Findings Of Fact Petitioners Flagler and St. Augustine have each applied for a CON to establish an inpatient cardiac catheter-ization program within HRS Service District IV. Each had the opportunity of responding to HRS' "omissions letter" for the cure of certain initial flaws. However, in its preliminary review of the applications, HRS denied both applicants and this proceeding followed. HRS initially denied Flagler's application, stating it had only partially complied with Sections 381.705(1)(a), (b), (i), (l), (n), and (2)(b) and (d) F.S. (1989) and Rule 10-5.011(1)(e)4.a, 4.c., and 8.b. F.A.C. HRS initially denied St. Augustine's application, stating it had only partially complied with Sections 381.705(1)(a), (b), (h), (i), (l), (n), and 2(b) and (d) F.S. and Rule 10-5.011(1)(e)4.a., 4.c., and 8.b. F.A.C. and that the applicant failed to demonstrate any compliance with Sections 381.705(1)(m) and (2)(a) F.S. Prior to formal hearing, the parties stipulated that there is a numerical need under Rule 10-5.011(1)(e)8. F.A.C. for one additional inpatient cardiac catheterization laboratory in HRS District IV for the applicable planning horizon for these applications. That planning horizon is January 1992. The parties further stipulated that both applicants have provided quality care; that, except for existing inpatient catheterization laboratories, there are no alternatives to the proposed facilities; that health manpower and management personnel are available for operation of the proposed programs; that the salaries listed on each application are reasonable; that the costs and methods of construction proposed are reasonable; that either applicant, if approved, would meet the scope of services, hours of operation, and health personnel requirements of Rule 10-5.011(1)(e) F.A.C.; and that St. Luke's Hospital in Jacksonville provides open heart surgery and is within one-half hour ambulance travel time from either applicant. It was also stipulated at formal hearing that the equipment costs proposed by both applicants are reasonable and that the costs of construction, as proposed in the applications, are reasonable. Facilities operated by Flagler Hospital, Inc. and St. Augustine General Hospital, L.P. are located in the city of St. Augustine, St. Johns County, Florida. The two facilities are less than 500 yards apart and, for all practical purposes, are directly across U.S. 1 from one another. Both facilities are 115-bed general acute care hospitals providing the same services except that Flagler provides obstetrics and St. Augustine does not. The service areas of the two hospitals consist of the five zip codes immediately surrounding the two facilities as the primary service area and St. Johns County, except the Ponte Vedra area, as the secondary service area. Flagler operates as a not-for- profit hospital. St. Augustine operates for profit. The applicant for CON 6011 is "Flagler Hospital, Inc." This corporation is based out of its only and local facility described supra and is locally operated. Regardless of any other terminology applied during HRS' review leading up to the formal Petition in DOAH Case No. 90-2035, and regardless of any inadvertent changes of the style of that cause thereafter, the "applicant" for CON 6012 is, in fact, "St. Augustine General Hospital, L.P.," a limited partnership. The applicant's August 23, 1989 Letter of Intent in CON 6012 is in the name of "St. Augustine General Hospital, L.P. d/b/a St. Augustine General Hospital." The Identification of Principal Parties form submitted by the applicant states that the legal name of the applicant/parent corporation is "St. Augustine General Hospital, L.P." and that the facility/project name is "St. Augustine General Hospital." As of the date of formal hearing, "St. Augustine Hospital, Inc." (no "General" in this name) was a wholly-owned subsidiary of "Healthtrust, Inc." and the only general partner in the applicant, and "Healthtrust, Inc." was the sole limited partner in the applicant. "Healthtrust, Inc." purchased the shares of all the other former limited partners in July 1990, only after this cause had reached the formal hearing stage. The Board of Directors of the general partner, "St. Augustine Hospital, Inc.," is located in Nashville, Tennessee, as is the Board of Directors of "Healthtrust, Inc." Health Corporation of America (HCA) owns a significant number of shares (approximately 30-34%) of "Healthtrust, Inc." "Healthtrust, Inc." is a nationwide hospital chain with approximately 90 hospitals, which "spun off" from HCA in 1987. Thus, "Healthtrust, Inc." is both the sole owner of the general partner and the sole limited partner in the applicant, a limited partnership. The past lineage of the several St. Augustine legal entities is somewhat convoluted, but it is a significant and material consideration for purposes of this CON proceeding that "Healthtrust, Inc." collects management fees from St. Augustine General Hospital, which is the applicant's d/b/a namesake, and that "Healthtrust, Inc." seems to have been underwriting St. Augustine General Hospital in one context or another for an uncertain period of time. St. Augustine General Hospital has been losing money annually. Its net loss for fiscal year 1990 was $2 million. By a September 25, 1989 letter from Stephen C. Brandt, "Healthtrust, Inc.," otherwise known as "The Hospital Company," has committed to loan "St. Augustine General Hospital, Inc." sufficient funding to implement and provide cardiac catheterization services at "St. Augustine General Hospital." The proposed recipient of "Healthtrust Inc.'s" commitment, which is "St. Augustine General Hospital, Inc.," is not the same entity or legal "person" as the applicant, "St. Augustine General Hospital, L.P.," and the parties further agree that there is no such legal entity as "St. Augustine General Hospital, Inc." (TR-132-133) Also, it is not clear from this record what other enterprises or ventures are attributable to "St. Augustine Hospital, Inc.," the general partner in the applicant. Therefore, even if the true intent of Mr. Brandt's letter was to show that the general partner, "St. Augustine Hospital, Inc." and not the nonexistent "St. Augustine General Hospital, Inc.," would receive funding from "Healthtrust, Inc.," there is no guarantee that "Healthtrust Inc.'s" funding commitment to the general partner would be used as a simple conduit to St. Augustine General Hospital, L.P., the applicant. With regard to quality of care, either applicant is capable of providing high quality cardiac catheterization services. However, St. Augustine's proposed physical plant is less ideal than that proposed by Flagler. St. Augustine proposes a lab with a procedure room that contains only 314.5 square feet of floor space. The industry standard is 480 square feet. The State of Florida has not adopted by rule a standard for the minimum size of a cardiac catheterization procedure room. However, the Inter-Society Commission for Heart Disease Resources has issued a report, relied upon by architects in designing cardiac care facilities, which recommends a minimum size for a procedure room of 50.4 square yards, which equals 453.6 square feet. The State Health Plan has adopted the Inter-Society Commission Report. Undersizing the lab has the potential to downgrade the quality of care in St. Augustine's proposed lab in several respects. It limits the storage space necessary and required to conduct routine procedures and crash procedures in cardiac arrest situations and interferes with maintaining the "sterile field," essential to routine catheterization procedures, but more importantly, in the event of a cardiac arrest or other emergency situation, there may not be adequate room for as many as five additional persons to enter the room, together with emergency equipment, to resuscitate and stabilize the patient. Concerns about undersizing of space are not applicable to Flagler's proposed catheterization lab. St. Augustine submitted that it could convert space adjacent to its proposed lab for its cardiac catheterization program at a cost of approximately $33,000, but expert testimony was persuasive that such a conversion could be considerably more expensive. To the extent that St. Augustine's planning would need to be revised, additional drawings would have to be prepared to show the reconfiguration of the room with the cost increase. Even assuming, arguendo, that St. Augustine's $33,000 figure is correct and that $33,000 is a proportionately low cost of such a change of plans in relation to St. Augustine's entire proposed project costs, it is found that such a construction conversion as proposed would constitute a change in the St. Augustine application so substantial that it would require amendment of St. Augustine's pending application and therefore such a conversion cannot be considered anew and without prior HRS review at this stage of the CON proceedings. The State Health Plan contains certain preferences relevant to this comparative CON review. Both applications benefit from the State Plan's favoring of an applicant proposing to provide cardiac catheterization services in a county that does not presently have a catheterization lab if it can be demonstrated that patients are leaving the county for such services. Upon the credible evidence as a whole, including but not limited to the testimony of Messrs. Jernigan and Nelson, Ms. Dudek, and Drs. Matthews, Prakash, and Mehrotra, it is found that a minimum of 225 patients had to travel outside St. Johns County, primarily to Jacksonville, Duval County, for such services in 1988, and there is competent, substantial evidence upon which a reasonable person may infer that that number is increasing (See Finding of Fact 20). HRS' viewpoint that freestanding labs which do not require a CON in order to operate in the proposed service area now accommodate these patients or will soon take up this slack is not supported by credible, competent substantial evidence. (See Finding of Fact 19) The State Health Plan also favors disproportionate Medicaid providers. Flagler is a federally designated disproportionate share hospital and qualifies for this preference. (See, also, Findings of Fact 15 and 20). Both applicants have committed to provide services to all patients regardless of their ability to pay and therefore both applicants meet this State Health Plan preference. The Local Health Plan also contains criteria relevant to these applications, among which is that plan's preference for an applicant who proposes to provide catheterization services in an area of concentrated population which is currently without an existing program. The city of St. Augustine constitutes such a designated area, and since both applicants' facilities are located there, they are each entitled to such preference. Both facilities are located in the District IV subdistrict with the highest use rate, and both are entitled to the Local Health Plan's preference for an applicant in the area of highest catheterization use. St. Augustine would be the logical place to put a catheterization lab if need were shown, and HRS' own rule reveals the need for one lab. (See also Finding of Facts 4, 14, 20) The Local Health Plan also prefers the applicant who will provide the proposed services in the most cost effective manner. Hospital Cost Containment Board (HCCB) figures suggest that Flagler is superior in this regard but are not persuasive in and of themselves. Historically, the applicants have been comparably cost-effective, dependent upon the procedure or service assessed. However, for the reasons set forth infra in respect to long-term financial feasibility in general, Flagler has the edge in this preference area. The Local Health Plan contains a preference for an applicant addressing a current access problem. HRS determines need for inpatient cardiac catheterization labs on a district-wide basis rather than a county-by-county basis. No cardiac catheterization subdistricts have been designed and promulgated by HRS rule. The Local Health Plan uses a subdistrict basis; subdistrict 3 contains St. Johns County without any inpatient cardiac catheterization programs and southeastern Duval County where three hospitals provide such services. Either applicant's facility meets the access standard of Rule 10-5.011(e)4.a. F.A.C., that is, access within one hour of automobile travel time under ordinary conditions for 90% of the district population. However, the access problem bears some further specific commentary. St. Johns County residents now regularly travel, primarily to Jacksonville, Duval County, and to a lesser extent, to Gainesville, Alachua County, to receive these services. Increased costs and duplicate procedures often accrue unnecessarily to patients who seek treatment outside the service area/county. Moreover, the need to travel probably depresses the number of catheterization procedures done on St. Johns County residents, either because of the genuine logistics of lack of continuity of care, travel costs to the patient and family, and stress on the patient and family caused by out-of-county procedures or because of the patients' perceptions that these problems exist. Health care of patients who forego catheterization for these reasons would be qualitatively improved if they could submit to the procedure in their own locale; likewise, health care and costs to all catheterization patients would be improved it they could access the procedure close by with lesser travel, stress, and peripheral costs. That an access problem exists has been thoroughly and conscientiously demonstrated by both applicants. It has also been established that the city of St. Augustine location of either applicant would enhance accessibility for the elderly, handicapped, and medically indigent who are the least likely patients to submit to travel for inpatient catheterization services. For those reasons and since the two facilities to be utilized by the applicants are in such close proximity, it can only be concluded that the award of a CON to either applicant would equally improve access to inpatient cardiac catheterization services on a geographic basis alone. Both applicants will be able to meet the personnel requirements of Rule 10-5.011(e)5.b. F.A.C. The premise that a de minimis higher FTE projection by St. Augustine automatically translates into better patient care was not proven and is suspect due to the size limitations of St. Augustine's proposed lab. (See Finding of Fact 10) Flagler's argument that because Flagler assigned a higher pay rate to different members of its catheterization team and because Flagler is willing to pay higher salaries overall does not translate into an advantage upon the state of this record as a whole. Either applicant will provide services to all persons in need, regardless of ability to pay, and each applicant further proposes serving Medicare, Medicaid, indigent, private pay, and HMO/PPO. Both applicants must, by law, comply with any conditions HRS may place on their CONs. In these respects, it is concluded that each applicant equally meets those respective Local Health Plan preferences, even though Flagler has clearly shown that its past "track record" in the area of Medicare, Medicaid, and indigent care exceeds that of St. Augustine in both quantity and quality. (See Findings of Fact 11 and 20) All capital projects or expenditures proposed by St. Augustine have to be approved by Healthtrust, Inc., although the hospital management can approve "substitutions" of capital items of less than $5,000 per invoice. This restriction on local management, St. Augustine's potentially imprudent freezing of its per procedure cost for two years, and its perennially low occupancy rate overall (42 out of 115 beds last year) impact unfavorably on both the short-term and long-term feasibility of its project. St. Augustine raised the valid point that since, due to litigation, neither applicant can meet its projected opening date, some adjustment of each applicant's pro forma, based on inflation, is in order, however what this adjustment should be was never persuasively quantified by the witnesses. St. Augustine challenged Flagler's pro forma statement on basically three grounds: that the nine-month earlier projected starting date (now past) for Flagler's lab projects an artificially lower patient charge due to inflation; that Flagler's supply expense of $200 is too low; and that Flagler did not amortize remodeling costs of $147,000. Both applicants' projections in the category of patient charge per procedure are found to be reasonable, but St. Augustine also suggested that Flagler's patient charge per procedure should be increased by 3.75%, which assumes a nine-month adjustment, at a 5% annual interest rate to increase Flagler's procedure charge from $1,385 to $1,437 for year one and from $1,475 to $1,530 for year two. Such a result would not render Flagler's proposal unreasonable and would have the effect of increasing Flagler's profitability. However, no evidence showed Flagler intended to increase its charge. Flagler's projected supply expense per procedure is reasonable. Assuming Flagler depreciates renovation costs over a 20 year period, the resulting minimal increase in depreciation is not a significant concern proportionate to Flagler's "bottom line" profitability. HRS opposes both applications in part upon its assertion that neither applicant can attain its proposed number of procedures so as to insure long term financial feasibility. One of HRS' premises for this assertion is its contention that there are few cardiologists residing or practicing in St. Johns County. This is a truism so far as it goes, but not a controlling factor in light of significant other forces at work. Rather than cardiologists' clientele "feeding" a cardiac catheterization lab, as HRS originally supposed, the undersigned finds, upon the greater weight and credibility of all witnesses, including HRS' Ms. Dudek, that the absence of an inpatient cardiac catheterization lab in the city of St. Augustine, St. Johns County, has, in fact, depressed the availability of cardiologists in the county. Upon the testimony of Mr. Conzemius and Dr. Lambert, it is found that because there is no inpatient cardiac catheterization lab available, cardiologists currently cannot be recruited by either applicant. Establishment of such a lab by either applicant would result in more cardiologists locating in St. Augustine and St. Johns County with a concomitant improvement in patient accessibility to cardiology services. HRS' assertion that neither applicant can attain its break-even use rate is not based upon any definitive or even cursory study by HRS of existing county use rates, CONs are not required for outpatient catheterization services which may be offered in freestanding facilities. The record does not establish with specificity the extent of utilization or service volume of outpatient cardiac catheterization labs, if any, in St. Johns County. There is expert cardiologist testimony that freestanding catheterization labs are not a medically acceptable alternative to inpatient programs in a hospital. HRS contended that neither applicant has projected reasonable patient utilization figures guaranteeing long-term financial feasibility of their respective projects, but conceded that either proposal would be financially feasible if it attracted the projected patient numbers. The greater weight of the credible evidence supports a finding that sufficient numbers of inpatient cardiac catheterization patients can be captured by either applicant. Typically, 20% of cardiac catheterizations are done on an outpatient basis, so the 225-patient figure demonstrated for 1988 understates the potential cardiac catheterization patients in St. Johns County by 20%. Thus, approximately 55 more patients obtained catheterization out of county in 1988 than are shown by the inpatient figures, so mathematically one could project 270 such procedures on St. Johns County residents actually occurred in 1988. Application of the statewide use rate of 8.9 such procedures per 1,000 people applied to the appropriate January 1, 1992 planning horizon with the predicted population increase would yield an even higher potential patient figure of 674. Subdistrict 3 has historically experienced a yet higher use rate of 10.1 cardiac catheterization admissions. Either Flagler's 250 (first year) and 300 (second year) or St. Augustine's 275 (first year) and 325 (second year) is a reasonable projection which meets the HRS recommended minimum volume of 300 procedures per year in the second year. See, Rule 10-5.011(e)8.a. and e. F.A.C. Having a cardiac catheterization program would complement the obstetrical care which is exclusive to Flagler. Both applicants indicated their willingness to make their services available to a broad payor mix. St. Augustine projects utilization by class of pay for both year one and year two of operation as 2.2% Medicaid, 56.9% Medicare, 38.9% insurance, and 2.2% indigent. Flagler projects utilization by class of pay for both years as 7% Medicaid, 60% Medicare, 31% insurance, and 2% indigent. St. Augustine's projection of 2.2% of its cardiac catheterization services for Medicaid patients is reasonable but its projection of that same percentage for charity is inconsistent with St. Augustine's prior service and is unreasonable. Considering Flagler's historical Medicaid and indigent service history, its several contracts to provide care to these classes of pay, and the comparable cardiac catheterization utilization experience of similar providers, Flagler's projections in this respect are reasonable. If Flagler has erred in this portion of its assessment, increased percentages of patients covered by insurance reimbursements would only improve Flagler's "bottom line" for long- term financial feasibility. Both applicants' pro forma statements are based on operation of the proposed cardiac catheterization lab only, not including ancillary services and other charges related to the entire patient episode of care. Both applicants will receive an incremental layer of profit from establishing a cardiac catheterization lab, but that amount was not quantified on this record. The greater weight of the credible expert evidence shows that St. Augustine's understatement of a number of expenses will result in its lab experiencing a net loss which it will be tempted to "pass on" through other hospital charges. St. Augustine's commitment to following Healthtrust, Inc.'s policies with regard to depreciation, amortization, and assigning useful life to equipment is not persuasive that these corporate principles are preferable to the generally accepted accounting principles used by Flagler. If St. Augustine's commitment to freezing its charge per procedure does not result in its raising fees elsewhere, this commitment may still aggravate instead of alleviate St. Augustine's financial predicament, for the entire facility currently operates at a net loss. Rule 10-5.011(1)(e)6. F.A.C. as amended, August 1988, requires that CON cardiac catheterization applicants who do not provide open heart surgery services include a written protocol for the transfer of emergency patients to a hospital providing open heart surgery which is within 30 minutes' travel time by emergency vehicle under average travel conditions. No statute, rule, or credible testimony herein defined "protocol" contrary to the interpretation given that term in Florida Medical Center et al. v. HRS, 11 FALR 3904 (1989). HRS' Ms. Dudek determined that each submittal met HRS' intent in the current rule. Her rule interpretation, based on agency expertise, is entitled to great weight. Flagler filed a protocol which is specific to cardiac catheterization patients in need of open heart surgery but did not specify which open heart surgery facility would be utilized. St. Augustine submitted a current transfer agreement between St. Augustine General Hospital, L.P. and St. Luke's Hospital, Jacksonville, the closest open heart surgery provider. This agreement is not specific to cardiac catheterization patients. St. Augustine also has an agreement with doctors at St. Luke's for open heart services backup. St. Luke's is within one-half hour's emergency travel time from either applicant's facility. There was no valid reason advanced in this record to suppose that Flagler could not also obtain travel and backup services with St. Luke's if it were granted the CON applied-for. Therefore, it is found that both applicants have complied with the current rule. Inherent in all challenges to the applicants' respective financial projections is the completeness of each application, and evidence as to the completeness of both applications has been received. Upon the testimony of HRS' health planning expert and agency representative, Elizabeth Dudek, it is found that at the time both applications were filed and at all times material to these applications, there was no consensus at HRS as to what constituted a "capital project" pursuant to Section 381.707(2)(a) F.S.; HRS had no definitional rule in place; HRS regularly looked to an applicant's audited financial statements with respect to the impact statement required under that