The Issue The issues for determination in this case are whether the following statement was made by Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION; whether the statement violates the provisions of Section 120.535, Florida Statutes; whether the statement constitutes a declaratory statement under Section 120.565, Florida Statutes; whether Petitioner, ALL CHILDREN'S HOSPITAL, INC., has standing to maintain this action; and whether Petitioner is entitled to attorney's fees and costs. The alleged agency statement which is at issue in this case is: The Agency for Health Care Administration takes the position that a shared service agreement may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and the shared service contract remains consistent with the provisions of Rule 59C-1.0085(4), Florida Administrative Code. In addition, the Agency takes the position that modifications to a shared service agreement do not require prior review and approval by the Agency.
Findings Of Fact Petitioner, ALL CHILDREN'S HOSPITAL, INC. (hereinafter ALL CHILDREN'S), is a medical facility located in St. Petersburg, Florida, which provides pediatric hospital care. Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with statutory authority to issue, revoke or deny certificates of need in accordance with the statewide and district health plans. Intervenor, BAYFRONT MEDICAL CENTER (BAYFRONT), is an acute care hospital located in St. Petersburg, Florida. ALL CHILDREN'S and BAYFRONT are located adjacent to each other and are connected by a thirty-yard tunnel. In 1969, ALL CHILDREN'S began operation of a pediatric cardiac catheterization program. ALL CHILDREN'S pediatric cardiac catheterization program existed prior to the statutory requirement for a certificate of need to provide such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services, issued a certificate of need for ALL CHILDREN'S cardiac catheterization program. Since 1969, ALL CHILDREN'S has expended at least $500,000 on upgrading the cardiac catheterization program. Since 1970, ALL CHILDREN'S has operated a pediatric open heart surgery program. ALL CHILDREN'S open heart surgery program existed prior to the statutory requirement for issuance of a certificate of need to perform such service. Neither AHCA, nor its predecessor agency, Florida Department of Health and Rehabilitative Services (HRS), issued a certificate of need for ALL CHILDREN'S open heart surgery program. By letter dated May 13, 1974, HRS specifically advised ALL CHILDREN'S that modifications to the ALL CHILDREN'S open heart surgery program were not subject to agency approval. In May of 1973, ALL CHILDREN'S and BAYFRONT entered into a shared service agreement to provide adult cardiac catheterization services. In accordance with the shared service agreement, the actual catheterizations are performed in the physical plant of ALL CHILDREN'S and with equipment located on the ALL CHILDREN'S campus. BAYFRONT contributed to the adult cardiac catheterization shared service program by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. Beginning in 1975, BAYFRONT has also provided adult open heart surgery services through a joint program with ALL CHILDREN'S with the actual surgeries being performed at the physical plant on ALL CHILDREN'S campus. BAYFRONT contributed to the adult open heart surgery shared service by providing, inter alia, patients, management, medical personnel, and pre- and postoperative care. The shared service agreement between ALL CHILDREN'S and BAYFRONT to provide adult cardiac catheterization and open heart surgical services was in existence prior to the statutory requirement for a certificate of need to perform such services. Neither AHCA, nor its predecessor agency, Florida Department of health and Rehabilitative Services, issued a certificate of need to provide such services. The cardiac catheterization and open heart surgery program operated by ALL CHILDREN'S and BAYFRONT was "grandfathered" in because the program existed prior to the certificate of need requirement. Because no certificate of need was issued to ALL CHILDREN'S and BAYFRONT for its shared adult cardiac service program, no conditions have been imposed by AHCA on the operation of the program. "Conditions" placed on certificates of need are important predicates to agency approval and typically regulate specific issues relating to the operation of the program and the provision of the service such as access, location, and provision of the service to Medicaid recipients. The ALL CHILDREN'S and BAYFRONT cardiac shared services program is the only "grandfathered in" shared service arrangement in Florida, and is the only shared service arrangement operating without a certificate of need in Florida. An open heart surgery program is shared by Marion Community Hospital and Munroe Regional Medical Center in Ocala, Florida. The Marion/Munroe program operates pursuant to a certificate of need issued by AHCA. On December 22, 1995, AHCA published a notice of its intent to approve a certificate of need for a shared pediatric cardiac catheterization program between Baptist Hospital and University Medical Center in Duval County, Florida. BAYFRONT has applied for, but has not yet been issued, a certificate of need to perform cardiac catheterization services independent of the shared services arrangement with ALL CHILDREN'S. The agency receives hundreds of inquiries each year requesting information and guidance from health care providers regarding the certificate of need application process and other requirements of the certificate of need program. On more than one occasion ALL CHILDREN'S and BAYFRONT have inquired either orally or in letters to the agency regarding whether certain changes in their adult cardiac shared services program would require agency approval through a certificate of need application. In response to a 1990 written inquiry from ALL CHILDREN'S and BAYFRONT regarding modifications to the shared services agreement, the agency (then HRS) by letter dated September 18, 1990, stated in pertinent part that "the alterations you propose still constitute shared services." The agency response went on to state that it is therefore "...determined that they (the proposed changes) have not altered the original intent." On January 31, 1991, Rule 59C-1.0085(4), Florida Administrative Code, governing shared service arrangements in project-specific certificate of need applications was promulgated. The rule provides: Shared service arrangement: Any application for a project involving a shared service arrangement is subject to a batched review where the health service being proposed is not currently provided by any of the applicants or an expedited review where the health service being proposed is currently provided by one of the applicants. The following factors are considered when reviewing applications for shared services where none of the applicants are currently authorized to provide the service: Each applicant jointly applying for a new health service must be a party to a formal written legal agreement. Certificate of Need approval for the shared service will authorize the applicants to provide the new health service as specified in the original application. Certificate of Need approval for the shared service shall not be construed as entitling each applicant to independently offer the new health service. Authority for any party to offer the service exists only as long as the parties participate in the provision of the shared service. Any of the parties providing a shared service may seek to dissolve the arrangement. This action is subject to review as a termina- tion of service. If termination is approved by the agency, all parties to the original shared service give up their rights to provide the service. Parties seeking to provide the service independently in the future must submit applications in the next applicable review cycle and compete for the service with all other applicants. All applicable statutory and rule criteria are met. The following factors are considered when reviewing applications for shared services when one of the applicants has the service: A shared services contract occurs when two or more providers enter into a contractual arrangement to jointly offer an existing or approved health care service. A shared services contract must be written and legal in nature. These include legal partnerships, contractual agreements, recognition of the provision of a shared service by a governmental payor, or a similar documented arrangement. Each of the parties to the shared services contract must contribute something to the agreement including but not limited to facilities, equipment, patients, management or funding. For the duration of a shared services contract, none of the entities involved has the right or authority to offer the service in the absence of the contractual arrangement except the entity which originally was authorized to provide the service. A shared services contract is not transferable. New parties to the original agreement constitute a new contract and require a new Certificate of Need. A shared services contract may encom- pass any existing or approved health care service. The following items will be evaluated in reviewing shared services contracts: The demonstrated savings in capital equipment and related expenditures; The health system impact of sharing services, including effects on access and availability, continuity and quality of care; and, Other applicable statutory review criteria. Dissolution of a shared services contract is subject to review as a termination of service. If termination is approved, the entity(ies) authorized to provide the service prior to the contract retains the right to continue the service. All other parties to the contract who seek to provide the service in their own right must request the service as a new health service and are subject to full Certificate of Need review as a new health service. All statutory and rule criteria are met. By letter dated October 22, 1993, ALL CHILDREN'S and BAYFRONT inquired again of the agency regarding modifications of the adult inpatient cardiac shared service program. AHCA did not respond to the 1993 inquiry, and AHCA ultimately considered the inquiry withdrawn. By letter dated February 24, 1995, BAYFRONT made further inquiry of the agency, and requested agency confirmation of the following statement: The purpose of this letter is to confirm our understanding that the Agency for Health Care Administration ("Agency") takes the position that the shared services agreement between Bayfront and All Children's may be modified, without prior approval of the Agency, as long as each party continues to contribute something to the program, and that the shared services contract remains consistent with the provisions of Rule 59C-1.0085(4) F.A.C. By letter dated March 16, 1995, the agency made the following reply to BAYFRONT from which this proceeding arose: The purpose of this letter is to confirm your understanding of this agency's position with reference to the reviewability of a modifica- tion of the shared services agreement between Bayfront Medical Center and All Children's Hospital set forth in your February 24, 1995 letter.
The Issue The issue is whether respondent's license as a physician should be disciplined for the reasons cited in the administrative complaint filed on December 21, 1992.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background Respondent, Kenneth Aung-Din, is a licensed medical doctor having been issued license number ME 0051923 by petitioner, Agency for Health Care Administration, Board of Medicine (Board). He is board certified in emergency medicine having received his certification in 1994. When the events herein occurred, respondent was an emergency room physician at Memorial Medical Center (MMC) in Jacksonville, Florida. On the evening of February 21, 1991, V. P., a thirty-five year old female who was then eight months pregnant, presented herself to the MMC emergency room complaining of lower abdominal discomfort, difficulty urinating, and a five-hour history of nausea and vomiting. After being examined and treated by respondent, and diagnosed as having a urinary tract infection, the patient was released the same evening. Less than an hour later, however, the patient went into labor and delivered a new born. On December 21, 1992, the Board issued a two-count administrative complaint charging that, while treating V. P., respondent failed to practice medicine with that level of care, skill, and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances in that he "failed to obtain fetal heart tones, determine fetal position, and ausculatate for fetal heart tones with a doppler that was available to him in the ER when he examined (the) patient, who was a high risk near term obstetrical patient." The complaint further alleges that respondent failed to keep written medical records justifying the course of treatment of V. P., "including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations." Respondent denied all material allegations and requested this hearing to contest these charges. Did respondent deviate from the standard of care? On presentment to the emergency room nurse around 8:53 p.m. on February 21, 1991, V. P. complained of generalized abdominal pain and pressure since around 3:30 p.m. that day, with nausea and two episodes of vomiting. She also complained that she was unable to urinate since approximately 2:30 p.m. An additional complaint was allegedly made by the patient, but it is not a part of the nurse's notes and thus is hearsay in nature. The patient further disclosed that this was her second pregnancy. After recording in her notes the patient's complaints, the nurse, on her own volition, conducted a nitrozine test which was negative. It later came to light that the test was improperly conducted by the nurse, but respondent was never told this fact. Respondent first observed the patient around 9:08 p.m. and recalled that she "was obviously in discomfort." Based on V. P.'s complaints, respondent initially suspected that she might be in preterm labor. After obtaining a patient history, respondent palpitated V. P.'s abdomen for any pain, tenderness, abnormalities or contractions. Although V. P. was eight months pregnant, she was nontender and exhibited no signs of active labor. The patient also denied that she was having contractions. Based on V. P.'s primary complaint of urinary retention, respondent asked the nurse to insert a Foley catheter in V. P.'s bladder. Before the nurse did so, V. P. was able to urinate on her own accord. Even so, respondent ordered a catheter inserted around 9:30 p.m. to empty any residual in the bladder. This