State Board of Physicians v. Bernstein

⁷¹⁹ DEBORAH S. EYLER, J. The Maryland Board of Physicians (“Board”), the appellant, challenges a judgment of the Circuit Court for Baltimore County reversing the Board’s decision reprimanding Steven Bernstein, M.D., the appellee, for failing to comply with appropriate standards of care. The Board presents two questions for review, which we have consolidated into one: Was the Board’s decision supported by substantial evidence in the agency record? 1 For the following reasons, we shall vacate the decision of the circuit court, and remand the matter to that court with instructions to remand the matter to the Board for further proceedings not inconsistent with this opinion. STATUTORY SCHEME Before recounting the facts, we shall review the process used by the Board to investigate and adjudicate complaints against physicians. Physicians in Maryland are governed by the Medical Practices Act (“the Act”), Md.Code (1982, 2000 Rep.Vol.), section 14- 101 at seq. of the Health Occupations Article (“HO”).

At the pertinent time in the case, the Act was administered by a 15- member Board. 2 [¶] § 14-202(a). The Board, comprised ⁷²⁰ of physicians and consumers, is responsible for the licensure and discipline of physicians in Maryland. It has adopted regulations governing the disciplinary process that are codified in the Code of Maryland Regulations (“COMAR”) 10.32.02. The Act authorizes the Board to reprimand a licensed physician, place a licensee on probation, or suspend or revoke a license to practice medicine for enumerated reasons, including the failure “to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care performed in an outpatient surgical facility, office, hospital, or any other location” in Maryland. [¶] § 14-404(a)(22).

When an allegation that may constitute grounds for disciplinary action under the Act comes to the Board’s attention, the Board generally initiates an investigation. [¶] § 14-401(a); COMAR 10.32.02.03A. If the allegation concerns the standard of care and, after an investigation, the Board elects to pursue further investigation, the Board then refers the complaint to the Medical and Chirurgical Faculty of Maryland (“Med Chi”) physician peer review. [¶] § 14-401(c)(2); CO-MAR 10.32.02.03(B)(1). The Board and Med Chi have adopted a “Peer Review Handbook” that governs the peer review process. Med Chi prepares a report addressing the allegations against the physician and submits it to the Board.

After receiving the Med Chi report, the Board determines whether reasonable cause exists to charge the physician with a failure to meet appropriate standards of care. COMAR 10.32.02.03(B)(2). If the Board files a charge, it refers the matter to an administrative prosecutor and sends notice to the physician. COMAR 10.32.02.03(C) ⁷²¹ At that point, the physician is entitled to a contested case hearing before an administrative law judge (“ALJ”), in the Office of Administrative Hearings (“OAH”), pursuant to the Administrative Procedure Act, Md.Code (1984, 1999 Repl.

Vol.), section 10-201 et seq. of the State Government Article (“SG”). [¶] § 14-405(a); see also COMAR 10.32.02.08(D). Following the hearing, the ALJ issues findings of fact, conclusions of law, and a proposed disposition. COMAR 10.32.02.03(E)(10). When the charge against the physician is failure to meet appropriate standards under [¶] section 14-404(a)(22), the standard of proof is clear and convincing evidence. [¶] § 14-105(a)(3).

Either party may file exceptions to the ALJ’s findings and proposed disposition. COMAR 10.32.02.03(F). The Board is not bound by the decision of the ALJ. Compare Md.Code (1994, 2005 Repl.Vol.), § 11-110 of the State Personnel and Pensions Article (providing that “the decision of [OAH] is the final administrative action”).

After receiving the ALJ’s proposed decision, the Board must review the record and the ALJ’s proposal, and hold a hearing on any exceptions. COMAR 10.32.02.03(F). It then issues a final decision stating its findings of facts, conclusions of law, and a disposition of the charge. COMAR 10.32.02.03(E)(10).

The Board’s final decision is subject to judicial review in the circuit court in accordance with the Administrative Procedure Act, and then to appeal to this Court. [¶] § 14-408(b). FACTS The basic, first-level facts in this case are not in dispute. The appellee is a Board-certified anesthesiologist. He obtained his undergraduate degree from the University of Maryland in 1979 and his medical degree from The John Hopkins Medical School in 1983.

