READ PARTS ONE AND TWO FIRST!!

In Parts 1 and 2 we learned what the definition of the Standard of Care is and that it is determined by expert witness testimony in court. We also discussed how an expert witness is certified by the court. Also discussed was the difference between civil law followed in medical malpractice cases and the administrative law which applies in state board proceedings. Now we get into the events in the operating room that led to action  by the Maryland Board of Physicians against Dr. Bernstein, what happened at the hearings and on appeal, and the final order of the board and its ramifications.

Dr. Bernstein was the anesthesiologist on duty the evening of October 13, 1998, at union Memorial hospital. There were two CRNAs on duty, Thomas Davis and a second CRNA who is not named in the record. Davis was the Chief CRNA at union, with 30 years of experience. The two had worked together since 1987. An 82 y/o female had been admitted at 5pm the previous evening with a fractured hip. She was on the schedule as well as another patient for an appendectomy. The hip patient’s chest x-ray was unremarkable, her EKG showed normal sinus rhythm, left axis deviation, PVC’s and “the possibility of a past myocardial infarction” (according to the record, but not elaborated on…where there Q waves? What was the basis of this finding?). Her SaO2 was 92.5%  (On room air? Unknown.), her PTT 20 (below 25 is generally considered low and signifies blood may not clot normally). Dr, Samara, an intensivist, examined the patient and cleared her for surgery stating that there was no evidence of a recent acute cardiac event, she was stable, and there was no need for any interventions prior to her surgery. Orthopedics also examined the patient. CRNA Davis saw the patient pre-op at about 7:30 pm and  completed an anesthesia preoperative evaluation form indicating he reviewed the chart, discussed the anesthetic with the patient and her daughter and obtained informed consent. From the record:

Patient A and her daughter signed a “consent to anesthesia form,” stating, “I authorize and consent to the provision of anesthesia service(s) by____ or other members of the Department of Anesthesiology.” Davis wrote his name and “CRNA” in the blank. The form listed the risks of general anesthesia and noted that Patient A’s risk of potential blood loss was “moderate.” Davis did not note Patient A’s Sa02 on the form. Davis assigned Patient A an ASA rating of three, which means that she had disease processes that were not well controlled and that her potential for complications resulting from anesthesia was increased over normal. The ASA rating is based on the patient’s overall health.

Bernstein did not examine the patient. At about 7:15 pm while Bernstein was in an OR caring for another patient, Dr. Mulaikal, an anesthesiologist who would be going home as soon as the schedule allowed, advised Bernstein that the hip and appendectomy were yet to go. Dr. Mulaikal agreed to do the appendectomy and Davis was assigned the hip.  Bernstein finished with his patient and relieved Dr. Mulaikal at 7:45 pm in the appendectomy. Shortly thereafter Davis came to the room and discussed the hip patient for “about a minute” and Bernstein approved the anesthesia plan. He did not see the chart nor was Dr. Samara’s evaluation discussed. At 8:00pm Davis put the hip patient to sleep. More from the record:

During induction, Patient A’s blood pressure dropped from 145/65 to 105/45. Davis administered medication to raise Patient A’s blood pressure. After 10 to 15 minutes, her blood pressure rose to 150/68. During the surgery, Patient A experienced significant blood loss. Davis requested blood from the hospital’s blood bank but compatible blood was not immediately available. Patient A experienced additional periods of hypotension, with her blood pressure dropping as low as 85/40, at 9:20 p.m. She also experienced tachycardia, which is an abnormally elevated heart rate. The appellee [Bernstein] finished providing services to the appendectomy patient at around 9:00 p.m. He went to have dinner in the operating room lounge, which is down the hall and around the corner from Patient A’s operating room, about a 30 second walk. He stayed in the lounge for about an hour. At 10 p.m., he went to Patient A’s operating room “as a matter of courtesy” and because he expected the surgery would be finishing about that time. As soon as the appellee entered the operating room, he became aware of Patient A’s elevated heart rate and her relatively low blood pressure. Davis was checking Patient A’s urine output. He informed the appellee that Patient A had suffered blood loss and that blood was not immediately available for transfusion. Davis already had started a second IV for additional fluid support, had administered a blood volume expander, and had given Patient A medication to elevate her blood pressure.

