In the Matter of Lee C.D. Hang-Fu, M.D. Case No.

07-CRF-020

The Boards notice letter also stated that Dr. Hang-Fus acts, conduct, and/or omissions, individually and/or collectively, constitute the following: (1) violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board, as set forth in Section 4731.22(B)(20), Ohio Revised Code, to wit: (a) Rule 4731-25-07(A), Ohio Administrative Code, a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code; Rule 4731-25-05(B)(1), Ohio Administrative Code, a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code; Rule 4731-25-03(B)(1), Ohio Administrative Code, a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code; and Section 4731.143, Ohio Revised Code.

(b)

(c)

(d) (2)

[m]aking a false, fraudulent, deceptive, or misleading statement in the solicitation of or advertising for patients; in relation to the practice of medicine and surgery, * * * or in securing any certificate to practice or certificate of registration issued by the board, as set forth in Section 4731.22(B)(5), Ohio Revised Code.

The Board advised Dr. Hang-Fu of his right to request a hearing, and his counsel filed a written request for hearing on December 24, 2007. (States Exhibits 1A, 1B) Appearances at the Hearing Nancy H. Rogers, Attorney General, by Barbara J. Pfeiffer, Assistant Attorney General, on behalf of the State of Ohio. Thomas P. Marotta, Esq., on behalf of the Respondent, Lee C.D. Hang-Fu, M.D.

EVIDENCE EXAMINED Testimony Heard Lee C.D. Hang-Fu, M.D.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

Exhibits Examined A. Presented by the State States Exhibits 1A through 1C: Procedural exhibits. [States Exhibit 1A was redacted in part to obscure the name of a patient.] States Exhibit 1D: Patient key. [Admitted under seal.] States Exhibits 2A and 2B: Not admitted. States Exhibit 3: Medical record of Patient 1. [Admitted under seal.] States Exhibits 4 and 5: October 2007 and November 2007 interrogatory responses from Dr. Hang-Fu. [Redacted in part to obscure the names of patients.] States Exhibit 6: December 14, 2007, report from the Accreditation Association for Ambulatory Health Care, Inc., regarding its survey of Dr. Hang-Fus office setting. [This exhibit is not a complete copy of the survey results. Also, this exhibit was originally marked as Respondents Exhibit G. It was withdrawn by Respondent, but admitted on rebuttal as States Exhibit 6.] B. Presented by the Respondent Respondents Exhibit A: Dr. Hang-Fus curriculum vitae. [Redacted in part to obscure telephone numbers and an e-mail address.] Respondents Exhibit B: Dr. Hang-Fus June 2005 request for a waiver of the accreditation requirement in the Accredited Surgical Facilities Bylaws of the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgeons, Inc. Respondents Exhibit C: 2005 and 2006 correspondence between Dr. Hang-Fus office and HCI, Inc., for accreditation consulting services; and a 2005 accreditation survey order form from Dr. Hang-Fus office to the Association for Ambulatory Health Care, Inc. [Redacted in part to obscure a credit card number.] Respondents Exhibit D: January 10, 2006, e-mail from Dr. Hang-Fus office to the Association for Ambulatory Health Care, Inc. Respondents Exhibit E: 2006 correspondence between Dr. Hang-Fus office and HCI, Inc., for further accreditation consulting services. [Redacted in part to obscure a bank account number.]

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

Respondents Exhibit F: 2005, 2006, and 2007 correspondence and a postal delivery confirmation receipt regarding a survey of Dr. Hang-Fus office by the Accreditation Association for Ambulatory Health Care, Inc. [Redacted in part to obscure bank account numbers.] Respondents Exhibit H: Handwritten notes by Dr. Hang-Fus former office administrator.

OFFICE-BASED SURGERY REQUIREMENTS IN OHIO On January 1, 2004, the Board implemented requirements for office-based surgery, which are delineated in Chapter 4731-35, Ohio Administrative Code [O.A.C.]. Relevant to this proceeding are the following definitions in Rule 4731-25-01, O.A.C.: (F) Minimal sedation (anxiolysis) means a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Minimal sedation shall not include sedation achieved through intravenous administration of drugs[.] *** (H) Moderate sedation/analgesia means a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from a painful stimulus is not a purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is maintained[.] Office setting means an office or portion thereof which is utilized to provide medical and/or surgical services to the physicians own patients and which is not an ambulatory surgical facility as defined in rule 3701-83-15 of the Administrative Code, 2 a hospital registered with the department of health pursuant to section 3701.07 of the Revised Code, or an emergency department located within such a hospital[.]

(I)

Ambulatory surgical facility is defined in relevant part in Rule 3701-83-15(A), O.A.C., as: [A] facility whether or not a part of the same organization as a hospital, which is located in a building distinct from another in which inpatient care is provided, and to which any of the following apply: (1) Outpatient surgery is routinely performed in the facility and the facility functions separately from a hospitals inpatient surgical service or emergency department, and from the office of private physicians, podiatrists, and dentists; * * *.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

*** (L) Surgery means the excision or resection, partial or complete, destruction, incision or other structural alteration of human tissue by any means, including through the use of lasers, performed upon the body of a living human being for the purposes of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defects, prolonging life, relieving suffering, or for aesthetic, reconstructive or cosmetic purposes, * * *.

In addition, the office-based surgery rules in Chapter 4731-25, O.A.C., include the following relevant provisions: Rule 4731-25-02, O.A.C.: (A) Anesthesia services in the office setting shall be provided only by physicians * * * and only in accordance with Chapter 4731-25 of the Administrative Code. *** (G) This chapter of the Administrative Code shall not apply to surgeries or special procedures in which the level of anesthesia is limited to minimal sedation as that term is defined in this chapter of the Administrative Code, or which use only local or topical anesthetic agents, and which are performed in an office setting except that liposuction procedures performed under tumescent local anesthesia shall be subject to the provisions of rule[s] 4731-25-05 and 4731-25-06. Procedures or surgery utilizing moderate sedation/analgesia or anesthesia services shall be performed in the office setting only on patients who are evaluated as level P1 or P2 according to the American society of anesthesiologists physical status classification system current at the effective date of this rule.

(H)

Rule 4731-25-03, O.A.C.: (B) Moderate sedation/analgesia may be administered in the office setting by only the following: (1) A physician who hold privileges to provide moderate sedation/analgesia from a local hospital accredited by the joint commission on accreditation of healthcare organizations or the

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

American osteopathic association or from a local ambulatory surgical facility licensed by the department of health[.] Rule 4731-25-05, O.A.C.: (A) A physician performing liposuction in the office setting shall meet the training requirements set forth in paragraph (A) of rule 4731-25-03 of the Administrative Code and must be in compliance with this rule. Liposuction in the office setting shall be performed in compliance with rules 4731-25-03 and 4731-25-04 of the Administrative Code as appropriate to the level of sedation being administered and in compliance with the following standards: (1) The cannula shall be no larger than 4.5 millimeters in diameter; *** (D) Liposuction using moderate sedation/analgesia or anesthesia services performed in an office shall be accredited in accordance with rule 4731-25-07.