procedure yielded approximately 200cc. of urine which was used for a urinalysis test. By now, having urinated at least once, and having her bladder emptied, V. P.'s pain and discomfort had gone away, and she appeared to be "totally comfortable and with no complaints." After seeing the results of the nitrozine test around 9:55 p.m., respondent conducted a pelvic examination. Still considering the possibility of preterm labor, respondent inserted a vaginal speculum into the patient to see if there was any bleeding or fluid. Neither was present, and a manual examination of the patient revealed that the opening to her cervix was thick and closed. A patient in preterm labor would generally present signs of bleeding or fluid, and the cervix would have begun to open and "thin out." Given these findings, and the fact that V. P. was exhibiting no signs of labor or discomfort, it was reasonable for respondent to conclude that V. P. was not in preterm labor. The results of the urinalysis were reviewed by respondent around twenty minutes before the patient's discharge. By that time, she had voluntarily urinated at least three times since first arriving at the emergency room. The test results revealed 1+ protein, trace ketones, and 0-2 white and red blood cells. Also, they indicated that a sterile (uncontaminated) specimen had been taken, and that trace bacteria were present. Because trace bacteria, if not treated, can lead to "a very significant" urinary tract infection, and V. P. had previously experienced abdominal "pressure" and an inability to urinate, both signs of an infection, respondent prescribed Ampicillin, an antibiotic, on the assumption V. P. had a urinary tract infection. This diagnosis is not unusual for pregnant women, and even petitioner's expert agreed that V. P. had presented some of the "classical signs" of a urinary tract infection. After having observed the patient for almost two hours, during which time V. P. exhibited no objective clinical signs of active labor, respondent discharged the patient around 10:50 p.m. In doing so, respondent relied not only on the above observations, but also upon the results of his pelvic and abdominal evaluations, the urinalysis test results, and the fact that all of V. P.'s complaints (pain, nausea and vomiting) had been resolved. It was also reasonable to conclude that had the patient been in preterm labor, her symptoms would have progressed, rather than abated, during the two hours she was in the emergency room. At the time of discharge, respondent gave V. P. instructions to make a follow-up visit that week with her primary physician at University Medical Center (UMC), and if her condition did not improve during the interim, to return to MCC or call the "emergency department right away for further assistance." She was also given a prescription for an antibiotic for the urinary tract infection. Just prior to leaving the hospital, V. P. urinated one last time and allegedly told the nurse that she had started "spotting." Even if V. P. actually reported this critical fact, the nurse failed to disclose this to respondent, and he cannot be faulted for the nurse's omission. Had respondent known, or even suspected, that she had just begun bleeding, he would have sent her upstairs to the obstetrical wing for further observation. The complaint levels a number of criticisms at respondent's conduct which, if true, indicate that he failed to meet the appropriate standard of care. In addressing these criticisms, it should be noted that petitioner's own expert agreed that, at best, this was "a difficult case," and one that all emergency room physicians "hate to see." The complaint characterizes V. P. as a "high risk near term obstetrical patient." The use of the term "high risk" is based principally on the fact that an ultrasound conducted at UMC on February 19, 1991, revealed that the fetus was in a breech position. But respondent was never told this fact, and even petitioner's expert conceded that without this information, it was reasonable for respondent to consider V. P. as a normal risk pregnancy. The complaint first alleges that respondent "failed to assess the status of the fetus by neglecting to auscultate for fetal heart tones with a doppler that was available to him in the Emergency Department." A doppler is a device used to listen for fetal heart tones and, while not as effective as other monitoring devices, is nonetheless useful in detecting fetal distress or preterm labor. Here, respondent did not assess the status of V. P.'s fetus because her pain and discomfort had disappeared after her urinary tension was resolved, and she no longer exhibited any signs, clinical or otherwise, of preterm labor. At the same time, while doppler machines were available in emergency rooms, including MMC, during the early 1990's when this incident occurred, it was not prevailing protocol for emergency room physicians to automatically conduct fetus monitoring for what they perceived to be normal risk pregnancies. While the standard for emergency room physicians has subsequently changed, and fetal heart tones are now routinely monitored on all pregnant women twenty weeks and above, respondent did not deviate from the prevailing standard of care in February 1991 by failing to use a doppler. The complaint next alleges that a prudent physician "would have telephoned (V. P.'s) treating physician from UMC, or the obstetrician- gynecologist on call in order to properly assess (her) condition." As to calling V. P.'s treating physician, however, the more persuasive evidence shows that it would have been imprudent to attempt to contact V. P.'s primary treating physician because she had been treated by an unknown resident at another hospital, and at that hour of the night the chance of speaking with that resident was highly improbable. Then, too, since her complaints had been resolved, there was no need to contact another physician. As to respondent's failure to obtain a specialist consultation, the more persuasive evidence shows that the diagnosis of urinary tract infection was reasonable under the circumstances, and after the patient exhibited no signs of distress for at least an hour and a half, her discharge was appropriate. While it is true, as petitioner suggests, that the initial complaints by V. P. of pressure, nausea, vomiting and abdominal pains can be signs of preterm labor, these complaints were resolved after the catheter was inserted, and there were no corroborating indications of labor. Then, too, based on the information at hand, respondent reasonably concluded that V. P. was a normal risk pregnancy. Finally, later inquiry disclosed that during her first pregnancy, V. P. was in labor for only fifteen minutes, a remarkably short period of time. Respondent was not aware of this fact at the time of treatment. As it turned out, V. P. experienced another remarkably short period of labor on the evening of February 21, 1991. In summary, the more persuasive evidence supports a finding that, while treating V. P. in February 1991, respondent practiced medicine with that level of care, skill and treatment which was recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. C. Adequacy of Medical Records The complaint generally alleges that respondent failed to keep written medical records justifying the course of treatment of the patient. In the history section of his notes for patient V. P., which have been made a part of this record, respondent made the following recordations: 2110 - 35-year old white female, eight months pregnant; complaining of unable to urinate; dysuria; feels like pressure; denies vaginal bleeding; no contractions; Under the physical examination portion of his notes, respondent reported as follows: white female, well developed, awake, alert, times 3. Abdomen, pregnant uterus equals 8 months; nontender. Pelvic - zero blood; oz thick and closed. Late entry - 2/26/91, Nitrozine Test performed, which was negative. Finally, under his diagnostic impressions and discharge instructions, respondent wrote as follows: UTI (urinary tract infection) Ampicillin 250 mg, q.i.d., for 7 times. Tylenol if needed. Follow up, UMC this week. Return if any problems. In responding to the charge that his notes were inadequate or incomplete, respondent agreed that the diagnostic impressions section would have been more accurate and complete if he had written "urinary retention- resolved/UTI" rather than "UTI" alone. This is because urinary retention was a secondary diagnosis which was resolved during the patient's visit. In this respect, the records are not adequate. In addition, because the records fail to note that V. P.'s symptoms of abdominal pain and pressure were resolved, they lack completeness. In all other respects, they are found to be adequate.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding respondent guilty of violating Section 458.331(1)(m), Florida Statutes, as described above, and that he be given a reprimand. Count I should be dismissed. DONE AND ENTERED this 1st day of October, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 1996. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Kevin W. Crews, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 W. Jerry Foster, Esquire 1342 Timberlane Road, Suite 101-A Tallahassee, Florida 32312-1775 Jerome W. Hoffman, Esquire Agency for Health Care Administration Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The basic issues in these consolidated cases concern whether Rule 10- 5.032, Florida Administrative Code, is an invalid exercise of delegated legislative authority. The validity of the rule has been challenged on both procedural and substantive grounds.
Findings Of Fact South Miami is an acute care hospital located in Dade County. South Miami has a open cardiac catheterization program which means any physician within the community can apply for privileges, and, if granted, perform cardiac catheterizations at South Miami. Until recently, it was a closed program. Doctors' Hospital is an acute care hospital located in Coral Gables, Florida. Doctors' has had a cardiac catheterization program since December of 1986, and is authorized to perform diagnostic catheterization on both inpatients and outpatients. Baptist is a 500 bed full service hospital located in Dade County. Baptist has a cardiac catheterization program serving both inpatients and outpatients. Approximately 2,000 cardiac catheterizations are performed at Baptist each year. Deering is a 260 bed hospital in Miami, Florida. The agency has noticed its intent to grant Deering a CON to initiate a cardiac catheterization program. The Agency for Health Care Administration ("AHCA") is designated as the single state agency to issue, revoke, or deny certificates of need and to issue, revoke, or deny exemptions from CON review in accordance with the district plans, the statewide health plan, and present and future federal and state statutes. In 1987, the certificate of need statute was amended to deregulate all outpatient services. At the same time, the capital expenditure cap was raised from $500,000 to $1 million, and the meaning of "major medical equipment" was redefined to include only equipment which has been approved by the United States Food and Drug Administration for less than three years for general usage. These changes had a major impact on the ability of health care providers to acquire and replace equipment. They could now acquire equipment virtually at will, with the Legislature only expressing a limited interest in controlling expensive emerging technologies. This legislative expression was a major policy change with respect to planning for the distribution of health care resources. Prior to these statutory changes, all cardiac catheterization services had been treated as inpatient institutional health services requiring a certificate of need. With the deregulation of outpatient services, without exception, outpatient cardiac catheterization laboratories were deregulated by the statutory changes. With cardiac catheterization equipment being totally deregulated, and the capital expenditure threshold raised, inpatient cardiac catheterization providers could now expand their catheterization facilities and completely replace their equipment without a certificate of need. For these reasons, the then existing cardiac catheterization rule could not be applied because the policy constraints articulated in it were no longer recognizable by the underlying statewide policy expressed in the amended CON statute. The rule then in effect controlled the expansion of existing laboratories in many cases because the necessary equipment for expansion exceeded the then existing capital expenditure threshold. Furthermore, that rule simply did not contemplate the development of unregulated outpatient cardiac catheterization services. These facts led AHCA to conclude that they could no longer control the capacity of existing providers to offer cardiac catheterization services. The rule in existence at that time was believed to be inoperable because it was based upon the assumption that an inventory of laboratories could be established and predicted for future horizons. Under the statutory changes, this assumption was believed to be no longer valid because the number of laboratories was subject to change without constraint at any given time. Initially, the rule amendment process began with internal discussions. Next, a work group was convened to discuss these specific issues. Next, various possible need methodologies were modeled using a variety of assumptions. An updated literature search was undertaken and the comments of the work group were considered. Subsequently, a rule was developed and circulated for internal review at AHCA. Finally, in April of 1988, the proposed amendment was published in the Florida Administrative Weekly. Administrative challenges were brought against the rule. Based upon concerns of the challengers, changes were made to the rule. The rule, with the changes, was filed for adoption with the Secretary of State on July 18, 1988. It became effective, according to the certification of the Secretary of State, on August 7, 1988, and remained in effect until November of 1991. On July 29, 1988, The changes were published in the Florida Administrative Weekly. Within 21 days of the Notice of Change publication in the Florida Administrative Weekly on July 29, 1988, but after the rule became effective, several challenges were launched against the Notice of Change. These challenges purported to be Section 120.54 challenges to proposed amendments. A final order was issued on June 30, 1989, on the challenges to the changes in the 1988 rule amendments. See Florida Medical Center, et al. v. Dept. of