitals licensed for Level I or Level II adult cardiovascular services shall participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons. As required by Subsection 408.0361(5), Florida Statutes (2004), AHCA created the TAP, which convened and met over the course of two years at a series of public hearings. The TAP also received written materials and comments from interested parties. Thereafter, AHCA convened rule development workshops to formulate the proposed rules at issue in this proceeding. The proposed rules were initially noticed in the September 28, 2007, Florida Administrative Weekly (Vol. 33, No. 39). Subsequent Notices of Changes to the proposed rules were published in the Florida Administrative Weeklies of November 16, 2007 (Vol. 33, No. 46); March 28, 2008 (Vol. 34, No. 13); and May 9, 2008 (Vol. 34, No. 19). There is no evidence that AHCA failed to comply with statutory requirements related to the rule adoption process. As required by Subsection 408.0361(3)(a), Florida Statutes (2008), the proposed rules set forth the procedures by which a hospital may apply for licensure as a Level I or Level II provider of adult cardiovascular services without differentiation based on the availability of on-site cardiac surgery. The proposed rules applicable to a hospital seeking licensure as a Level I provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(16). The proposed rules applicable to a hospital seeking licensure as a Level II provider of adult cardiovascular services are set forth at Proposed Rule 59A-3.2085(17). Subsection 408.0361(3)(b), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level I program. Accordingly, Proposed Rule 59A- 3.2085(16)(a) provides, in relevant part, as follows: 1. A hospital seeking a license for a Level I adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 1: Level I Adult Cardiovascular Services License Application Attestation; AHCA Form, Section 18(a) of this rule ), signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) Subsection 408.0361(3)(c), Florida Statutes (2008), establishes minimum volume reporting requirements for licensure as a Level II program. Accordingly, Proposed Rule 59A- 3.2085(17)(a) provides in relevant part as follows: 1. A hospital seeking a license for a Level II adult cardiovascular services program shall submit an application on a form provided by the Agency (See Form 2: Level II Adult Cardiovascular Services License Application Attestation; AHCA Form , Section 18(b) of this rule ) to the Agency, signed by the chief executive officer of the hospital, attesting that, for the most recent 12-month period, the hospital has provided a minimum of a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-9-CM codes 410.0 through 414.9). a. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant. (Emphasis supplied) St. Anthony's asserts that the proposed rule is invalid on the grounds that it fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. St. Anthony's asserts that the exclusion of cardiac catheterization procedures performed within the hospital's cardiac cath lab but not billed by the hospital is arbitrary and capricious, modifies, enlarges, or contravenes the specific provisions of the statute implemented, fails to establish adequate standards for agency decision making, and vests unbridled discretion in the agency. The evidence fails to support these assertions. Although the phrase "block lease" is undefined by statute or rule, the evidence establishes that insofar as relevant to this proceeding, the term refers to a practice by which a group of cardiologists lease blocks of time from a hospital for exclusive use of a hospital's cardiac cath lab. St. Anthony's has a leasing arrangement with a group of cardiologists identified as the "Heart and Vascular Institute South" ("HAVI South") whereby St. Anthony's leases blocks of time in a cardiac cath lab to HAVI South cardiologists. The facility is located in a privately-owned medical office building physically attached to St. Anthony's hospital building. St. Anthony's leases the medical office building from a developer. HAVI South cardiologists perform cardiac catheterization procedures at the St. Anthony's facility during both leased and non-leased time. St. Anthony's provides personnel to staff the cardiac cath lab regardless of whether the procedure is performed during leased or non-leased time. The HAVI South cardiology group develops the schedule of cardiac catheterization procedures to be performed during the leased time and notifies St. Anthony's of the schedule. The HAVI South cardiology group bills for both their professional fees and the facility charges (referred to as the "technical component") for the cardiac catheterization procedures performed during leased time. St. Anthony's does not bill for cardiac catheterization procedures performed during the leased time. For the cardiac catheterization procedures performed during non-leased time, the HAVI South cardiology group bills for professional fees, and St. Anthony's bills for the technical component. Patricia Sizemore, vice-president for patient services at St. Anthony's, acknowledged that other hospitals could have block-leasing arrangements different from those existing between St. Anthony's and the HAVI South group. The proposed rules would preclude St. Anthony's from including the outpatient cardiac catheterization procedures done by HAVI South during the block-leased time within those procedures available to meet the numeric threshold requirements identified in the statute. The evidence fails to establish that the proposed rule fails to provide a clear and reasonable methodology for assessing and verifying the number of diagnostic catheterization procedures performed. The relevant language of Subsection 408.0361(3), Florida Statutes (2008), identifies the hospital as the applicant and requires that the applicant "provide" the procedures or discharges being reported to meet the specified volume thresholds. The applicable definition of hospital is set forth at Subsection 408.032(11), Florida Statutes (2008), which defines a hospital as a health care facility licensed under Chapter 395, Florida Statutes. Subsection 395.002(12), Florida Statutes (2008), sets forth the following definition: (12) "Hospital" means any establishment that: Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and Regularly makes available at least clinical laboratory services, diagnostic X- ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. Physicians are not "hospitals" and are not licensed or regulated by Chapter 395, Florida Statutes. Physicians are not authorized to apply for licensure under the provisions of the statute and proposed rules at issue in this proceeding. Nothing in the statute suggests that entities other than hospitals may apply for licensure of a Level I or Level II adult cardiovascular services program. The rationale underlying the restriction of reportable procedures to those for which the applicant hospital issues bills for payment is based upon AHCA's reasonable intention to validate the procedure volume data submitted by applicant hospitals. Jeffrey Gregg, chief of AHCA's Bureau of Health Facility Regulation and CON Unit, testified that "the only practical, realistic way" for AHCA to routinely verify the accuracy of the procedure volume identified by a hospital's licensure application is through AHCA's ambulatory patient database. The reporting requirements for the ambulatory patient database are set forth at Florida Administrative Code Chapter 59B-9 and include elements such as demographic information, diagnosis codes, and charges. The database provides AHCA with access to patient record documentation and directly allows AHCA to verify the procedure volume identified in the licensure application. Because St. Anthony's has no charges related to the procedures performed by HAVI South cardiologists during the leased time, St. Anthony's has not reported procedures performed during leased time to the ambulatory patient database. St. Anthony's reports far more cardiac catheterization procedures to the local Suncoast Health Council than it does to AHCA's ambulatory patient database and asserts that AHCA could rely on health council data. AHCA has no organizational relationship with the local health council, and the evidence fails to establish that such data is as reliable as that collected by the ambulatory patient database. AHCA asserts that an additional basis to exclude procedures performed by entities other than the applicant hospital is that AHCA has no direct regulatory authority over the non-hospital entity. St. Anthony's asserts that AHCA would have its customary authority over the hospital and, by extension, over the third-party leasing the cardiac cath lab from the hospital. At best, AHCA's authority to obtain records from the non-hospital operator of the hospital's cardiac cath lab is unclear. St. Anthony's position effectively would permit a third-party operator to lease all of the time in a hospital's cardiac cath lab, yet allow the hospital to apply for and receive an adult cardiovascular service license. Nothing in Section 408.0361, Florida Statutes (2008), suggests that the Legislature intended to provide such an option. The proposed rule designating the reportable cardiac catheterization procedures is logical and rational, is not arbitrary or capricious, and does not modify, enlarge or contravene the specific provisions of the statute implemented. The evidence fails to establish that the designation of appropriately reportable cardiac catheterization procedures constitutes a failure to establish adequate standards for agency decision making or vests unbridled discretion in the agency. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that the proposed rules include provisions "that allow for" compliance with the most recent guidelines of the American College of Cardiology and AHA guidelines for "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." Subsection 408.0361(5), Florida Statutes (2008), requires that the TAP "develop procedures and standards for measuring outcomes" and that, based thereon, AHCA adopt rules that include a risk adjustment procedure that accounts for variations in severity and case mix, outcome standards specifying expected levels of performance, and "specific steps to be taken by the agency and the licensed hospitals" that fail to meet outcome standards. The statute also requires that licensed hospitals participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The TAP determined that the appropriate method of measuring outcome was to utilize the data available through the clinical outcome reporting systems referenced in the statute. Accordingly, Proposed Rule 59A-3.2085(16)(a) identifies the guidelines applicable to Level I adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level I hospital must comply; requires that the Level I hospital participate in the statutorily-identified data reporting system; and requires that Level I hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides, in relevant part, as follows: All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A- 3.2085(13), F.A.C., the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule. Hospitals are considered to be in compliance with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Proposed Rule 59A-3.2085(17)(a) identifies the guidelines applicable to Level II adult cardiovascular services; identifies the specific provisions of the guidelines with which a Level II hospital must comply; requires that the Level II hospital participate in the statutorily-identified data reporting system; and requires that Level II hospitals document a quality improvement plan to meet performance measures set forth by the data reporting system. The proposed rule provides in relevant part as follows: All providers of Level II adult cardiovascular services programs shall operate in compliance with subsections 59A-3.2085(13) and 59A-3.2085(16), F.A.C. and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. The applicable guidelines, herein incorporated by reference, are the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Hospitals are considered to be in compliance with the guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention; and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons. In addition to the requirements set forth in subparagraph (16)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. The Petitioners generally assert that the proposed rules insufficiently identify or establish the minimum standards identified as "guidelines" and "benchmarks" in the rule. The evidence fails to support the assertion. The guidelines are specifically identified and incorporated by reference within the rule. There is no evidence that the documents identified do not constitute the "most recent guidelines of the American College of Cardiology and the American Heart Association" as required by the statute. Hospitals are not obligated to meet all of the requirements set forth in the guidelines. A licensed hospital is deemed to be in compliance when, as specified in the statute, the hospital adheres to the standards related to staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The Petitioners generally assert that such distinctions between the various compliance elements are unclear. The evidence fails to support the assertion. There is no credible evidence that the guidelines, albeit technical and complex, are not commonly understood by appropriate medical practitioners and hospital administrators. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(a)5. is vague on grounds that it requires Level I hospitals to operate in compliance with the referenced guidelines while Proposed Rule 59A-3.2085(16)(a)9. authorizes provision of elective PCI at Level I hospitals. Martin Memorial further asserts that because the proposed rules provide for elective PCI in hospitals without onsite cardiac surgical programs, the proposed rules enlarge, modify or contravene the enacting statute. Subsection 408.0361(3)(d), Florida Statutes (2008), requires that AHCA include "provisions that allow for" the following: Compliance with the most recent guidelines of the American College of Cardiology and American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. (Emphasis supplied) Proposed Rule 59A-3.2085(16)(a)9. provides as follows: Notwithstanding guidelines to the contrary in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214 and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention), all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. (Emphasis supplied) Martin Memorial's disagreement with the proposed rule is premised on the following statement in the ACC/AHA/SCAI 2005 Guideline Update: Elective PCI should not be performed at institutions that do not provide onsite cardiac surgery. (Level of Evidence: C) The statement is contained within subsection 4.3 ("Role of Onsite Cardiac Surgical Backup") within Section 4 ("Institutional and Operator Competency"). The statement is defined as a "Class III" standard, meaning within the "conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful." According to the "Level of Evidence: C" identification, the statement reflects "consensus opinion of experts, case studies, or standard of care." A footnote to the statement provides as follows: Several centers have reported satisfactory results based on careful case selection with well-defined arrangements for immediate transfer to a surgical program (citation omitted). A small but real fraction of patients undergoing elective PCI will experience a life-threatening complication that could be managed with the immediate onsite availability of cardiac surgical support but cannot be managed effectively by urgent transfer. Wennberg, et al., found higher mortality in the Medicare database for patients undergoing elective PCI in institutions without onsite cardiac surgery (citation omitted). This recommendation may be subject to revision as clinical data and experience increase. The guidelines are statements of "best practices" in health care delivery. They are intended to assist practitioners and facility administrators in making appropriate decisions. The cited statement neither prohibits nor requires performance of elective PCI in hospitals without onsite cardiac surgical programs. Whether a practitioner performs elective PCI in a licensed Level I hospital remains a medical decision under the provisions of the enacting statute and proposed rules. The footnote recognizes that elective PCI is available at some hospitals without onsite cardiac surgery through "careful case selection with well-defined arrangements for immediate transfer to a surgical program." The proposed rule specifically establishes staff and transfer requirements designed to facilitate rapid transfer of a patient from a Level I to a Level II facility. There is no evidence that such staff and transfer requirements are insufficient or otherwise inappropriate. Patient selection criteria are those which expressly identify clinical presentations of patients who are appropriate for revascularization through PCI. Section 5 of the referenced ACC/AHA/SCAI 2005 Guideline Update, titled "Clinical Presentations" explicitly addresses such criteria and constitutes the patient selection criteria contained within the document. The patient selection criteria do not regulate the location where PCI procedures are performed. As stated previously, the Florida Legislature, presented with the option of limiting the availability of cardiac catheterization services available at Level I hospitals to emergent patients, rejected the limitation. The evidence fails to establish that Proposed Rule 59A-3.2085(16)(a)5. is vague or that Proposed Rule 59A-3.2085(16)(a)9. enlarges, modifies or contravenes the enacting statute. Martin Memorial and St. Anthony's assert that the proposed rule contravenes Subsection 408.0361(5)(a), Florida Statutes (2008), which provides that AHCA adopt rules that include "at least the following" elements: A risk adjustment procedure that accounts for the variations in severity and case