(B)

Rule 4731-25-07, O.A.C.: (A) No physician or podiatric physician shall perform procedures or surgery using moderate sedation/analgesia or anesthesia services in an office setting unless that office setting is accredited by an accrediting agency approved by the board, except that physicians and podiatric physicians who are performing such procedures or surgeries in office settings that are not accredited on the effective date of this rule shall apply for accreditation within eighteen months of the effective date of this rule and shall receive accreditation within three years of the effective date of this rule. 3 Accrediting agencies approved by the board include the following: (1) The joint commission on accreditation of healthcare organizations;

(B)

Eighteen months after the effective date of Rule 4731-25-07(A), O.A.C., was July 1, 2005. Three years after the effective date of Rule 4731-25-07(A), O.A.C., was January 1, 2007.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

(2)

The accreditation association for ambulatory health care, inc. [AAAHC]; * * *

MEDICAL MALPRACTICE NOTICE REQUIREMENTS IN OHIO Section 4731.143(A), Ohio Revised Code, states in pertinent part the following: Each person holding a valid certificate under this chapter authorizing the certificate holder to practice medicine and surgery * * * who is not covered by medical malpractice insurance shall provide a patient with written notice of the certificate holders lack of that insurance coverage prior to providing nonemergency professional services to the patient. The notice shall be provided alone on its own page. The notice shall provide space for the patient to acknowledge receipt of the notice * * *. The certificate holder shall obtain the patients signature, acknowledging the patients receipt of the notice, prior to providing nonemergency professional services to the patient. The certificate holder shall maintain the signed notice in the patients file. 4

SUMMARY OF EVIDENCE All exhibits, even if not specifically mentioned, were thoroughly reviewed and considered by the Hearing Examiner prior to preparing this Report and Recommendation. Background 1. Lee C.D. Hang-Fu, M.D., is a cosmetic plastic surgeon. For his undergraduate studies, he attended the University of Western Ontario in London, Ontario, studying chemistry. He entered the medical degree program at the University of Western Ontario in 1979, and earned a medical degree in 1983. His curriculum vitae reflects that, during his final year of medical school, he spent time at the University of Alberta, in Edmonton, studying cranio-facial surgery, and at the Hand Surgery Association in Louisville, Kentucky, studying hand surgery. (Hearing Transcript [Tr.] at 29; States Exhibit [St. Ex.] 4 at 6, 79; Respondents Exhibit [Resp. Ex.] A) From 1983 to 1986, Dr. Hang-Fu completed a one-year general internship at Victoria Hospital in London, Ontario, and two years in a general surgery residency at Memorial University, in St. Johns, Newfoundland. Then, between 1986 and 1989, he participated in plastic surgery research and non-research programs at McMaster University in Hamilton, Ontario. Between 1989 and 1991, Dr. Hang-Fu practiced plastic, reconstructive and cosmetic surgery in New Jersey. During that same period of time, he was also an assistant professor of plastic surgery

2.

This is the current version of Section 4731.143(A), Ohio Revised Code. The prior version, which was in effect at the time of Patient 1s surgical procedure in 2005, is substantively identical. Any difference in text is inconsequential.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

at the University of Medicine and Dentistry of New Jersey in New Brunswick, New Jersey. (Tr. at 91-92; St. Ex. 4 at 79; Resp. Ex. A) 3. In 1991, Dr. Hang-Fu moved to Ohio. From 1991 to 1994, he worked in a medical practice in Cleveland with another physician, Dr. Pandrangi. At that time, he held privileges at eight area hospitals and surgery centers. In 1994, he opened a medical practice, called Serche, Inc., d.b.a. Aesthetic Avenue Plastic Surgery, in Fairview Park, Ohio. He closed that medical practice in April 2008, pending an outcome of this proceeding and accreditation approval. Between 1996 and 2002, Dr. Hang-Fu also was a surgical clinical instructor at Fairview Hospital. Additionally, he worked for a medical practice in Toledo, Luna Cosmetic Center, between 2006 and 2007, and he had an office in Michigan for a period of time. (Tr. at 22-23, 92, 154, 174; St. Ex. 4 at 79; Resp. Ex. A) Dr. Hang-Fu holds active medical licenses in Michigan, New Jersey and Ohio. He is boardcertified by the American Board of Plastic Surgery [ABPS]. He has given presentations and lectures in the United States and in other countries, he has had three articles published, and he has been involved with numerous research projects. (St. Ex. 4 at 19, 79-83; Resp. Ex. A; Tr. at 41-42) Additionally, Dr. Hang-Fu obtained a masters degree in business administration from Cleveland State University in 1999. (St. Ex. 4 at 79; Resp. Ex. A)

4.

5.

Dr. Hang-Fus Office in Fairview Park 6. Since 1994, Dr. Hang-Fus medical practice has been located at 21080 Lorain Road, Fairview Park, Ohio. The practice occupies 3,700 square feet of the 6,000-square foot, free-standing building in which it is located. The office is composed of a waiting area, consultation room, three examination rooms, a business office, another office and a surgery suite. The surgery suite contains a 20-feet by 25-feet operating room, a short-stay recovery room and a physiciandressing room. The operating room has its own heating and cooling facilities, electrical source, and a scrub sink. Dr. Hang-Fu noted that the surgical suite had been designed by the architect who had designed Lakewood Hospital. (Tr. at 19-22, 93, 131-132) Dr. Hang-Fu acknowledged that the surgical suite has not been accredited, has not been licensed by the Ohio Department of Health, is not a hospital, and is not an emergency room within a hospital. (Tr. at 22, 77) No other physicians have worked with Dr. Hang-Fu in his Fairview Park practice. (Tr. at 30)

7.

8.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

Dr. Hang-Fus Surgeries at Fairview Park 9. Dr. Hang-Fu testified that, at the Fairview Park office, he had performed five to 10 surgeries per week during busy periods such as spring, and two to four surgeries per week during slower periods. He noted that he had performed only outpatient surgeries in his facility, and that the operating room was used exclusively for surgeries. (Tr. at 125-126) Dr. Hang-Fus office reported that it had handled the following number of patient visits and conducted the following number of surgeries from 2004 through 2006: Number of Patients Seen 726 391 373 Number of Surgeries Performed 103 177 211

10.

Year 2004 2005 2006 (St. Ex. 4 at 41, 56) 11.