Health and Rehabilitative Services, 11 FALR 3904 (June 30, 1989). In the closing paragraphs of the Final Order in the FMC case, the Hearing Officer ordered the following: That the amendments to Rule 10- 5.011(1)(e), F.A.C., published by the Department of Health and Rehabilitative Services on July 29, 1988, with the exception of the amendments to paragraph 2(h), paragraph 3(c)III, and paragraph 6(a) and the amendment regarding the definition of "inpatient visit", are an invalid exercise of delegated legislative authority, because they were adopted by the Department without adhering to the proper procedures for adoption delineated in Section 120.54, Florida Statutes. That should the Department seek to proceed with the other revisions to the rule previously published on July 29, 1988, it must afford interested parties an opportunity to comment on the merits of those proposed revisions in the manner provided for in Section 120.54, Florida Statutes, with a new point of entry. An appeal of the Final Order was taken by AHCA. On April 9, 1991, the District Court of Appeals upheld the final order of the Hearing Officer, holding that, as to those changes which AHCA was without authority to make, it must either withdraw the changes or reinstitute the rulemaking process. AHCA worked closely with its attorneys and with the Joint Administrative Procedures Committee to come to agreement on the interpretation of the appellate court decision and on the procedure to follow to comply with the court's decision. On July 5, 1991, AHCA published its interpretation of the rule resulting from the Final Order affirmed by the District Court of Appeals, by withdrawing the portions of the rule which had been invalidated. A Section 120.54 challenge was mounted against this publication by South Miami Hospital and others, but the challenges were later voluntarily dismissed. On August 9, 1991, AHCA published the amendments it proposed to adopt to replace those which had been withdrawn. This publication was not challenged. These amendments were filed for adoption with the Secretary of State on October 22, 1991, and became effective November 11, 1991. The current version of the challenged rule, Rule 10- 5.032, Florida Administrative Code, reads as follows, in pertinent part: 3/ Departmental Intent. This rule amendment implements the provision of section 381.706 (1)(c), F.S., which provides that a certificate of need shall not be required for an expenditure to provide an outpatient service. This rule defines the requirements for the establishment of inpatient cardiac catheterization services, including minimum requirements for staffing, equipment, and a need methodology for cardiac catheterization programs. A certificate of need for the establishment of inpatient cardiac catheterization services shall not normally be approved unless the applicant meets all relevant statutory criteria, including the standards and need determination criteria set forth in this rule. A cardiac catheterization program which is established and utilized for the purpose of serving outpatients exclusively is not regulated under this rule. A cardiac catheterization program which provides services to inpatients, regardless of the reason for their admission, including but not limited to coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts, or pediatric cardiac catheterization, requires a certificate of need. Hospitals operating more than one hospital facility under the same hospital license in the same district, shall obtain a separate certificate of need for the establishment of a cardiac catheterization program in each health care facility. Definitions. Cardiac Catheterization. Cardiac catheterization is defined as a medical procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow. Cardiac catheterization also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries. Coronary Angioplasty. Coronary angioplasty is defined as a hospital inpatient procedure requiring the dilation of narrowed segments of the coronary vessels, via a balloon-tipped catheter. Catheterization Program. A cardiac catheterization program is defined as an institutional health service which is provided by or on behalf of a health care facility and which consists of one or more laboratories which comprise a room or suite of rooms, and has the equipment and staff required to perform cardiac catheterization serving inpatients and outpatients. A cardiac catheterization program approved for angioplasty services, or other types of therapeutic cardiac procedures shall have the additional necessary equipment and staff to perform angioplasty procedures. Approved Program. A proposed cardiac catheterization and angioplasty program, not operational as defined by this rule, for which a certificate of need, a letter of intent to grant a certificate of need, or a final order granting a certificate of need was issued, consistent with the provisions of 10- 5.008 (2)(b), Florida Administrative Code, on or before the most recent published deadline for agency initial decisions prior to publication of the fixed need pool, as specified in 10-5.008 (1)(1), Florida Administrative Code. Cardiac Catheterization Annual Program Volume. The cardiac catheterization annual program volume equals the total number of inpatient and outpatient admissions to the cardiac catheterization program, for the purpose of cardiac catheterization or angioplasty, for the 12-month period specified in paragraph (8)(c). A single admission is equivalent to one patient visit to the cardiac catheterization program. Each patient visit will be counted in determining the actual program volume regardless of whether the patient is an inpatient or outpatient at the facility performing the procedure, or has been admitted as an inpatient or outpatient at another facility. Inpatient. An inpatient is defined as a person who has been admitted to a hospital for bed occupancy for purpose of receiving inpatient hospital services. A person is considered an inpatient if he was formally admitted as an inpatient with the expectation that he would remain at least overnight and occupy a bed, even though it later develops that he can be discharged or that he is transferred to another hospital and does not actually use a hospital bed overnight. An inpatient of a hospital cannot be considered an outpatient of that or any other hospital at the same time. Outpatient. An outpatient is defined as a person who receives cardiac catheterization in a health care facility and does not meet the definition of inpatient in paragraph (e) [sic]. Service Planning Area. The service planning area for a cardiac catheterization program is the applicable HRS district unless cardiac catheterization subdistricts have been defined by the respective local health council and promulgated into rule by the department. . . . Operational Program. A new cardiac catheterization and angioplasty program approved by the department that has performed at least one inpatient or outpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or, in the case of programs which performed only outpatient cardiac catheterization prior to departmental approval, a program that has performed at least one inpatient cardiac catheterization as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool. Scope of Service. Each cardiac catheterization program shall be capable of providing immediate endocardiac catheter pacemaking in cases of cardiac arrest, and pressure recording for monitoring and to evaluate valvular disease, or heart failure. Applicants for cardiac catheterization programs shall document the manner in which they will meet this requirement. A range of non-invasive cardiac or circulatory diagnostic services must be available within the health care facility itself, including: Hematology studies or coagulation studies; Electrocardiography; Chest x-ray; Blood gas studies; and Clinical pathology studies and blood chemistry analysis. At a minimum a cardiac catheterization program shall include: A special procedure x-ray room; A film storage and darkroom for proper processing of films; X-ray equipment with the capability in cineangiocardiography, or equipment with similar capabilities; An image intensifier; An automatic injector; A diagnostic x-ray examination table for special procedures; An electrocardiograph; A blood gas analyzer; A multichannel polygraph; and Emergency equipment including but not limited to a temporary pacemaker unit with catheters, ventilatory assistance devices, and a DC defibrillator. Service Accessibility. Travel Standard. An adult inpatient cardiac catheterization program shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area's population provided that the cardiac catheterization program can meet other applicable statutory and related rule criteria. Hours of Operation. Every cardiac catheterization program shall have the capability of rapid mobilization of the study team within 30 minutes for emergency procedures 24 hours a day, 7 days a week. Applicants for new cardiac catheterization programs shall document the manner in which they will meet this requirement. Underserved Population Groups. Applicants for a cardiac catheterization program shall indicate the projected number of medically indigent and Medicaid patients to be served annually. Applicants shall indicate their past provision of health care services to medically indigent and Medicaid patients. Service Quality. Accreditation. Any health care facility providing inpatient catheterization only, or inpatient and outpatient cardiac catheterization, or angioplasty, must be fully accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) for special care units, or be accredited by the American Osteopathic Association. Availability of Health Personnel. Any applicant proposing to establish a cardiac catheterization program must document that adequate numbers of properly trained personnel will be available. At a minimum, a team involved in cardiac catheterization consists of a physician, one nurse, and one or more technicians. An applicant for a new cardiac catheterization program shall document that the following staff are available: A program director, board-certified or board- eligible in internal medicine, or radiology with subspecialty training in cardiology or cardiovascular, radiology; . . . A physician, board-certified or board- eligible in cardiology, radiology, or with specialized training in cardiac catheterization and angiographic techniques who will perform the examination; Support staff, specially trained in critical care of cardiac patients, with a knowledge of cardiovascular medication and an understanding of catheterization and angiographic equipment; Support staff, highly skilled in conventional radiographic techniques and angiographic principles, knowledgeable in every aspect of catheterization and angiographic instrumentation, with a thorough knowledge of the anatomy and physiology of the circulatory system; Support staff for patient observation, handling blood samples and performing blood gas evaluation calculations; Support staff for monitoring physiologic data and alerting the physician of any changes; Support staff to perform systematic tests and routine maintenance on cardiac catheterization equipment, who must be available immediately in the event of equipment failure during a procedure; Support staff trained in photographic processing and in the operation of automatic processors used for both sheet and cine film; and A Medical Review Committee which reviews medical invasive procedures such as endoscopy and cardiac catheterization. Coordination of Services. Cardiac catheterization programs proposed in a facility not performing open heart surgery must submit a written protocol as part of their certificate of need application for the transfer of emergency patients to a hospital providing open heart surgery, which is within 30 minutes travel time by emergency vehicle under average travel conditions. Cardiac catheterization programs which include the provision of coronary angioplasty, valvuloplasty, or ablation of intracardiac bypass tracts must be located within a hospital which also provides open heart surgery. * * * Service Cost. Cost data for cardiac catheterization programs, among similar institutions, shall be comparable when patient mix, cost accounting methods, labor market differences and other extenuating factors are taken into account. Need Determination. In order to assure patient safety and staff efficiency and to achieve maximum economic use of existing resources, the following criteria shall be considered in the approval of certificate of need applications for new adult cardiac catheterization programs. The minimum annual projected net program volume need for the establishment of a new adult cardiac catheterization program shall be at or exceed an annual program volume of 300 admissions for the service planning area. Applicants shall demonstrate that they will be able to reach an annual program volume of 300 admissions within 2 years after the program becomes operational. Need Determination. A new adult cardiac catheterization program may be approved if the difference between the projected program volume and the number of adult cardiac catheterizations performed in the service planning area during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, minus the number of approved adult programs times 300, is at or exceeds a program volume of 300 for the applicable service planning area. This need formula is expressed as follows: NN = PCCPV - ACCPV - APP Where: NN is the 12-month net adult program volume need in the service planning area projected 2 years into the future for the respective planning horizon. Net need projections are published by the department as a fixed need pool twice a year. The planning horizon for applications submitted between January 1 and June 30 shall be July of the year 2 years subsequent to the year the application is submitted. The planning horizon for applications submitted between July 1 and December 31 shall be January of the year 2 years subsequent to the year which follows the year the application is submitted. PCCPV is the projected adult cardiac catheterization program volume which equals the actual adult cardiac catheterization program volume (ACCPV) rate per thousand adult population 15 years and over for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, multiplied by the projected adult population 15 years of age and over 2 years into the future for the respective planning horizon. The population projections shall be based on the most recent population projections available from the Executive Office of the Governor which are available to the department 3 weeks prior to the fixed need