He completed a residency in anesthesiology at The John Hopkins Hospital in 1986, and a fellowship in anesthesiology, also at Hopkins, in 1987. When the events in this case happened, he was an employee of Parkway Anes ⁷²² thesia, the anesthesiology group for Union Memorial Hospital in Baltimore. On October 12, 1998, in the afternoon, Patient A, an 82-year-old woman, was transported to Union Memorial’s emergency room after she fell off a small stool at her home, injuring herself. She had a past medical history of colon cancer treated by resection and chemotherapy beginning in April of that year.

She was diagnosed with a fractured left hip and admitted to the hospital at about 5 p.m. Patient A was evaluated by Frank Ebert, M.D., an orthopedic surgeon, who recommended a left total hip replacement. The surgery was scheduled for the following evening, October 13,1998. The appellee was the anesthesiologist on call at Union Memorial from 3 p.m. on October 13 until the next morning.

Thomas Davis, a certified registered nurse anesthetist (“CRNA”), also was on call. Davis was the chief nurse anesthetist at Union Memorial and had worked as a CRNA for about 30 years. The appellee had worked with Davis since 1987. A second CRNA, whose name is not disclosed in the record, and had no involvement in Patient A’s case, also was on duty.

An EKG and chest X-ray taken prior to surgery showed that Patient A had a normal sinus rhythm with a rate of 82, a left axis deviation, and some premature ventricular contractions (“PVCs”). She had a blood oxygen saturation (“Sa02”) of 92.5%. The EKG also showed the possibility of a past myocardial infarction, i.e., “heart attack,” sometime after her evaluation in April 1998. Patient A’s partial thromboplastin time (“PTT”), or measure of blood coagulation, was 20, which is low.

Dr. Waiel Samara, an internist, examined A and cleared her for surgery. He found “no evidence of acute cardiac event.” He also found that she was “hemodynamically stable, asymptomatic,” and that there was “no need for any intervention.” He noted that Patient A had PVCs. He did not remark on the possibility of a past myocardial infarction. An orthopedic ⁷²³ admission physician also performed a preoperative evaluation.

He noted that he had counseled Patient A and her son about the risks of the surgery. CRNA Davis examined Patient A on the evening of the surgery, at about 7:30 p.m. He completed a form entitled “anesthesia evaluation and post anesthesia record.” The form reflects that Davis reviewed Patient A’s chart, discussed general anesthesia with Patient A and her daughter, and then obtained informed consent. 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. The appellee did not examine Patient A or review her chart prior to the surgery.

At approximately 7:15 p.m., the appellee was providing anesthesia services to another patient. Dr. Peter Mulaikal, another anesthesiologist, told him that there were two cases remaining for surgery that evening: an emergency appendectomy and Patient A’s hip replacement. Dr. Mulaikal agreed to work on the appendectomy. Davis was assigned to Patient A. After the appellee was finished treating the patient he was assigned to, at 7:45 p.m., he went to the room where Dr. Mulaikal was working on the appendectomy, to relieve him.

While the appellee was working on the appendectomy, Davis came into the operating room to discuss his evaluation of Patient A and her anesthesia plan. The discussion lasted about a minute. The appellee approved the plan but did not ⁷²⁴ read Patient A’s chart. Davis did not discuss Dr. Samara’s evaluation with the appellee.

At approximately 8:00 pan., Davis administered the anesthesia to Patient A. 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 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 ⁷²⁵ 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. 3 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.” ⁷²⁶ PROCEEDINGS Complaint and Charges On December 16, 1998, Patient A’s son filed a complaint with the Board, alleging that the appellee had “committed acts of negligence and medical malpractice” by, among other things, “failing] to provide close supervision of the CRNA administering [Patient A’s] anesthesia[.]” The appellee, 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 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 Patient A’s medical records. Both reviewers are Board certified in anesthesiology. On November 28, 1999, Dr. Lyles mailed his report to Med Chi. In it, he summarized the events surrounding Patient A’s hip replacement surgery.