mix found in hospitals in this state. Outcome standards specifying expected levels of performance in Level I and Level II adult cardiovascular services. Such standards may include, but shall not be limited to, in-hospital mortality, infection rates, nonfatal myocardial infarctions, length of stay, postoperative bleeds, and returns to surgery. Specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans. The TAP recommended to AHCA that existing outcome data reporting systems created by the American College of Cardiology and the Society of Thoracic Surgeons be utilized for data collection related to licensed hospital adult cardiovascular services programs. Subsection 408.0361(5)(b), Florida Statutes (2008), requires that hospitals licensed under the proposed rules participate in clinical reporting systems operated by the American College of Cardiology and the Society of Thoracic Surgeons. The requirement was adopted by the 2007 Legislature based on the TAP recommendation. Proposed Rule 51A-3.2085(16)(a)8. requires licensed Level I hospitals to participate in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) and sets forth additional directives related to such participation. The ACC-NCDR system is a risk adjusted outcome reporting system that accounts for variation in severity and case mix. It collects approximately 200 data elements and is in use in approximately 2,000 hospitals. Proposed Rule 51A-3.2085(17)(a)6. directs licensed Level II hospitals to participate in the Society of Thoracic Surgeons National Database (STS database) and sets forth additional requirements related to such participation. The STS database provides information generally similar to the ACC-NCDR database. Although Proposed Rule 59A-3.2085(17)(a)5. states that the Level II hospital must meet or exceed the performance standards identified within the ACC-NCDR, there appears to be no specific requirement in the proposed rules that a Level II hospital participate in the ACC-NCDR system. Proposed Rule 59A-3.2085(17)(a)6. contains a citation to Proposed Rule 59A-3.2085 (16)(a)7. The cited paragraph consists of text that is similar to the paragraph preceding the citation. The intent of the reference is unclear. If the reference were intended to incorporate the ACC- NCDR reporting requirements with those applicable to Level II hospitals, the citation in Proposed Rule 59A-3.2085(17)(a)6. should have been to Proposed Rule 59A-3.2085(16)(a)8., where the ACC-NCDR requirements are identified. In any event, the statute requires participation by licensed hospitals in the reporting systems, and, as stated previously, Level II hospitals must document plans to ensure that the cited standards are met; so, it is logical to presume that Level II hospitals will participate in the ACC-NCDR system, in addition to the STS database. Martin Memorial and St. Anthony's assert that the proposed rule does not include the "outcome standards specifying expected levels of performance" required by Subsection 408.0361(5)(a)2., Florida Statutes (2008), and that the proposed rules fail to identify the "national quality and outcome benchmarks" referenced therein. The evidence fails to support the assertions. 93. Proposed Rules 59A-3.2085(16)(a)7. and 59A- 3.2085(17)(a)5. require that each licensed hospital must document a "quality improvement plan to ensure" that the specified cardiac services meet or exceed "national quality and outcome benchmarks" reported by the ACC-NCDR and the STS databases. The word "benchmark" is not defined by statute or rule. Merriam Webster's dictionary defines "benchmark" as "a point of reference from which measurements may be made" or "something that serves as a standard by which others may be measured or judged." The evidence establishes that the "national quality and outcome benchmarks" referenced in the proposed rules are the "expected levels of performance" identified through the ACC-NCDR system. Each hospital participating in the ACC-NCDR system receives a detailed quarterly outcome report indicating the particular hospital's performance relative to all other reporting hospitals on a variety of elements associated with cardiac catheterization and PCI provided at the hospital. Accompanying each periodic report is an "Executive Summary" that identifies the relative performance of the hospital receiving the report on ten specific "PCI and Diagnostic Catheterization Performance Measures," including six "PCI Quality Measures," two "PCI Utilization Measures," and two "Diagnostic Quality Measures." The Executive Summary information visually displays the data through a set of "box and whisker plots" that present the range of data reported by all participating hospitals on each specific measure. The summary received by each hospital identifies its specific performance through an "arrow" and numeric data printed on the plot. The plot visually displays "lagging" and "leading" performance levels. The plot identifies hospitals performing below the tenth percentile of all participating hospitals as "lagging" hospitals. The plot identifies hospitals performing above the 90th percentile as "leading" hospitals. The evidence, including review of the ACC-NCDR data reporting system, establishes that the "expected levels of performance" are rationally those levels within the broad range of hospitals which are neither "leading" nor "lagging" according to the data. It is reasonable to assume that a "leading" hospital is performing at a level higher than expected and that a "lagging" hospital is performing at a level lower than expected. By reviewing the plot for each measure, a hospital can determine its performance relative to other participating hospitals on the ten measures included in the Executive Summary. The additional numeric data contained within the quarterly report permit additional comparison between an individual hospital and all other participating hospitals. Subsection 408.0361(5)(a)2., Florida Statutes (2008), does not require that AHCA establish numeric minimal standards, but only requires that the rule identify "outcome standards specifying expected levels of performance." The ACC-NCDR reporting system required by the statute and adopted by the proposed rules sufficiently identifies expected levels of performance. By their very nature, the outcome standards are not fixed. It is reasonable to presume that as hospital practices change, measurements of relative performance will also change. The rule requires only that each licensed hospital include within a quality improvement plan, documentation to ensure that such outcome standards will be met or exceeded, essentially encouraging a pattern of continual improvement by licensed programs. Subsection 408.0361(5)(a)3., Florida Statutes (2008), requires that the rule include the "specific steps to be taken by the agency and licensed hospitals that do not meet the outcome standards within specified time periods, including time periods for detailed case reviews and development and implementation of corrective action plans." The proposed rule complies with the requirements of the statute. Enforcement of outcome standards requirements applicable to Level I programs is addressed at Proposed Rule 59A-3.2085(16)(f) which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. Enforcement of outcome standards requirements applicable to Level II programs is addressed at Proposed Rule 59A-3.2085(17)(e), which provides as follows: Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction. AHCA does not routinely conduct surveys of accredited hospitals. Such surveys are conducted by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). AHCA generally conducts hospital surveys only during the investigation, pursuant to Florida Administrative Code Rule 59A-3.253(8), of a complaint filed against a hospital. AHCA would likely review ACC-NCDR and Society of Thoracic Surgeons data reports associated with the investigation of a specific complaint related to adult cardiovascular services. Assuming that AHCA's review of the data identified a deficiency, the proposed rules provide the licensee a 15-day period to develop a plan of correction acceptable to AHCA, unless the issue poses "a threat to the health, safety or welfare of patients" in which case it is reasonable to expect that a more prompt resolution of a deficiency would be required. Pursuant to Florida Administrative Code Rule 59A- 3.253, a hospital could be sanctioned for failing to submit a plan of correction related to an identified deficiency, or for failing to implement actions to correct deficiencies specified in an approved plan of correction. There is no evidence that AHCA's enforcement authority under the proposed rules differs in any significant manner from the general enforcement authority already available to the agency. There is no evidence that the proposed rules would result in any alteration of AHCA's investigative practices. Martin Memorial notes that, while the proposed rule provides a 15-day period for development of a plan of correction, AHCA's general enforcement rules already provide a ten-day period and asserts that the proposed rule is therefore inconsistent, fails to establish adequate standards for agency decisions, and vests unbridled discretion in the agency. The specific time period set forth in the proposed rule is clearly applicable, and there is no credible evidence of legitimate confusion in this regard. AHCA has suggested that "lagging" hospitals could be specifically regarded as failing to meet the outcome benchmarks identified in the ACC-NCDR data, but the proposed rule makes no specific reference to any systematic classification of hospital performance, and the statute does not require that a minimal performance level be established. Martin Memorial asserts that the Proposed Rule 59A- 3.2085(17)(a)6. is capricious because it requires that "each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database," but only physicians can participate in the database. The enacting statute requires such participation. Subsection 408.0361(5)(b), Florida Statutes (2008), directs AHCA to adopt rules that require Level I or Level II licensed hospitals to "participate in clinical outcome reporting systems operated by the American College of Cardiology and the Society for Thoracic Surgeons." The proposed rule clearly implements the directive established by the statute. There is no credible evidence that the proposed rule is irrational or that a licensed Level II hospital would be unable to meet the obligations of the rule by requiring that its thoracic surgeons participate in the STS database. Martin Memorial asserts that the requirement that an applicant hospital's chief executive officer attest to compliance with certain guidelines is vague because "it is unclear what guidelines apply and what guidelines will not." The evidence fails to support the assertion. The referenced requirement applicable to a hospital seeking licensure as a Level I facility is set forth at Proposed Rule 59A-3.2085(16)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-214; and the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The referenced requirement applicable to a hospital seeking licensure as a Level II facility is set forth at Proposed Rule 59A-3.2085(17)(a)2., which provides as follows: The request [for licensure] shall attest to the hospital’s intent and ability to comply with applicable guidelines in the American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: Bashore et al, ACC/SCA&I Clinical Expert Consensus Document on Catheterization Laboratory Standards, JACC Vol. 37, No. 8, June 2001: 2170-2; in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention); and in the ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery) Developed in Collaboration With the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Proposed Rule 59A-3.2085(16)(a)6. designates the guidelines applicable to the operation of Level I hospital services. Proposed Rule 59A-3.2085(17)(a) designates the guidelines applicable to the operation of Level II hospital services. The specific elements of the referenced guidelines are identified in both the statute and the proposed rules. Martin Memorial asserts that the proposed rule is vague as to training requirements applicable for physicians performing elective PCI in Level I hospitals. In making the assertion, Martin Memorial references training requirements established at Proposed Rule 59A-3.2085(16)(b)2. and applicable to Level I physicians performing emergent PCI with less than 12 months experience. There is no credible evidence that the proposed rule is vague. Proposed Rule 59A-3.2085(16)(b), in relevant part, provides as follows: Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level I adult cardiovascular licensure application or renewal application. Physicians with less than 12 months experience shall fulfill applicable training requirements in the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention) prior to being allowed to perform emergency percutaneous coronary interventions in a hospital that is not licensed for a Level II adult cardiovascular services program. The rule provides that a physician with less than 12 months experience working in a Level I facility can perform emergent PCI only if applicable training requirements have been met. The proposed rule does not authorize performance of elective PCI in a Level I hospital by a physician not meeting the minimum annual procedure volume requirements. Proposed Rule 59A-3.2085(17)(b) clearly identifies the requirements applicable to Level II physicians and in relevant part provides as follows: Each cardiac surgeon shall be Board certified. New surgeons shall be Board certified within 4 years after completion of their fellowship. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification. Each cardiologist shall be an experienced physician who has performed a minimum of 75 interventional cardiology procedures, exclusive of fellowship training and within the previous 12 months from the date of the Level II adult cardiovascular licensure application or renewal application. Martin Memorial asserts that the experience requirements set forth at Proposed Rule 59A-3.2085(16)(b)3. (related to Level I hospitals) and Proposed Rule 59A- 3.2085(17)(b)3. (related to Level II hospitals) are arbitrary or capricious. The evidence fails to support the assertion. The text of both proposed rules provides as follows: The nursing and technical catheterization laboratory staff shall be experienced in handling acutely ill patients requiring intervention or balloon pump. Each member of the nursing and technical catheterization laboratory staff shall have at least 500 hours of previous experience in dedicated cardiac interventional laboratories at a hospital with a Level II adult cardiovascular services program. They shall be skilled in all aspects of interventional cardiology equipment, and must participate in a 24-hour-per-day, 365 day-per-year call schedule. Martin Memorial argues that there is no evidence to suggest that 500 hours of experience indicates that appropriate competency levels has been achieved. The evidence establishes that the required experience level was developed by AHCA's hospital licensure unit staff and is the training level currently applicable for hospitals providing emergency PCI services under existing exemptions from CON requirements. The training requirements are not arbitrary or capricious. Martin Memorial asserts that the Proposed Rule 59A-3.2085(16)(c)1. is arbitrary or capricious. The cited rule requires that a Level I hospital make provisions for the transfer of an emergent patient to a Level II hospital, as follows: A hospital provider of Level I adult cardiovascular services program must ensure it has systems in place for the emergent transfer of patients with intra-aortic balloon pump support to one or more hospitals licensed to operate a Level II adult cardiovascular services program. Formalized written transfer agreements developed specifically for emergency PCI patients must be developed with a hospital that operates a Level II adult cardiovascular services program. Written transport protocols must be in place to ensure safe and efficient transfer of a patient within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested at least every 3 months, with appropriate documentation maintained. Martin Memorial asserts that the rule is arbitrary or capricious because it does not include a requirement that a Level I hospital make provisions for the transfer of an elective patient to a Level II hospital. There is no credible evidence to support the assertion. There is no evidence that a patient undergoing elective PCI at a Level I would not be regarded as an emergent patient were circumstances such that an emergent transfer to a Level II hospital warranted. There is no credible evidence to suggest a rationale for transferring a non-emergent patient from a Level I to a Level II hospital. Martin Memorial asserts that the proposed rule enlarges, modifies or contravenes the enacting statute on grounds that, although AHCA is directed to adopt rules to ensure compliance "with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories," the proposed rule provides that "in case of conflicts between the provisions of this rule and the designated guidelines" the rule provisions "shall prevail." Such provisions appear in Proposed Rule 59A-3.2085(13)(j), Proposed Rule 59A-3.2085(16)(g), and Proposed Rule 59A-3.2085(17)(f). The enacting statute requires that hospitals licensed under the provisions of the proposed rules comply with guidelines "for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety." To the extent that guidelines that relate to elements other than "staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety," the enacting statute does not require compliance by properly- licensed Florida hospitals. Other than as addressed elsewhere herein, the evidence fails to identify any specific conflicts between the guidelines and the proposed rules and, accordingly, fails to establish that the cited proposed rules enlarge, modify or contravene the enacting statute.