pool publication. ACCPV equals the actual adult cardiac catheterization program volume for the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool. APP is the projected program volume for approved adult programs. The projected program volume for each approved program shall be 300 admissions. Irrespective of the net need calculated under paragraph (c), no additional cardiac catheterization program shall normally be granted unless ACCPV divided by the number of operational programs for the service planning area is at or exceeds a program volume of 300 patient admissions. * * * (g) Actual inpatient and outpatient migration from one service planning area to another shall be considered in the review of Certificate of Need applications. Decisions on certificate of need applications for the expansion of existing programs shall be made on the basis of the applicant's justification for the level of the proposed capital expenditure and the utilization of existing laboratories in the facility. The approval of an additional laboratory(ies) in a facility with an operational or approved inpatient program shall not reduce the net program need as calculated according to the formula contained in paragraph (8)(c). Briefly summarized, the current rule projects a number of anticipated admissions to cardiac catheterization programs in the horizon year by multiplying the current use rate (number of admissions per thousand adult population) times the projected population. If the difference between the current volume and the projected volume is greater than 300, a new program may be awarded, so long as all of the existing programs, plus the proposed program, are projected to perform an average of 300 admissions each. An approved program is assigned a value of 300 for purposes of determining the average. The rule takes into consideration the demographic characteristics of the population by establishing a use rate for cardiac catheterization services in a given service area. The use rate identifies the number of individuals per one hundred thousand who used the service in a defined recent historical period. If the demographics of an area cause the service to be used at a greater or lesser rate than the State as a whole, that fact will be revealed in the use rate. In the same way, the use rate takes into account the health status of the individuals seeking services in the service area because a deviation from normal health status will typically result in a higher or lower use rate than the State as a whole. Since the use rate is based on place of access to the service it is reflective of district-wide gross service use patterns. The rule need methodology does not take into account differences in service use patterns as between numbers of inpatient and numbers of outpatient cardiac catheterization procedures, nor does it take into consideration differences in service use patterns as between number of procedures performed in cardiac catheterization programs in facilities performing open heart surgery and numbers of procedures performed in cardiac catheterization programs in facilities not performing open heart surgery. An example of relevant service use patterns that are not taken into account by the rule methodology is the significantly higher utilization of cardiac catheterization laboratories located in facilities that also offer open heart surgical back-up. Cardiac catheterization laboratories in facilities that do not offer open heart surgical back-up receive only seven percent of the inpatient admissions from the MDC-5 patient pool, compared to thirty-eight percent in cardiac catheterization laboratories with open heart surgery back-up in the same facility. Similar differences in service use patterns are reflected at Tab "D" of SMH Exhibit 10, which shows that there were a total of 9,362 inpatient admissions in the laboratories with open heart surgical back-up, compared with only 553 total inpatient admissions in cardiac catheterization laboratories without open heart surgical back-up. The rule addresses quality of care standards at paragraph (5), headed "Service Quality." Within that section, applicants must document accreditation for special care units, availability of adequate numbers of specified properly trained personnel, and medical review procedures. Paragraph (6) of the rule, entitled "Coordination of Services", also establishes quality standards by requiring a written protocol for the transfer of emergency patients to a hospital providing open heart surgery by providing that only hospitals authorized to perform open heart surgery can perform angioplasty, and providing that pediatric cardiac catheterization can only be performed in hospitals performing pediatric open heart surgery. Paragraph (8) of the rule, which contains the various considerations in determining need, also attempts to address quality of care considerations. The extent to which such considerations are adequately treated is addressed further below. Minimum cost efficiency standards are addressed in the need methodology at subparagraphs (8)(a) and (8)(b) of the rule where it requires that applicants must demonstrate that they will be able to reach an annual program volume of 300 admissions within two years after the program becomes operational and net need must equal a minimum of 300 admissions before a new adult program may be established. The extent to which these standards are adequate is addressed further below. Trends in total usage are taken into account by the rule in that the use rate is updated every six months. If a service area is experiencing a significant increase, that trend will be reflected in the updated use rate which is used to project need. But, as noted above, the rule methodology does not take into account certain usage trends related to type of patient or type of facility. The rule contains a geographic access standard at subparagraph (4)(a) where it provides that adult inpatient cardiac catheterization shall be available within a maximum automobile travel time of 1 hour, under average travel conditions, for at least 90 percent of a service planning area's population. The rule addresses market economics in several ways. First, by utilizing the number of admissions to the service area programs, second by projecting population into a future horizon, third, by subtracting the existing volume of providers and fourth by prohibiting, generally, the addition of a new program unless the average patient volume within the district is at least 300. Through the use of this data, the rule looks at current market conditions, and purports to protect current market share while projecting future need. The extent to which the rule is adequate in this regard is addressed further below. The rule does not take into consideration the number of individual catheterization laboratories, rather it considers the number of cardiac catheterization programs. The difference is that an individual hospital will have only one program, but it may have more than one laboratory in each program. Because of the ability of existing providers to expand to add new laboratories without certificate of need approval in most cases, it has become difficult for AHCA to establish and maintain an inventory of existing laboratories for the purpose of projecting need. This difficulty caused AHCA to reject any methodology based upon the number of existing laboratories because AHCA felt there was no way the number of existing cardiac catheterization laboratories could be predicted in the horizon year. AHCA does have the ability to control the growth of programs, however, and, therefore, can establish a reliable inventory of programs and predict their number in the horizon year. The agency's thinking in this regard overlooks the obvious fact that programs are, by definition, comprised of one or more cardiac catheterization laboratories and that existing programs can in most cases continue to add laboratories to their program without going through certificate of need review. Such being the case, the ability to regulate and reliably predict the number of future programs does not in any way enhance the ability to predict the number of future laboratories. Further, because programs are comprised of one or more laboratories, one can reach useful conclusions regarding such things as the efficiency or capacity of existing programs only by considering the number of existing laboratories within each of the existing programs. The extent of usage of any individual laboratory cannot be predicted in advance with certainty because it depends on many variables. This uncertainty is supported by the Florida data which demonstrates that laboratory admissions vary greatly from a very low volume after several years to volumes of 1800 to 2000. But because programs, by definition, are comprised of one or more laboratories, it is equally difficult, for the very same reasons, to predict the extent of future usage of programs. Difficult and uncertain as it may be to do so, any effort to predict future need for new cardiac catheterization services must take into account the capacity of the existing laboratories that make up the existing programs. The rule takes into account the recent usage volume of existing providers by subtracting existing volume of catheterizations performed from projected volume, and by protecting an average of 300 admissions to all inpatient programs, and a minimum of 300 for all approved programs. The rule does not, however, address the capacity of existing cardiac catheterization programs or the capacity of existing cardiac catheterization laboratories. The pre-1988 cardiac catheterization rule used a different formula entirely to predict need. As a minimum threshold requirement, it utilized an average of 600 procedures per lab. The National Guidelines For Health Planning 4/ upon which the previous standard of 600 procedures was based include the following provisions: Sec. 121.208 Cardiac catheterization. Standard. (1) There should be a minimum of 300 cardiac catheterizations, of which at least 200 should be intracardiac or coronary artery catheterizations, performed annually in any adult cardiac catheterization unit within three years after initiation. * * * There should be no new cardiac catheterization unit opened in any facility not performing open heart surgery. There should be no additional adult cardiac catheterization unit opened unless the number of studies per year in each existing unit in the health service area(s) is greater than 500. . . . Discussion. The modern cardiac catheterization unit requires a highly skilled staff and expensive equipment. Safety and efficacy of laboratory performance requires a case load of adequate size to maintain the skill and efficiency of the staff. In addition, the underutilized unit represents a less efficient use of an expensive resource and frequently reflects unnecessary duplication, Based on recommendations from the Inter-Society Commission on Heart Disease Resources, the Department believes that a minimum level of 300 catheterizations per year is indicated to achieve economic use of resources. Several State health planning agencies, such as New Jersey, suggested a higher minimum level and the Department will be considering whether a higher level should be established in the future. The Department has also determined the existing units should be performing more than 500 cardiac catheterizations or 250 pediatric cardiac catheterizations before a new unit is opened. The 500 level is based on an average of two catheterizations a day, a rate that is in the Department's judgement readily achievable in most institutions providing these services and that will foster more effective uses of current resources prior to the development of additional resources. More than 600 procedures are performed annually in some institutions. Pediatric cardiac catheterizations require special facilities and support services. Lower target numbers are presented in these cases because of the special conditions and needs of children. The established levels are consistent with the recommendations of the Section on Cardiology of the American Academy of Pediatrics and the Inter-Society Commission on Heart Disease Resources. The patient studied in the cardiac catheterization unit is frequently recommended for open heart surgery. While acceptable inter-institutional referral patterns exist in some areas, cardiac catheterization units should optimally be located within a facility in which cardiac surgery is performed. Other guidelines regarding the utilization and establishment of new cardiac catheterization laboratories appear in the 1983 Report of Inter-Society Commission for Heart Disease Resources. Page 898A of the Inter-Society Report includes the following: Although the rate of development of new cardiac catheterization laboratories has declined in recent years, there is concern that the performance of many laboratories is less than optimal. This represents a duplication of resources that may seriously compromise quality and safety of studies and increase cost of care. Study of costs of each laboratory on a per-procedure basis does not adequately characterize the total costs and/or needs of a region. A footnote to the above quoted language notes the following: Results of a recent survey suggest that many available laboratories are underutilized. Data indicate that 40 percent performed fewer than 300 catheterization studies per year in the 350 hospitals surveyed. Fifty-five percent of 310 hospitals performing open heart surgery did fewer than 200 operations per year. Additional relevant comments at pages 898A-899A of the Inter-Society Report include the following: There is also a compelling economic reason for high utilization of facilities (fig. 1). The cost of equipping and supporting laboratories is extraordinarily high. Equipment life is relatively short and must be amortized within 5 - 7 years and be included in the cost of the laboratory. If case loads are low, there will be an inadequate depreciation fund for new and replacement equipment. *** Laboratories performing adult studies should maintain a minimal case load of 300 per year to justify the financial outlay for the laboratory and personnel and to keep the skills of the personnel, both physician and non-physician, up to date. (Emphasis added) *** Laboratories supporting an active coronary surgical program should have a case load of approximately nine procedures a week, or 450 cases per year. In many hospitals, economic operation of the laboratory will require this level of use. (Emphasis in original) Figure 1 at page 898A of the Inter-Society Report illustrates the equipment amortization cost per examination and clearly shows that the cost per examination decreases as the number of examinations per year increases. The illustration shows that this decrease continues at least to the point of 1,000 examinations per year. Examples derived from Figure 1 are as follows: Examinations per year Amortized equipment cost each exam 200 Approximately $575.00 300 Approximately $400.00 400 Approximately $350.00 600 Approximately $275.00 1000 Approximately $250.00 Also, the ACC/AHA Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories published in 1991 by the American College of Cardiology/American Heart Association Ad Hoc Task Force On Cardiac Catheterization include the following at page 1167: For optimum laboratory performance and cost- effectiveness, an adequate caseload is required for the staff to maintain their skills and efficiency. The laboratory should be used only for cardiac catheterization procedures; use as a general or multi-purpose radiology room is no longer acceptable. If catheterizations are not performed on a daily basis, then the laboratory should not continue to exist as a cardiac catheterization laboratory. Laboratories for adult studies should maintain a minimum caseload of 300 per year. AHCA modeled several working drafts of the rule using different minimum standards. The standard of 300 was settled on because, according to the agency's interpretation of the Intersociety Commission guidelines, a cost efficient program can operate at the 300 level. Cost efficiency is a major goal of the certificate of need program. Since the agency believed the goal could be achieved at 300, and given the statutory changes which prompted the rule changes, it was felt by the agency that a higher number would be unduly restrictive. The agency's decision to use 300 as the threshold number of procedures is an unexplained deviation from the earlier 600-procedure standard, an unexplained departure from the National Guidelines For Health Planning, and an unexplained departure from other published guidelines recognized as authoritative. 