Noting that the appellee was the “responsible anesthesiologist providing medical direction, supervising Mr. Davis,” he concluded that the appellee had breached the standard of care by failing to participate in Patient A’s care preoperatively or perioperatively, and that Davis “was permitted to assume what may be even considered independent responsibility for the anesthesia care of [Patient A].” One month later, on December 30, Dr. Forbes submitted his report to Med Chi. Dr. Forbes concluded that, overall, Patient A had “received anesthesia care that met the necessary standard of care.” However, like Dr. Lyles, he concluded that the appellee 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, ⁷²⁷ “The reviewers concur that [the appellee] breached the standard of care in the supervision of a CRNA in this case.” On November 22, 2000, the Board brought charges against the appellee under [¶] section 14-104(a)(22), with respect to his treatment of Patient A. 4 The statement of charges listed thirteen failures to meet the standard of care: a.

Failure to perform a physician preoperative anesthesia evaluation and examination of Patient A including review of laboratory orders, EKG, chest x-ray; b. Failure to supervise the CRNA including reviewing the CRNA’s evaluation and possibly ordering a specialty specific cardiac evaluation, ordering further laboratory testing regarding Sa02 status and possibly deferring surgery, as part of the pre-anesthesia date base; c. Failure to prescribe a plan for anesthesia and to discuss the anesthesia plan with the CRNA; d. Failure to discuss alternative methods of anesthesia (general v. regional) with Patient A; e.

Failure to obtain Patient A’s informed consent to general anesthesiology; f. Failure to be present during induction of Patient A; g. Failure to be physically available to the CRNA for supervision in anticipation of anesthetic risks such as adverse cardiac and neurological sequelae during surgery; h. Failure to be physically available to the CRNA for supervision in anticipation of anesthetic risks attributed to Patient A’s low Sa02 as noted in the preoperative laboratory work-up; i.

Failure to be physically available to the CRNA to provide diligent, anticipatory, and knowledgeable medical management of Patient A during surgery to lessen the ⁷²⁸ anesthetic risks with appropriate consultation and intervention; j. Failure to be physically available to the CRNA to provide immediate anticipatory vascular volume replacement therapy for Patient A with early anticipatory intervention; k. Failure to be physically available to the CRNA to provide full vascular volume replacement during Patient A’s surgery; l. Failure to be present during reversal of anesthesia and extubation and during Patient A’s emergence from anesthesia; and m.

Permitting himself to be the anesthesiologist of record for Patient A at a time when he was not able to be physically available and to provide proper supervision for the CRNA; or, conversely failing to decline to be the anesthesiologist of record for Patient A at a time when he was not able to be physically available to provide proper supervision for the CRNA. The statement of charges summarized the events surrounding Patient A’s surgery and directed the Office of Administrative Hearings to hold a contested case hearing on the matter. Administrative Hearing A contested case hearing was held before an ALJ on May 22, 28, and 24, 2001. The focus of the hearing was expert testimony about the appropriate standard of care.

Exhibits 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 ⁷²⁹ 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. ⁷³⁰ 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. The Union Memorial Policy on “The Anesthesiologist-Nurse Anesthetist Relationship” states: Whenever a [CRNA] administers anesthesia alone or under the supervision of an Anesthesiologist, the medical responsibility is still that of the Anesthesiologist.

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. The Union Memorial Policy on “Major Duties and Responsibilities of Nurse Anesthetists” describes the specific duties of the CRNA in the following areas: 1) Administers anesthesia for cases as assigned by the Anesthesia Coordinator. 2) Performs Preoperative Assessments. 3) Inspects equipment prior to administering anesthesia. 4) Provides intraoperative management consistent with accepted [American Association of Nurse Anesthetists], ASA standards and Departmental Policies. ⁷³¹ 5) Maintains complete and accurate records of anesthetic management. 6) Provide for safe transition from [operating room] to [post anesthesia care unit]. 7) Provide verbal report pertinent to the surgical procedure and anesthetic management to PACU personnel. 9) Follow Departmental Safety Standards. 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”). 5 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) (emphasis added). 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. ⁷³² Expert Testimony for the Board The Board called Drs. Lyles and Forbes as expert witnesses. Both were qualified as experts in the field of anesthesiology. Dr. Lyles received his Ph.D. in materials engineering prior to obtaining 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. 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.

Dr. Lyles has served as President of the MSA. At the time of the hearing, he was representing the MSA on the Board Office Surgery Committee and was serving on the Med Chi and the MSA legislative committees. Dr. Lyles also is a member of numerous professional organizations. His curriculum vitae cites roughly 300 publications and presentations related to medical topics and the subject of his Ph.D. Dr. Lyles testified that, in drafting his peer review report in this matter, he referred to various “guidelines and standards” from the ASA.