section; and HRS did not require that there be a separate page labelled "assessment" for compliance with that section. Ms. Dudek reviewed both applications in the context of Section 381.707(2)(a) for HRS against other information already internal to HRS (exemptions, determinations for exemptions, or non-reviewables) and determined for purposes of initial review that both applicants had "captured" what HRS needed to know under Section 381.707(2)(a). This remained her opinion at formal hearing. (TR-586-589, 591- 593) St. Augustine expressly stated in its omissions response that it "has no capital projects applied for, pending, approved or underway in any state" (emphasis in original). In fact, the HCCB reported that for the eight-month period ending August 31, 1989, St. Augustine had $59,000 in construction in progress. Moreover, St. Augustine failed to list a lobby and patient wings renovation project costing approximately $540,000. St. Augustine's application contained no mention of these projects and no assessment, discussion, or analysis of their impact. St. Augustine's own Comptroller, David Chapman, would have defined these as capital projects (TR-93-94), and a common understanding of the English language would suggest that his is a reasonable interpretation of the clear statutory language. Flagler provided a page titled "FLAGLER HOSPITAL, INC. CURRENT CAPITAL PROJECTS" (Flagler-10), which listed the following "capital projects," as their expert witnesses defined that term under the statute. Maintenance and Yard Service Facility $61,000 (Review exemption pending) Storage Room Improvements $75,000 (Review exemption pending) Flagler Hospital Replacement Facility CON #2883; $21,728,558 Cost overrun application is being developed Rick Knapp, a certified public accountant and Flagler's expert in health care finance, accounting, and financial feasibility, also testified that Flagler's inclusion of the replacement hospital in the application as a "capital project" when the replacement hospital was essentially paid out before Flagler's CON application was even filed was probably not necessary under the statute but was intended for full disclosure. In fact, the evidence at formal hearing shows that Flagler's $21 million-plus replacement facility was completed, occupied, and paid for prior to Flagler's submission of the CON application to HRS in September 1989. The audited financial statements submitted with Flagler's application also indicated that, as of September 30, 1988, there had been construction in progress of $17 million, and an estimated $7.5 million for expected completion of construction in fiscal year 1989. Evidence admitted at formal hearing showed that the construction had been completed and the facility occupied in February 1989. Flagler began to depreciate its replacement facility upon occupancy. An overrun of approximately four million dollars was accrued and paid as of February 1989, but determining its exact amount was delayed by litigation with the architect and retainage by the general contractor. It cannot be determined from the application and omissions response that the cost overrun had been financed in full, but the two smaller capital projects were considered in the preparation and submission of Flagler's omissions response and specifically, depreciation expenses are included in the omissions response for all three of the above-identified projects. The hospital-wide pro forma contained in Flagler's omissions response shows a "healthy bottom line" for Flagler, even after consideration of the then-pending capital projects. Mr. Knapp represented that pages R-1, 2 of Flagler's omissions response (Flagler-11) meet the requirements of Section 381.707(2)(a) F.S., requiring a complete listing of all capital projects and an assessment of the capital projects' impact on the applicant's ability to provide the proposed cardiac catheterization lab. However, a close reading of pages R-1, 2 reveals that pages R-1, 2 do not repeat the list of capital projects just described or "showcase" Flagler's capital projects' impact on Flagler's ability to provide the services of the proposed catheterization lab, but rather, they make the detailed evaluation of the impact of the proposed cardiac catheterization lab on the cost of other services provided by Flagler, which detailed evaluation is required by Section 381.707(2)(c) F.S. Indeed, R-1 is entitled "IMPACT OF PROPOSED PROJECT ON COSTS OF OTHER SERVICES PROVIDED BY THE APPLICANT." Flagler's own witnesses concede that pages R1, 2 must be read in conjunction with Flagler's audited financial statements in order to arrive at the analysis of how other "health facility development projects and health facility acquisitions applied for, pending, approved or underway" will affect Flagler's ability to finance its catheterization lab. However, when compared to the pro forma on Table 3.3 of the application, it is clear that there is no impact of the listed capital projects on the proposed program. According to Mr. Conzemius, Flagler applied to HRS in March 1989 (six months prior to the filing of Flagler's CON application) and was turned down for an exemption on its overrun, and in the future Flagler will be applying for a CON regarding it. Flagler has disguised none of its activities from HRS and resolved and paid out the cost overrun prior to formal hearing so that the overrun, if it ever could have impacted on Flagler's proposed project, cannot do so now. Flagler's proposed cardiac catheterization lab will be paid for by cash funds in hand; the application contained a typographical error indicating that the funds were assured, when in fact, they are in hand. There will be no debt incurred by Flagler for the construction of the project.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that HRS enter a final order granting CON 6011 to Flagler Hospital, Inc. and denying CON 6012 to St. Augustine General Hospital, L.P. RECOMMENDED this 29th day of January, 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 29th day of January, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 90-2034 and 90-2035 The following constitute specific rulings pursuant to Section 120.59(2) F.S. upon the parties' respective proposed findings of fact (PFOF): Petitioner Flagler's PFOF (1-77): Accepted: 7, 10, 15, 16, 22, 23, 30, 34, 58 Rejected as irrelevant, unnecessary and nondeterminative: 4, 5 Rejected as subordinate or unnecessary: 66, 67, 68, 69, 70 Accepted except where subordinate, unnecessary, or cumulative to the facts as found; not necessarily adopted: 1-3, 11, 12, 13, 14, 17, 18, 19, 20, 21, 24, 25, 26, 27, 31, 33, 38, 39, 40, 41, 42, 53, 54, 55, 56, 59, 61, 62, 65 Rejected as mere legal argument: 6 Subjects covered but proposals rejected in form proposed because they are mere legal argument or recital of unweighted, unreconciled testimony and/or exhibits: 71, 72, 73 Covered as modified to reflect actual stipulations and credible record evidence as a whole, eliminating subordinate matters and mere legal argument: 8, 9, 28, 29, 32, 35, 36, 37, 43-52, 57, 60, 63, 74-77 The weight and credibility of all the evidence has been weighed within the RO and applies to all rulings. Petitioner St. Augustine's PFOF 6-(69)-73: [NOTE: St. Augustine numbered its preliminary matters 1-5 and its PFOF begin with #6; it also proposed two #69's] Accepted, except where subordinate, unnecessary, or cumulative to the facts as found: 6-15, 17-24, 26, 27, 28, 33, 35, 37, 38, 40, 41, 47 Accepted as modified to more closely conform to the material facts of record or to eliminate subordinate or unnecessary proposed facts or facts which were not proven: 31, 34, 48, 49, 52, 53, 54, 55, 58, 66, 67, 68, 69#2, 72 Accepted, except where subordinate, unnecessary or mere legal argument: 39, 43 Rejected as subordinate, immaterial or mere legal argument: 16, 25, 29, 32, 36 Subjects covered but proposals rejected in the form proposed because they are mere legal argument or recital of unweighted, unreconciled testimony and/or exhibits: 30, 42, 44, 45, 46, 50, 51, 60, 70 Rejected as not proven for the reasons set out in the RO: 56 Accepted in part, the remainder is rejected in part as mere legal argument, recital of unweighted, unreconciled testimony and exhibits, and/or not proven: 57 PFOF 59: First paragraph cumulative. All paragraphs beginning with a dash on the same page under 59: Subordinate and unnecessary to the facts as found or mere recital of unweighted or unreconciled testimony and/or exhibits and legal argument. Dash 1 on next page: Rejected as contrary to the credible record evidence as a whole. Remaining dashes beginning on that page: subordinate and not determinative and/or mere recitation of unweighted or unreconciled testimony and exhibits. Credibility determination made. Accepted but cumulative that historically Flagler has served more Medicaid patients than St. Augustine and is a disproportionate Medicaid provider. The remainder is rejected as mere legal argument or recital of unweighted or unreconciled testimony and/or exhibits: 61 Rejected that the same payor mix may be expected. The evidence supports Flagler's projected 7% Medicaid rate. The remainder is mere legal argument, subordinate and cumulative to the facts as found, and/or contrary to the weight of the credible record as a whole: 62-65 Accepted as modified to eliminate mere legal argument and to more closely conform to the material facts of record: 69#1 In all its parts, is rejected as mere legal argument and not determinative of any material fact: 71 PFOF 73: The subject matter is covered within the RO. Recital of deposition testimony in a belated attempt to impeach a witness who has testified has been rejected as not a proposed finding of material fact. The remainder is mere recitation of unweighted or unreconciled testimony/exhibits. The weight and credibility of all the evidence has been weighed within the RO and applies to all rulings. Respondent's PFOF (1-13): Accepted, except as subordinate or unnecessary: 1, 2, 3, 4, 7, 11, 13 Rejected in part as mere legal argument or unweighted or unreconciled testimony or exhibits (not proven upon the credible record evidence as a whole); otherwise accepted: 5, 6, 8, 9, 10, 12 The weight and credibility of all the evidence has been weighed within the RO and applies to all rulings. COPIES FURNISHED: Kenneth F. Hoffman Patricia A. Renovitch Attorneys at Law Oertel, Hoffman, Fernandez & Cole, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507 Jay Adams, Esquire Attorney at Law 1519 Big Sky Way Tallahassee, Florida 32301 Richard Patterson Assistant General Counsel Department of Health and Rehabilitative Services 2727 Mahan Drive Fort Knox Executive Center Tallahassee, Florida 32308 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Conclusions Having reviewed the Administrative Complaint, and all other matters of record, the Agency for Health Care Administration finds and concludes as follows: 1. The Agency has jurisdiction over the above-named Respondent pursuant to Chapter 408, Part Il, Florida Statutes, and the applicable authorizing statutes and administrative code provisions. 2. The Agency issued the attached Administrative Complaint and Election of Rights form to the Respondent. (Ex. 1) The Election of Rights form advised of the right to an administrative hearing. 3. The parties have since entered into the attached Settlement Agreement. (Ex. 2) Based upon the foregoing, it is ORDERED: 1. The Settlement Agreement is adopted and incorporated by reference into this Final Order. The parties shall comply with the terms of the Settlement Agreement. 2. The Respondent shall pay the Agency $5,000. If full payment has been made, the cancelled check acts as receipt of payment and no further payment is required. If full payment has not been made, payment is due within 30 days of the Final Order. Overdue amounts are subject to statutory interest and may be referred to collections. A check made payable to the “Agency for Health Care Administration” and containing the AHCA ten-digit case number should be sent to: Office of Finance and Accounting Revenue Management Unit Agency for Health Care Administration 2727 Mahan Drive, MS 14 Tallahassee, Florida 32308 3. Conditional licensure status is imposed on the Respondent beginning on February 15, 2013 and ending on March 15, 2013. 1 Filed August 27, 2013 2:59 PM Division of Administrative Hearings ORDERED at Tallahassee, Florida, on this 28-day of Arpt 2013. wie Elizabg¢th Dudek, Bery etary Agency for Health Care Administration
Other Judicial Opinions A party who is adversely affected by this Final Order is entitled to judicial review, which shall be instituted by filing one copy of a notice of appeal with the Agency Clerk of AHCA, and a second copy, along with filing fee as prescribed by law, with the District Court of Appeal in the appellate district where the Agency maintains its headquarters or where a party resides. Review of proceedings shall be conducted in accordance with the Florida appellate rules. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed. CERTIFICATE OF SERVICE I CERTIFY that a true and eos Final Order was served on the below-named persons by the method designated on this7S" ry of Ld / ; , 2013. ane Agency for Health Care Administration 2727 Mahan Drive, Bldg. #3, Mail Stop #3 Tallahassee, Florida 32308-5403 Telephone: (850) 412-3630 [ Jan Mills Finance & Accounting Facilities Intake Unit Revenue Management Unit (Electronic Mail) (Electronic Mail) Andrea M. Lang, Senior Attorney Margaret Chamberlain, Esq. Office of the General Counsel Attorney for Respondent Agency for Health Care Administration Kitch Drutchas Wagner Valitutti & Sherbrook (Electronic Mail) 2379 Woodlake Drive, Suite 400 Okemos, Michigan 48864 (U.S. Mail) | STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case Nos. 2013002508 SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against SA-PG - VERO BEACH LLC d/b/a PALM GARDEN OF VERO BEACH (hereinafter “Respondent”), pursuant to Sections 120.569 and 120.57 Florida Statutes (2012), and alleges: NATURE OF THE ACTION This is an action against a skilled nursing facility to impose an administrative fine of FIVE THOUSAND DOLLARS ($5,000.00) pursuant to Section 400.23(8)(b), Florida Statutes (2012), based upon two (2) Class II deficiencies and to assign conditional licensure status beginning on February 15, 2013, and ending on March 15, 2013, pursuant to Section 400.23(7)(b), Florida Statutes (2012). The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2012). EXHIBIT 1 2. The Agency has jurisdiction over the Respondent pursuant to Section 20.42, Chapter 120, and Chapter 400, Part II, Florida Statutes (2012). 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the regulatory authority responsible for the licensure of skilled nursing facilities and the enforcement of all applicable federal and state statutes, regulations and rules governing skilled nursing facilities pursuant to Chapter 400, Part II, Florida Statutes (2012) and Chapter 59A-4, Florida Administrative Code. The Agency is authorized to deny, suspend, or revoke a license, and impose administrative fines pursuant to Sections 400.121 and 400.23, Florida Statutes (2012); assign a conditional license pursuant to Section 400.23(2), Florida Statutes (2012); and assess costs related to the investigation and prosecution of this case pursuant to Section 400.121, Florida Statutes (2012). 5. Respondent operates a 180-bed nursing home, located at 1755 37" Street, Vero Beach, Florida 32960, and is licensed as a skilled nursing facility, license number 1415096. Respondent was at all times material hereto, a licensed skilled nursing facility under the licensing authority of the Agency, and was required to comply with all applicable state rules, regulations and statutes. COUNTI The Respondent Failed To Ensure Physician Orders Shall Be Followed As Prescribed in Violation Of Rule 59A-4.107(5), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, all physician orders shall be followed as prescribed, and if not followed, the reason shall be recorded on the resident’s medical record during that shift. Rule 59A- 4.107(5), Florida Administrative Code. 8. On or about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 9. Based on observation, interview and record review, it was determined the facility failed to follow physician orders for catheter placement, pain medication and skin sweeps for one (1) of twenty eight (28) residents, specifically Resident number ninety six (96), which resulted in significant pain for the resident. 10. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to inclide urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. and Resident number ninety six (96) was holding his/her hands over his/her genital area. 11. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented; keep the catheter up and taped to abdomen and positioned out of top of pants. There is an order on the Physician Order Sheet for weekly skin assessment due Friday on the 3:00 p.m. to 11:00 a.m. shift. 12. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for Resident number ninety six (96). As the Certified Nursing Assistant moved the resident’s scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident onto his/her back to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly with a grimace on his/her face and his/her eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “. Lidocaine Jelly 2% was not applied to the urethra. The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 13. In. an interview with the Registered Nurse who was providing care for Resident number ninety six (96) on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would check the catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly. The catheter was still threaded through the bottom of the adult brief and not taped to Resident number ninety six’s (96) abdomen. 14. A review of the February Medication Administration Record revealed no lidocaine jelly 2% listed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants." The last skin sweep documented is February 1, 2013 and did not document anything about redness to the groin area. 15. In an interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that was not transcribed onto the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96) nor was the weekly skin sweep done as ordered on February 8, 2013. 16. | The Unit Manager went with the surveyor to assess Resident number ninety six (96) at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. Resident number ninety six (96) would still flinch and moan when touched, and the Unit Manager stated he/she was in pain. 17. Resident number ninety six (96) was observed with the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. Resident number ninety six (96) was fidgeting in the wheelchair. When asked, Resident number ninety six (96) stated the catheter did not feel okay. The catheter was angled downwards through the leg of the brief and not taped to the abdomen as ordered. The Licensed Practical Nurse acknowledged the catheter tubing was incorrectly placed and not taped to the abdomen as ordered. 18. The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 19. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class Il deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 20. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT IL The Respondent Failed To Ensure The Right To Receive Adequate And Appropriate Health Care in Violation of Section 400.022(1)(I), Florida Statutes (2012) 21. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 22. Pursuant to Florida law, all licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following: The right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the Agency. Section 400.022(1)(), Florida Statutes (2012). 23. Onor about February 11, 2013 through February 15, 2013, the Agency conducted a Licensure Survey of the Respondent’s facility. 24. Based on observation, interview and record review, it was determined the facility failed to provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being for three (3) of twenty eight (28) residents, specifically Resident number ninety six (96), Resident number three hundred five (305) and Resident number two hundred forty two (242), regarding failure to assess and manage pain for a resident with an urethral erosion and two (2) residents with no medical justification for their catheters respectively. 25. Resident number ninety six (96) was admitted on January 7, 2013 with diagnoses to include urinary retention and urethral erosion. An observation was made of Resident number ninety six (96) on February 13, 2013 at 8:30 a.m. to be holding his/her hands over his/her genital area. 26. Catheter care was observed on February 13, 2013 at 8:33 a.m. As the Certified Nursing Assistant started to perform the catheter care, Resident number ninety six (96) moved into the fetal position and started moaning and grunting. The Certified Nursing Assistant stated this is normal for the resident. As the Certified Nursing Assistant moved Resident number ninety six’s (96) scrotum, the left groin area was noted to be bright red and patchy. Resident number ninety six (96) yelled out and tried crossing his/her legs. Resident number ninety six (96) was not asked if he/she was in pain. The Certified Nursing Assistant drew back the foreskin of the penis and it appeared to be bright red and excoriated. The resident was moaning when touched, mumbling “Oh God “. Resident number ninety six (96) kept crossing his/her legs and trying to get back into the fetal position and the Certified Nursing Assistant would reposition the resident to wash the catheter and genital area. At one point, Resident number ninety six (96) lifted his/her head and groaned loudly, with a grimace on his/her face and the eyes bulging. At this point the Certified Nursing Assistant asked Resident number ninety six (96) if he/she was in pain. The resident stated “a little “The catheter was then brought out the bottom of the adult brief, not anchored to any anatomical site. 27. There is a Pain Evaluation in Advanced Dementia sheet in Resident number ninety six’s (96) chart that has the residents name on it but is not filled out. Based on the criteria listed on the form, the combination of "repeated calling out, loud moaning or groaning, crying", "facial grimacing" and "rigid, fists clenched, knees pulled up, pulling or pushing away" indicates distressing pain. On February 14, 2013 at 1:13 p.m., the Director of Nursing acknowledged the form was in the chart and should have been filled out. 28. ‘In an interview with the Registered Nurse on February 13, 2013 at 9:01 a.m., the Registered Nurse stated that she would first give Resident number ninety six (96) medications, then she would check Resident number ninety six’s (96) catheter to make sure it is patent and positioned properly. The Registered Nurse checked for exudate on the penis and checked the indwelling catheter to make sure it was draining properly. The Registered Nurse stated that the catheter was positioned properly and did not assess the groin or pull back the foreskin to properly assess the penis. Resident number ninety six (96) was still moaning and the nurse asked if he/she was in pain but the resident said no. Resident number ninety six (96) appeared more relaxed in bed, not grimacing. The Registered Nurse stated the Certified Nursing Assistant was supposed to tell the nurse when the resident stated he/she is in pain. 29. A review of the medical record documented a physician order dated January 25, 2013 for Keflex 250mg by mouth four (4) times daily for seven (7) days for urethral erosion and lidocaine jelly 2% to the urethra as needed four (4) times a day. The February Physician Order Sheet documented keep the catheter up and taped to abdomen and positioned out of top of pants. 30. A review of the February Medication Administration Record revealed no lidocaine jelly 2% transcribed. The Treatment Administration Record documented “keep Foley catheter taped to abdomen and position out of top of pants. The last skin sweep found is February 1, 2013 and did not document anything about redness to the groin or penis. 31. Inan interview with the Unit Manager at 9:28 a.m. on February 13, 2013, the Unit Manager acknowledged that there is an order written for lidocaine jelly 2% that is not listed in the Medication Administration Record. The Unit Manager also verified that there was nothing in the chart to indicate a rash or redness to the groin of Resident number ninety six (96). 32. The Unit Manager went with the surveyor to assess the resident at 9:35 a.m. The Unit Manager acknowledged that the catheter tubing was not taped to Resident number ninety six’s (96) abdomen, nor was it up and over the top of the residents’ adult brief. The Unit Manager also acknowledged excoriation in the left groin and penis. The Unit Manager acknowledged Resident number ninety six (96) was acting as if he/she was in pain, groaning and guarding his/her genitals when touched. 