Findings Of Fact Based upon the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner's facility opened in January of 1976 as the Hubert Rutland Hospital. Its name was subsequently changed to Gateway Community Hospital and, after purchase by petitioner, it became Humana Hospital Northside. Dr. D. K. Mukherjee, Board-certified in internal medicine and cardiology, came to petitioner's facility in 1976 for the prime purpose of developing a cardiac catheterization laboratory, and assisted in preparing a list of equipment necessary to begin operation of such a laboratory. On December 31, 1976, petitioner's predecessor entered into a medical equipment service agreement for cardiac catheterization and monitoring equipment. That equipment, costing less than $100,000.00, was delivered to the hospital on or before June 17, 1977. Since that time, cardiac catheterization procedures, as defined in Rule 10-5.11(15), Florida Administrative Code, have been performed on a continuous and regular basis at petitioner's facility in Special Procedures Room No. 3. Over the past eight to nine years, the longest interval between the performance of such procedures has been approximately one or two weeks. Special Procedures Room No. 3, while also utilized for other purposes, has the equipment, staff and support services necessary for providing the studies and procedures associated with cardiac catheterization. The hospital itself is capable of providing the ancillary diagnostic services, such as hematology studies, electrocardiography, chest x-rays, blood-gas studies, pathology, blood chemistry analysis and nuclear studies pertaining to cardiology. Prior to July 1, 1977, Certificate of Need review was not required for the purchase of cardiac catheterization equipment by a hospital unless it involved a capital expenditure of more than $100,000.00. Commencing on July 1, 1977, Certificate of Need review was required when a health care facility sought to provide a substantial change in service, defined as a service which was not offered on a regular basis within the prior twelve-month period. Section 381.494(1)(c), Florida Statutes, and Rule 10-5.02(19), Florida Administrative Code. Because of technological and scientific advances, petitioner desired to replace and update the equipment purchased in 1976 for the performance of special procedures. Accordingly, in April of 1984, it submitted an application for a Certificate of Need to replace special procedures equipment at a project cost of $1,269,000.00. The application, in Section 3 stating the need and justification for the project, noted that: "Our existing equipment is totally inadequate to perform state-of-the-art cardiac catheter- ization and coronary angioplasty. When we began performing cardiac catheterization in 1977 this equipment was adequate, but today it is totally unacceptable. This proposed equipment will not only provide state-of-the- art equipment for these procedures, but will do so in a cost-effective manner since combined utilization of such high cost equip- ment contributes to the reduction of the cost of medical care." HRS issued petitioner Certificate of Need number 3261 for the replacement of special procedures equipment at a total project cost of $1,269,000.00, as requested. However, in a cover letter transmitting the issued Certificate of Need to the petitioner, HRS noted: "Please be advised that neither this office, the Office of Licensure and Certification nor the Local Health Council has documen- tation to support the performance of cardiac catheterization procedures at this hospital." Local Health Councils are private nonprofit corporations which contract with HRS to conduct local planning activities, including the collection of data, the publication of various utilization reports and the development of Local Health Plans. When HRS reviews proposed health care projects which require a Certificate of Need, it utilizes the data submitted to it by the various Local Health Councils, particularly in those instances where its rules contain a methodology or formula which includes as a factor an accounting of existing facilities or services. Application of the methodology contained in HRS's rule for determining the need for additional cardiac catheterization laboratories requires a knowledge of the number of procedures performed per year by existing and approved laboratories. Rule 10-5.11(15), Florida Administrative Code. The Health Council of Pasco/Pinellas, Inc. collects data from hospitals within Pasco and Pinellas Counties regarding bed utilization and service information. Hospitals in the district are requested to complete and submit certain information on a "Monthly Hospital Utilization Form." Among the items of information requested is the number of cardiac catheterization procedures performed during the reporting period. The Health Council also publishes and distributes annual and semi-annual utilization reports for the district. There is no provision in the statutes or rules which require hospitals to report utilization or service data to the various Local Health Councils, and HRS itself does not require that such information be reported to it. It is not unusual for hospitals to report inaccurate, incomplete or inconsistent data to Local Health Councils. Indeed, it is recognized in the "1984 Annual Hospital Utilization Report for District V Pasco/Pinellas Health Council, Inc." that, while all hospitals in the District submitted monthly hospital utilization information, "One limitation to this report involves those institutions who did not, for various reasons, submit data for beds by service categories and/or data pertaining to specialty services." HRS Exhibit F, p. 1. The form utilized by the Pasco/Pinellas Health Council contains no definition of cardiac catheterization procedures and no directions as to how to complete the form. While it has regularly submitted a monthly utilization form to the Local Health Council, petitioner has never reported the performance of cardiac catheterizations at its facility. The various reports published by the Local Health Council do not list petitioner as performing cardiac catheterization procedures. While a health care facility may obtain a written determination from HRS that a given service is exempt from Certificate of Need review due to its "grandfathered" status, there is no agency rule or policy which requires a facility to obtain such a written exemption. It has generally been the agency policy that equipment and services acquired by a facility prior to the date that such acquisition became reviewable under the Certificate of Need law are not reviewable on a retroactive basis.
Findings Of Fact Lawnwood Regional Medical Center is a 225 bed community hospital in Ft. Pierce, Florida. It currently holds a CON to add an additional 50 beds. Lawnwood is owned and operated by Hospital Corporation of America, (HCA). On October 14, 1985, Lawnwood submitted a CON application for authorization to provide cardiac catheterization and open heart surgery programs at the facility. The project for both services would involve a total of approximately 10,000 sq. ft. of construction consisting of both new construction and renovation of the present facility, with a project cost of approximately $3.6 million. Lawnwood developed the project because it found a need therefor as a result of various visits to the administrator by physicians practicing in the area who indicated a growing demand for the services. The physicians in question indicated they were referring more and more patients to facilities out of the immediate area and the services in question were very much needed in this locality. The main service area for Lawnwood consists of the northern four counties of DHRS District IX, including St. Lucie, Martin, Okeechobee, and Indian River Counties. The majority of the cardiology practitioners in this service area find it necessary, because of the lack of cardiac catheterization and open heart surgery programs, to transfer patients to facilities either in Palm Beach County, which are from one to two hours away, or to facilities outside the District, primarily in Miami or the University of Florida area, which are even further. While many heart patients are not severely impacted by this, one specific class of patient, the streptokinase patient is. This procedure, involving the use of a chemical injected by catheter to dissolve a clot causing blockage must he done within a relatively short period of time after the onset of the blockage to be effective. However, this can he done outside a cardiac cath lab. A representative sampling of doctors testifying for Lawnwood indicated that during the year prior to the hearing, one doctor, Kahddus, sent 140 patients outside the district for catheterization procedures and 90 additional patients for open heart surgery. Other physicians referring outside District IX included Dr. Hayes - 4; Dr. Marjieh - 240; and Dr. Whittle - 12. Doctors indicated that the situation was so severe that some physicians practicing in the Palm Beach area, who have cardiac catheter and open heart surgery services available to them in the immediate locale are nonetheless referring patients outside the District for these procedures. No physician who does this testified, however. St. Mary's Hospital is a 358 bed not for profit hospital located in Palm Beach County. It has been issued a CON for a cardiac catheterization lab expected to come on line in April, 1987. Palm Beach Gardens Medical Center is a 204 bed acute care hospital which currently operates a cardiac catheterization laboratory and an open heart surgery program. It, too, is located in Palm Beach County. A second cardiac catheterization laboratory was scheduled to open at this facility in February, 1987. An additional cardiac catheterization laboratory is operating at Delray Community Hospital and this facility, as well as the currently existing facility at PBGMC are the only two currently operating cardiac catheterization laboratories within DHRS District IX. There are, however, other cardiac catheterization labs approved for District IX. These include the aforementioned second PBGMC lab, the aforementioned St. Mary's lab, one at JFK Hospital and one at Boca Raton Community Hospital. These latter four facilities are not yet operational. As to open heart surgery programs, only PBGMC and Delray Community Hospital have open heart surgery programs on line. JFK has been approved for an open heart surgery program. DHRS has promulgated rules for determining the need for cardiac catheterization and open heart surgery programs. These rules are found in Section 10-5.11(15) and (16), F.A.C. and establish methodologies based on use rates to determine need. The use rate for the applicable time period here, July, 1984 through June, 1985, is to be multiplied by the projected population for the District in the planning horizon, (July, 1987) which figure is then divided by 600 procedures per laboratory to determine the need for catheterization labs or 350 open heart procedures to determine the need for additional open heart surgery programs. The difficulty in applying this methodology to the current situation is in the calculation of the "use rate" used to measure the utilization of a service per unit of population. For the rule here, it is expressed as the number of procedures per 100,000 population. There is more than one way to calculate a use rate and the DHRS rules do not specify the method of calculation. An "actual use rate" is determined by applying the actual number of procedures performed within a particular geographical area in a particular time period. Data to determine an actual use rate for catheterization services or open heart surgery is not currently available in District IX, however. Applying the formula cited above to the existing figures, however, reflects a use rate of 62.3 procedures per 100,000 population in District IX. This is far below the 409.7 procedures per 100,000 population statewide. Lawnwood proposes to apply the statewide use rate rather than the District IX use rate because District IX is currently in a start up phase and does not have sufficient historical information available to provide an accurate use rate for the purpose of the need methodology. The lower the use rate, the lower the need will be shown to be. If the lower District IX rate is applied, in light of the numerous other laboratories coming on line approved already, there would clearly be no need for any additional services in either the catheterization or open heart surgery areas. Some experts offer as a potential substitute for the actual use rate a "facility based use rate" which involves determining the number of procedures performed in all hospitals within a particular geographic area for the applicable time period and dividing that number of procedures by the population of that area. DHRS evaluators employed this "facility based use rate" in their need calculations. At least one expert, however, contends that the "facility based use rate" is appropriate only when certain conditions exist. These include an adequate supply of facilities or providers in the area; historical, long-standing experience rather than start-up programs; and a lack of a high number of referrals outside of the particular area. Since these three conditions are not met here, it would seen that the "facility based use rate" would not be appropriate. In determining the statewide use rate of 409.07, Mr. Nelson, consultant testifying on behalf of Lawnwood, derived that figure by compiling utilization data for all hospitals in the state providing cardiac catheterization during the time period in question divided by the statewide population as of January 1, 1985. The resulting figure was thereafter converted into a rate per unit of population. A statewide figure such as this includes patients of all ages and it would appear that this is as it should be. Catheterization and open heart surgery services would be open to all segments of the state population and it would seem only right therefore that the entire population be considered when arriving at figures designed to assess the need for additional services. On the other hand, experts testifying on behalf of the intervenors utilized statistical manipulation which tended to indicated that the need, reflected as greater under Mr. Nelson's methodology, was in fact not accurate and was flawed. He that as it may, it is difficult to conclude which of the different experts testifying is accurate and the chances are great that none is 100 percent on track. More likely, and it is so found, the appropriate figure would be one more extensive than the population figures and resultant use rate for District IX alone and closer to the statewide rate across a broad spectrum of the population. When the fact that the older population of the District IX counties, the age cohort more likely to utilize catheterization and open heart surgery services, is greater in the District IX counties than perhaps in other counties north of that area, the inescapable conclusion must be reached that a use rate significantly higher than 62.3 would be appropriate. This may not, however, require the use of a statewide rate of 409.7. Utilizing, arguendo, the statewide use rate of approximately 409 procedures per 100,000 population results in a projected number of procedures of 4,576 in District IX if the projected population figure of slightly more than 1.1 million holds true. When that 4,576 figure is divided by the minimum number of procedures required by rule prior to the addition of further cardiac catheterization labs, (600),a need for 7.63 labs in District IX is shown. With six labs existing or approved, a net need of two additional labs would appear to exist since DHRS rounds upward when the number is .5 or higher. A similar analysis applied to open heart surgery, using a statewide use rate of 120.94 per 100,000 population results in a procedure number of 1,353 for the same population. Utilizing the DHRS rule minimum of 350 procedures per lab for open heart surgery procedures, a net yield of 3.87 programs would be needed in District IX in January, 1988. Subtracting the three existing or approved programs now in the district, and rounding up, would show a need of one additional open heart surgery program. These are the figures relied upon by Lawnwood. Accepting them for the moment and going to the issue of financial feasibility, DHRS apparently has agreed that the project costs for this facility are reasonable. Lawnwood has shown itself to be a profitable hospital and HCA is a large, well run corporation