The Issue The ultimate issue is whether the application of Venice Hospital for a CON should be approved. The factual issue is whether Venice Hospital meets the criteria set forth in the statute and rules.
Findings Of Fact The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law the Hearing Officer would recommend that this CON be granted with appropriate conditions relating to the maintenance of staff and the level of training of the staff which must be met and maintained in order for Petitioner to continue the operation of the laboratory. DONE and RECOMMENDED this 26th day of October, 1984 in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 1984. COPIES FURNISHED: Kenneth F. Hoffman, Esquire David Watkins, Esquire 646 Lewis State Bank Building Tallahassee, Florida 32301 Douglas Mannheimer, Esquire 137 North Calhoun Street Tallahassee, Florida 32302 Robert A. Weiss, Esquire The Perkins House 118 North Gadsden Street Tallahassee, Florida 32301 and Lamar Matthews, Esquire 1550 Ringling Boulevard Sarasota, Florida 33578 Courtesy Copy to: William B. Wiley, Esquire 666 Lewis State Bank Building Tallahassee, Florida 32301 =================================================================
Findings Of Fact North Broward, Plantation, and Cypress are each existing acute care hospitals located in Broward County, Florida. Each has submitted CON applications to establish cardiac catheterization laboratories and open heart surgery facilities to HRS. There are presently five existing cardiac catheterization and open heart surgery units available in Broward County. As indicated above, each of these applicants was denied a CON by HRS, which now takes the position that two of the three applications should be granted. Stipulations of the parties and evidence of record in this proceeding affirmatively establish that North Broward, Plantation, and Cypress each meet applicable statutory and rule criteria to entitle them to the issuance of the requested CON. By promulgating Rule 10-5.11(15), Florida Administrative Code, HRS has established a need formula for calculating and predicting the gross and net need for cardiac catheterization laboratories two years into the future in each of the 11 department service districts through the State. The rule uses a two-year planning horizon, and each of the parties to this proceeding has conceded that 1986 is the appropriate year to consider need for the services proposed in these applications. In applying the formula, the number of catheterization procedures projected to be delivered in Broward County in 1986 is derived by multiplying the 1981 use rate in the service area by the projected population in that service area in 1986. This figure is then divided by 600 to project the total number of catheterization laboratories needed in 1986, which presumes a minimum of 600 procedures per laboratory as a threshold requirement. Broward County comprises all of HRS District X. In applying the formula contained in Rule 10-5.11(15), the 1981 use rate for Broward County is determined by dividing the total number of procedures performed in that year into the 1981 district population. This step produces a 1981 use rate of 3.37 cardiac catheterization procedures per 1,000 population. When this use rate is divided into the 1986 projected population of District X, 4,013 procedures are projected for 1986. When divided by the required 600 average number of catheterizations performed per year by existing and approved laboratories, the total number of laboratories needed in 1986 is 6.68. Since, as indicated above, there are five existing laboratories in District X, the net need in 1986 is 1.68 laboratories. HRS department policy is to round the number of laboratories to 2.0, thereby demonstrating a need for an additional two laboratories in District X in 1986. However, as conceded by HRS, a strict application of the need methodology contained in Rule 10-5.11(15) ". . . has not proven to be accurate in Broward County." In fact, need projections for cardiac catheterization laboratories for 1985 were, in fact, exceeded in 1982, because the utilization of cardiac catheterization services had increased faster than the population in Broward County. In 1981 there were 3,546 cardiac catheterization procedures performed in Broward County. By 1982, that figure had increased to 4,311, and, in 1983, 4,840 procedures were performed. When 1982 actual data is substituted for 1981 data in the formula contained in Rule 10-5.11(15), a gross need of 7.96 laboratories, and a net need of 2.96 laboratories is shown. As indicated above this figure would be increased to 3.0 under existing HRS policy. Utilizing actual 1983 data, Rule 10-5.11(15) shows a gross need of 8.71 laboratories and a net need of 3.71 laboratories in 1986. The primary factors which appear to have contributed to a higher utilization rate in Broward than contemplated by Rule 10-5.11(15) are increased physician awareness of the potentialities of cardiac catheterization as a diagnostic tool, and a comparatively large elderly and middle age population requiring these services. There is no competent evidence of record to establish that the higher utilization rates experienced in Broward County can be attributed to out-of-county residents. While it is true that historical use data is extremely valuable as a planning tool, credible expert testimony of record in this proceeding establishes that actual use rates are a more accurate predictor of need, especially in a situation where, as here, a definitive trend exists markedly exceeding that shown by historical data. It is, therefore, specifically concluded that evidence of record in this proceeding shows, at a minimum, a need for three additional cardiac catheterization laboratories in Broward County in 1986. As a result, issues between the parties concerning appropriate batching and a comparison of the merits of the applications is unnecessary. North Broward, Plantation, and Cypress each applied for a CON to establish open heart surgery capabilities. However, both Plantation and Cypress have conceded that no need has been established for Broward County for 1986 when the requirements of Rule 10-5.11(16) are applied. North Broward, while conceding that the requirement of that rule that existing and approved open heart surgery programs operate at a minimum of 350 adult open heart surgery cases per year, contends that its application should be granted as an exception because members of its staff who would perform that service presently utilize several hospitals in the Broward County area for open heart surgery. North Broward contends that if its cardiac catheterization laboratory is approved, these physicians would be in a position to perform these services at North Broward, rather than having to transfer patients to other facilities. Even if this were true, however, there is no showing on this record that the other requirements of Rule 10-5.11(16) have been met. For example, there has been no showing that the establishment of an open heart surgical suite at North Broward would increase geographic or economic accessibility to that service, what effect the establishment of such a service would have existing programs, and no financial analysis to demonstrate what effect, if any, the granting of North Broward's application would have on patient costs or total expenditures for open heart surgery. In fact, the record in this cause affirmatively establishes that no need exists in Broward County in 1986 for the establishment of additional heart surgery facilities.
Findings Of Fact Based upon the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner's facility opened in January of 1976 as the Hubert Rutland Hospital. Its name was subsequently changed to Gateway Community Hospital and, after purchase by petitioner, it became Humana Hospital Northside. Dr. D. K. Mukherjee, Board-certified in internal medicine and cardiology, came to petitioner's facility in 1976 for the prime purpose of developing a cardiac catheterization laboratory, and assisted in preparing a list of equipment necessary to begin operation of such a laboratory. On December 31, 1976, petitioner's predecessor entered into a medical equipment service agreement for cardiac catheterization and monitoring equipment. That equipment, costing less than $100,000.00, was delivered to the hospital on or before June 17, 1977. Since that time, cardiac catheterization procedures, as defined in Rule 10-5.11(15), Florida Administrative Code, have been performed on a continuous and regular basis at petitioner's facility in Special Procedures Room No. 3. Over the past eight to nine years, the longest interval between the performance of such procedures has been approximately one or two weeks. Special Procedures Room No. 3, while also utilized for other purposes, has the equipment, staff and support services necessary for providing the studies and procedures associated with cardiac catheterization. The hospital itself is capable of providing the ancillary diagnostic services, such as hematology studies, electrocardiography, chest x-rays, blood-gas studies, pathology, blood chemistry analysis and nuclear studies pertaining to cardiology. Prior to July 1, 1977, Certificate of Need review was not required for the purchase of cardiac catheterization equipment by a hospital unless it involved a capital expenditure of more than $100,000.00. Commencing on July 1, 1977, Certificate of Need review was required when a health care facility sought to provide a substantial change in service, defined as a service which was not offered on a regular basis within the prior twelve-month period. Section 381.494(1)(c), Florida Statutes, and Rule 10-5.02(19), Florida Administrative Code. Because of technological and scientific advances, petitioner desired to replace and update the equipment purchased in 1976 for the performance of special procedures. Accordingly, in April of 1984, it submitted an application for a Certificate of Need to replace special procedures equipment at a project cost of $1,269,000.00. The application, in Section 3 stating the need and justification for the project, noted that: "Our existing equipment is totally inadequate to perform state-of-the-art cardiac catheter- ization and coronary angioplasty. When we began performing cardiac catheterization in 1977 this equipment was adequate, but today it is totally unacceptable. This proposed equipment will not only provide state-of-the- art equipment for these procedures, but will do so in a cost-effective manner since combined utilization of such high cost equip- ment contributes to the reduction of the cost of medical care." HRS issued petitioner Certificate of Need number 3261 for the replacement of special procedures equipment at a total project cost of $1,269,000.00, as requested. However, in a cover letter transmitting the issued Certificate of Need to the petitioner, HRS noted: "Please be advised that neither this office, the Office of Licensure and Certification nor the Local Health Council has documen- tation to support the performance of cardiac catheterization procedures at this hospital." Local Health Councils are private nonprofit corporations which contract with HRS to conduct local planning activities, including the collection of data, the publication of various utilization reports and the development of Local Health Plans. When HRS reviews proposed health care projects which require a Certificate of Need, it utilizes the data submitted to it by the various Local Health Councils, particularly in those instances where its rules contain a methodology or formula which includes as a factor an accounting of existing facilities or services. Application of the methodology contained in HRS's rule for determining the need for additional cardiac catheterization laboratories requires a knowledge of the number of procedures performed per year by existing and approved laboratories. Rule 10-5.11(15), Florida Administrative Code. The Health Council of Pasco/Pinellas, Inc. collects data from hospitals within Pasco and Pinellas Counties regarding bed utilization and service information. Hospitals in the district are requested to complete and submit certain information on a "Monthly Hospital Utilization Form." Among the items of information requested is the number of cardiac catheterization procedures performed during the reporting period. The Health Council also publishes and distributes annual and semi-annual utilization reports for the district. There is no provision in the statutes or rules which require hospitals to report utilization or service data to the various Local Health Councils, and HRS itself does not require that such information be reported to it. It is not unusual for hospitals to report inaccurate, incomplete or inconsistent data to Local Health Councils. Indeed, it is recognized in the "1984 Annual Hospital Utilization Report for District V Pasco/Pinellas Health Council, Inc." that, while all hospitals in the District submitted monthly hospital utilization information, "One limitation to this report involves those institutions who did not, for various reasons, submit data for beds by service categories and/or data pertaining to specialty services." HRS Exhibit F, p. 1. The form utilized by the Pasco/Pinellas Health Council contains no definition of cardiac catheterization procedures and no directions as to how to complete the form. While it has regularly submitted a monthly utilization form to the Local Health Council, petitioner has never reported the performance of cardiac catheterizations at its facility. The various reports published by the Local Health Council do not list petitioner as performing cardiac catheterization procedures. While a health care facility may obtain a written determination from HRS that a given service is exempt from Certificate of Need review due to its "grandfathered" status, there is no agency rule or policy which requires a facility to obtain such a written exemption. It has generally been the agency policy that equipment and services acquired by a facility prior to the date that such acquisition became reviewable under the Certificate of Need law are not reviewable on a retroactive basis.
Findings Of Fact On or about April 13, 1987, Petitioner, H.C.A. Gulf Coast Hospital, submitted its application for a Certificate of Need to operate a cardiac catheterization laboratory in Panama City, Florida. On September 22, 1987, Respondent, Department of Health and Rehabilitative Services (HRS), denied the application because the addition of a sixth cardiac catheterization lab in HRS District 2 would lower the average number of procedures below the 600 procedures required by Rule 10-5.011(1)(e)15, F.A.C. The actual reasoning behind the Letter of Denial was contained in the State Agency Action Report regarding CON 5121, the project concerned in this case, dated September 9, and 10, 1987. The relevant portions of the State Agency Action Report for purposes of this proceeding are contained on Page 8 and Page 10 of the Report. Petitioner's Composite Exhibit #4. On November 11, 1987, Petitioner requested the Respondent to reconsider its denial of its Certificate of Need for the cardiac catheterization lab. On December 3, 1987, the Respondent upheld its original denial of the Certificate of Need, citing the same rationale it had utilized earlier. Petitioner's Composite Exhibit #5. While pending reconsideration, Petitioner requested that a Section 120.57, F.S., hearing be convened on HRS's denial of Petitioner's CON, and the case was subsequently sent to the Division of Administrative Hearings to conduct the hearing. The Hospitals Petitioner is one of two hospitals located in Bay County, Florida. The other hospital and Gulf Coast Hospital's main competitor is Bay Memorial, located about ten minutes away from Petitioner's facility. Both of these hospitals are considered to be in District 2 and specifically in Subdistrict 2A for purposes of HRS CON review. District 2 consists of Bay, Calhoun, Franklin, Gadsden, Gulf, Holmes, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Washington and Wakulla Counties. See Chapter 10-5, F.A.C. Currently there are no cardiac catheterization facilities at Petitioner's hospital. The only facilities in Bay County are located at Bay Memorial. Bay Memorial has two labs at its facility. The Need Criteria All parties agreed that Rule 10-5.011, F.A.C., is the controlling rule in this case. The rule in itself requires a mathematical calculation to arrive at certain need criteria. Rule 10-5.011(1)(e)12, F.A.C. That formula is intended to calculate the number of catheterization procedures expected in a given year in the near future. In this case, the target date was January, 1989. In order to arrive at the expected number of catheterization procedures, the rule requires that one multiply the current number of catheterization procedures which have actually been performed in the applicant's intended service area per 100,000 of population times the projected population for the year service is initiated. The current number of catheterization procedures in District 2 is 3,215. In order to convert that figure to a figure per 100,000 of population, 3,215 must be multiplied by the current base population divided by 100,000. The current base population is 513,825. The first element of the need formula looks as follows: 3215 x 513,825/100,000. This calculation yields a current use criteria of 625.70 catheterization procedures per 100,000 of population. In order to arrive at the number of expected catheterization procedures in January, 1989, for District 2, it is necessary to multiply 625.70 times the projected population for January, 1989. The projected population in the year 1989 for District 2 is 543,518 persons. The calculation is as follows: 625.70 x 543,518/100,00. Based on the above calculations, the Department predicts that there will be 3,401 cardiac catheterizations performed in District 2 in January, 1989, or that there will be a need for 3401 catheterization procedures in January, 1989. Too Many Formulas The above need calculation is utilized by the Department to determine whether, under its rule, the applicant will meet the criteria and goals established in its Rule 10- 5.011, F.A.C. and obtain the goals set out in Chapter 381, F.S., and relevant local and state health plans. The Department adopted this rule in 1977. For purposes of this case and the issues involved herein, the rule has essentially remained the same since 1977. The relevant portions of Rule 10-5.011 involved in this case are as follows: 10-5.011(1)(e)6 F.A.C.: 6. Department Goal. The Department will consider applications for cardiac catheterization laboratories in context with applicable statutory and rule criteria. The Department will not normally approve applications for new cardiac catheterization laboratories in any service area unless additional need is indicated, as calculated by the formula in sub-paragraph 12, below, and unless the application satisfies the requirements set forth in sub-paragraph 15, below. and 10-5.011(1)(e)15.c. F.A.C.: Applications proposing to establish cardiac catheterization laboratories will not be approved if they would reduce the average volume of procedures performed by laboratories in the service area below 600 adult procedures and 275 pediatric procedures, based on projected need in the service area. At the rule's inception in 1977, the HRS staff at least two mathematical formulas to implement Rule 10.5011(1)(e)15.c F.A.C. The two formulas involved whether the need criteria outlined above should be divided by 600 and then round any resulting fractions to the nearest whole number, or by dividing the need number by the number of laboratories proposing to operate with no concomitant rounding of resulting fractions. In this case, the number of laboratories proposing to operate for January, 1989, would be six (five existing laboratories, plus the applicant Gulf Coast). The problem with the differing mathematical methodologies do not appear when both results show that there would not be enough future catheterization procedures to warrant an additional laboratory, or conversely that there would be enough procedures to warrant an additional laboratory. The anomaly of the two methodologies arises in the type of case presented here. In this case, the first calculation is represented by the methodology utilized in the State Agency Action Report on page 8. That calculation results in the Respondent concluding that in January, 1989, there is a need in District 2 for six catheterization laboratories, i.e., one additional laboratory than now exists. Gulf Coast, by requesting a Certificate of Need for a catheterization laboratory, has applied for that one additional space. The second mathematical formula is illustrated by the State Agency Action Report on page 10. There, the report concludes that six labs would be too many and divides the estimated need number by six or multiplies six by 600 which essentially yields the same result percent in essence, Respondent has concluded there is a need for six labs and then turned around and concluded there is not a need for six labs. Past Policy On Inconsistent Formulas And Its Reasons In either late 1983 or early 1984, these anomalous results were quite appropriately a concern to the Department. At that time, Gene Nelson, Petitioner's expert witness, was the Administrator of the Office of Community Medical Facilities in HRS. His duties entailed the entire oversight of the CON process for catheterization laboratories, including formulating agency policy regarding implementation of its rule on cardiac catheterization. The Department was concerned that it was reaching inconsistent results by utilizing the two mathematical methodologies outlined above and therefore were not treating applicants in a consistent manner. In order to resolve this inconsistent approach, the Department decided upon a policy that the first calculation would control the result of granting or denying an applicant's request. This policy was established in late 1983 or early 1984 and was disseminated verbally throughout Mr. Nelson's staff. The dissemination may not have been as complete as it should have been given the Agency's policy of not putting anything in writing for fear that it might be challenged as a rule. The policy apparently did not trickle down to Elizabeth Dudeck, who was then a CON applicant analyst under Mr. Nelson. The Department did not stop utilizing the second calculation. However, the second calculation was no longer considered to be the controlling methodology for purposes of granting or denying a CON application. The reason given by both Mr. Nelson and Thomas R. Porter, the then supervisor in the CON program, was to achieve internal consistency among the rules differing provisions and requirements for catheterization laboratory CON review. The differing provisions and requirements involved are Rule 10- 5.011(1)(e)9.d., F.A.C.: D. Minimum Service Volume. In order to assure quality of service, there shall be a minimum of 300 cardiac catheterizations performed annually in any adult cardiac catheterization laboratory within three years following its initiation of service. In order to assure quality of service, there shall be a minimum of 150 pediatric cardiac catheterizations performed annually in any laboratory performing pediatric cardiac catheterizations, within three years following its initiation of service. Applicants for either of these services must document that proposed laboratories can meet these minimum volume requirements. (emphasis added) and 10-5.011(1)(e)12, F.A.C.: 12. Need Determination. The need for cardiac catheterization capacity in a service area shall be determined by computing the projected number of cardiac catheterization procedures in the service area. The following formula shall be used in this determination: Nx= Uc X Px Where: Nx = N Number of catheterization procedures x projected for Year X; Uc = Actual use rate (number of procedures per hundred thousand population) in the service area for the 12 month period beginning 14 months prior to the Letter of Intent deadline for the batching cycle; Px = Projected population in the service area in Year x; and Year X = The year in which the proposed cardiac catheterization laboratory would initiate service, but not more than two years into the future. (emphasis added) and Rule 10-5.011(1)(e)15.c., F.A.C., noted earlier. As can be readily seen from the language of the rule, the various provisions listed above have differing time provisions for accomplishing the requirements that the particular rule provision addresses, or does not state any time provisions. The first calculation achieved consistency between these differing time requirements by recognizing that a new catheterization lab would be unlikely to achieve 600 procedures in two years in light of the fact that only 300 procedures are required in three years. Thus, the first calculation allows the time elements to be flexible and more reflective of reality and the start-up of a new business. The second calculation does not achieve this flexibility and internal consistency within the rule, and in fact, results in a very rigid rule which in effect presumes that a new lab will achieve 600 procedures in two years, regardless of whether it, in fact, can or desires to do so. Petitioner's application illustrates this point since its plan predicts Petitioner will perform only 325 procedures within three years from start up. In essence, Petitioner's new lab is nearly equal to 1/2 of a fully functional lab under the expectations of the Department's rule. The Department's original policy was given public recognition in Lee Memorial Hospital and Ft. Myers Community Hospital vs. HRS Case Numbers 82-1659 and 83-1518, 6 FALR 6774, (November 19, 1984). In that case, the Department specifically rejected a Recommended Order by a DOAH Hearing Officer who utilized the second calculation in recommending denial of the Petitioner's Certificate of Need. As in this case, the Hearing Officer was confronted with the situation where the first calculation recommended approval and the second calculation recommended denial. The Department specifically rejected the second methodology as being controlling and found that the first calculation was the controlling calculation and approved the Certificate of Need for the applicants. Since 1984, numerous other decisions of the department have followed the policy established by Mr. Nelson. See Humana Inc. v. DHRS, 6 FALR 2874 (1984), Plantation General Hospital v. DHRS, 6 FALR 6796 (1984), Humana Inc. v. DHRS, 492 So.2d 388 (Fla 4th DCA 1986), Humana Inc. v. DHRS, 469 So.2d 889 (Fla 1st DCA 1985), South Sarasota County Memorial Hospital Association, Inc. v. DHRS, 7 FALR 1345 (1985), Adventist Health Systems/Sunbelt d/b/a Medical Center Hospital v. DHRS, 7 FALR 3500 (1985) and Lawnwood Regional Medical Center v. DHRS, 9 FALR 2646 (1987). It is clear that Petitioner's CON would be granted under the Department's past policy. The New Policy and Its Reasons As noted earlier, during Mr. Nelson's tenure, and Mr. Porter's tenure Miss Dudeck, the Department's expert witness, was one the staff personnel who examined CON applications. She was also one of the staff personnel who believed the second mathematical method was the controlling calculation for purposes of CON approval or denial. Sometime after May of 1985, Miss Dudeck was promoted to occupy the space once filled by Mr. Porter, i.e., Supervisor in the CON Program. According to Miss Dudek's testimony, the Department apparently decided to change its policy regarding which mathematical methodology would be controlling in CON approval or denial approximately two years ago. The Department decided, again with nothing written down, that the second mathematical calculation would be the controlling factor in CON review. The only rationale given by the agency at the hearing for its changed course of action was stated by Miss Dudeck to be the result of a change in agency personnel and the fact she thought it was required by the rule. There was no rulemaking engaged in by the agency and no formal written statements or informal memos rendered by the agency. Additionally, there is no credible evidence that there is any established method by which a member of the public could deduce this change in policy. In effect, the Department's change in position has achieved an impossibility by its own rule. On the one hand, the Department is saying six labs are needed in District 2. On the other hand, the Department by another statistic has made that goal impossible to achieve. The Department has established a system where it bases its decision on hypothetical need. The Department then establishes a presumption that all facilities operating will be operating at a level of 600 catheterization procedures within two years. This presumption has absolutely no basis in fact, as was evidenced by the continued examples given by all parties where a lab, in fact, would not be operating at either the 600 or the 300 catheterization level within two years, and as was further evidenced by Petitioner's application. Moreover, the Department's original 1984 policy recognized that new businesses do not start at a 600 level, but are only required to achieve a 300 level after three years. When the 600 level is to be achieved is not stated in the rule, nor did anyone seem to know who testified. Similarly, there are no resulting consequences to an operating lab which does not attain the 600 or even the 300 level of procedures. The Department's newest policy clearly does not allow for the other provisions of its Rule and is not consistent with those provisions or Chapter 381, F.S.
