STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )
)
Petitioner, )
)
vs. )
)
JOHN BATISTA, M.D., )
)
Respondent. )
Case No. 03-0309PL
)
RECOMMENDED ORDER
Pursuant to notice, Lawrence P. Stevenson, Administrative Law Judge, Division of Administrative Hearings, conducted a formal hearing in the above-styled case on April 2, 2003, in Tampa, Florida.
APPEARANCES
For Petitioner: Bruce A. Campbell, Esquire
Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Christopher J. Schulte, Esquire
Burton, Schulte, Weekley, Hoeler & Beytin, P.A.
100 South Ashley Drive, Suite 600 Tampa, Florida 33602
STATEMENT OF THE ISSUE
Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections
458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient R.E., as alleged in the Administrative Complaint in this proceeding.
PRELIMINARY STATEMENT
On September 24, 2002, Petitioner alleged in an Administrative Complaint that Respondent failed to practice medicine with an acceptable level of care in the treatment of Patient R.E., in one or more of the following ways:
(a) Respondent failed to perform a complete physical examination of Patient R.E.'s right leg on January 16, 2001; (b) Respondent failed to take a complete history and Review of Systems; (c) Respondent failed to consider the diagnosis of atheriosclerotic peripheral vascular disease; (d) Respondent failed to schedule follow-up appointments to re-evaluate within three (3) days of the January 16, 2001, office visit; and (e) Respondent failed to order skin care precautions, duration of treatment, monitoring, and appropriate laboratory tests, such as kidney function or other follow-up instructions.
Further, Petitioner alleged that Respondent failed to keep a medical record justifying the course of treatment of Patient R.E., in one or more of the following ways: (a) Respondent's records failed to document the reason for not performing a complete physical examination of Patient R.E.'s right leg on January 16, 2001; (b) Respondent's records failed to document
the complete history and Review of Symptoms; (c) Respondent's records failed to document the reason for not considering the diagnosis of atheriosclerotic peripheral vascular disease; (d) Respondent's records failed to document follow-up appointments to re-evaluate within three (3) days of the January 16, 2001, office visit; (e) Respondent's records failed to document the reason for not ordering appropriate laboratory tests; (f) Respondent's records failed to document the Master Problem List, Current Medication List or Diabetic Flow Sheet to reflect management of Patient R.E.'s complex health problems; and (g) Respondent's records failed to document the office notes in a legible manner, and failed to communicate sufficient details to justify the course of treatment.
On October 15, 2002, Respondent submitted an Election of Rights form denying the allegations and requesting a formal hearing. On January 28, 2003, this matter was forwarded to the Division of Administrative Hearings for assignment of an Administrative Law Judge and conduct of a formal administrative hearing.
At the hearing, Petitioner offered the testimony of D.Y., the widow of Patient R.E.; and Patrick T.G. Hennessey, M.D. Four exhibits for Petitioner were admitted in evidence: Petitioner's Composite Exhibit 1 (Respondent's office records relating to the treatment of Patient R.E.), Petitioner's
Composite Exhibit 2 (Oak Hill Hospital records relating to Patient R.E.'s January 20, 2001, emergency room visit), Petitioner's Composite Exhibit 3 (Oak Hill Hospital records relating to Patient R.E.'s February 5, 2001, admission), and Petitioner's Exhibit 4 (curriculum vitae of Dr. Hennessey). Respondent testified on his own behalf. Six exhibits were received on behalf of Respondent: Respondent's Exhibit 1 (deposition testimony of Kent R. Corral, M.D.), Respondent's Exhibit 2 (deposition testimony of Mallik Piduru, M.D.), Respondent's Exhibit 3 (excerpts from Respondent's office telephone logs), Respondent's Exhibit 4 (list of Respondent's office appointments for January 26, 2001), Respondent's Exhibit
10 (Respondent's discharge summary from R.E.'s April 2001 admission to Oak Hill Hospital); and Respondent's Exhibit 11 (Dr. Kevin Palmer's consultation notes from R.E.'s April 2001 admission to Oak Hill Hospital).
A Transcript of the hearing was filed at the Division of Administrative Hearings on April 24, 2003. Respondent filed a Proposed Recommended Order on May 5, 2003. Without objection, Petitioner's Proposed Recommended Order was filed on May 12, 2003. Both parties' proposals have been given careful consideration in the preparation of this Recommended Order.