not known for the establishment of non- profitable operations. If one accepts that the actual utilization will approximate the projected utilization figures, then the operation would clearly be financially feasible. Both intervenors challenged the Petitioner's pro forma statement of earnings, but their efforts were not particularly successful. If Lawnwood can perform a sufficient number of procedures, then it should be able to break even without difficulty. Turning to the question of the impact that the opening of Lawnwood's facilities would have on the other providers or prospective providers in the area, both PBGMC and St. Mary's contend that there would be a substantial adverse impact on their existing services as well as on the prospective units already approved. Lawnwood proposes to service a portion of the indigent population with its two new operations. Were this to be done, indeed an impact would be felt by St. Mary's which is currently a substantial provider of indigent and Medicaid treatment and St. Mary's will be particularly vulnerable since it is in the start-up phase of its cardiac catheterization lab. Currently, PBGMC draws patients in both services from Martin and St. Lucie counties as well as from Palm Beach County. The percentage of patients drawn from these more northern counties is, while not overwhelming, at least significant, being 14 percent from Martin County and 9 percent from St. Lucie. Taken together, this constitutes 23 percent of the activity in these areas. St. Mary's anticipates a loss of 25 percent of its potential catheterization cases and if this happens, it will lose approximately $719,000.00 of its gross revenue in catheterization cases alone. St. Mary's further predicts that if Lawnwood's facility is opened, it will have difficulty recruiting and maintaining qualified personnel. PBGMC, figuring it's loss to be approximately $492,000.00, estimates that a layoff of nursing and other staff personnel or the redirecting them into other areas of the hospital would be indicated. PBGMC also refers to the cumulative impact not only of Lawnwood's proposal but of the other cardiac programs in the District which have been approved but are not yet on line. If all come into operation, PBGMC estimates it could lose as much as 69 percent of its activity in these areas. These negative predictions are not, however, supported by any firm evidence and are prospective in nature. From a historic perspective, it is doubtful that any lasting significant negative impact would occur to either PBGMC or St. Mary's overall operation by the opening of Lawnwood's facility. Turning to the question of staffing and its relationship to the issue of quality of care, there is little doubt that Lawnwood could obtain appropriate staffing for both its services if approved. Of the physicians already on staff at the facility, many are now certified and the hospital and the medical community plans training programs for those who are not. As to nurses and other support personnel, Lawnwood is satisfied that it can recruit from other HCA facilities and will recruit from the open market. It has a full time recruiter on staff. Quality of care is of paramount concern to the administration of Lawnwood. It has a current three year accreditation from the Joint Commission on Hospital Accreditation. It also has a quality control committee made up of both physicians and other staff members and the laboratory is approved by appropriate accrediting agencies. These same types of quality control programs would be applied to both new requested services as well. The rules in question governing the approval of cardiac catheterization laboratories and open heart surgery programs set down certain criteria for the approval of additional services which, as to the question of cardiac catheters states at subparagraph 15(o)1a that there will be no additional adult cardiac catheterization laboratories established in a service area unless the average number of catheterizations performed per year by existing and approved laboratories performing adult procedures in the service area is greater than 600. Much the same qualification relates to open heart surgery programs except that in that latter case, the minimum number would be 350 open heart procedures annually for adults and 130 for pediatric heart procedures annually. Ms. Farr, consultant for DHRS, feels that Petitioner's application would be inconsistent with the minimum standards set forth in the rule because she does not believe the Petitioner would do enough procedures in either cardiac catheterization or open heart surgery to meet the 600/350 criteria. She also contends that the proposal is not consistent with the District Health Plan, because the District plan requires the rule which addresses need be followed. Since, in her opinion, the application of the rule shows no need, there would be a violation of the District Health Plan if these proposals were approved. In the area of cardiac catheterization laboratories, of the six licensed and approved labs in District IX, only that existing currently at PBGMC is presently performing more than 600 procedures per year. Substantial testimony tending to indicate that a well organized cardiac catheterization lab can handle between 1500 and 2000 procedures per year, the 600 figure would tend to be a minimum and was so recognized by the drafters of the rule. No evidence was introduced by any party to show the numbers of open heart surgery procedures currently being performed in the three existing or approved open heart surgery programs in the District. Again, however, it would appear that DHRS criteria of 350 would be a minimum rather than an optimum or maximum figure. The parties have stipulated that as to the travel time criteria set forth in the rule for both procedures, 90 percent of the population of District IX is within two hour automobile travel time from availability to either or both procedures. It would further appear from an evaluation of the evidence, that while difficulty is experienced in arranging treatment for indigent transfer patients outside the District, little if any difficulty is experienced in arranging transfer treatment for those who can pay for the service. Little difficulty is experienced in securing treatment for these individuals in either Miami, Orlando, or elsewhere, and aside from inconvenience, there was no showing that a real, substantial health risk existed as a result of the transfer process. All things taken together, then, though the numerical evaluation under the rule process, applying a statewide use rate, tends to indicate that there is a "need" for this additional service, the subparagraph "o" criteria of 600/350 procedures requirement prior to authorization of additional service is not met.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Lawnwood's application for a CON to add a cardiac catheterization laboratory and open heart surgery program at its facility in Ft. Pierce, Florida, be denied. RECOMMENDED this 16th day of March, 1987 at Tallahassee, Florida. ARNOLD H. POLLOCK 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 16th day of March, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-1539 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. By Petitioner - Lawnwood 1 & 2. Accepted and incorporated. 3 & 4. Accepted and incorporated. 5. Accepted and incorporated. 6. Accepted and incorporated. 7. Accepted and incorporated. 8. Accepted and incorporated. 9. Accepted and incorporated. 10. Accepted and incorporated. 11. Accepted and incorporated. 12. Accepted and incorporated in substance. 13. Accepted and incorporated in substance. 14. Accepted and incorporated in substance. Rejected as indicating a need for 2 additional cath labs. Rejected as calling for determination of "not normal status for District IX. Accepted in general but rejected insofar as there is an implication that non-indigent patients experience "significant" difficulty securing treatment. Accepted. 19 & 20. Accepted as to the streptokinase patients specifically. Accepted but not considered to be of major significance. Accepted and incorporated. 23 & 24. Accepted and incorporated. 25 & 26. Accepted and incorporated. 27 & 28. Accepted and incorporated. 29. Accepted. 30 & 31. Accepted and incorporated in substance. 32. Rejected as not supported by the best evidence. 33-36. Accepted and incorporated. Rejected as contrary to the evidence. Accepted. 39-42. Accepted. By Intervenor - St. Mary's 1 - 4. Accepted and incorporated. 5 & 6. Accepted and incorporated. 7 - 9. Accepted and incorporated. 10. Rejected as not supported by the best evidence. 11 & 12. Accepted and incorporated. Accepted and incorporated. Accepted and incorporated. Rejected as not supported by the best evidence. Accepted. Accepted. Accepted. 19-21. Merely a summary of testimony. Not a Finding of Fact. 22-24. Summary of testimony. Not a Finding of Fact. Accepted as ultimate Finding of Fact. Rejected. Rejected as a summary of testimony. Not a Finding of Fact. Irrelevant. Accepted. Accepted. Subordinate. 32-36. Rejected as a recitation of testimony and not Finding of Facts. 37-40. Rejected as contrary to the weight of the evidence. 41 & 42. Accepted. 43-46. Accepted. Rejected. Irrelevant. Accepted. Rejected. By Intervenor - PBGMC 1 & 2. Accepted and incorporated. Accepted except for last sentence which is irrelevant. Accepted. Accepted and incorporated. 6 & 7. Accepted and incorporated. Accepted. 9. Accepted and Incorporated. 10 & 11. Accepted and incorporated. 12. Accepted. 13-16. Accepted and incorporated. Accepted. Accepted. Rejected ultimately as contrary to the weight of the evidence. Accepted. Rejected. Accepted. 23 & 24. Accepted. 25 & 26. Rejected as contrary to the weight of the evidence. 27. Accepted. COPIES FURNISHED: Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Thomas A. Sheehan, III, Esquire 9th Floor, Barnett Centre 625 North Flagler Drive West Palm Beach, Florida 33401 R. Bruce McKibben, Esquire 1323 Winewood Blvd. Building 1, Room 407 Tallahassee, Florida 32301 Eleanor A. Joseph, Esquire Harold F.X. Purnell, Esquire 2700 Blairstone Road, Suite C Tallahassee, Florida 32314 Robert S. Cohen, Esquire 306 North Monroe Street Post Office Box 10095 Tallahassee, Florida 32302
The Issue The ultimate issue is whether the application of Venice Hospital for a CON should be approved. The factual issue is whether Venice Hospital meets the criteria set forth in the statute and rules.
Findings Of Fact The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law the Hearing Officer would recommend that this CON be granted with appropriate conditions relating to the maintenance of staff and the level of training of the staff which must be met and maintained in order for Petitioner to continue the operation of the laboratory. DONE and RECOMMENDED this 26th day of October, 1984 in Tallahassee, Florida. STEPHEN F. DEAN, 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 26th day of October, 1984. COPIES FURNISHED: Kenneth F. Hoffman, Esquire David Watkins, Esquire 646 Lewis State Bank Building Tallahassee, Florida 32301 Douglas Mannheimer, Esquire 137 North Calhoun Street Tallahassee, Florida 32302 Robert A. Weiss, Esquire The Perkins House 118 North Gadsden Street Tallahassee, Florida 32301 and Lamar Matthews, Esquire 1550 Ringling Boulevard Sarasota, Florida 33578 Courtesy Copy to: William B. Wiley, Esquire 666 Lewis State Bank Building Tallahassee, Florida 32301 =================================================================
The Issue The issue is whether the application for the certificate of need for a cardiac catheterization laboratory filed by Humana Hospital Bennett should be approved. The proceeding is governed by Section 381.705(1), Florida Statutes (1987), and Rule 10-5.011(1)(e), Florida Administrative Code. Humana Bennett and the Department maintain that Section 381.705(2), Florida Statutes, is inapplicable to this matter, but the other parties believe that statute applies. Not all subsections of these statutes or rules are in dispute, however. According to the prehearing stipulation, the following are either not in dispute or inapplicable: 1. Section 381.705(1) (c) , (e) , (f) , (g) (h) [except for the applicant's ability to recruit health manpower resources], (i),(j),(k),(m) 2. As to Section 381.705(2), subsection (e) is not in dispute. 3. As to Rule 10-5.011(1) (e), the following subparagraphs are not in dispute: 7.a., 7.b., 7.c., 7.d., 8.a., 8.b., 9.a., 9.c., 9.d., 9.e. (II) and (III), 13., 14., and 15.b. The parties dispute whether the application of Humana Bennett meets the following statutory and rule criteria for a certificate of need: 1. Section 381.705(1) (a), (b) , (d) , [as to health manpower] (1), and (n). As to Section 381.705(2), the following: (a) , (b) , (c) , and (d). 3. As to Rule 10-5.011(1) (e) , the following: 8.c., 9.b., 9.e.(I), 10., 11., 12., 15.a., and 15.c. FINDINGS OF FACT Description of the parties and their characteristics Humana Hospital Bennett is a 204-bed, acute care medical surgical hospital located in west central Broward County. It is the westernmost facility in Broward County. It is owned by Humana, Inc., and operated or profit. Western Broward is growing faster than the mature communities on the Atlantic Coast. Humana Bennett is fully accredited by the Joint Commission on Accreditation of Hospitals, and provides an array of services for the diagnosis and treatment of coronary disease including electrocardiology, echocardiology, nuclear medicine heart studies, stress testing, and other non-invasive procedures. It does not offer open heart surgery. Humana Bennett also has a 14-bed intensive care/coronary unit, a 22-bed intermediate care unit, and a progressive cardiac rehabilitation program. The Humana medical staff is composed of 460 physicians, 28 of whom specialize in the treatment of cardiovascular disease; 24 of these 28 are board- certified in cardiology. An additional 12 physicians are board-certified in cardiovascular and thoracic surgery. About 63% of all discharges at Humana are cardiac- related. This percentage has increased over time. In fiscal year 1985 52.3% of discharges were cardiac-related. Humana Bennett has contracts with health maintenance organizations for hospital services. These include the Humana Care Plus and International Medical Center health maintenance organizations which are owned and operated by Humana, Inc. About 65,000 Broward County residents are subscribers to these plans. The Humana Bennett catheterization laboratory would involve 2,500 square feet of new construction and 750 square feet of renovation. The hospital projects that the laboratory will be operational by September 1989. The laboratory would be capable of providing a full range of diagnostic cardiac catheterization procedures, which would include a cardiac catheterization laboratory, a control area, a storage area, a darkroom, and other related preparation, recovery and support areas. The total project cost would be approximately $1,302,600. There are both diagnostic and therapeutic uses for catheterization; the therapeutic uses include angioplasty. By Department rule, only a hospital with an open heart surgery program may perform angioplasty. Humana Bennett's laboratory could perform only diagnostic catheterizations. The South Broward Hospital District was created by a special act of the 1947 Florida Legislature, Chapter 24415, Laws of Florida, as an independent taxing authority. It does not operate to produce a profit. It was created to provide health care services to the residents of south Broward County by constructing and operating health care facilities serving all types of health care needs within its boundaries. It provides services without regard to the ability of district residents to pay for health care. The service areas of South Broward's hospital (Memorial Hospital) and Humana Bennett overlap, and numerous physicians are on the staff of both facilities. If the Humana Bennett application is approved, the number of cardiac catheterizations performed at Memorial Hospital will be reduced. The catheterization laboratory at Memorial Hospital generates a substantial amount of income for South Broward Hospital District. The initiation of catheterization services at Humana Bennett would reduce revenues at Memorial Hospital without any offsetting reduction in costs at Memorial. The substantial interests of the South Broward Hospital District are affected by the application filed by Humana Bennett. Over the years, Memorial Hospital has been expanded from a 100-bed facility to a 737-bed full service hospital. It is