Recommendation Based on consideration of the foregoing, it is RECOMMENDED: That the Department of HRS grant Gulf Coast's - application for a Certificate of Need for a new cardiac catheterization service. DONE and ORDERED this 11th day of March, 1988, in Tallahassee, Florida. DIANE CLEAVINGER 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 11th day of March, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-4761 Petitioner's proposed Findings of Fact Numbers 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 and 32 have been adopted, in substance, insofar as material. Petitioner's proposed Findings of Fact Number 8 has been adopted as representing the correct figures in this case. The first three sentences and the fifth and sixth sentences of Petitioner's proposed Findings of Fact Number 17 have been adopted. The 4th sentence is subordinate. The - reference to exclusive method in the 6th sentence was not shown by the evidence. The evidence showed the method to be controlling. Petitioner had no proposed Findings of Fact Numbers 13 or 21. Respondent's proposed Findings of Fact Numbers 1, 2, 3, 4, 5, 6, 9 and 12 have been adopted in substance, insofar as material. Respondent's proposed Findings of Fact Numbers 7, 10, 11 and 13 were not shown by the evidence. Respondent's proposed Findings of Fact Number 8 reflects the correct math, but the evidence did not demonstrate that the rule requires either the mathematical procedure or the result. COPIES FURNISHED: Thomas Beason, Esquire MOYLE, FLANIGAN, KATZ, FITZGERALD & SHEEHAN 118 North Gadsden Street Tallahassee, Florida 32301 Stephen Presnell, Esquire MCFARLANE, FERGUSON, ALLISON & KELLY 215 South Monroe Street, 8th Floor Tallahassee, Florida 32302 Douglas J. Sale, Esquire BROWN & SMOAK Post Office Box 426 Panama City, Florida 32402 John Miller, Acting General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0955 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0955 Sam Power, HRS Clerk Department of Health and Rehabilitative Services 1323 Winewood Blvd. Tallahassee, Florida 32399-0955 =================================================================
The Issue The issues for determination are whether Petitioners should be awarded certificates of need authorizing the establishment of inpatient cardiac catheterization services at their respective facilities. As a result of stipulations of the parties, matters for consideration with regard to award of those certificates of need primarily involve a determination as to whether Petitioners' applications meet rule criteria relating to need (numeric and non-numeric), provision of a written protocol or transfer agreement, and utilization standards.
Findings Of Fact The legislature has deregulated the establishment of outpatient cardiac catheterization laboratories (cardiac cath labs), but a certificate of need (CON) is required before a hospital can operate an inpatient cardiac cath lab. The Department of Health and Rehabilitative Services (HRS) has not approved, as the result of initial agency action, a new cardiac cath lab CON in HRS' Service District Five since 1977. The Parties Palms Petitioner NME Hospitals, Inc., d/b/a Palms of Pasadena Hospital (Palms), is a 310 bed acute care hospital located in Pasadena, Florida. Pasadena is geographically located in the southern portion of Pinellas County, Florida. Pasadena, though geographically small, is one of the most densely populated cities in the United States. Within one half mile of Palms are 10,000 people of whom 60 percent are 65 years of age or older. Palms is a full service hospital with an extensive range of medical and surgical services, including a 24 hour emergency room; a coronary care intensive care unit; a surgical intensive care unit; and a respiratory intensive care unit. Palms also offers a full spectrum of non-invasive cardiology services including electrocardiography, echocardiagraphy, nuclear medicine, stress testing and 24 hour monitoring. Palms has five cardiologists, four of them invasive cardiologists, on its active staff and five cardiologists on its courtesy staff. The four invasive cardiologists would utilize a cardiac cath lab or program at Palms. Palms is situated on 13 acres with a main hospital complex that encompasses over 400,000 square feet. There are over 300 physicians on Palms' medical staff, representing virtually every medical specialty. The hospital is accredited by the Joint Commission on Accreditation of Healthcare Organizations. HRS Service District Number Five, which encompasses Palms location, is composed of Pinellas and Pasco Counties. The service district is heavily populated by persons age 65 and over; the persons who, nationally, have the highest rate of cardiac catheterization admissions per 1,000 persons. The rate for deaths resulting from major cardiovascular diseases and heart disease in Pinellas County is 150 percent above the rate for such deaths within the entire State of Florida. Notably, thirty percent of the approximately 200,000 persons within Palms' primary service area are age 65 or older. Further, sixty-eight percent of Palms' patients are medicare patients with an average age of 77 to 78 years. The average age of the medicare population at other hospitals in Pinellas County ranges from 72 to 73 years of age. During 1987 and 1988, 516 inpatients at Palms required cardiac cath services (238 in 1987 and 278 in 1988). A diagnostic cardiac catheterization (cardiac cath) is an invasive medical operation in which a catheter is passed via vascular access in the arm or leg into the heart for purposes of diagnosing cardiovascular diseases or measuring blood pressure flow. Significant advances in the technology of cardiac catheterization permits usage of cardiac caths in the emergency treatment of heart attacks through injection of thrombolytic agents directly into the blood clot causing the heart attack. While these medications can be given intravenously, such an option is not available in the case of elderly patients, who run a higher risk of internal bleeding as a side effect of the drug, and patients who delay seeking medical attention after the onset of a heart attack. Approximately 30 percent of the patients arriving at Palms' emergency room have a cardiac related problem. The number of these patients who are candidates for intravenous injection of thrombolytic agents is small. Approval of Palms' application would significantly improve the quality of care of these patients by permitting the injection of thrombolytic agents directly into the blood clot causing the heart attack, a permitted medical procedure in the process of administering a diagnostic cardiac cath. After the onset of a heart attack, there exists a six hour window during which potentially life-saving drugs can be administered. Due to the possible side effects of these drugs, cardiologists must often perform a cardiac cath to diagnose the ailment prior to administering the drugs. Consequently, patients who present themselves for treatment at Palms several hours after the onset of heart attack symptoms may be precluded from receiving these drugs in view of the lack of a cardiac cath lab or program at Palms. Mease Petitioner Mease Health Care, Inc., (Mease) owns and operates Mease Hospital Dunedin and Mease Hospital Countryside. Mease also operates clinics located in New Port Richey, Palm Harbor, Countryside and Dunedin, Florida. These clinics serve a combined 350,000 patients per year. Mease Hospital Dunedin is a 278 bed facility located in Dunedin, Florida. The Mease Dunedin Clinic houses approximately 60 physicians. Mease Countryside Hospital, opened in 1985, consists of 100 beds and is located approximately eight miles from Mease Hospital Dunedin. Approximately 30 physicians have offices at the Mease Countryside Clinic. Most physicians practicing in the clinics have hospital privileges only at the Mease facilities. Another 100 physicians on the staff of these two hospitals have practices in the surrounding area and admit patients to the Mease facilities. Physicians housed in the Mease Countryside and Dunedin Clinics provide a significant source of patient referrals for the two hospitals, since most physicians practicing in the two clinics have hospital privileges only at the Mease facilities. Ninety percent of patients hospitalized by physicians in the two clinics are hospitalized in Mease Dunedin or Mease Countryside hospital facilities. Mease currently operates a cardiac cath lab at its Mease Dunedin campus on an outpatient basis. This existing facility could be utilized by Mease for inpatient catheterization. The existing outpatient cath lab is outfitted with a Phillips Digital Cardiac Imaging System, the most medically advanced equipment of this type in Pinellas County. Mease's current outpatient cath lab meets all applicable standards for the operation of an inpatient cath lab and is adequately staffed to perform 600 cardiac caths per year. There is no difference in the physical layout of an inpatient cath lab versus an outpatient cath lab. Mease also provides diagnostic services such as echocardiography and nuclear cardiology. Growth in cardiology services experienced by Mease is consistent with the provision of these additional services. Morton Plant Morton F. Hospital, Inc., (Morton Plant) is a not-for-profit 740 bed general acute care hospital spread among twelve buildings on a 36 acre campus in Clearwater, Florida, approximately three or four miles from Mease. Morton Plant offers a wide range of health care services, including cardiac cath, open heart surgery, a cardiac rehabilitation program, post-cardiac surgery recovery areas and intensive coronary care units. HRS HRS is the state agency which is responsible for administering Sections 381.701 through 381.715, Florida Statutes, the "Health Facility and Services Development Act", under which applications for Certificates of Need (CON) are filed, reviewed, and either granted or denied by that department. Petitioners' Applications The applications of Mease and Palms, seeking a CON to implement inpatient cardiac cath services were filed with HRS on September 28, 1988. After initial review, HRS sent omissions letters to the applicants on October 13, 1988. Responses from Mease and Palms were made on November 11, 1988, and HRS denied both applications on January 12, 1989. Both Petitioners timely requested formal hearings regarding the denials. "Old Rule Versus New Rule" HRS has adopted procedures governing its review of applications, such as those of the petitioners, for CONs authorizing the establishment of inpatient cardiac catheterization programs. These procedures include HRS' numeric methodology for estimating need for cardiac cath labs or programs. This methodology has traditionally been found in Florida Administrative Code Rule 10- 5.011(1)(e). On April 22, 1988, HRS published a proposed "new" rule containing a new methodology for estimating cardiac cath program need. A key component of the new rule is the use of "admissions" to a cardiac cath program, as opposed to the old rule's use of "procedures", to determine numeric need for additional CONs. The new rule was timely challenged by two parties in proceedings before the Division Of Administrative Hearings. However, the matters in dispute between HRS and the challengers were resolved and the proceedings voluntarily dismissed. Subsequently, HRS filed the new rule as revised with the Secretary of State's office and published the new rule on July 29, 1988. The new revised rule was challenged within 21 days of publication pursuant to Section 120.54, Florida Statutes, by three new parties in Division Of Administrative Hearings Cases numbered 88-3970R, 88-4018R and 88-4019R. A Final Order eventually issued in those cases finding the rule challenges to have been timely brought pursuant to Section 120.54, Florida Statutes, and finding the revisions to be an invalid exercise of delegated legislative authority as a result of noncompliance by HRS with requirements of Section 120.54, Florida Statutes. Florida Medical Center v. DHRS, 11 FALR 3904 (Final Order issued June 29, 1989). The Final Order in Florida Medical Center has been appealed. The parties to this proceeding were permitted to present evidence of need for the respective applications under both the new and old versions of Rule 10- 5.011(1)(e) Florida Administrative Code, although all the parties were informed by order dated September 20, 1989, that the undersigned intended to apply those provisions of the administrative rule criteria in existence prior to the successful challenge to the proposed amendments treated in the Final Order issued in Florida Medical Center. Stipulations Palms and Mease stipulate that each other's application meets the quality of care criteria set forth in Section 381.705(1)(c), Florida Statutes. Morton Plant disputes only Mease's ability to insure quality of care through sufficient utilization. HRS stipulates that both applications meet quality of care criteria with the sole exception that neither applicant included a "written protocol" as noted on page II of the State Agency Action Report (SAAR). The parties stipulate that the requirement for a written protocol exists within the "new" version of the cardiac cath rule and not in the original version of the rule. The parties further stipulate that the terms "written protocol" and "transfer agreement" are not defined in either version of the cardiac cath rule. The parties stipulate that criteria contained in Section 381.705(1)(e), Florida Statutes, (relating to operation of joint, cooperative or shared health care resources) are not applicable to either of the applications in this case. HRS stipulates that criteria contained in Section 381.705(1)(f), Florida Statutes, (regarding the need within the service district of an applicant for special equipment and services not reasonably accessible within adjoining areas) are not applicable to either the Palms or Mease applications. Morton Plant contends these criteria are in issue with regard to Mease's application. All parties stipulate that criteria contained in Section 381.705(1)(g), Florida Statutes, (relating to need for research and educational facilities in conjunction with the applications) are not in issue. Criteria relating to manpower and resources contained in Section 381.705(1)(h), Florida Statutes, are not deemed applicable to the applications by HRS or the Petitioners. Morton Plant contends that these criteria are in issue with regard to the availability of necessary health manpower resources insofar as the Mease application is concerned. Petitioners agree that their applications meet immediate and long term financial feasibility requirements of Section 381.705(1)(i), Florida Statutes. HRS also joins in that agreement, provided costs associated with the cardiac cath lab director at the lab proposed by Palms does not affect the financial feasibility of Palms' project. Morton Plant contests the long term feasibility of Mease's project. All parties agree that criteria contained in Section 381.705(1)(m), Florida Statutes, relating to the costs and methods of proposed construction and equipment acquisition, are met by Palms' application and are not applicable to Mease's application. Criteria contained in Section 381.705(1)(n), Florida Statutes, relating to provision of services to Medicare and medically indigent patients, are met by the Petitioners according to HRS. The other parties contend these criteria are in issue. The parties agree that requirements of Section 381.705(2)(c) and (e), Florida Statutes, (relating to new construction alternatives and proposals for additional nursing bed capacity) are not applicable to the applications at issue in this case. The parties agree that the licensure and accreditation of the parties are not in issue and need not be proven. HRS stipulates that Palms' application and Mease's application satisfy all rule criteria under both the old and new versions of the cardiac cath rule with exception of those criteria relating to need (numeric and non-numeric), a written protocol or transfer agreement, and utilization standards set forth in the rule. Availability of existing services Palms Palms' patients requiring the services of a cardiac cath lab must be transferred by ambulance to other facilities where such service is available. Most of these transfers are made to All Children's Hospital (All Children's) in St. Petersburg, Florida, the nearest facility with cardiac cath services. Cath procedures are performed at that facility by cardiologists possessing staff privileges at Palms, as well as All Children's. On average, the transfer of a patient from Palms to All Children's takes an average of one and a half to two hours, although the actual automobile travel time is less than an hour. After a determination that a cardiac cath is needed, arrangements for the transfer involve negotiating an available time at All Children's and preparing the patient for transfer. Patient medical records are copied, consent forms signed, explanations given to patients and intravenous administration of fluids is begun. Because of their unstable condition, specialized nurses, capable of interpreting cardiac monitors and administering drugs associated with cardiac problems, must accompany these cardiac patients in the ambulance. All Children's ambulance is often not available for transfers from Palms. In those instances, Palms must provide an ambulance and nurse. If the need for such a transfer occurs in the middle of a nursing shift, Palms must pull a nurse from another unit in the hospital to accompany the patient. If plans for the transfer are known in advance of the beginning of a nursing shift, additional nursing staff is arranged for that shift. Some patients experience difficulties in the course of such a transfer. The number of intravenous applications (IVs) attached to a patient is limited during an ambulance transfer, consequently some patients must have some IVs removed. During transportation of the patient, IVs are often shaken loose, medications become unbalanced, other medical appliances become disconnected and some patients experience blood loss as well as a loss of blood pressure. Some patients have required blood transfusions upon arrival at the cardiac cath facilities. In view of the associated difficulties, some cardiovascular patients at Palms are simply too sick to undergo a transfer to another facility where cardiac cath services are available. If a cardiac cath lab or program existed at Palms, an estimated $68,000 in transportation charges would be saved in the first year alone. All Children's, a pediatric hospital, is the only hospital in the State of Florida that performs cardiac cath procedures on both adults and children in the same lab. Since All Children's is a tertiary, regional referral center, more than two thirds of the pediatric diagnostic cardiac caths are performed on nonresidents of the service district. Over 55 percent of all diagnostic cardiac caths at All Children's are performed on nonresidents of the district. Angioplasty is a therapeutic, as opposed to diagnostic, cardiac cath procedure. Such cardiac caths can only be performed at facilities providing open heart surgery services. All Children's is the only hospital in South Pinellas County able to perform angioplasty. All Children's has two cardiac cath labs. Both are heavily utilized. From July 1987 through June 1988, there were 1,268 cardiac admissions to the two labs. All Children's historic rate of 2.12 cardiac cath procedures per admission equates to 2,688 procedures performed on these patients. While this number of "procedures" is in excess of the minimum 600 "procedures" per lab standard applicable under the numeric need methodology used by HRS prior to publication of the proposed admission-based need determination formula, different definitions of the term "procedure" are ascribed to the term in accordance with the context of its usage. Under HRS' proposed admission-based need determination formula, there were 1,099 adult cardiac cath admissions to All Children's program from April 1987 through March 1988. This number of admissions is substantially in excess of the 300 admissions per program standard required for program operation under the proposed new rule policy. Currently 15 cardiologists normally use All Children's two labs on a regular basis. Three of these cardiologists deal with pediatric patients. A fourth pediatric cardiologist is being recruited by All Children's. This additional cardiologist will perform electrophysiology, a cardiac cath procedure involving use of multiple catheters. Electrophysiology studies are extremely time-consuming and this additional cardiologist's lab usage will contribute to present lab access difficulty. Presently, All Children's has a "block time" schedule for the different cardiologists on the active staff at the hospital. Each cardiologist has a scheduled block of time for usage of the cardiac cath labs. As a result, a cardiologist can not have a patient, admitted during the previous night, catheterized on a particular day unless that physician's block of time happens to fall on that day. This process effectively eliminates a majority of time during the week when a cardiologist may schedule catheterization for a patient. Pediatric cardiac caths require more lab time than adult cardiac caths and All Children's gives preference in scheduling caths to pediatric patients. Further, All Children's facilities are blocked all day on Mondays for pediatric patients. It is not unusual, in view of the preference given pediatric patients and emergency cath requirements, for adult cardiac cath patients to be "bumped" from the schedule after their arrival at All Children's. The length of hospitalization of adult cardiac cath patients therefore increases, along with a substantial increase in the patient's medical care costs. The decision of All Children's to block both of the