The Issue Whether Medicaid overpayments were made to Petitioner and, if so, what is the total amount of those overpayments.
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, including the parties' Joint Prehearing Stipulation, the following findings s of fact are made: Petitioner and his Practice Petitioner is a general practice physician. He has been licensed to practice medicine in Florida for the past ten years. He is now, and has been at all times material to the instant case, in private practice in Miami-Dade County, Florida Petitioner's Participation in the Medicaid Program During the Audit Period, Petitioner was authorized to provide physician services to eligible Medicaid patients. Petitioner provided such services pursuant to a valid provider agreement with AHCA.4 Petitioner's Medicaid provider number was, and remains, 3759873 00 Petitioner billed all of the Medicaid claims that are the subject of the instant controversy under this (individual) provider number. Handbook Provisions As a prerequisite to his entitlement to Medicaid payment for services rendered during the Audit Period, Petitioner was required to comply with, among other things, the provisions of the Physician Coverage and Limitations Handbook (PCL Handbook) then in effect. Medical Necessity Chapter 2 of the PCL Handbook provided that the Medicaid program would reimburse physician providers for services "determined [to be] medically necessary" and not duplicative of another provider's service, and it went on to state as follows: In addition, the services must meet the following criteria: the services must be individualized, specific, consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the recipient's needs; the services cannot be experimental or investigational; the services must reflect the level of services that can be safely furnished and for which no equally effective and more conservative or less costly treatment is available statewide; and the service must be furnished in a manner not primarily intended for the convenience of the recipient, the recipient's caretaker, or the provider. The fact that a provider has prescribed, recommended, or approved medical or allied care, goods, or services does not, in itself, make such care, goods or services medically necessary or a covered services. Radiology Services Chapter 2 of the PCL Handbook further provided that, "[t]o be reimbursed the maximum fee [or 'global fee'] for a radiology service, the physician must provide both the technical and professional components." A physician provider billing the "global fee" was not authorized, pursuant Chapter 2 of the PCL Handbook, to also seek additional payment for the "professional component" of that fee. Doing so amounted to impermissible "double-billing." Coding Chapter 3 of the PCL Handbook "describe[d] the procedure codes for the services reimbursable by Medicaid that [had to be] used by physicians providing services to eligible recipients." As explained on the first page of this chapter of the handbook: The procedure codes listed in this chapter [were] Health Care Financing Administration Common Procedure Coding System (HCPCS) Levels 1, 2 and 3. These [were] based on the Physician[]s['] Current Procedural Terminology (CPT) book. The CPT include[d] HCPCS descriptive terms and numeric identifying codes and modifiers for reporting services and procedures. . . . The Physicians' Current Procedural Terminology At all times material to the instant case, the American Medical Association's Physicians' Current Procedural Terminology (or the "CPT") referred to in Chapter 3 of the PCL Handbook contained an "[i]ntroduction," which read, in pertinent part, as follows: Current Procedural Terminology, Fourth Edition (CPT) is a systematic listing and coding of procedures and services performed by physicians. Each procedure or service is identified by a five digit code. . . . Inclusion of a descriptor and its associated specific five-digit identifying code number in CPT is generally based upon the procedure being consistent with contemporary medical practice and being performed by many physicians in clinical practice in multiple locations. . . . * * * Section Numbers and Their Sequences Evaluation and Management 99201 to 99499 * * * Surgery 10040 to 69979 Radiology (Including Nuclear Medicine and Diagnostic Ultrasound) 70010 to 79999 Pathology and Laboratory 80002 to 89399 Medicine (except Anesthesiology) 90701 to 99199 * * * The CPT had "[e]valuation and [m]anagement (E/M) [s]ervice [g]uidelines" (E/M Guidelines). It was noted on the first page of the E/M Guidelines that: The E/M section is divided into broad categories such as office visits, hospital visits, and consultations. Most of the categories are further divided into two or more subcategories of E/M services. For example, there are two subcategories of office visits (new patient and established patient) and there are two subcategories of hospital visits (initial and subsequent). The subcategories of the E/M services are further classified into levels of E/M services that are identified by specific codes. . . . "New and [e]stablished patient[s]" were described in the E/M Guidelines as follows: A new patient is one who has not received any professional services from the physician or another physician of the same specialty who belongs to the same group practice, within the past three years. An established patient is one who has received professional services from the physician or another physician of the same specialty who belongs to the same group practice, within the past three years. The concept of "[l]evels of E/M [s]ervices" was described, in pertinent part, as follows in the E/M Guidelines: Within each category or subcategory of E/M service, there are three to five levels of E/M services available for reporting purposes. Levels of E/M services are not interchangeable among the different categories of service. For example, the first level of E/M services in the subcategory of office visit, new patient, does not have the same definition as the first level of E/M services in the subcategory of office visit, established patient. The levels of E/M services include examinations, evaluations, treatments, conferences with or concerning patients, preventative pediatric and adult health supervision, and similar medical services, such as the determination of the need and/or location for appropriate care. Medical screening includes the history, examination, and medical decision-making required to determine the need and/or location for appropriate care and treatment of the patient (e.g., office and other outpatient setting, emergency department, nursing facility, etc.). The levels of E/M services encompass the wide variations in skill, effort, time, responsibility and medical knowledge required for the prevention or diagnosis and treatment of illness or injury and the promotion of optimal health. Each level of E/M services may be used by all physicians. The descriptors for the levels of E/M services recognize seven components, six of which are used in defining the levels of E/M services. These components are: history; examination; medical decision making; counseling; coordination of care; nature of presenting problem; and time. The first three of these components (history, examination and medical decision making) are considered the key components in selecting a level of E/M services. . . . The next three components (counseling, coordination of care, and the nature of the presenting problem) are considered contributory factors in the majority of encounters. . . . * * * The actual performance and/or interpretation of diagnostic tests/studies ordered during a patient encounter are not included in the levels of E/M services. Physician performance of diagnostic tests for which specific CPT codes are available may be reported separately, in addition to the appropriate E/M code. The physician's interpretation of the results or diagnostic tests/studies (i.e., professional component) with preparation of a separate distinctly identifiable signed written report may also be reported separately, using the appropriate CPT code with the modifier -26 appended. * * * Time . . . . The inclusion of time as an explicit factor beginning in CPT 1992 is done to assist physicians in selecting the most appropriate level of E/M services. It should be recognized that the specific times expressed in the visit code descriptors are averages, and therefore represent a range of times which may be higher or lower depending on actual clinical circumstances. * * * The E/M Guidelines contained "[i]nstructions for [s]electing a [l]evel of E/M [s]ervice," which read, in pertinent part, as follows: * * * Review of Level of E/M Service Descriptors and Examples in the Selected Category or Subcategory The descriptors for the levels of E/M services recognize seven components, six of which are used in defining the levels of E/M services. These components are: history; examination; medical decision making; counseling; coordination of care; nature of presenting problem; and time. The first three or these components (i.e., history, examination and medical decision making) are considered the key components in selecting a level of E/M services. An exception to this rule is in the case of visits which consist predominantly of counseling or coordination of care. . . . The nature of the presenting problem and time are provided in some levels to assist the physician in determining the appropriate level of E/M service. Determine the Extent of History Obtained The extent of history is dependent upon clinical judgment and on the nature of the presenting problem(s). The levels of E/M services recognize four types of history that are defined as followed: Problem Focused: chief complaint; brief history of present illness or problem. Expanded Problem Focused: chief complaint; brief history of present illness; problem pertinent system review. Detailed: chief complaint; extended history of present illness; problem pertinent system review extended to include a review of a limited number of additional systems; pertinent past, family and/or social history directly related to the patient's problems. Comprehensive: chief complaint; extended history of present illness; review of systems which is directly related to the problem(s) identified in the history of the present illness plus a review of all additional body systems; complete past, family and social history. * * * Determine the Extent of Examination Performed The extent of the examination performed is dependent on clinical judgment and on the nature of the presenting problem(s). The levels of E/M services recognize four types of examinations that are defined as follows: Problem Focused: a limited examination of the affected body area or organ system. Expanded Problem Focused: a limited examination of the affected body area or organ system and other symptomatic or related organ system(s). Detailed: an extended examination of the affected body area(s) and other symptomatic or related organ system(s). Comprehensive: a general multi-system examination or a complete examination of a single organ system. . . . For the purposes of these CPT definitions, the following body areas are recognized Head, including the face Neck Chest, including breasts and axilla Abdomen Genitalia, groin, buttocks Back Each extremity For the purposes of these CPT definitions, the following organ systems are recognized Eyes Ears, Nose, Mouth and Throat Cardiovascular Respiratory Gastrointestinal Genitourinary Musculoskeletal Skin Neurologic Psychiatric Hematologic/Lymphatic/Immunologic Determine the Complexity of Medical Decision Making Medical decision making refers to the complexity of establishing a diagnosis and/or selecting a management option as measured by: the number of possible diagnoses and/or the number of management options that must be considered; the amount and/or complexity of medical records, diagnostic tests, and/or other information that must be obtained, reviewed and analyzed; and -The risk of significant complications, morbidity and/or mortality, as well as comorbidities, associated with the patient's presenting problem(s), the diagnostic procedure(s) and/or the possible management options. Four types of medical decision making are recognized: straightforward; low complexity; moderate complexity; and high complexity. To qualify for a given type of decision making, two of the three elements [shown below] must be met or exceeded. Type of Decision Making: straightforward; Number of Diagnoses or Management Options: minimal; Amount and/or Complexity of Data to be Reviewed: minimal or none; Risk of Complications and/or Morbidity or Mortality: minimal Type of Decision Making: low complexity; Number of Diagnoses or Management Options: limited; Amount and/or Complexity of Data to be Reviewed: limited; Risk of Complications and/or Morbidity or Mortality: low Type of Decision making: moderate complexity; Number of Diagnoses or Management Options: multiple; Amount and/or Complexity of Data to be Reviewed: moderate; Risk of Complications and/or Morbidity or Mortality: moderate Type of Decision Making: High complexity; Number of Diagnoses or Management Options: extensive; Amount and/or Complexity of Data to be Reviewed: extensive; Risk of Complications and/or Morbidity or Mortality: high Comorbidities/underlying diseases, in and of themselves, are not considered in selecting a level of E/M services unless their presence significantly increases the complexity of the medical decision making. Select the Appropriate Level of E/M Services Based on the Following For the following categories/ subcategories, all of the key components, i.e., history, examination, and medical decision making, must meet or exceed the stated requirements to qualify for a particular level of E/M service: office, new patient; hospital observation services; initial hospital care; office consultations; initial inpatient consultations; confirmatory consultations; emergency department services; comprehensive nursing facility assessments; domiciliary care, new patient; and home, new patient. . . For the following categories/ subcategories, two of the three key components, (i.e., history, examination, and medical decision making) must meet or exceed the stated requirements to qualify for a particular level of E/M service: office, established patient; subsequent hospital care; follow-up inpatient consultations; subsequent nursing facility care; domiciliary care, established patient; and home, established patient. In the case where counseling and/or coordination of care dominates (more than 50%) of the physician/patient and/or family encounter (face-to-face time in the office or other outpatient setting or floor/unit time in the hospital or nursing facility) then time is considered the key or controlling factor to qualify for a particular level of E/M services. The extent of counseling and/or coordination of care must be documented in the medical record.