Dr. Hang-Fu indicated that he would always have with him in the operating room one of his employees, whom he called a circulator, to provide any necessary sutures, opening, and gauze opening kind of procedure. His circulator was originally hired as a medical assistant and Dr. Hang-Fu trained her to be a circulator for his surgeries. In addition, Dr. Hang-Fu had a surgical assistant in the operating room for anything more than a lumps and bumps [procedure] and [for] breast augmentation. Two surgical assistants work with him, both of whom also work for area hospitals, and they are credentialed by the hospitals. He explained that lumps and bumps procedures include surgeries related to moles, tattoos, and skin cancer. Procedures that qualify as more than lumps or bumps procedures and breast augmentation include tummy tucks, breast reduction, breast lifts, back skin excision, and lower lipectomies. (Tr. at 23-29)

Patient 1s March 30, 2005, Surgery at Fairview Park 12. Patient 1 is a female patient who was born in 1953. She became one of Dr. Hang-Fus patients in 1999 and, over the next several years, she had cosmetic plastic surgery on a number of occasions. (St. Ex. 3) On March 30, 2005, Dr. Hang-Fu conducted the following surgical procedures on Patient 1: Modified abdominoplasty: liposuction to remove excess fat in the abdomen and tightening of the excess abdominal skin. Abdominal, arms, and waist liposuction: liposuction to remove excess fat in both arms and the love handles of the waist.

13.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

10

Fat graft to the face and bilateral upper blepharoplasties: Injection of the removed fat into areas of the face (such as under the dark circle of the eye or lips) and in the eyelids.

(St. Ex. 3 at 111; St. Ex. 4 at 9, 17; Tr. at 54-55) 14. Dr. Hang-Fus post-operative report reflects the following with respect to the surgery on March 30, 2005: The patient was seen in the office surgery. Under IV sedation with 80 mg of Valium and 400 mg of [Demerol] over 6 doses in 4.5 hours. The patients back was prepped and infused with tumescent fluid. Approx. 750 cc of fat was removed bilaterally through a small midline incision. * * * Liposuction using 6-8mm cannula was performed to the upper abdomen removing 400cc of fat. (St. Ex. 3 at 111) Dr. Hang-Fu confirmed that the report correctly reflects that Patient 1 was given intravenous [IV] sedation, and that he had used a 6-8 mm cannula while performing the liposuction of her abdomen. (Tr. at 56, 61) Dr. Hang-Fus Use of Sedation at Fairview Park 15. Dr. Hang-Fu acknowledged that he had administered the sedation during his surgical procedures. Dr. Hang-Fu stated that, from January 2004 through 2007, he did not hold privileges to provide moderate sedation/analgesia from an accredited local hospital or from a local ambulatory surgical facility licensed by the Ohio Department of Health. Similarly, at the time of the hearing in June 2008, he did not hold any such privileges and was not attempting to obtain any such privileges. (Tr. at 73, 77; see also St. Ex. 4 at 21) Dr. Hang-Fu stated that, from 2004 through 2007, sedation was achieved in all his surgeries through IV administration of drugs. He also stated that the deepest level of sedation used in his office was light sedation, and that no moderate or deep sedation was used. He testified that his patients had not achieved a moderate sedation level, although he had administered the sedation intravenously. (St. Ex. 4 at 13, St. Ex. 5 at 9-10; Tr. at 99-100) He explained his use of sedation in a liposuction procedure such as Patient 1s March 30, 2005, surgery: For example, if Im doing an area of, say, liposuction of the abdomen, the patient is on their back, and I will inject my Valium and Demerol for that light sedation. And once I gave the light sedation of the drug, I will immediately

16.

17.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

11

numb the whole area up with the tumescent fluid which has local [anesthesia] in it. Once the local injection is in, the patient is usually very comfortable because they dont feel anything. Then after that time, the patient is then kept in the more relaxed sedative state. Essentially, the patient can talk to me throughout the procedure. (Tr. at 177; see also St. Ex. 4 at 9-10) Dr. Hang-Fu elaborated further: Q. So do you administer the IV sedating drugs, in the case of Patient 1 the Valium and the Demerol, shortly prior to administering the various [local anesthesia] on the various parts of the body? Yes. So when youre working on the stomach, once you do the local [anesthesia] into the stomach, do you ever administer more IV medication while youre working on the stomach and before you advance to a different part? Rarely. Sometimes. What would cause you to do that? When the patient gets a little bit more anxious. Because, as I said, they start to get out, become very light, some of them will talk to me, and some of them dont want to talk to me, some of them dont even want to know theyre on the table. So they get a little bit more anxious to the point where that tiny little bit will literally put them in a position where they just sleeping away.

A. Q.

A. Q. A.

(Tr. at 181) 18. Dr. Hang-Fu testified that, until he had received the Boards notice of opportunity for hearing, he had always used IV sedation for the more than a lumps and bumps procedures and breast augmentations. After the notice, he switched to oral and intramuscular sedation medications, but found that his patients were not as comfortable and, therefore, he has suspended his medical practice until further notice. (Tr. at 58-59, 65, 104-105)

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Dr. Hang-Fus Use of Cannulas at Fairview Park 19. Dr. Hang-Fu stated that he had used a six-millimeter cannula for Patient 1s liposuction procedure on March 30, 2005. Also, he admitted that, during all of his body liposuction surgeries, he had used a six-millimeter to eight-millimeter cannula. (St. Ex. 4 at 16; St. Ex. 5 at 10) Dr. Hang-Fu believes that the larger cannula is very appropriate for use in liposuction. He explained the basis for his opinion: [F]or the procedure that I perform of any liposuction of the abdomen in the amount that is greater than, say, 150 cc, the use of 6 millimeter is actually more appropriate than forcing a 4.5 millimeter to perform a liposuction. You have to understand, life experience of 19 years doesnt doesnt follow the rules of anything. Its purely based on the practice. 4.5 millimeter cannula cannot remove the volume within time, and surgery is time. If you perform your surgery in a longer time, youre not only increasing the infection rate, the risk of OR of the patient, so in a 4.5 millimeter and Ill be honest, I dont even know where that came from because that is very inappropriate to force a physician to use because 6 millimeter is definitely a better tool to cut down time, perform a better procedure, and also get the patient safely out of the OR without having any potential complication that may arise. (Tr. at 62-63) Dr. Hang-Fus Accreditation Efforts 21. Dr. Hang-Fu testified that, prior to 2005, he had begun to consider accreditation of his surgical facility because the ABPS was encouraging facility accreditation. 5 Dr. Hang-Fu testified that he had directed his administrator, Rose Leskovich, to pursue accreditation of his office. Ms. Leskovich had worked with Dr. Hang-Fu for numerous years, and he had relied upon her for this process. (Tr. at 35-36, 155, 159-160) Dr. Hang-Fu stated that he had sought accreditation, not because it was required, but in order to

20.

22.