hospital's labs for pediatric caths each Monday has resulted in the postponement of cardiac caths for Palms' patients until Monday night or Tuesday. The result is that weekend patients from Palms have a lengthened hospital stay, assuming the patients are stable and can endure the sometimes two or three days wait for a catheterization study. Palms' cardiologists also experience difficulty placing their patients after catheterization at All Children's. Since All Children's is a pediatric hospital, there are no adult beds with the exception of eight intensive care beds which are usually filled by open heart and other surgical patients. As a result of the lack of available beds at All Children's, alternatives are to transfer Palms' patients to Bayfront Medical Center, a facility adjoining All Children's, following catheterization, or return them by ambulance to Palms. This latter alternative is often followed since Bayfront Medical Center is frequently without available beds. Since a significant percentage of diagnostic cardiac cath patients must later undergo a therapeutic catheterization, Palms' patients, who are returned to Palms after diagnostic catheterization, must be transferred back to All Children's for additional cath work. In one instance, a Palms' inpatient was transferred a total of nine times. The difficulty of access to the cardiac cath labs at All Children's is particularly acute during the first quarter of each year when many elderly people come to the St. Petersburg area to enjoy the warmer climate. Significant health care risks to delaying diagnostic cardiac caths include instances at Palms where patients with unstable angina have suffered large myocardial infarctions before their transfer to another facility's cardiac cath lab. These risks are enhanced for Palms' cardiac inpatients, many of whom have multiple health problems. Palms' inpatients have a higher comorbidity index than all other hospitals in the service district. The approximately 30 primary care physicians on the active staff of Palms are not on the active staff of any other hospital. As a result, they are unable to follow their patients and continue treating their other ailments when those patients are transferred to another facility for cardiac catheterization work. If these primary care physicians could follow their patients, the quality of care would be improved. In addition to difficulty obtaining timely access to All Children's cath labs, the volume of work performed at the lab has resulted in cardiac cath technicians requesting, on at least one occasion, that a catheterization be stopped due to the fatigue of the technicians. Approval of additional inpatient diagnostic cath labs or programs in the area would reduce or eliminate the occasions of such stoppage in the future. Cardiac patients admitted to hospitals in the service district which do not have inpatient cardiac cath services wait, on the average, 1.5 days longer in the hospital before they receive catheterization than do those patients admitted to hospitals in the district providing such services. As a result, patients undergoing cardiac cath procedures and staying in a hospital without inpatient cardiac lab services average a stay which is 1.6 days longer than patients staying in a hospital with inpatient cath services. If Palms were able to provide inpatient cath services, an average additional charge of $1,800 per patient undergoing cardiac cath would be eliminated. This equates to a total savings of $200,000 to $300,000 in medical costs from the reduction of the average length of stay as the result of an inpatient program at Palms. Since hospitalized patients are at increased risk for developing nosocomial illness, diseases or infections contracted during a hospital stay, reducing the length of stay also lessens the patient's opportunity to develop such an illness. Approval of the Palms application, while temporarily lowering the number of diagnostic cardiac caths performed at All Children's, would eventually result in an increase in the number of cardiac caths performed at All Children's. This is particularly applicable to the increase in therapeutic caths that would occur at All Children's as the result of establishment of a diagnostic inpatient cardiac cath lab at Palms. The elderly and seasonal population which would be served by an inpatient cath lab at Palms would result in increased referrals from Palms to All Children's for therapeutic cath services. Two other hospitals in South Pinellas County operate inpatient diagnostic cardiac cath labs, St. Anthony's Hospital (St. Anthony's) and Humana Hospital Northside (Humana). Since neither hospital provides therapeutic cath services, a patient transferred there from Palms for the purpose of a diagnostic cath must later be transferred a second time to All Children's in the event therapeutic services are required. The diagnostic cardiac cath lab at St. Anthony's is owned and operated by the Rogers Heart Foundation, a private non- profit foundation. The emphasis at the Foundation on cardiac research has led to a very low use rate in its cath lab. Additionally, staff privileges are limited to those cardiologists willing to serve on rotation as an emergency room physician. As a result of the reluctance of cardiologists, who have limited their practice to cardiology, to meet the emergency room duty requirement, the staff of St. Anthony's is effectively a closed one. The cardiac cath equipment at St. Anthony's is out- dated and fails to produce quality images. Problems have been encountered by cardiologists with the quality of film developed by St. Anthony's cardiac cath lab. Consequently, the lack of growth and modernization of the St. Anthony's lab does not present a reasonable alternative to Palms' application. The alternative of Humana presents a shortage of intensive care and cardiac cath beds similar to that experience with All Children~s, especially during the winter months. Continued diagnostic catheterization of Palms patients at Humana will result in increased competition for an already insufficient number of beds. Humana is located even further from Palms than All Children's, worsening the current problems associated with transfer of Palms' patients to All Children's. Further, Humana, according to the rate of admissions to its cath lab in the second year of operation, will Substantially exceed the new proposed HRS policy of 300 admissions required to justify a program's operation. During 1988, Palms ranked fourth out of the 24 hospitals in the service district in the number of inpatients requiring diagnostic cardiac caths. If those hospitals operating cardiac cath labs are eliminated from the list, then Palms ranked first in the total number of inpatients requiring cath services at the remaining 17 hospitals. In 1988, Palms' 278 inpatients requiring diagnostic cardiac cath services was more than the 219 at St. Anthony's and the 174 for Humana's first year, even though those facilities had cath labs. Palms' total also exceeded the 201 patients requiring this service at both of the Mease hospital sites. The likelihood of discernable adverse impact on the cardiac cath programs at St. Anthony's and Humana as the result of establishing diagnostic cath services at Palms is small in view of the infrequent admission of Palms' patients to those programs. Serious problems will continue to be experienced by Palms' patients in obtaining inpatient diagnostic cardiac cath services if the Palms application is denied. In view of the demographics of the surrounding area and patient age composition at Palms, establishment of a diagnostic cardiac cath program in that hospital would result in an improvement of the standard of care received by inpatients there. The unique nature of All Children's primary mission as a pediatric hospital, and its inability to provide ready access to its cardiac cath labs by Palms' patients for the purpose of diagnostic cardiac cath services, coupled with other previously- noted access problems constitute exceptional and "not normal" circumstances sufficient to justify approval of a diagnostic cardiac cath lab at Palms without regard to numeric need requirements of either the "old" or "new" versions of Rule 10- 5.011(1)(e), Florida Administrative Code. Mease Accessibility to health services has two aspects; geographical accessibility and financial accessibility. The "old" rule policy of HRS has a two hour travel standard within which a cardiac cath lab must be available. The proposed rule has a one hour standard. Morton Plant is approximately three or four miles from the Mease Dunedin campus. Both hospitals provide services to the same population. The Mease Countryside Campus is approximately eight miles from the Mease Dunedin campus. The considerable testimony regarding the problem and inconvenience of transporting patients for cardiac cath presented by Palms is not appropriate to Mease. The cardiac cath labs at Morton Plant are not overcrowded, although alternatives to that possibility are being contemplated in the future through the addition of another cardiac cath lab. Based upon projections presented at the final hearing, an additional cath lab may be necessary by 1991. The present labs are not utilized on the weekends except for emergencies and difficulty in scheduling a diagnostic or therapeutic cath is rarely encountered. However, a scheduling suggestion was made by Morton Plant officials, requesting that cathing cardiologists not schedule elective cardiac caths on Mondays and Fridays. But, Morton Plant has not implemented any rule making the cath labs unavailable for elective procedures at those times. One of the Morton Plant labs has been in operation since 1985 and the equipment in that lab is scheduled to be replaced in the fall of 1990. This refurbishment should eliminate concerns regarding reliability of that lab's machinery, although all maintenance of the equipment in both labs is conducted at night to permit both labs to be functional during the day. Mease opened an outpatient cardiac cath lab in April, 1989. Mease expects to perform 160 to 175 outpatient diagnostic caths in the first year of operation. The lab is not presently profitable. However, transfer of inpatients to other facilities for purpose of inpatient caths does impact negatively on Mease. Mease loses approximately $133,000 per year as the result of inpatient transfers, exclusive of ambulance fees. These losses represent the difference between the medicare reimbursement to Mease and the charges that Mease must pay to the other facility for provisions of the inpatient cath services. From October 1, 1988 through September 30, 1989, between 250 and 260 Mease inpatients were transferred to other facilities to receive inpatient caths. Ambulance cost per patient varies depending upon the destination facility which is generally either Largo Medical Center in Largo, Florida, for a charge of $436 round trip or Morton Plant for a round trip charge of $378. An estimated one hour is needed to make the transfer of a patient from Mease to Morton Plant, although actual travel time to the nearby facility is obviously much less. The services of those Mease nurses who accompany each patient are unavailable to Mease for other services for approximately two hours. The transfer of any inpatient to another hospital constitutes less than optimal care and can compromise patient safety as illustrated by one instance of the transfer of a Mease patient who suffered a major heart attack en route to another facility and became a "cardiac cripple." However, such examples with regard to accessibility to other facilities by Mease patients are not sufficient to constitute exceptional or not normal circumstances for purpose of granting the Mease application. Need For The Proposed Projects Prior to publication of the new proposed rule, HRS recognized that multiple procedures may be performed on a single patient during one admission to a cardiac cath lab. However, in the course of application of the old rule methodology to determine need for additional cardiac cath CONs, HRs did not, as a matter of operational policy, ascribe that same meaning to the term "procedures" in formula computations made to determine numeric need for those labs. Typically, a patient undergoes more than one procedure in the course of a cardiac cath. To determine an actual number of procedures, in the generic sense of the word, performed by existing cardiac cath labs in the service district, Mease and Palms subpoenaed information from all those labs. As a result of that effort, Mease and Palms have shown that 7,507 cardiac cath procedures were performed in the service district during the period July 1987 through June 1988. Of this total, approximately 5,081 were diagnostic cardiac caths. Cardiac cath lab admissions for diagnostic and therapeutic cardiac caths during the July 1987 through June 1988 period totaled 4,057 patients in the service district, averaging 1.85 procedures per cath lab admission. Similarly, diagnostic cardiac caths averaged 1.47 procedures per admission. A Diagnosis Related Group (DRG) is a combination of variable diagnoses codes and procedure codes that are used by Medicare to assign a fixed level of reimbursement to the type of medical services rendered by a provider. The term ICD-9CM Code is an acronym for the Internal Classification of Diseases, 9th Revision, Clinical Modification. The ICD-9 coding system is a classification for morbidity and mortality statistics which are modified for use in the United States for statistical collection. There are five diagnosis codes which identity conditions treated and three procedure codes identifying the type of treatment provided. The federal government and the State of Florida's Health Care Cost Containment Board (HCCCB) require that Florida hospitals maintain and report ICD-9-CM Code information. The American Hospital Association, with input from the federal Health Care Financing Administration, the National Center for Health Statistics, and the American Medical Records Association, publishes standards and rules to ensure uniformity in the reporting of ICD-9 information. Further, the Peer Review Organization, as part of its contract with the Health Standards Quality Bureau, reviews the accuracy of ICD-9 coding by hospitals. Florida hospitals report ICD-9 information to the HCCCB by filling out a Uniform Hospital Discharge Data Sheet for each patient. The HCCCB requires Florida hospitals to report up to five diagnosis and three procedure codes. Different ICD-9 codes are assigned for different types of cardiac catheterization procedures. Hospitals are expected to Code each individual cardiac catheterization procedure performed on the patient in accordance with specific instructions published by the American Hospital Association. ICD-9 code information reported to the HCCCB by existing providers of cardiac cath services in the service district corroborates the findings derived by Petitioners from information obtained through subpoenas to those providers, and verifies there is generally some multiple of ICD-9 code procedures per patient in a single admission. While ICD-9 code information is the most reliable tool available for health care planning purposes, the counting of procedures by those codes is not an appropriate measuring tool or good indication of need for two reasons. First, certain procedures may be a component of each and every catheterization, such as pressure measurements and angiography. The same amount of time and resources per patient are utilized regardless of whether the event is recorded as one "admission" or two "procedures". Secondly, different hospitals do record or code the various procedures differently, thereby skewing the results of any attempt to average procedures district wide in order to develop a ratio of procedures to admissions. In this regard, it is noted that Mease and Morton Plant do not code angiography as a separate procedure, consequently they have a low ratio of procedures to admissions in comparison to Palms. In developing its proposed new rule policy, HRS considered methodical scenarios for converting prpcedures to admissions, including a conversion factor of 1.2 procedures per admission and a conversion factor of 1.9 procedures per admission. Neither of these conversion options are utilized in the proposed new rule. Further, the evidence presented at the final hearing fails to establish that HRS has in place any methodology for the conversion of cardiac cath lab procedures to admissions to cardiac cath programs. Petitioners contend that HRS relied in the past upon local health councils to gather the correct number of cardiac cath lab procedures performed by existing labs in a service district, and that hospitals with cardiac cath labs erroneously reported lab admissions to the District Five Local Health Council rather than the total number of procedures performed in the labs. Petitioners further contend that as a result of unwitting reliance upon the number of cardiac cath lab patient admissions instead of the number of procedures performed on patients admitted to those labs, HRS historically suppressed projections of cardiac cath lab need in the Service District Five when applying the "old" rule. The weight of the evidence presented at the final hearing supports a finding that actual need may be at some minor variance with that projected by HRS' need formula computation under the old rule. The extent that such need exceeds the projected amount, while not totally capable of discernment on the basis of the evidence presented, is probably in the neighborhood of 1.01 procedures per admission. It is found that HRS did not intentionally suppress need projections in the district and that the minor variance shown does not substantially affect numeric need determinations calculated under the old rule. As previously alluded to above, the term "procedure" in the rule methodology previously utilized by HRS historically meant the aggregate of what is performed on one admission to a cardiac cath lab. The old rule was based on federal guidelines providing that procedures were equal to an admission. At the time the old rule was written, the terms "cases", "cardiac catheterization", and "cardiac catherization procedures" were used interchangeably with the advent of DRGs for medicare reimbursement purposes, hospitals responded to local health councils' data collection requests by reporting "Procedures" used for reimbursement purposes. The resultant confusion spawned the motivation for HRS to propose the new rule methodology which uses the term "admission." HRS reviewed the applications at issue here pursuant to the proposed new rule and its "admissions" based numeric need methodology. That review, conducted on the basis of admissions, was consistent with the policy of HRS to interpret the term "procedure" to mean "admission." Further, in view of the equivalency accorded the those terms by HRS, the number of procedures for purposes of numeric need calculation under the "old" rule formula does not require inflation in order to apply the old rule's numeric need formula. HRS has candidly admitted that various providers reported the number of "admissions" rather than "procedures". The policy of HRS, although subject to a minor margin of error with the advent of DRGs, to count admissions as procedures is one that has been consistently and fairly applied without regard to whether the result led to the granting or denial of a particular application. From a health planning perspective, an admission or patient is the appropriate unit of measurement to determine future need for cardiac cath services. The goal of the CON program is to ensure an appropriate allocation of services while controlling capital expenditures. The Petitioners contend that cardiac catheterization admissions are not a good measure of resource consumption and that the type of catheterization, i.e., adult versus pediatric and therapeutic versus diagnostic, should be considered. To an extent, the position is well taken, but in the absence of an agency policy that measures numeric need in that fashion, the alternative proposed by the Petitioners is unpalatable. The Petitioners' overly broad proposal for consideration of "procedure" as a multiple of "admission" for purposes of need formula computation results in a proliferation of cardiac cath labs in derogation of the CON program goal previously mentioned. The use of 300 admissions as a minimum number required for a new lab under the proposed "new" rule is not a recognition by HRS of any applicable conversion factor of procedures to admissions. Instead, the number of 300 admissions is a standard that must be met after all existing providers have their present patient volume protected, as opposed to a simple minimal admission number required to maintain skill proficiency of medical personnel. Under the old rule, a volume of only 600 patients per lab is protected in contrast to the new rule's proposal to protect uncapped patient volume in existing cardiac programs. To that extent, the old rule does not place the same emphasis on utilization of existing labs or programs as does the new rule. HRS' SAAR on the Petitioners' applications confirmed a total of 4,712 admissions to cardiac cath labs in the service district from April, 1987 until March, 1988. If the number of admissions is equated to mean the number of procedures, in accordance with HRS rule policy applied to the formula previously used to determine numeric need, then the result of that computation under the "old" rule is no numeric need for additional cardiac cath labs in the service district. Likewise, computations under the proposed "new" rule need formula utilizing reported admissions during the base period also results in a finding of no numeric need for additional cath labs in the district. Out-migration While it is conceded by the parties that strict application of the numeric need