5/ Unlike open heart, which does contain a provision providing a minimum threshold at which all existing programs must be operating, the agency felt such a provision was not appropriate for cardiac catheterization. Although the literature regarding cardiac catheterization generally supports the notion that a laboratory should perform at least 300 procedures per year to maintain proficiency and enhance quality, and most health planners agree that 300 procedures is aa appropriate minimum level to maintain proficiency and quality, because there did not appear to be any empirical evidence of quality differences above and below the 300 level, the agency felt that requiring all existing laboratories to be operating at the 300 level was not warranted. The literature also contains proficiency and quality guidelines for minimum numbers of procedures to be performed by physicians. The use of the number 300 as the threshold average number of procedures to approve additional programs results in the unnecessary duplication of services when the existing cardiac catheterization laboratories are operating below their capacity or below their practical utilization level. This has an obvious adverse effect on the existing laboratories. An essential ingredient of any functional need determination methodology is a method for identifying unmet need. In order to function rationally, the methodology must not only identify a reasonable estimate of future need, but must also identify a reasonable estimate of the future capacity of existing providers to meet that need. The subject rule fails to address the future capacity of existing providers, because in the normal course of events the capacity of an existing program, even a program comprised of a single laboratory, will be much greater than 300 procedures per year. As a general rule, the practical capacity of a cardiac catheterization laboratory is in the range of 1000 to 1500 procedures per year. 6/ Up to the point of practical capacity, there is a direct, but diminishing, relationship between increased numbers of procedures and increased cost efficiency. 7/ Cardiac catheterization laboratories can be operated very efficiently at a level of 80 or 85 percent of capacity. The failure of the subject rule to consider the future capacity of existing providers in calculating future need has an adverse effect upon the ability to accurately predict future unmet need and also has a potential for adverse effect upon the quality of care offered by the existing providers. The rule authorizes the approval of a new inpatient cardiac catheterization program even though many of the existing programs may be operating substantially below their capacity. The addition of new programs under such circumstances has the adverse effect of tending to reduce utilization of existing facilities that are already functioning well below capacity.
The Issue Whether disciplinary action should be taken against the license to practice medicine of Respondent, Howard E. Gross, M.D., based on allegations that he violated Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material to this proceeding, Respondent was a licensed physician in the State of Florida, having been licensed in 1971 and issued license number ME 0017039. Respondent has never been disciplined previously. Respondent is board-certified in internal medicine (1970) and cardiovascular diseases (1973). He is an interventional cardiologist. He has practiced medicine in Orlando since 1971. For the past 10 years, he has done a high-volume catheterization practice. In the most recent one-year period, he did approximately 500 interventional procedures and 400 diagnostic procedure, and in almost all instances, the catheterization involved a ventriculogram. On or about February 18, 1997, patient L. D. L., an 84-year-old male with a history of coronary artery disease, presented to Orlando Regional Medical Center, for catheterization and possible rescue angioplasty to be performed by Respondent. Respondent performed a cardiac catheterization on the patient. During the catheterization procedure, Respondent advanced a 6-French pigtail catheter into the patient's left ventricle and performed a ventriculogram by injecting what he thought was approximately 20cc of ionic dye, utilizing a MEDRAD injector. During the catheterization procedure, Respondent noted that he did not obtain opacification of the left ventricle and noted that free air was in the left ventricle. In fact, Respondent injected the patient with approximately 15cc to 20cc of free air rather than dye. As a result, the patient suffered cardiac arrest, and his blood pressure fell to zero. Respondent initiated various life-saving measures to counter the effects of the injection of free air, which were unsuccessful, and the patient was pronounced dead at approximately 1:55 p.m., as a result of cardiac arrest brought on by an air embolus. At the time, Orlando Regional Medical Center (hereinafter "ORMC") had a policy/procedure (No. 3233-MEDRAD- 0001) for Cardiac Catheterization Laboratory (hereinafter "Cardiac Cath Lab") personnel (Respondent's Exhibit 1). It delineated specific procedures to ensure "the use and safe applications of the power injector." In particular, it states the procedure to be employed by Cardiac Cath Lab staff in loading the MEDRAD injector. At ORMC and other hospitals, Cardiac Cath Lab personnel load the MEDRAD injectors without physician supervision. As explained by both expert witnesses, loading the syringe with dye is a very simple task for a nurse or scrub tech to perform. In the instant case, the nurse loading the MEDRAD injector interrupted the loading procedure because she was concerned about the patient's lab values (kidney function) and was uncertain about what type of dye Respondent would order. Respondent was not yet in the Cardiac Cath Lab. The nurse anticipated asking Respondent which type of dye he wanted and then loading that type dye into the MEDRAD injector. When she interrupted the loading procedure, the nurse left the plunger positioned in the syringe where it appeared that the syringe had been loaded with 20 to 25cc of dye and the injector arm pointing upward. The nurse then left the Cardiac Cath lab to get her lead apron anticipating only a monetary absence from the lab. Unknown to her, Respondent entered the Cardiac Cath Lab within seconds after her departure. Respondent was not in the Cardiac Cath Lab at any time while the nurse was manipulating the MEDRAD injector. As the nurse secured her lead jacket, she was called to another patient to administer medication which required the presence of a registered nurse per hospital procedures. In the nurse's absence, the catheterization and ventriculogram of the patient proceeded. The Registered Cardiovascular Technician (hereinafter "RCT"), observing the MEDRAD injector in what appeared to be a prepared state, wheeled it to the patient's side and lowered the injector arm into a position to receive the catheter. The RCT testified that a MEDRAD injector would never be left as she found it, plunger at the 20 to 25cc mark and arm elevated, if the machine was not loaded with dye. The ionic dye used in the procedure is clear and, due to the nature of the MEDRAD plunger and casing, it is extremely difficult to tell if dye is in the syringe. Further compounding the difficulty in observing dye in the syringe is the fact that the lights in the Cardiac Cath Lab are lowered during the procedure to allow better visualization of the video monitor. While the RCT positioned the MEDRAD injector at the patient's side, Respondent was in the process of entering the catheter into the patient, manipulating the catheter in the patient, visualizing its position in the patient's heart on the video monitor and monitoring hemodynamics. Petitioner's expert witness testified that Respondent did justifiably rely on the Cardiac Cath Lab personnel to follow the procedure outlined in Respondent's Exhibit 1. The nurse and cardiovascular technician did not follow the policy/procedure and, as a result, allowed the presence of air in the MEDRAD injector. After the catheter is properly located in the patient's heart, the external end of the catheter is attached to the MEDRAD injector. Petitioner's expert witness opined the Respondent should have used extension tubing to effect the connection between the catheter and MEDRAD injector. Testimony revealed that extension tubing is used by many physicians who perform cardiac catheterization. Respondent's practice was not to use extension tubing. Both Petitioner's and Respondent's expert witnesses agreed that Respondent's choice not to use extension tubing was a "technique" choice and did not fall below the "standard of care." Petitioner's expert opined that Respondent should have been present in the Cardiac Cath Lab to observe the loading of the MEDRAD injector. Testimony revealed that at ORMC and other hospitals it was the Cardiac Cath Lab staff's responsibility to load the MEDRAD injector without the direct supervision of physicians and that physicians are rarely in the lab when the MEDRAD injector is loaded. The "standard of care" does not require the physician to watch the loading of dye or the expulsion of air from the syringe in the loading process. Petitioner's expert opined that Respondent should have performed a test injection (a process where a small amount of dye is injected into the heart prior to the main injection). Respondent's expert testified that under certain circumstances (none of which is applicable to the instant case) test injections were appropriate; those circumstances occur less than 5 percent of the time. Electing not to perform a test injection in the instant case does not fall below the "standard of care." Petitioner's expert opined that Respondent should have observed a "wet to wet" connection between the catheter and the MEDRAD injector to ensure that no air is in the system. This is accomplished by withdrawing a small amount of blood from the catheter into the MEDRAD injector. Small air bubbles may appear between the blood and dye and are then "tapped" to rise to the top of the syringe. However, Respondent performed the "wet to wet" connection and did not observe anything unusual. He has historically performed some "wet to wet" connections where no air bubbles were present between the blood and dye as it appeared in this case. The RCT confirmed that Respondent performed the "wet to wet" connection, looked for air in the syringe, and tapped on the syringe to loosen and expel air bubbles. Respondent's expert witness testified that he performed an experiment creating a "wet to wet" connection with air in the MEDRAD injector syringe instead of dye. He found that the miniscus formed by blood and air in the syringe has an identical appearance to blood contacting dye in the syringe. The "wet to wet" connection between blood and air in the syringe has the same appearance as a "perfectly clean", "wet to wet" connection between blood and dye in the syringe. Respondent's expert witness testified that from five to ten percent of the time a "perfectly clean", "wet to wet" connection occurs in which no air bubbles appear between the blood and dye. Petitioner's expert witness testified that the physician must make absolutely certain that no gross amount of air is injected into the patient, and, relying on his view that the Respondent as the physician was the "captain of the ship," he testified that "the injection of this volume of air during the ventriculogram fell below the cardiology "standard of care." Petitioner's expert rendered his opinion based upon his examination of the hospital records. Respondent's expert rendered his opinion based upon his examination of the following: Administrative complaint with supporting documents. Dr. Allen Seals' (Petitioner's expert) report and deposition. Agency for Health Card Administration investigative report. ORMC's Code 15 report. Respondent's February 21, 1997 memo for peer review purposes. Hospital records. Death résumé. ORMC's MEDRAD policy/procedure. Experimentation with a catheter and MEDRAD injector. Respondent's expert testified that Respondent met the standard of care in the instant case because he practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Based on the totality of the evidence presented, the undersigned rejects the expert opinion of Dr. Allen Seals, M.D., Petitioner's expert witness, and accepts as being more credible the testimony of David P. Browne, Jr., M.D., Respondent's expert witness.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order finding that Respondent is not guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint. DONE AND ENTERED this 13th day of February, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK 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 13th day of February, 2001. COPIES FURNISHED: Ephraim D. Livingston, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert D. Henry, Esquire Martin D. Buckley, Esquire Ringer, Henry & Buckley, P.A. Post Office Box 4922 Orlando, Florida 32801-4229 Tanya Williams, Executive Director Department of Health Board of Medicine 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