Dr. Hang-Fu does not recall receiving any information from the Board about the office-based surgery rules. He explained that he first became aware of the Boards rules when he was considering accreditation because the ABPS was encouraging it. Dr. Hang- Fu stated that he had checked the Boards website and had seen the deadline, the regulation, et cetera. (Tr. at 155, 173)

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improve patient confidence and for marketing purposes. (St. Ex. 5 at 6; Tr. at 43) He elaborated as follows: Cosmetic surgery is a very competitive field. As you can tell by turning on your radio, you get all kinds of marketing or advertising on it. To be able to present your your facility as a quad-A approved or [an] AAAHC approved, certified facility, it just makes a patient more comfortable no matter what theyre getting, their procedure, whether its local anesthesia or light sedation anesthesia, they will feel much more comfortable. Plus one should always consider is at least I consider, is what am I going to do with my practice down the road if I was to retire. And if you can sell the business with a facility thats certified, its definitely a better marketing. (Tr. at 43) 23. In seeking accreditation of Dr. Hang-Fus office, Ms. Leskovich contacted Healthcare Consultants International, Inc. [HCI]. HCI explained in May 2005 that, among other things, it assists various organizations with accreditation. (Resp. Ex. C at 1) Additionally, Ms. Leskovich completed an application for a waiver of the accreditation requirement of the American Society of Plastic Surgeons [ASPS]. On June 29, 2005, Dr. Hang-Fu signed that waiver application. The application states that Bylaws Article XII requires all Active Members and Candidates for Membership who perform plastic surgery under anesthesia, other than minor local anesthesia and/or minimal oral tranquilization, must perform all such plastic surgery in a surgical facility that meets at least one of the following criteria: Accredited by a national or state recognized accrediting agency/organization such as the AAASF, AAAHC, or JCAHC; Certified to participate in the Medicare program under Title XVIII and/or licensed by the state in which the facility is located. The ASPS agreed to grant one-year waivers to members who make tangible progress toward compliance with the Accredited Surgical Facilities Bylaws requirement. (Tr. at 133-136; Resp. Ex. B) Dr. Hang-Fu explained that, in 2005, he was not a member of ASPS, but was a candidate for membership. He thought Ms. Leskovich had had him sign the waiver application in order to maintain his candidacy for membership with the ASPS. Dr. Hang-Fu did not remember whether he had been granted a one-year waiver by ASPS. (Tr. at 106-107, 134-136; Resp. Ex. B) 25. Also as part of this process, Ms. Leskovich submitted an application with AAAHC, seeking accreditation of Dr. Hang-Fus office. The application was signed by Dr. Hang-Fu on July 11,

24.

In the Matter of Lee C.D. Hang-Fu, M.D. Case No. 07-CRF-020

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2005 and sent to AAAHC sometime thereafter. 6 Part of AAAHC evaluation process includes a visit, called a survey, by AAAHC personnel to Dr. Hang-Fus office. AAAHC responded in August 2005, noting that Dr. Hang-Fus application was incomplete and identifying the needed information. AAAHC stated that, if all missing information was not supplied by January 14, 2006, the July 2005 AAAHC application would expire. (Resp. Ex. F at 3-5; St. Ex. 4 at 31; Tr. at 32, 33) 26. In September 2005, Dr. Hang-Fus office engaged the consulting services of HCI to assist his office in obtaining accreditation from AAAHC. HCIs consulting role included an on-site visit from HCI personnel who would conduct a mock survey of the facilities. HCI visited Dr. Hang-Fus office in October 2005. This visit does not appear to have been the mock survey. (Resp. Ex. C; Resp. Ex. E at 1) In January 2006, Ms. Leskovich contacted AAAHC to reschedule the AAAHC survey, which apparently had been scheduled, because Dr. Hang-Fus office was going to be renovated. Also, she asked for an extension of time to supply additional information for the AAAHC application. At that time, the renovations were expected to be completed in July 2006. Dr. Hang-Fu explained that he had wanted the survey to take place after the renovations; he had been worried that, if the survey took place during the renovations, it could negatively impact the on-site survey. (Resp. Ex. D; Tr. at 110, 114) Dr. Hang-Fu further noted that, in 2006, he had asked Ms. Leskovich to call the Board, the ABPS, and other organizations to determine the impact of the delay due to the renovations. (Tr. at 110-111, 167) Specifically, he testified: * * * I am very positive of the fact that I would instruct her to call the boards, such as ABPS, the State, Cleveland Medical Association, to notify them that explain to them that we needed to reconstruct the building; we had our application in. Would the delay be What would happen if we did not meet the January 1st, 2007 deadline? My understanding is that she called, and and the response back is that as long as our application is in, we followed the right procedures, it should be okay. (Tr. at 149)

27.

28.

This application was sent after the July 1, 2005, date contained in Rule 4731-25-07, O.A.C., which allowed physicians who had been performing procedures or surgery using moderate sedation/analgesia or anesthesia services in an office setting to continue to do so, if they applied for accreditation by July 1, 2005, and received accreditation by January 1, 2007.

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29.

Dr. Hang-Fu produced a note made by Ms. Leskovich, confirming a conversation she had had with ABPS, although he was not sure that the note indicated that the ABPS was agreeable to a delay in accreditation. (Tr. at 111) The note states: 6-28-05. Spoke to Maggie @ A.B.P.S. @ 216-587-9322. She said we do not have to show proof to them because your certificate is before 1994. (Resp. Ex. H) 7

30.

Dr. Hang-Fu admitted that he has no evidence that Ms. Leskovich actually contacted the Board in 2006, but he recalled that she had told him that she had called the Board. He understood that all was okay because he had applied for accreditation from AAAHC and was waiting for the onsite survey. (Tr. at 110-113, 124, 167-168) With regard to why Dr. Hang-Fu asked Ms. Leskovich to contact the Board at that time, the following testimony was presented: Q. But before you had Rose make the call to the Board, was it your belief that Serche, Inc. needed to be accredited in order to continue on with the surgeries you had been doing? *** [Q]: No. *** Q. A. Q. What about as of January 1st, 2007? No. So why did you care whether or not the Board [gave] you an extension or a pass or whatever if you didnt think you needed to be accredited, according to the Board? Because I its in the process. I knew about the deadline. But when I was doing surgery, it was light sedation, and I know light sedation does not require a AAAHC accreditation. But I was in the process, I know about the deadline, I was merely inquiring about it.

31.

A.

Ms. Leskovichs note is dated June 28, 2005, prior the 2006 time frame during which Dr. Hang-Fu had been seeking to push back the accreditation process. It appears more likely that this handwritten note relates to another issue, perhaps Ms. Leskovichs initial inquiries about accreditation, which took place in 2005.

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Q.

But what I dont quite understand is And I understand up until a certain point in time you did not believe that the IV administration of the sedating drugs you utilized constituted moderate sedation, okay. I understand you didnt Yes. I understand that. So why did you care whether or not the facility was accredited at that point in time? Patient confidence and marketing, as I mentioned in the interrogatory. Okay. So what was this January 1st, 2007 deadline to you, then? Why did you care about that deadline? It was in the bylaw and I just wanted to follow the bylaw, bylaw recommendation date. Whose bylaw? The The State of Ohio State Board. The State Medical Board? Yes. So youre saying you believed you were subject to it? No. Im just saying that its in the bylaws so, therefore, Im just merely trying to follow, even though I know Im doing light sedation, but since Im in the application, I might as well try to get that deadline in. Even though you believed you didnt need it at the time? I dont believe I needed it; but since I was in application, I just thought it would be good to get into the date.