the only hospital in south Broward County which provides cardiac surgery, cardiac catheterization, physical rehabilitation with a distinct comprehensive unit, psychiatric services, pediatric surgical services, pediatric intensive care, full service neonatology, new born intensive care and progressive care, high-risk obstetric maternity care, and residential substance abuse programs. Some of the services Memorial Hospital provides are operated at a loss. Uncompensated care amounted to 22.1% of South Broward Hospital District's gross revenue in fiscal year 1987. The District projects that $44.9 million will be spent in the current fiscal year for uncompensated care. Operating revenues and the District's power to levy property taxes pay for the services provided to indigents. Memorial Hospital is the primary provider of services to the indigent and medically needy in south Broward County. Florida Medical Center is a 459-bed acute care hospital. It provides a broad range of cardiology services, including cardiac catheterization. It currently operates three separate cardiac catheterization laboratories. The first laboratory opened in 1974, the second two were equipped in 1983. The second laboratory was fully staffed at that time but the third was only fully staffed in December 1987. FMC has the present ability to perform three cardiac catheterization procedures simultaneously in its laboratories and the staff to perform procedures in that manner. Its third laboratory was opened primarily to accommodate the desire of physicians to perform catheterizations in the morning and is also used for other purposes. Florida Medical Center is located within five to six miles of Humana Bennett and under normal driving conditions the drive between the facilities takes 15 to 20 minutes. Florida Medical Center and Humana Bennett compete for patients within the same geographic area. Approximately 73% of the cardiac catheterizations performed at Florida Medical Center during 1987 were performed by physicians who are also on the staff of Humana Bennett. If the new cardiac catheterization service for Humana Bennett is approved, Florida Medical Center will lose patients and will therefore perform fewer catheterization procedures. Florida Medical Center would lose revenue without any offsetting reduction in its costs. The interests of Florida Medical Center are substantially affected by the CON application filed by Humana Bennett. Plantation General Hospital is a 264-bed general acute care hospital located in Plantation, Florida, which is in central Broward County. It is owned by and operated for profit by HealthTrust, Inc. It offers a broad range of cardiology services including cardiac catheterization. Its cardiac catheterization laboratory opened in April 1985. Plantation General is located approximately three and a half miles from Humana Bennett. Plantation General and Humana Bennett compete for substantially identical service areas and have overlapping medical staffs. Of the 37 cardiologists on the staff of Planation, 24 are also the on staff of Humana Bennett. Ten of 14 physicians performing cardiac catheterization procedures at Planation are on the staff of Humana Bennett. Approval of a cardiac catheterization service at Humana Bennett would result in fewer catheterizations being performed at Plantation. Plantation would suffer a loss of revenue without any offsetting reduction in costs. The interests of Plantation General Hospital are substantially affected by the CON application filed by Humana Bennett. FACTUAL FINDINGS CONCERNING THE APPLICABLE CRITERIA AGAINST WHICH THE APPLICATION MUST BE EVALUATED The criteria to be used in evaluating the application are found in statutes, and in the rules of the Department of Health and Rehabilitative Services which implement those statutes. The application will first be analyzed for consistency with Section 381.705(1), Florida Statutes, and, to the extent the rules make those criteria more specific, those considerations will be discussed in a later portion of this order. Consistency with Statutory Criteria Consistency with the state health plan and the District X local plan. Section 381.705(1) (a), Florida Statutes. a. The district health plan The District X Health Plan for 1985 is the most recent complete plan, and was the plan in effect when the Humana Bennett application was filed. it contains three recommendations relevant to approval of cardiac catheterization services. These are: Applicants for certificate of need approval should document either their intention and/or experience in meeting or exceeding the standards promulgated for the provision of cardiac catheterization and/or cardiac surgery by the appropriate national accreditation organization(s). Applicants proposing to initiate or expand cardiac catheterization or cardiac surgery must make their services available to all segments of the population regardless of the ability to pay. The provision of new cardiac catheterization or cardiac surgery programs should not be approved unless they meet or exceed the standards and criteria set forth by HRS. Humana Bennett is currently accredited by the Joint Commission on the Accreditation of Hospitals, and proposes to seek accreditation of its cardiac catheterization laboratory if approved. In 1985, Humana Bennett provided 1.2% of the total uncompensated care provided by Broward County hospitals. Humana Bennett's application, as revised in June 1987 in response to an omissions letter from the Department, proposed to provide 1% of patient days to Medicaid patients, 45% of patient days to Medicare patients, 43% of patient days to insurance patients, and 11% of patients days to private pay patients (Humana's exhibit 3, page 87).1/ Humana Bennett also has a Medicaid contract. Humana has the following emergency care policy for its hospitals Facilities will provide emergency care without regard to the patient's ability to pay. An indigent patient will be treated just as any other patient, and will receive whatever care is required to stabilize his/her condition. Non-emergency patients must make payment or arrangement for payment, before health services are delivered to them. (Humana exhibit 3, page 54.) For purposes of the Humana Bennett emergency care policy, indigent patients include "patients who are not eligible for Medicare or Medicaid, who do not have private or employer- provided health insurance, and who are unable to pay for their health care." Emergency patients are defined as patients "in a life or health threatening situation who require immediate treatment or hospitalization." After an attending physician determines that an indigent patient is stabilized, the patient is transferred to a hospital which receives government funds for indigent care; the Humana Bennett manager must approve this action before it is taken. All actions, including the attending physician's approval, are documented and maintained in the patient's business office folder. These policies indicate no substantial commitment to indigent care. Cardiac catheterization is not ordinarily an emergency procedure, but a diagnostic one. The existing emergency care policy, therefore, indicates that practically no catheterization will be done for indigents. This is inconsistent with the local health plan's requirement to make catheterization services available to all segments of the population. The application update submitted by Humana (exhibit 6, pro forma income statement) shows initial total patient revenues of $543,750, with a deduction of $27,188 for "indigent care/bad debt." This allowance is an indication of the amount the hospital expects to be unable to collect from patients it admitted with the expectation of payment. It is not the result of any community outreach to provide catheterization services to indigent residents of Broward County. The State Health Plan The 1985-87 State Health Plan discusses cardiac catheterization at pages 94 through 96. In the portion entitled "Criteria and Standards," the State Health Plan quotes from the Inter-Society Commission on Heart Disease Resources concerning the need for physical proximity and relationships between diagnostic catheterization facilities and open heart surgery programs. According to the Inter-Society Commission: ... there can be little justification for the development of these highly specialized facilities (cath labs) unless expertise in cardiology, cardiovascular radiology, and cardiovascular surgery are immediately available. Optimally therefore, catheterization laboratories should be located only in institutions with well organized and closely related programs of cardiovascular surgery. ... such an arrangement not only facilitates close inter-disciplinary cooperation and minimizes unnecessary, repetitive, inadequate, or unsafe diagnostic studies, but it also allows prompt intervention should life threatening complications develop during catheterization studies....it should be emphasized... that separation of the diagnostic laboratory from the surgical facility is less than optimal and may present serious problems. The National Health Planning Guidelines supports this emphasis through a recommendation that no new cardiac catheterization unit be opened in any facility not providing open heart surgery. (Humana exhibit 8) (emphasis supplied) Because there is no open heart surgery program at Humana Bennett, the proposal is inconsistent with the State Health Plan's clear preference for locating catheterization laboratories at facilities where open heart surgery is available. As discussed in section II B.3. of this order infra, the absence of a written referral agreement in the Humana Bennett application, identifying a facility with open heart surgery capability to which patients needing immediate open heart surgery will be transferred, is a serious deficiency in the application. 2. Availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization and adequacy of existing services. Section 381.705(1)(b), Florida Statutes There is no contention that existing cardiac catheterization laboratories in District X failed to provide quality care, and there is no geographic problem with the availability of catheterization services. Nothing in the Humana Bennett application would expand the availability of these services to segments of the population that are not currently being served for economic reasons. The issue of the efficiency and extent of utilization of existing services raises the question whether there is additional capacity in existing catheterization laboratories which ought to be utilized in preference to incurring the capital expenditure involved in constructing and equipping a catheterization laboratory at Humana Bennett. This consideration is related to the need calculation made under the Department rule discussed in a later portion of this order. When the Humana Bennett application was filed there were 10 existing laboratories in District X: one at Broward General, two at FMC, two at Holy Cross Hospital, two at North Ridge Medical Center, one at Plantation General, one at North Broward Medical Center, and one at Memorial Hospital. Shortly before the final hearing, Holy Cross Hospital reported that the physician who operates the catheterization laboratories there under contract with the hospital, Dr. Zachariah, had added a third laboratory. That physician opened the third laboratory for his own convenience, not because the volume of his practice required it. Florida Medical Center also added an additional laboratory for the convenience of cardiologists who practice there, which it also uses for other procedures. Expansion by existing providers can take place without certificate of need approval when the capital expenditure needed for expansion is less than one million dollars. These existing providers were able to add laboratories without the necessity of HRS approval. An additional laboratory also has been added to District X by the approval of the lab for imperial Point Medical Center, which had applied in the same batching cycle as Humana Bennett. No party objected to the issuance of that certificate of need, and therefore it should be considered in determining the statutory issue of the extent of the utilization and adequacy of like and existing health care services, because its services will be available at the planning horizon year, 1989 Humana Bennett could have prevented the consideration of that capacity by objecting to the grant of the certificate of need to Imperial Point and requiring a comparative hearing on the competing applications of Humana Bennett and Imperial Point but it decided not to do so. Some of the existing providers have argued that existing unused capacity at their facilities should be taken into consideration in determining whether there is a need for the Humana Bennett laboratory. Rule 10- 5.011(1)(e)12., Florida Administrative Code, provides in part that: The need for cardiac catheterization capacity in a service area shall be determined by computing the projected number of cardiac catheterization procedures in the service area. The capacity issue is therefore controlled by the provisions of the rule and will be discussed under the rule calculation. That competitors maintain they can provide more catheterizations than the rule projects for each provider is not legally relevant under this subsection of the statute. 3. The availability and adequacy of other health care services which may serve as alternatives to the services to be provided by the applicant. Section 381.705(1) (d), Florida Statutes. There is no persuasive evidence that there are other diagnostic procedures which serve as an alternative to cardiac catheterization which should be utilized in preference to catheterization. 4. Availability of resources including health manpower. Section 381.705(1) (h), Florida Statutes Nurses and technicians who work on cardiac catheterization teams have specialized skills and these skilled employees are difficult to recruit and retain. The proof demonstrates, however1 that Humana Bennett can staff the positions necessary for its catheterization laboratory by national recruitment and by cross-training of in-house nursing and radiology personnel. A catheterization lab requires cardiac care R.N.s, radiology technicians, and a specialized procedure/cardiovascular technician. Critical care nurses at Humana Bennett have already expressed an interest in becoming cardiac catheterization R.N.s and critical care nurses can easily be trained as cardiac catheterization nurses. Similarly, cross-training of existing radiology employees can fill the radiology technician positions. Humana Bennett has already received three resumes from cardiovascular technicians. 5. Probable impact of the proposed project on the cost of providing health services proposed by the applicant upon consideration of factors including, but not limited to, the effects of competition on the supply of health services being proposed. Section 381.705(1) (1), Florida statutes Humana Bennett projects gross revenue charges during the first year of operation of the catheterization laboratory of $1,450 and a net revenue per procedure in the first year of $913. The net revenue figure is lower because it reduces gross revenue by contractual allowances due to HMO/PPO discounts, and the difference between the hospital's customary charge and the amount reimbursed by Medicare or Medicaid for catheterization procedures. The gross charge for the second year of operation is $1,500 with a net revenue per procedure of $945. These projected charges are about the same as those charged by existing providers; FMC charges currently about $1,400-$1,500 with a net revenue of about $1,200-$1,300 for inpatient catheterizations. During the first four months of calendar year 1987, South Broward Hospital District (Memorial Hospital) charged about $1,431 for catheterizations. Plantation General charged approximately $2,300. Thus, there will be no increase in the charge for such procedures due to additional competition. There was no evidence from any existing provider that entry of Humana Bennett into the catheterization market would cause it to lose revenue to the point where any existing provider would withdraw from the catheterization market and thereby contract the supply of catheterization services. Providers do not have the option of simply raising charges to compensate for diminished market share because Medicare, Medicaid, and HMO/PPO charges are fixed, and open market competition will drive private pay patients to lower cost providers. Obviously, the entry of an additional provider into the market will reduce the current market share which existing providers enjoy. The certificate of need statute is not meant to protect competitors' incomes. While existing providers will be affected, the increased competition would be a positive impact, with the exception of the impact on the public health care provider, South Broward Hospital District. If the Humana Bennett catheterization laboratory is approved, South Broward Hospital District would lose approximately 50% of the catheterization procedures it now provides to persons who live in Humana Bennett's service area, and also would lose 10% of the referrals for open heart surgery or therapeutic catheterizations (angioplasty) for patients it would have served, but for the laboratory at Humana Bennett. The South Broward Hospital District would lose about $324,000 of net revenue. In 1987, South Broward Hospital District provided $41,392,000 in uncompensated care. Approximately 11 million dollars was provided by tax revenues and 30 million dollars was provided from profitable operations. This $324,000 probable loss in net revenue would add to the public hospital district's burden, but this revenue loss is not grave enough to restrict the entry of another competitor into the catheterization market in and of itself. 