The Issue The issue presented for decision herein is whether or not Proposed Rule 10- 5.005(2), Florida Administrative Code, as promulgated by DHRS constitutes an invalid exercise of delegated legislative authority. Based upon the following findings of fact, conclusions and analysis, proposed Rule 10-5.005(2)(a) and (b) is invalid.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. DHRS' Office of Health Planning and Development is divided into two separate divisions: The Office of Community Medical Facilities, which administers the State Certificate of Need Program and has responsibility for making recommendations regarding CON applications, and (2) the Office of Comprehensive Health Planning, which has primary responsibility for development of rules pertaining to Certificate of Need policy. Mr. Robert Maryanski, Administrator of the Office of Community Medical Facilities, believes his office made no formal comments (perhaps informal comments,) concerning the proposed rule. Mr. Maryanski considered that the proposed rule was objectionable based on his understanding of the statutes. (TR 33, 54). Elfie Stamm is employed by the Office of Comprehensive Health Planning and has primary responsibility for development of Proposed Rule 10-5.005. The text of the proposed rule is as follows: 10-5.005 Exemptions. * * * (2)(a) Physician offices or physician group practices which do not exist for the primary purpose of providing elective surgical care are exempt from certificate of need requirements for ambulatory surgical centers as specified in 10-5.011(30). This certificate of need exemption applies to offices and associated surgical suites maintained by one or more private physicians or a physician group which is used only by the physician or the physicians of the group practice, and in which 50 percent or more of the patients treated annually are non-surgical patients. (b) Physician offices, or physician group practices applying for designation as an ambulatory surgical center (ASC) by the Health Care Financing Administration (HCFA) and who meet the requirements for exemption from certificate of need review under the provisions delineated under paragraph (2), shall submit a request for exemption from certificate of need to the Department. The physician office or physician group practice shall provide the Department with at least 30 day's written notice of the proposed exemption from the certificate of need requirements for ambulatory surgical centers. Within 30 days of receipt of such written notice, the Department shall determine if the physician office or physician group practice is exempt and advise the applicant of its determination in writing. (Petitioner's Exhibit 6). The proposed rule exempts physician offices and physician group practices from CON requirements for ambulatory surgical centers (ASC) when at least 50 percent of the patients treated annually in these facilities are non- surgical patients. The proposed rule purportedly implements the Federal Health Care Financing Administration's (HCFA) policy allowing physician offices which are exempt from State CON and licensure requirements to apply directly (to HCFA) to receive ASC designation for medical facility reimbursement purposes without first obtaining a CON. Currently, "Ambulatory Surgical Center" means a facility, the primary purpose of which is to provide elective surgical care and in which the patient is admitted to and discharged from such facility within the same working day and which is not part of a hospital. However, a facility existing for the primary purpose of performing therapeutic abortions, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry shall not be construed to be an ASC. Section 395.002(2), Florida Statutes (1985). DHRS is trying to implement what it believes to be a statutory CON exemption for doctor's offices through the proposed rule. In so doing, HRS considers physicians' offices to be indistinguishable from physician group practices. In this regard, the relevant statutes do not reference physician group practices. Historically, HRS would not certify physician offices as medicare providers (in its role as surveyor for HCFA) because such certification entails the requirement that a physician's office comply with the State ASC Law. In short, a physician's office wishing to become an ASC had to satisfy both CON and State licensure requirements in order to be certified as a medicare providing ASC. Prior to promulgation of the proposed rule, DHRS never had a policy that group practices or physicians with operating suites are excluded from the statutory definition of an ASC. DHRS has no exemptions or exclusions for physicians' groups with surgical suites so that they could become ASCs for medicare certification. (Testimony of Tom Porter, previous supervisor for DHRS' Certificate of Need Program). DHRS took the position that it was without authority to grant an exemption to physician group practices and the related offices as an associated surgical suite without such facility having first obtained a CON as an ASC prior to offering such services. DHRS also took the position that a physician wishing to do minor surgical procedures as a sub-part of his office practice would not be required to obtain a CON as an ASC. These services could be done as an ancillary part of the physician's office. (Testimony of Gene Nelson, former Administrator, Office of Comprehensive Health Planning and Administrator of the Office of Community Medical Facilities prior to Mr. Maryanski's tenure with DHRS). Section 381.495, Florida Statutes, provides for several defined exemptions from CON review. As stated above, the proposed rule purports to grant an exemption to physician offices or to physician group practices from State CON requirements. Section 381.493 (3)(a), Florida Statutes (1985), states, in relevant part, that an office maintained by a physician for the practice of medicine is excluded from the definition of an ASC. The referenced statute does not grant an exemption from the ASC regulation nor has DHRS previously exempted a person or entity from CON review under such circumstances. DHRS has historically distinguished between a physician performing minor surgical procedures as an ancillary part of his office versus a full service ASC. HCFA clarified in Memorandum FQA-731, Ambulatory Surgical Center regulations relating to compliance with state licensure requirements and the application of state CON provisions as a prerequisite for medicare certification. (Pet. Exh. 8) In states where ASC licensure laws are in effect, facilities seeking to participate in medicare must meet such licensure requirements. Thus, 42 CFR Section 416.40 states, in pertinent part, that the ASC must comply with state licensure requirements. CON provisions must be met as a prerequisite for medicare licensure certification for an entity to operate legally within a state and CON approval is required before the decision to award a license is made. In instances where licensure is not required either by virtue of the absence of an ASC Licensure Law or the exemption of certain entities from the licensure law, compliance with CON provisions is not necessary for medicare eligibility as an ASC. It is through a series of correspondence between Mr. Robert Streimer of HCFA and Mr. Marshall Kelley, DHRS' Assistant Secretary for Program Planning that affords the proffered "basis" for the proposed rule. (TR 87). The Streimer letter provides that ASC services performed in a physician's office which is not required by state law to be licensed as an ASC and which meets all medicare ASC requirements would be covered and reimbursed by medicare at the ASC rate. As noted, DHRS historically took a different position. Nowhere in Mr. Kelley's letter to Mr. Streimer did HRS identify the specific criteria that would relate to an exemption request in Florida as currently stated in the proposed rule. DHRS, based on the proposed rule, now takes the position that any physician having a operating room and furnishing surgical procedures for less than 50 percent of his or her patients would be entitled to an exemption from CON requirements and in turn be entitled to apply for certification from HCFA as an ASC for ASC reimbursement (facility fee). The proposed rule allows for surgery currently performed in a physician's office to qualify for higher reimbursement from medicare (i.e., a facility fee). DHRS uses as authority for the proposed rule, Section 381.493(3)(a), Florida Statutes. Prior to receipt of Streimer's letter, DHRS considered HCFA's policy to be that if a facility did not have a CON and was not licensed as an ASC, there would be no medicare certification forthcoming from HCFA. The Streimer letter purportedly clarifies HCFA's policy although it does not represent a change in that policy. (Petitioner's Exhibit 6). The proposed rule defines "primary as 50 percent or more of the patients treated annually as being non-surgical patients. However, according to the 1982 federal regulations, an entity seeking application and certification as a medicare ASC must be dedicated exclusively to the provision of Ambulatory Surgical Services (42 CFR Section 416.2). Federal Rules provide that the requirement for ASC's to be certified in order to receive medicare payments was expected to exclude physicians offices. There appears to be no federal regulation dealing with reimbursement for the surgical procedures which are to be done in physicians' offices. To satisfy HCFA's certification requirements, an applicant must satisfy the relevant state licensure requirements if any, and meet federal certification requirements. As presently codified, it is impossible to simultaneously satisfy the proposed rule and the federal ASC definition contained in 42 CFR Section 416.02. Thus, an entity could not "exclusively" provide ASC services and at the same time not exist for the "primary" purpose of providing elective surgical care on an outpatient basis. They are mutually exclusive since the two definitions are inconsistent. The Streimer letter initiated HRS's evaluation of current statutes and the proposed rule is, according to HRS, designed to implement current statutes. HCFA's policy is that if a facility legally provides or is allowed to provide elective surgical procedures in Florida, without having to be licensed as an ASC or having gone through the CON process, it is inappropriate to require the facility to obtain a CON and be licensed as an ASC as a condition of that facility being approved for medicare reimbursement at the ASC rate. Prior to HCFA's correspondence, HCFA required an applicant for medicare ASC certification to meet State Law and also meet its certification requirements. This is still the case and the HCFA's correspondence to DHRS did not change that requirement. The purpose of the Health Facility and Health Services Planning Act, more commonly known as the CON law, (sometimes called the Act) is to protect the public health, safety and welfare of Floridians. These protections are further defined as a necessary increase in health care, minimizing duplication in health services, and minimizing situations where there is an underutilization of existing health care resources. The proposed rule does not relate to or otherwise address any "need" issue or capacity issue and contrary thereto, allows for uncontrolled growth of surgery suites as long as the physician group practice has 50 percent or more of total patients treated as non-surgical patients. It can be expected that there will be a proliferation of physicians, solo or group practices, with physician surgical practices developing in addition to hospital out-patient surgery. Additionally, there is no physical constraint on the location of the physician and a physician's group practice. Adoption of the proposed rule will also increase the cost of the total health care system in Florida as follows: The average cost per procedure increases when procedures are spread out over a greater number of fixed facilities and because of incentives that would be inherent in this additional capacity for additional unnecessary utilization. Physicians would receive a facility fee in addition to a professional fee. Physicians would thereby receive more money for doing the same procedures they are currently doing in their offices without the facility fee. The effect of the introduction of surgery centers where there is already excess capacity in hospitals and in freestanding surgery centers is to increase the cost of health care to the community. With the addition of new facilities, there are added fixed costs placed into the system that would remain until the facility becomes outmoded. With the addition of fewer procedures spread over more fixed costs, the average cost per procedure likewise increases even though the cost to an individual patient might appear to be lower in an alternative setting. Excess capacity leads to underutilization with the resultant increase in the rates for surgery. Without a capacity constraint, there will be more elective surgery performed. With the approval of the proposed rule, a doctor's office will be eligible for medicare reimbursement for a facility fee. Medicare reimbursement for a facility fee is unique to ASCs and does not apply to surgical procedures performed in a doctor's office. The purpose behind reimbursing for facility fees is that there is considerable overhead associated with performing relatively complex surgical procedures which require an operating room. If procedures are so simple as to be safely performed in a doctor's office, the intent of the rule is to distinguish between these two settings. It is desirable for procedures to be done in a doctor's office that are simple because it is the lower cost setting. Procedures performed in a physician's office will not qualify for the facility fee reimbursement and overhead payment because of the simplistic nature of the procedures and the lack of need for sophisticated equipment which is currently being used in ASCs. The federal regulations were intended to remove hospital surgery to ASCs, if appropriate, and to remove minor surgery to doctors' offices in order to avoid reimbursement for procedures which can be done in a less sophisticated setting. If more procedures are shifted to medicare certified ASCs, there would be an additional facility fee and physicians would be eligible for this reimbursement. An example of the operational effect of the proposed rule is the scenario surrounding Doctor Stephen S. Spector and the Presidential Eye Surgery Center in Palm Beach County. Doctor Spector was denied a CON for an ASC based on a lack of need for additional operating suites in Palm Beach County. After DHRS made its initial decision denying Dr. Spector's CON, he petitioned for a formal administrative hearing. A Recommended Order was entered denying Dr. Spector a CON and HRS then issued a Final Order denying a CON to Dr. Spector. Dr. Spector has since simply requested an exemption for a freestanding ASC pursuant to the proposed rule. DHRS will entertain this request and if granted, Dr. Spector will be entitled to medicare certification and a facility fee for surgical procedures performed in his office. The proposed rule will encourage the massive proliferation of outpatient surgery facilities and outpatient surgery suites. 