The blood for transfusion arrived in the operating room shortly after the appellee’s arrival. Davis administered the blood to Patient A at 10:00 p.m. The appellee monitored Patient A’s vital signs and gave her additional medications. The appellee and Davis both were in the operating room for the rest of the surgery, including extubation. By the time Patient A was transferred to the recovery room, at 10:50 p.m., her heart rate and blood pressure both were within the normal range. The appellee and Davis stayed in the recovery room with Patient A for about 15 minutes. Shortly after midnight, a recovery room nurse contacted the appellee to inform him that Patient A seemed slow to arouse. The appellee observed that, although Patient A’s vital signs were stable, it took a fair amount of stimulation to arouse her and she could not speak. The appellee administered a medication to counteract the effect of narcotics. Patient A then was able to move all of her extremities but still could not speak. The appellee transferred Patient A to a “step down unit” for continued observation. The transfer took place at about 1:00 a.m. The appellee returned to see Patient A at 6:30 a.m. Her vital signs remained stable and there was no change in her neurological status. Because the effect of the narcotics no longer could be considered as contributing to her neurological status, he requested a neurological consultation. He did not provide any additional care to Patient A after his morning visit on October 14.

On October 15, a cardiologist diagnosed the appellee’s condition as “probable CNS [central nervous system] changes including possible left parietal cerebrovascular accident[,]” i.e., a “stroke.” He opined that these changes may have “been the initiating factor in her fall from the stool or . . . may have come secondary to her anemia and hypotension from her surgical procedure.”

On December 16, 1998, Patient’s son, a physician himself, filed a complaint with the Board of Physicians, alleging that that Bernstein had “committed acts of negligence and medical malpractice” by, among other things, “fail[ing] to provide close supervision of the CRNA administering [the patient's] anesthesia[.]” Bernstein, through counsel, responded to the complaint, stating that he had provided appropriate supervision during the anesthetic management of the case and had met the accepted standards of care in all respects.

On September 10, 1999, the Board asked Med Chi, a statute created physician peer review body created for just this purpose, to conduct a peer review of the case. Two peer reviewers, Robert Lyles, M.D., and Dennis Forbes, M.D., independently reviewed the complaint, the appellee’s response, and the patient’s medical records. Both reviewers are Board certified in anesthesiology. On November 28, 1999, Dr. Lyles report summarized the events surrounding the hip replacement surgery, stating Bernstein was the “responsible anesthesiologist providing medical direction, supervising Mr. Davis,” he concluded that Bernstein had breached the standard of care by failing to participate in the patient’s  pre and postopertative care, and that Davis “was permitted to assume what may be even considered independent responsibility for the anesthesia care” of the patient. On December 30, Dr. Forbes submitted his report to Med Chi. Dr. Forbes concluded that, overall, the patient had “received anesthesia care that met the necessary standard of care.” However, like Dr. Lyles, he concluded that Bernstein had not provided the required degree of medical supervision of Davis. On January 27, 2000, Med Chi submitted the peer review committee’s report to the Board. The report summarized both Dr. Lyles’s and Dr. Forbes’s reviews and concluded, “The reviewers concur that [Bernstein] breached the standard of care in the supervision of a CRNA in this case.” On November 22, 2000, the Board brought charges against the Bernstein under Maryland Heath Occupations section 14-104(a)(22). We listed the charges in Part 2 of this series. They list a litany of failures in supervision, availability and participation in care.

The statement of charges also directed the Office of Administrative Hearings to hold a contested case hearing on the matter, which was held before and Administrative Law Judge (ALJ) on May 22, 23 and 24, 2001. From the record:

The Board introduced 17 exhibits, including Patient A’s medical records; the Union Memorial Policy on the Anesthesiologist-Nurse Anesthetist Relationship; the Union Memorial Policy on Major Duties and Responsibilities of Nurse Anesthetists; the curricula vitae of the Board’s experts; and several documents by the American Society of Anesthesiologists (“ASA”). The ASA is a national professional organization of anesthesiologists that has a membership of approximately 30,000. The first ASA document, “Guidelines for Patient Care in Anesthesiology,” defines the practice of
anesthesiology, sets forth the responsibilities of anesthesiologists, and describes the role of the anesthesiologist at each stage of surgery. It states:

Anesthesiologists’ responsibilities to patients should include:
A. Preanesthetic evaluation and treatment;
B. Medical management of patients and their anesthetic procedures;
C. Postanesthetic evaluation and treatment;
D. On-site medical direction of any nonphysician who assists in the technical aspects of anesthesia care to the patient.