A. Q.

A. Q.

A.

Q. A. Q. A. Q. A.

Q. A.

(Tr. at 150-153) 32. In September 2006, Dr. Hang-Fus office executed an addendum to the consulting contract with HCI. Also, Dr. Hang-Fu explained that, in late 2006, a contract with the construction company for the office renovations was executed. The renovations began in April 2007, and

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finished in the latter part of 2007. The renovations involved: siding replacement, window replacement, and replacement of an overhang in the parking area. During the renovations, Dr. Hang-Fu continued to see patients at the Fairview Park office. (Resp. Ex. E; Tr. at 143144, 153-154) 33. Dr. Hang-Fu testified that he was pretty sure that the mock survey by HCI took place in early July 2007. In addition, he stated that he had thought, at that time, he was in compliance with the Boards regulation because of the telephone conversation that Ms. Leskovich had reported. (Tr. at 115) In July 2007, Dr. Hang-Fu reapplied to AAAHC for accreditation of his facility. This application form was completed by Ms. Leskovich. The application reflects that accreditation was being sought because of a directive from [a] professional society or state legislature, and that the office had heard of AAAHC because the Board had required accreditation and listed it as an accrediting agency. Dr. Hang-Fu testified that he had signed the application, but he had not reviewed it. (St. Ex. 4 at 33-70; Tr. at 34-35; Resp. Ex. F at 2, 6) The 2007 accreditation application also reflects that Dr. Hang-Fus office used moderate sedation/analgesia (conscious sedation), minimal sedation and local/topical anesthesia. Dr. Hang-Fu explained that moderate sedation/analgesia (conscious sedation) was selected because it is possible that the patient will get into a moderate sedation state because of the IV solution. He also pointed out that the application materials reflect that, in 2004 through 2006, he had not used moderate sedation/analgesia (conscious sedation). (Tr. at 103; St. Ex. 4 at 56) 35. In August 2007, AAAHC confirmed receipt of the July 2007 application and found that it was complete. Additionally, AAAHC noted that it would soon contact Dr. Hang-Fus office to schedule the accreditation survey. (Resp. Ex. F at 1; St. Ex. 4 at 32) In October 2007, AAAHC conducted a survey of Dr. Hang-Fus office. In December 2007, AAAHC notified Dr. Hang-Fu that his office would not be accredited because it was not in substantial compliance with the ambulatory health care standards. The survey report outlined each of the deficiencies. AAAHC stated that the deficiencies can be corrected and another survey may be requested, but that must occur no later than June 10, 2008. (St. Ex. 6) At the time of the June 17, 2008, hearing, the resurvey had not taken place and Dr. Hang-Fus office was not accredited. (Tr. at 77, 157)

34.

36.

37.

Dr. Hang-Fus General Statements (in Response to Board Interrogatories) Regarding Compliance with the Office-Based Surgery Requirements 38. In August 2007, a Board enforcement attorney sent a set of interrogatories to Dr. Hang-Fu. The Board received Dr. Hang-Fus responses to those interrogatories on October 12, 2007. A

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second set of interrogatories were sent to Dr. Hang-Fu in October 2007, and Dr. Hang-Fu answered the second set of interrogatories in November 2007. (St. Exs. 4 and 5) 39. Dr. Hang-Fu stated in his October 2007 responses to the first set of interrogatories that his office was not accredited yet, but in the final phase of accreditation. Also, he stated that he was in compliance with the Boards office-based surgery rules and he had always been in complete compliance with the Boards office based surgery rules. In addition, Dr. Hang-Fu stated in his November 2007 responses to the second set of interrogatories that the level of sedation for all office-based surgeries that he had performed in his Fairview Park office for the years 2004 through 2007 was achieved through IV administration of drugs. (St. Ex. 4 at 7-8; St. Ex. 5 at 9-10) Dr. Hang-Fu testified that he had not looked at the Boards office-based surgery rules when he received the October 2007 interrogatories. (Tr. at 175) Dr. Hang-Fu testified that he had believed, at the time he had completed the interrogatories, that he had been in compliance with, and had always been in compliance with, the Boards office-based surgery rules. In addition, Dr. Hang-Fu stated that he had given correct and accurate answers to the interrogatories to the best of his knowledge. He further stated that he had not intended to mislead anyone. (Tr. at 120-121, 123, 129; St. Ex. 4 at 7-8)

40.

Dr. Hang-Fus Categorization of the Surgical Suite at Fairview Park 41. In 2007, the Board staff asked Dr. Hang-Fu whether he had performed office-based surgeries, i.e., surgeries in an office setting. Dr. Hang-Fu stated that he had performed office-based surgeries since 1989, and in particular at his Fairview Park office, from 1994 to October 2007. Moreover, Dr. Hang-Fu stated that Patient 1s March 30, 2005, surgery was an office-based surgery performed in the office-based OR. (St. Ex. 4 at 9, 12) At the hearing, Dr. Hang-Fu first testified that he considers the surgical suite to be a pareddown hospital operating room and an ambulatory surgical facility, where a patient can have surgery and go home all in the same day, and the surgical procedures do not require an overnight stay at the facility. Later, Dr. Hang-Fu testified that he believes that he performed his surgeries in an office-based surgery facility, not an ambulatory surgery facility. (Tr. at 71-72, 125)

42.

Dr. Hang-Fus Previous and Current Understanding of the Office-Based Surgery Requirements Sedation and Accreditation 43. When asked via interrogatory in 2007 whether the exact level of sedation for Patient 1s March 30, 2005, surgery was minimal sedation (anxiolysis), moderate sedation (axiolysis), [sic] or deep sedation/analgesia as defined in Rule 4731-25-01, O.A.C., Dr. Hang-Fu answered that the level of sedation was light sedation with Valium and Demerol. Dr. Hang-Fu defined

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light sedation as a state where the patient is responsive to verbal command and able to answer questions (if necessary) at the end of the case + during the case. (St. Ex. 4 at 9-10; St. Ex. 5 at 9) At the hearing, Dr. Hang-Fu defined light sedation in a similar manner, explaining that it is a drug-induced state where the patients cognitive abilities and consciousness are altered, but the patient is responsive to verbal commands and tactile responses. The sedation does not affect cardiovascular functions. Dr. Hang-Fu stated that he had developed that definition based on six years of post-medical school training, 19 years of life experience, practice in a hospital, talking with anesthetic colleagues, and reading medical journals. (Tr. at 97-98, 122) Dr. Hang-Fu testified that he is now familiar with the Boards definition of minimal sedation, which is set forth in Rule 4731-25-01(F), O.A.C. He stated that the Boards definition is the same as his definition of light sedation, except that minimal sedation is not induced by intravenous administration of medication. (Tr. at 97) 44. Dr. Hang-Fu defined moderate sedation as a drug-induced state that affects the consciousness and affects the respiratory and cardiovascular systems, and defined general anesthesia as the sedation state that requires respiratory assistance through a machine and oxygen tubing. (Tr. at 174-175) Dr. Hang-Fu stated that he had previously not believed that, at any time between 2004 and April 2008, he had used moderate sedation/analgesia in his practice, although he had sedated patients via IV injection. Rather, he had believed that what he had administered had constituted minimal sedation, and he had believed that he had not been required to have his facility accredited. (Tr. at 46-47, 49-50, 103) Additionally, Dr. Hang-Fu explained his current understanding of the various definitions of sedation in the Ohio Administrative Code, and the accreditation requirements for office-based surgeries: Q. Is it fair to say that your understanding, as you sit here today, with respect to the Board rules, that the Board rules basically provide that if you administer sedating drugs intravenously, that thats considered moderate sedation? Yes. Okay. Is it fair to say, then, for that reason that you understand that, you now realize that youre required, in order to do those procedures that require IV administration and sedating drugs, to have your facility accredited?