3/ Evidence adduced at final hearing indicates that CON approved and licensed freestanding ambulatory surgery centers are currently underutilized and not operating at optimal capacity. The result will be increased hospital and ASC costs per unit because fixed costs must then be spread over a smaller patient base. It is likely that there will be underutilization of existing facilities. The proposed rule does not foster the purposes of Florida's CON law and it will not restrain increases in health care costs. The proposed rule will enhance or maximize unnecessary duplication and promote underutilization of existing resources. Pursuant to Section 120.54(2), Florida Statutes (1985), the Department is required to prepare an economic impact statement of the proposed rule. For the proposed rule, HRS states, in part, in its economic impact statement as follows: The proposed amendment is expected to have an economic impact on hospital outpatient departments and ambulatory surgical centers licensed by the State. It is expected that some Medicare patients who previously have been referred to hospital outpatient departments or a freestanding ambulatory surgical center licensed by the State may have their elective surgeries performed in the physician's group practice. In addition, the proposed rule may encourage the development of physician group practices with surgical suites since they are exempted from the certificate of need process and State licensure requirements. The fiscal impact on hospitals and ambulatory surgical centers cannot be estimated since the Department has no data regarding the number of potential applicants under this Rule, the location of those applicants, the volume of surgeries which may be performed by these entities, or the number of surgeries which would have been performed in hospital outpatient departments or State licensed ambulatory surgical centers in the absence of these new entities. (Petitioner's Exhibit 7). The economic impact statement for the proposed rule does not provide any data or method used in making the required economic impact estimates. The statement does not include any data to analyze whether the rule will impact ASCs having less than one million dollars net worth and less than 25 employees or whether the proposed rule will have an economic impact on hospitals and ambulatory surgery centers. Although HRS has indicated that the exact amount of the fiscal impact is impossible to estimate due to the unknowns respecting the number of physician offices or group practices that will qualify for the exemptions and therefore no analysis was undertaken or developed, studies could have been made to determine the effect any level of participation would have on hospital costs and utilization of existing facilities. Although the task of compiling such data would, no doubt, be arduous, evidence adduced at final hearing indicates that DHRS could have, with effort, compiled a data base with a stratified sample which would have been reliable and could forecast the likely effect of the proposed rule within an acceptable margin of error. DHRS did not compile data which would provide an estimate as to the number of patients who would choose the physician's office over other facilities that perform Ambulatory Surgery. DHRS never requested input from hospitals or outpatient surgery centers with respect to pay or patient mix. DHRS conducted no surveys with respect to the number of potential applicants under the proposed rule. DHRS considered it not relevant to examine the capacity of existing freestanding surgery centers or hospitals having outpatient surgery facilities. DHRS conducted no studies to determine the accessibility of existing ASCs and hospital ASCs. No studies were done to examine the impact, as to the cost to patients, that the proposed rule is likely to have on existing providers. No studies were done to assess the impact the proposed rule will have on the medicare trust fund. No studies were done to determine the impact, if any, on Florida small and minority businesses. It is true that a great deal of the needed data was not readily available to HRS whereas, on the other hand, it made no attempt to gather such data. DHRS has the ability to assess the number of surgeries that could be performed in hospital outpatient departments and ASC's since DHRS does such compilations on a day to day basis when it projects the need for new ASCs. DHRS could have commissioned studies to determine the effect any level of participation would have on hospital costs and utilization. Development of an adequate data base and a meaningful economic impact of the proposed rule is paramount in view of the legislative mandate (to DHRS) to contain health care costs. Rules are promulgated to further the purpose and objective of the statutes they implement. To accomplish this, they must be consistent with the statute. Here, the purpose of the statute is cost containment. Evidence adduced at final hearing reveals, without contradiction, that the proposed rule will increase health care costs, contrary to the major purpose for its existence. Finally, DHRS compiled no data as to the impact on the ability of hospitals to provide indigent care under the proposed rule. As example, Florida Hospital projects that it will provide $48,000,000 in uncompensated care for fiscal year 1986. If the hospital were to lose revenue as result of this proposed rule, the level of indigent care will also correspondingly be reduced in order to offset the loss of revenue. Other parties herein provide services to indigent persons. The proposed rule does not require these exempt facilities to provide indigent care. In addition to the above economic impact which will be brought about by the proposed rule on the Health Care system as a whole, the proposed rule will have an economic impact on the existing hospitals and ASC's. (TR 276-277; 438-440). As example, one Petitioner herein advises that if one surgery suite were added by an existing physician group or formed near the hospital, the hospital will lose approximately $481,000 per annum. By letter dated August 29, 1986, DHRS forwarded a copy of the purposed rule to the statewide and local health councils requesting comments by September 12, 1986. The public hearing on the proposed rule was scheduled for October 20, 1986. Neither health council (state or local) participated in the public hearing for the proposed rule nor has either council submitted comments respecting the proposed rule. The notice provided to the local and statewide health councils for comments on the proposed rule was adequate and afforded the various councils an opportunity to voice any concerns or provide input about the proposed rule. Dr. Montgomery, an Intervenor herein, will receive additional medicare reimbursements of $500.00 per patient for a facility fee under the proposed rule. Dr. Montgomery approximated that he performed 320 cataract surgeries per year of which approximately 300 patients are paying patients. Approximately 85 percent of those patients are over 65. Therefore, Dr. Montgomery will receive medicare reimbursement for 255 patients or approximately $127,500.00 in additional fees if his office is certified as exempt under the proposed rule.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioners and intervenors each own and operate hospitals in Broward or Dade Counties. Each facility has applied to the respondent for a Certificate of Need for approval to construct and operate a cardiac catheterization service at their respective bSopitals. Each application was denied on the ground that the challenged Rule 10-5.11(15), Florida Administrative Code, did not reveal a need for further cardiac catheterization laboratories in the respective service districts. A cardiac catbeterization laboratory is a specialized x-ray room designed for taking pictures of the heart or doing procedures referrable to the heart. Cardiac catheterization encompasses both diagnostic and, more recently, therapeutic procedures or maneuvers. As a diagnostic procedure, cardiac catheterization is the most reliable test for determining the presence of coronary disease. Within the last 3 to 5 years, cardiac catheterization labs have been used to perform therapeutic procedures, such as the installation of an enzyme to dissolve a clot, the use of PTCA (percutaneous transluminal coronary angioplasty) to open up blockages and the placement of permanent and temporary pacemakers. With wider acceptance of bypass surgery and new advances in anpioplasty, the use of cardiac catheterization has increased in recent years. At this point in time, the effect of other emerging technologies, such as NMR (nuclear magnetic resonance), upon the use of the cardiac catheterization technique cannot be determined. Prior to the adoption of the current challenged rule, HRS's predecessor rule reguired denial of an application for a Certificate of Need for a proposed new cardiac catheterization laboratory unless all existing labs in the service area were performing more than 500 catheterizations per year. The prior rule also reguired the existence of or approval for an open heart surgery service at the applicant's facility. In August or September of 1982, HRS started a review of this rule which ultimately led to the adoption of the oresent challenged rule. As pertinent to the issues raised in this proceeding, the challenged Rule 10-5.11(15) contains a formula methodology for determining the need for new cardiac catheterization laboratories in a service area. The formula requires the utilization of a base year use rate (the number of procedures per hundred thousand population in the service area) to be multiplied by the projected population in the service area in the year in which the proposed lab would initiate service, said year not to be more than two vears into the future. Such multiplication results in the number of catheterization procedures projected to be delivered at the time of initiation of the proposed new service. The rule further provides that no additional cardiac catheterization laboratories may be established in a service area unless the average number of catheterizations performed per year by existing and approved labs performing adult procedures in the service area is greater than 600. The challenged rule specifically states that HRS will consider applications in context with applicable statutory and rule criteria, and will not normally approve new labs unless additional need is indicated by the above formula and unless the 600 average procedures per lab reguirement is met. Rule 10-5.11(15)(f). The current rule deletes the requirement for open heart surgical potential at the applicant's facility. During the rule-making process which spanned from July or August of 1982 through January, 1983, the HRS Office of Health Planning and Development held informal meetings with representatives of the medical community and health planners, and considered the criteria and standards included in the national guidelines, in other states and in various health systems plans. Medical journals were consulted and numerous written comments were received from interested perSons. Several variations of the rule evolved, and a public hearing was held on December 10, 1982. Based on the manv public comments received, changes in the rule were made. These changes were published, the final rule was filed with the Secretary of State on January 24, 1983 and Rule 10-5.11(15) became effective on February 14, 1983. Throughout the rule-making process, HRS weighed and considered different methodologies for predicting the future need for cardiac catheterization services. The use of an historical base year as opposed to the most current or recent year use rate was considered and was the subject of considerable public comment. It was finally determined that a 1981 base year use rate figure would be adopted, and a one time data collection effort was under taken by HRS for this purpose. This effort was not completed until after the challenged rule was adopted. Although recognizing that the use of a current or most recent year use rate would be preferable to and more accurate than the use of a static use rate, HRS was hampered by the fact that it no longer had the data gathering mechanism or manpower to obtain ongoing current information regarding cardiac catheterization utilization. Therefore, 1991 is the latest and most current year for which a complete data base of utilization is available. There is some support for the proposition that the continued increase in the utilization of cardiac catheterization procedures may tend to level off or even decrease as a result of emerging technologies and a decline in the rate of coronary disease. Balanced against this are the factors of increasing population, increased aging of the population and a wider acceptance of catheterization procedures, both diagnostic and therapeutic, on the part of physicians and patients. It is therefore difficult to predict with any degree of certainty whether utilization in the future will increase or decrease. It was the intent of HRS to design a need determination methodology which would pace the approval of new cardiac catheterization labs while observing what is occurring in that area of medicine. The actual experience in Broward and Dade Counties has been a steady increase in the use rate of catheterization procedures performed from 1977 through 1983. The rate of increase for the United States as a whole, while present in each year between 1977 and 1981, with the exception of 1978, has not been as great as that experienced in Broward County. The