33. In an interview with the Director of Nursing on February 13, 2013 at 2:42 p.m., the Director of Nursing stated Resident number ninety six (96) was transferred to the Reflections unit for behaviors of yelling and screaming and was given a care plan to reflect the behaviors. The Director of Nursing stated Resident number ninety six (96) is not necessarily in pain; this is just how the resident acts. In a subsequent interview with the Director of Nursing on February 14, 2013 at 1:13 p.m., she acknowledged the care plan indicates Resident number ninety six (96) had behaviors of resisting care, not yelling and screaming. The Director of Nursing also stated she was unable to find any documentation in the chart that indicates Resident number ninety six (96) had yelling behaviors. 34. — A nurse's note dated January 22, 2013 documented that Resident number ninety six (96) had pain which was manifested by fidgeting and shouting out intermittently. Routine pain medication was given and the effect was good with decreased fidgeting and decreased shouting. 35. The pain assessment dated January 7, 2013 documented under the question “Does the patient/resident exhibit any non-verbal signs that would indicate pain?” Moaning is checked off. Under nursing interventions, no evidence of pain is checked off. The monthly summary dated February 12, 2013 indicated Resident number ninety six (96) is alert and confused, quiet and cooperative with a flat affect. Resident number ninety six’s (96) speech is listed as difficult. 36. A review of the fourteen (14) day Minimum Data Set assessment with an Assessment Reference Date of January 24, 2013 revealed Resident number ninety six (96) was severely impaired with cognition. No behavioral symptoms are exhibited, including screaming and disruptive sounds. The Minimum Data Set identified Resident number ninety six (96) as having pain occasionally in five (5) of the seven (7) previous days with a level of five (5) out of ten (10). 37. In an interview with Resident number ninety six (96), the Licensed Practical Nurse on February 14, 2013 at 11:03 a.m. stated the catheter is to be positioned up over the brief and taped to the abdomen to prevent further irritation to the urethra. Resident number ninety six (96) has had a catheter for a long time. Because Resident number ninety six (96) is confused, the Licensed Practical Nurse stated she would watch for grimacing or fidgeting as signs of pain and that Resident number ninety six (96) tried to stand on his/her own if the catheter is placed incorrectly. The Licensed Practical Nurse stated that the staff does not use yelling as an indicator for pain because Resident number ninety six (96) often yells. Because Resident number ninety six (96) was trying to stand up in the activity room, the Licensed Practical Nurse brought him/her back into the room to check on the catheter. The resident stated to the nurse that the catheter "does not feel ok". Resident number ninety six (96) kept crossing his/her legs and fidgeting in the chair. A Certified Nursing Assistant came into the room to assist the Licensed Practical Nurse stand up Resident number ninety six (96). Resident number ninety six (96) stood to have his/her pants pulled down and his/her brief opened. The catheter was angled down and not taped to the abdomen as ordered. This was acknowledged by the Licensed Practical Nurse. When the nurse touched Resident number ninety six (96) he/she would yell out. There was also tape tangled in the pubic hair and as the nurse tried to remove it, Resident number ninety six (96) yelled out “It hurts a lot “. Resident number ninety six (96) kept trying to grab the nurse to make her stop but the Certified Nursing Assistant held his/her hands still. The catheter was then placed correctly. Resident number ninety six (96) stated he/she felt much better when the catheter was properly positioned. 38. Anobservation on February 12, 2013 at 3:25 p.m. revealed Resident number two hundred forty two (242) lying in bed. A Foley catheter (indwelling urinary drainage devise) was observed at bedside draining. 39. A review of the record revealed Resident number two hundred forty two (242) was admitted to the facility on December 31, 2012 with diagnoses to include urinary tract infection, functional decline, hypertension, deep vein thrombosis, anemia, hyperlipidemia, and renal insufficiency. A review of the Nursing Evaluation dated December 31, 2012 documented the existence of the Foley catheter. A review of the admitting physician's orders documented, "Catheter Orders" and further documented the ordered care and treatment for the catheter. A further review of the physician orders revealed the next order related to the Foley was not until nine (9) days after admission. This order was dated January 8, 2013 for the discontinuing of the catheter. A final review of the record lacked any evidence of a diagnosis or medical justification for the Foley catheter. 40. During a review of the record and interview with the Director of Nursing on February 15, 2013 at 9:30 a.m., the Director of Nursing agreed there was no valid diagnosis or medical justification for the Foley catheter for Resident number two hundred forty two (242) upon admission to the facility. When asked the standard procedure related to catheter use the Director of Nursing stated that they try to have the catheters discontinued within a few days of admission to their facility. 41. A review of the facility policy and procedure titled "Urinary Catheters" documents, “Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 42. During an interview on February 11, 2013 12:37 p.m., the Registered Nurse caring for Resident number three hundred five (305) was asked if the resident had a Foley catheter and the diagnosis or medical justification for the catheter. The Registered Nurse stated, "There is no valid reason for the catheter, Resident number three hundred five (305) came with it from the hospital. I'm going to call! the doctor to see if it can be removed." 43. An observation of Resident number three hundred five (305) on February 12, 2013 at approximately 11:45 a.m. revealed the resident sitting in a wheel chair at the nurse's station. Although the bag that holds and covers the Foley catheter for dignity purposes was noted, the Foley catheter was not present. 44. A review of the record documented Resident number three hundred five (305) was admitted to the facility from an acute care hospital on January 31, 2013 having sustained a cerebral vascular accident/stroke and subdural hematoma. Admitting diagnoses included diabetes, hypertension, left ventricle thrombus, hyperlipidemia, and intermittent atrial fibrillation. The record documented the existence of the Foley catheter upon admission to the facility as per the nursing evaluation dated January 31, 2013, the plan of care and in daily nursing notes from admission through February 11, 2012. A review of the plan of care dated January 31, 2013 for the indwelling catheter specifically documented the intervention "Identify documentation in the medical record which substantiates use of indwelling catheter, if absent confer with MD". An order to discontinue the Foley catheter was obtained on February 11, 2013 after surveyor questioning. A final review of the record lacked any diagnosis or medical justification for the catheter for Resident number three hundred five (305). 45. During an Interview on February 13, 2013 at approximately 4:00 p.m., the Unit Manager for the 300 unit was asked the procedure for residents admitted to the facility with a Foley catheter. The Unit Manger stated that the normal practice is to evaluate the resident and ask the physician for an order to discontinue the catheter within a few days of admission. The Unit Manager agreed that Resident number three hundred five (305) had a Foley catheter thirteen (13) days after admission to the facility with no appropriate diagnosis or medical justification. 46. A review of the facility policy and procedure titled "Urinary Catheters" documents, "Procedure: 1. Eliminate indwelling urinary catheters when possible. 2. Use catheters only when they must be used, and only with documented medical justification by a physician." 47, The Agency determined that this deficient practice compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. The Agency cited Respondent for a Class II deficiency as set forth in Section 400.23(8)(b), Florida Statutes (2012). 48. A Class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more Class I or Class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. 49. Based upon the above findings, the Respondent’s actions, inactions or conduct constituted an isolated Class II deficiency pursuant to Section 400.23(8)(b), Florida Statutes (2012). WHEREFORE, the Agency intends to impose an administrative fine in the amount of TWO THOUSAND FIVE HUNDRED DOLLARS ($2,500.00) against the Respondent pursuant to Sections 400.23(8)(b), and 400.102, Florida Statutes (2012). COUNT Il Assignment Of Conditional Licensure Status Pursuant To Section 400.23(7)(b), Florida Statutes (2012) 50. The Agency re-alleges and incorporates by reference the allegations in Count I. 51. The Agency is authorized to assign a conditional licensure status to nursing home facilities pursuant to Section 400.23(7), Florida Statutes (2012). 52. Due to the presence of one (1) Class I deficiency, the Respondent was not in substantial compliance at the time of the survey with criteria established under Chapter 400, Part II, Florida Statutes (2012), or the rules adopted by the Agency. 53. The Agency assigned the Respondent conditional licensure status with an action effective date of February 15, 2013. The original certificate for the conditional license is attached as Exhibit A and is incorporated by reference. 54. The Agency assigned the Respondent standard licensure status with an action effective date of March 15, 2013. The original certificate for the standard license is attached as Exhibit B and is incorporated by reference. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the Respondent conditional licensure status for the period beginning February 15, 2013 and ending on March 15, 2013 pursuant to Section 400.23(7)(b), Florida Statutes (2012). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the following relief against the Respondent as follows: 1. Make findings of fact and conclusions of law in favor of the Agency. 2. Impose an administrative fine against the Respondent in the amount of FIVE THOUSAND DOLLARS ($5,000.00.). 3. Assign conditional licensure status to the Respondent for the period beginning on February 15, 2013, and ending on March 15, 2013. 4. Assess costs related to the investigation and prosecution of this case. 5. Enter any other relief that this Court deems just and appropriate. Respectfully submitted this A¢-u day of ne , 2013. A ee ee cae J ‘Andrea M. Lang, Assistant General Counsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 NOTICE RESPONDENT IS NOTIFIED THAT IT/HE/SHE HAS A RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT/HE/SHE HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS. ALL REQUESTS FOR HEARING SHALL BE MADE AND DELIVERED TO THE ATTENTION OF: THE AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG #3, MS #3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 412-3630. THE RESPONDENT IS FURTHER NOTIFIED THAT IF A REQUEST FOR HEARING IS NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form were served to: Anthony Brunicardi, Administrator, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 1755 37" Street, Vero Beach, Florida 32960, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8511 and to Capitol Corporate Services, Inc., Registered Agent, SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach, 155 Office Plaza Drive, Suite A, Tallahassee, Florida 32301, by United States Certified Mail, Return Receipt No. 7011 1570 0002 1695 8528 on this ‘S &_ day of Wg , 2013. Net FP On od Andrea M. Lang, Assistant General‘Cdunsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 (239) 335-1253 Copies furnished to: Anthony Brunicardi, Administrator SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 1755 37" Street Vero Beach, Florida 32960 (U.S. Certified Mail) Andrea M. Lang, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Capitol Corporate Services, Inc. Registered Agent for SA-PG - Vero Beach LLC d/b/a Palm Garden of Vero Beach 155 Office Plaza Drive, Suite A Tallahassee, Florida 32301 (US. Certified Mail) Bernard Hudson, Health Services and Facilities Consultant Supervisor Bureau of Long Term Care Services Long Term Care Unit Agency for Health Care Administration 2727 Mahan Drive, Building #3, Room 1213B Tallahassee, Florida 32308 (Electronic Mail) Arlene Mayo-Davis Field Office Manager Agency for Health Care Administration 5150 Linton Boulevard, Suite 500 Delray Beach, Florida 33484 (Electronic Mail)
The Issue The issues in this case are whether Respondent: failed to keep proper medical records; (2) committed medical malpractice; or (3) knowingly performed professional responsibilities which he knew he was not competent to perform, as set forth in the Administrative Complaint, and if so, what is the appropriate sanction.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2014). At all times material to the complaint, Dr. Rivera-Kolb was a licensed medical doctor within the state of Florida, having been issued license number ME 40201. Events of June 25, 2008 On June 25, 2008, Patient J.D., a 43-year-old female, was scheduled for multiple procedures at Florida Atlantic Orthopedics ("the facility"). The procedures included a two- level discogram by Dr. Thomas Rodenberg, followed by a two-level lumbar discectomy by Dr. Roberto Moya, followed by a bilateral L3 to S1 facet radiofrequency lesioning by Dr. Rodenberg. On June 25, 2008, Dr. Rivera-Kolb was working at the facility. As he testified, he had been hired to "harvest information" in personal injury cases such as slip and falls or automobile accidents. He would routinely perform physical examinations, develop full medical histories, and "proceed to follow a certain pattern of doing x-rays, doing certain tests at different agreed times, to comply with regulations imposed on the PI industry." Dr. Rivera-Kolb would also render primary health care and provide patients with anti-inflammatories and muscle relaxants as necessary. As indicated by a "Pre-Op" form dated June 25, 2008, and signed with the name "L. Lerfald, R.N." in the "Signature of Nurse" block, on that morning Nurse Lerfald took various vital signs of J.D. and recorded them at 10:50 a.m. At that time, J.D. was given 8 mg of hydromorphone and 20 mg of Valium. Dr. Rodenberg, an anesthesiologist at the facility, placed a central intravenous line ("IV") in J.D.'s left jugular. Dr. Rivera-Kolb assumed the responsibility of monitoring J.D. and preparing an "Anesthesia Record" during the two-level discogram procedure that was to be performed first. J.D. had been a patient of Dr. Rivera-Kolb's in the weeks before the procedures, and he was aware that she had accelerated hypertension (very high blood pressure). Dr. Rivera-Kolb sat at the head of the operating table, monitored J.D.'s vital signs, and filled out the Anesthesia Record, while Dr. Rodenberg performed the discogram. Dr. Rivera-Kolb then left the operating room. The second procedure, the two-level lumbar discectomy, was performed by Dr. Moya, with Dr. Rodenberg as anesthesiologist. Dr. Rivera-Kolb returned to the operating room after the discectomy and resumed the responsibility of monitoring J.D. for the third procedure, the facet radiofrequency lesioning, which was performed by Dr. Rodenberg. When Patient J.D. was ready to be moved from the operating room to the Post Anesthesia Care Unit ("PACU"), she became unresponsive, with an oxygen saturation of 60 percent and a heart rate of 30. Dr. Rivera-Kolb was the only physician present with the operating room staff when these changes occurred. In a written statement he later submitted to Mr. Robert Yastremzki, medical investigator at the Department of Health, Dr. Rivera-Kolb wrote: She was lying prone on the OR table. The moment she was overturned to a supine position on the gurney, the oxygen saturation alarm went off. There was an abrupt drop in blood pressure and pulse. The OR staff and I made sure all connections were in place. When it was corroborated that all connections were intact, I summoned Dr. Rodenberg to the OR as I reached for ventilation mask to improve oxygen delivery. The symptoms she displayed were consistent with a vasovagal syndrome secondary to local anesthetics injected in the cervical area during the procedure, which is not an uncommon complication. The parties stipulated that Patient J.D. went into full cardiac arrest, and Dr. Rodenberg was emergently called back to the operating room. Dr. Rodenberg arrived almost immediately. J.D. received cardiopulmonary resuscitation ("CPR"), atropine by IV, and a laryngeal mask airway ("LMA"). The left jugular IV appeared to be infiltrated, so Dr. Rodenberg placed a new external jugular line on the right side. After J.D.'s vital signs were stabilized, Dr. Rodenberg replaced the LMA with an orotracheal tube. J.D. was now breathing spontaneously and saturating in the high 90's, and Dr. Rodenberg directed that she be moved to the PACU. Dr. Rivera-Kolb and Nurse Lerfald moved J.D. to the PACU. Once there, her head was elevated. Shortly thereafter, Nurse Lerfald noticed that the left side of J.D.'s face was beginning to swell. Dr. Rodenberg was called back again. When Dr. Rodenberg arrived in the PACU a minute later, J.D.'s face was completely swollen. Dr. Rodenberg assumed control of J.D.'s care. He concluded that the swelling was angioedema and felt that anaphylactic shock was imminent. He detected a faint pulse and directed that the patient be returned to the operating room, where she was placed on a ventilator. A few moments later, no pulse was present, and CPR was begun a second time. J.D. was given epinephrine and atropine, and "911" was called. Dr. Moya was called in to assist. When Dr. Moya arrived, he concluded that the subcutaneous emphysema was secondary to the IV lines in J.D.'s jugulars and that J.D. had bilateral apical pneumothorax. He immediately placed chest tubes, first into the right side, and then the left. When the right chest tube was placed in water to create a negative pressure, clear fluid and gas came out. When the left chest tube was done, white milky fluid and gas were discharged. The Boca Fire and Rescue arrived and resuscitation efforts continued for approximately 25 minutes, after which blood pressure and heart rate were restored. J.D. was then transported to Boca Community Hospital. Pharmacy bills reflect that both midazolam (Versed) and propofol were signed out for use in Patient J.D.'s procedures on June 25, 2008. Dr. Rivera-Kolb signed the Anesthesia Record for the discogram procedure.1/ It indicated that the anesthesia and surgery started at 11:25 a.m. and ended at 11:55 a.m. Under a section entitled "Technique," the form provided check blocks to choose the anesthesia that was used: "General"; "Epidural"; "Spinal"; "Axillary Blk"; or "Other." The block on the form next to "Other" was checked, followed by the hand-written notation "MAC local." The form reflects oxygen saturation levels of 95 and 96 for two consecutive 15-minute periods. It records other readings every five minutes. It indicates systolic blood pressure at levels of 160 and 170 and diastolic blood pressure ranging from 90 to 110. It records a respiration rate of between 10 and 20 and a heart rate between 80 and 90. It does not indicate what, if any, drugs were administered during the procedure. It does not indicate any temperature readings, breath sounds, or EKG readings. Dr. Rivera-Kolb signed his name on the Anesthesia Charge Sheet on the line labeled "Anesthesiologist 1."2/ This sheet indicates that Dr. Rodenberg was the "Surgeon/Referring MD." It shows Current Procedural Terminology (CPT) codes of "66290 x2," indicating two "lumbar discograms," and "77003," indicating "flouroscopic guided--spine." In the row marked "ASA Physical Modifiers," the notation "P3" is circled. The sheet indicates the procedure was to be conducted with "MAC" anesthesia. It indicates that the pre-op interview was begun at 11:05 a.m. and ended at 11:12 a.m., that the surgery started at 11:20 a.m. and ended at 12:00 p.m., and that anesthesia also started at 11:20 a.m. and ended at 12:00 p.m. Dr. Rodenberg prepared and signed two different Anesthesia Records. Each recorded information for both the discectomy and facet radiofrequency lesioning procedures, even though Dr. Rodenberg performed the facet lesioning procedure himself and so could not appropriately also have performed the duties of anesthesiologist for that procedure.3/ Each of these forms indicates that the surgeries started at 12:04 p.m. and ended at 13:14 p.m., that the patient was in the PACU at 13:20 p.m., and that anesthesia started at 12:01 p.m. and ended at 13:24 p.m. There are differences in the two forms, however. In the section entitled "Technique," the first form has "MAC" written in next to the "Other" block, while the second form has "MAC local" written in this space.4/ In addition to the drugs shown as administered on the first form, the second form also shows the administration of what appears to read "Depo Medrol" and "epinephrine." Neither form documents the administration of either midazolam or propofol. Neither form records any patient temperature readings or breath sounds. While the first form records the last reading of blood pressure and heart rate at 13:15 p.m., the second form shows additional readings taken at 13:20 p.m., which reflect a considerable drop in heart rate to 40, a drop in systolic blood pressure to 75, and a drop in diastolic blood pressure to 20. The second form also contains hand-written notations in the "Remarks" area of the form which appear to read "postop instability," "See Nursing Notes," "See separate dictation(s)," "1324," and "intubated to PACU SR->sat 96%." In the "Post Op Visit" area of the second form a box marked "Complications" is also checked. A hand-written note in J.D.'s file reads as follows: Dr[.] Noback Escobar wanted me to leave this for you. The record was corrected after the fact due to disconnected IV so there might be two slightly different versions. You may call if this is confusing in any way Dr. Rodenberg Assuming that this note was made with respect to the two different Anesthesia Records, it does not provide an adequate explanation of all of the differences in the forms. Most significantly, the second form includes notations at 13:20 p.m. reflecting significant changes in J.D.'s blood pressure and heart rate, and reference to her post-operative instability and complications. These differences would not be explained by a disconnected IV, and the note does not otherwise explain them. There is, however, only one Anesthesia Record prepared and signed by Dr. Rivera-Kolb in J.D.'s medical records. Dr. Rivera-Kolb testified repeatedly at hearing that this form pertained to the third procedure, that is, the facet radiofrequency lesioning.5/ Dr. Rivera-Kolb's testimony on this point is rejected as not credible. The times indicated on the Anesthesia Record he signed are those of the first procedure, the two-level discogram, and are consistent with the time of the pre- operation procedures as documented on the form signed by Nurse Lerfald, with the Anesthesia Charge Sheet also signed by Dr. Rivera-Kolb, and with the times indicated on the Anesthesia Records prepared by Dr. Rodenberg for the second and third procedures. While Dr. Rivera-Kolb insisted that he prepared and kept an Anesthesia Record for the facet radiofrequency lesioning, he offered differing accounts with respect to that form. Dr. Rivera-Kolb's written statement to the medical investigator notes that J.D. was finally stabilized and sent to the hospital, and then continues: In the aftermath of the above described events, I returned to the OR and noticed the anesthesia sheet that I had used to tabulate the vital signs for Dr. Rodenberg was left on the anesthesiologist's table. I retrieved the data and went to the administrative office to hand him the document. Dr. Rodenberg was in the administrator's office with Dr. Moya and Dr. Escobar so I waited outside until their conference was over. As I handed the document to the records keeper Johan Castenada, Dr. Rodenberg exited the office. When I told him that I was placing the document on the operative record, he instructed me to destroy the record. He stated that it was unnecessary for me to get involved in this case since he had been monitoring the patient from his position in the OR and he did not need my tabulations. I was hesitant to destroy the records and asked Dr. Escobar for advice in the matter. Dr. Escobar insisted that I place the recorded data in the operative records where it stands now. He also advised me to file an incident report which I did. Yet in his deposition, Dr. Rivera-Kolb testified that he did not initially record the numbers on the Anesthesia Record, but instead entered them on a Progress Note form: I asked him first, where's the anesthesia sheet? He responded, you know, I don't want you writing in my official documents. And then I was concerned that this could