methodology of the proposed "new" rule results in a finding of no need for additional cardiac cath labs, Petitioners contend that HRS is required to factor into that new need methodology the number of residents in the service district who go outside the district to obtain cardiac cath services. While subsection h of the "new" rule requires that HRS consider such data in the determination of need, there is no requirement that the number of such residents be included within the need determination formula. As established at the final hearing, out-migration serves to establish need for a facility, in the absence of numeric need, where it is shown that residents are leaving the service district due to unavailability of the services within the district. While residents are leaving the service district in this instance to obtain cardiac cath services, the evidence fails to establish that this action is due to service unavailability. Quality Of Care The parties stipulated that both applicants partially meet the statutory requirement requiring proof of the ability to render quality care and the previous record of the applicant to render quality of care. HRS contends both applicants failed to a provide a "written protocol" for the transfer of emergency patients to open heart surgery providers in compliance with requirements of the "new" rule. HRS concedes that both applications meet quality of care requirements, including those relating to a "transfer agreement" if reviewed under the "old" rule. HRS has not formally defined the term "written protocol", but no evidence exists that either applicant would fail to provide quality of care with regard to transfer of patients in the event such became necessary. The purpose of a written protocol is to assure HRS that proper quality of care procedures would be used in transferring open heart patients. HRS professes confidence in the ability of the applicants to perform this service and therefore this requirement is considered fulfilled in the event approval of the applications is determined pursuant to provisions of the "new" rule. Availability Of Resources Morton Plant's concerns regarding Mease's ability to render quality of care are restricted to whether Mease has provided for sufficiently trained staff to handle the projected volume of cases in the event that Mease's application is approved. Availability of appropriately trained professionals is also a Morton Plant concern. The projections of Mease for salaries, number of employees, expenses, training or acquisition of employees, and overtime costs are reasonable and meet requirememts relating to availability of resources. Consistency With State And Local Plans The state health plan in effect when these applications were filed contains a goal that an average of 600 cardiac cath procedures per lab be maintained within the district. HRS found this provision of the state health plan to be inapplicable since these applications were not reviewed in conjunction with requirements of the "old" rule. Regardless of this omission, neither application meets this goal in view of the traditional interpretation accorded the term "procedures" by HRS. With regard to the district plan, all counties within Service District Five have existing or approved cardiac catheterization providers. With the exception of the access difficulties noted with regard to Palms, services are well distributed. Neither applicant is a major referral hospital, although both have traditionally served all patients without regard to the ability of the patient to pay. Adequacy And Availability Of Other Services There are other existing providers of diagnostic inpatient cardiac cath services available in service district five, whose capacity is not fully utilized. Mease, whose Dunedin campus is located only three to four miles from Morton Plant, proposes to provide services to the same patient population. As previously noted, the concerns about the adequacy of equipment in one of the Morton Plant cath labs is in the process of being addressed through the installation of new equipment in the fall of 1990. Although there are existing providers available, the instances of access difficulty recited by witnesses for Palms are likely to be compounded as more patients undergo cardiac catheterization at those alternative facilities in the future. The demographics of Palms' elderly and multiple illness-laden inpatient population increase the complications likely to be experienced by those inpatients during transfer for purposes of diagnostic catheterization. Likewise, outpatient cath lab establishment would not be a realistic alternative for these patients, or a cost effective measure. While many inpatients would invariably have to be transferred later for therapeutic cath services, the rigors of such a journey would be avoided initially for all inpatients and a considerable number of inpatients thereafter. Impact On Existing Costs No testimony presented at final hearing supports a finding of an adverse impact on any existing provider in the event that Palms' application is approved. Of the three other full service hospitals in Palms' primary service area, only one has a cardiac cath program. Palms projects savings from the elimination of ambulance transfers and reductions in the length of stay for Palms' inpatients receiving diagnostic cardiac caths at approximately $157,000 in the first year of operation. Cost per cardiac cath patient for this service would be approximately $2,200 on average, an amount comparable to other providers in the Palms area. One thrust of Mease's argument, in terms of impact of its program upon the costs of inpatient cardiac cath, is directed to the losses which Mease experiences through the transfer of inpatients to Morton Plant. While increased utilization of Mease's present outpatient cardiac cath lab by its inpatients would decrease or eliminate the present loss of income experienced by the hospital, the burden of that cost benefit to Mease falls upon Morton Plant. The number of inpatients projected by Mease would be derived primarily from individuals who would otherwise receive cardiac cath services at Morton Plant. Approximately 30 percent of the total procedures performed at Morton Plant would be lost if the Mease application is approved. Such a loss would not be detrimental to the Morton Plant program, other than to require Morton Plant to postpone future contemplated increases in the number of cardiac cath labs in the present program. Approval of the Mease application would increase competition to some degree among other providers of diagnostic cath services to inpatients in Mease's primary service area. As previously noted, the impact of competition would be primarily upon Morton Plant, whose cardiac cath facilities, while nearing capacity limits, are not over utilized at the present time. Mease estimates that an average cath charge to inpatients would be $1,500 if its CON is approved. The loss of revenue to Morton Plant will average $1,606 for each inpatient cath lost to another facility, or $511,000 if Mease's application is approved. This amount closely approximates the positive revenue impact of $563,785 estimated by Mease in the event of CON approval. Financial Feasibility All parties, except HRS, stipulated that Palms' application was financially feasible. HRS' position was that Palms' application met this criterion, provided costs of Palms' cardiac cath lab director did not affect financial feasibility. Palms presented evidence at the final hearing amplifying the information in its application and establishing that the cost of the lab director will not affect financial feasibility of the project. The directorship will be a voluntary, non-paying position rotated among the cardiologists with privileges to perform catheterizations. Palms' proposal is financially feasible. HRS stipulated that Mease's project is financially feasible. Morton Plant disputes the long term financial feasibility of Mease's project. Mease maintains that its provision of inpatient cath service will have no cost because the equipment has already been purchased and is being used to do outpatient caths. However, Mease also has an expense item on its inpatient pro forma for depreciation of that same equipment and maintains that the cost for providing the cath service will decrease as costs will be spread over more patients with the advent of inpatient cath services. The more reasonable assumption is that the cost of the equipment is a cost associated with the present CON application, particularly since Mease admits to the motivation of implementing outpatient service in an attempt to enhance the probability of obtaining an inpatient lab. Notwithstanding this cost discrepancy, Mease's application is financially feasible. Medicaid And Medically Indigent HRS has stipulated that the Petitioners' past and proposed provision of health care services to Medicaid patients and the medically indigent is not at issue. However, the parties contend that the matter is in issue between them. As a not-for-profit hospital, part of Mease's mission is to provide needed medical care, independently of the patient's ability to pay. Mease would apply this same philosophy to patients needing services in its inpatient cath lab. Mease provides its fair share of medicaid and charity services relative to the community in which it is located. Palms has made a commitment to serve all patients regardless of ability to pay. Palms does not have any policies which would discourage Medicaid patients. Comparative Review There is insufficient numeric need under either the new or old rule formula to approve either of the Petitioners' applications on that basis. However, Palms presented considerable evidence of exceptional and not normal circumstances justifying approval of its application. In particular, the overcrowding at All Children's, inpatient transfer problems, the severity of the scheduling difficulties at All Children's and other access problems provide an adequate basis for approval of the Palms application. Palms generates more inpatients requiring inpatient diagnostic cath services than does Mease. Notably, 4.76 percent of the total service district diagnostic cath inpatients originate from Palms as opposed to 3.37 percent for Mease. The average age of Palms' inpatients is higher than that of Mease's inpatients. Palms' inpatients have a higher comorbidity index than both Mease and the service district as a whole. Palms has had, historically, more inpatients in the 45-64 age cohort and the over age 65 cohort undergo cardiac cath than has Mease. Mease provides more Medicaid care than Palms, but Palms does not provide obstetrics and pediatric services, two areas of care traditionally high in Medicaid utilization. If the comparison is limited to Medicaid utilization for cardiology services, Palms ranks higher than Mease. Capital costs of Mease's construction of an outpatient lab capable of provision of inpatient services is not included in its application, although depreciation and amortization of the lab and equipment is included. Mease's outpatient lab was constructed in an effort to improve its application for a CON to provide inpatient services, therefore exclusion of that cost results in an unfair comparison of capital expenditure between the two applications. Discounting Mease's claim that its provision of inpatient cath service will have no cost because the equipment has already been purchased and is being used to do outpatient caths, the application of Palms is superior to that of Mease.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered approving the application of Palms for an inpatient cardiac catheterization lab or program Certificate of Need, and denying the application of Mease. DONE AND ENTERED this 22nd day of March, 1990, in Tallahassee, Leon County, Florida. DON W. DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of March, 1990. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Mease's Proposed Findings. 1.-3. Adopted in substance. 4. Rejected as to cost, not supported by weight of the evidence. 5.-15. Adopted in substance. 16. Rejected, conclusion of law. 17.-20. Rejected, cumulative. 21.-25. Rejected, unnecessary. 26.-31. Adopted in substance, but qualified in some instances. Rejected, unnecessary. Adopted in substance. Rejected, unnecessary. Rejected, misrepresentative of HRS policy interpretation of "procedures" in the context of rule application. Rejected, not supported by the weight of the evidence. 37.-38. Adopted in substance. 39. Adopted. 40.-41. Rejected, not supported by weight of the evidence. 42.-43. Rejected, unnecessary. 44.-45. Rejected, not supported by weight of the evidence. Adopted. Rejected, not supported by weight of the evidence. 48.-51. Rejected, cumulative. 52.-58. Adopted by reference. Rejected, relevancy. Rejected as recitation of testimony, alternatively ultimate conclusion not supported by weight of the evidence. Adopted by reference. Rejected, relevancy. 63.-65. Adopted. Rejected, speculative. Adopted by reference. Rejected, not supported by weight of the evidence. Rejected, cumulative. 70.-72. Adopted in substance. Rejected, cumulative. Adopted in substance. 76. Rejected on basis of creditability. 77.-78. Adopted. 79.-81. Adopted in substance. 82.-84. Rejected, cumulative. 85.-86. Rejected, not supported by weight of the evidence. 87.-88. Adopted by reference. 89. Rejected, cumulative and speculative. 90.-91. Adopted in substance. 92. Rejected, not supported by weight of the evidence. 93.-94. Adopted in substance. 95.-97. Rejected, not supported by weight of the evidence. 98.-99. Adopted by reference. 100. Rejected, unnecessary. 101.-103. Adopted in substance. 104.-110. Rejected, not supported by weight of the evidence. 111. Adopted in substance. 112.-114. Rejected, not supported by weight of the evidence. 115.-116. Rejected on basis of creditability. 117.-122. Adopted by reference. Rejected, not supported by weight of the evidence. Adopted in substance. Rejected on basis of creditability. 126.-128. Rejected, cumulative. 129. Rejected, not supported by weight of the evidence. 130.-131. Adopted in substance. 132.-138. Adopted by reference, although cumulative. 139.-141. Rejected, relevancy. 142. Rejected, not supported by weight of the evidence. 143. Rejected, relevancy. 144. Adopted with modifications. 145. Rejected, not supported by weight of the evidence. Palms' Proposed Findings. 1.-10. Adopted in substance. 11. Rejected, unnecessary. 12.-25. Adopted in substance. 26. Rejected, unnecessary. 27.-41. Adopted in substance. 42. Rejected, not supported by the evidence. 43.-45. Adopted in substance. 46. Rejected, unnecessary. 47.-57. Adopted in substance, though not verbatim. 58. Rejected, conjecture unsupported by weight of the evidence. 59.-63. Adopted in substance. 64. Rejected, unnecessary. 65.-71. Adopted in substance. 72.-75. Rejected, unnecessary. 76. Adopted as to first sentence. Rejected as to second sentence as unsupported legal conclusion. 77.-79. Adopted in substance. Rejected, not supported by weight of the evidence. Adopted for recitation of factual background in recommended order. However, the term "procedure" refers to ICD-9 procedures and not to "procedures" as that term has been defined by agency policy for need formula calculation. Proposed finding's conclusion of additional lab numeric need is rejected as not supported by weight of the evidence. 82.-88. Adopted in substance, though not verbatim. 89.-92. Rejected, unnecessary. 93.-94. Rejected, unsupported by weight of the evidence. 95.-101. Rejected, unnecessary. 102. Rejected, not supported by weight of the evidence. 103.-105. Rejected as legal argument and conclusions unsupported by weight of the evidence to advance the theory that ICD- 9 procedures should govern over the agency's policy definition of procedures under the old rule, and that such other definition should control the determination of number of admissions used to calculate numeric need under the new rule. Rejected, unnecessary. First sentence adopted in substance, remainder of this proposed finding is rejected as argumentative legal conclusion not supported by weight of the evidence to the extent that subsection h data must be included in numeric need formula calculations. Rejected as to ultimate conclusion of this proposed finding as unsupported by weight of the evidence. 109.-114. Adopted in substance. 115.-117. Adopted by reference. 118.-119. Rejected, not supported by weight of the evidence. 120.-125. Adopted in substance. 126. Rejected, unnecessary. 127.-130. Adopted in substance. 131. Rejected, not supported by weight of the evidence. 132.-137. Adopted in substance, though not verbatim. Morton Plant's Proposed Findings. 1.-5. Adopted in substance. Adopted in substance with exception of last sentence which is not supported by weight of the evidence. Adopted by reference. Rejected as to ultimate conclusion as unsupported by the weight of the evidence. 9.-11. Adopted in substance. 12.-15. Adopted in substance. 16.-18. Rejected, unnecessary. First sentence reject, unsupported by evidence as to Palms. Adopted by reference as to remainder of this proposed finding. Adopted in substance. Rejected, unnecessary. Adopted in substance. Rejected, unnecessary. Rejected, except as to last sentence which is adopted in substance. Adopted by reference. 26-28. Adopted in substance. 29. Adopted in substance with exception of next to last sentence of this proposed finding which is rejected as unsupported by weight of the evidence. 30.-34. Adopted in substance. First sentence rejected as unsupported by the weight of the evidence. Remainder of this proposed finding is rejected as unnecessary. Rejected as unnecessary. 37.-38. Adopted in substance. 39.-40. Rejected, unnecessary. Ultimate conclusion of this proposed finding regarding accessibility of cardiac cath services to Mease inpatients is adopted in substance. This proposed finding is apparently directed only to the Mease application in view of the usage of the singular in the reference to denial of the "application" and as such the remainder is rejected as unnecessary. Adopted in substance. All aspects of this proposed finding are not supported by the weight of the evidence. Therefore, as a multiple proposed finding not susceptible to division, it is rejected for that reason. Adopted in substance. Rejected, not supported by the weight of the evidence. Rejected, not supported by the weight of the evidence. 47.-48. Rejected as unnecessary with exception of last sentence of proposed finding number 48 which is rejected as unsupported by the weight of the evidence. 49.-50. Rejected, not supported by the weight of the evidence. 51. Adopted in substance. 52.-56. Rejected, legal argument. 57. Adopted in substance. HRS' proposed findings. Adopted in substance, as to patients requiring angioplasty. Rejected, unnecessary. Rejected, not supported by weight of the evidence. Adopted in substance. Rejected, unnecessary. Adopted in substance. 7.-10. Adopted in substance. 11. Rejected, unnecessary. 12.-13. Adopted by reference. Rejected as unnecessary. First sentence adopted in substance, remainder rejected as speculative, not supported by weight of the evidence. Rejected, not supported by weight of the evidence. Adopted by reference. Adopted in substance. 19.-21. Adopted in substance. 22.-23. Rejected, unnecessary. 24.-25. Adopted in substance with exception of last sentence of proposed finding number 25 which is not supported by the weight of the evidence. 26.-27. Rejected, unnecessary. 28. Adopted by reference. 29.-30. Adopted in substance. Adopted in substance. Last sentence rejected as unsupported by the weight of the evidence. Adopted by reference. 34.-35. Adopted. Rejected, not supported by weight of the evidence. Adopted in substance. Not supported by the weight of the evidence. 39.-45. Adopted in substance. Rejected, unnecessary. Adopted in substance except as to last sentence which is rejected as unnecessary. Adopted. 49.-53. Rejected as unnecessary. 54. Adopted. 55.-56. Rejected, unnecessary. 57.-58. Adopted in substance. 59. Rejected, unnecessary. 60.-61. Adopted in substance. 62. Rejected, unnecessary. 63.-67. Adopted in substance. 68.-72. Rejected, unnecessary. 73.-77. Adopted in substance. 78.-79. Rejected as unnecessary. 80.-81. Rejected as legal conclusions. 82. Rejected as unnecessary. 83.-87. Rejected, legal conclusions and argument. 88.-89. Adopted in substance. 90.-92. Rejected, unnecessary. Adopted in substance. Rejected, unnecessary. Adopted in substance. 96.-98. Adopted by reference. 99. Rejected, unnecessary. 100.-101. Adopted in substance. Rejected, recitation of testimony. Rejected as to Palms, not supported by weight of the evidence. As to Mease, existing inpatient providers provide an alternative. 104.-105. Rejected, not supported by the weight of the evidence. 106. Rejected as cumulative. 107.-108. Rejected as unnecessary. Adopted by reference. Rejected, legal argument. Adopted in substance. Adopted by reference. 113.-114. Adopted in substance with modification. 115. Adopted in substance. COPIES FURNISHED: Edgar Lee Elzie, Jr., Esq. 215 South Monroe Street, Suite 804 Tallahassee, FL 32301 C. Gary Williams, Esq. Stephen C. Emmanuel, Esq. 227 South Calhoun St. P.O. Box 391 Tallahassee, FL 32302 Ken Hoffman, Esq. W. David Watkins, Esq. P.O. Box 6507 Tallahassee, FL 32314-6507 Cynthia S. Tunnicliff, Esq. Loula Fuller, Esq. P.O. Drawer 190 Tallahassee, FL 32302 Gregory L. Coler Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Sam Power Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 John Miller, Esq. General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 =================================================================
The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon allegations that he violated Sections 456.072(1)(bb), and 458.331(1)(t), Florida Statutes (2003), in the care and treatment of Patient H.J.?