application of the rule's need determination formula to Broward County, while permitting one additional lab, appears to under-estimate the need for cardiac catheterization services in that area. By employing the 1981 use rate, the formula projects fewer procedures for Broward County in 1984 than actually occurred in the year 1982. The estimated number of procedures for 1983, based upon the actual procedures performed during the first eight or nine months of 1983, exceeds the 1982 number by almost 1,000. Broward County's rate of increase in the utilization of cardiac catheterization procedures is much greater than the rate of increase either for the United States or for the State of Florida. This may be at least partially explained by the fact that the neighboring Palm Beach area has only one cardiac catheterization lab and there is a need in that area, even under the rule's methodology, for as many as five labs. There was no evidence presented that the existing labs in Broward County are overcrowded or unavailable to area residents. A cardiac catheterization procedure takes, on the average, one to one- and-a-half hours. Therefore, the actual capacity of any particular laboratory is well in excess of 1,000 procedures per year. In 1981, the statewide average for annual number of procedures performed per lab was 581. For quality of care reasons, a minimum of 300 procedures per year per lab is necessary. Studies regarding the cost effectiveness of labs at different levels of usage indicate that the main economies of scale accrue up to the number 400 and additional, less pronounced economies of scale continue to accrue to as high as about 700. Any consideration of costs must also include the costs of trans-porting a patient from a facility without a lab to an existing lab and the costs of increased lengths of hospital stay if delays occur because a lab is not available. As long as the cost of instituting a new lab does not exceed the capital expenditure threshold of Section 381.494(1)(c) Florida Statutes, (presently $600,000.00), an existing facility which presently offers cardiac catheterization capabilities could open a second laboratory without going through the Certificate of Need process and thus be exempt from the challenged rule and its method for determining need. This, of course, would allow an existing facility to have an advantage over new competitors who seek to enter the market to fill a demonstrated need. As a practical matter, such a situation would only occur when an existing facility already has a special procedures room and is willing to forfeit that room for the purpose of performing cardiac catheterization. Such a "loophole" is not a result of the challenged rule. The Certificate of Need thresholds are set by statute and the rule comes into effect only when a Certificate of Need is required. The Economic Impact Statement (EIS) prepared for the challenged rule, (as well as for Rule 10-5.11(16) pertaining to open heart surgery programs) does not attempt or purport to analyze the overall financial impact upon providers, prospective providers or consumers of regulating the number of cardiac catheterization labs in a service area. Instead, it attempts to give an estimate of the economic impact which the amended rule will have in comparison to the prior rule on the subject. Given the fact that the prior rule reguired a facility to have existing or approved open heart surgical capabilities and required every existing lab in the service area to perform at least 500 procedures per year before a new lab could be approved, it can be concluded that the new rule actually liberalizes the need demonstration requirements for a Certificate of Need. The EIS concludes that, other than the printing and distribution costs of the rule to the agency, no economic impact is anticipated as a result of this amendment. The EIS states that "Though the full extent of the economic impact is indeterminable, the rule is expected to contain health care costs by assuring optimal utilization of existing cardiac catheterization . . ., and by avoiding large capital outlay expendi- tures for unnecessary, duplicative services." The effect on competition and the open market is estimated as follows: "Consistent with the purpose of the Certificate of Need law, the proposed rules will restrain the development of costly excess cardiac catbeterization and open heart surgery capacity. The proposed rules permit the development of competitive new services among area cardiac catbeterization laboratories and open heart surgery programs when need for additional capacity is indicated by the need formula and the level of utilization of existing capacity." Absent from the EIS is a detailed statement of the data and method used in making the estimates of costs and benefits to persons directly affected and the estimate of impact on competition and the open market. However, the record of the rule-making proceeding clearly reveals that cost and benefit considerations were reviewed by those responsible for promulgating the challenged rule. It is clear from the testimony adduced in this hearing, as well as the documents received into evidence pertaining to the public comments and letters received by HRS in the rule-promulgation process, that factors involving cost efficiency, increased patient costs, optimal and actual utilization, lab capacity and guality of care were considered by HRS. Such considerations led to numerous changes in the language utilized in the rule. While the EIS perhaps could have been more explicit in specifying the possible economic impacts of these considerations, the fact that actual dollar amounts are not assigned to these considerations does not render the EIS inadeguate. The challengers to the rule offered no more specifics than that contained in the EIS as to the economic impact resulting from the rule. The impacts enumerated by the economic expert presented by the challengers in this proceeding result more from the fact of regulation itself than from the operation of the challenged rule.
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Nursing. The Petitioner regulates the practice of nursing pursuant to section 20.30, and Chapters 455 and 464, Florida Statutes. The Respondent, McDonald Knights, is a registered nurse and holder, at all times pertinent to these proceedings, of license number 1715572. He received his formal training in England and became licensed in the State of Florida by endorsement on or about May 5, 1986. At all times material to these proceedings, the Respondent was employed as a registered nurse assigned to work in the surgical cardiac care unit at Cedars of Lebanon Medical Center in Miami, Florida. Francesco Garofalo was a patient in the coronary care unit of the medical center on March 8, 1987, awaiting cardiac aortic bypass surgery the next morning as a result of acute myocardia infarction. He was being intravenously infused with two medications, lidocaine (for arrhythmia) and nitroglycerin (for pain). The medications were applied through continuous intravenous infusion at separate injection sites and through separate volumetric pumps. At approximately 7:45 p.m., the alarm sounded on the volumetric pump responsible for discharging the nitroglycerin intravenous infusion. The Respondent answered the alarm and noted the container of nitroglycerin was empty. Since the previous shift had not provided a back up container of the medication, it was necessary for Respondent to order a replacement be delivered from the unit's pharmaceutical supply. While awaiting delivery of the medication, the Respondent started a dextrose solution running into the patient to prevent the injection site from closing. At this time, the patient complained of pain at the site of his other intravenous injection for lidocaine. The Respondent determined that this injection site had been infiltrated with the lidocaine solution leaking into the subcutaneous tissue of the patient's arm, resulting in discomfort to the patient. The Respondent decided a new site should be secured. In the process of securing a new site for the lidocaine infusion, the Respondent removed a manual plunger apparatus termed a "cassette" from the volumetric pump. This action effectively discontinued the function of the pump. After inserting the needle in the new venous site, Respondent manually operated the plunger apparatus to insure that the line was open and effectively discharging a smooth flow of lidocaine medication into the patient's body. He did not establish a rate of flow for the medication into the patient's body beyond cutting down the manual flow to an amount equal, in his opinion, to 10 to 20 drops per minute. At this point, the Respondent went to take a telephone call and left the patient's care to another nurse who had entered the room. The time was approximately 7:47 p.m. Cordette Steer is a registered nurse with twenty years experience. When she entered the patient's room to allow the Respondent to take the telephone call, she received no instruction from the Respondent. She did not know the medication being injected was lidocaine. Due to the toxic nature of lidocaine and her observation that the volumetric pump for administering this medication had been effectively bypassed, Steer assumed the Respondent had hung a harmless saline or dextrose solution to keep the vein open for the injection. She proceeded to apply tape to secure the needle at the injection site because, as she testified, "nobody would expect lidocaine to be infusing off of the pump, this is something that is never done." At 7:50 p.m., the patient complained of chest pain. Steer was aware of the exhaustion of the patient's nitroglycerin and that a new bag had not yet arrived from the pharmacy. She stepped from the room and returned almost immediately with nitroglycerin tablets which she gave to the patient to relieve his chest pain. He shortly began to exhibit seizure symptoms commonly associated with lidocaine toxicity. Code Blue was sounded. The Respondent was among those personnel responding. He disconnected the lidocaine infusion, stopping the flow of lidocaine to the patient. The time was 7:55 p.m. Resuscitation attempts failed and the patient subsequently expired at approximately 8:30 p.m. Nancy Cox is a critical care educator employed with the Miami Children's Hospital. She is an expert in the fields of surgical and cardiac critical care. She reviewed the medical records pertinent to this proceeding and her expert testimony establishes that: Lidocaine is an extremely toxic medication which can be fatal if the volume administered to a patient is not closely controlled. The dosage the patient should have been receiving was 15 cubic centimeters per hour or approximately three teaspoons per hour. The volumetric pump sets the rate of delivery of an intravenous drug with a finite, or high, decree of accuracy. When the pump is turned off, with the cassette in place, the flow of medication is stopped. When the cassette is removed from the pump device, an open flow is established and the pump fails to act as a regulator. Finite control of drug administration is not possible manually, as was attempted by the Respondent in this case, without taking considerable time to adjust the rate of flow in concert with timed intervals. Even when this is done, the plunger may spring open and allow a greater than desired drug flow. The Respondent should not have established a smooth flow of lidocaine, but rather a dripping or slow rate of infusion. The Respondent deviated from accepted minimal standards of cardiac or critical care nursing when he used the lidocaine solution to initially infuse at an open, unregulated rate in order to determine if the new injection site was functioning as opposed to establishing a patent intravenous route by either injecting saline via a syringe into the catheter, or connecting a bag of a saline or dextrose solution to the catheter for this purpose and then allowing it to infuse, prior to re-connecting the lidocaine. The Respondent also deviated from accepted minimal standards of acceptable and prevailing nursing practice by not informing Cordette Steer that lidocaine was being administered intravenously to the patient without the use of the volumetric pump.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Nursing enter a final order finding the Respondent guilty of the offense charged in the administrative complaint, suspending his license for a minimum period of one year with probationary reinstatement thereafter conditioned upon 1) a showing by the Respondent that he has enrolled and completed continuing education courses, as deemed appropriate by the Board, in the area of cardiac critical care with an emphasis on intravenous medication applications, and 2) he agrees to comply with reasonable terms and conditions of the Board for a subsequent probationary period of two years. DONE AND RECOMMENDED this 22nd day of April, 1988, in Tallahassee, Leon County, Florida. DON W. DAVIS 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 22nd day of April, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-5633 The following constitutes my specific rulings, in accordance with requirements of section 120.59 Florida Statutes, on proposed findings of fact submitted by the parties. PETITIONER'S PROPOSED FINDINGS Included in finding number 2. Included in finding number 2 Rejected as unnecessary. Including in finding number 2. Included in finding number 3. Included in finding number 4. Rejected as unnecessary. Included in finding number 4. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 4. Included in finding number 4. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 6. Included in finding number 6. Included in finding number 5. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Included in finding number 6. Patient was pronounced officially dead at 8:52 p.m., but Respondent testified that death occurred earlier. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected as unnecessary. Rejected as unnecessary. Rejected as unnecessary. Included in finding number 7. Included in finding number 7. Included in finding number 5. Included in finding number 7. Rejected, not supported by the evidence. Included in finding number 7. Rejected as unnecessary. Included in finding number 7. Included in finding number 6. Rejected as a conclusion of law. COPIES FURNISHED: Lisa M. Bassett, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William E. Hoey, Esquire 2398 South Dixie Highway Miami, Florida 33133-2399 William O'Neill, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Judie Ritter Executive Director Department of Professional Regulation Room 504, East Coastline Drive Jacksonville, Florida 32201