have been a Monitored Anesthesia Care case, I was going to ask him what-–if there had been any changes but he said to me, this is still no anesthesia, local only case, like I told you before. * * * I looked for an anesthesia sheet. They told me they're supposed to be there. I opened a few drawers. I found a progress note and I wrote it on a progress note paper and later transferred it to this page [referencing the Anesthesia Record for the earlier discogram procedure]. * * * I had finished all the numbers in the monitors, yes. I had finished them all but I had to go to another room to transfer it to an anesthesia sheet that I found, you know, when I asked one of the circulating nurses. If the Anesthesia Record for the facet radiofrequency lesioning was not created in the operating room, but was created later in another room from notes made on a Progress Note sheet, the Anesthesia Record could not have been left on the anesthesiologist's table in the operating room following the third procedure. It is undisputed that Dr. Rivera-Kolb sat at the head of the table for the first and third of J.D.'s procedures on June 25, 2008. Numerous medical records of J.D. prepared at or near the time of her procedures provide clear and convincing evidence that the procedures were to be conducted under MAC. The Anesthesia Record dated June 25, 2008, and signed at the bottom by Dr. Rivera-Kolb indicates "MAC local." A Pre-Anesthesia Evaluation form dated June 25, 2008, indicates "MAC w/ GA b/u" after the words "anesthetic plan." The two different Anesthesia Records prepared by Dr. Rodenberg indicate either "MAC" or "MAC local." The Operative Report prepared by Dr. Moya dated June 25, 2008, and describing the second and third procedures, identifies Dr. Rodenberg as anesthesiologist and references "local MAC anesthesia." A Progress Notes form dated June 26, 2008, indicates "Anesth Rivera MD (MAC)." An Anesthesia Charge Sheet dated June 25, 2008, prepared for the discogram indicates the procedure is to be conducted under "MAC" and is signed by Dr. Rivera-Kolb as "Anesthesiologist 1." The Anesthesia Charge Sheet dated June 25, 2008, prepared for the discectomy and facet radiofrequency lesioning indicates that the anesthesia is "MAC" and shows an anesthesia start time of 12:01 p.m. and an anesthesia end time of 13:24 p.m. A Florida Atlantic Orthopedics form dated June 25, 2008, and signed by Nurse Lerfald shows "MAC," indicates the anesthesiologists as Dr. Rodenberg and Dr. Rivera-Kolb, and notes that anesthesia starts at 11:25 a.m. and ends at 13:14 p.m. Dr. Rivera-Kolb's argument that all of these references to MAC surgery should be ignored because the records might have been altered by Dr. Rodenberg is rejected. If Dr. Rodenberg had an opportunity to alter the records, it is not clear why he would not have simply replaced the Anesthesia Record rather than write a note to Dr. Noback. Even if Dr. Rodenberg did have an opportunity to alter the records, however, there is no apparent motive for him to systematically alter numerous documents prepared by different individuals to indicate that the surgeries were MAC if they were not, or any evidence that he did so. Mr. Escobar's testimony in general and, on this point in particular, was not credible. The documents prepared at or near the time of J.D.'s procedures are credited over other documents prepared after the procedures were completed, which were less consistent. A Physician Office Incident Report, which appears to have been stamped as received by the Department of Health on August 11, 2008, states that "[p]atient underwent lumbar discography, percutaneous discectomy, and facet ablation under local anesthesia." Dr. Rivera-Kolb's statement for the medical investigator, dated March 2, 2010, states that "Dr. Rodenberg, the anesthesiologist, requested that I monitor the patient's vital signs and post them in the anesthesia record sheet while he performed minimally invasive procedures under local anesthesia with Monitored Anesthesia Care." Dr. Moya, in his August 21, 2014, deposition, testified, "Well, at that stage of the procedure [the discography], which is done solely under local anesthesia, the person assigned by the anesthesiologist would be someone that looks at the graphs and makes sure that all is within normal limits." Dr. Moya went on to state that Dr. Rodenberg was always the anesthesiologist for all three procedures. Standards Dr. Orlando G. Florete, Jr., holds active and valid Florida Physician's License No. ME 0058430. He is a specialist in anesthesiology with a subspecialty in pain management. He is Board certified in anesthesiology, is a Diplomate of the American Board of Anesthesiology, and was recently elected as president of the Florida Society of Interventional Pain Physicians. He practices anesthesiology on a regular and routine basis at the Jacksonville Surgery Center. He is also the medical director of a pain management office at the Baptist Hospital in Jacksonville. He has been engaged by the U.S. Department of Justice as a consultant and is an expert medical advisor for the Florida Department of Labor and Employment Security and for the Florida Department of Health. He served as clinical assistant professor in the Departments of Anesthesiology and Medicine at the University of Florida, College of Medicine, from 1994 until 2000, where he trained residents, fellows, and medical students. He has recently been engaged by the university to teach again in the field of anesthesia and pain management. Dr. Florete is an expert in anesthesiology and has knowledge, skill, experience, training, and education in the prevailing professional standard of care recognized as acceptable and appropriate by reasonably prudent anesthesiologists in Florida. No evidence was presented that Dr. Florete has been recently engaged in active clinical practice, consultation, the instruction of students, or a clinical research program in the general practice of medicine. Dr. Florete conducted a complete review of records provided to him by the Department pertaining to J.D.'s medical treatment on June 25, 2008, including records prepared by Dr. Rivera-Kolb, Dr. Rodenberg, Dr. Moya, Mr. Escobar, and Nurse Lerfald. He also reviewed the depositions of Dr. Moya and Dr. Rivera-Kolb and heard live testimony from Dr. Rivera-Kolb. As Dr. Florete testified, under the American Society of Anesthesiologist's physical status classification system, a patient classified as "P2" is a patient with systemic disease with mild limitation. A classification of "P3" means that the patient has significant or severe systemic disease with definite severe systemic or physical dysfunction. As Dr. Florete testified, the classification of a patient has an impact on the procedure and type of anesthesia used; so, an anesthesiologist must know the physical status of the patient. As Dr. Florete testified, midazolam is a generic name for Versed, in the benzodiazepine class, that is a very potent intravenous sedative that can produce amnesia and loss of consciousness. Propofol, in a one percent emulsion, is a milky- colored intravenous anesthetic that can promote rapid loss of consciousness. Dr. Florete testified, and it is found, that Versed and propofol are the most commonly used combination under monitored anesthesia care to produce that unique level of sedation that allows the surgeon to perform surgery without the patient being agitated, moving, or crying out. As Dr. Florete explained, the acronym "MAC" stands for "monitored anesthesia care." Monitored anesthesia care is a type of anesthesiology in which a qualified anesthesiologist monitors the patient. MAC requires an anesthesiologist to monitor physiological variances of the patient, such as rising blood pressure, increase of heart rate, loss of airway, or agitation in the patient. In MAC, the anesthesiologist must determine what level of anesthesia is advisable and be prepared to administer the medications to induce deep sedation as required. As Dr. Florete testified, a nurse may "tabulate" a patient's oxygen levels, breathing, circulation, and temperature in a case involving only local anesthesia, but simple tabulation of these vital signs by a nurse is not permitted in a MAC case because a nurse is not qualified to make the required judgments. Only an anesthesiologist is authorized to perform monitoring in a MAC case or to fill out an Anesthesia Record. As Dr. Florete testified, a person who assumes the position at the head of the table monitoring a patient in a case of monitored anesthesia care assumes the responsibilities of an anesthesiologist. As Dr. Florete testified, the prevailing professional standard of care requires an anesthesiologist to perform a physical examination of the patient and review the history of the patient prior to MAC. An anesthesiologist must keep records that document the pre-operative medical examination; indicate the type of anesthetic technique employed; indicate the start and end times of anesthesia; record the patient's vital signs over time; and indicate who provided anesthesia to the patient and when. An anesthesiologist must stay with the patient after a procedure until the patient is safely delivered into the PACU. Dr. Florete testified that in a MAC case, it would be a violation of the prevailing professional standard of care for a single person to both perform surgery and attempt to act as anesthesiologist for that same procedure. In a local anesthesia case, a single person could perform both roles. Dr. Florete testified that because Dr. Rivera-Kolb was not an anesthesiologist he "had no business" filling out an Anesthesia Record. Dr. Florete credibly testified that in his opinion, Dr. Rivera-Kolb's actions in monitoring Patient J.D. during surgical procedures that he knew or should have known were to be conducted under MAC and in preparing the Anesthesia Record for a procedure constituted the acceptance and performance of the responsibilities of an anesthesiologist, which Dr. Rivera-Kolb was not competent to perform. Medical Records As Dr. Florete testified, in assuming the responsibility to perform the professional duties of an anesthesiologist, it was incumbent upon Dr. Rivera-Kolb to keep complete and accurate Anesthesia Records that documented a pre- operative medical examination of J.D.; indicated the type of anesthetic technique that was employed; indicated the start and end times of the anesthesia; recorded J.D.'s vital signs over time; and indicated who provided anesthesia to her and when. While Dr. Rivera-Kolb did prepare an Anesthesia Record for the discogram, it failed to record any temperature readings, breath sounds, or EKG readings. As Dr. Florete testified, this Anesthesia Record was incomplete. As for the facet radiofrequency lesioning procedure, it is clear that Dr. Rivera- Kolb, contrary to his testimony, did not keep an Anesthesia Record containing a complete and accurate report of J.D.'s vital signs or documenting who provided anesthesia and when. As Dr. Rivera-Kolb admitted in his testimony, he was the only physician present after the third procedure when J.D. began to exhibit bradycardia and desaturation. Yet he did not document his evaluation of these events in J.D.'s medical records to justify his treatment of J.D. There was no evidence that Dr. Rivera-Kolb conducted a complete physical examination at the time of either the first cardiac arrest in the operating room, or the second cardiac arrest in the PACU. Dr. Rivera-Kolb was present and assisting in the medical treatment of J.D. through two procedures and during two cardiac arrests; yet, the only medical records kept by Dr. Rivera-Kolb were those pertaining to the first procedure. While Dr. Rivera-Kolb maintained that he completed an incident report, this testimony is rejected as not credible. No such report is found in J.D.'s medical records, and Dr. Rivera-Kolb's suggestion that Dr. Rodenberg may have removed it for some unknown reason is only unsupported speculation. There is clear and convincing evidence that Dr. Rivera- Kolb failed to keep legible medical records that justified the course of treatment of Patient J.D., including Anesthesia Reports and records of his evaluations. Dr. Rivera-Kolb was charged with violating the standard of care both in performing as an anesthesiologist during J.D.'s procedures and in assisting in treatment of her complications afterwards. He failed to keep medical records reflecting his participation in the treatment of J.D. for either of those times. The Department did not show that in earlier discipline, Dr. Rivera-Kolb was found to have failed to keep medical records. Medical Malpractice Dr. Rivera-Kolb assumed the responsibility of monitoring J.D. and preparing Anesthesia Records, thereby practicing as an anesthesiologist when he was not competent to do so. As Dr. Florete testified, the prevailing professional standard of care for a given health care provider is that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. In assuming the responsibilities of an anesthesiologist, Dr. Rivera-Kolb is held to the standards recognized by reasonably prudent anesthesiologists. The Department proved that Dr. Rivera-Kolb did not complete a residency, have adequate training, and did not have board certification in anesthesia, all of which Dr. Rivera-Kolb himself admitted. As Dr. Florete testified, a general practitioner engaged in providing anesthesia care would not meet the prevailing professional standard of care. In evaluating Dr. Rivera-Kolb's actions after the three procedures that were performed on J.D., however it was not clearly shown that Dr. Rivera-Kolb continued to act as an anesthesiologist. To the contrary, it appears that Dr. Rivera- Kolb performed as an anesthesiologist during the procedures themselves, in part, because he knew that the surgeon was an anesthesiologist. After the procedures, Dr. River-Kolb resumed the role of a general practitioner, deferring to Dr. Rodenberg and Dr. Moya, and even acting at their direction. The prevailing professional standards of care applicable to the general practice of medicine with respect to J.D.'s post-operative complications were not established. Dr. Florete did testify that, as an "intensivist" who used to "run codes" for some hospitals in Jacksonville, he was familiar with emergency and critical care procedures. He also testified that "any medical doctor" should be able to diagnose pneumothorax "within one minute," because air trapped under the skin produces bulges or swelling which when pressed produces an unmistakable "crackling" sound as the gas is pushed through the tissue. He provided compelling testimony as to the proper diagnosis and treatment of pneumothorax. However, it was not shown that Dr. Florete was qualified to give expert testimony regarding the prevailing standards of care for a general practitioner.6/ Moreover, even if these had been established as the prevailing professional standards of care applicable to a general practitioner, it is not clear that they were violated by Dr. Rivera-Kolb in his treatment of Patient J.D. on June 25, 2008. Dr. Rivera-Kolb was charged with failing to fully evaluate the cause of the bradycardia and the desaturation once the first cardiac arrest occurred. The evidence showed that Dr. Rivera-Kolb immediately put a mask over J.D. and began to ventilate her. Dr. Rodenberg arrived within one minute and assumed control over the situation. Dr. Florete credibly testified that because of training and experience, an anesthesiologist should take the lead in such "code" situations, followed by the surgeon, and finally a general practitioner. It was therefore appropriate for Dr. Rivera-Kolb to defer to Dr. Rodenberg when he arrived. The evidence did not show that before Dr. Rodenberg arrived, there was sufficient time for Dr. Rivera-Kolb to have performed a complete physical examination of J.D. or to auscultate J.D.'s lungs, even if he had had a stethoscope, which he testified that he did not. There is no evidence that in this brief period of time, Dr. Rivera-Kolb caused any significant delay in recognizing the evolving medical emergency or in beginning treatment of J.D. Dr. Rivera-Kolb was also charged with medical malpractice in connection with the treatment of Patient J.D. after she had been stabilized following the first cardiac arrest and moved to the PACU. The Department alleges that Dr. Rivera- Kolb misdiagnosed J.D.'s condition, failed to identify the pneumothorax, and caused delay of treatment. One allegation of misdiagnosis stems from the written statement provided to the Department's medical investigator, as quoted earlier: The symptoms she displayed were consistent with a vasovagal syndrome secondary to local anesthetics injected in the cervical area during the procedure, which is not an uncommon complication. Dr. Florete did testify that vasovagal syndrome could be drug induced. However, contrary to Dr. Rivera-Kolb's statement, it is clear that no local anesthetic would have been administered intravenously through J.D.'s jugular for her procedures. The statement therefore fails to provide an explanation of J.D.'s condition to that extent. In his deposition, Dr. Rivera-Kolb admitted this, testifying that he became confused when writing the statement "two years later." He said that he was thinking that perhaps the jugular IV had pulled away from the vein and was "dripping all those chemicals" into her. Dr. Rodenberg did in fact conclude that the left jugular IV was infiltrated, which is why he inserted the second external jugular line into J.D.'s right side. In any event, Dr. Rivera-Kolb's statement was written some 20 months after the event. It is not clear that Dr. Rivera-Kolb's statement was his diagnosis on June 25, 2008. It may have been that the analysis in his statement was simply Dr. Rivera-Kolb's recollection of Dr. Rodenberg's diagnosis or simply his own opinion in looking back at the events of that day. Another allegation of misdiagnosis is predicated on Nurse Lerfald's identification of J.D.'s facial swelling. Nurse Lerfald went to get Dr. Rodenberg as soon as she noticed it. Patient J.D.'s face was "completely swollen" when they returned, and Dr. Rodenberg immediately assumed control of her treatment. However, there is scant evidence as to how much time passed between the time the swelling was first noticed and the time Dr. Rodenberg arrived. Nurse Lerfald's statement doesn't discuss it. Dr. Rodenberg's statement notes only that when he was called back to the PACU "[a]bout ten minutes had elapsed since the initial period of instability," with no mention of how long it took him to respond after he received the summons. Dr. Rivera- Kolb testified in his deposition that after the swelling was noticed, he put the head of J.D.'s bed down and pushed the endotracheal tube down, saying "[i]t took about less than a minute" before Dr. Rodenberg arrived. While Dr. Florete also testified that it should take "less than a minute" to diagnose pneumothorax from observation of the swelling, it was not clearly shown that Dr. Rivera-Kolb had even that much time before Dr. Rodenberg assumed control for the second time. It is clear that once the pneumothorax was identified, it should have been immediately treated by inserting a large-bore needle into each side of the chest to allow the air to escape while waiting to place the chest tubes. The failure of Dr. Rivera-Kolb to insert such needles immediately after the diagnosis was also alleged to constitute malpractice. But, it is undisputed that the pneumothorax was identified by Dr. Moya; after which diagnosis, Dr. Moya immediately began to insert the chest tubes. The diagnosis and treatment occurred very close in time. It was not clear from the evidence that there was any "wait" time after the diagnosis but prior to Dr. Moya's insertion of the tubes in which Dr. Rivera- Kolb could have acted, even assuming it was appropriate for him, as a general practitioner, to take over treatment of the patient from the orthopedic surgeon who had just made the diagnosis. Even if there had been competent testimony as to the prevailing professional standard of care for a general practitioner, the evidence did not clearly show that Dr. Rivera- Kolb failed to meet that standard or failed to use reasonable care. The Department established by clear and convincing evidence that Dr. Rivera-Kolb committed medical malpractice when, as a general practitioner, he engaged in providing anesthesia care. Scope of Practice The Department presented evidence indicating that propofol was in fact administered to J.D. on June 25, 2008. First, there were pharmacy bills in J.D.'s medical record indicating propofol had been issued for her procedures on that date. Second, there were written statements from Nurse Lerfald and Dr. Rivera-Kolb himself that when the left chest tube was placed, air bubbles and a white-colored fluid were discharged. Dr. Florete indicated that the discharge of the whitish fluid from the chest tube was evidence that propofol was given to J.D., because no other drugs administered in this case other than propofol would have produced a white milky fluid.7/ It was not necessary for the Department to show that Dr. Rivera-Kolb himself administered propofol to J.D., that he knew that Dr. Rodenberg had done so during J.D.'s second procedure, or even that he "feared that that was the case" in order to show that Dr. Rivera-Kolb accepted or performed professional responsibilities which he knew he was not competent to perform. The evidence is clear and convincing that Dr. Rivera-Kolb knew, or should have known, that the procedures were to be conducted under MAC.8/ He signed more than one paper indicating this, once in a block designated as "Anesthesiologist 1." He also knew, from his earlier treatment of Patient J.D., that she had accelerated hypertension and that MAC procedures might be advisable. Despite his testimony to the contrary, it is clear that Dr. Rivera-Kolb accepted the responsibility to act as an anesthesiologist during two procedures and to prepare the Anesthesia Record for at least the first of these, and then proceeded to do so. The fact that Dr. Rivera-Kolb knew that Dr. Rodenberg was an anesthesiologist and was in the room performing the surgeries does not excuse Dr. Rivera-Kolb's actions or lessen his responsibility. If Dr. Rivera-Kolb at the time of the facet radiofrequency lesioning did not know specifically what sedatives were and were not administered earlier by Dr. Rodenberg or some other person, that fact would not be exculpatory, but incriminating. Dr. Rivera-Kolb is not board certified in anesthesiology. He has not completed a residency in anesthesiology and has not had adequate training in anesthesiology for him to perform the duties of an anesthesiologist. Dr. Rivera-Kolb knew that he was not competent to perform the professional responsibility of providing monitored anesthesia care to Patient J.D. during her procedures. There is clear and convincing evidence that Dr. Rivera- Kolb accepted and performed the professional responsibilities of an anesthesiologist, which he knew that he was not competent to perform. Dr. Rivera-Kolb's actions in knowingly accepting and performing professional responsibilities which he knew that he was not competent to perform exposed J.D. to potentially severe injury or death. Prior Discipline In December 2003, an Administrative Complaint was filed against Dr. Rivera-Kolb in the Department's Case No. 2001-22573. The complaint alleged that he failed to keep required medical records, prescribed a legend drug other than in the course of his professional practice, and committed medical malpractice in violation of sections 458.331(1)(m), (1)(q), and (1)(t), Florida Statutes (2001), respectively. In December 2003, another Administrative Complaint was filed against Dr. Rivera-Kolb in Case No. 2002-13550. The complaint alleged that he failed to keep required medical records and committed medical malpractice in violation of sections 458.331(1)(m) and (1)(t), Florida Statutes (2002), respectively. In February 2006, Dr. Rivera-Kolb entered into a Consent Agreement with the Department of Health in settlement of these two complaints. In a Final Order incorporating the Consent Agreement issued on April 19, 2006, the Department imposed a reprimand, fine, and two-year period of probation against Dr. Rivera-Kolb's license. The Consent Agreement contained no provision finding that Dr. Rivera-Kolb had committed any of the offenses alleged in the complaint. Dr. Rivera-Kolb was not under any legal restraints on June 25, 2008. It was not shown that Dr. Rivera-Kolb received any special pecuniary benefit or self-gain from his actions on June 25, 2008. It was not shown that the incidents involved any trade or sale of controlled substances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Health, Board of Medicine, finding that Dr. Rivera- Kolb violated sections 458.331(1)(m), (t), and (v), Florida Statutes, as charged in the Administrative Complaint, and imposing an administrative fine of $20,000.00 and a four-year suspension of his license to practice medicine. DONE AND ENTERED this 19th day of December, 2014, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of December, 2014.