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 pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes.
Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0057927. Respondent practices primary care and internal medicine. He is board-certified in internal medicine, and has never had disciplinary action taken against his license.
Patient R.E., a male who was 78 years old in January 2001, had a history of diabetes, hypertension, heavy smoking, high blood pressure, and circulatory problems.
Respondent had first treated Patient R.E. on August 28, 2000, while covering for the physician with whom Respondent shared a practice. Patient R.E. had been a patient of the practice for several years. In August or September 2000, Respondent purchased the other physician's portion of the practice. The other physician remained as an employee of the practice until January 2001, when Respondent assumed the total care of Patient R.E.
On January 16, 2001, Patient R.E. presented to Respondent with a complaint of redness and swelling in the right ankle that made walking difficult. Patient R.E. did not have a regularly scheduled office visit, but Respondent "squeezed him in" after Patient R.E. telephoned Respondent's office complaining of a great deal of pain.
On January 16, 2001, the complete patient chart from the previous physician was available to Respondent and became part of Respondent's office chart for Patient R.E.
Patient R.E.'s chart contained a "problem list" reflecting diagnoses made throughout his treatment at that office. A problem list assists the physician in tracking on- going problems with a patient. Patient R.E.'s problem list included a diagnosis of "PVD," or peripheral vascular disease.
Peripheral vascular disease describes reduced blood flow to the extremities. It can be caused by a narrowing of large blood vessels, and exacerbated by diabetes-related small vessel disease.
Prior to Respondent's involvement with his treatment, Patient R.E. had been evaluated for peripheral vascular disease, and was referred to a vascular specialist who recommended revascularization by way of bypass surgery. However, Patient
R.E. declined the referral and elected to undergo chelation therapy instead. Mainstream physicians do not consider
chelation an effective therapy for peripheral vascular disease, though Patient R.E. believed that it relieved his symptoms.
After the November 11, 1999, physical exam, Patient
R.E. was seen by the previous physician for three-month follow- ups on February 24, 2000, and June 5, 2000, with no particular complaints. As noted above, Respondent first saw Patient R.E. on August 28, 2000. This visit was for shortness of breath, diagnosed as bronchitis and treated with antibiotics and inhalants. Patient R.E. returned to see the previous physician on September 11, 2000, with chest congestion and coughing. This was his last office visit prior to January 16, 2001.
The office visit of January 16, 2001, was a complaint- driven visit, meaning that Respondent's exam addressed Patient R.E.'s specific complaint. Such an exam is appropriate where the physician has a chart with a record of a complete history and physical exam.
Respondent checked Patient R.E.'s blood pressure and listened to his heart and lungs, which were clear. Respondent then examined Patient R.E.'s right ankle, finding erythema (redness) and tenderness to palpation. Respondent did not perform an examination to address peripheral vascular disease, because he did not consider peripheral vascular disease as the presenting problem and was already aware that peripheral vascular disease was present in this patient.
Respondent recorded a diagnosis of "? gout vs. cellulitis." Gout is an inflammation of the joints caused by deposition of uric acid crystals in the joint fluid. Cellulitis is a term given to an infection of the tissue, typically skin and underlying soft tissue. Gout and cellulitis are symptomatically similar conditions, in that both typically present with pain, stiffness, swelling, and redness of the affected area.
Respondent prescribed Levaquin, an antibiotic, and Indocin, a medication for gout with some pain-relieving properties. Respondent told Patient R.E. to follow up in ten days, and gave Patient R.E. a quantity of medication for ten days' duration. Respondent's office chart did not clearly indicate instructions for the frequency or duration of the Levaquin prescription. The chart indicated that the Indocin was to be taken three times per day, but did not indicate a duration for taking the medication.
On January 17, 2001, Patient R.E. telephoned Respondent's office to request a walker. On January 18, 2001, Respondent ordered a walker through a home health care provider and had it delivered to the patient's home.
Respondent heard nothing from Patient R.E. on January 19, 2001. On Saturday, January 20, 2001, Respondent's office was closed. That evening, he received a telephone call
from Patient R.E.'s wife, who told him that her husband was in a lot of pain. Respondent told the wife that Patient R.E. had not been on the prescribed medications long enough to cure his condition, and that if his pain became worse she should take him to the hospital emergency room.
