medical board of california department of consumer affairs...

BEFORE THE MEDICAL BOARD OF CALIFORNIA

DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA

In the Matter of the Accusation Against:

Allen Jan Thomashefsky, M.D.

Physician's and Surgeon's Certificate No. G 22085

Respondent

) ) ) ) ) ) ) ) )

Case No. 8002015012960

DECISION AND ORDER

The attached Stipulated Surrender of License and Order is hereby adopted as the Decision and Order of the Medical Board of California, Department of Consumer Affairs, State of California.

This Decision shall become effective at 5:00 p.m. on March 1 4 , 2 0 1 7

IT IS SO ORDERED March 7, 201 7

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KATHLEEN A. KENEALY Acting Attorney General of California ROBERT MCKIM BELL Supervising Deputy Attorney General REBECCA L. SMITH Deputy Attorney General State Bar No. 179733 California Department of Justice

300 South Spring Street, Suite 1702 Los Angeles, California 90013 Telephone: (213) 897-2655 Facsimile: (213) 897-9395

Attorneys for Complainant

BEFORE THE MEDICAL BOARD OF CALIFORNIA

DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA

11 In the Matter of the Accusation Against: Case No. 800-2015-012960

12 ALLEN THOMASHEFSKY, M.D. 64 North Third Street

OAH No. 2016021070

STIPULATED SURRENDER OF LICENSE AND ORDER

13 Ashland, Oregon 97520

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Physician's and Surgeon's Certificate No. G22085,

Respondent.

IT IS HEREBY STIPULATED AND AGREED by and between the parties to the above-

entitled proceedings that the following matters are true:

PARTIES

l. Kimberly Kirchmeyer (Complainant) is the Executive Director of the Medical Board

of California (Board). She brought this action solely in her official capacity and is represented in

this matter by Kathleen A. Kenealy, Acting Attorney General of the State of California, by

Rebecca L. Smith, Deputy Attorney General.

2. Respondent Allen Thomashefsky, M.D. (Respondent) is represented in this

proceeding by attorney Jack R. Reinholtz, 310 Golden Shore, Fourth Floor, Long Beach,

California 90802.

Ill

Stipulated Surrender of License (Case No. 800-2015-0 12960)

3. On March 15, 1972, the Board issued Physician's and Surgeon's Certificate No.

2 022085 to Respondent. That license was in full force and effect at all times relevant to the

3 charges brought in Accusation No. 800-2015-012960 and expired on August 31, 2016.

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6 4.

JURISDICTION

Accusation No. 800-2015-012960 was filed before the Board and is currently pending

7 against Respondent. The Accusation and all other statutorily required documents were properly

8 served on Respondent on January 5, 2016. Respondent timely filed his Notice of Defense

9 contesting the Accusation. A copy of Accusation No. 800-2015-012960 is attached as Exhibit A

10 and is incorporated by reference.

11 ADVISEMENT AND WAIVERS

12 5. Respondent has carefully read, fully discussed with counsel, and understands the

13 charges and allegations in Accusation No. 800-2015-012960. Respondent also has carefully read,

14 fully discussed with counsel, and understands the effects of this Stipulated Surrender of License

15 and Order.

16 6. Respondent is fully aware of his legal rights in this matter, including the right to a

17 hearing on the charges and allegations in the Accusation; the right to confront and cross-examine

18 the witnesses against him; the right to present evidence and to testify on his own behalf; the right

19 to the issuance of subpoenas to compe 1 the attendance of witnesses and the production of

20 documents; the right to reconsideration and court review of an adverse decision; and all other

21 rights accorded by the California Administrative Procedure Act and other applicable laws.

22 7. Respondent voluntarily, knowingly, and intelligently waives and gives up each and

23 every right set forth above.

24 CULPABILITY

25 8. Respondent understands that the charges and allegations in Accusation No. 800-2015-

26 012960, if proven at hearing, constitute cause for imposing discipline upon his Physician's and

27 Surgeon's Certificate and hereby surrenders his Physician's and Surgeon's Certificate No. 022085

28 for the Board's formal acceptance.

2

Stipulated Surrender of License (Case No. 800-2015-012960)

9. Respondent understands that by signing this stipulation he enables the Board to issue

2 an order accepting the surrender of his Physician's and Surgeon's Certificate without further

3 process.