The Issue The issue for determination in this proceeding is whether the Respondent, the Department of Professional Regulation, should pay the Petitioner, Kirk A. Woodson, M.D., attorney fees and costs under Section 57.011, Fla. Stat. (1989), the Florida Equal Access to Justice Act. As reflected in the Preliminary Statement, the parties stipulate that the Petitioner is a "prevailing small business party" and that reasonable fees and costs exceed $15,000, the statutory cap. The only remaining issue under the statute is whether the Respondent was "substantially justified" in filing the Administrative Complaint in Case No. 90- 5986 against the Petitioner. 1/
Findings Of Fact On or about June 7, 1988, a complaint was filed against the license of the Petitioner, Kirk A. Woodson, M.D., subsequent to closure of a professional malpractice liability claim against him without payment of indemnity. The substance of the complaint was that, on January 1, 1986, Woodson saw and performed a hysterectomy on a patient who had presented at the emergency room at University Community Hospital in Tampa, Florida, with heavy and continuous vaginal bleeding. The complaint stated that post-surgery the patient developed Adult Respiratory Distress Syndrome (ARDS) and died. The complaint questioned whether Woodson failed to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. By letter dated June 30, 1988, the Department of Professional Regulation (the Department or DPR) notified Woodson that it had received the complaint and that it was initiating an investigation. DPR subpoenaed the hospital records which revealed that the patient arrived at the UCH emergency room at 5:28 a.m. on January 1, 1986, with at least a three-day history of vaginal hemorraging. An emergency room physician saw the patient, gave her two units of packed blood cells, and admitted her to Woodson's service. Woodson was called at approximately 8:30 a.m. and saw the patient later that morning. The patient's admission to surgery to determine the cause of the bleeding and perform necessary procedures was delayed until at least approximately 2:00 p.m. because the patient refused to consent to a dilation and curettage (D and C); she was insisting on a hysterectomy only. She finally consented to a D and C to be followed by a hysterectomy if Woodson found it to be medically necessary. During this delay, the patient continued to bleed and was transfused with two more units of packed blood cells at approximately 1:45 p.m. After the consent was given, there was a further delay, not explained by the records, until approximately 6:00 p.m. in getting the patient to surgery. The patient continued to bleed. Surgery took almost five hours. During surgery, the patient's bleeding got worse, and she was transfused with four more units of whole blood during the surgery. The DPR investigator was unable to ascertain from the hospital records the reason for the length of the surgery. The DPR investigator attempted to arrange an interview with Dr. Woodson and his attorney on or about February 28, 1989. The appointment was cancelled. When the DPR investigator contacted Woodson to reschedule the interview, Dr. Woodson questioned why DPR was pursuing the complaint when the malpractice claim was closed without payment of indemnity. Dr. Woodson agreed to be interviewed but expressed his preference that the investigator first review the "extensive depositions" taken in the malpractice litigation. 4/ Having already determined to request an expert evaluation of the case, the investigator decided to postpone the interview with Dr. Woodson. On July 10, 1989, the DPR asked a probable cause panel of the Board of Medicine to authorize the retention of an expert in gynecology to review the information obtained through investigation to that point in time to assist in the determination whether Woodson's treatment of the patient fell below that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances. On July 22, 1989, the probable cause met and authorized the expert review. On or about November 2, 1989, the DPR requested an expert review by Doris N. Carson, M.D., a Board-certified gynecologist with extensive surgical experience, including emergency room experience. Dr. Carson reviewed the hospital records supplied by DPR, some of which were difficult to read. By letter dated November 20, 1989, Dr. Carson reported her impressions. Dr. Carson believed the records supported Dr. Woodson's diagnosis and ultimate course of treatment. In the patient's condition, the proper course of treatment was to attempt to stop the vaginal bleeding by doing a D and C; a hysterectomy only should have been attempted if the D and C did not stop the bleeding. However, Dr. Carson perceived other problems that were not explained to her satisfaction by the hospital records. First, Dr. Carson did not see anything in the records to justify the length of the surgical procedures performed by Dr. Woodson. She reported: Careful review indicated that the subject attempted to remove the fibroids vaginally, and when this only increased the bleeding, then decided to do a laparotomy. The uterus, although enlarged, was not huge and the procedure as described seemed to move along without difficulty. When, however, the time is reviewed five hours would indicate very serious problems of technique or what seems more likely a lot if indecision about how to proceed. Evidently there was no physician surgical assistant, and the subject proceeded alone. In retrospect better operationg room help should have been available. Second, Dr. Carson felt that the patient received too much whole blood replacement during the course of the day and the surgery. Her reading of the hospital records indicated to her that five units of whole blood were given to the patient in addition to four units of packed cells. She felt: "Packed cells altogether would have been a better choice in light of the volume given to the patient." Her concern was that "volume overload," rather than ARDS, may have resulted ultimately in the death of the patient. However, she disclaimed the necessary expertise to render a conclusive opinion on the question and recommended that, if the DPR wanted a conclusive opinion on the cause of death, it should have a specialist in intensive care or a respiratory expert review the records. Dr. Carson had some difficulty with the delay in getting the patient to the operating room. The records indicated that at least some of the delay was caused by the patient's unwillingness to give consent to the recommended D and C. But Dr. Carson nonetheless had concerns that the delay added to the amount of blood transfused. Dr. Carson closed her letter with this remark: "In conclusion: A poorly done sugical proceeding below the recognized normal level of care." For reasons not apparent from the evidence presented, DPR did not interview Dr. Woodson before asking the probable cause panel to find probable cause and file a draft Administrative Complaint against Dr. Woodson based on Dr. Carson's expert review and the rest of the investigative report, including the hospital records. The draft Administrative Complaint, drawn in two counts, sought to discipline Dr. Woodson under Count I for failure to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as being acceptable under similar conditions and circumstances, in two respects: first, for allegedly causing volume overload in the patient by ordering units of whole blood, instead of packed blood, to replace the patient's blood loss; and, second, for allegedly taking too long, without justification, to perform the necessary surgery. Count II alleged that Woodson failed to keep written medical records justifying the course of treatment of the patient, specifically with respect to ordering whole blood instead of packed units and with respect to the length of the surgical procedures. The probable cause panel considered the matter at its meeting on June 22, 1990. Counsel for the panel pointed out that the "extensive depositions" Woodson had indicated he wanted the DPR investigator to read before Woodson was interviewed were not in the packet of materials reviewed by the panel. 5/ But members of the panel indicated that they had reviewed the material that was in the packet and that they thought the information contained in it was adequate to make a probable cause determination. One of the doctors on the panel called it a "horrendous case." She felt that Woodson had "swamped out the patient" and had performed "inappropriate types of fluid therapy and blood therapy." The other member mentioned the "five-hour operating time . . . without any real explanation." The panel's attorney pointed out the part of the report of investigation that referenced the patient's refusal to consent to Dr. Woodson's proposed surgery and asked whether it constituted "any semblance of an explanation for a delay?" It is not clear from the transcript of the probable cause proceeding how the panel resolved the attorney's question, but the panel voted to find probable cause notwithstanding the question. 6/ There is information in the materials reviewed by Dr. Carson, and by the probable cause panel, which tends to explain some of the time it took for Dr. Woodson to perform surgery on the patient. Some of this partially exculpatory information was difficult to read and decipher in the records. Some of the partially exculpatory information was acknowledged by Dr. Carson and may also have been taken into account independently by the panel. Notwithstanding this partially exculpatory information in the record, the finding of probable cause was substantially justified.
The Issue Should Petitioner discipline Respondent's license to practice medicine?
Findings Of Fact At the times relevant to the inquiry Petitioner was the state agency charged with regulating the practice of medicine in Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician within the state of Florida, having been issued license No. ME0045474, effective December 28, 1984. Respondent's last known address is 1401 Centerville Road, Suite 202, Tallahassee, Florida 32308. Respondent is board-certified in obstetrics and gynecology. The board certification is by the American Board of Obstetrics and Gynecology. Respondent is a fellow of the American College of Obstetricians and Gynecologists. Respondent received his undergraduate degree from Florida State University and his medical degree from Howard University. His training at Howard University included a four- year residency program from 1982 to 1986. Respondent holds staff privileges at Tallahassee Memorial Hospital (TMH) in Tallahassee, Florida. Patient A.G. Patient A.G. began treatment with Respondent in 1998 and continues as Respondent's patient. A.G. is an Hispanic female who is not proficient in English. When seen by Respondent in his office she has been accompanied by an interpreter that would allow Respondent to discuss details of her health care in English for translation into Spanish for the patient's benefit. Respondent's understanding of Spanish is limited to education in high school and a year at the university. He has the ability to describe some matters that are pertinent to gynecologic practice or obstetric practice and in particular as it relates to telling patients, for example "how to push and when not to push." The record does not reveal that Respondent has the ability to discuss A.G.'s overall health care in Spanish, her language. A.G.'s husband, T.Q., who accompanied her at relevant times principally spoke Spanish and not English. He is somewhat proficient in English. On June 16, 1999, A.G. had an office appointment with Respondent. At that time A.G. had undergone gallbladder surgery but her pelvic pain persisted. In consultation on that day it was decided that A.G. would undergo diagnostic laparoscopy to explore the reason for her chronic pelvic pain. Through the discussion the patient was told that biopsies of the pelvic anatomy might be performed during the procedure and that any problems that could be addressed through laparoscopy would be addressed as Respondent felt comfortable in carrying out that correction. Otherwise, Respondent said that he would "take pictures" and "get out of the case" with the decision to offer further treatment left for another time. Patient A.G. had been referred to Respondent for her persistent pelvic pain following an examination on April 27, 1999, that had been made by Margaret Cantor, a Nurse/Mid-Wife and Registered Nurse. She conducted a pelvic examination of the patient that date. The examination included the use of speculum to examine the cervix and vagina in the interest of looking for abnormalities, lesions, growths, and discolorations. No cervical lesions were found in this examination. A pap smear taken at the time revealed normal results with some inflammation. Diagnostic laparoscopy is a surgical procedure involving an incision in the abdominal wall through which a scope is inserted to visualize the abdominal cavity. Typically the workup for performing a diagnostic laparoscopy would include use of ultrasound, pelvic examination, and a pap smear. Possible complications in this procedure include vascular injury, bowel injury, bladder injury, infection, and bleeding. Preliminary to the diagnostic laparoscopy it is the custom and practice in the medical community to perform a vaginal examination with the use of a speculum. On July 1, 1999, patient A.G. was seen by the Respondent in his office for her pre-operative check. On this occasion A.G. was unaccompanied by a translator. Nonetheless, Respondent was able to perform a brief physical and obtain a history with the assistance of A.G.'s husband. Respondent listened to the patient's heart and lungs and performed a bi- manual examination in which one or two fingers were inserted in the vagina and with a hand on the abdomen compression was performed on the pelvic viscera, uterus, tubes, and ovaries and the lower section of the pelvis. Nothing significant was observed in the patient since last seen. On July 1, 1999, an employee in Respondent's office witnessed patient A.G. sign a consent form allowing the diagnostic laparoscopy. The consent form makes no reference to the agreement for Respondent to perform a loop electrocautery excision procedure, referred to by abbreviations as a "LEEP" conization biopsy procedure or a LEEP cone. No evidence of such consent is contained in patient A.G.'s medical records maintained at Respondent's office. The diagnostic laparoscopy was to be performed at TMH. On July 1, 1999, Patricia Charbonneau, a clinical nurse at the hospital, reviewed a consent form with patient A.G. concerning the diagnostic laparoscopy for the purposes of that facility. Nurse Charbonneau was aware of the scheduling of the diagnostic laparoscopy by reference to the history and physical prepared by the Respondent. This conference involved the discussion of potential risks and complications of the laparoscopy. No discussion was conducted concerning possible risks and complications of a LEEP conization biopsy. The consent form from TMH pertaining to patient A.G. and the diagnostic laparoscopy stated "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure, I request and authorize my physician to proceed." Nurse Charbonneau was left with the impression that the patient understood the explanation concerning the upcoming procedure and gave her consent. Ms. Charbonneau was assisted in this communication by A.G.'s husband. No discussion was held concerning the performance of a LEEP cone biopsy, in that the permit from Respondent made no mention of that procedure. Ms. Charbonneau took steps for an interpreter to be available the next morning when the surgery was to be performed given the nature of the surgery, the use of anesthesia and the desire to have "everything" reviewed again. A LEEP conization is a form of biopsy performed either in an office or hospital setting with anesthesia. The cervix is examined with the assistance of a speculum. Lugol solution is placed on the cervix to identify any abnormal cells and an excesion is made by shaving a small piece of the cervix for examination. The workup for LEEP conization includes a pap smear and a colposcopy. The performance of LEEP conization presents potential risks and complications related to infection, endometrious, bleeding, cervical stenosis, and cervical incompetence. On July 2, 1999, patient A.G. came to the TMH outpatient surgery center for her scheduled diagnostic laparoscopy to be performed by Respondent. She was the fourth patient on a schedule of surgeries to be performed by Respondent on that date. Respondent was conversant with the sequence of surgeries to be performed. Patient A.G. was placed in a holding area in the outpatient surgery center to prepare her for her surgery and to await transport to the operating room. Sometime before moving the patient to the operating room Respondent saw the patient in the holding area. Respondent addressed patient A.G. by saying hello and asking her how she was doing. This was not a visit intended to educate the patient and was not involved with any other medical purpose. At the time the patient's husband was with her during this brief encounter which was intended to confirm that the patient was there for the surgery as had been previously arranged. Several hours may have passed between the time Respondent saw patient A.G. in the holding area and when he next encountered the patient in the operating room. Respondent also saw patient N.C. in an adjacent cubicle to where patient A.G. was located while the patients were awaiting their surgery. Patient N.C. was the third patient on the schedule, there for the performance of a LEEP conization biopsy. Respondent followed his surgical schedule for the first two patients in the intended sequence. Some delay was occasioned by a problem experienced in the surgery performed on the second patient. Valerie Anne Lazzell, M.D., is an anesthesiologist licensed to practice in Florida. She is employed by Anesthesiology Associates of Tallahassee, Florida. It was intended that she provide anesthesia during Respondent's performance of the diagnostic laparoscopy for patient A.G. It was anticipated that the patient be subjected to general anesthesia which involves a rapid loss of consciousness and blocks the sensory, mental and motor functions of the patient. A general anesthesia can be provided by using an endotracheal tube, with a mask or with an LMA. This is as distinguished from the use of a neurolept employed in most instances when performing LEEP conization biopsies. In that setting the patient is generally anesic, not really aware, and has analgesia "on board." The use of a neurolept promotes a pain-free state of immobility and an insensitivity to pain and is usually accomplished by use of IV medications. From the record, it appears that Jean Mauch, C.R.N.A., with Anesthesiology Associates was scheduled to provide anesthesia by neurolept for the third patient N.C. who was scheduled for LEEP conization biopsy. Patient A.G. at the time in question was 4'9" tall and weighed 103 pounds. Patient N.C., an African-American woman was 5'2" tall and weighed 242 pounds. Their skin tone was similar in color. Dr. Lazzell saw patient A.G. before the patient was taken for surgery. In this examination the doctor filled out the patient's airway, listened to her heart and lungs, and considered the patient's ASA classification which was one of good health. Dr. Lazzell considered the plan for anesthesia with an endotracheal tube. She gained the assistance of a Dr. Becker who was fluent in Spanish in explaining the use of anesthesia to the patient. Dr. Lazzell sought Dr. Becker's assistance when the hospital did not make an interpreter available. Dr. Lazzell discussed the possible risks and complications of use of this form of anesthesia and a consent form was signed and dated. While this assessment was being made A.G.'s husband was in attendance. It was Dr. Lazzell's expectation that the patient A.G. would next be seen as scheduled when the nurse anesthetist called Dr. Lazzell to the operating room to intubate patient A.G. in association with the provision of anesthesia for the diagnostic laparoscopy. Jean Mauch, C.R.N.A., when performing her duties in the operating room setting at TMH outpatient surgery center was expected to induce anesthesia, maintain the anesthesia, monitor vital signs, treat untoward events during surgery and maintain fluids in the patient while under the supervision of the physician, in this instance, Dr. Lazzell. Nurse Mauch was principally responsible for providing the anesthesia for the third procedure on patient N.C., the LEEP conization biopsy. This included preparation in the operating room of medications and other related tools and supplies. The third procedure, the LEEP conization biopsy for N.C., was referred to on a typed surgical schedule in the preoperative desk in the outpatient surgery center. Having checked the schedule Nurse Mauch obtained the chart for N.C. and went to the cubical, not of N.C. but A.G. When Nurse Mauch arrived at A.G.'s cubical, Jamie Martin, R.N., the pre-op nurse and Dale Dunsmore, R.N., the circulating nurse, were there. Nurse Dunsmore and Nurse Mauch arrived at the cubicle where patient A.G. was located at about the same time. When arriving at the cubicle for patient A.G., Nurse Mauch had in mind that the process was one in which she was getting ready for the surgery to be performed on patient N.C. While in the cubical Nurse Mauch introduced herself to the person she believed to be the patient N.C., at which time Nurse Dunsmore said that the patient only speaks Spanish. Nurse Mauch recalls that a translator was not available for assisting in any communication with patient A.G. Realizing that Nurse Dunsmore was checking the armband for identification, the reference to the fact that the patient only spoke Spanish did not cause Nurse Mauch any concern. Nurse Mauch never heard Nurse Dunsmore orally refer to patient A.G. by name. Nurse Mauch continued with her presentation by commenting that she was the nurse anesthetist who was going to put the patient to sleep. Patient A.G. nodded her head in response to Nurse Mauch's physical gesture that the patient was going to be put to sleep. Beyond that point Nurse Mauch and Nurse Dunsmore took patient A.G. to the operating room ostensibly as the third patient on the schedule for provision of a LEEP conization biopsy wherein Nurse Mauch would provide the necessary anesthesia. The chart for N.C. was brought to the operating room. Before the patient was removed from the cubicle Nurse Martin provided pre-op medication to patient A.G., phenergan robinul. The fact that Nurse Martin was giving preoperative medication and that Nurse Dunsmore was checking the armband on what turned out to be patient A.G. led Nurse Mauch to believe that patient A.G. was patient N.C. the third scheduled patient, according to Nurse Mauch. As Nurse Mauch recalls, when the Respondent entered the operating room where the third scheduled procedure was to be performed he checked the chart for patient N.C. Respondent went out and washed his hands, returned and started the procedure. At the end of the procedure Nurse Mauch recalls Respondent commenting that the next patient speaks only Spanish, to which Nurse Mauch said, "No, this patient," meaning the patient who had been subjected to the procedure is the one who speaks Spanish. Respondent replied "I must be mixed up." Nurse Mauch recalls Dr. Lazzell arriving at the door of the operating room with patient A.G.'s chart. Dr. Lazzell looked surprised to find the circumstances. Nurse Mauch told Dr. Lazzell that this is the neurolept, the case involving the LEEP conization biopsy. Dr. Lazzell commented that "No it isn't." Nurse Mauch heard Dr. Lazzell ask Respondent, "What procedure did you do?" Respondent replied "LEEP conization." Dr. Lazzell said "No, this was supposed to be the diagnostic laparoscopy." Nurse Mauch observed Respondent leave the room and return. Patient A.G. was re-preped and the diagnostic laparoscopy scheduled to be provided was performed with the patient being intubated by the use of an endotracheal tube. Nurse Martin in her capacity as pre-op nurse was responsible for receiving patients and getting the patients ready for administering medications that were prescribed and getting IVs and things started on the patients prior to the patients being sent to the operating room. She recalls performing pre- operative duties on the patient A.G. Nurse Martin was familiar with the schedule of patients, the sequence. She understood that patient A.G. was the fourth patient in the schedule and provided the pre-anesthetic to patient A.G. in preparation for the operation. This involved the use of phenergan. Nurse Martin made no mistake in identifying patient A.G. when providing care. Nurse Martin heard Nurse Dunsmore identify patient A.G. in Nurse Martin's presence and agreed with that identification. Nurse Martin had seen the patient A.G. before the occasion at which Nurse Mauch and Nurse Dunsmore were there with the patient in Nurse Martin's presence and the patient A.G. was taken to the operating room. Nurse Martin had reviewed patient A.G.'s chart earlier in caring forward responsibilities for preparing the patient for the operation. Nurse Dunsmore identified her duties as circulating nurse at TMH outpatient surgery center as being related to setting up rooms for surgeries, transporting patients from pre-op holding areas, identifying patients, verifying surgeries, verifying allergies, and so forth. Ordinarily Nurse Dunsmore in performing her duties would read the chart of the patient scheduled for a procedure to make certain that all permits were signed. She would then go to where the patient was being held, introduce herself to the patient and ask for identification, verifying the surgery that is scheduled for the patient, and perform other related