STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 88-6103

)

SAROJA L. RANPURA, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, Don W. Davis, held a formal hearing in the above- styled case on May 25 and 26, 1989, in Orlando, Florida; and May 31, 1989, in Tallahassee, Florida.

APPEARANCES

For Petitioner: David G. Pius, Esquire

Department of Professional Regulation The Northwood Centre, Suite 60

1940 North Monroe Street Tallahassee, Florida 32399-0750

For Respondent: Sidney L. Matthew, Esquire

135 South Monroe Street, Suite 100 Tallahassee, Florida 32302

STATEMENT OF THE ISSUES

The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, sufficient to justify the imposition of disciplinarysanctions against her license. The resolution of this issue rests upon a determination of whether Respondent intubated the esophagus of a patient, as opposed to the patient's trachea, in the course of rendering anesthesia care; and whether Respondent then failed to provide a record justifying such a course of medical treatment.

PRELIMINARY STATEMENT

On November 2, 1988, Petitioner issued an Administrative Complaint charging Respondent with failure to practice medicine with the level of care, skill and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances; a violation of Section 458.331(1)(t), Florida Statutes. The Administrative Complaint further alleged that Respondent had failed to keep medical records justifying the course of treatment accorded a patient; a violation of Section 458.331(1)(m), Florida Statutes.

Respondent requested a formal administrative hearing on the charges set forth in the Administrative Complaint. Subsequently, the matter was transferred to the Division Of Administrative Hearings to conduct a formal hearing pursuant to Section 120.57(1), Florida Statutes. A Notice of Final Hearing was issued by Hearing Officer Robert E. Meale on March 16, 1989. Subsequently, Hearing Officer Meale granted the parties' request for a bifurcated hearing due to conflicts in the schedules of major witnesses in the case.

At the hearing, Petitioner presented the testimony of Jean Allen, L.P.N.; Margaret Bloom, R.N.; Norma Masters, R.N.; JohnC. Kruse, M.D.; and David Alan Cross, M.D. Deposition testimony of Frank Snydle, M.D. was also admitted in evidence. Petitioner presented one evidentiary exhibit and one other evidentiary exhibit jointly with Respondent.

In addition to the joint evidentiary exhibit, Respondent presented five other evidentiary exhibits, along with testimony of Deane Briggs, M.D.; Saroja

1. Ranpura, M.D.; Roy D. Graham, R.N.; and Gilbert Stone, M.D. Testimony of Graham and Stone were presented by deposition; Stone's was a video taped deposition.

   
   

   The transcript of the portion of the hearing held in Orlando, Florida, was filed with the Division Of Administrative Hearings on June 14, 1989. The transcript of the portion of the hearing held in Tallahassee, Florida, was filed with the Division Of Administrative Hearings on June 19, 1989. The parties requested and were granted leave to file posthearing submissions more than 10 days after the filing of the transcript, and in accordance with Rule 22I-6.031, Florida Administrative Code, waived provisions of Rule 28-5.402, Florida Administrative Code.

   
   

   Proposed findings of fact submitted by the parties are addressed in the appendix to this recommended order.

   
   

   FINDINGS OF FACT

   
   

   1. Respondent is Saroja L. Ranpura, a licensed physician at all times pertinent to these proceedings, holding medical license number ME 0039872. Respondent was licensed in the State of Florida on April 27, 1982. She currently practices medicine in Ohio.

      
      

   2. Petitioner is the Department of Professional Regulation, Board of Medicine, the state agency charged with the regulation of physicians in the State of Florida.

      
      

   3. On August 29, 1985, Frank Snydle, M.D., performed a laparoscopy on patient C.P. at Heart of Florida Hospital in Haines City, Florida. This medical procedure was performed on an outpatient basis. As a result, C.P. came into the hospital on the day the surgery was to be performed. She met Respondent, who later provided anesthesia care to her in the course of the laparoscopy. Respondent examined C.P. at that time, prior to the surgery, and noted that C.P. had a small mouth.

      
      

   4. Later, C.P. was brought into the operating room on a stretcher and moved herself over onto the operating table. Present in the operating room at that time were Jean Allen, L.P.N., Norma Masters, R.N., and Respondent.

   5. Respondent proceeded to do an unusual procedure known as a "blind nasal intubation." The procedure requires the placement of an tube in the patient's throat through the nose, as opposed to the mouth, in order to maintain an open airway during later anesthesia administration in the process of surgery. C.P. was sedated, but awake, during this process and was intubated with a minor degree of difficulty.