[5] The CPT contained the following codes and code descriptions for "E/M" office and other outpatient services: New Patient 99201 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: a problem focused history; a problem focused examination; and straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problems are self- limited or minor. Physicians typically spend 10 minutes face-to-face with the patient and/or family. * * * 99202 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: an expanded problem focused history; an expanded problem focused examination; and straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 20 minutes face-to-face with the patient and/or family. * * * 99203 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a detailed history; a detailed examination; and medical decision making of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate severity. Physicians typically spend 30 minutes face-to-face with the patient and/or family. * * * 99204 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a comprehensive history; a comprehensive examination; and medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 45 minutes face-to-face with the patient and/or family. * * * 99205 Office or other outpatient visit for the evaluation and management of a new patient which requires these three key components: a comprehensive history; a comprehensive examination; and medical decision making of high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problems are of moderate to high severity. Physicians typically spend 60 minutes face-to-face with the patient and/or family. * * * Established Patient 99211 Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services. * * * 99212 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a problem focused history; a problem focused examination; straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self- limited or minor. Physicians typically spend 10 minutes face-to-face with the patient and/or family. * * * 99213 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: an expanded problem focused history; an expanded problem focused examination; medical decision making of low complexity. Counseling and coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 15 minutes face-to-face with the patient and/or family. * * * 99214 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a detailed history; a detailed examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 25 minutes face-to-face with the patient and/or family. * * * 99215 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a comprehensive history; a comprehensive examination; medical decision making of high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 40 minutes face-to-face with the patient and/or family. The CPT provided separate codes for "prolonged physician service with direct (face-to-face) patient contact" and contained the following explanation as to when these codes were to be used: Codes 99354-99357 are used when a physician provides prolonged service involving direct (face-to-face) patient contact that is beyond the usual service in either the inpatient or outpatient setting. This service is reported in addition to other physician service, including evaluation and management service at any level. Appropriate codes should be selected for supplies or procedures performed in the care of the patient during this period. Codes 99354-99357 are used to report the total duration of face-to-face time spent by a physician on a given date providing prolonged service, even if the time spent by the physician on that date is not continuous. Code 99354 or 99356 is used to report the first hour of prolonged service on a given date, depending on the place of service. Either code also may be used to report a total duration of prolonged service of 30-60 minutes on a given date. Either code should be used only once per date, even if the time spent by the physician is not continuous on that date. Prolonged service of less than 30 minutes total duration on a given date is not separately reported because the work involved is included in the total work of the evaluation and management codes. Code 99355 or 99357 is used to report each additional 30 minutes beyond the first hour, depending on the place of service. Either code may also be used to report the final 15-30 minutes of prolonged service on a given date. Prolonged service of less than 15 minutes beyond the first hour or less than 15 minutes beyond the final 30 minutes is not reported separately. * * * The Audit and Aftermath Commencing in or around August 2000, AHCA conducted an audit of paid Medicaid claims submitted by Petitioner for services assertedly rendered from May 22, 1998, through May 22, 2000.6 Petitioner had submitted 4,574 Medicaid claims for services assertedly rendered during the Audit Period to 492 patients, for which he had received payments totaling $156,903.14. From the 492 Medicaid patients to whom Petitioner had assertedly provided services during the Audit Period, AHCA randomly selected a "cluster sample" of 41, and obtained from Petitioner medical records he had on file for these 41 patients. Petitioner had submitted a total of 325 claims for services assertedly rendered to the 41 patients in the "cluster sample" during the Audit Period and had received a total of $11,562.14 in Medicaid payments for these services.7 Each of these claims was reviewed to determine whether it was supported by information contained in the medical records obtained from Petitioner. Based on a preliminary review, AHCA determined that Petitioner had been overpaid a total $58,157.96 for the Medicaid claims he had submitted for services assertedly rendered during the Audit Period. By letter dated September 10, 2002, AHCA advised Petitioner of this preliminary determination and "encourage[d] [him] to submit any additional information or documentation" in his possession that he believed would "serve to reduce the overpayment." The antepenultimate and penultimate paragraphs of the letter read as follows: Since you have a choice of accepting the above overpayment or submitting additional information, this is not a final action by the Agency for Health Care Administration. If you have not made payment within thirty (30) days, we will prepare and send to you the final agency determination, taking into consideration any information or documentation that you submit within that time period. Petitioner did not "ma[k]e payment within thirty (30) days" of AHCA's September 10, 2002, letter. As promised, following another review conducted after the expiration of this 30-day period, AHCA "prepare[d] and sen[t] to [Petitioner]" its Final Agency Audit Report showing the calculation of overpayments made to Petitioner during the Audit Period.8 AHCA's Final Agency Audit Report was dated January 28, 2003, and in the form of a letter to Petitioner, which read, in pertinent part, as follows: Medicaid Integrity has completed the review of your Medicaid claims for the procedures specified below for dates of service during the period May 22, 1998 through May 22, 2000. A Provisional Agency Audit Report, dated September 10, 2002, was sent to you indicating that we had determined you were overpaid $58,157.96. Based upon a review of all documentation submitted, we have determined that you were overpaid $58,157.96 for services that in whole or in part are not covered by Medicaid. Pursuant to Section 409.913, Florida Statutes (F.S.), this letter shall serve as notice of the following sanction(s): The provider is subject to comprehensive follow-up review in six months. In determining the appropriateness of Medicaid payment pursuant to Medicaid policy, the Medicaid program utilizes procedure codes, descriptions, policies, limitations and requirements found in the Medicaid provider handbooks and Section 409.913, F.S. In applying for Medicaid reimbursement providers are required to follow the guidelines set forth in the applicable rules[9] and Medicaid fee schedules, as promulgated in the Medicaid policy handbooks, billing bulletins, and the Medicaid provider agreement. Medicaid cannot pay for services that do not meet these guidelines. The following is our assessment of why certain claims paid to your provider number do not meet Medicaid requirements. The audit work papers detailing the claims affected by this assessment are attached. REVIEW DETERMINATION(S) Medicaid policy specifies how medical records must be maintained. A review of your medical records revealed that some services for which you billed and received payment were not documented. Medicaid requires documentation of the services and considers payments made for services not appropriately documented an overpayment. Medicaid policy defines the varying levels of care and expertise required for the evaluation and management procedure codes for office visits. The documentation you provided supports a lower level of office visit than the one for which you billed and received payment. The difference between the amounts you were paid and the correct payment for the appropriate level of service is considered an overpayment. Medicaid policy requires services performed be medically necessary for the diagnosis and treatment of an illness. You billed and received payments for services for which the medical records, when reviewed by a Medicaid physician consultant, indicated that the services provided did not meet the Medicaid criteria for medical necessity. The claims, which were considered medically unnecessary, were disallowed and the money you were paid for these procedures is considered an overpayment. Medicaid policy addresses specific billing requirements and procedures. In some instances, you billed a procedure code as global and also billed the professional when the professional component was incorporated in the global fee. The difference between the amounts you were paid and the appropriate fee is considered an overpayment. The overpayment was calculated as follows: A random sample of 41 recipients respecting whom you submitted 325 claims was reviewed. For those claims in the sample which have dates of service from May 22, 1998, through May 22, 2000, an overpayment of $5,004.04 or $15.39704606 per claim was found, as indicated on the accompanying schedule. Since you were paid for a total (population) of 4,574 claims for that period, the point estimate of the total overpayment is $15.39704606 x 4,574=$70,426.09. There is a 50 percent probability that the overpayment to you is that amount or more. There was then an explanation of the "statistical formula for cluster sampling" that AHCA used and how it "calculated that the overpayment to [Petitioner was] $58,157.96 with a ninety-five percent (95%) probability that it is that amount or more." The concluding portions of the letter advised Petitioner of his right to "request an administrative hearing [on this overpayment determination] pursuant to Sections 120.569 and 120.57, Florida Statutes." The "Medicaid physician consultant" referred to in AHCA's January 28, 2003, letter was Lisa Kohler, M.D., a Florida-licensed "family physician," who is certified by the American Board of Family Practice and is a fellow of the American Academy of Family Physicians. Dr. Kohler received her medical education at the University of South Florida College of Medicine, from which she graduated in 1985. After graduation, she did her internship and residency at Tallahassee Memorial Regional Medical Center's Family Practice Residency program. In 1988, following the completion of her residency, she entered private practice. She currently serves as the Associate Director of the Tallahassee Memorial Regional Medical Center's Family Practice Residency program. In addition, she is a Clinical Assistant Professor in the Department of Family Medicine at the University of South Florida College of Medicine and the Volunteer Medical Director of the Neighborhood Health Services in Tallahassee, Florida, a health clinic that provides free medical care to indigent patients. In accordance with the "peer review" provisions of Section 409.9131, Florida Statutes, which became effective July 1, 1999, AHCA had Dr. Kohler review all of the records that Petitioner had provided regarding the 41 patients in the "cluster sample"10 to determine whether there was documentation to support the Medicaid claims relating to these patients that Petitioner had submitted for services assertedly rendered during the Audit Period. In conducting her "peer review," Dr. Kohler did not interview any of the 41 patients in the "cluster sample," nor did she take any other steps to supplement the information contained in the records she examined. Her assessment of the propriety of Petitioner's billing was based exclusively on what was in those records and no other information. On February 19, 2003, Petitioner requested an administrative hearing on the overpayment determination (announced in AHCA's January 28, 2003, letter to Petitioner). On or about August 20, 2003, following a meeting between the parties, AHCA made a downward revision in its overpayment calculation, to $47,931.79. AHCA has made no additional revisions to its overpayment calculation in the instant case. It maintains that Petitioner received $47,931.79 in Medicaid overpayments for services claimed to have been provided during the Audit Period. In making this final overpayment calculation, AHCA determined, correctly, that Petitioner was overpaid a total of $3,867.62, or $11.90036931 per claim, for the 325 claims he had submitted seeking reimbursement from Medicaid for services assertedly rendered during the Audit Period to the 41 patients in the "cluster sample." Using a statistical formula the validity of which Petitioner has not disputed, AHCA extended these results to the total "population" of 4,574 Medicaid claims that Petitioner had submitted for services assertedly rendered during the Audit Period, and it correctly calculated that Petitioner had been overpaid a total of $47,931.79. Simple Mistake or Fraud? There has been no allegation made, nor proof submitted, that any of Petitioner's overbillings was the product of anything other than simple mistake or inadvertence on Petitioner's part.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that AHCA enter a final order finding that Petitioner received $47,931.79 in Medicaid overpayments for paid claims covering the period from May 22, 1998, through May 22, 2000, and requiring Petitioner to repay this amount to AHCA. DONE AND ENTERED this 15th day of June, 2004, in Tallahassee, Leon County, Florida. S STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of June, 2004.
The Issue The issue in this case is whether the allegations of the Amended Administrative Complaint are correct and, if so, what penalty should be imposed.
Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in the State of Florida. At all times material to this case, the Respondent has been a licensed physician in the State of Florida, license #ME 0035994. In August, 1987, the Respondent met with a married couple for treatment of the wife's (patient) recurrent ovarian cysts and pain. The couple were referred to the Respondent for the consultation by another physician. The patient was hospitalized at the time of the consultation. As part of the initial examination of the couple, the Respondent conducted a routine infertility physical and history, including questions related to sexual history and practices. During the examination, the Respondent learned that the couple's sexual activity was infrequent and that the marriage was troubled. The Respondent determined that the cause of the medical problem was related to a fertility medication prescribed by another physician. At that time, and on subsequent occasions, the Respondent advised the couple to obtain marital and sexual counseling. The Respondent did not provide marital or sexual counseling to the couple. After the patient recovered from the ovarian cysts, she consulted with the Respondent in regards to her ongoing fertility and ovulatory problems. The Respondent began administering fertility medication to induce ovulation. The medical treatment was eventually successful and the patient became pregnant. The child was born in 1989. At some point during the fertility treatment, the patient complained to the Respondent of experiencing migraine headaches. The Respondent referred the patient to a neurologist who prescribed narcotic pain relievers. After the birth of the first child, the patient returned to the Respondent for further fertility treatment (apparently in late 1989 or early 1990) in order to conceive a second child. Again, the treatment was successful and the patient became pregnant. The Respondent referred the pregnant patient back to her obstetrician by letter dated April 23, 1990. Beginning in mid-1990, the patient and her husband began to engage in social activities with the Respondent. On occasion, the three had dinner, went swimming with their children, and went to view a fireworks show. The patient had been employed as a pharmaceutical representative, but was interested in changing careers. She expressed an interest to the Respondent in establishing a medical transcription business. The Respondent provided typing work to the patient. By April 23, 1990, the patient was typing letters for the Respondent. The letter from the Respondent to the obstetrician closes, "[p]lease forgive the typographical errors, as I am sure [patient] will be typing this letter." The patient gave birth to the second child on October 26, 1990. After the birth of the second child, the Respondent employed the patient as a medical transcriptionist. She also worked for her obstetrician as a transcriptionist. Based on the suggestion in 1990 by the patient, the Respondent began to employ the patient's husband as a certified public accountant. Throughout the remainder of 1990, the Respondent continued to socialize with the couple. The Respondent was aware that the couple's marriage was troubled. The continuing marital problems of the couple eventually resulted in separation when the patient's husband moved from their home into an apartment. The evidence fails to conclusively establish the date of the separation, but it apparently occurred prior to April, 1991. By April 1991, the patient and the Respondent continued to meet on a social basis. The Respondent was divorced. The patient and her husband remained separated. At times, the Respondent and the patient discussed their marital experiences. During this period, the Respondent and the patient expressed romantic feelings for each other. They began to "date," and the Respondent paid to take the patient to dinners and movies. In April or May of 1991, and continuing thereafter for a period of approximately three and a half years, the patient and the Respondent engaged in consensual sexual activity. It is critical for an obstetrician-gynecologist, as well as for a specialist in reproductive endocrinology, to understand and respect the sexual boundaries between physician and patient. The sexual boundary between a patient and a reproductive endocrinologist must be absolute. In order to receive appropriate medical treatment, the patient is requested to reveal intimate details of her sexual activities and the emotional nature of a marriage. The patient must be able to completely trust the physician. The information is and must remain confidential. From the time of the Respondent's initial examination and history of the patient, through the initiation of the sexual relationship, the Respondent was aware of the marital and sexual problems of the patient and her husband. The Respondent asserts that by the time the sexual relationship began, the physician-patient relationship had been terminated by the letter of April 23, 1990. Based on credited expert testimony, the evidence establishes that the physician-patient relationship continued to exist at the time the sexual activity began. The evidence establishes that the referral of a pregnant patient back to an obstetrician does not terminate the relationship with a fertility specialist, who may again be called upon to render assistance in treatment of continuing fertility problems. The evidence also establishes that prescribing of narcotics necessarily establishes a physician-patient relationship. Subsequent to the letter of April 23, 1990, the Respondent wrote prescriptions to refill narcotic pain medications which the patient had obtained from her neurologist. Although documentary evidence regarding the actual prescriptions is deemed to lack reliability, both the Respondent and the patient acknowledged that the prescriptions were written. The Respondent wrote the refills after the patient, with continuing migraine headaches, complained that she would have to see the prescribing physician and pay for an office visit to get them refilled. Although the Respondent claims to have reviewed an early report done by the neurologist to whom he had referred the patient, there is no evidence that the Respondent did a physical examination at the time he wrote the refill prescription. The evidence establishes that, because a physician can prescribe narcotics, there is potential for abuse by a physician who may attempt to trade drug prescriptions for sexual activity. It is unethical for a physician to induce a patient into sexual activity. Allowing an emotional relationship to begin and develop within the physician-patient relationship constitutes an inducement of the patient into sexual activity. The Respondent failed to maintain sexual boundaries with his patient. He allowed and encouraged an emotional and sexual relationship to develop, and as such, used the physician-patient relationship to engage and induce the patient into sexual activity.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order determining that Stephen Ward Weldon has violated Sections 458.329 and 458.331(1)(x), Florida Statutes, reprimanding the Respondent and placing the Respondent on probation for a period of two years. DONE and RECOMMENDED this 28th day of September, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM 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 28th day of September, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-6032 To comply with the requirements of Section 120.59(2), Florida Statutes, the following constitute rulings on proposed findings of facts submitted by the parties. Petitioner The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 6. Rejected, unnecessary. 19-20. Rejected, not established by clear and convincing evidence. 22. Rejected, cumulative. 29. Rejected, cumulative. Respondent The Respondent's proposed findings of fact frequently refer to an alleged termination of the physician-patient relationship. Such references are rejected as contrary to the greater weight of credible and persuasive evidence. Otherwise, the proposed findings are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected. The prehearing stipulation filed by the parties does not address certification. 9. Rejected as to patient's desire for her marriage to continue, and as to the assertion that her marital difficulty was "unrelated" to the eventual development of her relationship with the Respondent, irrelevant. Rejected, irrelevant. Rejected, recitation of testimony is not a finding of fact. 16-17. Rejected, recitation of testimony is not a finding of fact. 18-20. Rejected, irrelevant. DOAH CASE NO 94-6032 COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303-4131 Joseph S. Garwood, Esquire Agency for Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Grover Freeman, Esquire 201 East Kennedy, Suite 500 Tampa, Florida 33602-5829
Findings Of Fact The Department of Health and Rehabilitative Services (HRS) received a letter of intent (LOI) dated October 21, 1988 from "Ocala Healthcare Associates Joint Venture." That letter of intent provided that the proposed applicant sought to add twenty-five community nursing home beds to its 35 bed facility then under construction, in HRS District 3 in Marion County, Florida. The letter of intent was a prerequisite to filing an application for a certificate of need (CON) authorizing those beds. The October 21, 1988 LOI was accompanied by a "certificate of resolution" of Ocala Healthcare Associates Joint Venture of even date. That resolution was certified by Winston A. Porter. HRS generally does not recognize a joint venture as a legal person or entity capable of applying for and holding a certificate of need, based upon an opinion of its legal counsel and based upon the fact that Chapter 10-5 Florida Administrative Code, at its definition of "applicant" does not include the entity known as a "joint venture." There is no specific prohibition, by statute or rule, against joint ventures holding certificates of need, however, and the Department's witness, Ms. Gordon-Girven also acknowledged that the Department has no specific policy prohibiting issuance of a CON to a joint venture. In any event, on November 23, 1988, "Ocala Healthcare Associates General Partnership" filed an application for a certificate of need pursuant to the previously filed letter of intent. In its letter of December 2, 1988, HRS rejected that application on the basis that "the applicant submitting the application was not the same as the applicant identified in the letter of intent." Upon learning of this, Mr. Winston A. Porter, the owner of the parent entity and chief operating officer of the applicant entity, or general partner, immediately notified HRS that the joint venture named in the letter of intent and the general partnership named in the application were actually one and the same entity and that the use of the term "joint venture" in the letter of intent and resolution was a mere clerical error. In corroboration of this position, in fact, Ocala Healthcare Associates general Partnership (Ocala) had already altered its form from a joint venture to a general partnership by way of "an amendment and conversion of Ocala Healthcare Associates Joint Venture to General Partnership Agreement" entered into and dated December 10, 1987. That conversion agreement had been done at the behest of HRS, based upon its advice to Mr. Porter and Ocala Healthcare Associates, Inc. that the Department did not recognize joint ventures as capable of holding certificates of need. It was thus done to comply with HRS' own requirements. HRS does not license joint ventures to operate nursing homes but does license general partnerships for that purpose. The minimum requirements for the certificate of need application require that the legal name of the applicant and parent corporation be given. Rule 10-5.008(1)(d), Florida Administrative Code quoted below, contains no specific "minimum requirements" regarding how the name of an applicant should be listed on an application nor that it should agree or be the same in all cases as that depicted on the letter of intent. The Rule merely incorporates the application form as to "minimum requirements" by reference. The form, in turn, requires only that the applicant's name be entered, not that the name be the same as that on the letter of intent. Ocala, on its certificate of need application listed its legal name just as it truly is, that is, Ocala Healthcare Associate General Partnership. It, of course, had listed its name by mistake, on the letter of intent as "Ocala Healthcare Associates, Joint Venture." The CON application, however, also indicated that the current general partnership, Ocala Healthcare Associates General Partnership, was indeed the same entity as the former joint venture. Further, HRS was on constructive and actual notice of the change in business form undergone by Ocala at HRS' behest in December, 1987. Be that as it may, however, no rule or policy of the Department specifically states that an application for a CON and the related letter of intent must be filed by exactly the same entity. In fact, however, here the evidence shows that the letter of intent and the application were actually filed by the same entity. The controlling and owning members or partners of Ocala Healthcare Associates General Partnership were listed in the letter of intent, even though it was mistakenly called a joint venture, and were also listed in the application. They were named as, and are, one and the same entities. Further, the minimum requirements depicted in the application form say nothing about the applicant's name and the name depicted in the letter of intent being identical. HRS' position that the letter of intent and the application be identical or filed by the same entity is designed to put potential competitors on notice of who the new attempted market entrant is. Here that purpose was accomplished anyway. Ocala never attempted to mislead anyone by its filing of the letter of intent under the "joint venture" name. The joint venture is owned and controlled by the same entities as the general partnership and the component parts of the joint venture and general partnership are identical. Further, HRS personnel involved with this matter were on notice, both constructively and actually, that the joint venture had been dispensed with and the general partnership had supplanted it. Finally, the agency was not prohibited from notifying Ocala of the apparent discrepancy in the names depicted on the letter of intent and on the application, but it took no such action, even though its certificate of need review personnel were on actual notice that Ocala had altered its business form from that of joint venture to general partnership.