The second ASA document, “Guidelines for the Ethical Practice of Anesthesiology,” summarizes the ethical responsibilities of anesthesiologists. It defines “medical direction” as [A]nesthesia direction, management or instruction provided by an anesthesiologist whose responsibilities include:
a. Preanesthetic evaluation of the patient.
b. Prescription of the anesthesia plan.
c. Personal participation in the most demanding procedures in this plan, especially those of induction and emergence.
d. Following the course of anesthesia administration at frequent intervals.
e. Remaining physically available for the immediate diagnosis and treatment of emergencies.
f. Providing indicated postanesthesia care. An anesthesiologist engaged in medical direction should not personally be administering another anesthetic and should use sound judgment in initiating other concurrent anesthetic and emergency procedures.

The final ASA document, “The Anesthesia Care Team,” is a position statement. A position statement represents the opinion of the ASA House of Delegates, but is not subject to the same level of scientific scrutiny as an ASA standard or guideline. “The Anesthesia Care Team” statement provides, “Certain aspects of anesthesia care may be delegated to other properly trained professionals. These professionals, medically directed by the anesthesiologist, comprises [sic] the Anesthesia Care Team.” (Emphasis added.) It then repeats the definition of “medical direction” found in the Guidelines for the Ethical Practice of Anesthesiology.

Had this been in civil court rather than under administrative law rules at an administrative hearing, such evidence would never have been allowed since only expert witness testimony may establish a standard of care in civil court. As we have already explained, professional organizations and societies do not determine the standard of care, even when they publish documents entitled “Standard of Care”. But, as noted earlier, the rules of evidence in administrative hearing are fast and loose, and basically almost anything goes, including hearsay. So from the get go it was clear that the Board was relying heavily on ASA propaganda and publications for their case against Bernstein. Also included were the Union Memorial policies on MDA/CRNA practice which are listed in Part 2 which state in part:

The Anesthesiologist is responsible for:
1. Discussing the patient condition and prescribing a plan for that anesthesia with the [CRNA].
2. Being physically available in the most demanding procedures in this plan. Specifically those of induction and emergence when indicated.
3. Remaining physically available for diagnosis and treatment of emergencies.
4. Providing any indicated post-anesthesia care.

This policy falls far short of the ASA ‘standards’  which would have the anesthesiologist responsible for the conducting a preopertive evaluation of the patient as well as being physically present in the operating room, standing next to the patient, during induction and emergence, not just physically available which can be interpreted as ‘somewhere in the hospital and available’. However, physically available generally means ‘not otherwise engaged’, which Bernstein in fact was for a time, since he was doing an appendectomy. But, as the hearing progressed the ASA bias of Board witnesses becomes clear.

Bernstein was forced to play on the same Administrative Law field and thus had to also introduce evidence which would not be allowed in civil court in determining the standard of care, including medicare billing rules and state statutes. Again form the record:

The appellee introduced 7 exhibits, including COMAR 10.27.06, part of the Maryland Nursing Board regulations; the bill for the anesthesia services provided to Patient A; the billing regulations devised by Health Care Finance Administration’s (“HCFA”), the federal agency in charge of Medicare payments; the curricula vitae of his expert witnesses; several Maryland House of Delegates bills; and a May 2001 newsletter from the Maryland Society of Anesthesiologists (“MSA”)

COMAR 10.27.06, entitled “Practice of Nurse Anesthetist,” lists the responsibilities of CRNAs. It defines the practice of nurse anesthesia as “the performance of acts in collaboration with an anesthesiologist, licensed physician, or dentist, which require substantial specialized knowledge, judgment, and skill related to the administration of anesthesia[.]” COMAR 10.27.06.01(B)(9). It further provides that “[a]n anesthesiologist, licensed physician, or dentist shall be physically available to the nurse anesthetist for consultation at all times during the administration of, and recovery from, anesthesia.” COMAR 10.27.06.06(A)(1) House Bill 986 of the 2001 session of the General Assembly would have added to the Health Occupations Article a section defining the word “collaboration” and required that a physician be on site to supervise a CRNA while anesthesia is being administered. The MSA supported that bill, but the Maryland Nursing Board opposed it. The bill did not pass.