Shortly after 8:00 p.m., on January 20, 2001, Patient
R.E. presented at the emergency room of Oak Hill Hospital complaining of pain and tenderness in his right ankle. There was an intact red blister over the ankle. The emergency room physician performed an examination, ordered blood tests, and confirmed the diagnosis of cellulitis. Patient R.E. was given injections of insulin and of Rocephin, an antibiotic. The emergency room physician instructed Patient R.E. to continue taking the Levaquin, and to stop taking the Indocin for the suspected gout.
Respondent consulted with the emergency room physician by telephone. At Respondent's suggestion, the emergency room physician also prescribed Flagyl, another antibiotic, to ensure coverage against all potential anaerobes or aerobes that could cause cellulitis. The emergency room physician told Patient
R.E. to follow up with Respondent on Monday, January 22, 2001.
The emergency department of Oak Hill Hospital provided Patient R.E. with written discharge instructions for his cellulitis, including the following information:
With antibiotic treatment, the size of the red area will gradually shrink in size until the skin returns to normal. This will take 7-10 days.
The red area should never increase in size once the antibiotic medicine has been started.
FOLLOW UP with your doctor or this facility as directed. If you were not given a specific follow-up appointment, look at the infected area in two days for the warning signs listed below.
RETURN PROMPTLY or contact your doctor if any of the following occur:
Increasing area of redness
Increasing swelling, or pain
Appearance of pus or drainage
Fever over 100.5 orally
Patient R.E.'s wife telephoned Respondent's office on Tuesday, January 23, 2001, to schedule a follow-up visit. The office visit was scheduled for January 26, 2001. On the scheduled date, Respondent examined Patient R.E. and found that his ankle had worsened and begun to develop necrosis. Respondent referred Patient R.E. to Dr. Malik Piduru, a vascular surgeon, for debridement, instructed him to continue taking the prescribed antibiotics, and to soak his foot in soapy water, which would help to debride the necrotic tissue in the interim.
On February 1, 2001, Dr. Piduru examined Patient R.E. and noted a blue-black discoloration on the right lateral aspect of the lower right leg. The physical examination notes stated: "On the right lateral aspect of the leg approximately 6 x 4 cm
necrotic, gangrenous patch of skin which appeared to be very fluctuant indicating underlying either abscess or hematoma of necrosis. The foot itself does not appear to be acutely ischemic and appears to be pink and viable." Dr. Piduru recommended hospitalization, excision of the necrotic area, and evaluation for further peripheral vascular disease correction. He also discussed the option of amputation if the leg did not heal. The surgeon noted that Patient R.E. understood the options presented to him, and the risks involved, but that Patient R.E. preferred to pursue another course of chelation therapy rather than undergo the recommended bypass surgery to correct the PVD.
On February 5, 2001, Patient R.E. was admitted to the hospital for debridement of the right ankle. While in the hospital, Patient R.E. underwent an angiogram that revealed multiple occlusions of the blood vessels of the right leg.
Dr. Piduru recommended bypass surgery, though he estimated the chances of success at around 30 percent. After discussion of all the options, Patient R.E. elected to have his right lower leg amputated. Dr. Piduru agreed that this was a reasonable decision in light of all the known factors. Patient R.E.'s right leg was amputated below the knee on February 12, 2001.
In March 2001, Patient R.E. suffered an infection of the stump requiring additional hospitalization for debridement.
His health continued to decline due to his multiple medical problems, including pain and peripheral vascular disease. On April 14, 2001, Patient R.E. was again admitted to Oak Hill Hospital with cellulitis of the left foot and the right stump. He declined any invasive procedures to restore circulation to his left leg. Patient R.E. was discharged to a hospice on April 20 and died on April 23, 2001.
Dr. Patrick Hennessey, Petitioner's expert, testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient R.E. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient R.E., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes.
Dr. Hennessey also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient R.E.