Recommendation Having considered the foregoing findings of fact and conclusions of law, the evidence of record and the candor and demeanor of the witnesses, it is therefore, RECOMMENDED that a Final Order be entered accepting Ocala's application for a certificate of need for comparative review with other applicants in the November 1988 batching cycle. DONE AND ORDERED this 2nd day of June, 1989, in Tallahassee, Leon County, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of June, 1989. APPENDIX Petitioner's Proposed Findings of Fact: Paragraph 1: Accepted. Paragraphs 2-16: Accepted. Respondent's Proposed Findings of Fact: Paragraph 1: Accepted. Paragraph 2: Accepted. Paragraph 3: Accepted. Paragraph 4: Accepted. Paragraph 5: Accepted. Paragraph 6: Accepted. Paragraph 7: Rejected as contrary to the preponderant weight of the evidence and as subordinate to the hearing officers findings of fact on this subject matter. Paragraph 8: Rejected as to its' material import and as contrary to the preponderant evidence and subordinate to the hearing officers findings of fact. Paragraph 9: Rejected as not material to resolution of the narrow range of issues in this proceeding. COPIES FURNISHED: R. Bruce McKibben, Jr., DEMPSEY AND GOLDSMITH Post Office Box 10651 Tallahassee, FL 32302 Richard H. Patterson, Assistant General Counsel Department of Health and Rehabilitative Services 2727 Mahan Drive Tallahassee, FL 32308 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, FL 32399-0700
Findings Of Fact The Respondent, Peter Alagona, Jr., is licensed to practice medicine in the State of Florida. He is board-certified in internal medicine with a subspecialty in cardiology and has practiced cardiology since 1981. There is no evidence that the Respondent has been the subject of professional discipline except for this proceeding. In 1989, the Respondent became acquainted with V.P., who worked as a receptionist at a hospital where he had practice privileges. Their work relationship became friendly and, although the Respondent was married and had children, he and V.P. responded to each other's friendly manner by mutual flirtation. At first, their flirting was discrete but later became more open and romantic. The Respondent began to write V.P. notes and greeting cards and send her flowers. In approximately May, 1989, V.P. indicated her willingness to begin an intimate and sexual relationship. The Respondent did not hesitate to oblige her. There is no evidence that the Respondent used a doctor-patient relationship to induce V.P. to engage in sexual activity with him, as alleged. When the sexual relationship began, there was no doctor-patient relationship between them. During her tenure at work at the hospital, V.P. from time to time complained of a rapid heart beat, and one of the four cardiologists at the hospital would respond to her complaint. The Respondent was one of the several doctors who had occasion to respond. No treatment ever was required. V.P.'s heart beat would soon return to normal, and everyone would return to work. No true doctor-patient relationship was established, and neither the Respondent, the other doctors nor V.P. ever thought one had been established. The allegation that the Respondent essentially intentionally used drugs he prescribed for V.P. during the course of their affair to control her and prolong the sexual relationship with V.P. against her will hinges on the following reference in V.P.'s deposition transcript: Q. Just so that I'm clear, did Alagona ever tell you that if you did not have sex with him, he would not write prescriptions for you? A. Those aren't the words. He has made comments about, "Where are you going to get your prescriptions?" Q. When did he make those comments? A. I don't know. During the relationship, at the end of the relationship. Q. Give me some of the circumstances surrounding those comments. A. It was, I'm sure, during an argument or something. I don't know. In view of all the evidence, that allegation is rejected as not proven. It is factual that, in another poor judgment that flowed from the poor judgment in initiating and conducting the affair in the first place, the Respondent began to act as V.P.'s personal physician for limited purposes during the course of the affair. When she complained of migraine headaches, he prescribed pain medication such as Tylox, a Schedule II controlled substance containing oxycodone, and Inderal, a beta-blocker and a legend drug. For stress, he prescribed Valium, which contains diazepam, also a legend drug. Although the Respondent clearly was acting as the doctor in a doctor-patient relationship when he prescribed these drugs, he still did not view himself as acting in that role and did not keep a written record of the drugs or the course of treatment in connection with those prescriptions. The allegation that the Respondent failed to practice medicine in accordance with required standards of care by not ordering the patient to receive mental health counseling but instead inappropriately allowing the patient to remain on Tylox also depends in large part on the testimony of V.P. In view of all the evidence, V.P.'s testimony pertinent to this allegation is rejected. The evidence was that the Respondent repeatedly advised V.P. to seek counseling, albeit not for drug abuse. Until April, 1990, the Respondent was not aware that V.P. was abusing drugs. The Respondent's Tylox prescriptions were not excessive and would not, in and of themselves, have indicated to the Respondent that V.P. was abusing Tylox or inappropriately remaining on Tylox; nor did V.P. exhibit clear signs of drug abuse or addiction prior to April, 1990. However, V.P. apparently was obtaining Tylox and other legend drugs from other sources without the Respondent's knowledge. She was seeing other physicians for the purpose of obtaining prescriptions, and she also was forging the Respondent's and other doctors' names to prescriptions to obtain additional drugs illegally. (One of the doctors whose name she forged predeceased the date of the forged prescription.) In April, 1990, the Respondent was notified that V.P. had been hospitalized for a drug overdose. In response to the request for advice from the attending physician, the Respondent recommended a psychiatrist for counseling. However, V.P. did not cooperate. She attended only one counseling session and refused further counseling. After the overdose hospitalization, the Respondent did not prescribe any more Tylox. However, again without the Respondent's knowledge, V.P. continued to obtain Tylox and other drugs from her other sources. The Respondent's judgment continued to be distorted and poor as a result of his intense sexual and romantic relationship with V.P. He continued to urge V.P. to obtain counseling for several reasons but, again, not specifically for drug abuse. By mid-1990, V.P. had dissolved her marriage, and she began putting pressure on the Respondent to divorce his wife and marry her. She began acting erratically, and her judgment also was poor. During a week- long visit to her family's home during the summer of 1990, she contacted an old boy friend, married him, changed her mind, and began annulment proceedings. By late 1990, V.P. started dating another doctor, and the pressure on both V.P. and the Respondent increased. The Respondent was unable to decide what to do, and the stress got ever greater as V.P. threatened to end the affair with the Respondent. While probably genuinely concerned for V.P.'s welfare, the Respondent probably also believed that, if V.P. got counseling, she would "see the light" and decide not to end their affair. Finally, the Respondent himself felt the need for counseling due to the stress of the affair, and he probably believed that she felt the same stress. Eventually, in early 1991, V.P. followed through on her threat and made it known to the Respondent that she was dropping him and choosing the other doctor. For some time, the Respondent was devastated and continued to try to persuade V.P. to return to him. Meanwhile, V.P. remained less than resolute, holding out to the Respondent some hope that she would return to him if he divorced his wife. Finally, practically an emotional wreck and despairing of any other way to get over his affair with V.P., the Respondent checked himself into an out-of-town residential psychiatric program. He purposely did not tell V.P. where he was, but she found out and, on the day of his discharge, sent him flowers with a card saying that she would never let him go. Eventually, the affair ended, and V.P. married the other doctor soon after.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent not guilty under Counts I and II but guilty under Count III; (2) placing him on probation for two years; (3) requiring him to take appropriate continuing medical education, if available, dealing with the physician-patient relationship and the prudence of avoiding the dual sexual/physician-patient relationship; and (4) imposing on him an administrative fine in the amount of $2,500. DONE and ENTERED this 7th day of May, 1996, in Tallahassee, Florida. J. LAWRENCE JOHNSTON, 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 7th day of May, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-2467 To comply with the requirements of Section 120.59(2), Florida Statutes (1995), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-5. Accepted and incorporated to the extent not subordinate or unnecessary. However, as to second sentence of 5., although he cannot now remember when he prescribed Tylox, the Respondent's testimony is accepted that, at the time, and for this extraordinary patient, he was able to bear in mind adequately approximately when and what he last prescribed so as not to expose V.P. to a health risk. 6. Accepted and incorporated to the extent not subordinate or unnecessary. However, as to the last sentence, although he cannot now remember his prescriptions, the Respondent's testimony is accepted that, at the time, and for this extraordinary patient, he was able to bear in mind adequately when and what he last prescribed so as not to expose V.P. to a health risk. 7.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven that patients need to be kept under "surveillance." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. As to last sentence, rejected as not proven that all "drugs," in all doses, "control a patient's emotional state and level of pain." Accepted that some can, in certain doses, and otherwise accepted and incorporated to the extent not subordinate or unnecessary. Accepted that it is not the only indication; subordinate to facts contrary to those found, and unnecessary. 13.-16. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven that the Respondent "did not follow through with V.P.'s medical problems." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Accepted and incorporated to the extent not subordinate or unnecessary. First two sentences, rejected as not proven; third, accepted that she said it, but subordinate to facts contrary to those found. First sentence, rejected as not proven; rest, accepted that she said it, but subordinate to facts contrary to those found. Rejected as not proven that he reviewed all of the prescription and hospital records. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Accepted and incorporated. To the extent not conclusion of law, accepted and incorporated. First sentence, rejected as not proven; second, cumulative; third, in part cumulative and in part rejected as not proven (that he had no justification); fourth, accepted but subordinate to facts contrary to those found (he did some diagnostic testing); and last two rejected as not proven in that the evidence was that V.P. rejected the Respondent's repeated recommendations to her that she seek mental health counseling, but otherwise accepted and incorporated to the extent not subordinate or unnecessary. Last sentence, accepted but not necessary; rest, rejected as not proven. Respondent's Proposed Findings of Fact. 1.-22. Accepted and incorporated to the extent not subordinate or unnecessary. Accepted but subordinate. Conclusion of law. Accepted and incorporated. 26.