assignments. In performing her duties Nurse Dunsmore would accompany the patient with the anesthesiologist to the operating room. The method of identification in effect at the time in question would be to compare an addressograph card which accompanied the patient's chart with the information on an identification bracelet worn by the patient. Nurse Dunsmore verified that the operating room for the third procedure was set up for a LEEP conization biopsy. After the second procedure on the schedule, Nurse Dunsmore recalls that she went to patient A.G.'s room. However Nurse Dunsmore had handed Nurse Mauch patient N.C.'s chart. Nurse Mauch carried the chart to patient A.G.'s cubicle. The two nurses essentially entered the cubicle together. Nurse Martin and patient A.G.'s husband were already there. Nurse Martin left the cubicle shortly thereafter. Nurse Dunsmore introduced herself to the patient and reached for the patient's identification bracelet and read it out loud. The patient smiled and nodded in response. In turn the patient's husband smiled and nodded in response. Patient A.G. was then taken to the operating room by Nurse Dunsmore and Nurse Mauch. The patient was sedated by Nurse Mauch and positioned for provision of the LEEP conization biopsy. Nurse Dunsmore observed the Respondent enter the operating room and look at the chart which was in relation to patient N.C., not patient A.G. Nurse Dunsmore saw Respondent leave the operating room to scrub. Nurse Dunsmore was in attendance when the procedure was performed. Nurse Dunsmore recalls Dr. Lazzell entering the operating room at the end of the procedure with the chart belonging to patient A.G. and the realization by those in attendance that the chart in the operating room was for N.C., whom they understood to be undergoing the procedure when in fact the patient undergoing the procedure was A.G. Diane Jordan was a surgical technician assigned to assist in the third procedure, the LEEP conization biopsy. She recalls the patient being put to sleep by Nurse Mauch and the patient being prepared for the procedure. The patient was covered by draping towels across the upper portion of the thighs. A blanket was placed over the patient's torso. The patient was placed in the lithotomy position allowing observation of the patient's buttocks, vulva, vagina and external pelvic organs. The patient had a mask on her face and a surgical hat to cover her hair. All of these arrangements had been made before Respondent entered the operating room. Ms. Jordan recalls that the chart in the room was for N.C., the patient anticipated to undergo the LEEP conization biopsy. Ms. Jordan did not realize that the patient in reality was patient A.G. Ms. Jordan recalls that the Respondent when entering the room asked is this "such and such" in relation to a LEEP conization biopsy and that Nurse Dunsmore replied in the affirmative. Ms. Jordan remembers Respondent looking at the chart for N.C. and signing it. Ms. Jordan was in attendance while the procedure was performed. Ms. Jordan heard Respondent mention something about a lesion before he started. Ms. Jordan provided medication to be injected during the LEEP conization. Ms. Jordan identified the fact that a specimen was obtained which was given to her and provided to the nurse to send to pathology for evaluation. When Respondent entered the room for what he anticipated to be the third procedure what he asked specifically was "Is this Ms. C our case for the LEEP?" referring to the LEEP conization to be performed on patient N.C. That is when Nurse Dunsmore responded in the affirmative. After inquiring about the identification of the patient in association with the nature of the procedure Respondent expected to perform and in receiving an affirmative response, Respondent took no further steps to personally confirm the identity of the patient. Respondent opened the chart that was patient N.C.'s chart. Respondent took a drawing from his pocket that a Dr. Thompson had made of patient N.C.'s cervix when he had treated the patient. The drawing was in association with a colposcopy. Respondent intended to compare that drawing with what was observed in the patient during the performance of the LEEP conization biopsy in locating the suspected pathology. In proceeding with what he considered to be the third scheduled procedure for N.C., Respondent placed the speculum, applied the tenaculum and observed what looked to be a lesion that roughly approximated what he anticipated it would be based upon the drawing from Dr. Thompson. Respondent applied Lugol's solution and proceeded with the LEEP conization biopsy. Having applied the solution there was an indication of some pathology in roughly the position as the drawing had depicted. Respondent obtained the sample from the cervix. The size of the specimen was less than the diameter of a dime with a depth or thickness of about two dimes. The performance of the LEEP conization biopsy took less than five minutes. As Respondent finished Dr. Lazzell came to the operating room and informed Respondent that this was not the patient the he thought he was treating. Having been told by Dr. Lazzell that there was a misidentification, Respondent for the first time while engaged with the patient in the operating room proceeded to the front of the table and looked at the patient while the patient was being unmasked. By doing so Respondent discovered that indeed the patient had been misidentified and that he had actually performed surgery on patient A.G., not patient N.C. Respondent left the operating room and informed patient A.G.'s husband of the problem. Respondent returned to the operating room. The patient was provided anesthesia by Dr. Lazzell and the diagnostic laparoscopy that was scheduled was performed. Notwithstanding that it was never intended that Respondent perform a biopsy on patient A.G. from the cervix, Respondent expresses the opinion that if the physician encounters a visible lesion some form of biopsy is in order. Respondent expresses the opinion that in performing procedures such as a diagnostic laparoscopy greater latitude is afforded in terms of what the physician can do when he or she discovers "What's amiss with the patient." This in Respondent's view is because the patient is going into the procedure with the understanding that there may be an unanticipated problem and if the unexpected problem can be addressed, it should be taken care of. Of course this assumes that the biopsy that was performed on patient A.G. was in association with the scheduled diagnostic laparoscopy, when in fact the biopsy was the product of happenstance, in that, Respondent when addressing what he considered to be the condition in the patient N.C., by chance observed a similar condition in the patient A.G. Respondent concedes that prior to patient A.G.'s arrival at the outpatient surgical center that LEEP conization was not an indicated procedure for that patient. The biopsy that was performed was with the misapprehension as to the patient whose needs were being addressed, not merely an unanticipated circumstance in a patient whose identity was established when Respondent performed the biopsy. This was not an additional surgical procedure that came about in connection with the scheduled diagnostic laparoscopy; it was perceived by Respondent as the intended surgery being performed on a different patient when the case began. As a consequence it is the planned- for diagnostic laparoscopy which became the additional procedure. Nonetheless, Respondent tries to explain his result by expressing the opinion that other unexpected and unplanned-for procedures may be undertaken in the instance "Within the realm of the comfort level of the physician and the patient ahead of time; where they know each other, other things can be done as well." Respondent believes that the ability to proceed with the biopsy on patient A.G. while thinking that he was responding to the case involving patient N.C. is implicit and is promoted by "A feeling of trust that we had developed at the point in time." This refers to the point in time at which the other surgery, the diagnostic laparoscopy was being discussed with the patient A.G. The type of pathology that was encountered by Respondent with patient A.G. that led to the biopsy was compatible with condyloma with warty atypia. That is what Respondent observed and collected for evaluation. The laboratory confirmation of the specimen was performed by Dr. Woodard Burgert, a board-certified anatomic and clinical pathologist. In his assessment Dr. Burgert observed that the cone biopsy in question was compatible with condyloma with warty atypia. There was no significant dysplasia. Expert Opinions Dr. Edward Zelnick is a board-certified obstetrician and gynecologist who practices in Florida. He has hospital privileges at Hollywood Medical Center and Memorial Regional Hospital. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. In the instance where pathology is found in examining the cervix, Dr. Zelnick believes that action should be taken in addressing that pathology, but only in the instance where the pathology has been discussed with the patient and the appropriate alternative treatment has been discussed. Absent an emergency it is necessary to provide the patient the alternative to surgery and identify the risk of surgery. Absent life-threatening circumstances, a biopsy such as that performed on patient A.G. should not be performed without the patient's consent, which had not been given. Dr. Zelnick further describes the instance in which a biopsy in a case such as this would be in order, would be in relation to an instance in which it appeared that the circumstance was an immediate threat to the health of the patient that needed to be addressed. None of the exigent circumstances existed in this case. Therefore, Dr. Zelnick expresses the opinion that the performance of the biopsy by Respondent did not meet the expected standard of care. Based upon his familiarity with the form of consent in this case which states, "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure I request and authorize my physician to proceed," Dr. Zelnick believes that the physician's responsibility there is to respond during the course of the surgery, if medically necessary, to such matters as repairing of a blood vessel that has been cut or damage to an internal organ or bowel. None of those circumstances were associated with the biopsy performed on the patient A.G.. While Dr. Zelnick delegates patient identification to surgical staff or nursing staff, he believes that the ultimate responsibility for patient identification to make certain that the right operation is performed on the proper patient resides with the surgeon. To do less is to practice below the standard of care universally accepted and a matter of common sense. According to Dr. Zelnick, Respondent did not meet that standard when performing the biopsy on patient A.G. who was misidentified. Whatever rules and procedures may be in place setting standards for identification in a hospital, Dr. Zelnick does not believe those standards abrogate the duty of the physician to properly identify the patient. What is expected of a physician is 100 percent certainty as to who the proper patient is and to assure that the proper procedure is carried out on the proper patient. The method of arriving at that determination is not significant, in Dr. Zelnick's view. Dr. Roberto Fojo is a board-certified obstetrician and gynecologist licensed to practice medicine in Florida. He has hospital privileges at Jackson Memorial and North Shore Medical Center in South Florida, and he is affiliated with the University of Miami, Department of Obstetrics and Gynecology, Division of Gynecology. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He does not view a diagnostic laparoscopy as being intended to discover and diagnose cervical lesions, where, as here, the lesion is on the surface of the cervix and vagina. A diagnostic laparoscopy is not intended to promote an examination of the cervix, according to Dr. Fojo. Dr. Fojo is familiar with the consent form executed by patient A.G., the language previously described. He has seen that language before or something similar to it and considers it part of the standard surgical consent in connection with a diagnostic laparoscopy that was intended in this case. The consent is designed to allow the surgeon to address matters such as puncture of the bowel or a problem with a major artery or veins or scar tissue or adhesions. This consent would not include addressing lesions on the cervix. A LEEP conization procedure is not an accepted procedure to perform in the patient undergoing diagnostic laparoscopy unless the LEEP conization had already been discussed and there was a problem with the cervix that the patient knew about. There, in Dr. Fojo's perception, the patient would be undergoing what he refers to as dual procedure. Dr. Fojo does not believe that surgery should be performed on a patient absent the patient's consent as being part of the original procedure or in an emergency. The LEEP conization biopsy by Respondent was not related to the consent that had been provided nor pertaining to an emergency. In this sense, Dr. Fojo expresses the opinion that Respondent failed to meet the standard for medical practice when performing the LEEP conization biopsy on Patient A.G. Dr. Fojo believes that a surgeon should ascertain without any doubt that the patient in the room is a patient that he or she should be performing surgery on, the appropriate surgical procedure. This need for identification is an independent responsibility of the physician and may not be delegated. It requires 100 percent accuracy, according to Dr. Fojo. Dr. Fojo holds to the opinion that the physician is responsible for the identification regardless of his or her efforts that may have been compromised by others in attempting to properly identify the patient and perform the indicated procedure. He believes this to be common medical practice. Respondent was not within the standard of care in performing the LEEP conization procedure on patient A.G. under Dr. Fojo's assessment. Dr. Michelle McCallanahan is a board-certified obstetrician and gynecologist who is licensed in Florida and practices in Jacksonville, Florida. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. The consent form executed by patient A.G. is not unfamiliar to Dr. McCallanahan. Her perception of this consent language is that it relates to complications that occur during the course of the diagnostic laparoscopy that were not foreseen and constitute an emergency requiring an immediate procedure to correct the condition. Examples are vascular injuries to vessels, bowel injury, bladder injury, infection and bleeding. By contrast, lesions on the cervix do not constitute an example of an unforeseen circumstance. Dr. McCallanahan expresses the opinion that an appropriate workup for LEEP conization was not done for the patient A.G. Nonetheless, there are some circumstances in which it would not be violative of the standard of care to perform LEEP conization without conducting a workup. That circumstance would be in the instance where the lesion that was observed was highly suggestive of cervical cancer, according to Dr. McCallanahan. The case that Respondent was presented with did not constitute such a condition. Ordinarily, the standard of care contemplates the discussion of possible risks or complications associated with LEEP conization procedures before performing them. According to Dr. McCallanahan it would be appropriate to perform a surgical procedure without discussion of the risks and possible complications in an emergency when the patient was unconscious and could not give consent in advance. Those are not the facts here. While Dr. McCallanahan relies upon the assistance of other persons within the surgical and nursing staff, she expresses the opinion that the ultimate responsibility for patient identification prior to the performance of surgery resides with the physician. She believes that it is below the standard of care to not correctly identify the patient before the procedure is done and perform an improper procedure or non- consenting procedure on that patient, as was the case here. Dr. Jana Bures-Forstheoefel is a board-certified obstetrician and gynecologist who is licensed in Florida. She practices in Tallahassee, Florida, and has privileges at TMH and performs surgeries in the outpatient surgery center. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. She believes that Respondent met the standard of care for identifying patient A.G. before performing surgery on the patient. The method used by Respondent to identify the patient was common to the practice of other physicians who performed surgeries in that setting, according to Dr. Forstheoefel. In the event that Dr. Forstheoefel was performing a diagnostic laparoscopy and observed a cervical lesion she would evaluate the condition to include the performance of a biopsy, the most common method for cervical biopsy being a LEEP conization. Notwithstanding the lack of specific consent by the patient for Respondent to perform the LEEP conization, Dr. Forstheoefel holds to the opinion that it was correct to biopsy, given what was observed in the patient. The prospect that a physician would be 100 percent accurate in identifying a patient undergoing surgery is not humanly possible and is a standard that should not be imposed upon a physician in Dr. Forstheoefel's opinion. She considers that the matter of proper identification preoperatively is a team effort. One person should not be solely responsible for all things in making certain of the patient's safety and assuring that the right thing is done. Dr. Kenneth John McAlpine is a board-certified obstetrician and gynecologist. He is licensed in Florida. At times relevant he performed surgeries at the TMH outpatient surgery center. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He believes that Respondent met the standard of care in identifying the patient A.G. before performing the surgery and in performing the LEEP conization on that patient. Although Dr. McAlpine has not experienced a situation in which he observed a reason to do a LEEP conization in a diagnostic laparoscopy case, where consent for LEEP conization had not been given ahead of time, he does not question the decision to address the condition observed, such as in the case at issue. From his point of view, it was acceptable to do a LEEP conization biopsy to address the lesion. Although no prior indication existed before the lesion was observed during the procedure Dr. McAlpine would not want to ignore the lesion. Dr. McAlpine believes that the process that Respondent undertook in identifying the patient A.G. before surgery was consistent with practices in effect at the hospital, this included reliance on staff in the operating room. Dr. McAlpine does not believe that it is necessary for a physician to be 100 percent accurate in the identification as a person ultimately in charge. No matter as to the facts, he sees the issue of the identification being a multi-disciplinary approach among health care providers. Dr. David O'Bryan practices obstetrics and gynecology. He is licensed in Florida. At times relevant he performed surgeries at TMH outpatient surgery center. He is familiar with the type procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. The method employed by Respondent in identifying the patient was consistent with the practice used in the immediate medical community at the time, according to Dr. O'Bryan. Dr. O'Bryan believes that the Respondent performed the appropriate surgery on Patient A.G. For Dr. O'Bryan, what is more important in addressing the patient's needs is the apparent pathology, not the consent that may have been provided by the patient in advance of the procedure. It would be negligent not to address the lesion on the cervix in his view. The pathology present determines the response even without a consent for the procedure. Dr. O'Bryan did not consider that the pathology constituted an issue of life or death. The fact that the LEEP conization biopsy was not planned was less significant than the need to address the pathology. It does not matter if the patient were A.G. or N.C. or some other patient, Dr. O'Bryan believes that it was appropriate to perform the biopsy. Dr. O'Bryan believes that the surgeon bears a great deal of responsibility in patient identification, but the ultimate responsibility for identification does not reside with the physician or any other operating room staff member in Dr. O'Bryan's assessment. Dr. O'Bryan does not conceive that there can be any greater comfort in the identification than in the instance where the "operating room crew" tells the physician who it is and the physician has a chart in his hands which indicates that it is the same patient as the operating staff has identified and the pathology that was found is consistent with what had been anticipated according to the patient chart and the staff identification. Nothing in medicine involves the imposition of a 100 percent standard of care to include properly identifying the patient preoperatively, according to Dr. O'Bryan. Dr. Roberto Morales is a board-certified obstetrician in gynecology licensed to practice in Florida. At times relevant, he performed surgery at the TMH outpatient surgery center. He is familiar with the type procedures involved in Patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. Dr. Morales believes that Respondent met the standard of care for identifying the patient A.G. in that hospital and in other places as well. Dr. Morales believes that the patient was correctly identified by Respondent earlier in the day and that the incorrect patient was brought back to the operating room. Under those circumstances, Respondent did what was appropriate to identify the patient in the performance of the LEEP conization on patient A.G. and was within the standard of care, according to Dr. Morales. Assuming the patient was scheduled for a diagnostic laparoscopy, if during the examination, visualization of the cervix, a lesion was observed, a biopsy would be the typical next step, according to Dr. Morales. The caveat to his opinion in the ability to perform that biopsy would depend upon the patient that was being taken care of and the sense that the physician had about the patient's expectations of what should be done and not done. It is assumed that Dr. Morales believed that the level of relationship between Respondent and Patient A.G. would allow the performance of the LEEP conization biopsy. Dr. Morales believes that the attempt to be 100 percent accurate in the identification of patients preoperatively is an aspirational goal, not a requirement. For him all persons concerned have the responsibility for taking care of the patient. Having considered the opinions expressed by the experts, the ultimate facts to be determined must be based upon the realization that Respondent proceeded to perform the LEEP conization biopsy on patient A.G. without advance written consent, that Respondent believed that he was confronting the case of patient N.C., and that the performance of the LEEP conization on Patient A.G. was not in its timing and justification part of the diagnostic laparoscopy scheduled to be performed on Patient A.G. The earlier effort by Respondent to identify his patient in the holding area was sufficient for that stage of the process. Respondent acted in the customary manner in relying upon his knowledge that Patient N.C. was to be the third patient based upon the schedule. It was not unexpected that Respondent would rely upon the surgical staff in orally confirming the patient identity and the procedure to be performed when entering the operating room for the scheduled third procedure. This identification was further confirmed by the presence of the chart for Patient N.C. Respondent's failure to take further steps to physically identify the patient by looking at her arm bracelet, by looking at her face, or in some other manner recognizing the mistake that had been made by others in readying Patient A.G., and not Patient N.C. for surgery could be forgiven if there were no consequences, but there were. Although Respondent should not be the absolute guarantor in the identification of the patient, what he did in the operating room was not enough, when the result is that Respondent performed the LEEP conization that was not consented to in advance, and performed believing that the patient was N.C., the patient for whom the procedure was intended, and was not in response to an emergency regardless of patient identity. As a result, Respondent failed to meet the standard of care for reasonably prudent similar physicians under acceptable similar conditions and circumstances in his actions. In mitigation, the outcome was not harmful to the patient. Moreover, other health care professionals were in great measure responsible for the failure to properly identify the patient.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes, and imposing a $1,000.00 administrative fine and costs of investigation and prosecution. DONE AND ENTERED this 8th day of November, 2002, in Tallahassee, Leon County, Florida. 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 8th day of November, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Kim Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 David W. Moye, Esquire Linda Loomis Shelley, Esquire Fowler, White, Boggs and Banker, P.A. Post Office Box 11240 Tallahassee, Florida 32302 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 The issues for determination are whether Petitioner should have changed the status of Respondent's license from standard to conditional; and whether Petitioner should impose administrative fines of $7,500 and recover costs for alleged deficiencies in the care of four residents of a nursing home.