Dr. Hennessey's opinion as to the standard of care was based on several criticisms of the examination conducted on January 16, 2001. First, Dr. Hennessey opined that Respondent should have scheduled a follow-up appointment within three days
to evaluate Patient R.E.'s clinical response to the prescribed medicines. The quick follow-up was indicated because of Patient R.E.'s advanced age, and because Patient R.E.'s diabetes and peripheral vascular disease could cause the cellulitis to progress rapidly. Dr. Hennessey also noted that peripheral vascular disease can reduce the effectiveness of antibiotics, further indication of the need for a prompt follow-up examination.
Dr. Hennessey also believed that a three-day follow-up was necessary to definitively rule out the differential diagnosis of gout, if Respondent seriously believed gout was a possibility. Dr. Hennessey testified that Indocin should have provided relief from gout within three days, and that Levaquin should have stopped any increase in swelling, pain, or size of the affected area if Patient R.E. was suffering from cellulitis. In Dr. Hennessey's opinion, a three-day follow-up appointment would have allowed Respondent to determine whether Patient R.E. was obtaining relief and, if not, to try a different antibiotic regime or pursue other avenues of treatment.
Dr. Hennessey also believed that Respondent should have tested Patient R.E.'s blood sugar level on January 16, 2001. Dr. Hennessey testified that diabetes has an impact on a person's ability to fight infection, and that the right antibiotic would be inadequate if the patient had uncontrolled
diabetes. Thus, Respondent should have assessed Patient R.E.'s current and recent diabetic controls.
Finally, Dr. Hennessey criticized Respondent for failing to give Patient R.E. adequate instructions for monitoring his own progress after the January 16, 2001, appointment. Dr. Hennessey testified that the instructions that the Oak Hill Hospital emergency room provided to Patient R.E. on January 20, 2001, set forth in full above, were precisely the kind of instructions Respondent should have given to Patient
R.E. on January 16, 2001.
Dr. Hennessey could not say whether the amputation of Patient R.E.'s right leg was inevitable, though he conceded it was likely to occur within a year or two even if his preferred course of treatment had been followed. He concluded that, on January 16, 2001, the correct alternative was to undertake an "aggressive evaluation" and to make the case to Patient R.E. that he should undergo surgical re-vascularization immediately, while the skin was still intact. Dr. Hennessey's "best guess" was that this course could have given Patient R.E. "probably fifty percent or better likelihood" of avoiding amputation, though he also conceded that "there's a lot of unknowns in there." Dr. Hennessey concluded that the time lost between January 16 and February 1, when Patient R.E. was seen by
Dr. Piduru, the vascular surgeon, made a successful outcome much less likely.
Respondent's expert, Dr. Kent Corral, testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient R.E. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent did not deviate from the accepted standard of care in his treatment and care of Patient R.E. Dr. Corral also testified that in his opinion, Respondent did not violate Subsection 458.331(1)(m), Florida Statutes, by failing to compile appropriate medical records reflecting the treatment and care provided to Patient R.E.
Dr. Corral testified that Respondent's examination of Patient R.E. was within the standard of care. The examination was complaint-driven, directed at the immediate presenting problem, a common and acceptable method employed by nearly all physicians in office practice. Dr. Corral testified that gout versus cellulitis is a very common differential diagnosis, especially in a patient with diabetes. Because there was inflammation of the ankle, peripheral vascular disease would fall very low on the list of possible diagnoses. Had Patient
R.E. presented with a cold, necrotic foot, then peripheral
vascular disease would have been more likely to be the presenting problem. Respondent knew that Patient R.E. had peripheral vascular disease, and it was apparent from the presenting symptoms that peripheral vascular disease was not the acute problem on January 16, 2001.
Dr. Corral agreed that setting a three-day follow-up appointment would have met the standard of care. However, Dr. Corral disagreed that it was necessary to do so. He believed that Respondent reasonably elected not to schedule a
three-day follow-up, but to follow up in ten days. Based on the information available on January 16, 2001, it was not unreasonable for Respondent to test the ten-day course of the prescribed antibiotics before scheduling a follow-up appointment.
Dr. Corral testified that no laboratory tests were necessary to arrive at the differential diagnosis of gout versus cellulitis. He agreed that there was "potentially" some benefit to be derived from testing Patient R.E.'s blood sugar, but did not agree that Respondent's failure to do so amounted to practice below the standard of care. When Patient R.E.'s blood sugar level was checked in the emergency room on January 20, 2001, it was only slightly elevated.