45.

46.

A. Q.

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A. Q.

Yes. Okay. But at the time in 2004 through 2008 when you were doing these procedures, the more enhanced procedures where you did administer IV sedating drugs, your understanding was that was considered you used the term light sedation, and that that did not require your facility to be accredited. Is that a fair [assessment?] Yes.

A.

(Tr. at 50-51; see also Tr. at 122-123) Cannula 47. Dr. Hang-Fu testified that, at the time he answered interrogatories in 2007, he had been unaware that there was a maximum diameter for the cannulas in liposuction surgeries in the office setting. (Tr. at 79) At the time of the hearing, Dr. Hang-Fu understood that a six-millimeter cannula could be used in a non-office-based setting, and, according to the Boards rule, only a 4.5-millimeter cannula can be used in an office-based setting. (Tr. at 124-125)

Dr. Hang-Fus Lack of Medical Malpractice Insurance 48. Dr. Hang-Fu explained that he had elected to stop purchasing medical malpractice insurance when the cost jumped from $45,000 per year to $125,000 per year, at a time when he was performing only cosmetic surgery and was not on-call at any hospitals. He noted that I did not see the need to pay that much because I wasnt going into the hospital. (Tr. at 172) Dr. Hang-Fu also explained that, for approximately 12 months between mid-2006 and mid2007, 8 he had worked for a company in Toledo, Ohio, in addition to maintaining his Fairview Park practice. He pointed out that he had had medical malpractice insurance during those 12 months because that company purchased the insurance for him. (Tr. at 172-173, 183-184; see also St. Ex. 5 at 7, 11, 16-24) Dr. Hang-Fu stated that, when he had not purchased medical malpractice insurance, he had informed his patients of that fact. Additionally, Dr. Hang-Fu stated that his office policy was that all patients be provided such notification prior to receiving nonemergency services, and that all patients sign an acknowledgement, which was to be kept in the patients medical

49.

50.

Dr. Hang-Fus first interrogatory responses referred to that 12-month period as occurring between 2006 and 2007. His second interrogatory responses referred to that 12-month period as occurring from July 2006 to July 2007. (St. Ex. 4 at 18; St. Ex. 5 at 7)

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record. He also noted that, in 2007, he had revised his standard notice. (Tr. at 127-128, 174; St. Ex. 4 at 18, 77) 51. In his October 2007 interrogatory responses, Dr. Hang-Fu stated that he had provided a notice to all of his patients. (St. Ex. 4 at 18) Dr. Hang-Fu acknowledged that Patient 1s medical record does not include a notice signed by Patient 1 in which she had acknowledged being informed that Dr. Hang-Fu did not have medical malpractice insurance at the time of her March 30, 2005 surgery. Because that written acknowledgement is not in Patient 1s chart, Dr. Hang-Fu assumes that she was not asked to sign the acknowledgement prior to that surgery. (Tr. at 69-70) He explained how that probably occurred: She was a patient back in Aug/99. I had insurance [then]. Since 02 9 we provided all new patients with the form from the 1st consult. This patient slipped thru the crack. (St. Ex. 5 at 8; see also Tr. at 71, 126-127) Dr. Hang-Fu characterized the lack of acknowledgement in Patient 1s chart as an aberration. (Tr. at 71)

52.

FINDINGS OF FACT 1. Lee C.D. Hang-Fu, M.D., stated in his responses to the Boards First Set of Interrogatories, which the Board received on October 12, 2007, that: (a) (b) (c) (d) He had performed office-based surgeries at his office in Fairview Park, Ohio, from 1994 through 2007; His office setting/facility was not accredited, but was in the final phase of accreditation; He was, and had always been, in compliance with the Boards office-based surgery rules; With respect to a March 30, 2005, office-based surgery, which included a modified abdominoplasty, that he had performed on Patient 1 (as identified in a Patient Key), he had used light sedation with Valium and Demerol; and He had not used moderate sedation for office-based surgeries from 2003 through 2007.

(e)

The exact year in which Dr. Hang-Fu began providing the notice to his patients is unclear from the record. Dr. HangFus testimony referred to 2003, his October interrogatory responses referred to 2001, and his November interrogatory responses referred to 2002. (Tr. at 126, 172, 174; St. Ex. 4 at 18; St. Ex. 5 at 8) This is inconsequential, however.

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In his sworn responses to the Boards Second Set of Interrogatories, which the Board received on November 5, 2007, Dr. Hang-Fu stated that the level of sedation for all office-based surgeries that he had performed at his Fairview Park office for the years 2004 through 2007 was achieved through intravenous administration of drugs. The evidence establishes that Dr. Hang-Fu used moderate sedation for surgeries in the office setting at his facility in Ohio from 2004 through 2007. His responses to the 2007 Board interrogatories, along with the medical record for the March 30, 2005 surgical procedure that Dr. Hang-Fu performed on Patient 1, establish that the level of sedation utilized in Dr. HangFus office-based surgeries was moderate sedation, as that term is defined in Rule 4731-2501(H), Ohio Administrative Code [O.A.C.], because the level of sedation was achieved through the intravenous administration of drugs. Despite Dr. Hang-Fus assertion that he was and had always been in compliance with the Boards office-based surgery rules, his office setting in Ohio had not been accredited by an accrediting agency approved by the Board by January 1, 2007, as mandated by Rule 4731-2507(A), O.A.C. Furthermore, his surgical suite is not an ambulatory surgical facility because the facility does not function separately from Dr. Hang-Fus office. 2. Dr. Hang-Fu indicated in his responses to the October 2007 Board Interrogatories that, in addition to the modified abdominoplasty that he had performed on Patient 1 on March 30, 2005, he also had performed liposuction on Patient 1 at his office facility on that same date. Dr. Hang-Fu further stated in his responses to the 2007 Board Interrogatories that the cannula utilized for the liposuction procedure was larger than 4.5 millimeters in diameter, which is the maximum size authorized by Rule 4731-25-05(B)(1), O.A.C. Dr. Hang-Fu also indicated that he had utilized a cannula of six to eight millimeters for all body liposuction procedures in his practice. Dr. Hang-Fu indicated in his responses to the October 2007 Board Interrogatories that, since January 2004, he had not held privileges to provide moderate sedation/analgesia from a local hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations, or from a local ambulatory surgical facility licensed by the Ohio Department of Health. Despite the lack of such privileges, Dr. Hang-Fu administered moderate sedation to patients in an office setting, which is contrary to Rule 4731-25-03(B)(1), O.A.C. Dr. Hang-Fu indicated in his responses to the 2007 Board Interrogatories that he was not covered (or the medical procedures that he was performing on patients were not covered) by medical malpractice insurance from 2001 to July 2006, and after July 2007. While Dr. HangFu was able to provide the Board with a copy of the general written notice form that he asserted he had provided to patients regarding his lack of medical malpractice insurance, he

3.