-27. Accepted and incorporated to the extent not subordinate or unnecessary. Accepted but subordinate and unnecessary. In large part, argument and conclusion of law; in part, accepted but largely subordinate and unnecessary. Rejected as contrary to the greater weight of the evidence that it is "clear . . . that V.P. feels that Alagona left her." (Much of their behavior is difficult to explain, such as why V.P. would act as if she did not want to let Alagona go, while chosing Palay over Alagona.) Otherwise, accepted but largely subordinate and unnecessary. Accepted but largely subordinate and unnecessary. Last sentence of C), rejected as contrary to the greater weight of the evidence that it is "safe to infer that V.P. forged these prescriptions." (The evidence raises the question and possibility of forgery, especially in the absence of testimony on the subject from V.P. and Palay, but it is not "safe to infer.") Otherwise, accepted but largely subordinate and unnecessary. First four sentences, argument and subordinate. Rest, generally accepted and incorporated to the extent not subordinate or unnecessary. (However, while V.P. may have been "in the emotional driver's seat," it does not appear that she knew where she was going.) Accepted but subordinate and unnecessary. Last sentence, rejected as contrary to the greater weight of the evidence in that the Respondent did not suggest psychiatric counseling. Otherwise, accepted but subordinate to facts found, and unnecessary. Second sentence, rejected as contrary to the greater weight of the evidence in that the Respondent did not suggest psychiatric counseling. Otherwise, accepted but subordinate to facts found, and unnecessary. Second sentence, rejected as contrary to the greater weight of the evidence in that the Respondent did not suggest psychiatric counseling. Otherwise, accepted but subordinate to facts found, and unnecessary. As to the third and fourth sentences, there was no evidence as to the nature of doctors' "orders." But, based on the evidence, the Respondent did not "order" counseling. He suggested or recommended it and offered to help her get it, and V.P. declined. If the Respondent had "ordered" counseling, the patient still may or may not have followed his "order." In either case, it would appear that the critical decision is what a physician does in the face of the patient's failure to comply. It would seem that the only thing a physician reasonably can do in this situation is stop prescribing and, if necessary, terminate the physician-patient relationship. As to the rest, accepted but subordinate to facts found, and unnecessary. 39.-42. Accepted but subordinate and unnecessary. Accepted and incorporated to the extent not subordinate or unnecessary. Accepted but subordinate and unnecessary. Accepted and incorporated. COPIES FURNISHED: Steven Rothenburg, Esquire Agency for Health Care Administration Regional Office VI-Legal Division 9325 Bay Plaza, Suite 210 Tampa, Florida 33619 L. D. Murrell, Esquire 319 Clematis Street, Suite 400 West Palm Beach, Florida 33401-4618 Dr. Marm Harris Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman, Esquire General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact Respondent Ahmed Elkadi, who holds a license to practice medicine in Florida, No. 0031490, was one of two surgeons (among some half dozen physicians) on the staff of Weems Memorial Hospital in Apalachicola, Florida, in August of 1988. Whether the physicians on staff who were not surgeons had other specialties and, if so, what they were, the proof did not show. A duly licensed 29-bed general hospital, Petitioner's Exhibit No. 7, Weems Memorial had, "on a . . . stat basis," (Fitzgerald Deposition at 13), despite its small size, "24-hour respiratory therapy capability, 24-hour laboratory coverage, [and] 24-hour radiology coverage," (Fitzgerald Deposition at 5), which did not, however, include computed tomographic scanning or magnetic resonance imaging technology, both available only at facilities some 60 or 70 miles away. Continuous cardiac monitoring was available in house. Id. at 16. Weems Memorial had a physician in house 24 hours a day and a registered nurse on duty 24 hours a day, along with "at least one LPN," (Fitzgerald Deposition at 6), and two nurse's aides. Id. On average, Weems Memorial only had five or six inpatients at any one time during 1988. Staff off premises but on call were required to report within 30 minutes of being summoned. Fitzgerald Deposition at 13. On August 22, 1988, Dr. Elkadi admitted A. L. as a patient, in preparation for gastric bypass surgery the following day. A 29-year-old woman, A. L. (who worked as a nurse at the hospital) stood 5 feet 1.5 inches tall and weighed 303 pounds, when admitted. A chest x-ray taken before she was admitted uncovered no abnormalities other than obesity. Because she "was in excess of twice her standard weight for height," (MacGregor Deposition, p.7) and had "blood cholesterol elevation and [elevated levels of] blood triglycerides," Id., p.8, and because of her age, A. L. was an appropriate candidate for gastric bypass surgery, Corwin Deposition. She signed a form consenting to the operation. Roux-en-Y Dr. Elkadi performed the surgery, a "gastric bypass with Roux-en-y gastrojejunostomy," Petitioner, Exhibit No. 2, p. 7, on August 23, 1988. A. L., who was anxious about the impending operation, received Valium as well as anesthesia before the procedure began. While A. L. lay on her back anesthetized, he cut open her abdomen and partitioned her stomach with staples, thus reducing the capacity of her stomach to receive food; and joined the small, newly segregated, upper portion of her stomach directly to the small intestine. In a contemporaneous operative note, Dr. Elkadi described the procedure: . . . . The TA 90 stapler was used twice to proximal gastric from the proximal apply a double staple line across the stomach to separate a small proximal pouch with a capacity of about 30 cc remaining stomach cavity. A loop of in side using inner for was jejunal completed. 14 the the jejunum was pulled up through an opening the transverse mesocolon and anastomosed to side to the proximal gastric pouch a running suture of 3-0 chromic for the layer and interrupted 3-0 silk sutures the outer layer. A naso-gastric tube passed into the distal limb of the loop before the anastomosis was The gastrojejunostomy measured about 12- mm in diameter. The proximal limb of jejunal loop was then disconnected just proximal to the gastrojejunostomy using GIA stapler, and the cut end was anastomosed to the distal limb about 60 cm distal to the also gastrojejunostomy. The GIA stapler was used for the entero-enterostomy supported by a running 3-0 silk suture for the serosal transverse loop layer. The edges of the opening of the mesocolon were sutured to the jejunal . The using a fascia, a of using interrupted 3-0 silk sutures. . . abdominal wall was closed in layers running suture of #1 Dexon for the running suture of #3-0 Dexon for the subcutaneous layer, and a running suture #3-0 Nylon for the skin. . . . Petitioner's Exhibit No. 2. As reported and as is customary, Dr. Elkadi severed the small intestine just above the newly fashioned connection to the "small proximal gastric pouch." Because gastric juices continue to leave the distal stomach and travel through the disconnected intestinal segment, the procedure was not complete until this segment of the jejunum was rejoined to the small intestine lower down. In manipulating the jejunum to accomplish the reconnection, it was necessary to cut and tie off various blood vessels, including tributaries of the mesenteric vein. Dr. MacGregor, one of petitioner's expert witnesses, testified that "[t]he record indicates that [the surgery] was done appropriately." T.15. On deposition, petitioner's counsel asked and Dr. MacGregor answered: Q. It seems to be a normal surgery? A. Right. Q. Except for the amount of time? A. Correct MacGregor deposition 15. The operation took four hours. The other surgeon petitioner called as an expert testified that "probably four hours would be a reasonable time." Corwin Deposition at 12. Petitioner produced no witness who testified that respondent's work in the operating room failed to meet standards of any kind. Sequelae In the wake of operations of this kind, "mortality can be as high as 2.7 to 2.9 per cent at training centers who have documented teams of specialists and post op care specialists." T.15. Complications "tend to be in two major groups . . . pulmonary embolism and infections." Id. The "most important complication of gastric bypass surgery is perforation or leakage," (MacGregor Deposition at 16) which leads to infection. In many hospitals, nursing administration routinely assigns a formal nursing plan for postoperative patients, after consulting with the surgeon. MacGregor Deposition at 15. But practices vary (Corwin Deposition at 13) and the omission of a formal nursing plan altogether "in and of itself . . . is not unusual," (Fitzgerald Deposition at 12) at least in smaller hospitals. No formal, written nursing or contingency plan was drawn up for A. L. Dr. Elkadi did not originally direct care for A. L. "beyond what [staff] would normally do [for] any postoperative surgical patient." Fitzgerald Deposition at 11. A. L. left the operating room at ten before two on the afternoon of August 23, 1988. An hour and 40 minutes later, her pulse rate was 84 and her respiration was 28. Petitioner's Exhibit NO. 2. At ten o'clock that night, her pulse was 112 and her respiration was 36; and, at or about the same time, her temperature was approximately 97.2o F. A half hour later, with Dr. Elkadi present, A. L. was standing by her bedside and taking a few steps. The next morning she sat up, first on the side of her bed, then in a chair. At half past one on August 24, 1988, she walked to the nursing station, which she "tolerated well." But, after she returned to her bed, she complained of "surgical pain." At six o'clock that evening she walked a short distance in the hall, returned to her room, sat in a chair and, after she had gone back to bed, again complained of "surgical pain." A chest x-ray taken the day after the operation revealed "[s]mall areas of linear atelectasis . . . in the lung bases," Petitioner's Exhibit No. 2, p. 43, which a radiologist attributed to A. L.'s not having taken a full breath. He found that a "full inspiration was not taken during filming," Id., and that the atelectasis was "probably for this reason." Id. On the evening of August 24, 1988, the nursing notes reported "slight drainage of dark green fluid" from the nasogastric tube. Earlier that day, bloody drainage ("scant") was reported for what may have been the first and only time. The last entry in the nurse's notes characterized the drainage as dark brown; "scant amt greenish drainage," Petitioner's Exhibit No. 2, was reported as late as four o'clock on August 26, 1988. Also at four o'clock on the afternoon of August 26, 1988, the nurse's notes reported, "Bowel sounds [were] audible in all 4 quadrants." Petitioner's Exhibit NO. 2. At seven o'clock that evening, according to the same source, A. L. "had small tan colored lo[ose] stool." Id. A blood specimen drawn at nine o'clock on the morning of August 26, 1988, yielded a "WBC" test result of "19.9." Id. at an unnumbered page. The white blood cell count had "c[o]me down to 11,000 on the day of [A. L.'s] admission." Petitioner's Exhibit No. 2, p. 7. On the morning of August 25, 1988, another walk in the hall ended with A. L.'s sitting in a chair. The nurses' notes reported that she was "[t]olerating activity well." Petitioner's Exhibit No. 2. At eleven o'clock that night, "belching incessantly," she complained of back and stomach pain, and a nurse helped her take a walk. She was still up (sitting in a chair) at midnight, when a second walk resulted in "much relief in stomach." Pain and belching persisted, nevertheless, and Dr. Elkadi was called, arriving at ten before one o'clock in the early morning of August 26, 1988. After seeing A. L., respondent ordered an enema and a dose of Vistaril. At quarter past one, she was pushing on her stomach to relieve gas pains. The nurses' notes reported that she was "extremely anxious," and Dr. Elkadi prescribed five milligrams of Valium. She continued to belch, and Dr. Elkadi was notified of her distress and anxiety at three o'clock in the morning. After she received another five milligrams of Valium (presumably at Dr. Elkadi's behest), she fell asleep. At 5:20 that morning, she was given a third five milligram dose of Valium, and at seven o'clock three milligrams more. In each instance, it was administered intravenously by "slow push." Awake by seven, when she complained of abdominal pain, she was given two milligrams of Levodromoran, after walking to and from the nursing station. When the respiratory therapist saw her at nine o'clock, she was sitting in a chair, again complaining of abdominal pain. But an hour later, when she went to the shower, she said she had less gas pain. That afternoon, she rested in bed, sat in a chair, and