Findings Of Fact Stipulated Facts Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME: 65565. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes. On or about July 21, 2003, the Respondent performed peritoneal dialysis catheter removal on Patient H.J. at Bay Medical Center (Bay Medical). Peritoneal dialysis is a technique that uses the patient's own body tissues inside of the abdominal cavity to act as a filter. On or about August 25, 2003, Patient H.J. presented with erythema (a redness of the skin resulting from inflammation) and induration (localized hardening of soft tissue of the body) in the area where the peritoneal dialysis catheter had been removed. On or about December 3, 2003, the Respondent performed exploratory surgery of Patient H.J.'s wound. Additional Facts Patient H.J. suffers from end-stage kidney failure, diabetes and heart disease. Dr. Ahmad Oussama Refai treated Patient H.J. for his kidney failure. Dr. Refai is a board- certified Nephrologist. Dr. Refai referred Patient H.J. for placement of a peritoneal dialysis catheter (catheter) to address the end-stage kidney failure. The catheter, as Dr. Refai describes it, was intended to remove the poisonous material in the blood of Patient H.J. By using the catheter clean fluid is introduced into the abdomen where it remains for a period of about four hours. The fluid introduced contains electrolytes put in the patient's blood stream. After the residence time for the fluid expires, the fluid is withdrawn through the catheter removing the harmful material. The patient, once instructed, is capable of performing the procedures described. The other option in performing this method of dialysis is to use a device that is employed at nighttime called a cycler, used while the patient is asleep and without the need for the patient to conduct the process. The patient's use of the catheter for dialysis is referred to as "home dialysis." Before Dr. Refai referred the patient to Respondent to place the catheter, the patient had been treated for his end- stage renal disease through a forearm AV graph to provide hemodialysis. That technique allows access to the patient's blood through a shunt, with the blood being run through a machine and cleansed and returned back to the patient. This procedure is done several times a week at out-patient centers, whereas the peritoneal dialysis is done daily by the patient or at night. On June 30, 2000, Respondent saw Patient H.J. and determined that the patient was a good candidate for the surgery necessary to place the catheter to perform peritoneal dialysis. On July 19, 2000, Respondent placed the catheter and peritoneal dialysis treatment was commenced. Following the placement the catheter was used by the patient as overseen by the Dr. Refai. As Dr. Refai describes it, the catheter is a silestic tube that has two cuffs. The cuff at the lower level sits on the fascia where it is secured and the other cuff is just under the skin or in the subcutaneous tissue. Dr. Refai describes the cuffs as fuzzy. The cuffs are expected to induce an inflammatory process promoting scarring so that the body forms tissue to hold the catheter in place. Dr. Refai calls this a bond. Dr. Refai explains that the other parts of the catheter are "slippery." It is the fuzzy part that holds the catheter in place. Petitioner's Exhibit No. 5 is an unused catheter similar in design to that placed in Patient H.J. On July 7, 2003, Respondent, Dr. Refai, and a Dr. Dean discussed Patient H.J. and the plan to remove the catheter that was no longer adequately performing the dialysis. On July 21, 2003, Respondent did surgery to remove the catheter from Patient H.J. On July 17, 2003, before Respondent did the surgery to remove the catheter, an explanation was made to Patient H.J. of the risks associated with the surgery as to bleeding, infection, MI stroke, death, and allergic reaction following removal of the catheter. Following the surgery Dr. Refai as the treating physician was aware that the wound associated with the surgery was not healing well and Dr. Refai sent Patient H.J. back to Respondent. Dr. Refai is familiar with the course of antibiotics prescribed for Patient H.J. to respond to the condition and the surgical exploration done by Respondent where a piece of cuff, as Dr. Refai describes it, was removed and the wound healed. December 3, 2003, was the date of the exploratory surgery. At that time, Patient H.J. was on hemo-dialysis and was being seen by Dr. Refai once a week. In Dr. Refai's opinion Patient H.J. was doing remarkably well, making allowances for his underlying condition (illnesses). At present Dr. Refai is aware that the patient is on the list to receive a kidney transplant. On August 1, 2003, Respondent saw Patient H.J. In his notes Respondent stated: His wounds look good. There is no evidence of infection. No fever or chills. He looks well. He is not taking any pain medicine. I am going to see him back in a month for a final visit. On August 25, 2003, Respondent saw Patient H.J. again. The Respondent's notes stated: His p.d. catheter removal site which was removed 4 weeks ago has some erythema and induration around it. I ultrasounded it here in the office and it looked like there was a little fluid. I anesthetized the area and opened it. There was no gross pus. I am going ahead and treat [sic] him with some Keflex and have him see Dr. Beaver on Friday as I am going to be out of town. This may come to a head and become an abscess. It may just be some cellulitis. I am not real sure why he would have cellulites as it certainly did not look like a hernia. I am going to have him see Dr. Beaver on Friday and make sure it is improving. On August 29, 2003, a note was made by Dr. Beaver concerning his visit with Patient H.J. In that note Dr. Beaver said: Patient of Dr. Kinsey. He was seen back for re-check. Apparently he was having some questionable cellulites around his p.d. cath today. He states that he is feeling much better. On examination, I see no redness at all and per the office assistance it has much improved. There is really not tender [sic]. It looks to me like it is improving. We will plan for him to see Dr. Kinsey back next week. On September 12, 2003, Respondent saw Patient H.J. and in the office note stated: The area in his left lower quadrant is completely healed. He is doing well. I am going to see him back in one month for a final visit. On September 16, 2003, Respondent saw Patient H.J. again and in the office note stated: He had some drainage from his previous p.d. catheter site. It does not appear to be infected. I am going to follow this area and see him in the office in a month. On September 30, 2003, Respondent saw Patient H.J. again and in the office note it states: He still has some drainage from the p.d. catheter exit site [sic] it was done about eight weeks ago. I told him that I would like to leave that along [sic] for at least three months and follow that. If it does not improve after three to four months then we may need to explore the wound but it may be a piece of suture that it [sic] trying to spit. We will see him back in the office in about 6 to 8 weeks. On November 11, 2003, Respondent saw Patient H.J. and noted: He is still draining from his p.d. catheter exit site. This has been 5 months. It is time to explore the wound. We will proceed to the operating room for exploration in the sinus tract. I suspect that there will be a piece of the catheter in the bottom of the wound. On December 1, 2003 Respondent saw Patient H.J. for the pre-operative visit. At that time he noted: He is here for a pre-op for a wound exploration for his p.d. catheter removal site. He still has some granulation tissue there. I am going to plan to probe the area and evaluate where the sinus goes. On December 3, 2003, the surgery was conducted on Patient H.J. and Respondent noted: He underwent a left lower quadrant wound exploration. The p.d. catheter cuff was within the subcutaneous tissue and that is why his wound [sic] not close. This was removed and then the would [sic] was closed. He tolerated the procedure well. The various surgeries that have been discussed which were performed by Respondent took place at Bay Medical in Panama City, Florida. In the operative procedure report at the hospital related to the December 3, 2003 exploratory operation Respondent described a pre-operative diagnosis as: Non-healing wound, left lower quadrant of the abdomen. The post-operative diagnosis stated: Non-healing wound, left lower quadrant of the abdomen. Foreign body (peritoneal dialysis catheter cuff), left lower quadrant abdominal wound. The procedure performed was described as: Wound exploration and foreign body removal. The intra-operative findings related to the operation were: He was found to have a cuff of the catheter within the tissue. He had a small piece of p.d. catheter attached to it. The cuff had obviously broken. The catheter was broken with a cuff remaining in the subcu tissue. There was no intra-abdominal portion. In comparison, on July 21, 2003, in the operative/procedure report at Bay Medical through the description of the procedure to remove the catheter Respondent stated: . . . The previous incision in the left hypogastric area was anesthetized with local anesthetic and sharply incised. This was carried into the subcutaneous tissue and p.d.-catheter dissected and divided. The catheter was then pulled from the subcutaneous tissue at the exit site. The catheter was then delivered into the wound and abdominal wall cuff sharply incised and the catheter removed. The fascial edges were then reapproximated with 2 figure-of-eight0- vicryl sutures. On July 21, 2003, when Respondent removed the catheter from Patient H.J. no pathology was ordered. On December 3, 2003, following the exploratory surgery and retrieval of the catheter pathology was ordered. Daniel G. Dena was the pathologist at Bay Medical who addressed the specimen which was described by the pathologist as: "Tissue-p.d. catheter cuff" The anatomic diagnosis referred stated: "p.d. catheter cuff: plastic catheter, with attached fibro-fatty tissue at one end, showing acute and chronic inflammation." The macroscopic examination in the pathology report stated: "The specimen is labeled 'pd catheter cuff'. Received is a portion of plastic tubing measuring approximately 5 cm in length and up to 0.5 cm in diameter, with a cuff of soft tissue at one end measuring 2.5 cm in length and 1.2 cm in diameter." On July 26, 2004, in responding to the investigation that led to this prosecution Respondent stated in writing in relation to Patient H.J.: The original peritoneal dialysis catheter removal had gone uneventfully and I felt that both cuffs of the catheter had been removed in their entirety. But this was found not to be the case. I have placed a number of these catheters and removed a number as well and have not had this type of problem before. Visual inspection of the catheter on removal is routinely undertaken to ensure that the cuffs are removed and I felt that this had been completely removed but I was obviously mistaken. I am not sure if this was a defect in the catheter. Evaluation of the catheter and assurance of complete cuff removal would have probably prevented this process. I am certainly more cognizant of this being a problem in subsequent catheters that I have removed. At the original time of catheter removal the operative site appeared appropriate. At hearing Respondent offered additional explanation concerning the July 21, 2003 operation to remove the catheter from Patient H.J. and the exploratory surgery on December 3, 2003. As Respondent explained, in the July 21, 2003 surgery Respondent made a 3-to-4 cm incision about the belly button towards the middle of the abdomen through the skin, subcutaneous tissue, the fascial layer and muscle and peritoneal layer. The peritoneal layer is a semi-permeable membrane that waste products removed in the dialysis will cross. The catheter is placed into the abdomen. The catheter is 12 to 14 inches in length with a curlicue tail and holes in the end of the catheter that allows the fluids to be introduced and withdrawn from the abdomen. As Respondent explained the catheter has two cuffs, the smaller of which is designed for placement in the rectus muscle located along the inset part of the abdomen. The smaller cuff sits inside that muscle. Tissue attaches to that cuff to keep fluid from leaking out, to keep the catheter in place and to prevent bacteria from going down the outside of the catheter. There is a segment of the catheter between that cuff and a larger cuff which sits underneath the skin in the subcutaneous tissue. The tissue in that area attaches to the cuff and serves to hold the catheter in place. When removing the catheter on July 21, 2003, Respondent used an incision of about 3 cm and encountered the mid-portion of the catheter located between the two cuffs which was dissected down through the fascia and taken out with the portion in the abdomen being removed first. Before making the incision to remove the catheter, Respondent cut the portion of the catheter outside the body of Patient H.J. off, including the metal and plastic valves and other paraphernalia hanging out of the patient. The purpose of removing the catheter outside the patient's body was in the interest of protecting the surgical field from contamination to avoid wound infection. The part removed inside the patient initially was the intra-abdominal portion. The intra-abdominal portion of the catheter, including the cuff in that area was sharply removed. The cuff was 2 or 3 times the size that it would have been when first placed and the part around the cuff was cut to allow the catheter to be extracted. The area of the fascia was closed. Next Respondent addressed the subcutaneous portion of the catheter by following it out and sharply cutting the tissue around the catheter and the subcutaneous cuff with scissors to remove that portion which also had an ingrowth of scar and fibroblastic tissue. Once the portions of the catheter with the cuffs, had been removed Respondent looked to determine if he had both cuffs which appeared at that time as a wad of scar and tissue. Respondent then closed the wound. Respondent believed that he had removed the whole catheter, to include the cuffs. In fact the subcutaneous cuff was not entirely removed and another portion of the catheter remained in the patient following the July 21, 2003 surgery. Respondent's estimate of what had been left in the patient and removed on December 3, 2003, was about 2 cm of the subcutaneous cuff and then a portion of the balance of the catheter. In commenting on the difference between the pathology report and his visual assessment on December 3, 2003, Respondent remarked about "all the stuff" grown onto the cuff and catheter. He also said it had a lot of specimen, taken to mean the "stuff" attached to the cuff and catheter. Although in the operative notes from December 3, 2003, Respondent says the catheter broke, at hearing he stated that he did not know whether the catheter had been cut or broke during the July 21, 2003 procedure to remove the catheter. No independent tests were conducted to determine whether the catheter broke during the July 21, 2003 surgery or was cut by Respondent. Respondent does not precisely remember the appearance of the catheter, to include the cuffs, when examining it on July 21, 2003. But he believed that he had successfully removed the entire catheter. In his testimony Respondent describes the office visits subsequent to the July 21, 2003 surgery. When he saw Patient H.J. he observed cellulitis around the area of the incision which was treated with oral antibiotics and resolved. Respondent used ultrasound to determine whether fluid had collected in the area where he observed the cellulitis. No fluid collection was seen. Drainage was noticed around the exit site where the catheter came out of the skin, which ordinarily takes a month to six weeks to heal. Concerning the drainage around this exit site, Respondent expected the drainage to resolve within around five weeks unless there were a piece of suture or other kind of event keeping the site opened and draining. The wound site where the incision was made healed without incident. The exit site continued to drain. After a time Respondent concluded that the reason for the drainage was either an epithelilized sinus tract, a piece of suture, a piece of catheter, a piece of cuff, or a piece of dressing for the wound. Respondent waited a time before doing the exploratory surgery in view of the use of an absorbable suture in the July 21, 2003 surgery which would have dissolved over time, precluding the need to do the exploration. Respondent, given the problem with the drainage from Patient H.J. following the July 21, 2003 surgery to remove the catheter, does not believe that the failure to remove this fragment would have killed the patient or have caused a lot of problems, but it was bothersome enough that it was worth the effort to try and find it and get the patient healed. Respondent in dictating his post-operative note on December 3, 2003, thinks that the catheter had broken and continues to hold to that belief, although he recognizes that it may have been cut in the prior surgery. Concerning his practice at Bay Medical, Respondent did not routinely have an X-ray done for patients undergoing surgery without a more specific reason for ordering it. Nor did he order a pathology examination following surgery absent the need for specific information. Patient H.J. in his testimony described the level of pain following the July 21, 2003 surgery to remove the catheter as "a little pain." Expert Opinion Dr. Stanley P. Kococki is a general surgeon licensed in Florida. He is board-certified in general surgery. He has had experience placing and removing peritoneal dialysis catheters. He was qualified to offer expert opinion testimony concerning Respondent's treatment of Patient H.J., in particular, the surgery performed July 21, 2003. Dr. Kococki expressed the opinion that the Respondent fell below the standard of care in treating Patient H.J., in that Respondent failed to recognize that he had left a portion of the catheter in the patient, which Dr. Kococki describes as a retained foreign body and that this caused the patient to undergo a second unnecessary procedure, meaning that the second procedure would not have been necessary if the catheter had been removed completely in the first surgery. The failure to remove could possibly have caused serious problems for the patient, to include septicemia and death, according to Dr. Kococki. Dr. Kococki refers to the Respondent's obligation in removing the catheter, to make certain that the whole catheter was removed and that the wound properly healed beyond that point so that the patient would not experience problems. While recognizing that there are different techniques for removing the catheter from Patient H.J., Dr. Kococki took issue with the method employed by the Respondent. Dr. Kococki believes that there are other methods for avoiding the problem with infection than to cut the catheter outside the body. There was no description of the use of a hemostat or clamps to hold the retained part of the catheter once the outside segment had been cut, so that the remaining portion of the catheter would not be lost under the skin. In addition, by cutting the catheter in two places there was a chance of leaving a piece of the catheter in the patient. Dr. Kococki expressed the opinion that when you cut the catheter in several places you have to remember where the pieces of the catheter are left in the patient. Given other circumstances during the surgery that occupy the surgeon's mind, it can lead to leaving a piece of catheter behind. Dr. Kococki expressed the opinion that leaving the catheter behind was not in the best interest of the patient because it led to subsequent surgery and had the sinus tract closed over the foreign body would have caused a localized infection and abscess formation around that area and possibly allowed for the bacteria from the abscess to enter the patient's bloodstream causing sepsis, and abscess formation in other organs, possibly the abdominal cavity, with a possible rupture intra-abdominally causing the patient to have generalized peritonitis. That can be life threatening and ultimately lethal. It is more of a problem with the person that has end-stage renal failure, in that the patient has a weakened immune system and lessened prospects to fight off infection. Dr. Kococki relied upon the pathology report made after the December 3, 2003 surgery to accurately describe the size of the segment that was left in the patient. In order to ascertain what actually happened with the catheter Dr. Kococki believes that the company or an independent examining body would have to determine if the catheter was defective. Even in the instance where the catheter may have broken in the initial surgery to remove it on July 21, 2003, the onus is still on the surgeon removing the catheter to examine it to make certain it was removed intact. Dr. Kococki characterizes the catheter as commonly present and utilized in surgical procedures to place and remove peritoneal dialysis catheters. Dr. Kococki describes the catheter as a medical device, unlike a sponge, forceps, clamp or surgical needle. Dr. Kococki recognizes that the purpose of the catheter is to perform dialysis but the retained portion left after the initial surgery to remove the catheter does not have a medical purpose, in his judgment. Dr. Kococki describes the cuff in the field related to the abdominal wall as providing a seal to avoid bacteria. The cuff as he understands it has an antibiotic coating that will help fight off infection. The cuff reacts with the patient's body tissue to act as a sealant. To have avoided the problem of failing to account for a portion of the catheter during the initial surgery to remove it from Patient H.J., Dr. Kococki believes that the easiest thing to have done was while the patient was in the operating room send the catheter to a pathologist and have it measured for comparison against the known size of the catheter when first placed. A second safe-guard would be to use a portable X-ray of the abdominal cavity to make sure that there was no radiopaque material in the abdomen or subcutaneous tissue. The catheter has radiopaque material allowing this identification in Dr. Kococki's understanding. Dr. Kococki was not familiar with the procedures at Bay Medical where the catheter removal from Patient H.J. was performed. The bylaws of the institution do not require that the catheter be sent to pathology following removal. Dr. Thomas A. Gadacz testified in the interest of Respondent. He is licensed in several states. He is not licensed in Florida. He is an expert in the field of general surgery. He has placed and removed peritoneal dialysis catheters. Dr. Gadacz describes the catheter as a medical device. It has nothing in common with a sponge, forceps, clamp or surgical needle, in his opinion. As a surgeon Dr. Gadacz refers to sponges, forceps, clamps and surgical needles as items whose sole purpose is to assist during an operation, not intended to be left in the body. They are to facilitate an operation to provide exposure, to conduct the operation but they are not a therapeutic modality. By contrast the peritoneal dialysis catheter is used primarily for therapy by remaining in the patient for specified periods of time to treat the patient. Other aids in performing an operation are cotton balls called kitners, metal retractors and cannulas. Dr. Gadacz explains that the purpose of the cuffs related to the catheter is to react to the body so that tissue grows around them. The other part of the catheter made of Teflon is designed to be non-reactive. Dr. Gadacz is aware that catheters of the type under discussion have fractured or broken. Dr. Gadacz explained that the fracture of a cuff is not common. In his experience, in the instance where a segment broke in a catheter, Dr. Gadacz removed it. On the other hand the failure to remove the piece is not necessarily below the standard of care as Dr. Gadacz explains, "because some times this happens, and its, you don't know that that has happened." The possibility of knowing that the segment broke off is difficult. As Dr. Gadacz describes, it was impossible given the tract involved with the surgery here. The gross inspection of the catheter once removed from the patient is a process in which it is difficult to make certain that both cuffs are there because of the encrusting fibrous tissue found after removing the cuffs, causing the cuffs to no longer have the same appearance as when first placed. The visual inspection made of the catheter after removal would not necessarily reveal whether it was removed in its entirety, according to Dr. Gadacz. Dr. Gadacz is unfamiliar with surgeons who would use an X-ray after removal of the catheter to confirm that the entire catheter had been removed. Instead he defers to Respondent's operative note on December 3, 2003, where the Respondent says that the catheter had obviously broken to explain the failure to retrieve the catheter. Dr. Gadacz does not believe sending the catheter to pathology after it was removed on July 21, 2003, would necessarily have been useful because it would take familiarity on the part of the pathologist with that form of catheter to recognize that a part was missing. Dr. Gadacz recognizes that the fragment from the catheter left in Patient H.J. at the end of the initial surgery to remove the catheter is medically considered a foreign body because it was not part of the human body. Dr. Gadacz found nothing in the care provided by Respondent by to Patient H.J. after the July 21, 2003 surgery that was questionable. Dr. Gadacz did not find the technique Respondent used in removing the catheter on July 21, 2003, from the Patient H.J. to be below the standard of care. Generally Dr. Gadacz did not express the opinion that Respondent practiced below the standard of care. Dr. Gadacz explained that had the segment continued to be present in the patient there would have been a major risk of continuing infection and ultimately the patient could have developed a serious abscess in the subcutaneous tissue that could become life-threatening or nothing may have happened, and the segment may have been walled off by the patient's body. In determining the comparability of what is described in Section 456.072(1)(bb), Florida Statutes (2003), as "other paraphernalia," to those items listed within that section, "such as a sponge, clamp, forceps, surgical needle," that are "used in surgical examination, or other diagnostic procedures," reliance is made upon testimony from Dr. Gadacz. As a surgeon, the opinion by Dr. Kococki is rejected for reasons that will be explained in the conclusions of law. When considering whether Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, as envisioned by Section 458.331(1)(t), Florida Statutes (2003), with the specificity called for in that provision, Dr. Kococki is more compelling in his opinion that the fragment left in Patient H.J. should have been removed in the earlier operation whether it broke or was cut by Respondent. The notion that there are times when some portion of the catheter may have been left in the patient, as was the case here, with no consequences to the practitioner, as expressed by Dr. Gadacz is not persuasive. Disciplinary History The Respondent has no prior disciplinary history.
Recommendation Based upon the findings of fact, and conclusions of law, and the guidance set forth in Florida Administrative Code Rule 64B8- 8.001, it is RECOMMENDED: That a final order be entered finding that Respondent did not violate Section 456.072(1)(bb), Florida Statutes (2003); that Respondent did violate Section 458.331(1)(t), Florida Statutes (2003); placing Respondent on probation for two years; imposing an administrative fine in the amount of $2,500.00; requiring Respondent to perform 50 hours of community service; requiring the completion of 5 hours of continuing medical education on "risk management" and requiring him to present a one-hour lecture to a group of peers discussing retention of foreign bodies in surgeries and techniques to avoid the retention. DONE AND ENTERED this 14th day of February, 2006, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of February, 2006. COPIES FURNISHED: William F. Miller Ephraim D. Livingston Assistants General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue At issue here is whether Memorial should be authorized to operate the cardiac catheterization service it has already initiated. The parties have stipulated that criteria specified in Section 381.494(6)(c)(5), (7), (9), (10) and (13), Florida Statutes (1983), are not in contention and that Section 381.494(6)(d)(5), Florida Statutes (1983), does not apply. Still in dispute is whether Memorial's application conforms to the criteria set out in Section 384.494(6)(c)(1), (2), (3), (4), (6), (8), (11), (12) and (6)(d)(1), (2), (3) and (4), Florida Statutes (1983), and Rule 10-5.11(15), Florida Administrative Code. Among the parties' posthearing submissions are proposed findings of fact. By order entered February 3, 1984, Fort Myers Community Hospital's motion to strike DHRS' proposed findings of fact, conclusions of law and final order was denied. Proposed fact findings have been considered in preparation of the following findings of fact, and have been adopted, in substance, except where not supported by the weight of the evidence, immaterial, cumulative or subordinate.