Dr. Corral also disagreed that Respondent failed to meet the standard of care in not giving Patient R.E.
instructions on monitoring his own progress. Dr. Corral concluded that instructions would have made no difference. In his opinion, the antibiotic therapy was the only essential treatment to pursue on January 16, 2001. Dr. Corral believed that anything beyond the antibiotics would amount to "a hope and a prayer."
In summary, Dr. Corral found the examination adequate and the diagnosis correct. He believed that the criticism of Respondent was due entirely to the poor outcome for Patient R.E., and that the poor outcome was not caused by anything Respondent did or did not do on January 16, 2001.
In his own defense, Respondent testified that, prior to the January 16, 2001, appointment, he knew he was dealing with a very difficult patient who had a history of declining surgical intervention to resolve his circulatory problems. Respondent testified that his "first and foremost belief" was that Patient R.E. had cellulitis, and that the only other option, given the presenting symptoms, was an acute attack of gout. The potential for gout led him to prescribe Indocin as well as the antibiotics, because the Indocin would control the pain. Respondent noted that the emergency room physician confirmed his diagnosis of cellulitis on January 20, 2001.
Respondent did not chart peripheral vascular disease on January 16, 2001, because that was not the presenting
problem. Further, Respondent testified that Patient R.E.'s cellulitis was not necessarily related to peripheral vascular disease. Patient R.E. had several other problems, such as his heavy smoking and his diabetes, that could have generated cellulitis independently of peripheral vascular disease.
Respondent disagreed with Dr. Hennessey's suggestion that "aggressive evaluation" and immediate surgery might have saved Patient R.E.'s foot, because it would not be prudent to undertake surgery until the cellulitis infection was cleaned up. Immediate surgery would have the potential of infecting the bypass grafts. On January 16, 2001, Patient R.E.'s foot was not gangrenous, and Respondent believed it essential to give Patient
R.E. a reasonable trial of antibiotic therapy before sending him for surgical evaluation.
Respondent's opinion on this issue was supported by Dr. Malik Piduru, the vascular surgeon who performed the amputation on Patient R.E.'s right leg. Dr. Piduru testified that in a patient with peripheral vascular disease and a diagnosis of cellulitis with no acute gangrenous changes or acute pain, the standard of care is to treat the infection first, then perform the re-vascularization.
The weight of the evidence does not support an ultimate finding that Respondent failed to practice medicine with an acceptable level of care in the treatment of Patient
R.E. Dr. Hennessey's conclusion that a more "aggressive evaluation" might have improved the chances of saving Patient R.E.'s leg rests on the assumption that Patient R.E. would have agreed to the proposed surgery had it been recommended on January 16, 2001. Patient R.E. rejected bypass surgery on his left leg before he became Respondent's patient, rejected it again in February 2001, and rejected it a third time in
April 2001 when his right leg was threatened by cellulitis. There is little reason to assume that his decision would have been different on January 16, 2001.
In view of all the evidence, the expert testimony of Dr. Corral was at least as persuasive as that of Dr. Hennessey in regard to the standard of care and Respondent's actions in this matter. Dr. Hennessey believed that the standard of care required a more aggressive approach to Patient R.E.'s presentation from the outset. Dr. Corral agreed that Dr. Hennessey's approach to the case would have met the standard of care, but also concluded that Respondent's approach was unexceptionable. Further, Dr. Hennessey could state with no degree of confidence that his own approach would have changed the ultimate outcome for Patient R.E.
Dr. Hennessey opined that Respondent should have taken a blood sugar level and have given Patient R.E. detailed instructions for self-monitoring similar to those he later
received at Oak Hill Hospital. Dr. Corral agreed that a blood sugar level might have been helpful, but was not necessary to meet the standard of care given the presentation and differential diagnosis. Dr. Corral believed that the failure to provide instructions was de minimus at most. Given the facts presented, Dr. Corral's opinion on these issues was at least as persuasive as Dr. Hennessey's.