The board called their two reviewers as expert witnesses. Dr. Lyles obtained his medical degree from the University of Juarez in Mexico in 1981. He worked as an attending anesthesiologist at University of Maryland Shock Trauma from 1984 to 1987 and then as the Chief of Anesthesiology at Jefferson Hospital in Alexandria, Virginia from 1987 to 1992. From 1990 to 2000, he served as the Chief of Anesthesiology at Doctors Community Hospital in Lanham, Md. He worked with CRNAs at all three hospitals, although Doctors Hospital stopped using CRNAs in 1995. At the time of the hearing, he had not held admitting privileges at any Maryland hospital for 18 months and was the President of the Maryland Society of Anesthesiologists. Dr. Lyles testified that, in drafting his peer review report in this matter, he referred to various “guidelines and standards” from the ASA. From the record:

Dr. Lyles opined that the standard of care required the appellee 1) to be physically involved in the pre-operative evaluation of Patient A, as opposed to merely delegating that duty to Davis; 2) to personally explain the risks of anesthesia and the alternatives to Patient A; 3) to be present during Patient A’s induction; 4) to check on Patient A approximately every hour during the surgery; 5) to be physically available to come to Davis’s aid; and 6) to be present during emergence and extubation of Patient A. He further opined that, in the case of a patient with an ASA 3 rating, “the supervising anesthesiologist . . . would be more diligent, more anticipatory, accumulate maybe a larger, more sufficient database with an ASA 3 than you would with an ASA 1 or ASA 2,” because he “may have to control [the ongoing] disease processes during the anesthetic.” He also stated that Patient A’s SaO2 level of 92.5 was “low” and that the appellee should have addressed it in a preanesthesia evaluation. Further, Dr. Lyles testified that, given the combination of Patient A’s low Sa02, her PVCs, the possibility of her having had a myocardial infarction, her low PTT, and the changes from her April 1998 evaluation, a “cardiac evaluation by the anesthesiologist[] would be reasonable.”

On cross-examination, Dr. Lyles acknowledged that the ASA document entitled “Anesthesia Care Team,”  which he relied upon in drafting his peer review report, is not an actual guideline or standard, but a position statement. He opined that the Union Memorial policy on the major duties of nurse anesthetists is contrary to generally accepted standards of medical care. He stated that, in contrast to what the Union Memorial policy permits, an anesthesiologist must “personally participate” in the preoperative assessment, induction, and emergence of his patient.

Counsel for the appellee questioned Dr. Lyles about the billing system devised by HCFA, the federal agency overseeing Medicare. Dr. Lyles testified that, in order to bill HCFA for medical services, an anesthesiologist must provide services consistent with the ASA Guidelines for the Ethical Practice of Anesthesiology. If he provides services that do not meet the medical direction criteria, he may bill for services by use of the “QZ modifier.” Dr. Lyles testified that, even though HFCA recognizes and specifically provides for a lesser degree of anesthesiologist involvement than medical direction, billing HCFA through the QZ modifier is “fraudulent” because it is inconsistent with state medical standards. He opined that “any physician in the State of Maryland who collaborates with a CRNA in the provision of anesthesia services in a manner inconsistent with medical direction is in violation of the standard of care.”

Dr. Lyles testimony is extraordinary. Not only does he rely entirely on a professional organization’s documents and philosophy rather than what a reasonable professional would do when similarly situated, he claims that Medicare supports violating the standard of care and, as a result we have to conclude that thousands of anesthesiologists violate the standard of care each day. Of course, all of this would be barred as testimony in civil court and, if he revealed this as his testimony during a Daubert Hearing he would not be qualified as an expert. But, as I said, anything goes here, even bullshit.