Findings Of Fact Community and Memorial are in Fort Myers, Florida, about three miles apart. Since 1974, Community has offered cardiac catheterization services. Memorial instituted these proceedings in hopes of obtaining authority to establish a second cardiac catheterization service in Fort Myers. Memorial already had an arteriographic radiology room and had only to spend approximately $232,835 in order to acquire a polydiagnostic-parallelogram, a cine pulse M-400 single plane system, a 35 millimeter camera, a "CMB-A Combilabor 2 Cine" film processor and a film projector. With this new equipment, Memorial has gained cardiac catheterization capability, but it is still unequipped for open heart surgery. Memorial instituted cardiac catheterization service in July of 1983. Under an agreement between the hospitals, Memorial's Exhibit No. 5, cardiac patients at Memorial needing open heart surgery can be transferred to Community, once the need is apparent. DISTRICTS In 1981, and as late as the time of the hearing, Lee, Collier, Hendry, Glades, Charlotte, Sarasota, DeSoto, Highlands, Hardee and Polk Counties comprised District 8. As of October 1, 1983, however, the district shrank to seven counties, with the shift of Highlands, Hardee and Polk Counties to District No. 6. In 1981, there were three cardiac catheterization laboratories in what was then District 8: one each at Community, Lakeland Regional Medical Center and Sarasota's Memorial Hospital. Lakeland Regional in Polk County is now in District 6. Population projections for the ten counties originally in District 8 are as follows, for the years 1981, 1982, 1983, 1984 and 1985: 1981 Total Population Percent 0-64 Total Percent 0-64 65+ Total 65+ Percent 0-14 CHARLOTTE 62088.0 66.146 41086.6 33.854 21019.4 12.258 COLLIER 91456.8 80.428 73557.1 19.572 17899.7 18.464 DESOTO 19531.2 83.715 16350.5 16.285 3180.7 21.719 GLADES 6153.6 84.737 5214.4 15.263 939.2 22.697 HARDEE 19663.2 88.488 17399.6 11.512 2263.6 27.396 HENDRY 19339.2 91.255 17647.9 8.745 1691.3 28.362 HIGHLANDS 49460.8 73.075 36143.6 26.925 13317.2 17.605 LEE 215752.8 77.297 166770.2 22.703 48982.6 17.485 POLK 329801.6 85.519 282043.7 14.481 47757.9 21.750 SARASOTA 209440.8 69.897 146392.8 30.103 63048.0 13.664 SUM OF COUNTIES DISTRICT8 1022688.0 78.470 802588.5 802508.3 21.530 220099.5 220179.7 18.389 PROJECTION 1982 Total Population Percent 0-64 Total Percent 0-64 65+ Total 65+ Percent 0-14 CHARLOTTE 65716.0 66.255 43540.2 33.745 22175.8 12.258 COLLIER 96942.6 79.921 77477.6 20.079 19465.0 18.464 DESOTO 20023.4 83.655 16750.5 16.345 3272.9 21.719 GLADES 6315.2 84.177 5316.0 15.823 999.2 22.697 HARDEE 19947.4 88.350 17623.5 11.650 2323.9 27.396 HENDRY 20079.4 91.112 18294.8 8.888 1784.6 28.362 HIGHLANDS 51395.6 72.509 37266.4 27.491 14129.2 17.605 LEE 226239.6 76.941 174070.8 23.059 52168.8 17.485 POLK 337951.2 85.350 288440.7 14.650 49510.5 21.750 SARASOTA 216630.6 69.761 151124.0 30.239 65506.6 13.664 SUM OF COUNTIES DISTRICT8 1061241.0 78.184 829904.3 829719.6 21.816 231336.7 231521.4 18.389 PROJECTION 1983 Total Population Percent 0-64 Total Percent 0-64 65+ Total 65+ Percent 0-14 CHARLOTTE 69344.0 66.364 46019.7 33.636 23324.3 12.258 COLLIER 102428.4 79.414 81342.5 20.586 21085.9 18.464 DESOTO 20515.6 83.594 17149.8 16.406 3365.8 21.719 GLADES 6476.8 83.617 5415.7 16.383 1061.1 22.697 HARDEE 20231.6 88.211 17846.5 11.789 2385.1 27.396 HENDRY 20819.6 90.969 18939.5 9.031 1880.1 28.362 HIGHLANDS 53330.4 71.942 38367.1 28.058 14963.3 17.605 LEE 236726.4 76.585 181296.7 23.415 55429.7 17.485 POLK 346100.8 85.180 294810.1 14.820 52190.7 21.750 SARASOTA 223820.4 69.625 155835.7 30.375 67984.7 13.664 SUM OF COUNTIES DISTRICT8 1099794.0 77.897 857023.3 856710.0 22.103 242770.7 243084.0 18.389 1984 Total Population Percent 0-64 Total Percent 0-64 65+ Total 65+ Percent 0-14 CHARLOTTE 72972.0 66.474 48507.1 33.526 24464.9 12.258 COLLIER 107914.2 78.907 85151.7 21.093 22762.5 18.464 DESOTO 21007.8 83.534 17548.6 16.466 3459.2 21.719 GLADES 6638.4 83.057 5513.7 16.945 1124.7 22.697 HARDEE 20515.8 88.073 18068.8 11.927 2447.0 27.396 HENDRY 21559.8 90.827 19582.1 9.173 1977.7 28.362 HIGHLANDS 55265.2 71.376 39446.0 28.624 15819.2 17.605 LEE 247213.2 76.229 188447.9 23.721 58765.3 17.485 POLK 354250.4 85.011 301152.3 14.989 53098.4 21.750 SARASOTA 231010.2 69.490 160527.9 30.510 70482.3 13.664 SUM OF COUNTIES DISTRICT8 1138347.0 77.611 883945.6 883479.4 22.389 254401.4 254867.6 18.389 PROJECTION 1985 Total Population Percent 0-64 Total Percent 0-64 65+ Total 65+ Percent 0-14 CHARLOTTE 76600.0 66.583 51002.4 33.147 25597.6 12.258 COLLIER 113400.0 78.400 88905.3 21.600 24494.7 18.464 DESOTO 21500.0 83.473 17946.7 16.527 3353.3 21.719 GLADES 6800.0 82.497 5609.8 17.503 1190.2 22.697 HARDEE 20800.0 87.934 18290.3 12.066 2509.7 27.396 HENDRY 22300.0 90.684 20222.5 9.316 2077.5 28.362 HIGHLANDS 57200.0 70.809 40503.0 29.191 16997.0 17.605 LEE 157700.0 75.873 195524.4 24.127 62175.6 17.485 POLK 362400.0 84.842 307466.2 15.158 54933.8 21.750 SARASOTA 238200.0 69.354 165200.5 30.646 72999.5 13.664 SUM OF COUNTIES DISTRICT8 1176900.0 77.324 910671.1 910027.8 22.676 266228.9 266872.2 18.389 PROJECTION These figures come from Community's Exhibit No. 1, as to which all parties stipulated. USE RATES The parties also agreed that, during the calendar year 1981, cardiac catheterization procedures in the district amounted to 743 at Community, 739 at Memorial Hospital in Sarasota, and 409 at Lakeland Regional, for a total of 1891 procedures, of which 1482 occurred at cardiac catheterization laboratories still in District 8. Since no cardiac catheterization laboratory in District 8 takes pediatric patients, this segment of the population must be excluded in calculating District 8 cardiac catheterization use rates. Of the total 1981 population of what was then District 8, 18.389 percent was under the age of fifteen. It follows that 834,626 persons 15 or older lived in District 8 in 1981. 1/ Dividing 1891 cardiac catheterization procedures by the adult population yields a 1981 use rate of 226.56854 per 100,000 persons for "old" District 8. Excluding cardiac catheterization procedures performed at Lakeland Regional and excluding the population of Highlands, Hardee and Polk Counties, the 1981 use rate for what has become District 8 can be calculated by dividing 1482 by 521526.76. This yields a use rate of 284.15666 per thousand persons resident in 1981 in the area of which District 8 is now comprised. In the state as a whole, 28,497 adult cardiac catheterizations occurred in 1981. Community's Exhibit No. 2. Dividing by Florida's projected 1981 population of 10,028.317, Community's Exhibit No. 1, the statewide cardiac catheterization use rate in 1981 was 284.16532. HRS no longer uses the cardiac catheterization projections in the State Health Systems Plan. CALCULATIONS REQUIRED BY RULE The parties have stipulated to the applicability of Rule 10-5.11(15), Florida Administrative Code, which is in evidence as Joint Exhibit No. 4, and of which official recognition has been taken. This rule prescribes multiple numerical standards. First is a minimum service volume of "300 cardiac catheterizations performed annually . . . within three years . . . [of] initiation of service." Rule 10-5.11(15)(i)(4), Florida Administrative Code. Without a need for catheterization services, no applicant could meet this requirement but the minimum service volume requirement is designed to ensure that the technicians do their work often enough to remain proficient and is not, strictly speaking, a need criterion. It is clear from the evidence that Memorial can meet this minimum service volume requirement. Fifty or sixty procedures had already occurred at the Memorial laboratory by the time of the hearing. The other arithmetic calculations called for by the cardiac catheterization rule relate specifically to need. Because 1983 is the year in which Memorial initiated cardiac catheterization services, Rule 10-5.11(15)(1), Florida Administrative Code, requires that the number of cardiac catheterization procedures in the service area "Nx" be calculated for 1983. The rule specifies that this is to be accomplished by multiplying the 1981 use rate by the 1983 population. For purposes of the rule, the pertinent 1983 population is the adult population of present District 8, which, based on Community's Exhibit No. 1, amounts to 568,097 persons. Whether the statewide use rate or the use rate prevailing in what has become District 8 is used, the result is virtually identical. Multiplying by the 1981 use rate calculated with reference to the territory that is now District 8 yields 1614.3365 procedures in 1983. Multiplying by the 1981 use rate for Florida statewide yields 1614.3346. Multiplying by the 1981 use rate for what was then District 8 yields 1287.126, but this number cannot be said to relate to the population to be served in District 8 as it is presently constituted. For purposes of Rule 10-5.11(15)(1), Florida Administrative Code, therefore, "Nx" equals 1614. Rule 10-5.11(15)(o), Florida Administrative Code, requires that "Nx" be divided by the number of "existing and approved laboratories performing adult procedures in the service area." Memorial's program has never received final approval, even though it is in fact operating and therefore "existing" within the meaning of the rule. Since Community and Sarasota's Memorial also have existing programs, the rule requires that 1614 be divided by three, yielding 538 as the average number of procedures per laboratory per year. Rule 10- 5.11(15)(o)(1), Florida Administrative Code, provides that there shall be no additional adult cardiac catheterization laboratories established in a service area unless: The average number of catheterizations performed per year by existing and approved laboratories performing adult procedures in the service area is greater than 600. . . . No party contends that Memorial's application meets this rule criterion. All agree that three is the appropriate divisor. Nor is there any justification for adding the minimum service volume (300) to the need for cardiac catheterizations (1614) which the rule establishes for District 8. The rule treats the 300 as a subset of the 1614 total. COMMUNITY'S LABORATORY UNDERUTILIZED During the period January 3 to June 30, 1983, the cardiac catheterization laboratory at Community performed 517 catheterizations 2/ for an average of 4.34 procedures per day the laboratory was open. The cardiologists schedule their own procedures, by asking their office staff to arrange times with the Community employee who keeps the appointment book for the laboratory. Tuesday is most popular. During the period from January 3 to June 30, 1983, an average of 4.75 cardiac catheterizations occurred on Tuesdays in Community's laboratory. Wednesdays and Thursdays saw comparable, although lower utilization, but the average number of procedures dropped to 4.08 for Mondays and to 3.74 for Fridays. As a rule, cardiologists in Fort Myers do not perform these procedures on weekends. The cardiac catheterization laboratory at Community can handle five procedures a day comfortably. A single crew of technicians occasionally did seven cases a day, but this involved working overtime. The laboratory normally in operation no earlier than eight in the morning and no later than two or three in the afternoon. The average case takes an hour and fifteen minutes or so. When manipulation of the catheter beyond a heart valve proves exceptionally difficult, a case may take as long as two and a half hours. Without adding staff or lengthening its hours or changing its methods, the Community laboratory easily has the capacity to perform 25 cardiac catheterization procedures a week or 108 a month. In no month has this number been exceeded. In only one was it approached. On the basis of a 50 week year, 1250 procedures can be done without changing anything other than physicians' schedules on Mondays and Fridays. In 1982, Community performed only 806 procedures. The laboratory at Community has substantial unused capacity. Changes short of increasing hours of operation could increase the laboratory's capacity drastically. Of the time expended in a normal cardiac catheterization at Community, only 15 to 20 minutes actually entails use of specialized laboratory equipment. Preparing the patient for catheterization and administering post-catheterization care need not take place inside the laboratory proper. Experience in Florida has taught that moving pre- and post- care outside the laboratory itself makes seven or eight cases a day possible without going beyond two in the afternoon. Changes that would not require a certificate of need could increase Community laboratory's capacity substantially. There are eight cardiologists in the Fort Myers area, all of whom are on staff both at Community and at Memorial, and one possibility would be adding a second shift, or a sixth or seventh day. Either of these steps might entail adding not only catheterization technicians but also additional personnel for ancillary services, however. There is talk of introducing coronary transluminal angioplasty at Community, which would increase the demands on the laboratory, by some ten percent. (Approximately five percent of cardiac catheterization patients are candidates for coronary transluminal angioplasty and this procedure takes twice as long as the ordinary catheterization, on average.) Changes at Community's laboratory not requiring a certificate of need could readily offset any such an increase in utilization. EMERGENCY CATHETERIZATIONS A cardiac catheterization constitutes emergency therapy when, in order to restore normal blood flow, the catheter is used to introduce streptokinase, an enzyme that dissolves blood clots. Streptokinase may be injected intravenously so that it reaches a blockage at the desired strength, but there is a risk of untoward side effects. Use of the catheter permits local application of the enzyme to a blood clot blocking an artery. Neither of the cardiac catheterization laboratories in Fort Myers has ever administered streptokinase through a catheter, however. When a patient is admitted to hospital complaining of chest pains, and other tests do not indicate otherwise, cardiac catheterization may be appropriate, before the patient leaves the hospital. Once or twice, when there was an equipment failure at the Community laboratory, patients in this category had to be discharged and readmitted in order to be catheterized. On about ten occasions in the course of a year patients admitted with severe chest pains had to wait more than 12 hours for the laboratory to be free and in some of these cases the wait exceeded 24 hours. By comparison, the laboratory is idle for much longer periods weekends. Between two o'clock Friday afternoon and eight o'clock Monday morning, there are of course 66 hours; and there was no evidence of any use of the Community cardiac catheterization laboratory on weekends in recent times. CONTINUITY OF CARE About forty percent of the patients who are catheterized are deemed appropriate candidates for open heart surgery. Since Memorial does not have open heart surgery capability, patients must be transferred by ambulance to Community, in emergency situations. Otherwise they are discharged from Memorial and later enter Community or another hospital where open heart surgery is performed. EQUIPMENT COMPARABLE Nobody questions the adequacy of Community's laboratory. Memorial and Community offer identical cardiac catheterization services and each has all the equipment necessary to perform the services offered. Both Memorial and Community have digital vascular imaging equipment, but Community's vascular imaging equipment is not available for cardiac catheterization procedures. It is used in connection with other radiological techniques and is located elsewhere in the hospital. Since Memorial does cardiac catheterization in its radiology room, its digital vascular imaging equipment is available for cardiac catheterizations. Memorial cannot get more precise images with its equipment, but computer enhancement does allow precise images to be obtained with the use of less dye. According to uncontroverted testimony, however, the difference in the amount of dye is not large enough to affect the risk "as regards [anaphylactic] type reactions" (T. 403) to the dye. Memorial also has a U-arm apparatus that Community does not have. This facilitates taking pictures from different angles, but increased facility in this regard is only important in the performance of angioplasty procedures, which Memorial does not offer. Pursuant to Rule 10-11.5(15)(i)(5)(b), Florida Administrative Code, Memorial cannot offer coronary angioplasty because, unlike Community, it does not have facilities for open heart surgery. FINANCES Memorial's charges for a routine left heart catheterization exceed Community's charges for the same procedure by half, and are about 25 percent higher than average in the country. Memorial's charges exceed Community's for all catheterization procedures. There was no showing that anybody has ever been denied a cardiac catheterization at Community for inability to pay. The evidence suggested that this is more to the credit of the medical staff than to Community's administration, however. Memorial obviously had money available to finance initiation of its cardiac catheterization service, and might even make money on the service after a couple of years, if allowed to continue. It is losing money now, at least if its catheterization service is viewed apart from the "spinoff." One effect of permitting Memorial to operate a duplicative cardiac catheterization service in Fort Myers would be to divert revenues Community would otherwise have received to Memorial. Not only revenues for the catheterization procedures themselves, but also revenues attributable to the use of hospital rooms and other hospital services would be diverted, making the resulting marginal profit available to subsidize medical care at Memorial for which full charges go unpaid. Memorial has a high charity load and about double the proportion of medicaid patients that Community has. This undoubtedly contributes to making Memorial's charges in many categories among the very highest in the state. Community realizes profits of about $3,500,000 annually and could, at least theoretically, absorb the drop in profit that would attend its loss of revenue, without raising charges. But the fact remains that the cost of medical care to the community has increased because of Memorial's higher charges for identical services. In this case, competition increases rather than decreases total charges, as well as costs. The community could expect to pay more for catheterization services in the future if there are two laboratories in Fort Myers. MANPOWER Memorial hired its chief cardiac technician away from Community, which was still seeking a replacement at the time of the hearing. There is every reason to believe that enough staff can be obtained to man both laboratories, but it is the duplication of these salaries, more than the relatively insignificant duplication of capital costs, that makes two cardiac laboratories in Fort Myers a wasteful proposition at present.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED that the Department of Health and Rehabilitative Services deny Memorial's application for a certificate of need for a new catheterization service. DONE AND ENTERED this 29th day of August 1984 in Tallahassee, Florida. ROBERT T. BENTON, II 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 29th day of August 1984.