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 anticipato ⁷³³ ry, 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 Sa02 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.” Dr. Lyles concluded his testimony on direct examination by opining that the appellee had breached the standard of care by failing to conduct the preanesthetic evaluation, by not being present and available during the administration of anesthesia, and by not being present when the Patient A suffered an adverse event. 6 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 ⁷³⁴ 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.” 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 also was questioned about House Bill 986.

The appellee’s counsel confronted Dr. Lyles with the fact that the Maryland Nursing Board had opposed the bill because it “has interpreted the ‘physical availability’ supervision requirement [in COMAR 10.27.06] to mean that the collaborating physician should be ‘available in person or by telephone and able to reach the site should his/her presence be required.’ ” Despite the language of House Bill 986 and the Nursing Board’s interpretation of COMAR 10.27.06, 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. He further acknowledged having testified on behalf of Med Chi in support of House Bill 986. ⁷³⁵ On re-direct examination, Dr. Lyles was asked about his statement in the MSA newsletter that “a high degree of variability exists in ... collaboration agreements.” He clarified the statement by explaining that “the nurse at shock trauma might have very different duties and responsibilities than the nurse anesthetist at, say, a surgery center because of the severity and illness of the patient.” Dr. Forbes testified by telephone from Salisbury. He 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 then worked as both the Assistant Chief and the Chief of the Department of Anesthesia at Peninsula Regional Medical Center (“PRMC”) in Salisbury. At the time of the hearing, Dr. Forbes had been in private practice in Salisbury since 1989, and was the Head of Quality Assurance at PRMC. PRMC had 12 anesthesiologists and CRNAs on staff. Dr. Forbes worked with CRNAs twice a month.

Dr. Forbes testified that his understanding of the standard of care comes from his training at the Medical College of Virginia and his private practice in Salisbury. 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, [Tjhere was no evidence that he personally participated in the pre anesthesia evaluation. There’s no evidence that he ⁷³⁶ 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 also stated that Patient A’s ASA rating of 3 meant that she could “possibly have more potential for complications” and that the physicians would be “more involved and more vigilant than say an ASA 1 patient that has no medical conditions and they’re going to impact their surgery.” On cross-examination, 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. Expert Testimony for the appellee The appellee called two expert witnesses, Timothy Gilbert, M.D., and James Pepple, M.D. Both were qualified as experts in anesthesiology. Dr. Gilbert received his medical degree from the University of Virginia in 1987.

He completed his residency in anesthesiology at George Washington University in 1992. While there, he served as Chief Resident, and then undertook a fellowship in cardiothoracic anesthesia. He also worked as a clinical instructor at George Washington University for two years and as an instructor for a CRNA program for the U.S. Navy in the District of Columbia. Dr. Gilbert worked with CRNAs while at GWU.

At the time of the hearing, he was an Associate Professor of Anesthesiology and Cardiology and the Section Chief of Car-diothoracic Anesthesiology at the University of Maryland Hospital. That hospital does not use CRNAs. Dr. Gilbert also had privileges at Maryland Shock Trauma and at Baltimore Veteran’s Hospital. CRNAs are used at both of these institutions. ⁷³⁷ Dr. Gilbert is Board certified in anesthesiology and critical care medicine.

He has published numerous articles. Dr. Gilbert testified about a study he published in the American Journal of Orthopedics in 2000 about the use of spinal versus general anesthesia for elderly hip fracture patients. In his study, which took place in the 1990’s, he evaluated 1,000 patients at eight hospitals and two academic institutions in Maryland, including the following hospitals: Northwest Medical, Franklin Square, Greater Baltimore Medical Center, St. Agnes, St. Joseph’s, Sinai, Union Memorial, and the University of Maryland. Seven out of the eight hospitals use CRNAs.

Although the primary focus of the study was not the level of physician supervision of CRNAs, one focus was on determining whether anesthetic care has “an impact on outcome in elderly patients in Baltimore who had hip fractures.” As part of this research, Dr. Gilbert reviewed how anesthetic care is structured and delivered. Dr. Gilbert testified that there’s a high degree of variability in the collaboration between an anesthesiologist and a [CRNA]. As evidence to what I found in the study that we performed, there are a continuum of collaborations that depend somewhat on the degree of expertise of the CRNA and the hospital policies and procedures that are in place at a given hospital. It ranges from an anesthesiologist providing care solely by themselves to the other end of the continuum where a CRNA is providing care solely by themselves with the backup supervision or collaboration of a physician or collaboration of a physician or dentist or podiatrist.