Findings Of Fact Petitioner is the state agency responsible for licensing and regulating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes (2003). Respondent is licensed to operate a 150-bed nursing home located at 2916 Habana Way, Tampa, Florida 33614 (the facility). Respondent admitted Resident 1 to the facility on March 9, 2001. The admitting diagnoses included tracheal bronchitis, diabetes mellitus, morbid obesity, and acute respiratory failure. From the time Resident 1 entered the facility until her death, Resident 1 lived with a tracheal tube in place. Resident 1 died on March 4, 2003, at 10:20 a.m. in the emergency room at St. Joseph's Hospital in Tampa, Florida. The tracheal tube of Resident 1 was completely occluded with hardened secretions when Resident 1 arrived at the hospital. The emergency room (ER) physician that treated Resident 1 testified by deposition. The ER physician diagnosed Resident 1 with respiratory arrest and death. However, the diagnosis is merely a clinical impression and is not a medical determination of the cause of death. No certain cause of death could be determined without an autopsy, and no one performed an autopsy on Resident 1. The diagnosis made by the ER physician is a clinical impression that is an educated guess. The respiratory arrest suffered by Resident 1 could have been precipitated by various causes including an occluded tracheal tube, a heart attack, or acute respiratory failure. The ER physician did not determine that the facility committed any negligence and found no evidence of negligence. The ER nurse who assisted the ER physician believed that the facility had been negligent in clearing the tracheal tube of Resident 1. The ER nurse suspected that secretions had been accumulating in the tracheal tube for several days and that the facility did not monitor or clean the tube because the tube was completely occluded when Resident 1 arrived at the hospital. The ER nurse notified Petitioner of her suspicions. On March 11, 2003, Petitioner conducted a complaint investigation of the facility in connection with the death of Resident 1. Petitioner determined that Respondent either had not assessed whether Resident 1 was capable of performing her own tracheal tube care; or had not monitored the respiratory status of Resident 1 between March 2 and March 4, 2003; or both. Petitioner determined that the alleged failure to assess and monitor Resident 1 violated 42 CFR Section 483.25(k)(4) and (5). Florida Administrative Code Rule 59A- 4.1288 applies the federal standard to nursing homes in Florida. 42 CFR Section 483.25(k)(4) and (5) requires Respondent to "ensure that residents receive proper treatment and care for . . . tracheostomy care (sic) . . . [and] tracheal suctioning." Petitioner assigned the charged deficiency a severity rating of class "II." In relevant part, Section 400.23(8)(b), Florida Statutes (2003), defines a Class II deficiency as one that has: compromised the resident's ability to maintain or reach his or her highest practicable physical, mental and psychosocial well-being, as defined by an accurate and comprehensive assessment, plan of care, and provision of services. Petitioner determined that a Class II rating was appropriate because the facility's alleged failure to provide Resident 1 with appropriate tracheal tube care harmed Resident 1. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective March 11, 2003, when Petitioner completed the complaint survey of the facility. The Conditional rating continued until April 10, 2003, when Petitioner changed the rating to Standard. Petitioner also proposed an administrative fine of $2500 pursuant to Section 400.23(8)(b), Florida Statutes (2003). The preponderance of evidence shows, by various measures, that Respondent provided Resident 1 with proper treatment and care for her tracheotomy tube within the meaning of 42 CFR Section 483.25(k)(4) and (5). First, it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. It is more likely that secretions coughed up will block the tracheal tube immediately. Second, the emergency medical team (EMT) that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. Rather, EMT personnel administered oxygen through the existing tube. Third, Resident 1 had normal oxygen saturation levels on March 2, 2003. Finally, Resident 1 was experienced in maintaining her tracheal tube, was capable of clearing her own tube, and asked members of the nursing staff to clear the tube whenever Resident 1 needed assistance. On March 4, 2003, Resident 1 complained of shortness of breath rather than a blocked tracheal tube. The ER physician's testimony shows it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. The ER nurse that suspected secretions had been accumulating in the tracheal tube of Resident 1 for several days had no experience caring for nursing home residents with tracheal tubes. Gradual accumulations of secretions in a tracheal tube are generally associated with a productive cough from causes such as infiltrated pneumonia. There is no evidence that Resident 1 had such a condition. It is more likely that any material Resident 1 coughed up would have occluded the tracheal tube immediately rather than accumulating over time. EMT personnel that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. When EMT personnel arrived at the facility, Resident 1 was non- responsive. When confronted with a non-responsive patient, standard protocol requires EMT personnel to ensure an open airway. EMT personnel placed an oxygen "bag" over the existing tube to provide Resident 1 with oxygen. EMT personnel then transported Resident 1 to the hospital emergency room. In the emergency room, the ER physician found the tracheal tube of Resident 1 to be completely blocked with hardened secretions. He removed the tube, replaced it with an open tube, and unsuccessfully attempted to ventilate Resident 1. It is likely the hardened secretions found in the tracheal tube at the emergency room blocked the tube between the time EMT personnel administered oxygen to Resident 1 at the facility and the time the treating physician removed the tracheal tube in the emergency room. A contrary finding would require the trier of fact to speculate that EMT personnel found the tracheal tube to be blocked and administered oxygen to a closed tube; or incorrectly diagnosed Resident 1 with a clear tracheal tube before administering oxygen. There is less than a preponderance of evidence to support either finding. Sudden deposits of hardened secretions in the tracheal tube of Resident 1 are consistent with medical experience. A person with a tracheal tube may develop calcified secretions in their lung known as concretions that can be coughed into the tube and cause it to become instantly blocked. It is unlikely that the hardened secretions found in the tracheal tube at the emergency room were present before Resident 1 collapsed in the facility. Hardened secretions can be cleared with a suctioning device or by coughing them through the tube and out of the opening near the neck if the resident has sufficient muscle strength. Resident 1 was a cognitively alert, 40-year-old, and physically capable of cleaning her own tracheal tube with a suctioning device. Resident 1 also had sufficient muscle strength to cough some secretions through the opening in her tube. Whenever Resident 1 was unable to clear her tube through the suctioning device or by coughing, she became anxious and immediately notified a nurse, who would then suction the tube and clear it for her. On March 2, 2003, Resident 1 complained to a nurse that she was experiencing shortness of breath. Significantly, Resident 1 did not complain that her tracheal tube was blocked. The nurse on duty at the facility notified the treating physician of Resident 1's complaints, and the physician ordered the nurse to measure the oxygen saturation levels of Resident 1. The oxygen saturation levels were within normal range, at 97 percent. The treating physician then ordered bed rest for Resident 1 and ordered the nurse to give Resident 1 a breathing treatment. Resident 1 had no further problems on March 2, 2003. On March 4, 2003, at approximately 9:30 a.m., Resident 1 summoned a nurse to come to her bedside and told the nurse that she did not feel well. Resident 1 did not complain that her tracheal tube was blocked. Her skin color was gray. She then passed out and fell to the floor. Nursing staff immediately called for EMT assistance, and EMT personnel arrived at the facility at approximately 9:32 a.m. EMT personnel transported Resident 1 to the emergency room at approximately 9:52 a.m. Between March 2 and March 4, 2003, the preponderance of evidence shows that the tracheal tube of Resident 1 was clear. Nursing staff at the facility monitored Resident 1 three times on March 3, 2003. Resident 1 had no breathing difficulties and did not express any complaints or discomfort. Resident 1 took her scheduled medications and meals on March 3, 2003. The nurse on duty during the 11 p.m. to 7 a.m. shift for March 4, 2003, provided oxygen and suctioning, "as needed," to Resident 1. This action would have cleared secretions, if any, that would have been "accumulating" in the tracheal tube of Resident 1. Resident 1 placed her finger over the opening to her tracheal tube when she spoke to the nurse about not feeling well on March 4, 2003. Resident 1 covered her tracheal tube to force air around her vocal cords so that the nurse could hear Resident 1. It would not have been necessary for Resident 1 to cover her tracheal tube if the tube were occluded. The findings in paragraphs 25 through 27 are based on notes prepared by the unit manager on March 4, 2003, in response to the directive of the facility's risk manager. The risk manager was responsible for investigating the incident and required all nurses who had contact with Resident 1 on March 3 and 4, 2003, to document their experiences with Resident 1. The unit manager then placed the accounts in the medical record. Petitioner questions the credibility of the unit manager notes because they are late-filed entries in the medical records. The trier of fact finds the unit manager and her notes to be credible and persuasive. The testimony and notes of the unit manager are consistent with the apparent determination by EMT personnel that the tracheal tube was clear. In addition, the Medication Administration Record for March 4, 2003, indicates that Resident 1 received a dose of an ordered medication at 6:00 a.m. and did not complain of not feeling well until some time later. If the notes and testimony of the unit manager were disregarded, the trier of fact cannot ignore the administration of oxygen by EMT personnel. The preponderance of evidence shows that the tracheal tube of Resident 1 was clear when EMT personnel administered oxygen. If it were determined that the tracheal tube of Resident 1 were fully occluded at the facility before Resident 1 collapsed on March 4, 2003, such a finding would alter the outcome of this case. Petitioner failed to show by a preponderance of evidence that an occlusion occurred as a consequence of inadequate assessment or monitoring. Resident 1 had normal oxygen saturation levels on March 2, 2003. The preponderance of evidence does not show that facility staff had reason to believe that the tracheal tube of Resident 1 was occluded after March 2, 2003, and failed to take action to clean the tube prior to the time Resident 1 collapsed on March 4, 2003. There is no preprinted or accepted assessment form for nursing homes to use to assess and monitor the ability of Resident 1 to clean her own tracheal tube. The parties agree that the process involves nothing more than a simple observation of Resident 1 to confirm that she understood and could clean the tracheal tube either by suctioning or coughing. Resident 1 was capable of cleaning her tracheal tube. Relevant orders from the treating physician did not require cleaning to be performed by facility staff. One physician's order indicated that Resident 1 could participate in her own self-care. Another physician's order indicated that Resident 1 was to have "trach care" three times a day, but did not describe the nature and scope of the care or designate who was to provide such care. Another physician's order indicated that Resident 1 was to receive oxygen through her tracheal collar while in bed and "suction trach as needed." However, nothing in the order indicated who was to provide those services. Resident 1 had her tracheal tube for more than a year prior to March 4, 2003. Facility staff routinely observed Resident 1 successfully suctioning and otherwise cleaning her own tracheal tube. Resident 1 also routinely notified staff when she could not remove a blockage in her tube. Facility staff appropriately determined that Resident 1 was capable of performing self-care on her tracheal tube. It was appropriate for facility staff to rely on Resident 1 to inform them if Resident 1 were unable to clean the tube. Her transfer to the hospital on March 4th and her subsequent death were not the product of any inadequate or erroneous assessment or monitoring of Resident 1. On May 12, 2003, Petitioner conducted another complaint investigation of the facility. Petitioner determined that Respondent failed to provide adequate care for pressure sores for three residents identified in the record as Residents 1A, 4, and 5, in violation of 42 CFR Section 483.25(c). Florida Administrative Code Rule 59A-4.1288 applies the federal requirements for pressure sore care to nursing homes in Florida. Petitioner assigned the charged deficiency a class II rating. Petitioner determined that a Class II rating was appropriate because actual harm or a negative outcome allegedly occurred with each of the residents cited in the deficiency. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective May 12, 2003, and continued until June 16, 2003, when Petitioner changed the rating to Standard. Petitioner also proposes a $5,000 fine against Respondent. The fine is calculated by doubling the prescribed fine of $2,500, based on the alleged deficiency in the survey conducted on March 11, 2003, in accordance with Section 400.23(8)(b), Florida Statutes (2003). For reasons stated in previous findings, Respondent committed no violation in connection with the survey conducted on March 11, 2003. The fine for the alleged deficiency found on May 12, 2003, cannot exceed $2,500. Petitioner alleges that the pressure sore care provided by Respondent for Residents 1A, 4, and 5 violated 42 CFR Section 483.25(c). In relevant part, 42 CFR Section 483.25(c) requires a nursing home to ensure that: resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 CFR Section 483.25(c) Petitioner alleges that Respondent failed to provide Resident 1A with necessary treatment and services to promote healing of an existing pressure sore on the coccyx of Resident 1A. Resident 1A acquired the pressure sore before Respondent admitted Resident 1A to the facility. In April 2003, Resident 1A had surgery to cover the pressure sore with a skin graft taken from her thigh. The surgery required approximately sixty staples to secure the graft. The alleged improper care of Resident 1A is based on several observations made by the surveyor on May 12, 2003. The surveyor observed that the staples used in the surgical process had not been removed even though a physician's order dated April 16, 2003, directed staff to set up an appointment with the plastic surgeon within two weeks of the date of the order. The surveyor found no evidence that staff had scheduled an appointment or taken any other steps to remove the staples. The surveyor observed that the skin was reddened and growing over some of the areas around the staples. The surveyor also observed Resident 1A positioned on her back in bed in such a manner that her weight was on her coccyx area. The area in question was not a pressure sore. Petitioner has adopted a written definition of a pressure sore in the guidelines that Petitioner requires its surveyors to use in interpreting the federal regulation at issue. In relevant part, the guidelines define a pressure sore as: . . . ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or sheer. If the area of concern were the area over the coccyx of Resident 1A, that area would have been over a "bony prominence" within the meaning of definition of a pressure sore. However, it is undisputed that the area of concern for Resident 1A was located in the fleshy part of the buttocks where staples were used to secure the skin flap to the skin. The area of concern was a surgical wound site, rather than a pressure sore because of its origin and location. The preponderance of evidence shows that the area of concern failed to satisfy the definition of a pressure sore adopted by Petitioner. Section 120.68(7)(e), Florida Statutes (2003), prohibits Petitioner from deviating from its officially stated policy unless Petitioner explains the deviation. Petitioner failed to provide any evidence to explicate legitimate reasons for deviating from its written definition of a pressure sore in this case. Assuming arguendo the staples around the wound site were a pressure sore, the preponderance of evidence shows that Respondent provided necessary treatment to promote healing. Respondent turned and repositioned Resident 1A every two hours in accordance with standard protocol. That schedule included a period during which Resident 1A was on her back in bed, with the head of her bed elevated. The single observation by the surveyor of Resident 1A on her back in bed did not show that Respondent failed to properly turn and reposition Resident 1A. The failure to timely comply with the physician's order for Resident 1A to consult with a plastic surgeon did not deprive Resident 1A of the care necessary to promote healing of a pressure sore. The removal of staples from a skin flap is not an element of required care for a pressure sore. Rather, removal of staples is part of the established care for a surgical wound site. The failure to timely provide a consult was not a violation of the requirements for care of pressure sores. If the removal of staples were required for treatment of pressure sores, the failure to timely obtain a consult and the failure to timely remove the staples did not cause harm to Resident 1A. The undisputed purpose of the physician's order to see a plastic surgeon was to evaluate whether the staples should be removed from the wound site. Respondent removed the staples from the wound site shortly after the survey with no complications to the resident. The surgical wound site healed in a timely and complete manner. The absence of harm to Resident 1A precludes a rating as a Class II deficiency. Petitioner alleges that Respondent allowed avoidable pressure sores to develop on Resident 4 and failed to provide necessary treatment after the pressure sores developed. During the survey, the surveyor and a nurse, who was a clinical consultant to the facility, twice observed Resident 4 lying on a special air mattress that was not inflated. After the second observation, the surveyor and consultant examined Resident 4 and observed what each determined to be two stage II pressure sores on each of the outer heels of Resident 4, a stage IV pressure sore on the right toe, two stage II areas on her left side above her rib cage, and a stage II area under her left breast. The surveyor and the nurse-consultant found nothing in the medical record to indicate that these areas had been previously identified by facility staff. Nor did they find any treatment orders for the areas of concern. The areas of concern were not pressure sores. It is undisputed that pressure sores involve deep tissue damage, do not heal quickly, and would have been present a few days later during examination. The director of nursing and the wound care nurse for the facility examined Resident 4 on May 13, 2003, and found no evidence of the areas that caused concern to the surveyor and nurse-consultant on May 12, 2003. The director of nursing asked the treating physician to examine Resident 4 to confirm the director's observations. On May 19, 2003, the treating physician examined Resident 4 and found no areas of concern on Resident 4. Resident 4 had no conditions that placed her at risk for developing pressure sores. The failure to inflate the special air mattress under Resident 4 did not create any risk for pressure sores. The mattress had not been ordered for Resident 4 and was not necessary for her care because Resident 4 was not at risk for developing pressure sores. Resident 4 was on the mattress because she had moved into a new room, and facility staff had not yet removed the mattress from the bed in the room that was used by the previous occupant. Petitioner alleges that Respondent failed to provide necessary treatment to promote healing of existing pressure sores on Resident 5. Resident 5 had three open areas on his skin: one on each hip and one over the coccyx. The areas on each hip were surgical wounds from hip surgeries prior to admission to the facility. For reasons stated in previous findings, these areas were surgical wound sites and were not pressure sores. It is undisputed that the remaining area on Resident 5 was a stage II pressure sore over the coccyx that was present upon admission to the facility. During the survey, the surveyor and the nurse-consultant observed Resident 5 on a specialty air mattress that contained a number of air chambers. Two of the chambers were not inflated. The surveyor and nurse-consultant determined that the area over the coccyx had worsened to a stage IV pressure sore. Petitioner alleges that Respondent failed to provide necessary care to Resident 5 by failing to properly inflate his specialty air mattress during the survey. Respondent did not fail to properly inflate the air mattress for Resident 5. The level of inflation of that mattress is not determined or set by the facility. Rather, the manufacturer calculates and sets the level of inflation for the mattress. The alleged failure to properly inflate the air mattress did not cause harm to Resident 5. The director of nursing observed the area of concern the day after the survey and determined it to be a stage II, rather than a stage IV, pressure sore. The clinical records that charted the size and stage of the pressure sore for the month after the survey show that the area was never more than a stage II pressure sore. A stage IV pressure sore would not have improved to a stage II sore within a month. Petitioner failed to show by a preponderance of the evidence that the alleged improper inflation of an air mattress caused the pressure sore on Resident 5 to worsen from a Stage II to a Stage IV pressure sore.
Recommendation Based on the foregoing findings of fact and conclusions of law, It is RECOMMENDED that Petitioner enter a Final Order deleting the disputed deficiencies from the survey reports for March 11 and May 12, 2003; replacing the Conditional ratings with Standard ratings; and dismissing the proposed fines and investigative costs with prejudice. DONE AND ENTERED this 2nd day of March, 2004, in Tallahassee, Leon County, Florida. S DANIEL MANRY 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 2nd day of March, 2004. COPIES FURNISHED: Gerald L. Pickett, Esquire Agency for Health Care Administration Sebring Building, Suite 330K 525 Mirror Lake Drive, North St. Petersburg, Florida 33701 Donna Holshouser Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300 R. Davis Thomas, Jr. Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302-1300 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308
The Issue Whether the Respondent committed the acts alleged in the administrative complaint contrary to Section 458.331(1)(t), Florida Statutes.