Findings Of Fact At all times pertinent to the issues involved herein, Respondent was licensed as a registered nurse in the State of Florida under license number 01271-2. Respondent has been licensed as a registered nurse in Florida since 1951. Since that time she has taken various continuing education courses in the nursing profession and is up-to-date on her continuing education requirements. She began work as a registered nurse with Methodist Hospital in 1967 and remained there until she was terminated 15 years later in December, 1982. According to Mrs. Scott the patient in question here, Mrs. Thornton, was first assigned to her care on the morning of November 26, 1982. This was the first day she met her. Respondent came into Mrs. Thornton's room that morning to get the patient up and ready for the day. At this point, Mrs. Thornton said she did not feel well and was very weak. Instead of a bath, she asked merely for a light sponge bath. The patient was wearing a high-neck "granny flannel" gown which she would not allow the Respondent to remove even to give her the sponge bath. At that time, Mrs. Scott says, Mrs. Thornton had one IV tube connected to an Abbott pump. This IV was connected to the patient's right forearm. Mrs. Scott did not see nor did she know that Mrs. Thornton had a subclavian catheter installed. Mrs. Scott contends that when she did rounds with Dr. Eye in the afternoon of November 26, he advised her to discontinue the IV in Mrs. Thornton's arm because of puffiness of the arm where the IV was connected. When she went to do that, she states she noticed one suture on the inside of the patient's right arm just above the elbow which was not connected to the IV. She showed this to Dr. Eye, who told her to take it out. As a result, she removed the suture and took out the intravenous tube from the right arm. At this point, she asked Dr. Eye if he wanted to send it to the lab and he said no. As a result, she put the IV set and all other throwaways in the wastebasket. At this point, Dr. Eye gave her an oral order to apply warm compresses to the arm. This order was subsequently reduced to writing. Mrs. Scott categorically denied having removed a left subclavian catheter from Mrs. Thornton. In fact, because of the gown Mrs. Thornton was wearing, Mrs. Scott denies even knowing that such a catheter had been installed. In any case, she would not have removed it by herself, she says, because she had been taught never to remove a subclavian catheter without someone else being present. She contends the catheter she removed was not a CVP (central venous pressure) catheter, as she subsequently charted by mistake. In that regard, she wrote in her nurse's notes, she says, merely what Dr. Eye had written in his order as to the description of the catheter to be removed. Dr. Eye had indicated in his orders to "D/C central line", which meant to disconnect the central line catheter (here, the subclavian) and because of the tremendous confusion at the nurses' station at the time she wrote her notes, she put in the wrong procedure. The subclavian catheter in question here was installed by Dr. Nunn, Mrs. Thornton's surgeon, on November 19, 1982.. During the procedure he inserted a 20-gauge catheter into the patient through the left subclavian area. He did not install any other catheter of a similar size. Somewhat later, he received a call from Mrs. Thornton's physician, Dr. Garcia, regarding the fact that a portion of the catheter was still in the patient and as a result, he performed surgery to remove it. He found a part of the catheter outside the wall of the subclavian vein and the remainder still in the vein. The entire portion of the catheter that was left in the patient was removed and the patient recovered satisfactorily from the surgery. In this regard, the danger inherent in leaving a piece of a catheter like this one inside a patient is that the broken remains could cause blockage of either a coronary artery, or if in the vein, a venal blockage. A third possibility is that of infection though this is somewhat more remote. According to Dr. Nunn, there are various causes for a catheter to break. The catheter may be subjected to rough treatment. The catheter itself may be weak. The catheter could be cut by the person removing it when the suture holding it in place is cut, and, although quite unlikely, the catheter might be broken when it is passed through the needle used to insert it. In Dr. Nunn's experience going back to 1955, however, he has never seen an instance where part of a subclavian catheter was left in a patient by accident. Mrs. Grace E. Davis, Mrs. Thornton's daughter, recalls that on the day Mrs. Thornton was released from the hospital, Mrs. Davis had to wait for her in the waiting room while an additional procedure was accomplished prior to the discharge. As Mrs. Davis recalls, when they got home from the hospital, she asked her mother why they had had to wait and Mrs. Thornton said that it was for the purpose of removing the catheter in her heart through which she was getting nitroglycerin. According to Dr. Earl T. Cullins, who reviewed Mrs. Thornton's medical records, she was in the hospital from November 17 through December 6, 1982. The medical records for that period indicated that the only catheters, IV's, or CVP's in the patient on November 26 may have been an Abbott Intravenous in the right arm and a subclavian catheter on the left side. The records further reveal that Dr. Eye gave verbal orders to disconnect the centerline (catheter) on November 26 and the nurse's notes written by Mrs. Scott indicate that on November 26, a CVP (central venous pressure--centerline catheter) was discontinued by her. CVP insertions are generally made in the subclavian plane or through the jugular vein, with the subclavian insertion being preferred. The records are, according to Dr. Cullins, somewhat confusing. For example, he cannot tell from the records whether the subclavian catheter was -being used for medication or whether it was covered with a pressure dressing on November 26. In any event, the records do not indicate that the left subclavian catheter was removed. Instead, they show that a CVP line (centerline catheter) was removed. While he feels that they are one and the same, he cannot tell for certain whether or not they are. At no place do the records or nurse's notes refer to the two together or as one and the same. Dr. Cullins had much to say about the performance of many of the other professionals involved in this case. For example, he described Dr. Eye as a "spastic" personality and questions the order that Mrs. Scott received to "remove the line." Dr. Cullin feels that if there were two lines in place, it cannot be certainly determined from the notes as to which one she removed. He also contends that Dr. Nunn made a mistake when he inserted the subclavian catheter on November 19 by not taking an X-ray after insertion. Another difficulty with the records, according to Dr. Cullin, is in that they reflect the intravenous needle was inserted in the patient's right hand on November 18 and was thereafter moved from hand to hand until November 26 when all drugs, which required two IV's, were stopped. To Dr. Cullin this indicates that even though the records do not specifically show the second line (other than the fact that the intravenous needle is in the right hand) there had to be one from a medical standpoint. Dr. Cullin is convinced that since the incident took place late in the day, it would not be at all unusual for Mrs. Scott to have mischarted the removal of the intravenous needle from the hand as the CVP needle which is in the only entry relating to removal of any intravenous lines. Dr. Cullin also states that the medical records, which on November 25 reflect "IV site good", and the fact that on- November 25, the nurse's notes refer to a transfer of the patient from the intensive care unit with the CVP line intact, without any other intravenous lines being mentioned, does not mean that there were no other lines. In short, Dr. Cullin is stating that the records are so confused it is impossible to tell whether there was one, two, or more intravenous lines in Mrs. Thornton on November 26, and which one was removed by Mrs. Scott. Ms. Ann Halley, Director of Nursing at Methodist Hospital, became aware of the situation involving Mrs. Thornton when she received a phone call from Dr. Nunn, who had installed the catheter and who told her that when he saw Mrs. Thornton that morning for a follow-up check, about a week after her discharge from the hospital, an X-ray showed that a portion of the subclavian catheter he had installed was still in her chest. Mrs. Thornton was returned to the hospital that afternoon for removal of the remaining piece of catheter, at which time Ms. Halley called for the medical records. when she checked them over, she saw that Respondent was the one who allegedly had removed the catheter. She contacted Ms. Jan G. Headrick, the head nurse on the floor with Mrs. Scott on November 26. Ms. Halley and Ms. Headrick had a discussion with Respondent about the situation during which Respondent admitted she had removed the catheter. In fact, she stated that when she cut the suture, the catheter simply fell out. According to Ms. Halley, Respondent did not actually use the term "subclavian" in regard to the catheter in question. However, in her opinion, there was little indication that Respondent was confused as to which catheter was in issue. Mrs. Thornton's patient records, as they relate to the catheter issue, were reviewed by Dr. Eileen Austin, a consultant with many years experience in the field of nursing. Dr. Austin concluded that a subclavian catheter had been removed from Mrs. Thornton in part by a nurse and that the remaining portion left in at the time of initial removal was surgically removed. Her review of the records revealed that three catheters were inserted during the first period of Mrs. Thornton's hospitalization. These were: An intravenous line inserted in the Patient's right hand on November 18, 1982 initially, but which was restarted several times and moved from hand to hand until it was finally capped on November 22, 1982. A catheter of this nature is always less than one inch in length and is never anywhere near seven and a half inches in length. A sub-clavian catheter inserted on November 19, 1982 which is also inserted in a vein. The purpose of this one appeared, here, too for administering drugs. It is approximately twelve inches in length and was removed, according to the records, by Respon- dent on November 26, 1982. An arterial line installed on November 19, 1982 following inser- tion of the sub-clavian catheter described above. The purpose of this line was for the withdrawal of blood for blood gas determination. It is called an arterial catheter and the longest one Dr. Austin has ever seen is two and a half inches. On the basis of the above, it appears obvious that the only one of the three catheters inserted, according to the records, long enough to have been left in the patient, was the subclavian catheter. A subclavian catheter is inserted into the clavian vessel so that the tip of the catheter is near the heart. It is inserted just below the collarbone. The records here reflected no reference in the nurse's notes after Mrs. Scott indicated removal of the subclavian catheter except for two references to dry dressings over the entry area. According to Dr. Austin, the proper procedure for the removal of a catheter is for the nurse to clip the suture holding the catheter to the skin without cutting the catheter. Thereafter, the nurse withdraws the catheter very carefully and, upon complete withdrawal, compares the length of the portion withdrawn with that of the catheter inserted as described in the patient's records. If a piece is broken off inside the patient, the visual examination in this way will reveal that that taken out is shorter than that put in, thereby indicating that some was left in the patient. Here, according to Dr. Austin, the Respondent failed to exercise proper procedure in two areas: one, she failed to note the length of the catheter inserted so that a comparison with removal could be done and, two, she failed to inspect the tip of the catheter on removal. It should be smooth and round. Anything else indicates that the catheter was broken or cut and part was left therein. This must be immediately reported to the physician. In Dr. Austin's opinion, a nurse who would remove a catheter and fail to insure the entire item was removed, and thereafter fails to report that it was not all removed, is unprofessional and puts the patient in a life- threatening situation. Further, assuming that the Respondent's sole improper activity was in mischarting the actual catheter removed, as Respondent contends, this could constitute substandard performance itself. However, the right arterial catheter in Mrs. Thornton was removed on November 20, 1982 at approximately 2:45 a.m. by Randy G. Martin, the hospital supervisor for the 11 - 7 shift that evening. He removed this catheter because the nurse on duty at the time saw that it was bent and there was some concern that it might break or otherwise do harm. At the time of this operation, Mr. Martin noticed that Mrs. Thornton had a subclavian catheter in place. When the arterial catheter was removed, it was measured and examined to see that the edges were good and then saved for the physician to examine the next day. If this arterial catheter was removed on November 20, it could not have been there on November 26, as Respondent says. Dr. Eye gave certain orders to discontinue all intravenous medication on November 22, 1982. The doctor's orders are as follows: D/C central line Per. with other meds this way Warm heat to rt arm Penicillin 500 mg-p/o Q.I.D. Serum theophyllin 6 hours after dose (scratched out) Room air arterial blood gas Sunday am. D/C all IV medication Dr. Eye's orders O.K.'d w Dr. Garcia Respondent as was stated before, contends she did not remove the subclavian catheter but instead removed the arterial catheter in the right arm, thereafter inaccurately charting its removal as the CVP catheter. She said she did this because she merely quoted the doctor's order. Thorough consideration of the above evidence admitted both for and against the Respondent, considered in light of the inherent probabilities and improbabilities of the evidence, results in the inescapable conclusion that Respondent did in fact withdraw the subclavian catheter from Mrs. Thornton and, in doing so, failed to insure that the entire catheter was removed. As a result, a 5 to 6 centimeter long piece of the catheter was left in Mrs. Thornton's chest which was surgically removed several days later. It is neither alleged nor found that Mrs. Scott was responsible for the catheter breaking. However, the evidence is clear that when she removed the catheter she failed to take those steps necessary and dictated by proper nursing procedures to insure that the entire catheter was removed. An independent examination of Mrs. Thornton's medical records by Dr. Austin, who had no part whatever in the scenario as it was acted at the time in question, revealed that three catheters were inserted in Mrs. Thorton during the period of her initial hospitalization: the subclavian catheter in the left portion of her chest; the arterial catheter in the right arm; and the peripheral catheter in one or both hands from time to time. The arterial catheter was removed by Nurse Martin on November 20, 1982. The peripheral catheter was capped on November 22, 1982. As a result, the only catheter remaining in Mrs. Thornton on November 26, 1982 was the subclavian catheter. when that fact is considered, along with the fact that Mrs. Scott's initial notes, regardless of her current explanation for them, revealed that she removed the CVP catheter (here it should be noted that CVP catheter is, in this case, the same as subclavian catheter), the conclusion is inescapable that she is the individual who removed the subclavian catheter leaving a portion in the patient. There simply is no evidence aliunde Mrs. Scott's own statement that any other catheter remained in the patient on November 26, 1982. This is so notwithstanding the testimony of Mrs. Davis concerning what her deceased aged mother advised happened the day of her discharge. It is difficult to believe that hospital officials would remove a subclavian catheter from Mrs. Thornton on the morning she is released from the hospital and Mrs. Davis' testimony as to that issue is rejected.
The Issue The main issue in these proceedings is whether the Respondent Doctors is entitled to a certificate of need to establish a cardiac catheterization laboratory in Sarasota County. The parties stipulate that the only statutory and rule criteria which remain to be reviewed by the Hearing Officer areas follows: 1. Sections 381.705(1)(a) , (b) , (c) , (d) , , and (h), Florida Statutes. Section 38l.705(1)(h)) will be reviewed insofar as it refers to the availability of health manpower, management personnel, funds for capital and operating expenditures, the alternative uses of the applicant's resources, and the extent to which the proposed services will be accessible to all residents of the district. Section 38l.705(1)(1) and (n), Florida Statutes. Section 381.705(2)(a) , (b) and () Florida Statutes. Rule 10-5.011(1)(e), Florida Administrative Code. 5. Rule 10-5.011 (8)b and (8)0, (9)b, (9)d, (9) e (1) and (9)e(ll) The other statutory criteria and the remaining subsections of the rule have either been stipulated to by the parties or are inapplicable.
Findings Of Fact Respondent Doctors is a 168 bed, acute care general hospital. The hospital has a 40 bed cardiac care unit in which all beds are monitored. Hospital Corporation of America (HCA) owns Doctors. HCA owns or operates four hundred hospitals, including nineteen in Florida. Three of the in-state hospitals have cardiac catheterization laboratories (CCLs) . Two of the existing labs, located in Bradenton and Tallahassee, are available to assist in training and preparation which may be needed in the creation of a cardiac catheterization lab at Doctors. In September 1987, Doctors applied for Certificate of Need No. 5283 to establish a cardiac catheterization laboratory. The certificate of need has been preliminarily approved by the Respondent HRS. The initial agency action has been challenged by the Petitioner, Memorial. Memorial is the primary existing health care facility which would compete with Doctors by providing cardiac catheterization services in the same city where the new lab is to be located. Consistency with State and Local Health Plans The local health plan does not directly address the need for CCLs in the area. As nothing in the plan is relevant, no inconsistencies are created with the plan in the balancing of criteria with regard to the certificate of need determination. The State Health Plan provides that an average of 600 cardiac catheterization procedures per laboratory are to be maintained in each district through 1990. To determine the use rate under Rule 10-5.011, Florida Administrative Code, HRS must look to the number of procedures provided in the district between June 1984 and July 1986. The data reveals that seven programs completed 5,841 procedures. The required averages were exceeded by over two hundred procedures per lab. The need criteria has been met by Doctors for purposes of the State Health Plan, and the local plan, as it existed at the time of the initial review of the application. Existing Facilities Memorial is an 849 bed, acute care hospital which is a regional referral hospital in the area. The hospital provides Level 3 cardiac services. These services include angioplasty and open heart surgery in addition to cardiac catheterization. Memorial's first catheterization lab opened in 1978. Memorial currently contains two CCLs that assist in fulfilling the health care needs of the district. Before the recent addition of three CCLs within the district, Memorial served as the center for cardiac services. Manatee County and Charlotte County now have their own CCLs, which reduces Memorial's pool of potential patients in need of those services. In spite of reductions in the patient pool in the past, Memorial's use of its two CCLs has continued to grow. The Sarasota County area has a unique characteristic in that many tourists who arrive in the winter months (October-April) make use of the two local hospitals, Doctors and Memorial. The use of Memorial's CCLs increases as the local cardiologists need to complete a number of diagnostic tests in order to evaluate these new patients quickly, in times of critical need. Because of the season, Memorial's CCLs are heavily utilized for emergency procedures in the winter months. Accordingly, patients who have elective procedures scheduled are often reprioritized because of the emergency needs for use of the CCLs for more seriously ill patients. This last-minute rescheduling results in prolonged hospitalizations for the nonemergency patients and increases the cost of their medical care. Although the quality of testing does not appear to suffer from the season, a significant pool of patients is denied the opportunity for convenient medical care. The treating physicians are denied lab use and test results at the anticipated times within these patients' courses of treatment. Because of Memorial's inability to make the labs readily accessible to the pool of patients scheduled for elective procedures in the winter, a need exists for a CCL for this pool of patients. Doctors primarily seeks to provide cardiac catheterization services for diagnostic purposes. However, the lab will be capable of providing immediate endocardiac catheterization pacemaking in cases of cardiac arrest. A rapid mobilization team will be available for emergency procedures when the need arises. Angioplasty and open heart surgery procedures are not planned in conjunction with the CCL services. The lab will be in operation from 7:30 a.m. to 4:00 p.m. Monday through Friday, excluding holidays. Quality of Care Doctors currently provides quality care. There are no complaints outstanding, and the hospital has sufficient capabilities and support services to provide for a CCL. Doctors is JCAH accredited and provides the necessary services required under the catheterization rule. The same cardiologists are on staff of both Memorial and Doctors. Most of these physicians admit patients to both hospitals. Approximately one-third of Doctors' admissions are patients with cardiac problems. Many of these patients require catheterization and are transferred to Memorial. If it is determined that a catheterization is needed before admission, physicians admit those patients to Memorial. Alternative Care The other CCL which currently exists in Sarasota is an outpatient lab. This facility is owned and operated by a group of invasive cardiologists who also perform catheterizations at Memorial. Because the outpatient lab restricts a patient's selection of a physician able to perform a cardiac catheterization to the lab owners, this lab is not a realistic alternative for most patients or the referring physicians. A hospital-based lab gives those involved greater personal choice, and it is better equipped to handle unanticipated emergencies. Reasonable and Economic Accessibility Memorial's CCL services are not always accessible at the times scheduled for elective procedures. Some patients have remained hospitalized for days until they can be rescheduled. The delays increase the costs attached to the procedures due to the length of the hospital stay and the additional services required. Patients admitted to Doctors who require the services of a CCL are moved to Memorial by ambulance and have to be admitted there. These transfers cost patients an additional $180-$340. The ambulance charges are not reimbursed by medicare so the majority of the patients pay these charges themselves. The proposed lab will be capable of providing a range of diagnostic tests without the need to admit patients to another hospital prior to, or during treatment at, Doctors. This will reduce costs two ways: The additional ambulance and hospital costs will be omitted, and the proposed charge for the service is less than the current charge set by Memorial. Availability of Resources Doctors currently has a staff of trained cardiac nurses. There are two nurses on staff who have taught cardiac catheterization techniques at an accredited nursing school prior to moving to Sarasota. Although the husband and wife team was originally recruited to the area by Memorial, the two nurses chose to leave that facility because of the stress from the high level of activity in those labs. Doctors plans to cross train staff and to allow for a trained special procedures staff with alternating roles and duties. The proposed CCL will be staffed with 2.5 FTEs. These consist of the 1 FTE cardiac nurse and 1.5 FTE special procedures technicians. The budgeted FTEs do not include an allocation of time for an administrative director or secretarial/clerical services. The assistant hospital administrator anticipates that provisions will be made for management personnel at a later stage of the lab's development. Although the number of FTEs scheduled is less than those anticipated for a CCL which provides more complex procedures, the number scheduled by Doctors is reasonable for the number of services and kind of services it seeks to provide for the type of cardiac patients in its care. The proposal for the lab, as described in the application and revised in the omissions response, is financially feasible. The proposed expenditure of funds will serve the needs of the hospital's current patient pool as well as the special needs of the community for cardiac catheterization services. While Doctors' proposal does not increase geographic access, it will increase access in the population center, where services are currently inaccessible for one pool of patients at certain times. A need for a project is evidenced by the utilization of like and existing services. The rule which contains the need methodology takes into account the utilization of existing facilities in determination of numeric need. Numeric needs exists in this district, pursuant to Rule 10-5.011. Written Referral Agreement Doctors submitted a written referral agreement with a facility with open heart surgery services within 30 minutes travel time by emergency vehicle under average travel conditions. The agreement meets the general requirements of HRS. The agency does not require a detailed agreement during the preliminary granting of a certificate of need because other local providers do not wish to assist applicants during the CON process. However, such applicants are able to obtain more detailed agreements after the certificate is approved. The agency has determined that the agreement is sufficient. Because a rational basis has been given for the determination, the agency's acceptance of the agreement is given great weight by the Hearing Officer. Competition and Service Doctors' project will affect competition between Doctors and Memorial. Doctors will provide services for patients who would have gone to Memorial for such services in the past because Doctors was unable to provide the service. This is because of the geographic location and the fact that the same cardiologists are on staff at both hospitals. It appears that Doctors will be providing services for patients who are not in critical need of the services. This will allow Memorial to concentrate on the more complex cases has traditionally dealt with in the past. The stress from "unhappy" elective patients will be reduced at Memorial's labs, but so will the economic incentive for the staff which is related to the number of procedures performed. The elective cardiac catheterizations are quicker and easier to perform and increase the earnings of the lab staff. Both hospitals compete directly for staff. There is a "revolving- door" situation in staffing as local heath care personnel negotiates and works in either hospital, most of the time. Because of cash bonuses offered by Doctors for joining its staff Memorial is concerned about the adverse impact upon its CCL staff. Testimony presented at hearing showed by substantial and competent evidence that Memorial is committed to equipping its two labs with the most responsive equipment available for its more complex needs. The preservation of its current lab staff has been planned for by an able administrator. Recruitment is done nationwide and plans are being made with the local community college to provide nurses training involving cardiac catheterizations. The evidence also demonstrated that Memorial plans to meet the competition by improving the health services delivery, quality assurance, and cost-effectiveness. It appears that there is room for all three labs in Sarasota, and that healthy competition will occur in the area. Past and Proposed Indigent care Doctors has given little care to the medically indigent in the past. In fact, the hospital has maintained a written policy suggesting that those who cannot pay for services should be transferred by physicians to another hospital. Rather than admit such patients, the Doctors has chosen to pay into an indigent care fund. The new assistant director maintains that the current hospital policy is to provide health care to Medicaid and indigent patients in the CCL. Doctors projects that 2.5 per cent of its catheterization volume will be Medicaid and .75 per cent will be indigent care. Alternatives to the Project The alternative which has been developed and studied by Doctors is its past use of Memorial's CCLs. This use has been found to be more costly for elective cardiac catheterizations than the current proposal. The status quo has not met the needs of the elective catheterization patients in the geographical area. Similar Inpatient Services Memorial is using its similar facilities in an efficient manner. It is not using the facilities in an appropriate manner as most elective catheterization patients do not want to be in a hospital any longer than necessary. These people are predominantly type A personalities who do not like being rescheduled and charged additional hospital costs. Problems in Outpatient Inpatient Care Elective catheterization patients have a problem obtaining local inpatient care when they want it and when their cardiologists have prepared for it in their treatment plans. This does not appear to be a serious health problem, but the evidence has demonstrated it is a serious problem. Proposed Volume of Catheterizations Based upon numeric need, utilization of Memorial, physician support, and the growth history of other providers within the district, the projected utilization of 246 procedures in 1990, 294 in 1991, and 351 in 1992 is reasonable. There is no evidence which has been extrapolated from reliable data which shows that the proposed lab, coupled with alternative treatments and currently available noninvasive technological advancements, will reduce the average number of procedures per lab within the district below 600 each year. Due to the population growth projections for Sarasota County, approval of Doctors' application will have minimal impact on lab utilization at Memorial or other facilities within the district. Doctors' projected number of procedures will not decrease procedures at Memorial below its 1987 level of 2,495 cardiac catheterization procedures performed on an annual basis.