Dr. Gilbert opined that these levels of collaboration, while varying, all are “acceptable” and meet the standard of care. According to Dr. Gilbert, the standard of care can be met without medical direction, and “medical direction is not related inherently to the standard of care, but is more directly related to billing terminology.” He noted that, in six out of the eight hospitals he examined for his study, the level of involvement of CRNAs in patient care was “relatively similar” to Union ⁷³⁸ Memorial’s policy. He concluded that Union Memorial’s policy complies with the standard of care, and that the appellee did not breach the standard of care in his treatment of Patient A. Dr. Gilbert also testified that, contrary to Dr. Lyles’s conclusions, Patient A’s Sao2 level was not an issue of concern, due to her injury, her age, and the fact that she had been given pain medication. On cross-examination, Dr. Gilbert clarified that, in about half of the cases in his study, anesthesia was delivered directly by anesthesiologists; in the other half, anesthesia was delivered by a CRNA in some level of collaboration with an anesthesiologist.

He testified that, although non-compliance with the ASA standards for medical direction is not “de facto malpractice,” the standards are “important things to look at when we’re defining quality.” Dr. Gilbert further opined that, when medical direction is not used, the anesthesiologist and CRNA still should work together, because “no one wants to be left out in a room by themselves without any kind of help. But I would expect that’s not so much a standard of care issue. It’s just how a business is run.” Dr. Gilbert agreed with the statement that, under the medical supervision model of care, “the nurse is in charge and gets consultation with the doctor as the nurse decides.” On re-direct examination, Dr. Gilbert stated that the standard of care gives CRNAs a significant role in administering anesthesia and allows them to decide when to call for help, because of their “expertise, training and knowledge.” Dr. Pepple obtained his medical degree at the University of Missouri in 1974. He completed his internship and residency in pediatrics at Johns Hopkins and then completed a residency in anesthesiology at the University of Pennsylvania.

From 1983 to 1995, he worked as a staff anesthesiologist at Greater Baltimore Medical Center, where CRNAs are used. He also held the position of Assistant Professor of Anesthesiology and ⁷³⁹ Critical Care Medicine at The Johns Hopkins Hospital from 1983 to 1996. Dr. Pepple has been Board-certified in anesthesiology since 1983. At the time of the hearing, he was Chairman of Anesthesia for the Upper Chesapeake Health System — which includes Harford Memorial Hospital, Upper Chesapeake Medical Center, and Harford Surgery Pavilion — and was the Anesthesia Director for the Towson Surgical Center.

He has worked with CRNAs at Hopkins, the Greater Baltimore Medical Center, Harford Memorial Hospital, Towson Surgical Center, and Upper Chesapeake Health System. He also has authored numerous publications. Dr. Pepple testified that, in Maryland, an anesthesiologist need not practice medical direction to satisfy the standard of care. Rather, medical direction is a term that “grew out of compliance issues that HCFA was having with ... physicians billing lots and lots and not being clear how many people were involved in care.” He stated that the ASA pronouncements are “not observed,” and represent a political, “ideal position.” Dr. Pepple testified that several hospitals in Maryland follow the Union Memorial model of collaboration, including Franklin Square, Carroll County, and Harford Memorial.

He opined that Union Memorial’s policies exceed the standard of care. Dr. Pepple stated that, when CRNAs practice “unmedi-cally directed,” that is a personnel decision made to avoid any problems with HCFA compliance. He added, [I]t’s a manpower issue. If you have so many people that have to be on call so much of a period of time, if it becomes too burdensome, you won’t have any staff at all.