4.

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was unable to provide the Board with a copy of a written notice signed by Patient 1 with respect to the surgery he performed on her on March 30, 2005.

CONCLUSIONS OF LAW 1. The acts, conduct, and/or omissions of Lee C.D. Hang-Fu, M.D., as set forth in Finding of Fact 1 above, individually and/or collectively, constitute violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board, as set forth in Section 4731.22(B)(20), Ohio Revised Code, to wit: Rule 4731-25-07(A), Ohio Administrative Code [O.A.C.], a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code. Furthermore, Dr. Hang-Fus acts, conduct, and/or omissions, as set forth in Finding of Fact 1 above, individually and/or collectively, also constitute [m]aking a false, fraudulent, deceptive, or misleading statement in the solicitation of or advertising for patients; in relation to the practice of medicine and surgery, * * *; or in securing any certificate to practice or certificate of registration issued by the board, as set forth in Section 4731.22(B)(5), Ohio Revised Code. 2. Dr. Hang-Fus acts, conduct, and/or omissions, as set forth in Finding of Fact 2 above, individually and/or collectively, constitute violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board, as set forth in Section 4731.22(B)(20), Ohio Revised Code, to wit: Rule 4731-25-05(B)(1), O.A.C., a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code. Dr. Hang-Fus acts, conduct, and/or omissions, as set forth in Finding of Fact 3 above, individually and/or collectively, constitute violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board, as set forth in Section 4731.22(B)(20), Ohio Revised Code, to wit: Rule 4731-25-03(B)(1), O.A.C., a violation of which also violates Section 4731.22(B)(6), Ohio Revised Code. Dr. Hang-Fus acts, conduct, and/or omissions, as set forth in Finding of Fact 4 above, individually and/or collectively, constitute violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provisions of this chapter or any rule promulgated by the board, as set forth in Section 4731.22(B)(20), Ohio Revised Code, to wit: Section 4731.143, Ohio Revised Code.

3.

4.

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The violations of the office-based surgery rules have been amply demonstrated in this matter. Dr. Hang-Fu conducted many surgeries, including liposuction surgery under tumescent local anesthesia, at his office setting in Fairview Park after the office-based surgery requirements went into effect January 1, 2004. 10 Dr. Hang-Fu did not timely seek accreditation, he did not obtain accreditation, he used moderate sedation/analgesia, he did not hold privileges to provide moderate sedation/analgesia, and he used oversized cannulas during liposuction surgeries. Moreover, Dr. Hang-Fu did not fully comply with the statutory notice obligations for physicians who do not carry medical malpractice insurance. The question of whether Dr. Hang-Fu intentionally made false statements to the Board in his interrogatory responses is less clear-cut. Dr. Hang-Fu argued at hearing that, between 2004 and 2007, he had not understood the office-based surgery requirements, had not intentionally violated those requirements, and thus had not intentionally tried to mislead the Board in answering questions about his practice vis--vis those requirements. The Hearing Examiner is not convinced that Dr. Hang-Fus interrogatories responses resulted from innocent misunderstandings and unintentional errors. Dr. Hang-Fus repeated statement that he administered only light sedation was contradicted when he testified that the sedation sometimes reached the point where that tiny little bit will literally put them in a position where they just sleeping away. A review of the interrogatory responses indicates that a number of the direct, simple questions were either not appropriately answered or were evasively answered, such as the following: (a) When asked to identify the location and individuals present for an interview by a Board investigator in or around March 2007, Dr. Hang-Fu listed the office and its address only. (October response to question 5a) Dr. Hang-Fu stated that he was currently and had always been in compliance with the Boards office-based surgery rules (October response to questions 6 and 8), but later testified that he had not even reviewed those rules at the time he answered the interrogatories. When asked the exact level of sedation for Patient 1s March 30, 2005, surgery and given three options as examples, Dr. Hang-Fu described the level of sedation with different terminology. (October response to question 10c)

(b)

(c)

It should be noted again, however, that physicians in unaccredited office settings who timely applied for accreditation of their office settings were not precluded from conducting office-based surgeries using moderate sedation/analgesia or anesthesia services in those settings from January 1, 2004 through January 1, 2007. Rule 4731-25-07(A), O.A.C.

10

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(d)

(e)

(f)

(g)

(h)

When asked to explain why his office setting is not accredited, Dr. Hang-Fu stated We are applying + examiner is coming Nov/07. (October response to question 14) When asked to provide documents that show his office applied for accreditation, Dr. Hang-Fu provided only his July 2007 AAAHC application. (October response to question 15d) When asked to explain why his office is seeking accreditation, he wrote: Application started 1 yrs ago (approx). Examiner comes Oct 30th/07. (November response to question 3a) When asked to explain why his office was not accredited by January 1, 2007, and to specify any reasons for delay, he wrote: Light sedation is not required and Jan 1st/07 is required date but application was submitted much earlier. (November response to question 3c) When asked for the dates before July 12, 2007, on which he had malpractice insurance, he wrote: No, we revised the new form date after July 19th/07 (or in this case July 12/07) because my job with Luna finished 4/12/07. (November response to question 5a) Dr. Hang-Fu claimed that he had sought accreditation solely to add value and distinguish his medical practice from others, and had not sought accreditation in order to comply with the office-based surgery requirements. If that were truly the case, it is unlikely that Dr. Hang-Fu would check with the Board when he decided in 2006 to delay the accreditation survey, and it is unlikely that he would have worried about meeting the January 1, 2007, accreditation deadline at all. Plus, he would not have needed to look at the Boards website and read about the Boards office-based surgery requirements. When Dr. Hang-Fu began considering accreditation, he took the initiative to investigate this states requirements by looking at the Boards website and reading the office-based surgery requirements, including the accreditation deadline of January 1, 2007. Dr. Hang-Fu presented unconvincing and not credible testimony at the hearing that he had considered his office setting to be an ambulatory surgical facility (and, for that reason, he had believed that he was not subject to the office-based surgery requirements). This casts doubt upon Dr. Hang-Fus credibility regarding his claim that he had not intentionally tried to mislead the Board in answering the interrogatories.