Findings Of Fact (Stipulated) The Respondent is and was at all times material to the allegations a licensed physician in Florida, holding license number ME 0050839 issued by the state. The Respondent was a board certified internist and board certified cardiologist practicing with Diagnostic Cardiology Associates at St. Vincent's Medical Center (St. Vincent's) at the time of the events which gave rise to these allegations. On or about June 25, 1988, W.V., referred to in the complaint as Patient #1, was admitted to St. Augustine General Hospital in St. Augustine, Florida. W.V. was a 68 year old male with a history of heart problems including four bypasses performed in 1977, a pacemaker implantation in 1979, chronic obstructive pulmonary disease, and prior prostate surgery. W.V. was determined to have had an acute myocardial infarction for which he was treated at St. Augustine General Hospital for five days. As W.V.'s condition improved, he was encouraged to walk at St. Augustine where he complained of chest pain and weakness. A echocardiogram showed segmental wall motion disturbance involving the posterior wall of the heart. A second electrocardiogram was performed which showed ventricular pacemaker rhythm and ST-T wave changes. On this basis, given his history and myocardial infarction, he was referred for a cardiac catheterization to St. Vincent's where his earlier heart surgeries had been performed. The patient was monitored during his hospitalization in St. Augustine, and did not show any signs of arrhythmias. On June 30, 1988, W.V. was transferred to St. Vincent's and received through the Emergency Room, where he was interviewed by the Respondent. After giving the Respondent a brief outline of his problems, W.V. was placed on a general medical floor for the evening, and scheduled for cardiac catheterization the following day. Cardiac catheterization and its risks were explained to W.V., who signed the patient consent forms authorizing the procedure. On the morning of July 1, 1988, after examining the patient and finding no changes, the Respondent performed on W.V. a cardiac catheterization, which verified the recent acute myocardial infarction, the blockage of two of the bypasses, damage to the heart muscle serving the lungs, and high vascular resistance with severe pulmonary hypertension. The patient tolerated the procedure well and showed no signs of arrhythmias during or after the procedure. The test results indicated that he could not benefit from surgery or angioplasty. W.V.'s primary health threat was from congestive heart failure, a condition likened to drowning in one's own fluids. (Tx-129, line 1.) A patient suffering from congestive heart failure will call for assistance from the nursing staff, as one of the expert's phrased it, "he would have been crawling out the door on his hands and knees calling for the nurse." (See Dr. Gilmore, Tx-130, line 8.) Conversely, heart failure alone would not have caused the patient to have chest pains, unless the patient developed elevated pressures to the point where pulmonary hypotension caused chest pain. However, the chest pain in such a case is not caused by clogged arteries or an impending heart attack, but by build up of fluid in the lungs which causes the heart to work harder to pump the blood through the lungs. (Dr. Campbell, Tx- 107, line 16.) The Respondent's post-catheterization order initially directed that W.V. be moved to a monitored bed following the procedure. The purpose of monitoring a patient is to observe, document and ultimately treat cardiac rhythm disturbances. (Dr. Gilmore, Tx-117,line 6.) Approximately 75 percent of post- catheterization patients were placed on telemetric monitoring (monitoring or telemetry hereafter). Monitored beds existed on 3 East (eight monitored beds), 5 East (eight monitored beds), Coronary Care Unit (eight monitored beds), Intensive Care Unit (12 monitored beds), and open heart unit which, although monitored, would not take catheterization patients. Notwithstanding the number of monitored beds, the critical piece of equipment is the monitor because each room on a monitoring unit was set up to receive telemetry. The monitor is a small radio transmitter that relays information from leads attached to the patient to receivers in each room. The monitors are removed by patients upon discharge, thrown into the laundry, and into the trash. They also require repair. As a result, the actual number of monitors varied from the planned number of monitored beds. Upon completion of the catheterization, the catheterization nurse would advise the nurse in charge of placing patients that the cardiac catheterization patient was ready for admission to the hospital, and whether the doctor had ordered a monitored or unmonitored bed. If the doctor had ordered a monitored bed and one was not available, the placement nurse would ask the admitting physician whether the patient being admitted really needed monitoring given the critical number of monitored beds available and the necessity to poll the treating physicians of all the monitored patients to see if any could be taken off monitoring. Inferentially, the Respondent considered the status of his other patients who were being monitored. If the physician deemed the patient's need for monitoring critical, then the placement nurse would poll the physicians of all other monitored patients, and request that they reassess the needs of their patients on monitoring. (See Lipsky Deposition, Page 26) The unit which normally received post-catheterization patients, 5 East, had eight monitored beds and eight unmonitored beds which were used as "stepdown" beds for patients taken off monitoring so that the monitors could be changed, but the patient retained in the same bed. Not only were all the monitored beds occupied on 5 East, the post-catheterization unit, but that unit had almost a full census. (See Lipsky Deposition, Page 20 - Page 26) The hospital's procedures required cardiac catheterization patients to remain in the catheterization laboratory until a monitored bed was available if the doctor stated that the patient was to go to a monitored bed. The catheterization patient would be held in the catheterization laboratory where there was a shortage of nursing care until a bed was found. Contrary to the experts' testimony which presumed the authority of the Respondent to place the patient in a monitored bed, it was the placement nurse who placed the patient once the doctor ordered a monitored bed post-catheterization. No evidence was received regarding her authority to place patients requiring monitoring in the ICU or CICU. Typically, doctors reassessed their patients' need for monitoring during morning rounds, and those that were stable were removed from monitoring so the monitor became available for a more critical patient. (See Libsky deposition, Page 24, line 20) W.V. catheterization was completed at approximately 11:00 a.m., following morning rounds when a maximum number of monitors should have been available; however, no evidence was received when a monitor would have been available. Testimony revealed that the wait could be as long as two hours for a monitored bed. During that time, under hospital protocols, W.V. would have remained in the catheterization lab. Contrary to facts assumed by the Petitioner's experts, the Respondent's options for placing the patient were: to place the patient in an unmonitored bed on the cardiac floor, or to retain the patient in a monitored bed in the holding area where he would be monitored by the cardiac catheterization nurse until the patient placement nurse found a monitored bed. The Respondent did not retain the patient in the cardiac catheterization area because the nurses could not adequately monitor W.V. and perform their other duties. The Respondent did not place W.V. in the Cardiac Care Unit or the regular Intensive Care Unit to obtain monitoring because it was not his function to place the patient. The only way he could have placed W.V. in CICU or ICU would have been to change W.V.'s status to justify the overall intensive care of the patient. However, this would have been unsupportable if questioned given the patient's condition which was stable upon admission six days after the myocardial infarction, and remained stable after the procedure. See Dr. Edwards Depostion, Page 41, line 19 et seq. Staffing levels on 5 East at the time of W.V.'s hospitalization were one nurse to four or five patients. There were five nurses, a charge nurse, and nursing assistant, and 22 beds on the unit. (See Lipsky Deposition, Page 72, line 15.) The Hospital's Standing Order 01-009 provided that "The critical care nurse, in consultation with the charge nurse, may initiate the following (list of nursing interventions) and notify the physician as soon as possible in the event of an acute deterioration [of] patient status and in the absence of a physician." (See Burnsed Deposition, Page 112, line 4) The Hospital Standing Order 01-017 provided "Any changes in the patient's condition will be called to the attention of the attending physician and appropriate consulting physicians. The emergency standing orders may be initiated by the nursing staff, but the physician must be informed of their use." (See Burnsed Deposition, Page 113, line 10) The Respondent placed the patient on 5 East, the cardiac care floor, in an unmonitored bed at approximately 11:50 a.m., as indicated by the notation on the patient's chart "nonmonitored," which indicated a change from the initial orders. (See Cavin Deposition, Page 34, line 7 and Page 35, line 7 et seq.) There was no order that W.V. should not be resuscitated. The Respondent's standing orders called for the patient's vital signs, together with shortness of breath and chest pain, to be monitored every 15 minutes for four hours. This was done until 3:15 p.m., when the monitoring was reduced to every 30 minutes. The Respondent advised the cardiac catheterization nurse, Mary Cavin, who accompanied the patient to the floor, of his findings, to include evidence of a recent myocardial infarction, and the patient's response to the procedure. (See Cavin Deposition, Page 19-20) Ms. Cavin identified her handwriting on the charts describing the Respondent's findings. However, these notes do not mention the recent myocardial infarction. The referenced notes were not sufficiently identified to check in the patient's charts. W.V. was taken to 5 East by Mary Cavin. Ms. Cavin had worked in this area at St. Vincent's for three years. Cardiac catheterization nurses were described by one of the experts as being among the best trained nurses in the profession, who because they work with the medical staff continuously during the procedures, are aware of the physician's findings and the patient's status. They pass this information along to the floor nurses when they transport the patients back to the floor. Ms. Cavin did not remember specifically W.V., but testified in her deposition regarding her normal practice when delivering a patient. She advised the staff on 5 East how the patient did during the catheterization, and what the findings had been. However, as stated above, in Cavin's notes she did not mention the recent myocardial infarction, and it is unclear whether she mentioned this to the staff of 5 East. The record is unclear to whom Ms. Cavin reported W.V.'s condition; however, Ms. Burnsed received a report on W.V. when she came on duty from Carolyn Johnson, the nurse who had cared for W.V. on the preceding shift. Ms. Burnsed was advised by Ms. Johnson that W.V. was stable post-catheterization, that he had previous open heart surgery, and that one of his grafts was blocked, but "had good collateral circulation to that." Further, Johnson advised Burnsed that W.V.'s vital signs were good, and he had no problems. Johnson did not mention the recent myocardial infarction suffered by W.V. Although Ms. Burnsed could not specifically remember her actions, her general course of action was to do a complete assessment upon starting the shift, make sure her patients were all right and having no problems, and orient them about the call light and calling her. Her physical assessment of W.V. revealed an apical heart rate of 72, respiration 18, and blood pressure of 100/70. W.V.'s vital signs were monitored by the staff of 5 East every 15 minutes as ordered by the Respondent until 3:15 p.m., when this was reduced to every 30 minutes. At 5:00 p.m., the Respondent saw W.V., who had no complaints and was stable. Ms. Burnsed found W.V. up going to the bathroom at 5:30 p.m., and got him back into bed explaining that it was important that he stay in bed because of his incision for at least 24 hours. Ms. Burnsed checked W.V.'s incision, and found that it was not bleeding at that time. At 7:00 p.m., Ms. Burnsed administered Lasix to W.V., and W.V. asked for and was provided sleeping medication at 9:00 p.m., at which time, Ms. Burnsed took W.V.'s vital signs which were essentially unchanged and stable. At 9:20 p.m. the patient's charts reflect that he was complaining of mild shortness of breath (SOB), and pains in his chest. Pursuant to the Respondent's orders, Ms. Burnsed administered nitroglycerin, 150 grains times one, after checking his blood pressure to insure it was within limits for the administration of nitroglycerine, and oxygen via nasal cannula, two liters, pursuant to emergency orders. This relieved the patient's symptoms. Ms. Burnsed did not report to the Respondent that W.V. had suffered mild shortness of breath and chest pain because the nitroglycerin and oxygen relieved his symptoms. The decision to notify or not to notify the treating physician was described as a nursing judgment based upon the nurse's assessment of the patient's condition after being medicated and placed upon oxygen. (See Lipsky Deposition, Page 56, line 8 et seq.) Ms. Burnsed did not consider the patient's condition to have deteriorated given his response to the medication, and did not notify the Respondent. Subsequent to administering the nitroglycerin and oxygen, Ms. Burnsed spoke with W.V.'s wife on the telephone. It is intimated in the depositions that Mrs. W.V. called to advise that her husband had called complaining of shortness of breath and chest pains and an inability to get anyone to assist him; however, no evidence was submitted regarding the content of the conversation between Ms. Burnsed and Mrs. W.V. Five to ten minutes after speaking with W.V.'s wife, Ms. Burnsed returned to W.V.'s room, where she found him resting in bed without complaint. W.V. stated that he wanted to go to sleep. Ms. Burnsed did not remember checking his vital signs on this second visit, and it is most probable that she did not because he was trying to go to sleep. Ms. Burnsed checked W.V. at 10:10 p.m., and found he was not breathing, had no pulse, and was unresponsive. The Cardiac Resuscitation Team was called, and responded. Despite their efforts, W.V. was pronounced dead at 10:50 p.m. Although a partial autopsy was performed which confirmed the findings of the catheterization and the diagnosis of a recent myocardial infarction, the cause of death was not precisely determined. It was assumed by the experts that W.V. did not die of congestive heart failure because he would have complained more. Therefore, the experts concluded that his death was relatively sudden, most probably brought on by an arrhythmia or perhaps a stroke. There was a suggestion that the Respondent did not put W.V. on a monitor because he had a pacemaker. While patients with pacemakers are at no less risk of developing arrhythmias than patients without pacemakers, there was no evidence that this was a consideration of Respondent in placing the patient on a cardiac floor following cardiac catheterization. It was general practice to place cardiac catheterization patients who exhibited signs of cardiac pathology on telemetry for 24 hours following the procedure. The initial orders of the Respondent were consistent with this practice. Testimony was received from the Petitioner's experts was that the Respondent's care was substandard because he did not place the patient on monitoring as they would have done by placing the patient in the emergency room, or the intensive care unit, or the cardiac intensive care unit to obtain telemetry monitoring, or retain the patient in the cardiac catheterization area pending the availability of a monitored bed. Their assumptions regarding the doctor's authority were inconsistent with the procedure for placing patients at St. Vincent's which was the function of the placement nurse. The Petitioner's experts also testified that placing a patient on telemetry notified the nursing staff that the patient required special attention. The Respondent's witnesses were more credible in stating that placing a patient on telemetry was not the way to indicate to nursing staff that the patient required special attention. The testimony of Respondent's witnesses that intensive care personnel were not as well trained as personnel on the cardiac floor to deal with cardiac emergencies is not credible. Both groups of personnel, if not equally versed in cardiac care, are sufficiently skilled in steps to be taken in the event of a cardiac emergency that there would be no appreciable difference in the care provided. Placing the patient in the regular intensive care unit or the cardiac intensive care unit would have required changing the patient's medical status be changed, and there was no change in the patient's condition which would have warranted the change. The patient was extremely ill upon admission, and his prognosis was very poor. W.V. was going to die because of his cardiac condition and chronic pulmonary congestion unless he had a stroke. His condition was irreversible in the opinions of the various experts; however, he would have been released the day following the catherization and treated medically for his problems. The Petitioner's experts opined that the Respondent's decision not to place W.V. in a monitored bed was substandard care because they felt that there was an ethical duty to monitor the patient in the absence of orders directing that efforts not be made to resuscitate notwithstanding the dismal chances for success. Their opinion assumed the Respondent could direct the placement of the patient in a monitored bed on a specific unit within a relatively short period of time because of all the monitored beds in the hospital. The Respondent's experts opined that the decision not to monitor W.V. was within the acceptable standards of medical care by physicians under similar circumstances, i.e., retain the patient in the catherization laboratory where nursing care would have been inadequate pending availability of a monitored bed for up to two hours. Their opinion considered the circumstances at St. Vincent's, and is deemed more credible.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the charges against the Respondent be dismissed. DONE and ENTERED this 2nd day of June, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1995. APPENDIX The parties filed proposed findings of fact which were read and considered. The following states which of those findings were adopted, and which were rejected and why: Petitioner's Recommended Order Findings Paragraph 1-3 Paragraph 1-3. Paragraph 4 Paragraph 5. Paragraph 5 Paragraph 3. Paragraph 6 Paragraph 6. Paragraph 7 While true, this finding is unnecessary to a consideration of the issues. Paragraph 8 Paragraph 7. Paragraph 9 Paragraph 9. Paragraph 10 Paragraph 32. Paragraph 11 Subsumed in Paragraph 37. Paragraph 12 Subsumed in Paragraph 38,39. Paragraph 13 Rejected as contrary to more credible evidence. Paragraph 14 If arrythmias were undetected, they would have been irrelevant to consideration of the patient's condition. Paragraph 15 Subsumed in Paragraph 9. Paragraph 16 Paragraph 46. Paragraph 17 Subsumed in Paragraph 9. Paragraph 18 Contrary to more credible evidence; See Parag 48. Paragraph 19 Rejected at Paragraph 43. Paragraph 20 Rejected at Paragraph 40. Paragraph 21 Rejected as contrary to more credible evidence; See Paragraph 12. Paragraph 22 Accurately states the expert's credentials, but is not relevant to consideration of the issues. Paragraph 23 Rejected as contrary to more credible evidence; See Paragraphs 42 and 47. Paragraph 24 Subsumed in Paragraphs 9,12,47-49. Paragraph 25 Rejected at Paragraph 16. Paragraph 26 See comments to Paragraph 22. Paragraph 27 See comments to Paragraph 23. Paragraph 28 While the may have been a national standard of care, there was not a national set of circumstances which impact the issue of whether the Respondent adhered to the appropriate standard of care. Paragraph 29 Subsumed in Paragraph 47. Paragraph 30 Subsumed in Paragraph 24. Paragraph 31 Subsumed in Paragraph 9. Respondent's Recommended Order Findings Paragraph 1 Paragraph 4,5. Paragraph 2,3 Paragraph 6. Paragraph 4 Paragraph 6,4. Paragraph 5 Paragraph 9. Paragraph 6 Rejected as contrary to most credible evidence; See Paragraphs 12-14. Paragraph 7-10 Subsumed in Paragraphs 17-19. Paragraph 11 Accurate; however, the patient was stable upon admission. Paragraph 12 Subsumed in Paragraph 46. Paragraph 13 Paragraph 46. Paragraph 14 Paragraph 24. Paragraph 15 Subsumed in Paragraph 25-28. Paragraph 16 Paragraph 24. Paragraph 17 Paragraph 31. Paragraph 18 Subsumed in Paragraph 33. Paragraph 19 Paragraph 37. Paragraph 20 Subsumed in Paragraph 46. Paragraph 21 Paragraph 38,48. COPIES FURNISHED: Hugh R. Brown, Esq. Agency for Health Care Administration 1940 N. Monroe St. Tallahassee, FL 32399-0792 Michael J. Obringer, Esq. Osborne, McNatt, Shaw, et al One Enterprise Center 225 Water St., Ste. 400 Jacksonville, FL 32202-5147 Marm Harris, M.D. Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esq. Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Petitioner, Mease Health Care, Inc. (Mease), is a private, not-for- profit acute care community hospital in Dunedin, Florida. It is located in District V, a health planning district established by respondent, Department of Health and Rehabilitative Services (HRS). Intervenors, Morton F. Plant Hospital, Inc. (Plant) and Bayfront Medical Center, Inc. (Bayfront), are acute care hospitals also located within District V. Mease has pending in Case Nos. 89-1652 and 89-4888 a challenge to HRS's fixed need pool determination for new cardiac catherization services and an application for a certificate of need (CON) authorizing it to establish a new inpatient cardiac catherization program in Dunedin, Florida. In the instant case, Mease has challenged an HRS policy as being an illicit rule. Respondent is the state agency responsible for the administration of the Health Facility and Services Development Act. For the purpose of assisting it in administering the act, HRS has promulgated Rule 10-5.011(1)(e), Florida administrative Code (1989), which pertains to inpatient cardiac catherization services and defines the requirements for the establishment of such services. Paragraph 8.c. of the rule contains the formula used for calculating fixed need pools for new inpatient cardiac catherization programs. The formula is: NN PCCPV - ACCPV - APP, where NN is the annual net program volume need, PCCPV is the projected adult cardiac catherization program volume, ACCPV is the actual adult cardiac catherization volume, and APP is the projected program volume for approved programs. This formula was applied by HRS to the September 1988 batching cycle, which was the first batching cycle after the rule became effective. For that cycle, HRS calculated NN to be -53 for District V. NN was therefore less than 300. Paragraph 8.d. of the rule provides the following relevant instructions on how the formula should be applied to batching cycles subsequent to September 1988: If NN is less than 300 in the first batching cycle after the rule becomes effective, the ACCPV value which is subtracted from the PCCPV will be the same value as ACCPV in the first batching cycle until the projected net need in a future batching cycle reaches a program volume of 300 or more. . . For the March and September 1989 batching cycles, which were the two batching cycles immediately subsequent to the first batching cycle after the rule became effective, HRS did not keep the ACCPV value constant, "or the same . . . as in the first batching cycle", even though NN was "less than 300 in the first batching cycle." Put another way, in all batching cycles after September 1988 HRS has recalculated ACCPV even though in the first batching cycle NN was a negative number and therefore was less than 300. HRS's affidavit confirms that this is the manner in which ACCPV has been calculated in all cases since the adoption of the rule. Since the policy has been consistently used in the above manner in all cases, creates rights and requires compliance, and is not apparent from a literal reading of the rule, the policy necessarily constitutes a rule. There is no dispute that the policy has not been formally adopted as a rule.