Findings Of Fact At all times material, Respondent was licensed as an osteopathic physician in the state of Florida, having been issued license number 050004170. Respondent practices in the field of general surgery, and at all times material to this action, Respondent was on staff as Chief of Surgery at the University Hospital, Holly Hill, Florida. The incident which gave rise to the charges herein arose on August 5, 1987 when Respondent inserted a chest tube into patient W.T.'s right chest wall so as to relieve a pneumothorax which had actually occurred in W.T.'s left lung. A pneumothorax is a pocket of air in the cavity surrounding the lung which causes the lung to contract upon itself. At all times material, Patient W.T. had a subcutaneous pacemaker on the left side of her chest. However, the evidence from all credible witnesses is consistent that pacemakers are routinely placed on either the right or left side and that there is no reasonable medical presumption that pacemakers are always placed in someone's left chest area. The subcutaneous pacemaker did not enter significantly into W.T.'s case management at University Hospital. It operated on "automatic" and since it did its job, none of the University Hospital physicians involved in W.T.'s care paid much attention to it. W.T. was admitted to University Hospital for treatment of a drug overdose on July 9, 1987. As a part of her treatment, an Ewald tube was inserted into her stomach by a physician other than the Respondent. Patient W.T. was discharged from the hospital on July 18, 1987 with a portion of the tube inadvertently left in her stomach and her esophagus. On July 21, 1987, W.T. was readmitted to University Hospital. She was suffering from septicemia and bilateral pneumonia. X-rays revealed that a portion of the tubing had not been removed. This tubing was removed by the Respondent via successful gastroesophagoscopy on July 23, 1987. At Respondent's order, W.T. was placed in the Intensive Care Unit (ICU) following the removal of the tube. Dr. Desai was called in as a pulmonologist. When W.T. had been admitted to University Hospital on July 21, 1987, she already had been in a "guarded" condition. Despite successful removal of the Ewald tube, W.T.'s overall condition continued to deteriorate. Prior to the night of August 4, 1987, W.T. had developed adult respiratory distress syndrome (ARDS) which involves a breakdown in the capillary barriers within the lung itself, resulting in a diffuse leakage of fluid throughout all of the air space of the patient's lung. Because of the patient's serious lung condition, Dr. Desai placed her on a volume respirator, and the respirator pressure (PEEP) was progressively increased during her admission until it was set at 20 PEEP at the time of the incident. Twenty PEEP is an unusually high level of respirator pressure which was necessary in this case because of the patient's severe lung problem. The volume respirator essentially breathed for the patient and involved a tube being secured in her mouth. Often, between her admission to the ICU and the date of the incident, W.T. had torn the respirator tube out of her mouth, so she had been continuously restrained and sedated to keep this from happening again. Each time W.T. had extubated herself she had been "blue coded," meaning she had suffered either cardiac arrest or shock. Whether or not W.T. weighed between 225 and 250 pounds or weighed 350- plus pounds cannot be determined with any reasonable degree of accuracy since there is equally credible evidence over the entire foregoing range of poundage. It is material, however, that by all accounts of all witnesses, W.T. was markedly and grossly obese to the extent that her size, shape, and weight contributed to her several health problems and rendered her a patient more difficult to diagnose, more difficult to x-ray, more difficult to move, and more difficult to nurse and medically attend than she would have been otherwise. The evidence as to whether W.T.'s obesity impeded medical personnel from correctly interpreting her breath sounds on August 5, 1987, the date of the incident, is divided, as is the evidence as to whether or not on that date W.T.'s pacemaker was visible to the naked eye, but upon the greater weight of the credible evidence as a whole, it is found that on August 5, 1987, W.T.'s obesity, generally deteriorated condition, and left pneumothorax rendered the presence, volume, and location of breath in each lung subject to interpretation and "judgment call," and that unless one were specifically looking and feeling for a pacemaker, one would not necessarily have been able to detect the pacemaker in W.T.'s left chest due to the extraordinarily heavy pad of fat and the absence of scarring in that location. The foregoing finding of fact has been reached because with the exception of the complaining witness, Nurse Counihan, all factual witnesses either testified that they did not notice a pacemaker scar or they specifically noticed there was no scarring on W.T.'s chest. Also, with regard to breath sounds, both Mr. Starr and Respondent listened for W.T.'s breath sounds on the morning of the incident and within a very few minutes of each other. Mr. Starr described W.T.'s breath sounds when he entered her room as decreased on the right and absent on the left. His findings were consistent with a left pneumothorax but he never informed Respondent what he had found. Respondent arrived only a few minutes later and could not get any breath sounds from either side. Dr. O'Leary, accepted as an expert in pulmonology and the insertion of chest tubes, opined persuasively that one could not rely on breath sounds to locate which side the pneumothorax was on in the face of a recent x-ray. Also, the use of the respirator could have been misleading to either or both Mr. Starr or Respondent. X-rays taken of W.T.'s chest at least ten times between July 23, 1987 and July 31, 1987 clearly depict that the pacemaker was on the left side of W.T.'s chest. These x-rays were reviewed by Respondent with a radiologist the day before the events which are the focus of these charges took place. The radiology reports of W.T.'s chest x-rays dated July 25, 1987, July 28, 1987, and July 31, 1987 specifically mention the pacemaker but only the report dated July 28, 1987 states that the pacemaker overlies the left thorax. Respondent did not review any narrative reports when he and the radiologist were reviewing the actual x-rays together. There is no evidence that this procedure was outside the appropriate standard of care. Dr. Dworkin, expert in radiology and quality assurance and review, Dr. O'Leary, and Dr. Rosin, Petitioner's internal medicine expert, all testified that it is not below the professional standard of care for a treating physician to forget within a day after such an x-ray review which side a pacemaker is on unless the pacemaker enters significantly into his treatment of the patient, which in this case it did not. By the early morning hours of August 5, 1987, W.T. had become even more critically ill with multiple system failures, including a failure in the cardiopulmonary systems, a neurological deficit, and failure of her renal functions. The mortality rate of a patient suffering from ARDS, without considering the other conditions from which W.T. was suffering, exceeds 50%, and responsible medical retrospective estimates made at formal hearing of W.T.'s specific survival chances in the early morning hours of August 5, 1987 fall in the 10-50% range. During the early morning hours of August 5, 1987, the nurses on duty in ICU were having trouble maintaining W.T.'s blood pressure. They began telephoning Dr. Desai and Respondent at approximately 4:00 a.m. One of those doctors, most probably Dr. Desai, ordered a portable chest x-ray of W.T., which was accomplished at 6:30 a.m. by Josephine Christnagel, R.T., who is a registered x-ray technologist. At the time this x-ray was performed, W.T. was already in critical condition and could not speak or respond. W.T.'s condition was such that she probably was not salvageable when Respondent arrived on the scene at 7:00 a.m. on August 5, 1987. Unbeknownst to anyone at this point in time, the 6:30 a.m. x-ray had been inadvertently mislabeled by Ms. Christnagel so that the left side of the patient's chest appeared on the x-ray with a lead marker, "R" (for "right") , on it. This chest x-ray revealed that W.T. had a pneumothorax, and because it was mislabeled, the pneumothorax appeared to be on the right side. If a chest tube is properly inserted from the outside chest wall on the side of the pneumothorax, into the chest cavity, the air can be released and the lung can re-expand, delivering oxygen to the patient and raising blood pressure to normal. At all times material on August 4-5, 1987, the ranking ICU nurse on W.T.'s case was Carey Beninger ne' Counihan, R.N. The ICU nurses notified Dr. Desai by phone of the pneumothorax and he, in turn, notified Respondent. Because Respondent was more nearly ready to go to the hospital, Respondent rushed to the hospital to insert a chest tube into W.T., treatment which he and Dr. Desai, the attending pulmonologist, had agreed was the appropriate treatment for W.T.'s pneumothorax. For the reasons given infra with regard to the time the nurses' notes were compiled and Nurse Counihan's confusion over the x-ray itself, the evidence is not clear and convincing that Respondent was ever told by Dr. Desai or by the nurses by phone that the pneumothorax was on W.T.'s left side (the correct side). Even if Respondent had been so informed by Dr. Desai, since Dr. Desai had never seen the x-ray, it still would have been appropriate for Respondent to rely on the x-ray itself once he got to the hospital, unless at the hospital, something or someone clearly alerted him to the fact that the pneumothorax was actually on the left side. At approximately 7:00 a.m., just prior to the arrival of Respondent, Dr. Michael Danzig, D.O., who was the day-shift emergency room doctor, and Wesley Starr, R.P.T., a respiratory therapist, arrived at ICU and entered W.T.'s room. At approximately the time they arrived, the night-shift emergency room doctor, Dr. Haas, left the room. By all accounts, there was a continuing "commotion," a "ruckus," or "an emergency situation" in progress with at least two nurses, including Nurse Counihan, and other personnel providing various therapies to W.T. who had no palpable blood pressure and was in shock. This atmosphere continued after Respondent arrived shortly thereafter, with the nurses' and Mr. Starr's attention directed to care of the patient. When Respondent arrived, Dr. Danzig became, essentially, an observer. Upon arrival at W.T.'s room, Respondent examined the 6:30 a.m. x-ray against a window with daylight showing through. The x-ray, as it was mismarked, showed a massive tension pneumothorax on W.T.'s right side and a pacemaker on the same side, the right. After review of the x-ray, Respondent examined W.T., including listening for breath sounds. He heard nothing significant from either lung. Dr. O'Leary's opinion that such a finding was not unusual and that Respondent could not rely on either his own examination of breath sounds or that of Mr. Starr (had he even known of Mr. Starr's hearing breath sounds on the right but not the left) at that point is persuasive. Under these circumstances, breath sounds would not have alerted Respondent to a mislabeled x-ray. Respondent relied on the mislabeled x-ray and began to prep the right side of the patient for the chest tube. As Respondent began to prep W.T.'s right side, a dispute arose between himself and Nurse Counihan. Having weighed and evaluated all the testimony and the documentary evidence and exhibits, having reconciled that evidence which can be reconciled, and having eliminated that evidence which is not credible, it is found that the most credible version of this dispute is that Nurse Counihan asked Respondent why he was prepping the right side if W.T. had a left pneumothorax, and Respondent replied, "No, it isn't. Look at the x-ray." To this, Nurse Counihan said, "Yes, it is. I'm sure of it," and pointed to the lung on the x-ray which did not show a pneumothorax (the side next to the nameplate and the side without either a pacemaker or a pneumothorax). Respondent said, "No, it isn't. Look at the damn x-ray!" Respondent then proceeded to intubate on the right side while referring frequently to the mislabeled x-ray. In making the foregoing finding, it is noted that there were significant differences between the testimony of Nurse Counihan and all other witnesses, both factual and expert. Nurse Counihan deposed/testified that both she and another nurse had pointed out to Respondent that the patient's pacemaker was on the patient's left side and so was the pneumothorax. The other three factual witnesses, Starr, Danzig, and Respondent, all testified that they have no recollection whatsoever of anyone mentioning a pacemaker. Even Wesley Starr, called by the Petitioner, and who was present in W.T.'s room at the head of the patient's bed throughout the time of these discussions, testified that, to the best of his recollection, no one mentioned a pacemaker and that he did not recall anyone except Nurse Counihan challenging the Respondent's prepping W.T.'s right side. Also, Dr. Danzig, who was present in the room during the argument, and who testified that he had placed over 200 chest tubes during the course of his medical residency training, testified that if Nurse Counihan had, indeed, mentioned a pacemaker, he would have intervened in order to assist Respondent in determining the correct side of the pneumothorax. Although Petitioner asserted that Dr. Danzig is not credible due to his friendship with Respondent, that argument is not persuasive both due to the remoteness and degree of the friendship and Dr. Danzig's insistence that if Respondent should say that Nurse Counihan pointed to the side of the x-ray showing the pacemaker, then Respondent would be wrong. Respondent apparently did not review W.T.'s records either before or after the dispute with Nurse Counihan. These records were either in her room or elsewhere in the ICU unit, but since, at that point, the nurses' notes had not been compiled from their scratch pads to the patient's chart since before 4:00 a.m., there was nothing in W.T.'s chart/records to alert Respondent that the x- ray was mislabeled or that the patient had a pneumothorax on the left side even if he had reviewed the record. Also, he would have had to go back to the July 31 x-ray or the July 28 radiology narrative before he could have discovered that the pacemaker was on the left. This would have been very time consuming. Also, Dr. Danzig, who actually had made a cursory review of the patient's records when he first arrived in the room, was not alerted by Nurse Counihan's words or her pointing to the x-ray to any reason to search the records for information about the pacemaker. In further assessing Nurse Counihan's testimony, the undersigned has weighed in her favor the consistency of her recent deposition testimony with her notes and the incident report which she completed within five hours after the intubation incident on August 5, 1987. However, weighing against her credibility with regard to her statements then and now that she told Respondent that the pacemaker was on W.T.'s left side is the fact that even her August 5, 1987 report and notes were prepared in the glow of a hindsight favorable to her position and that her deposition shows that she is confused about how a pneumothorax appears on an x-ray. Reconciling all the testimony one can, it is remotely possible that Nurse Counihan said, "It is a left pneumothorax," while pointing to the lung shown on the x-ray as not having a pneumothorax and which, due to the "R" marker on the other lung could be inferred to be the left lung. It is even remotely possible (although not probable or persuasive given the three other factual witnesses' testimony that she had never mentioned a pacemaker) that Nurse Counihan could have told the Respondent, "The pneumothorax is on the same side as the pacemaker," which also was consistent with the x-ray as mislabeled. However, upon the credible evidence as a whole, the only reasonable conclusion is that if Nurse Counihan did mention a pacemaker at the time of her dispute with Respondent, she was ineffective in clearly conveying to Respondent or to anyone else in the room that the pacemaker and the pneumothorax were on the patient's left side or that there was any reason to further search the records or the patient's body to resolve the dispute. It is uncontroverted that, prior to the insertion of the chest tube in W.T.'s right side, absolutely no one, including Nurse Counihan, was aware that the x-ray was reversed, and that Ms. Counihan never informed the Respondent that the x-ray was reversed. Respondent's testimony is accepted that upon placement of the chest tube in W.T.'s right side (the side without the pneumothorax) he heard an immediate audible gush of air. That others in the room did not hear this rush of air is understandable due to the noise and confusion in the room, particularly the respirator sounds. Also, it is uncontroverted that upon placement of the chest tube in W.T.'s right side, the patient's blood pressure, which had been zero, immediately rose into normal range. A dramatic and rapid reestablishment of the patient's blood pressure is the expected result of a proper placement of a chest tube with a tension pneumothorax. All health care personnel present seem to have regarded the blood pressure stabilization as proof that the Respondent had placed the chest tube on the correct side of the patient, because no one, including Nurse Counihan, thereafter protested that a misplacement had occurred. Release of pressure and a return in blood pressure is not normally associated with placement of a chest tube in the wrong side of a patient and there is no definitive medical explanation of why it occurred in this instance, despite Dr. O'Leary's speculation that the gush of air could have been a leak of air across the Mediastrum. After placement of the chest tube in the patient's right side, Respondent ordered an immediate repeat chest x-ray to be certain the tube was placed in the correct lung and was placed correctly. After the patient's blood pressure had been reestablished, Dr. Danzig left the intensive care unit because he believed that the pneumothorax had been relieved completely and because the patient was now stable. If W.T. had not been stable, Dr. Danzig would have remained in the room since he was the day- shift emergency room doctor and he did not know if any physicians other than Respondent and himself were even in the hospital yet. After securing the chest tube and dressing the chest, Respondent left the floor and went to the operating room (OR) to notify the OR staff that there would be a delay before he could begin previously scheduled surgery. Thereafter, on his way to check the new x-ray he had just ordered, Respondent met Ms. Christnagel, who was bringing it to him. Ms. Christnagel then informed Respondent that she had mislabeled the 6:30 a.m. preintubation x-ray. Respondent simultaneously reviewed the new, postintubation x-ray and discovered that he had placed the chest tube in the wrong side of W.T.'s chest. At approximately the same time, W.T.'s blood pressure again dropped and a "code blue" was called. Dr. Gloria Mikula, M.D., who happened to be in the ICU at the time W.T. coded, "ran the code" to attempt to reestablish the patient's blood pressure. Throughout the time in which Dr. Mikula was running the code on this patient, no one, including Nurse Counihan, said anything to the effect that W.T. may have had a chest tube placed in the wrong side. In fact, the nursing staff did not even inform Dr. Mikula that this patient had had a pneumothorax and chest tube insertion prior to the code being called. Such information would have been important from a medical standpoint because it would have allowed Dr. Mikula to act immediately to relieve the tension in the patient's chest. Immediately upon reviewing the repeat chest x-ray and upon hearing the announcement of the code blue at the same time, Respondent rushed back to W.T.'s room, placed a chest tube in the patient's left side, and the patient's blood pressure was again reestablished. However, some time later in her hospitalization, W.T. expired. Nurse Counihan's failure to say anything to Dr. Mikula about the pneumothorax is further indicative of her immediate satisfaction that Respondent's intubation on the right side had been acceptable and that it was only after he discovered his error through the new x-ray and correctly intubated W.T. on the left side that Nurse Counihan completed her notes and incident report describing his error for the chart. The notes were transposed from her scratch pad and memory at approximately noon, August 5, 1987. Dr. Rosin, Petitioner's expert in internal medicine, criticized Respondent's performance as below the professional standard of care because he felt that once Respondent was made aware in the patient's room by Nurse Counihan that the pneumothorax could be on the patient's left side, Respondent had an obligation to make further inquiry or investigation before inserting the chest tube in the patient's right side. In Dr. Rosin's opinion, Respondent's investigation could have taken several routes: review of earlier x-rays and the patient's record, further conversation with the nurse, further hands-on examination of the patient for signs of the pacemaker, and/or ordering a new x- ray. Although Dr. Rosin testified that Respondent should have ordered a repeat x-ray so as to resolve the dispute with Nurse Counihan before inserting the chest tube on W.T.'s right side, he also conceded that the only possible adverse effect of the decision Respondent made was the delay in relieving W.T.'s condition. The chest intubation involved is not a benign or casual procedure, but no actual harm occasioned by misplacement of the chest tube was demonstrated in this case, and the maximum amount of time which would have been saved, under Dr. Rosin's approach, would have been that short period of time it took for the Respondent to place the chest tube and dress the wound. Under the circumstances, if Respondent had delayed intubation, W.T. would probably have "coded blue" before the correctly labelled chest x-ray could have been performed anyway. In light of the confused state of the patient's breath sounds, obesity, and lack of scarring, the fact that no nurses' notes had been codified since before 4:00 a.m., Nurse Counihan's own confusion about the mismarked x-ray, and how far back in the patient's chart Respondent would have had to look before he would have been able to locate anything useful about the pacemaker, it is found that Respondent behaved reasonably in an emergency situation, and Dr. O'Leary's and Dr. Dworkin's expert opinions that he did not violate the professional standard of care in the first insertion of the chest tube are accepted. It is also found that the Respondent's procedure in ordering the new chest x-ray and leaving the room after the first intubation without further search of the records or further conversation in the room was reasonable and appropriate under the circumstances.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Physicians enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 25th day of July, 1991, at Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 1991.