      
      

   6. Prior to placement of the endotracheal tube, Respondent had the patient breath pure oxygen through a mask covering the mouth and nose. The preoxygenation process, according to Respondent, provided extra oxygen "as a reservoir and as astorage" to C.P.'s body tissues. By letting a patient breath

      100 percent oxygen for three to four minutes, the resultant saturation permits a margin of four to six minutes for such an intubation to be safely completed without risk of the patient becoming hypoxic.

      
      

   7. Jean Allen, with almost 25 years of nursing experience in a surgical assistance career where she assists in 400 to 600 operations per year, observed Respondent during the entire intubation process, inclusive of the preoxygenation phase. Accepted medical practice after such an intubation requires that the person placing the tube then listen for breath sounds over each lung and over the area of the stomach. Respondent maintains that she did listen for those breath sounds with the aid of a stethoscope. The anesthesia record completed by Respondent has a notation "BEBS" for bilateral and equal breath sounds which Respondent testified that she heard with the stethoscope prior to administering additional sodium pentothal to the patient and inflating the cuff of the endotracheal tube. This testimony of Respondent is not credited in view of the testimony of Ms. Allen that she observed Respondent during this entire time and that Respondent did not listen for the breath sounds with a stethoscope prior to administering the additional sodium pentothal to the patient. Allen's testimony is also afforded the greater credibility due to her opportunity as a neutral witness to observe the events which transpired and her testimony that although she didn't observe Respondent closely after the additional sodium pentothal was administered, she maintained that she would have recalled Respondent's use of the stethoscope prior to that point. Notably, it is at that point prior to the administration of the additional sodium pentothal and inflation of the cuff of the endotracheal tube where Respondent maintains she listened for the breath sounds.

      
      

   8. Respondent, after completion of the placement of the endotracheal tube, administered additional sodium pentothal to the patient without listening for breath sounds; connected the tube to the anesthesia machine; and remarked that "it must be in place, the bag is moving" in reference to the bag on the anesthesia machine which generally inflates as the lungs of the patient deflate. While inflation or deflation of a breath bag on an anesthesia machine is one part of the procedure for checking placement of an endotracheal tube, the expert testimony of John Kruse, M.D., and David Alan Cross, M.D., establishes that this procedure alone is not a reliable method of determining proper tube placement.

      
      

   9. Frank Snydle, M.D., who had entered the operating room by this time in the sequence of events, did a manual vaginal examination of the patient, left the room, scrubbed his hands and returned. He then donned surgical gloves and gown, moved to the left side of the patient and prepared to proceed with the operation. Ms. Allen took her position at the foot of the table, between the patient's legs with an unobstructed view of Respondent.

      
      

   10. Dr. Snydle proceeded to make a small incision in the patient's abdomen through which he inserted a hollow, "Verres" needle. Carbon dioxide was then

       introduced to C.P.'s abdominalcavity to push the abdominal wall away from the internal organs. Next, a device known as a "trocar" and a "trocar sleeve" was inserted through the incision into the abdomen. The trocar was then withdrawn and a laparoscope was inserted into the sleeve. Built somewhat like a telescope with a built-in light source, the laparoscope permits the surgeon to look inside the abdomen and visually observe the patient's internal organs.

       
       

   11. During this procedure, Nurse Allen commented that she heard a sound like a fog horn or frogs croaking when she touched the patient's abdomen. Allen's remark is corroborated by Norma Masters and Dr. Snydle. The proof establishes, as corroborated by expert testimony of Dr. Kruse, that such sounds were associated with air, captured in C.P.'s stomach as the result of esophageal intubation, escaping from the stomach when pressure was applied.

       
       

   12. When Dr. Snydle made his first incision in the patient's abdomen, Allen observed that the blood was dark and Dr. Snydle agreed. Respondent inquired whether it could be venous blood. Snydle indicated he didn't think this was the case. Notably, the dark blood was observed, according to Respondent's medical records at 10:27 a.m. Further, Petitioner's experts, Dr. Kruse and Dr. Cross, based on their review of C.P.'s medical records, determined that the patient was initially intubated at approximately 10:15 a.m. Thus, approximately 12 minutes transpired from the beginning of the intubation process and conclusion of preoxygenation of the patient until the observation of dark bloodat the time of incision.

       
       

   13. After her inquiry regarding whether the blood could be venous, Respondent further responded that she was giving the patient 50 percent oxygen. She testified that she then increased the oxygen level to 100 percent. While the anesthesia record indicates administration of 100 percent oxygen, there is no time notation when this occurred.