walked in the hall. The day after the operation, A. L.'s temperature had risen to 100.5o F., and her pulse had reached 128. When her pulse declined on the following day, August 25, 1988, her temperature remained elevated. On August 26, however, her temperature dropped to normal and her pulse leveled off at the low to mid 90s. On August 23, 1988, the day of the surgery, and again on each of the two following days, Dr. Elkadi ordered extra intravenous fluids. On more than one occasion, the nurse's notes reported that intravenous solution was infusing with difficulty, or words to that effect. While a 1500-milliliter per day discrepancy between fluid intake and urine output is to be expected, the discrepancy averaged some 3500 milliliters per day in A. L.'s case, following her surgery. After surgery, she was given morphine in five-milligram doses, intravenously, as needed. The day after the operation, A. L. also received Levodromoran for pain. On August 25, 1988, although she again received both pain-killing medications, she required less morphine. On August 26, 1988, however, in response to complaints of pain, the amounts both of morphine and of Levodromoran she received increased over the previous day's totals. Dr. Elkadi also prescribed Valium and Vistaril; and A. L. received a total of 100 milligrams of the latter, on August 26, 1988, in multiple doses. In addition, Dr. Elkadi prescribed and A. L. received Nubain, an analgesic that, according to Dr. MacGregor, "is a narcotic antagonist." Petitioner's Exhibit No. 1 to MacGregor Deposition. It is therefore possible that Nubain offset the increased dosages of narcotics in whole or in part. The Last Day A. L. awoke at half past six on the morning of August 27, 1988, complained of pain, and received an injection of Nubain. Only 30 minutes later, she complained of "pain between shoulders," but she received no more pain medication, according to the nurse's notes, until five after two that afternoon, when she was given an injection of five milligrams of Valium. (Twelve hours earlier, she had received ten milligrams of Valium.) At seven o'clock on the morning of August 27, 1988, the nurse's notes again reported "good bowel sounds heard in all quad." Id. Early that afternoon, after an enema, according to the nurse's notes, "pt had good results of flatus & sm amt of lg stool." Id. At four o'clock, she "passed some flatus." Id. At quarter of eight that morning, and again at nine, A. L. used a spirometer. Dr. Solman saw her at eight o'clock. She complained of shortness of breath at nine. A chest x-ray taken August 27, 1988, showed "areas of atelectasis in each lung base, somewhat more pronounced on the right side." Id. at 44. At three o'clock that afternoon, she was hyperventilating. When Dr. Loutfi saw her at half past three, her lungs were clear, and the X-ray taken earlier in the day had evidently not yet been seen by a radiologist. At half past four, a nurse gave A. L. ten milligrams of Valium "for relaxation/rest," Petitioner's Exhibit No. 2, and, fifteen minutes later, a "bag to breathe in," which A. L. used for about five minutes. The nurse initialled A. L.'s chart next to a physician's order that concluded: "Valium 10 mg. IV slowly." Petitioner's Exhibit No. 2. Asked on deposition who ordered the Valium, Dr. Corwin testified: And then it says. I can't read what it says. record to Loutfi in far as NAR? I don't know. DR. ELKADI: Dr. Ludwig [sic]. BY DR. ELKADI: Q. All right. In patients having - - MRS. SMALL: I would object for the the questioner testifying. Corwin Deposition at 42. Perhaps Dr. ordered the Valium. The order was not, any event, given by the respondent, as the evidence shows. At quarter past five, the nurse "encouraged [A. L.] to slow/deep breathe." Id. Ten minutes later she found A. L., whom she had last seen sitting on the side of her bed, sprawled across it. Cyanotic around the mouth, she was not breathing. After Drs. Loutfi and Elkadi tried in vain to resuscitate A. L., respondent pronounced her dead, at 6:30 p.m. on August 27, 1988. Cause of Death Unclear Each of the four physicians who testified at hearing or on deposition assigned a different reason for A. L.'s death. Dr. Elkadi reported the following in a discharge summary: The postoperative course during the first 4 occasional the blood of be Patient the The was patient was days was uneventful except for episodes of anxiety, usually related to incisional pain or discomfort caused by NG-tube, and which always responded to sedation or analgesis medication. The oxygenation was measured during several these anxiety episodes and was found to satisfactory with 02 saturation level of 95-97% using the finger tip oxymeter. was walking outside the room already on first postoperative day. By the fourth postoperative day the Foley catheter was removed and she had 2 bowel movements. incision was healing well, and the chest clear to auscultation. On 8/27/88, about 5:20 p.m., the suddenly arrested, and cardiopulmonary resuscitation was carried out. There heart to over an The of considerable airway resistance, and the was in asystole which failed to respond large doses of cardiac drugs. After hour of intensive resuscitative efforts, patient was pronounced dead at 6:30 p.m. course of events was strongly suggestive massive pulmonary embolism. Petitioner's Exhibit No. 2. After the autopsy revealed that the only blood clots in the lungs had formed post mortem, Dr. Elkadi refined his hypothesis, and posited a fat embolus or emboli in the lungs, which, he surmised, degraded into free fatty acids before the autopsy took place, perhaps before death occurred. He testified that free fatty acids produce serotonin, which causes bronchospasms, and he cited resistance the airway offered during the unsuccessful attempt to resuscitate A. L. Ventilation and oxygenation were virtually impossible, even though the endotracheal tube was already in place. Although Dr. Mahoney, the pathologist who performed the autopsy, found a fatty liver, he ruled out a pulmonary fat embolism because he saw no evidence of infection or trauma to the liver (which might have dislodged fat) and because examination of lung and brain tissue (a single section of each) revealed no fat globules. "No intravascular lipid vacuoles were identified in the lung." Petitioner's Exhibit No. 2. On the other hand, "[o]ccasional perivascular lipid vacuoles were seen . . . in the brain section . . . ," Id., indicating fat cells must have passed through the lungs at some point. The autopsy report made no mention of any mechanical blockage or of distension of any part of the gastrointestinal track. Nor was there evidence of alimentary leakage. All sutures held. "Inspection [during the autopsy] of the surgical sites where the surgeon had done anastomotic, reanastomosis of stomach and bowel . . . [showed] these sites were intact and grossly appeared viable." T. 9. Dr. Mahoney listed as a major finding in the autopsy report "[i]schemic enteritis with focal necrosis of the proximal jejunal segment at the entero-enterostomy junction of the Roux-en-y procedure; mesenteric vein thrombosis." Petitioner's Exhibit No. 2. But at hearing he testified, consistently with reported results of microscopic examination, that "major findings at the autopsy . . . [included] a segment of intestine, the jejunal segment, which had undergone a hemorrhagic necrosis." T. 8. Ischemic changes occur when blood supply is insufficient, while hemorrhagic changes are the result of insufficient ability to remove blood. Blood clots blocked veins serving the necrotic tissue. At hearing, Dr. Mahoney concluded "that the most probable cause [of A. L.'s death] was this dead bowel segment essentially causing sepsis." T. 13. Microorganisms penetrating the transmural necrosis caused localized infection outside the bowel or peritonitis, he testified, which led to infection in the blood stream. Septic toxins circulating in the blood caused cardiovascular failure, he theorized. These conclusions rest on autopsy findings of serositis and "approximately 1 liter of cloudy brown fluid with fibrin strands," (Petitioner's Exhibit No. 2) in the abdominal cavity. But Dr. Mahoney did not find "certain types of cells" (T.94) usually found two and a half to three days after peritonitis sets in. In fact, the autopsy findings "are not unusual findings after abdominal surgery without any complication." T.130. Dr. Corwin, one of two surgeons testifying as experts for petitioner, testified that "the autopsy report . . . [contained] essentially no indication of peritonitis." Corwin Deposition at 46. In a report petitioner put in evidence, Dr. Corwin had earlier written that "there really is no evidence of peritonitis." Dr. Corwin wrote, on June 25, 1990, after examining A. L.'s records, "In my opinion the heavy dose of intravenous Valium within the hour before the patient's sudden cardiac arrest almost certainly caused apnea, respiratory shutdown and subsequent to this, the patient suffered a cardiac arrest from which she could not be resuscitated." Petitioner's Exhibit No. 3. Dr. Mahoney testified that the final administration of Valium "may have actually contributed to a respiratory arrest" (T.15) and so to A. L.'s death. A. L. received her last dose of valium 45 minutes before she was last seen alive and 55 minutes before she was found dead. Dr. Corwin conceded that he had ordered Valium for patients in circumstances comparable to A. L.'s over a period of some 17 years, but always, he said, in situations where the patient would be watched, until the effects of the drug wore off. When administered intravenously, Valium has its maximum effect within five minutes. As far as the evidence showed, A. L. did not have an adverse effect to any earlier dose of Valium. For moderate anxiety, the Physicians' Desk Reference (1987 ed.) recommends dosages of "2 mg to 5 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." For severe anxiety, the same reference recommends dosages of "5 mg to 10 mg, I. M. or I. V. Repeat in 3 to 4 hours, if necessary." "Valium is indicated for the management of . . . short-term relief of the symptoms of anxiety." Respondent's Exhibit No. 2. Contraindications are "known hypersensitivity" and glaucoma. Dr. MacGregor, the other surgeon whose opinion petitioner relied on, testified that the "fundamental cause [of A. L.'s death was hypovolemic shock . . . [shock brought on by l]ow blood volume." MacGregor Deposition at 30. When asked, Dr. MacGregor agreed that Valium "may have contributed," id. at 29, to A. L.'s death. But his principal contention was that the focal necrosis created an ileus or physiological obstruction, which caused distension of the stomach and upper gastrointestinal tract which in turn led to a loss of fluid into the lining of the stomach and bowel and ultimately to hypovolemic shock. Recordkeeping Petitioner presented evidence from the same two surgeons on the question whether respondent had adequate medical records while treating A. L. In a letter attached to Dr. Corwin's deposition as an exhibit, he wrote: Did the subject prepare and keep written medical records justifying the course of treatment of the patient, including history, examination and test results? The answer to this question is yes. Deposition of Corwin, Petitioner's Exhibit No. 3. Dr. MacGregor testified that respondent's operative note was "inadequate in terms of . . . [d]etails of sutures and the techniques that were used . . . the instruments used . . . not the number of sutures but the type of sutures and the number of layers." Deposition of MacGregor at 12. But on cross-examination, Dr. MacGregor conceded that "similar operative notes [are] found in many other surgeons' records." Deposition of MacGregor at 35. The hospital records contain a separate, presumably complete list of the surgical instruments Dr. Elkadi used. Although Dr. Elkadi ordered arterial blood gas evaluations, and blood tests specifically to determine oxygen saturation, results of these tests are not in the hospital records, insofar as the hearing officer could discover. Dr. MacGregor testified the results were not in the copy of the records he was furnished. He testified: I think a blood gas was obtained but it's not two helpful normal in the records; and oxygen saturation on occasions. . . . [T]hey would be quite because they might well indicate fairly levels in a patient who has a rapid respiratory rate . . . Deposition of MacGregor at 24. Dr. MacGregor testified that he "would have thought that [it] would have been standard hospital procedure for whoever obtained those, to have recorded them in the record." Deposition of MacGregor at 25.