So it’s practical solution. CRNAs are “expected to do all of the care themselves ... to do everything from A to Z themselves.” Dr. Pepple characterized the rules on collaboration between anesthesiologists and CRNAs as “very loose.” He opined that, in this case, there was nothing about the cardiac status or any of the laboratory results for Patient A that altered the standard of care for the provision of anesthesia services to ⁷⁴⁰ her. He explained that an Sa02 level of 92 for an elderly person is within the normal range. He concluded that the appellee did not violate the standard of care in any way in providing anesthesia services to Patient A. Dr. Pepple qualified his opinion about the standard of care by saying that, when he testified that a CRNA could perform anesthesia care “A to Z,” he was not “endorsing any of this stuff.” He was “just reporting as to what is occurring in Maryland, which would be the standard of care.” His personal practice in administering anesthesia differs from the standard of care.

His opinions about the standard of care are based on the COMAR regulations and on “what has been occurring in the state and country.” He noted that, to the best of his knowledge, no Maryland hospital permits CRNAs to give anesthesia in open heart surgery. Dr. Pepple also stated that, despite Patient A’s ASA rating of 3, the standard of care had been met, given that Patient A was “awake and talking and doing everything normally” and CRNA Davis had 30 years of experience. The appellee also called Charles F. Hobelman, Jr., M.D., Chairman of the Department of Anesthesiology at Union Memorial. He testified that Union Memorial does not use medical direction, but rather a “looser form of direction,” and that its model of collaboration is similar to that used at Franklin Square.

He described how the anesthesia department at Union Memorial is staffed in the evenings. He testified that the handling of Patient A’s case did not differ from the standard operating procedure under similar circumstances at Union Memorial. On cross-examination, Dr. Hobelman stated that, at Union Memorial, a CRNA may request “more specific management by an anesthesiologist.” Otherwise, the CRNA handles the anesthetic responsibilities without assistance. Finally, the appellee testified on his own behalf about the events surrounding Patient A’s surgery and the level of supervision of CRNAs at Union Memorial.

He said that he had worked with CRNAs at Union Memorial and had learned ⁷⁴¹ about the standard of care from his work there. He opined that Union Memorial’s policies exceed the standard of care because they require some consultation between the CRNA and the anesthesiologist, and there must always be an anesthesiologist present on site for consultation. Like Drs. Gilbert and Pepple, he characterized medical direction as a billing concept; stated that the ASA position statement does not establish the standard of care; and agreed that the issue of collaboration between anesthesiologists and CRNAs is a “hot and debated topic.” In summarizing his version of the events surrounding Patient A’s surgery, the appellee testified that an Sa02 level of 92.5 is not unusual for an elderly patient and that there were no special risks of Patient A’s surgery that required a physician to perform the preanesthetic evaluation.

Had he performed the evaluation, it would have been no different than the one Davis performed. Given that Patient A “had relatively few medical conditions aside from the acute process that needed to be treated that night,” his one-minute discussion with CRNA Davis about Patient A’s anesthesia plan was appropriate. In ten years of collaboration, Davis always had provided the appellee with all relevant information about a patient for anesthesia evaluation. After counsel gave closing arguments, the ALJ stated that she would issue her proposed decision within 90 days.

The ALJ’s Decision On August 14, 2001, the ALJ issued a written proposed decision, recommending that the charges against the appellee be dismissed. The ALJ first defined the applicable terms, including CRNA, collaboration, the various stages of the anesthesia process, and “physically available.” She reviewed the relevant ASA documents and the Union Memorial policies. She then summarized Patient A’s medical condition and the events of October 13,1998. ⁷⁴² The ALJ set forth two questions she considered to be central to the case: 1) whether the model of collaboration used by the appellee itself constituted a per se violation of the standard of care; and 2) assuming, arguendo, that the answer to that question was “no,” did the appellee breach the standard of care by delegating duties in Patient A’s case to Davis? The ALJ observed that the Board’s experts had testified that the medical direction model of collaboration is the minimum standard for providing quality medical care and that the standard of care for anesthesiologists requires that they follow that model.

She further observed, however, that the appel-lee’s experts were “even more impressive,” and that they had testified that the method of collaboration used by the medical community is consistent with the Union Memorial Hospital mode. She found the testimony of the appellee’s expert witnesses, that medical direction is not the only acceptable collaboration model, to be “entirely credible.” She further found that testimony of the Board’s experts was “not persuasive.” The ALJ noted that, although Dr. Lyles had referred to the ASA position statement in asserting that medical direction is the only collaboration model that meets the standard of care, he later conceded that the document was non-binding. Further, although Dr. Lyles testified that he had reached his conclusion about the standard of care independent of the ASA documents, this testimony, in the ALJ’s view, was not credible. She pointed out that Dr. Lyles made several concessions on cross-examination about HCFA, the Nursing Board’s opinions, and his article in the MSA May 2001 newsletter, which “belie[d] not only the credibility of the stated basis for his conclusion, but also the persuasiveness of his overall opinion.” The ALJ also found both Dr. Lyles and Dr. Forbes to be lacking in experience with CRNAs.