The evidence did not support a finding that Respondent took lightly Patient R.E.'s condition, or failed to consider any of the many variables created by Patient R.E.'s complicated history in arriving at a therapeutic approach. Respondent correctly diagnosed Patient R.E.'s cellulitis, and reasonably decided to attempt a course of antibiotic treatment to heal the infection before pursuing surgical options. The evidence presented at the hearing failed to establish that Patient R.E.'s poor outcome could be fairly attributed to Respondent's treatment of Patient R.E. on January 16, 2001.
The main evidence submitted in support of the contention that Respondent failed to keep adequate medical records was directly related to the standard of care claim. Dr. Hennessey conceded that Respondent's medical record was minimally sufficient to justify the treatment provided. His chief criticism of Respondent's records for the January 16, 2001, appointment focused on the lack of documentation to
explain actions that Respondent did not take, i.e., set a three- day follow-up appointment, order laboratory tests, and provide detailed instructions to Patient R.E. Because it has been found that the standard of care did not require Respondent to take these actions, his medical records cannot be faulted for failure to explain why he did not take them.
However, Dr. Hennessey rightly criticized the lack of examination detail noted in the records of the January 16, 2001, examination. It was established at the hearing that Respondent charted by exception, meaning that he noted only positive findings rather than every unremarkable detail of the examination. Dr. Hennessey noted that, while this method of charting is acceptable practice, it was not acceptable that Respondent provided no description of the size or location of the erythema or the extent of the swelling of the ankle. Such detail would be essential to a subsequent treating physician in determining whether Patient R.E.'s condition had worsened.
Further, Respondent did not note the frequency or duration of the Levaquin prescription, or the duration of the Indocin prescription, though Respondent credibly testified that he gave Patient R.E. oral instructions as to both medications. Again, a subsequent treating physician would need to know the details of Patient R.E.'s current medications before undertaking treatment.
Finally, Respondent's notes were in several places illegible. Petitioner did establish that Respondent's records failed to document the office notes in a completely legible manner. The detail in Respondent's records was sufficient to justify the course of treatment on January 16, 2001, but their illegibility and lack of detail made them of limited use to anyone other than Respondent in assessing Patient R.E. for subsequent treatment. Patient R.E. was not exposed to potential injury because Respondent was consistently available to consult with the other treating physicians, but this fact does not cure Respondent's failure to keep adequate, legible records.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding, pursuant to Subsection 120.57(1) and Section 120.569, Florida Statutes, and Section 456.073(5), Florida Statutes.
Pursuant to Subsection 458.331(2), Florida Statutes, the Board of Medicine is empowered to revoke, suspend or otherwise discipline the license of a physician for the following violations of Subsections 458.331(1)(m) and (t), Florida Statutes:
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the
licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; and reports of consultations and hospitalizations.
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(t) Gross or repeated malpractice or the failure to practice medicine with that level or care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. . . .
Rule 64B8-9.003(2), Florida Administrative Code, provides:
A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken.
Rule 64B8-9.003(3), Florida Administrative Code,
provides:
The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and
hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request for the physician and relied upon by the physician in determining the appropriate treatment of the patient.
Patient records must contain a sufficient amount of information so that "neutral third parties can observe what transpired during the course of treatment of a patient." Robertson v. Dept. of Professional Regulation, Board of Medicine, 574 So. 2d 153, 156 (Fla. 1st DCA 1990).
When the Board finds any person guilty of any of the grounds set forth in Subsection 458.331(1), Florida Statutes, it may enter an order imposing one or more of the following relevant penalties set forth in Subsection 456.072(2), Florida Statutes:
Suspension or permanent revocation of a license.
Restriction of practice or license, including, but not limited to, restricting the licensee from practicing in certain settings, restricting the licensee to work only under designated conditions or in certain settings, restricting the licensee from performing or providing designated clinical and administrative services, restricting the licensee from practicing more than a designated number of hours, or any other restriction found to be necessary for the protection of the public health, safety, and welfare.
Imposition of an administrative fine not to exceed $10,000 for each count or separate offense. If the violation is for
fraud or making a false or fraudulent representation, the board, or the department if there is no board, must impose a fine of
$10,000 per count or offense.
Issuance of a reprimand or letter of concern.
Placement of the licensee on probation for a period of time and subject to such conditions as the board, or the department when there is no board, may specify. Those conditions may include, but are not limited to, requiring the licensee to undergo treatment, attend continuing education courses, submit to be reexamined, work under the supervision of another licensee, or satisfy any terms which are reasonably tailored to the violations found.