Recommendation It is, accordingly, RECOMMENDED: That petitioner dismiss the administrative complaint against respondent. DONE and ENTERED this 25th day of January, 1991, in Tallahassee, Florida. Administrative Hearings 1550 the Administrative Hearings 1991. ROBERT T. BENTON, II Hearing Officer Division of The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399- (904) 488-9675 Filed with the Clerk of Division of this 28th day of January, APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact Nos. 1 through 7, 12, 14, 15, 16, 18, 20, 21, 22 and 28 have been adopted, in substance, insofar as material. With respect to petitioner's proposed findings of fact Nos. 8 and 9, see paragraphs 11 through 28 of the findings of fact. With respect to petitioner's proposed findings fact No. 10, the record showed dosages, before the final dose, of five, five, five, three, ten and five milligrams. With respect to petitioner's proposed finding of fact No. 11, some tests were done; others were not. Petitioner's proposed findings of fact Nos. 13, 19, 23, 24, and 26 pertain to subordinate matters. With respect to petitioner's proposed findings of fact Nos. 17 and 25, the cause of death was not clear. Petitioner's proposed findings of fact Nos. 27 and 29 were not proven. Petitioner's proposed findings of fact No. 31 is immaterial. Respondent's proposed findings of fact Nos. 1, 2 and 3 in Part 1 and 3 in Part 2, have been accepted, in substance, insofar as material. With respect to respondent's proposed finding of fact No. 4 in Part 1 and No. 10 in Part 3, these matters are not material to the allegations of the administrative complaint. With respect to respondent's proposed finding of fact No. 5 in Part 1 and Part 2, the cause of death is unclear. With respect to respondent's proposed findings of fact Nos. 1, 2 and 8 in Part 3, see findings of fact Nos. 11 through 28. With respect to respondent's proposed finding of fact No. 4 in Part 3, the autopsy report does not reflect this but he so testified at hearing. Respondent's proposed findings of fact Nos. 5, 6, 7 and 9 pertain to subordinate matters. COPIES FURNISHED: Wellington H. Meffert, II, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Ahmed Elkadi, M.D. 236 S. Tyndall Parkway Panama City, FL 32404 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue presented for decision in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on July 28, 1998.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: Petitioner is the state agency charged with regulating the practice of medicine in the State of Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license no. ME 0031639 on October 26, 1977. Respondent is board certified in general surgery and has worked and trained as a general and vascular surgeon. Respondent has practiced medicine in Tampa since 1988. Respondent offered testimony establishing that his peers respect his ability as a surgeon. Until 1996, Respondent had not been the subject of disciplinary action by the Board of Medicine or by any other licensing entity. On January 26, 1996, the Board of Medicine issued a final order in Division of Administrative Hearings Case No. 95-3925, imposing discipline on Respondent’s license to practice medicine. Case No. 95-3925 involved two separate incidents in which Respondent performed surgical procedures that had not been specifically consented to by the patients. In the first incident, Respondent removed the severely diseased left leg of the patient when the signed consent to surgery was for removal of the right leg. The patient was well known to Respondent, and it was understood between Respondent and the patient that both legs would eventually require amputation. In the second incident, Respondent removed a toe that had become dislocated during a debridement of the patient’s foot. The toe was connected only by ligament and necrotic tissue, and Respondent removed it during the debridement procedure rather than waiting to obtain specific consent for its removal. In the final order, the Board of Medicine concluded that Respondent had violated Sections 458.331(1)(p) and (t), Florida Statutes, by failing to obtain proper consent from a patient and by practicing medicine below the standard of care. Based on these conclusions, the Board of Medicine imposed the following relevant disciplinary measures: Respondent’s license to practice medicine is REPRIMANDED. Respondent shall pay an administrative fine in the amount of $10,000 to the Board of Medicine, within one year of the date this Final Order is filed. Respondent’s license to practice medicine in the State of Florida is SUSPENDED for a period of 6 months including the time served under the emergency suspension. Respondent shall submit a practice plan prior to reinstatement to be approved by the Board’s probation committee. Within 6 months of the effective date of this Final Order, Respondent shall have an independent, certified risk manager review Respondent’s practice. Specifically, this independent consultant shall review the Respondent’s practice concerning preoperative procedures including patient consent. This consultant will prepare a written report addressing Respondent’s practice. Such report, if necessary, will include suggested improvements of the quality assurance of Respondent’s practice. Respondent will submit this report to the Board’s Probation Committee with documentation that demonstrates compliance with the suggestions enumerated in the consultant’s report. Upon reinstatement, Respondent’s license to practice medicine in the State of Florida shall be placed on PROBATION for a period of two years, subject to the following terms and conditions: Respondent shall comply with all state and federal statutes, rules and regulations pertaining to the practice of medicine, including Chapters 455, 458, 893, Florida Statutes, and Rules 59R, Florida Administrative Code. Respondent shall appear before the Probation Committee at the first meeting after said probation commences, at the last meeting of the Probation Committee preceding termination of probation, quarterly, and at such other times requested by the committee. Respondent shall be noticed by the Board staff of the date, time and place of the Board’s Probation Committee whereat Respondent’s appearance is required. Failure of the Respondent to appear as requested or directed shall be considered a violation of the terms of this Probation, and shall subject the Respondent to disciplinary action. * * * 6. Respondent shall not practice except under the indirect supervision of a physician fully licensed under Chapter 458 to be approved by the Board’s Probation Committee.... The responsibilities of a monitoring physician shall include: Submit quarterly reports, in affidavit form, which shall include: Brief statement of why physician is on probation. Description of probationer’s practice. Brief statement of probationer’s compliance with terms of probation. Brief description of probationer’s relationship with monitoring physician. Detail any problems which may have arisen with probationer. * * * Respondent shall submit quarterly reports in affidavit form, the contents of which shall be specified by the Board. The reports shall include: Brief statement of why physician is on probation. Practice location. Describe current practice (type and composition). Brief statement of compliance with probationary terms. Describe relationship with monitoring/supervising physician. Advise Board of any problems. * * * 11. Respondent understands that during this period of probation, semi-annual investigative reports will be compiled by the Agency for Health Care Administration concerning his compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine. On January 31, 1996, Respondent submitted to the Board of Medicine the practice plan required by the final order. The practice plan named Joseph Diaco, M.D., as Respondent’s monitoring physician, and stated that Dr. Diaco would review twenty percent of Respondent’s patient charts. The practice plan stated that Respondent would comply specifically with all the terms and conditions of the final order, and with the recommendations of the certified risk manager. The practice plan further stated: ... Dr. Sanchez will have specific discussions with his surgical patients prior to any anesthesia being administered, wherein he will discuss the intended surgical procedure again, and will have the intended surgical site marked with indelible ink. The record does not document that the Board of Medicine’s Probation Committee formally approved Respondent’s practice plan, or addressed the terms of the practice plan in any way. Such approval is presumed from the fact that Respondent appeared before the Probation Committee on several occasions subsequent to filing the practice plan, and the record does not indicate that the Probation Committee registered any objection or suggested any modifications to the practice plan. Respondent made the required appearances before the Probation Committee. Respondent and Dr. Diaco submitted the required quarterly reports to the Board of Medicine, and Dr. Diaco fulfilled the monitoring requirements of the practice plan. Periodically during the probation period, Mr. Richard Hess, an investigator with the Agency for Health Care Administration, would contact Respondent and Dr. Diaco to inquire as to Respondent’s practice and compliance with the terms of probation. Mr. Hess would inquire regarding such matters as the submission of quarterly reports, the payment of the administrative fine, and the current locations at which Respondent was practicing. Mr. Hess would submit his reports to the Agency for Health Care Administration and to the Board of Medicine, and these reports were used to supplement the information submitted directly by Respondent and Dr. Diaco. Based upon the information he was provided by Respondent and Dr. Diaco, Mr. Hess never found Respondent out of compliance with the terms of his probation. On the morning of November 2, 1997, an order was entered at Vencor Hospital by the primary treating physician for placement of a central venous line for patient D.M., an 80 year- old female patient. A central venous line is most often placed for access to the circulatory system for the provision of medications and/or fluids when the peripheral venous system is not available for such use. A central venous line may be ordered if the patient has no veins remaining for the insertion of a peripheral catheter, or for extended access, such as when a patient requires a long-term cycle of antibiotics for a bone infection. Patient D.M. required the central line for antibiotics to treat infected ulcerations on her lower extremities. The placement of a central line may be performed by any licensed physician, though surgeons are often called in to perform the procedure for primary physicians. Two physicians who teach at the University of Miami testified that third-year residents are allowed to perform the procedure with only indirect supervision. Dr. Diaco testified that nurse practitioners may perform the procedure under the supervision of a physician. The procedure is performed at the patient’s bedside, not in an operating room. No general anesthesia is required. A local anesthetic is administered at the point of insertion. The entire procedure takes two to three minutes to perform. The central line may be placed in at least three locations in the body: the leg, the neck, or the collarbone. In the case of D.M., Respondent placed the line by way of the collarbone. A needle is inserted under the clavicle and into the vein that unites with the jugular vein to form the second largest vein in the human body, the superior vena cava. Using a guide wire, a catheter is threaded through the subclavian vein and placed inside the superior vena cava. Prior to performance of the procedure, the patient’s head is typically placed lower than her feet in what is called the Trendelenburg position. If the patient has a feeding tube, it is typically turned off prior to the procedure to prevent aspiration of tube material. Proper placement of the central line is confirmed by X- ray taken immediately after the procedure. Such confirmation of placement is necessary due to the risks associated with incorrect placement. The most immediate risk is pneumothorax, the puncturing of the patient’s lung. Other less common complications are blood loss, cardiac arrest, infection, and irregular heartbeat. The consensus of the experts who testified at hearing was that the procedure poses no greater risk of complication for elderly patients such as D.M., but that elderly patients who do suffer complications may have a harder time recovering than would younger, more robust patients. D.M. was an 80 year-old female patient who shared Room 218 at Vencor Hospital with J.P., an 89 year-old female patient. D.M. and J.P. were of the same general age, ethnic origin, and gender. They had similar medical problems, including bilateral lower extremity decubiti and ulcerations. D.M. was able to understand conversation and could verbally communicate with staff. D.M. signed on her own behalf the consent form for the insertion of the central venous line. The signature on the consent form was obtained by and witnessed by Elizabeth Rood, a registered nurse on duty during the day of November 2, 1997. Ms. Rood testified that she believed D.M. was rational enough to sign the form on her own behalf. Vencor Hospital policy dictated that informed consent be obtained from the patient by the surgeon who was to perform the procedure. The nursing employees of Vencor Hospital and Respondent all testified that, despite the stated policy, it was common practice at the time for nurses to obtain the signatures of patients on the consent forms. The express terms of Respondent’s practice plan also required Respondent to have “specific discussions with his surgical patients prior to any anesthesia being administered. ” J.P. suffered from organic brain syndrome and was generally unable to communicate verbally. J.P. was unable to give consent for surgical procedures on her own behalf. Ms. Rood obtained D.M.’s signature on the informed consent form at about 10:00 a.m. Shortly thereafter, hospital staff contacted Respondent to inform him of the order and request that he perform the placement of the central line. Respondent replied that he was unable to perform the procedure at that time because of a more urgent consultation at St. Joseph’s Hospital, but would come to Vencor Hospital later to perform the procedure. Shortly before the start of the nursing night shift, the central line cart with supplies for the procedure was brought by the day supervisor to the second floor of Vencor Hospital and placed outside Room 218. Lisa Cotroneo was the night charge nurse. When she arrived for her shift, she received report from the day charge nurse. That report indicated that D.M. was to receive a central line placement at some time during the evening. The nursing staff at Vencor was divided into teams of two or three nurses assigned to particular rooms on the floor. Team three was responsible for Room 218. At the start of the night shift, Nurse Cotroneo informed two of the three nurse on team three, Donna Maranto and Fortune Ndukwe, that a central line was to be placed on patient D.M. that evening. Nurse Cotroneo did not inform the third nurse, Mary Shogreen, because Nurse Shogreen was a pool nurse called in to work on short notice and had not yet arrived for her shift. Nurse Shogreen was the nurse on team three who was assigned primary care duties for the patients in Room 218. Nurse