She noted that Dr. Lyles’s experience was limited to hospitals that use only the medical direction model of collaboration or do not employ CRNAs at all; and that, at the time of the hearing, he had not held admitting privileges at any Maryland hospital for about ⁷⁴³ 18 months. Further, the ALJ found that Dr. Lyles was a biased witness, as he “is clearly on one side of [the CRNA collaboration] debate.” The ALJ observed that Dr. Forbes’s experience was limited to his practice in Salisbury and that he had not published any papers or done any research on varying models of collaboration. She stated: [W]hile I am convinced that Dr. Forbes believes that medical direction is the minimal standard, I do not believe his conclusion is based on a full understanding of the range of practices utilized by reasonably competent practitioners in anesthesiology in the same or similar circumstances within the Maryland medical community. In contrast, the ALJ found that the “breadth of experience of the [appellee’s] witnesses demonstrated a fuller understanding of the practices of the Maryland medical community.” She described Dr. Gilbert as “extremely impressive” and found that he provided the “most objective and compelling evidence” about the standard of care.

She cited with approval his study in the American Journal of Orthopedics about elderly hip fracture patients. She noted that Dr. Gilbert had “credibly testified” that there is a continuum of practices of physical availability and that medical direction is a billing practice, not a minimum standard of care. She then summarized Dr. Pepple’s testimony and Dr. Hobelman’s testimony. Writing rhetorically, the ALJ asked, if medical direction is the only collaboration model that satisfies the standard of care, why would legislation such as House Bill 986 be sought to ensure that the anesthesiologist be on site?

She concluded by stating: [The appellee] presented compelling, consistent expert testimony that [the appellee] used the same degree of care and skill in selecting the “medical supervision” model of collaboration that “reasonably competent anesthesiologists” in the same or similar circumstances would use. I agree with [the appellee] that it is incorrect to conclude that his failure to adhere to the medical direction method of collaboration with CRNA Davis, in and of itself, constituted a breach of the standard of care. Like [the appellee], I agree that the ⁷⁴⁴ evidence fails to establish that “medical direction” is the only acceptable method of collaboration. To hold otherwise would be to conclude that all the anesthesiologists, at numerous hospitals, including Union Memorial, are daily in violation of the standard of care when they practice in conformity with their peers.

The ALJ then turned to the question of whether the appel-lee’s collaboration with Davis, given the facts of this case, breached the standard of care. She observed that this is a factual question, because “the only real guidance about the standard of care is that the collaborating physician must be physically available to assist the CRNA during anesthesia services.” The ALJ concluded that none of the charges brought by the Board established a breach of the standard of care by clear and convincing evidence. Charge 1, that the appellee was not present during extubation and emergence, was factually unsupported by the evidence. She found no merit to the charges that the appellee was not physically available, because he never left the operating suite while Patient A was in surgery, there was a second CRNA who could have relieved him, and he could have arrived at Patient A’s operating room within minutes to assist Davis, if necessary.

The ALJ then found that the appellee’s delegation of responsibility to Davis met the standard of care. She noted Davis’s extensive experience and the appellee’s testimony that Davis had never given him reason to question [Davis’s] judgment. She observed that there was no evidence presented that the appellee’s confidence in Davis was misplaced. Turning to the Board’s argument that, had the appellee performed the preanesthesia assessment, he might have ordered additional laboratory reports, delayed the surgery, or altered the plan, the ALJ found that “no testimony was presented that would suggest that the ultimate anesthesia plan was incorrect” and, in fact, Dr. Forbes had opined that the overall anesthetic care met the standard of care.

Further, ⁷⁴⁵ both Dr. Gilbert and Dr. Pepple had testified that Patient A’s Sa02 level of 92.5 was not cause for concern. The ALJ further found that, although the Board suggested that Patient A’s hypotension would