Corrective action.
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(j) Requirement that the practitioner undergo remedial education.
Rule 64B8-8.001, Florida Administrative Code, sets forth the recommended range of penalty for various violations of Subsection 458.331(2), as follows in pertinent part:
64B8-8.001 Disciplinary Guidelines.
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Violations and Range of Penalties. . . .
VIOLATION
(m) Failure to Keep appropriate written medical records. (458.331(1)(m), F.S.)
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(t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. (458.331(1)(t), F.S.)
FIRST OFFENSE
(m) From a reprimand to denial or two (2) years suspension followed by probation, and an administrative fine from $1,000.00 to
$10,000.00.
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(t) From two (2) years probation to revocation or denial, and an administrative fine from $1,000.00 to $10,000.00.
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Aggravating and Mitigating Circumstances. Based upon consideration of aggravating and mitigating factors present in an individual case, the Board may deviate from the penalties recommended above. The Board shall consider as aggravating or mitigating factors the following:
Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;
Legal status at the time of the offense: no restraints, or legal constraints;
The number of counts or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
The involvement in any violation of Section 458.331, F.S., of the provision of controlled substances for trade, barter or sale, by a licensee. In such cases, the Board will deviate from the penalties recommended above and impose suspension or revocation of licensure;
Any other relevant mitigating factors.
License disciplinary proceedings are penal in nature.
State ex rel, Vining v. Florida Real Estate Commission, 281 So. 2d 487 (Fla. 1973). In this disciplinary proceeding, Petitioner must prove the alleged violations of Subsections 458.331(1)(m) and (t), Florida Statutes, by clear and convincing evidence.
Department of Banking and Finance, Division of Securities and Investor Protection v. Osborne, Stern & Co., 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).
The definition of "clear and convincing" evidence is adopted from Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983), which provides:
[Clear] and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered, the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must
be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
See also Evans Packing Co. v. Department of Agriculture and Consumer, 550 So. 2d 112, 116 n.5 (Fla. 1st DCA 1989).
The determination of whether a physician deviated from the applicable standard of care requires consideration of the factual circumstances of each case. As recently held in Gross v. Department of Health, 819 So. 2d 997 (Fla. 5th DCA 2002), the determination of whether a physician has violated the applicable standard of care is a fact question for the Administrative Law Judge.
Petitioner has alleged that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in the following ways:
By failing to perform a complete physical of Patient R.E.'s right leg on January 16, 2001;
By failing to take complete history and Review of Systems;
By failing to consider the diagnosis of atherosclerotic peripheral vascular disease;
By failing to schedule follow-up appointments to re-evaluate within three (3)
days of the January 16, 2001 office visit; and
By failing to order skin care precautions, duration of treatment, monitoring, and appropriate laboratory tests, such as kidney function or other follow-up instructions.
The clear and convincing standard utilized in this case holds that, based upon the entire record in this case, the proof presented by Petitioner must produce a firm belief or conviction, without hesitancy, that Respondent deviated from the standard of care. The testimony and documentary evidence was insufficient to establish that such a deviation occurred.
The heart of Petitioner's case is that Respondent was insufficiently aggressive on January 16, 2001, in establishing a definitive diagnosis of cellulitis and presenting the surgical alternative to Patient R.E. at the earliest possible moment. However, the evidence presented indicates that Respondent acted reasonably within the standard of care based upon the presenting symptoms of Patient R.E. on January 20, 2001.
Petitioner attempted to demonstrate that Patient R.E.'s chances of avoiding amputation would have increased had Respondent acted more aggressively. Even Dr. Hennessey, Petitioner's expert, conceded that it was speculative whether immediate surgical re-vascularization would have ultimately saved Patient R.E.'s right leg.
Adding to the speculative nature of Petitioner's case is the question whether Patient R.E. would have consented to the surgical bypass procedure in any event. He had declined such a procedure in favor of chelation therapy prior to Respondent's assuming his care, he refused the procedure when Dr. Piduru proposed it in February 2001, and he later refused the procedure for his left leg. Petitioner offered no firm evidence that Patient R.E.'s answer would have been different in late
January 2001 had Respondent proposed immediate surgery.