From the surrounding circumstances, it is reasonable for the Board to conclude that Dr. Hang-Fu made statements in his interrogatories, as set forth in Finding of Fact 1, that were intended to mislead the Board.

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PROPOSED ORDER It is hereby ORDERED that: A. SUSPENSION OF CERTIFICATE: The certificate of Lee C.D. Hang-Fu, M.D., to practice medicine and surgery in the State of Ohio shall be SUSPENDED for an indefinite period of time, but not less than one year. REQUIRED REPORTING WITHIN 30 DAYS OF THE EFFECTIVE DATE OF THIS ORDER: 1. Required Reporting to Employers and Others: Within 30 days of the effective date of this Order, Dr. Hang-Fu shall provide a copy of this Order to all employers or entities with which he is under contract to provide health care services (including but not limited to third-party payors), or is receiving training; and the Chief of Staff at each hospital or health-care center where he has privileges or appointments. Further, Dr. Hang-Fu shall promptly provide a copy of this Order to all employers or entities with which he contracts to provide health care services (including but not limited to third-party payors), or entities to which Dr. Hang-Fu applies for or receives training, and the Chief of Staff at each hospital or health-care center where he applies for or obtains privileges or appointments. This requirement shall continue until Dr. Hang-Fu receives from the Board written notification of the successful completion of the probation. In the event that Dr. Hang-Fu provides any health-care services or health-care direction or medical oversight to any emergency medical services organization or emergency medical services provider in Ohio, within 30 days of the effective date of this Order, he shall provide a copy of this Order to the Ohio Department of Public Safety, Division of Emergency Medical Services. This requirement shall continue until Dr. Hang-Fu receives from the Board written notification of the successful completion of the probation. Further, Dr. Hang-Fu shall provide the Board with one of the following documents as proof of each required notification within 30 days of the date of each notification: (1) the return receipt of certified mail within 30 days of receiving that return receipt, (2) an acknowledgement of delivery bearing the original ink signature of the person to whom a copy of the Order was hand delivered, (3) the original facsimile-generated report confirming successful transmission of a copy of the Order to the person or entity to whom a copy of the Order was faxed, or (4) an original computer-generated printout of electronic mail communication documenting the e-mail transmission of a copy of the Order to the person or entity to whom a copy of the Order was e-mailed. 2. Required Reporting to Other State Licensing Authorities: Within 30 days of the effective date of this Order, Dr. Hang-Fu shall provide a copy of this Order to the proper

B.

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licensing authority of any state or jurisdiction in which he currently holds any professional license, as well as any federal agency or entity, including but not limited to the Drug Enforcement Agency, through which he currently holds any license or certificate. Also, Dr. Hang-Fu shall provide a copy of this Order at the time of application to the proper licensing authority of any state in which he applies for any professional license or reinstatement/restoration of any professional license. Further, Dr. Hang-Fu shall provide this Board with one of the following documents as proof of each required notification within 30 days of the date of each such notification: (1) the return receipt of certified mail within 30 days of receiving that return receipt, (2) an acknowledgement of delivery bearing the original ink signature of the person to whom a copy of the Order was hand delivered, (3) the original facsimile-generated report confirming successful transmission of a copy of the Order to the person or entity to whom a copy of the Order was faxed, or (4) an original computer-generated printout of electronic mail communication documenting the e-mail transmission of a copy of the Order to the person or entity to whom a copy of the Order was e-mailed. C. REQUIRED REPORTING OF CHANGE OF ADDRESS: Dr. Hang-Fu shall notify the Board in writing of any change of principal practice address or residence address within 30 days of such change. CONDITIONS FOR REINSTATEMENT OR RESTORATION: The Board shall not consider reinstatement or restoration of Dr. Hang-Fus certificate to practice medicine and surgery until all of the following conditions have been met: 1. Application for Reinstatement or Restoration: Dr. Hang-Fu shall submit an application for reinstatement or restoration, accompanied by appropriate fees, if any. Professional Ethics Course or Courses: At the time he submits his application for reinstatement or restoration, Dr. Hang-Fu shall provide acceptable documentation of successful completion of a course or courses dealing with professional ethics. The exact number of hours and the specific content of the course or courses shall be subject to the prior approval of the Board or its designee. Any courses taken in compliance with this provision shall be in addition to the Continuing Medical Education requirements for relicensure for the Continuing Medical Education period(s) in which they are completed. In addition, at the time Dr. Hang-Fu submits the documentation of successful completion of the course or courses dealing with professional ethics, he shall also submit to the Board a written report describing the course(s), setting forth what he learned from the course(s), and identifying with specificity how he will apply what he has learned to his practice of medicine in the future.

D.

2.

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3.

Practice Plan: At the time he applies for reinstatement or restoration, or as otherwise determined by the Board, Dr. Hang-Fu shall also submit to the Board and receive its approval for a plan of practice in Ohio. The practice plan, unless otherwise determined by the Board, shall be limited to a supervised structured environment in which Dr. Hang-Fus activities will be directly supervised and overseen by a monitoring physician approved by the Board. Dr. Hang-Fu shall obtain the Boards prior approval for any alteration to the practice plan approved pursuant to this Order. At the time Dr. Hang-Fu submits his practice plan, he shall also submit the name and curriculum vitae of a monitoring physician for prior written approval by the Secretary or Supervising Member of the Board. In approving an individual to serve in this capacity, the Secretary or Supervising Member will give preference to a physician who practices in the same locale as Dr. Hang-Fu and who is engaged in the same or similar practice specialty. The monitoring physician shall monitor Dr. Hang-Fu and his medical practice, and shall review Dr. Hang-Fus patient charts. The chart review may be done on a random basis, with the frequency and number of charts reviewed to be determined by the Board. Further, the monitoring physician shall provide the Board with reports on the monitoring of Dr. Hang-Fu and his medical practice, and on the review of Dr. Hang-Fus patient charts. Dr. Hang-Fu shall ensure that the reports are forwarded to the Board on a quarterly basis and are received in the Boards offices no later than the due date for Dr. Hang-Fus quarterly declaration. In the event that the designated monitoring physician becomes unable or unwilling to serve in this capacity, Dr. Hang-Fu must immediately so notify the Board in writing. In addition, Dr. Hang-Fu shall make arrangements acceptable to the Board for another monitoring physician within 30 days after the previously designated monitoring physician becomes unable or unwilling to serve, unless otherwise determined by the Board. Furthermore, Dr. Hang-Fu shall ensure that the previously designated monitoring physician also notifies the Board directly of his or her inability to continue to serve and the reasons therefor.

4.

Additional Evidence of Fitness To Resume Practice: In the event that Dr. Hang-Fu has not been engaged in the active practice of medicine and surgery for a period in excess of two years prior to recommencing the practice of medicine in Ohio, the Board may exercise its discretion under Section 4731.222 of the Revised Code to require additional evidence of his fitness to resume practice.