6. The applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent. Section 381.705(1) (n), Florida Statutes Humana Bennett maintains a Medicaid contract and does admit and treat Medicaid patients who present themselves. In fiscal year 1987, 5.31% of Humana's gross revenues were provided for uncompensated care, which equates to 3.15 million dollars. There is, however, no proof that this figure is anything other than money which the hospital had expected admitted patients to pay, but which, for whatever reasons, went unpaid. Accordingly, the proof is not persuasive that any portion of that 3.15 million dollar amount was generated by a conscious commitment on the part of Humana Bennett to provide hospital services to indigents on a charity basis. While prudent accounting requires a for-profit hospital to have a reserve for bad debts, it is not entitled to have its application viewed more favorably by passing off its bad debt reserve as if it were charity care. This factor, therefore, does not enhance the Humana Bennett application; neither does it detract from it. Consistency with rule criteria Service accessibility to undeserved population groups. Rule 10-5.011(1) (e)8.c. Florida Administrative Code This rule criteria requires little additional analysis to that already expressed above in Section II. A.1 and 6 of this order under Section 381.705(1)(b) and (n), Florida Statutes. While the applicant does propose to serve all persons needing catheterizations, including Medicare and Medicaid patients, the Medicaid projected utilization is only 1%, which is essentially cosmetic. It shows no real commitment to serve the medically needy and shows no commitment to indigent patients, as distinct from that group of patients which may be served but who may not pay their bills, thereby producing "bad debt" on the hospital's books. The emergency policy of the hospital is such that indigents would be eligible to be served in the unlikely event catheterization was needed on an emergency basis. The application, therefore, is sufficient to meet the requirements of this portion of the rule. The means by which it does so, however; does not enhance the application when balancing all of the statutory and rule criteria to determine whether the application should be granted. 2. Availability of health personnel. Rule 10- 5.011(1) (e)9.b., Florida Administrative Code The proof demonstrates that Humana Bennett has documented the ability to staff its cardiac catheterization laboratory under the standards in this rule. 3. Coordination of services. Rule 10-5.O11(1)(e)9.e.(I) Florida Administrative Code The rule requires that proposed cardiac catheterization laboratories and facilities not performing open heart surgery must submit, at the time of certificate of need application, a written referral agreement with a facility providing open heart surgery services which is within 30 minutes' travel time by emergency vehicle under average travel conditions. (emphasis supplied) It is undisputed that no referral agreement was included when Humana Bennett filed its application. Humana argues that it sought referral agreements with hospitals in the service district which offered open heart surgery, including Broward General Hospital, North Ridge Medical Center, Holy Cross Hospital, and Memorial Hospital, but none of those hospitals agreed to accept transfers from Humana Bennett. The executive director of Humana Bennett personally contacted an official of Florida Medical Center to obtain a referral agreement. That official specifically declined to enter into a referral agreement in order to prevent Humana Bennett from competing with FMC for cardiac catheterization services. There is no evidence that the other hospitals declined to enter into a referral agreement simply to block Humana Bennett's application. It may be that those other hospitals had other valid reasons for declining to enter into referral agreements. Nothing to the contrary was proven. Eventually, Humana Bennett did receive a referral agreement from the executive director of North Ridge Medical Center. It is dated January 8, 1988, six months after the Department of Health and Rehabilitative Services declared the Humana Bennett catheterization laboratory application complete. (Humana exhibit 30) Due to the absence of a referral agreement, the Humana Bennett application should have been rejected by the Department as incomplete when submitted. 4. Service costs. Rule 10-5.011(1)(e)10. Florida Administrative Code 43. The cost for cardiac catheterizations to be provided by Humana Bennett is projected to be about the same or less than the charges of current providers. The projected charges are reasonable. The application meets this portion of the rule. 5. Relationship with the state and local health plans. Rule 10-5.011(1) (e)11. Florida Administrative Code 44. This matter has already been discussed in Section II A.1. of this order with respect to statutory criteria 381.705(1) (a), Florida Statutes, and will not be repeated, except to say that the application is not consistent with the local and state health plans and therefore does not meet this rule criteria. 6. Need determination. Rule 10-5.011(1)(e)12. and 15. Florida Administrative Code The Department's rule provides that it will "not normally" approve applications for new cardiac catheterization services unless need is shown as calculated through an algorithm. See Rule 10-5.011(1)(e)6., Florida Administrative Code. The algorithm is found at Rule 10-5.011(1)(e)12., Florida Administrative Code. Several versions of how the formula should be applied were presented at the hearing. Witnesses for Humana Bennett and the Department of Health and Rehabilitative Services found need for an additional catheterization laboratory in Broward County according to their analysis of how "need" is defined in the algorithm. Health planners for FMC and South Broward Hospital District applied the algorithm in a manner demonstrating that there is no need for an additional catheterization service. The interpretations differed in two respects. First, the health planners disagreed on the number of catheterization procedures that were performed during the 12- month period that is used under the rule to establish an historical use rate, i.e., the number of procedures performed per 100,000 population in the district in the past. They also disagreed as to the number of catheterization laboratories presently operating in Broward County. The algorithm projects the number of catheterization "procedures" that will be performed for the year in which the catheterization laboratory will begin service. The laboratory obviously will not open on the date the application is filed; but at some date in the future. That future time is the "planning horizon" for which a projected use rate in the service area is determined. An actual use rate is first determined. It is the number of catheterizations performed per 100,000 population during the 12-month period which begins 14 months prior to the date the health care facility must file its letter of intent to file an application for a new service. This actual use rate is multiplied by the projected population at the planning horizon and then divided by 100,000. The result is the projected number of procedures at the planning horizon. The projection is divided by 600 in order to establish the number of catheterization laboratories that can be approved in the District. The number of existing laboratories is subtracted from that number to determine how many, if any, additional laboratories should be approved. It is important to determine the number of "procedures" performed in the applicable 12-month period to determine the actual use rate. The higher that number, the higher will be the number of projected procedures, and therefore the more likely it will be that additional laboratories may be approved. Rule 10-5.011(1) (e)2. and 4., Florida Administrative Code, defines the terms "cardiac catheterization" and "procedure" as follows: 2. Cardiac Catheterization. Cardiac catheterization is defined as a medical procedure used as a diagnostic and therapeutic tool for heart and circulatory conditions.... * * * 4. Procedure. Procedure means an angiographic study, a physiologic study or a therapeutic activity within a cardiac catheterization laboratory which utilizes the equipment customarily used in cardiac catheterization. These definitions are unclear because they are circular--a catheterization is defined as a procedure, and a procedure means a study utilized in cardiac catheterization. The term "study" is not defined by rule. Florida Medical Center contended that when a patient visited a cardiac catheterization laboratory, more than one study might take place as tubes are inserted into a blood vessel in the patient's arm or leg to diagnose circulatory conditions. Even if a patient undergoes multiple studies during one visit to the laboratory only one catheterization "procedure" takes place. In contrast, the Department of Health and Rehabilitative Services and Humana Bennett argued that if one patient underwent multiple studies during one visit, each should be counted as a different procedure. The substantive portions of Rule 10-5.011(1) (e) variously use the term catheterization or procedure. For example, in setting a minimum service volume for laboratories, Rule 10-5.011(1) (e)9.d. requires a minimum service volume defined in terms of cardiac catheterizations. On the other hand, in the need algorithm, the calculation is based upon the number of cardiac catheterization procedures. See Rule 10-5.011(1)(e)12., Florida Administrative Code. Rule 10-5.011(1) (e)15.a.(I), and c. further add to the difficulty in interpreting the rule by using the words "catheterization" and "procedure" interchangeably: There shall be no additional adult cardiac catheterization laboratories established in a service area unless: (i) The average number of catheterizations performed per year by existing and approved laboratories performing adult procedures in the service area is greater than 600;.... * * * Applications proposing to establish cardiac catheterization laboratories will not be approved if they would reduce the average volume of procedures performed by laboratories in the service area below 600 adult procedures. ...(Emphases added) The State Health Plan, Volume II, at page 95 contains a discussion which is informative on the issue of whether, in applying the need algorithm, one should count individual studies on a patient or patient visits, stating: Up until 1977 the literature showed a consensus on the need for minimum caseloads. Since 1977, expert opinion has become more divided on the issue, with many provider representatives advocating that the standards now reflected in federal and many state laws are no longer necessary and justifiable. However, a general opinion among the medical profession is that a certain minimum caseload is essential to assure quality results. ...The established federal and state minimum standards of 300 procedures annually for adult [patients] ... are believed to be adequate to maintain the expertise of the professional team engaged in this highly specialized service. (Humana exhibit 8) (Emphasis added) Thus, the term "cases," which focuses on number of patients, and "procedures" appear to be used synonymously. The National Health Planning Guidelines are referenced in the State Health Plan and were influential in the drafting of the catheterization rule. The Guidelines were published in the Federal Register on March 29, 1978, and Section 121.208(a) (1) of the Guidelines stated: There should be a minimum of 300 cardiac catheterizations,...within 3 years of initiation. in subsection (b), the Guidelines stated: Based on recommendations from the Inter-Society Commission on Heart Disease Resources, the Department [of Health, Education and Welfare] believes that a minimum level of 300 catheterizations per year is indicated to achieve economic use of resources. The report of the Inter-Society Commission on Heart Disease Resources, referenced in both the State Health Plan and the National Health Planning Guidelines, also assist in interpreting the use of the terms "catheterizations" and "procedures" in the Florida rule. That entity publishes a journal, Circulation, in which it is stated: To maintain adequate performance levels and to minimize risks, each team of physicians should perform, on the average, at least 600 adult examinations* a week, or 300 cases per annum. *An examination includes all cardiac diagnostic procedures (angiographic and physiologic studies) performed on a patient during one session in the laboratory. Report of the Inter-Society Commission for Heart Disease Resources. Circulation, Volume 53, No. 2, page 8-9 (1976) The Society's publications indicate an understanding that many patients have multiple procedures and specifically rejected a further breakdown of their caseload recommendation: in considering this matter, we have decided against further breakdown of caseload recommendations. The number of patients requiring only angiographic or physiologic evaluation is rapidly decreasing: in most cases both angiographic and selected hemodynamic studies are now performed. Therefore, in the hands of an appropriately trained and experienced team these "mixed" caseloads generally should be adequate to maintain an acceptable level of performance. Id. The Inter-Society Commission reports used the terms "procedure" and "case" interchangeably: Laboratories supporting an active coronary surgical program may generate a caseload close to 9 procedures a week or 450 cases per annum. Id. The representative of the Department of Health and Rehabilitative Services testified at the hearing, and stated her view that when referring to a minimum service volume of 300 catheterizations annually, Rule 10-5.011(1) (e)9.d. was speaking of the number of procedures, which could be 100 patients receiving 3 procedures, 150 patients receiving 2 procedures, or 300 patients receiving 1 procedure. Clearly more than one "procedure" can be performed during a visit to a laboratory, often through a single catheter inserted into a patient on a single occasion. Many of these "procedures" take just a few minutes. Each procedure or study may generate a separate billing to the patient, however. The more persuasive proof on how to properly county "procedures" under the rule was presented by FMC's expert health planner, Mr. Konrad, whose opinions are credited. Mr. Konrad had been employed with the Department of Health and Rehabilitative Services and had developed the first State Health Plan. He testified that the existing rule on cardiac catheterization came from the Inter-Society Commission for Heart Disease Resources Report, which is referenced in the Federal Health Planning Law. While the Florida rule has been amended since its first promulgation, no amendment has altered the original concept regarding the definition of procedure. According to Mr. Konrad the procedure means "a case" and all studies performed during one visit to the catheterization lab constitute one procedure. The number of cardiac catheterization procedures that were performed in laboratories in HRS District X during 1986 was 7,611. The laboratories then operating were located at Broward General, FMC, Holy Cross Hospital, North Ridge, Plantation General, North Broward Medical Center, and Memorial Hospital. The counts for the numbers of procedures performed at these laboratories were reported by the facilities to the District X Local Health Council. FMC originally reported it performed 2,166 procedures in 1986. Subsequently, officials at FMC realized their figures were erroneous and notified the Local Health Council and the Department that the correct number of procedures was 1,840. The lower figure is correct. The difference in figures is accounted for by the confusion over whether a single cardiac catheterization was a "procedure" or whether a single patient catheterized for a number of studies should have been recorded as the number of "procedures" equal to the number of studies performed. This reduces the total number of procedures performed in District X during 1986 to no more than 7,611. Fewer procedures than that were likely performed, because the Local Health Council never defined the term "procedure" for the hospitals reporting to it. Consequently the numbers are probably inflated somewhat because some hospitals incorrectly counted each study as a procedure, rather than counting only the number of patient visits for catheterization as one "procedure". The July 1986 population of Broward County was 1,165,922. This figure is divided by 7,611 to produce an actual cardiac catheterization use rate per 100,000 for District X in 1986, of 652.78. The total projected population for District X during 1989, the year in which Humana Bennett intends to open its service, is 1,234,484. When the 1986 use rate is applied to this population, the estimated number of procedures for 1989 is 8,058. This figure is then divided by 600 according to Rule 10- 5.011(1)(e)15.a.