       
       

   14. Blood again welled up from the incision and Nurse Allen commented that the blood appeared black. The less oxygenated blood becomes, the darker it appears. By this time, Dr. Snydle had inserted the laparoscope in C.P.'s abdomen. He observed that the internal organs were a "blueish color" ; an observation consistent with a decreasing level of oxygen in the patient's blood and an indication that the patient was hypoxic.

       
       

   15. When the patient's internal organs were discerned to be blue, Respondent asked Dr. Snydle to wait a moment and requested the assistance of Norma Masters, the circulating nurse. Masters came to the head of the operating table and was handed another endotracheal tube by Respondent. Respondent then began the process of intubating the patient with that tube through the mouth. The original nasal tube was left in place during the insertion of the second tube; an unheard of possibility, according to expert testimony, unless one tube was in the patient's esophagus and the other in the trachea. Nurse Allen's testimony establishes that the second tube, inserted via the patient's mouth, became foggy after insertion. The observation by Allen is consistent with experttestimony and establishes the fog was created by warm moist air from the patient's lungs flowing through the second tube. Respondent's testimony that she placed the second tube at the conclusion of the surgical procedure is not credited in view of the very clear, contradictory testimony of Masters and Allen that the endotracheal tube was replaced contemporaneously with the notation that the blood was dark and the patient's organs "blueish".

       
       

   16. After removal of the nasal tube and connection of the second tube to the anesthesia machine, Respondent manually squeezed the anesthesia bag to

       ventilate the patient. Dr. Snydle observed that the organs were turning pink again, and continued the procedure without further incident. After finishing the procedure, Snydle went out of the operating room, sat at a desk across the hall and began to write his orders.

       
       

   17. Following the procedure, the patient was wheeled to the recovery room, a short distance away. Nurses Allen and Masters did not see C.P. open her eyes during this process. Respondent's assertion that the patient opened her eyes and was responsive to commands is corroborated only by Dr. Snydle. However, while he noted in his operative report and his deposition that C.P. was awake following the operation, Snydle's observation is not credited in view of other proof establishing that his back was to the patient as she was wheeled past and that he assumed an awake state in the patient because Respondent was speaking to

       C.P. In view of the foregoing, Respondent's testimony that the patient was awake or responsive to commands following the surgery is not credited.

       
       

   18. After the patient was removed approximately 15 feet away to the recovery room, Respondent maintains that she informed Margaret Bloom, R.N., who was on duty there, that the patient's endotracheal tube was not to be removed, although she omitted telling Bloom about the dark blood incident. Bloom, who is also a certified registered nurse anesthetist, maintains that Respondent told her nothing about C.P.'s condition; instead, she went rapidly to the rest room in the lounge area. Bloom, left in the recovery room with the patient, then proceeded to hook up appropriate monitors and oxygen to the patient's endotracheal tube and began the process of monitoring C.P.'s vital signs. Bloom places the time of C.P.'s arrival time in the recovery room at approximately 11:05 a.m.

       
       

   19. The patient was not responsive to Bloom's spoken commands when brought to the recovery room. The patient appeared well oxygenated to Bloom; a judgement she made based on her observation of the color of C.P.'s lips and fingernails, since C.P. is a black female. Bloom rated C.P.'s circulation at twenty to fifty percent of preanesthetic pressure and determined the patient to be totally unconscious. Respondent returned to the recovery room at this time, told Bloom that she had done an "awake intubation" on the patient and that the tube should remain in place until Bloom determined that the patient was ready for it to be removed. Respondent then left the recovery room.

       
       

   20. As the result of blood tinged mucus filling the patient's endotracheal tube, Bloom removed the tube after thepatient registered breathing difficulties and attempts by Bloom to suction the mucus failed. She replaced that tube with a device known as an oral pharyngeal airway which goes in the patient's mouth and curves down the throat, holding the tongue forward. The device does not reach to the lungs. Shortly thereafter the patient began making glutteral noises and Bloom placed a venturi mask on the patient. The mask controlled the percentage of oxygen going to the patient, estimated by Bloom to be sixty to one hundred percent oxygen. The patient's breathing improved.

       
       

   21. Bloom completed replacement of the endotracheal tube with the airway device and mask shortly before Respondent again returned to the recovery room. Respondent, upset at Bloom's action in removing the endotracheal tube, proceeded to replace the oral airway device with a nasal tube. At 11:20 a.m., Bloom noted in her records that the patient's state of consciousness was unchanged. Later the patient made moaning sounds and was responsive to pain stimulation at approximately 12:20 p.m.