Counsel further questioned Dr. Lyles about an article he wrote for the May 2001 newsletter of the MSA, in which he stated, “A high degree of variability exists in the individual supervision/collaboration agreements with regard to the definition of clinical responsibilities and duties.” Dr. Lyles testified that he did not have personal knowledge of “different ways of collaborating with CRNAs” because the collaboration agreements he has had with CRNAs “have all been standard agreements.” Dr. Lyles asserted that “the only acceptable mode [of collaboration] allowed by the standard of care in Maryland . . . is that described in the ASA [position statement].” He agreed that the question of the “necessary level of supervision for CRNAs” by anesthesiologists is a “hot topic” nationwide and in Maryland and that, through his activities with Med Chi and the MSA, he is active in that debate.

How much more clear can it be that Dr. Lyles only basis for his opinion of the standard of care is the position statements of a private club, the ASA? But then again, who is his audience? The Board of Physicians, who have their own interests at heart. Period. Maybe their next witness has some objectivity. Dr. Forbes received his medical degree in 1978 from the Medical College of Virginia, where he later completed residencies in anesthesiology and internal medicine. At the time, the Medical College of Virginia was a training facility for CRNAs. He had been the Assistant Chief and the Chief of the Department of Anesthesia at Peninsula Regional Medical Center (“PRMC”) in Salisbury, Md. and was the Head of Quality Assurance. PRMC had 12 anesthesiologists and CRNAs on staff. Dr. Forbes worked with CRNAs twice a month.

He opined that the ASA “standards” are not mandatory but have become “standards de facto by the practice that we’ve chosen to adhere to and the practice that I understand it to be that which occurs in the majority of . . . Maryland” and the rest of the country. In his view, to meet the standard of care, the appellee was required to personally review Patient’s A’s medical records, personally perform a physical examination and assess Patient A’s laboratory work, personally obtain Patient A’s informed consent, be present for induction, and check on the CRNA every 45 to 60 minutes during the surgery. Dr. Forbes concluded that the appellee failed to provide appropriate medical care because, [T]here was no evidence that he personally participated in the pre anesthesia evaluation. There’s no evidence that he personally participated in the induction. He partially fulfilled the criteria of responding and checking on the patient at times during the case, and it’s unknown whether he was present fully for emergence.

Dr. Forbes acknowledged that CRNAs can perform inductions for cataract surgery; that he is not familiar with COMAR 10.27.06 or any anesthesia groups that allow CRNAs to practice without medical direction; and that he is not familiar with anesthesia practices in parts of the state other than Salisbury. He said he believes that Union Memorial’s policies on CRNAs are in violation of the standard of care. He acknowledged that he has never taught CRNAs.

Who knows what the ‘inductions for cataract surgery’ nonsense is. Cataracts are done under sedation. Presumably he is saying a CRNA can sedate a cataract without an anesthesiologist present. So, he is not familiar with Maryland law which states that CRNAs work in collaboration with a physician, but his testimony, like Lyles, finds that state law violates the standard of care since it does not require anesthesiologist supervision (nor does any state by law). How he works with CRNAs twice per month and does not know anything about the law that says he has to have a collaboration agreement with them is mystifying and makes one wonder why HE is not charged by the Board. Oh, right…that is a Board of Nursing Rule which the Board of Physicians find to be irrelevant.

I really got on a roll here and it has become clear that we’ll have to finish in Part 4!

Related Posts

1. Anesthesia Standard of Care: Dr. Bernstein, the ASA, Maryland Board of Physicians, and Random GPS Locations: Part 4
2. Anesthesia Standard of Care: Dr. Bernstein, the ASA, Maryland Board of Physicians, and Random GPS Locations: Part 2
3. Anesthesia Standard of Care: Dr. Bernstein, the ASA, Maryland Board of Physicians, and Random GPS Locations: Part 1
4. READ: Maryland Board of Physicians Charges Against Dr. Midei.
5. The Standard of Care in Anesthesia….not what you think