(I), Florida Administrative Code, to produce the number of laboratories needed in the District at the planning horizon, which is 13. At the time the application was submitted, there were 10 existing cardiac catheterization laboratories in the district. North Broward Hospital District filed in the same batch as Humana its application for a catheterization laboratory at Imperial Point. As stated earlier, that application was approved giving a total of 11 existing or approved laboratories. There is, therefore, a need projected by the algorithm for an additional laboratory which Humana Bennett can fill. None of the cardiac catheterization laboratories in Broward County are providing fewer than 300 adult catheterizations per year. The limitation on additional laboratories found in Rule 10-5.011(1) (e)15.a.(II), Florida Administrative Code, therefore does not prohibit the approval of an additional laboratory. Findings with respect to Section 381.705(2), Florida Statutes The prehearing stipulation indicates that Humana Bennett and HRS maintain that Section 381.705(2), Florida Statutes, is not applicable to this proceeding, while the other parties maintain that it does apply. Nothing in the prehearing stipulation explains the basis on which any party argues that this statute does or does not apply. The application discloses the total cost for the project is approximately $1,300,000. Consequently, it would appear to be a "capital expenditure proposal" as that term is used in Section 381.705(2) , Florida Statutes. The definition of capital expenditure found in Section 381.702(1), Florida Statutes, refers to the dollar limit of 1 million dollars found in Section 381.706(1) (c), Florida Statutes. Section 381.705(2) does apply, and the following findings of fact are made. 1. Less costly, more efficient or appropriate alternatives to inpatient services. Section 381.705(2)(a), Florida statutes 65. No party has proven that outpatient catheterization services are a more appropriate alternative to the catheterization laboratory purposed by Humana Bennett. Moreover, all parties have stipulated that the design and construction costs, as well as equipment costs and other miscellaneous costs in Humana Bennett's proposal are reasonable. Prehearing stipulation, section D. 4 and 5. 2. Use of the existing inpatient facilities in an appropriate and efficient manner. Section 381.705(2) (b), Florida Statutes 66. Existing catheterization laboratories are performing more than the minimum service volume prescribed in Rule 10-5.011(1)(e)9. d., Florida Administrative Code, of 300 catheterizations annually. On the average, they were also performing more than the 600 catheterizations annually required by Rule 10-5.011(1)(e)15. A. (I), Florida Administrative Code. 3. Alternatives to new construction such as modernization or sharing arrangements. Section 381.705(2) (c),Florida Statutes Given the demonstration of need pursuant to the need algorithm, the establishment of a new service is one appropriate method of meeting that need. Existing catheterization laboratories do have the capacity, however, to serve many additional patients. More extensive utilization of these facilities avoids the additional capital construction and equipment costs of opening a new cardiac catheterization laboratory. The ten existing cardiac catheterization laboratories each have the ability to perform, on the average, at least 1,000 catheterizations per year. The new laboratory at Imperial Point will also have a similar capacity. The laboratories in Broward County, therefore, have an ability to provide approximately 11,000 catheterizations per year (this ignores the intermittent use of the third "convenience" laboratories at Holy Cross and at FMC). Assuming the need for 8,060 catheterization procedures at the 1989 planning horizon, there is still an excess capacity, using only existing or approved laboratories, to provide annually an additional 2,940 catheterizations. More intensive use of existing and approved facilities would certainly be a more efficient way of providing catheterization services than is spending approximately $1,300,000 to construct and equip the laboratory at Humana Bennett. 4. Problems in obtaining inpatient care in the absence of the proposed new service. Section 381.705(2)(d), Florida Statutes There is no evidence that patients will have difficulty in obtaining cardiac catheterization services in Broward County if the proposed laboratory at Humana Bennett is not approved.
Recommendation It is recommended that the application of Humana Hospital Bennett for a certificate of need to establish a cardiac catheterization laboratory be denied. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 30th day of September, 1988. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1050 (904) 488-9765 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1988.
Findings Of Fact Case Status On October 15, 1986, Petitioner, Holy Cross Hospital, Inc. (Holy Cross), filed an application with the Respondent, Department of Health and Rehabilitative Services (Department), for a certificate of need to establish an inpatient cardiac catheterization laboratory at its existent acute care hospital in Broward County, Florida. On June 12, 1987, the Department published notice in the Florida Administrative Weekly of its intent to deny Holy Cross' application, and Holy Cross timely petitioned for formal administrative review. Intervenors, Zachariah P. Zachariah (Zachariah), North Ridge Medical Center (North Ridge), Florida Medical Center (FMC), and North Broward Hospital District d/b/a North Broward Medical Center, and Broward General Medical Center (North Broward), current providers of cardiac catheterization services in Broward County, sought and were granted leave to intervene in this proceeding. The standing of these intervenors, with the exception of Zachariah, is not in dispute. Background Holy Cross is a private, not for profit, general acute care facility located at 4725 North Federal Highway, Fort Lauderdale, Broward County, Florida. Currently, Holy Cross operates 574 general acute care beds and 23 intensive rehabilitation beds. Holy Cross has, since 1974, operated an open-heart surgery program at its facility. In 1974, Holy Cross sought leave of the Department to establish a cardiac catheterization laboratory at its facility. That application was denied. As a consequence of that denial, Holy Cross actively solicited physicians to establish such a program within its hospital. In August 1976, Holy Cross negotiated a ten-year lease with Zachariah whereby it leased him 2,833 square feet of space on the third floor of the hospital for use as a cardiac catheterization laboratory. Zachariah purchased the necessary equipment, and has operated a cardiac catheterization laboratory at Holy Cross since 1976. In March 1985, following Zachariah's expansion of his laboratory facilities, he and Holy Cross executed a new lease agreement to continue the operation of his laboratory within the hospital. This lease was for 6,956 square feet of space on the third floor of the hospital and was for a five year term commencing October 15, 1985, with a five year renewal option. Currently, Zachariah has three cardiac catheterization laboratories within the space he leases at the hospital. The proposed facility Holy Cross proposes to renovate and dedicate, as a cardiac catheterization laboratory, 2,500 square feet of existing hospital space immediately adjoining Zachariah's existing catheterization laboratories. The physical renovations are estimated to cost $315,000 and equipment to cost $600,000 for a total capital expenditure of $915,000. The laboratory, as proposed, is capable of providing a range of angiographic studies and physiologic studies without the need to move patients to perform related procedures. Holy Cross currently has the capability of providing immediate endocardiac catheter pacemaking in cases of cardiac arrest, and the proposed laboratory will likewise have such capability available to it. Currently, approximately 13 physicians practicing at Holy Cross possess such skills. Holy Cross currently provides, and will continue to provide, a ranged of non-invasive cardiac or circulatory diagnostic services within its health care facility, including: hematology studies and coagulation studies; electrocardiography; chest x-ray; blood gas studies; clinical pathology studies and blood chemistry analysis; nuclear studies pertaining to cardiology; and echocardiography. Additionally, Holy Cross currently provides, and will continue to provide, the following services within its facility: pulmonary function testing; and microbiology studies. As sited, the proposed cardiac catheterization laboratory will be readily accessible to the population of Broward County. Accessibility does not, however, present a problem in Broward County since all approved facilities are located strategically throughout the county. The hours of operation for the proposed laboratory will typically be either 8:00 a.m. to 4:00 p.m. or 9:00 a.m. to 5:00 p.m., with the capability of rapid mobilization of the study team for emergency procedures 24 hours a day, 7 days a week. Holy Cross is fully accredited by the Joint Commission of Accreditation of Hospitals (JCAH) for special care units, as well as its intensive and cardiovascular intensive care unit. The parties have stipulated that the staffing requirements proposed by Holy Cross are reasonable, and that it will be able to recruit the necessary staff. Currently, Holy Cross maintains an ongoing program of staff education and skills upgrading. Additionally, Holy Cross maintains an ongoing educational program for the community whereby citizens Acre afforded the opportunity to learn what specialty services are provided by the hospital. These programs will continue to be provided by Holy Cross. The proof established that Holy Cross can be reasonably expected to perform a minimum of 300 cardiac catheterizations annually within three years following its initiation of service. The proof further established that the average number of catheterizations performed each year by existing and approved laboratories performing adult procedures in the service area was greater than 600 and that, if the Holy Cross application is approved, the average volume of procedures performed by those laboratories would not be reduced below 600 procedures each year. The service cost proposed by Holy Cross is comparable to similar institutions within the service area when patient mix, reimbursement mechanisms and cost accounting methods are taken into consideration. Need determination The Department has established by rule the methodology whereby the need for cardiac catheterization capacity in a service area shall be determined. Pertinent to this case, Rule 10-5.011(e) 12, Florida Administrative Code, provides: Need Determination. The need for cardiac catheterization capacity in a service area shall be determined by computing the protected number of cardiac catheterization procedures in the service area. The following formula shall be used in this determination...(Emphasis added). In the instant case, the proof established that between July 1985 and June 1986 7,017 cardiac catheterization procedures were performed in the service area. The population estimates from the Office of the Governor, dated January 1, 1986, demonstrate an adult population within the service area of 962,987 for January 1986, and 1,009,557 for July 1988. Utilization of this data in the methodology prescribed by the rule, calculates that 7,356.3 catheterization procedures will be performed in July 1988 (the horizon year). When divided by the 600 procedure standard, there is a need for 12.26 cardiac catheterization laboratories in the service area to support the projected number of adult procedures in July 1988. At the beginning of the review cycle for the Holy Cross application the inventory of cardiac catheterization laboratories in the service area (Broward County) was as follows: Zachariah-3, Florida Medical Center (FMC)-3, North Ridge Medical Center-2, North Broward Medical Center-1, Broward General Medical Center-1, Plantation General Hospital-1, and Memorial Hospital-1, for a total of 12 laboratories. However, one of Zachariah's laboratories and one of Florida Medical Center's laboratories are backup laboratories, and no more than two laboratories are ever utilized or capable of being utilized at those facilities simultaneously. Pertinent to this case, Rule 10-5.011(e)1, Florida Administrative Code, provides: A cardiac catheterization laboratory is defined as a room or suite of rooms in a hospital which has the equipment, staff and support services required to perform angiographic and physiologic cardiac catheterization procedures, and which is customarily used to perform cardiac catheterization procedures. The number of cardiac catheterization laboratories in a hospital is equal to the number of patients who can undergo the catheterization procedure simultaneously... (Emphasis added). Accordingly, the proof demonstrates that for purposes of calculating the need for cardiac catheterization capacity in Broward County under the rule methodology that there existed 10 cardiac catheterization laboratories in the service area for this review cycle. Therefore, there exists a numeric need for 2.26 additional cardiac catheterization laboratories in Broward County. Consistency with State and Local Health Plans Pertinent to this case, the local health plan, District X, provides, as its general policy number 3, that: Services provided by all proposed and existing facilities should be made available to all segments of the residential population regardless of the ability to pay. Priority #1 - Services and facilities should be designed to treat indigent patients to the greatest extent possible, with new project approval based in part on a documented history of provision of services to indigent patients. Priority #2 - Applicants should have documented a willingness to participate in appropriate community planning activities aimed at addressing the problem of financing for the medically indigent. With specific regard to cardiac catheterization, the local health plan contains the following pertinent recommendations: Applicants proposing to initiate or expand cardiac catheterization...must make those services available to all segments of the population regardless of the ability to pay. The provision of new cardiac catheterization surgery programs should not be approved unless they meet or exceed the standards and criteria set forth by HRS. Holy Cross currently holds a Medicaid contract with the state, and proposes that its cardiac catheterization laboratory will be available to all persons in need and independent of their ability to pay. Holy Cross is not, however, an historic provider of significant indigent care, nor does it propose significant indigent care at its proposed laboratory. According to its application, the patient day percentage breakdown at its laboratory will be as follows: medicare-59.6 percent, medicaid-1.0 percent, insurance-36.0 percent, private pay-1.7 percent, and indigent-1.7 percent The proof demonstrates that Holy Cross' basic policy is to serve in a Christian-like manner, and to serve the indigent with open arms, respect and caring. In application, however, Holy Cross' "approach" to indigent care is "if they show up, we treat them." Clearly, Holy Cross does not actively promote the availability of its services to the indigent, and it offered no proof that it participated in any community planning activities aimed at addressing the problem of financing for the medically indigent. There was no proof, however, that indigent patients in Broward County (District X) were being denied cardiac catheterization care, notwithstanding the fact that over one-half of the laboratories in the county, (Zachariah, FMC, and North Ridge) have provided little or no medicaid or indigent care within the past 2 years. Under the circumstances, Holy Cross' failure to dedicate more resources toward indigent care is less significant than it might otherwise be if such need existed. However, it must still be concluded that the Holy Cross application is not consistent with the local health plan since its proposal to provide the services regardless of ability to pay is, in view of its "approach" to serving that segment of society, an obligation that will rarely, if ever, be fulfilled. To the extent the Holy Cross application may fail to comply with statutory and rule criteria, as hereinafter discussed, it is also not consistent with the local health plan. The state health plan devotes a section to cardiac catheterization, and the Holy Cross application conforms to the recommended minimum annual average of catheterization procedures, and the recommended physical proximity between open-heart surgical capacity and cardiac catheterization laboratories. The plan also provides as a goal, to assure the appropriate availability of cardiac catheterization and open-heart surgery services at a reasonable cost. As previously noted, the costs proposed by Holy Cross are reasonable. However, in view of Zachariah's existing facilities, the proposal does little of significance to enhance availability. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care services in the service district. The demand for cardiac catheterization services in the district has been increasing at a significant rate over the course of the past five years. Between 1982 and 1983 the number of cardiac catheterizations performed in the service area increased over 20 percent (from 4,162 to 5,009), between 1983 and 1984 there was an approximate decrease of 1 percent, between 1984 and 1985 there was an increase of 17.8 percent, between 1985 and 1986 there was an increase of 38.9 percent, and between 1986 and 1987 a projected increase of approximately 27 percent. Annualized data for 1987 demonstrates that 9,810 procedures will be performed in 1987. The historic demand for catheterization services within the district is a reliable proxy, and demonstrates that the demand for such services will increase by at least 20 percent in the year 1988. Such increase will result in the need to accommodate an additional 1,962 procedures in the year 1988, or 981 procedures by Holy Cross' planning horizon of July 1988. Accordingly, by July 1988 the district should experience a demand for approximately 10,791 procedures. During 1987, the existent facilities within the district were projected to perform the following number of procedures: Zachariah - 1,166, FMC - 2,134, North Ridge - 2,382, Broward General Medical Center - 1,430, Plantation General - 702, North Broward Medical Center - 532, and Memorial Hospital - 1,464. The maximum capacity of a cardiac catheterization laboratory is between 1,000 and 1,400 procedures annually, depending upon the mix of patients, the skills of the cardiologist, and the hours of operation of the laboratory. North Ridge's expert, Deborah Krueger, conducted a survey of existing facilities to discover what they considered to be the maximum number of procedures they could accommodate in each of their laboratories. While not wholly reliable, as hereinafter discussed, the responses regarding the maximum number of procedures that could be accommodated in each laboratory of the existing facilities was as follows: Zachariah - 1,000, FMC -1,250, North Ridge - 1,300, Broward General Medical Center - 1,040-1,248, Plantation General - 1,000, North Broward Medical Center - no response, and Memorial Hospital - no response. Comparing the number of procedures projected for existing facilities in 1987 with the results of Ms. Krueger's survey could lead one to conclude that there is an unused capacity within the district to accommodate up to 2,584 additional procedures in 1988. Such conclusion is not, however, supported by the proof. Notwithstanding Ms. Krueger's survey, the proof demonstrated that FMC is currently at capacity. North Ridge, which estimated it could perform 1,300 procedures per lab, is projecting 2,382 procedures in 1987, only 219 procedures less than its estimated maximum capacity. Yet, the North Ridge medical director is the only physician currently performing catheterizations at the hospital, and is sometimes doing up to 17 a day and working 12 hour shifts. Under the circumstances, to suggest that North Ridge is not currently at capacity is not credible. The only facilities with available capacity are Zachariah, Plantation General, and North Broward Medical Center. These facilities have the capacity to handle an additional 1,600 procedures in 1988: Zachariah (834), Plantation General (298), and North Broward Medical Center (468). Accordingly, there exists excess capacity within the district for the relevant time frame. As previously noted, there exists no accessibility problem within the district, and there is no proof that any patient has experienced any serious problem in obtaining catheterization services. There is, further, no dispute concerning the quality of care provided by existing facilities, and no issue raised concerning the efficiency and appropriateness of existing services. The ability of the applicant to provide quality of care and the applicant's record of providing quality of care Holy Cross has been a provider of a broad range of services within the district since 1959. The parties stipulated that the staffing requirements proposed by Holy Cross were reasonable, that it would be able to recruit the necessary staff, and that it had the necessary resources for project accomplishment and operation. Accordingly, no issue was raised concerning Holy Cross' ability to render quality care. Therefore, it is concluded that Holy Cross has provided, and will continue to provide quality care for its patients. Availability and adequacy of alternative services There was no evidence that any alternative service (a non-inpatient catheterization laboratory) is available within the district to satisfy the need for inpatient cardiac catheterization. Probable economies and improvements in service that may be derived from operation of joint, cooperative, or shared health care resources. Holy Cross and Zachariah have, since 1976, enjoyed a mutually beneficial arrangement, albeit one of landlord and tenant. At Holy Cross' request, Zachariah established a catheterization laboratory within the hospital's facility, and has since added two additional laboratories. But for a limited number of physicians, Zachariah's laboratory enjoys significant support from and is generally accepted by the physicians on the Holy Cross medical staff. Holy Cross has certainly benefited from this arrangement by being able to provide catheterization services for its patients within the facility, and as a referral base for its open-heart surgery program. Holy Cross does not contest the quality of care offered by Zachariah, nor does it point out any credible reason why their existing arrangement cannot continue to satisfy the needs of Holy Cross and the residents of the district as a whole. Holy Cross' rationalization for its need to initiate inpatient catheterization services is that Zachariah's service is a "closed" laboratory, and that if it were permitted to establish such services its laboratory would be "open." An open laboratory, Holy Cross asserts, would increase accessibility and improve quality of care. Holy Cross' contentions, and the proof it advanced to support them, are not credited. While the proof did establish that Zachariah's laboratory was closed, the proof also demonstrated that the laboratory proposed by Holy Cross would be closed. Further, quality of care, utilization, and accessibility are not favorably or unfavorably impacted within the district by virtue of whether a laboratory is classified as open or closed. Holy Cross' proposal is, essentially, a duplication of an existing program, sited within its own facility, that has the apparent capacity to meet the needs of Holy Cross and the community at large. Under the circumstances, the cooperative arrangement between Holy Cross and Zachariah offers a more economical alternative than Holy Cross' proposal. The need in the service district for special equipment and services not accessible in adjoining areas. There was no proof offered that any need existed in the service district for special equipment and services which are not reasonably and economically accessible in adjoining areas. The need for research and educational facilities. No proof was offered concerning the need for any research or educational facilities. Further, no proof was offered that Holy Cross proposed any such programs, or that its services would be available to health professionals for training purposes. Use of resources. The Department asserts that the proposed project is a waste of hospital space, a valuable resource, that could be more appropriately utilized in light of Zachariah's existing facility than through dedication as a catheterization laboratory. No proof was offered, however, to demonstrate what other health service would be a more appropriate use of such resource. The immediate and long-term financial feasibility of the project The immediate financial feasibility of the project is not at issue since the parties have stipulated that Holy Cross has the available resources for project accomplishment and operation. At issue, however, is the long-term financial feasibility of the project. Holy Cross premises its financial feasibility analysis on its projection that it will achieve 800 catheterization procedures in its first year of operation, and 850 procedures in its second year of operation. Holy Cross proposes a patient day percentage breakdown as follows: medicare - 59.6 percent, medicaid - 1.7 percent, insurance - 36.0 percent, private pay - 1.7 percent, and indigent - 1.7 percent. The rate per procedure advanced by Holy Cross is $1,000 during the first year of operation, and $1,050 during the second year of operation. Based on the foregoing assumptions, the Holy Cross pro forma statement of revenue and expenses projected a $57,700 net income at the conclusion of its second year of operation. That pro forma contains, however, several errors which must be considered. First, its bad debt assumption of $12,000 was understated by $24,000. Second, its overhead allocation of $183,600 was overstated by 50 percent ($91,800). Third, its expense line item for supplies failed to reflect a 5 percent inflation factor which results in a supply expense of $223,000 instead of the $213,000 projected by Holy Cross. Fourth, Holy Cross inappropriately adopted a 40 year depreciation schedule, as opposed to 20 years, for its renovations resulting in an understatement of depreciation by $8,000 per year. Adjusting the Holy Cross pro forma for the foregoing errors and omissions demonstrates that the proposed project will generate a net income of $107,000 at the conclusion of its second year of operation if it can attain its projected 850 procedures. Whether Holy Cross can attain such level of service is, however, problematic. By July 1988 there will be only 981 new cardiac catheterization procedures demanded within the district. Existing facilities with capacity will be competing for those procedures along with Holy Cross, and all facilities will be striving to maintain their share of the current market. Under the circumstances, it is not reasonable to conclude that Holy Cross can attain its projection solely from increased demand but, rather, that it must likewise compete with existing providers for a portion of their existing market share. Zachariah, whose existing laboratories are located on the same floor and adjacent to the facility proposed by Holy Cross has the capacity to accommodate up to 834 additional procedures. There is no dispute regarding the quality of care offered by Zachariah, and his service enjoys significant support from the physicians on the Holy Cross medical staff. To penetrate the catheterization market, Holy Cross must therefore not only disrupt physician referral patterns district wide, but must also disrupt such patterns within its own facility. Holy Cross did not, however, advance any plan to market its proposed service. To demonstrate its ability to attract referrals, Holy Cross undertook a physician survey which, if accepted, would demonstrate that it could capture 269 to 327 procedures. Such survey was not, however, independently verified and was otherwise not a reliable indicator of project utilization. At best, it demonstrated interest in an alternative facility, but its utilization projections were merely speculative. Holy Cross also pointed to the recent success of Plantation General as indicative of the reasonableness of its 850 procedure projection. Plantation General initiated its catheterization services in April 1985. Notwithstanding the fact that it was located in close proximity to FMC, had no open-heart surgery program, and had no referral base, Plantation General attained 759 procedures by the end of 1986. Juxtaposed with Plantation General, Holy Cross has a long-standing open-heart surgery program and broad physician referral base. While the Holy Cross analogy is inviting, it is unpersuasive. While Plantation General may have been at 795 procedures by the end of 1986, its 1987 performance dropped to 702. Additionally, North Broward Medical Center initiated service in January 1986, and it is projected to only reach 532 procedures by the end of 1987. On balance, the proof fails to demonstrate that Holy Cross can reasonably expect to attract the necessary referrals to reach its projection of 850 procedures, or any lesser number of procedures, that would render its project financially feasible in the long term. Needs of entities providing service to individuals not residing in the service district. There was no proof that Holy Cross provided a substantial portion of its services or resources to individuals not residing in the service district such as to demonstrate special needs and circumstances for its proposed project. The probable impact of the proposed project on the costs of providing cardiac catheterization services. Holy Cross stipulated that all intervenors, except Zachariah, have standing to participate in this proceeding. Accordingly, it is established, except for Zachariah, that the initiation of the proposed service will substantially adversely impact the existing cardiac catheterization programs at those facilities. There was, however, no reliable proof that such competition would adversely affect the supply of catheterization services. Likewise, there was no competent proof that such competition would improve the delivery of health services. Regarding Zachariah, the proof demonstrated that he would lose patients if the proposed service is initiated. While the magnitude of his loss could not be quantified because dependent on future events, it must be concluded that since Holy Cross would disrupt the existing referral patters he has established with Holy Cross' medical staff, Zachariah's program would be substantially adversely affected by the proposed project. Costs of Construction. The parties stipulated that the costs for construction and equipment are reasonable.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered denying Holy Cross' application for a certificate of need to initiate inpatient cardiac catheterization services. WILLIAM J. KENDRICK 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 12th day of February, 1988.