   22. Respondent concedes that C.P. suffered an hypoxic event at some point which resulted in damaged brain function. It is Respondent's position that such event occurred in the recovery room as the result of laryngospasm, occasioned by Bloom's removal of the endotracheal tube. Allen and Masters working in the operating room a short distance away testified that the sounds they heard emanating from the area of the recovery room were not the type of noise they associated with laryngospasm. Bloom, trained to recognize laryngospasm, testified that C.P. did not have sucha spasm. The expert testimony of David Cross, M.D., based on a study of arterial blood gases of C.P. following the surgery, establishes that the patient suffered an hypoxic episode too severe and too protracted to have been the result of a possible laryngospasm in the recovery room and that, in his expert opinion, she did not have a recovery room laryngospasm.

       
       

   23. Respondent's defense that C.P.'s survival of such a lengthy esophageal intubation in the operating room is an impossibility, is not persuasive. The opinion of Respondent's expert, Dr. Gilbert Stone, that no esophageal intubation occurred in the operating room is predicated on his belief that the tube was not changed during the surgery. Dr. Stone conceded that replacement of the tube during surgery at the time the dark blood was noticed with resultant improvement in the patient's condition permits a conclusion that esophageal intubation was the cause of the hypoxia. Testimony of Petitioner's experts, Dr. Cross and Dr. Kruse, are consistent in their conclusions that C.P. was esophageally intubated by Respondent, although they differ in their reasons for C.P.'s survival of the event. The opinion of these experts, coupled with the eye witness testimony of Allen and Masters, further support a finding of Respondent's esophageal intubation of the patient in the operating room and that she failed to recognize such intubation in a timely manner as a reasonable and prudent physician should have.

       
       

   24. The expert opinion testimony of Dr. Cross establishes that C.P. was intubated in her esophagus and survivedas a result of oxygen, going into her stomach under pressure, being forced back up her esophagus into the pharynx and then drawn by negative pressure into the lungs. This resulted in a effect similar to, but not as efficient as, the technique known as apneic oxygenation. The technique, once used to provide marginally adequate oxygen levels to maintain a patient's neurological and cardiac status, has fell into disfavor since patients suffered from respiratory acidosis due to the buildup of carbon dioxide in the lungs. Cross also pointed out that the heart can function for a much longer period of time without adequate oxygen than is possible for the brain. Cross's testimony provides an explanation for C.P.'s neurological damage without similar cardiac impairment. Cross also noted that the preoxygenation process which C.P. initially underwent after entering the operating room added to the time she was able to undergo oxygen deprivation before the onset of tissue damage.

       
       

   25. Respondent notes the discovery of a tumor in C.P.'s throat some months later as a possible contributor to the patient's hypoxic event during surgery. Another of Respondent's experts, Dr. Deane Briggs, an otolaryngologist specializing in diseases of the ears, nose and throat, treated C.P. in October of 1985, following the August, 1985 surgery. He discovered the existence of a sub-glottic tumor in the patient's throat. However, the existence of the tumor at the time of the initial surgery is not established. Testimony of anesthesiologist experts, including Respondent's own expert, Dr. Stone, do not support a finding that the tumor, if itexisted, had any effect during the operation. Further, Dr. Briggs' opinion that Respondent probably intubated the patient's right stem bronchus, as opposed to the esophagus, and that

       neurological damage therefore occurred in the recovery room is not credited in view of the conflict of this testimony with that of other witnesses and expert opinions.

       
       

   26. A finding that C.P.'s neurological impairment following surgery may have been exacerbated by a possible laryngospasm in the recovery room is relevant only with regard to mitigation of the severity of penalty to be imposed for Respondent's misconduct. Respondent's esophageal intubation of the patient in the operating room, and the resultant hypoxic event are established by clear and convincing evidence. The fact that C.P. suffered brain damage is undisputed by the parties. The proof clearly and convincingly establishes that the severe and protracted hypoxic episode sustained by the patient resulted not from a possible mild recovery room laryngospasm, but from Respondent's esophageal intubation of that patient in the operating room.

       
       

   27. It is concluded with respect to treatment of C.P., 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.

       
       

   28. Respondent failed to keep medical records which justified her course of treatment of the patient, C.P. This finding is based upon the testimony of Dr. Cross that Respondent'smedical records did not justify her course of treatment, as well as the testimony of Respondent's expert, Dr. Stone. While testifying that he did not believe Respondent had intubated the patient's esophagus, Stone also acknowledged that Respondent's records would be inadequate if such had indeed occurred.

       
       

       CONCLUSIONS OF LAW

       
       

   29. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter. Section 120.57(1), Florida Statutes.