Respondent performed a complaint-driven examination of Patient R.E. sufficient to establish a differential diagnosis, he correctly diagnosed cellulitis, and he prescribed antibiotic treatment to clear the infection before pursuing surgical options. Based upon the symptoms presented by Patient R.E. on January 16, 2001, Respondent's course was within the standard of care, if less aggressive than the course some other practitioners might have taken.
Based upon all of the evidence of record, it is concluded that Petitioner has not made the requisite showing to prove by clear and convincing evidence that Respondent violated Subsection 458.331(1)(t), Florida Statutes, in his treatment of Patient R.E. by failing to practice medicine with that level of care, skill, and treatment, which is recognized by a reasonably
prudent similar physician as being acceptable under similar conditions and circumstances.
Petitioner has alleged that Respondent's medical records of the care and treatment of Patient R.E. are inadequate in that they fail to properly identify the course of treatment or justify Respondent's treatment of R.E. in one or more of the following ways:
By failing to document the reason for not performing a complete physical examination of Patient R.E.'s right leg on January 16, 2001;
By failing to document the complete history and Review of Symptoms;
By failing to document the reason for not considering the diagnosis of atheriosclerotic peripheral vascular disease;
By failing to document follow-up appointments to re-evaluate within three (3) days of the January 16, 2001 office visit;
By failing to document the reason for not ordering appropriate laboratory tests;
By failing to document the Master Problem List, Current Medication List or Diabetic Flow sheet to reflect management of Patient R.E.'s complex health problems; and
By failing to document the office notes in a legible manner, and not communicating sufficient details to justify the course of treatment.
Petitioner has demonstrated by clear and convincing evidence that Respondent failed to maintain accurate medical
records in violation of Subsection 458.331(1)(m), Florida Statutes, in the single limited respect that the records were in some places illegible and lacked the detail that would make them useful to a subsequent treating physician. The lack of detail is mitigated by the fact that Respondent was at all times available to consult with subsequent physicians and, in fact, did consult with the emergency room physician on January 20, 2001.
In all other respects, Petitioner's argument that Respondent failed to maintain accurate medical records was tied directly to the standard of care claim. Most of Petitioner's case on the standard of care claim involved actions that Petitioner claimed Respondent should have taken but did not, i.e., conducting a complete physical examination, scheduling a follow-up appointment, considering the diagnosis of peripheral vascular disease. Likewise, most of Petitioner's case as to the medical records involved Respondent's failure to document his reasons for not taking the actions that Petitioner contended he should have. Because Petitioner failed to establish by clear and convincing evidence that the standard of care required Respondent to take those actions, Petitioner has likewise failed to establish that Respondent should have documented his reasons for not taking those actions.
There are no aggravating factors present in this case.
Respondent's penalty should be mitigated by the facts that he has practiced for twelve years specializing in internal medicine without prior discipline, and that all the violations alleged in the Administrative Complaint arise from a single occurrence.
There was no element of self-gain and no exposure of the patient or public to injury or potential injury arising from Respondent's failure to maintain detailed, legible medical records in this case. In light of the above, it is recommended that Respondent receive a written reprimand for the violation of Section 458.331(1)(m), Florida Statutes, found above.
Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated Subsections 458.331(1)(t), Florida Statutes, in his treatment of Patient R.E., and that the evidence is clear and convincing that Respondent has violated Section 458.331(1)(m), Florida Statutes, in his failure to keep appropriate written medical records regarding his treatment of Patient R.E. and that Respondent be reprimanded for that violation.
DONE AND ENTERED this 17th day of July, 2003, in Tallahassee, Leon County, Florida.
S
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 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 17th day of July, 2003.
COPIES FURNISHED:
Bruce A. Campbell, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
Christopher J. Schulte, Esquire Burton, Schulte, Weekley,
Hoeler & Beytin, P.A.
100 South Ashley Drive, Suite 600 Tampa, Florida 33602
Larry McPherson, Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399-1701
William W. Large, General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
R.S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 17, 2003 | Agency Final Order | |
| Jul. 17, 2003 | Recommended Order | Petitioner failed to demonstrate that Respondent did not meet standard of care in treatment of diabetic patient with cellulitis, but did establish that Respondent`s medical records were inadequate. Reprimand recommended. |