Shogreen was later informed by Nurse Ndukwe that one of her patients would be receiving a central line placement that evening. Nurse Shogreen testified that she intended to check with the charge nurse to confirm the order for a central line placement, but that she never did so. At around 8:00 p.m., Respondent telephoned the nursing unit to inform the charge nurse that he was on his way to perform the placement of the central line. Nurse Cotroneo conveyed this information to Nurses Maranto and Ndukwe, and told them to be sure everything was ready for Respondent’s arrival. Respondent arrived at Vencor Hospital shortly after 8:00 p.m. and proceeded to the second floor nursing station, where he asked for and received the chart for patient D.M. He reviewed the chart, which contained the signed consent form and the order for placement of the central line. After reviewing the chart, Respondent inquired as to the location of D.M. and the nurse who would assist him in the procedure. Respondent was told that D.M.’s nurse was down the hall. Respondent walked down the hall and approached a group of three or four nurses. Respondent did not know any of them. He informed the group that he was Dr. Sanchez and was there to perform the central line placement. One of the nurses, later identified as Mary Shogreen, told him she was ready for him. She led him down the hall toward Room 218. Respondent paused at the central line cart outside Room 218 to pick up a pair of surgical gloves and the kit used for the central line placement. When Respondent entered the room, he observed Nurse Shogreen already at the bedside. The room was dark, save for a single light over the bed of the patient where Nurse Shogreen was working. Respondent saw that Nurse Shogreen was turning off the feeding tube to the patient, a common precursor to performance of a central line placement. Respondent walked to the other side of the patient’s bed and addressed the patient by the name of D.M. He told her that he was Dr. Sanchez and that her physician had asked him to insert a central venous catheter in her. Respondent looked into the patient’s eyes and realized she was not comprehending what he said. Nurse Shogreen was standing directly across the bed and could hear Respondent’s efforts to talk to the patient, including his addressing that patient as “D.M.” Respondent asked Nurse Shogreen if the patient was “always like this,” i.e., unresponsive. Nurse Shogreen answered that she had never had the patient before, but believed that was the usual condition of the patient. It would not be unusual for an elderly patient such as D.M. to be communicative and able to understand and sign a consent form at 10:00 a.m., but then be uncommunicative in the evening. The medical community informally refers to this phenomenon as "sundown syndrome." Respondent told Nurse Shogreen to assist him in placing the patient in the Trendelenburg position, and to get a rolled towel to place between the patient’s shoulder blades. While Nurse Shogreen was getting the towel, Respondent examined the patient’s neck and chest. Nurse Shogreen returned with the towel, but was unable to adjust the bed into Trendelenburg position. Respondent told her to go get another nurse who knew how to work the bed. She brought in Nurse Ndukwe, who was also unable to get the bed into the proper position. At length, they found a certified nurse assistant who was able to place the bed into position. Neither Nurse Shogreen nor Nurse Ndukwe expressed any concern to Respondent regarding the identity of the patient. Nurse Ndukwe had received an explicit report concerning the fact that patient D.M. was to receive a central line placement. Nurse Shogreen had heard Respondent address the patient as D.M. Respondent completed the procedure, which took about one minute. He proceeded to the nurse’s station and ordered the standard X-ray to confirm the proper placement of the central line, completed the consult form, and dicated both his consultation report and operative report. Nurse Shogreen remained behind in the room to clean up after the procedure. She made notations in the bedside chart of patient J.P., the mistaken recipient of the central line. Even at this point, Nurse Shogreen did not realize that the wrong patient had received the central line. The findings as to events in Room 218 on the evening of November 2, 1997, were based on the testimony of Respondent. Nurse Shogreen testified that it was Respondent who led the way into the room, Respondent who proceeded to the wrong bed, and Respondent who prevented Nurse Shogreen from going out to get the patient’s chart to confirm her mental condition after questioning by Respondent. Nurse Shogreen agreed with Respondent’s version of the problems with getting the bed into proper position, but testified that Respondent was so angry and in such a hurry that he performed the central line placement before the staff was able to place the bed in the proper position. Based on both the substance of the testimony and the demeanor of the witnesses, it is found that Respondent’s version of events is more believable, and that Respondent is a more credible witness than Nurse Shogreen. The undersigned is unable to credit testimony that a physician of Respondent’s skill and experience would plunge ahead into the room and commence a procedure on a patient he had never seen, without doing anything to ascertain her identity. The undersigned finds it more plausible that Respondent followed Nurse Shogreen’s lead, observed the visual cues she was providing, and assumed that the patient to whom Nurse Shogreen attended was in fact patient D.M. Respondent's proffer of testimony regarding inconsistencies in Nurse Mary Shogreen's testimony before the Peer Review Committee was disregarded in formulating these findings of fact. Several physicians offered expert testimony as to whether it is within the standard of practice for a surgeon to rely on his assisting nurse for patient identification. Dr. David Shatz, an associate professor of surgery at the University of Miami, testified that any surgeon must be absolutely sure he is working on the right person. He testified that once Respondent was unable to get a verbal response from the patient, he should have asked the nurse if he was speaking to patient D.M. Dr. Shatz concluded that it is a deviation from the standard of care to perform a procedure on a noncommunicative patient without checking the patient’s identification bracelet. Dr. Stephen Michel agreed that Respondent failed to meet the standard of care by placing the central line in the wrong patient. Dr. Michel’s other conclusions regarding the events in question cannot be credited because he admitted he was assuming that Dr. Sanchez was not permitted by the terms of his probation to be working in Vencor Hospital at all. This assumption was incorrect, and colored the remainder of his conclusions. Dr. Enrique Ginzburg, also an associate professor of surgery at the University of Miami, testified that a surgeon is usually unfamiliar with the patient in a central line placement, and stated that he could not remember the last time he checked an identification bracelet when the nurses were in the room with him. He agreed that it would be easy to check the armband, but that physicians simply do not check the armband if nurses are present to identify the patients. Dr. Jerry Diehr, an anesthesiologist at St. Josephs Hospital in Tampa, testified that a reasonably prudent physician would do what Respondent did. He stated that he relies on nurse identifications in similar circumstances, and that it is common practice for physicians to do so. Dr. Diehr testified that physicians rely on nurses for all manner of patient identification. He noted that care is often dictated by telephone calls. When a nurse calls him and tells him about the condition of his patient, the underlying assumption is that the nurse has correctly identified the patient and adequately reported the condition. Physicians may base their entire course of treatment on such reports from nurses, and must be able to rely on the nurses for such identification and reporting. Dr. Diaco strongly opined that physicians must be able to rely on nurses for patient identification. It is the nurse’s responsibility to identify the correct patient when the physician does not know the patient. Dr. Diaco testified that if physicians cannot rely on nurses for such basic information as the identity of their patients, they may as well live in the hospital and administer their own medications. Peter Shute, an expert in general nursing practice, opined that the three nurses on duty at Vencor Hospital on the evening of November 2, 1997, were negligent in their duty to know the patients on their assigned unit. He testified that Nurse Shogreen was particularly negligent, because she had not received full report on her patients, found out that one of her patients was to receive a central line placement that evening, but did not immediately obtain a full report and take steps to ensure that all preparations had been made. The weight of the evidence is that it was within the standard of care under the conditions and circumstances for Respondent to rely on Nurse Shogreen’s identification of the patient. This finding does not minimize the fact that Respondent bears ultimate responsibility for the performance of an invasive procedure on a patient who did not give informed consent. After Respondent dictated his notes and left the hospital, David Vallejo, the X-ray technician, came to the floor to obtain the X-ray ordered by Respondent. He discovered that the patient who received the central line was J.P., not D.M. Mr. Vallejo went to the nurse’s station and informed Nurse Cotroneo, who called the nursing supervisor to come to the room with her. Nurse Cotroneo and the supervisor confirmed that both patients in Room 218 were wearing their identification bracelets. The nursing supervisor called J.P.’s primary physician, who ordered an X-ray, which confirmed that J.P. suffered no ill effects from the placement of the central line. He also ordered removal of the central line, which was accomplished without incident. Respondent was informed of the error by telephone. He came to Vencor Hospital the next day, November 3, 1997, and documented the error in the medical records of both D.M. and J.P. On that day, a different surgeon performed the central line placement on D.M. All of the expert witnesses agreed that Respondent’s charting and recording of the incident, both before and after he learned of the error, were adequate and indicated no effort to conceal the facts of the situation. The experts also agreed that marking the intended surgical site with indelible ink serves no purpose in a central line placement. Petitioner's own expert, Dr. Shatz, stated that marking the site of a central line placement would be "silly." On November 3, 1997, Vencor Hospital suspended Respondent’s hospital staff privileges pending an investigation of the incident. Respondent immediately contacted Dr. Diaco, his indirect supervisor, as soon as he learned of the error. Respondent fully informed Dr. Diaco of the facts of the situation. Dr. Diaco told Respondent that he did nothing wrong and that “the nurse is in big trouble.” Respondent also sought the counsel of his attorney, Michael Blazicek. Mr. Blazicek conferred with Dr. Diaco, and also concluded that this was a nursing problem, not a standard of care problem for Respondent. The results of the hospital’s internal Peer Review Committee review seemed to bear out the opinions of Dr. Diaco and Mr. Blazicek. On November 26, 1997, Respondent was restored to full privileges at Vencor Hospital. Nurse Shogreen received verbal counseling and a one-day suspension for failure to render proper treatment to the correct patient. Vencor Hospital’s “Root Cause Analysis Team” found that nursing protocols should be changed to prevent a recurrence of patient misidentification. Patients would henceforth be identified by bed letter designation. Identification of the patient and consent to treatment would be verified by two people, one of whom must be a hospital employee. On November 17, 1997, the quality review manager of Vencor Hospital submitted an Adverse or Untoward Incident Report (Code 15) regarding the incident, pursuant to Sections 395.0197(6) and 641.55(6), Florida Statutes. A Code 15 Report is a report of serious adverse incidents in licensed facilities. The Code 15 Report identifies the physicians and nurses involved by their license numbers, and identifies the patient and facility. It describes the nature of the incident and all actions taken by the hospital in response to the incident. The purpose of the Code 15 Report is to notify the Agency for Health Care Administration and the Department of Health within 15 days of a serious adverse incident so the Agency may review the incident and begin an investigation. Respondent appeared before his Probation Committee on November 13, 1997. At this time, Respondent knew that the hospital would be filing a Code 15 Report, though it had not actually done so. Respondent was still on summary suspension at Vencor Hospital, pending review. Prior to his Probation Committee appearance, Respondent conferred with his attorney, Mr. Blazicek, who counseled him to answer any questions forthrightly, but not to volunteer information about the incident to the Probation Committee. This advice was based on the facts that the incident was still under investigation, that there had been no finding of wrongdoing by Respondent, and that summary suspension was a standard procedure for such incidents indicating no conclusions as to ultimate responsibility. Mr. Blazicek testified that he knew Respondent still had one more written quarterly report to file in January 1998. He reasoned that if the hospital's investigation resulted in adverse findings, Respondent could report the incident in that later filing. The Probation Committee raised no questions as to the Vencor Hospital incident, and determined that Respondent’s probation would terminate as scheduled upon payment of the administrative fine. Respondent did not volunteer information about the incident or the summary suspension. Respondent and Dr. Diaco filed their final quarterly reports in January 1998. Neither of them reported the Vencor Hospital incident. Respondent reported that he was in full compliance with all probationary terms. By the time the final quarterly reports were received, the Department of Health was aware of the Code 15 Report. Nonetheless, the Department issued an Order of Termination on February 2, 1998, finding that Respondent had satisfactorily completed the term of his probation as of January 26, 1998.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Health, Board of Medicine enter a final order determining that Rolando R. Sanchez has violated Section 458.331(1)(p), Florida Statutes, and suspending his license for a period of nine months from the date of the Order of Emergency Suspension of License, imposing a fine of $2,500.00 and placing Respondent on probation for a period of two years from the date the suspension expires. DONE AND ENTERED this 24th day of November, 1998, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON 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 Filed with the Clerk of the Division of Administrative Hearings this 24th day of November, 1998. COPIES FURNISHED: Albert Peacock, Esquire John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast Bin A-02 Tallahassee, Florida 32399-1703 Tanya Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