       
       

   30. Section 458.331(2), Florida Statutes, authorizes Petitioner to take various disciplinary actions against a licensed physician, including revocation or suspension of licensure; restriction of practice; imposition of an administrative fine up to $5,000; placement of licensure status on probation; or reprimand or censure of the licensee.

       
       

   31. The imposition of such disciplinary action is permitted for violation of Section 458.331(1)(m), Florida Statutes, which reads:

       
       

       (m) Failing to keep written medical records justifying 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.

       
       

   32. Disciplinary action is also permitted for violation of Section 458.331(1)(t), Florida Statutes, which reads in pertinent part as follows:

       
       

       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.

       
       

   33. Respondent is charged in the Administrative Complaint filed in this case with performance below the acceptable level of skill and treatment in violation of Section 458.331(1)(t), Florida Statutes, by intubation of the patient's esophagus while attempting a tracheal intubation and failing to recognize that error. The complaint further alleges that Respondent failed to keep medical records justifying the course of treatment in violation of Section 458.331(1)(m), Florida Statutes.

       
       

   34. Petitioner bears the burden of proof of the charges set forth in the Administrative Complaint. Proof that Respondent has committed those violations must be clear and convincing. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987).

       
       

   35. The proof clearly and convincingly establishes that when Respondent intubated her patient, C.P., she failed to listen for breath sounds over the patient's lungs and abdomen. Further, the proof clearly and convincingly established that Respondent intubated the patient's esophagus rather than the trachea; and that a reasonably prudent anesthesiologist would have listened for such breath sounds and would not have relied solely on the movement of the bag attached to the anesthesia machine to ascertain whether the tube was properly placed. Respondent is guilty of violation of 458.331(1)(t), Florida Statutes.

       
       

   36. Respondent's subsequent failure to record the esophageal intubation or provide justification for such an intubation on the medical chart is also proven by clear and convincing evidence. Such conduct constitutes failure to keep medical records justifying the course of treatment of patient C.P., a violation of Section 458.331(1)(m), Florida Statutes, as charged in the administrative complaint.

       
       

   37. Rule 21M-20.001, Florida Administrative Code, provides a recommended penalty for violation of Section 458.331(1)(t), Florida Statutes, ranging from a two year term of probation to revocation of licensure and imposition of an administrative fine from $250 to $5,000. For violation of Section 458.331(1)(m), Florida Statutes, the penalty recommended by the rule ranges from a reprimand to two years suspension of licensure followed by probation and an administrative fine from $250 to $5,000.

RECOMMENDATION

Based on the foregoing, it is hereby

RECOMMENDED that a Final Order be entered for Respondent's violation of Section 458.331(1)(t), Florida Statutes, placing Respondent's license on probation for a period of three years upon terms and conditions to be determined by the Board of Medicine, including, but not limited to, a condition requiring Respondent's participation in appropriate continuing medical education courses; and imposing an administrative fine of $2,000.

IT IS FURTHER RECOMMENDED that such Final Order impose a penalty for Respondent's violation of Section 458.331(1)(m), Florida Statutes, of an administrative fine of $500 and a letter of reprimand.

DONE AND ENTERED this 28th day of August, 1989, in Tallahassee, Leon County, Florida.

DON W.DAVIS

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Fl 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 28th day of August, 1989.

APPENDIX

The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties.

Petitioner's Proposed Findings.

1.-28. Accepted.

29. Unnecessary to result. 30.-31. Accepted.

32.-34. Adopted by reference. 35.-61. Adopted in substance.

62. Unnecessary to result. 63.-68. Adopted in substance. 69.-87. Adopted by reference.

Respondent's Proposed Findings.

1.-3. Rejected, not supported by the evidence.

4.-5. Rejected, not supported by the evidence, Further, proposed findings that records were adequate constitute legal conclusions.

6. Rejected, not supported by the evidence.

COPIES FURNISHED:

David G. Pius, Esq.

Department of Professional Regulation The Northwood Centre, Suite 60

1940 N. Monroe St. Tallahassee, FL 32399-0750

Sidney L. Matthew, Esq. Suite 100

135 South Monroe St. Tallahassee, FL 32302

Kenneth Easley, Esq.

General Counsel

Department of Professional Regulation The Northwood Centre, Suite 60

1940 N. Monroe St. Tallahassee, FL 32399-0750

Dorothy Faircloth Executive Director Board of Medicine

Department of Professional Regulation The Northwood Centre

1940 N. Monroe St. Tallahassee, FL 32399-0750

Docket for Case No: 88-006103

Orders for Case No: 88-006103