4 CONTINGENCY

5 10. This stipulation shall be subject to approval by the Board. Respondent understands

6 and agrees that counsel for Complainant and the staff of the Board may communicate directly

7 with the Board regarding this stipulation and surrender, without notice to or participation by

8 Respondent or his counsel. By signing the stipulation, Respondent understands and agrees that he

9 may not withdraw his agreement or seek to rescind the stipulation prior to the time the Board

lO considers and acts upon it. If the Board fails to adopt this stipulation as its Decision and Order,

II the Stipulated Surrender and Disciplinary Order shall be of no force or effect, except for this

12 paragraph, it shall be inadmissible in any legal action between the parties, and the Board shall not

13 be disqualified from further action by having considered this matter.

14 11. The parties understand and agree that Portable Document Format (PDF) and facsimile

15 copies of this Stipulated Surrender of License and Order, including PDF and facsimile signatures

16 thereto, shall have the same force and effect as the originals.

17 12. In consideration ofthe foregoing admissions and stipulations, the parties agree that

18 the Board may, without further notice or formal proceeding, issue and enter the following Order:

19 ORDER

20 IT IS HEREBY ORDERED that Physician's and Surgeon's Certificate No. G22085, issued

21 to Respondent Allen Thomashefsky, M.D., is surrendered and accepted by the Medical Board of

22 California.

23 1. The surrender of Respondent's Physician's and Surgeon's Certificate and the

24 acceptance of the surrendered license by the Board shall constitute the imposition of discipline

25 against Respondent. This stipulation constitutes a record of the discipline and shall become a part

26 of Respondent's license history with the Medical Board of California.

27 2. Respondent shall lose all rights and privileges as a physician in California as of the

28 effective date of the Board's Decision and Order.

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1 3. Respondent shall cause to be delivered to the Board his pocket license and, if one was

2 issued, his wall certificate on or before the effective date of the Decision and Order.

3 4. If Respondent ever files an application for licensure or a petition for reinstatement in

4 the State of California, the Board shall treat it as a petition for reinstatement. Respondent must

5 comply with all the laws, regulations and procedures for reinstatement of a revoked license in

6 effect at the time the petition is filed, and all of the charges and allegations contained in

7 Accusation No. 800-2015-012960 shall be deemed to be true, correct and admitted by Respondent

8 when the Board determines whether to grant or deny the petition.

9 5.

10 petition for reinstatement of a license, by any other health care licensing agency in the State of

11 California, all of the charges and allegations contained in Accusation, No. 800-2015-012960 shall

12 be deemed to be true, correct, and admitted by Respondent for the purpose of any Statement of

13 Issues or any other proceeding seeking to deny or restrict licensure.

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15 ACCEPTANCE

16 I have carefully read the above Stipulated Surrender of License and Order and have fully

17 discussed it with my attorney, Jack R. Reinholtz. I understand the stipulation and the effect it will

18 have on my Physician's and Surgeon's Certificate. I enter into this Stipulated Surrender of

19 License and Order voluntarily, knowingly, and intelligently, and agree to be bound by the

20 Decision and Order of the Medical Board of California.

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22 DATED: ... ~ '7'1\.J I tJ 2-0 j + 23

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I have read and fully discussed with Respondent Allen Thomashefsky, M.D. the terms and

conditions and other matters contained in this Stipulated Surrender of License and Order. I

approve its form and content.

DATED: V11/J?

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ENDORSEMENT

2 The foregoing Stipulated Surrender of License and Order is hereby respectfully submitted

3 for consideration by the Medical Board of California of the Department of Consumer Affairs.

4 Dated:

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Respectfully submitted,

KATHLEEN A. KENEALY Acting Attorney General of California ROBERT MCKIM BELL Supervising D~uty Attorney General

I -:··/ J

REBECCA L. SMITH Deputy Attorney General Attorneys for Complainant

Stipulated Surrender of License (Case No. 800-2015-0 12960)

Exhibit A

Accusation No. 800-2015-012960

1 KAMALA D. HARRIS Attorney General of California

2 ROBERT McKIM BELL Supervising Deputy Attorney General

3 REBECCA L. SMITH · Deputy Attorney General

4 State Bar No. 179733 California Department of Justice

5 300 South Spring Street, Suite 1702 Los Angeles, California 90013

6 Telephone: (213) 897-2655 Facsimile: (213) 897-9395

7 Attorneys for Complainant

FILED STATE OF CALIFORNIA

MEDICAL BOARD OF CALIFORNIA SACRAMENT.Q:!"'V\"'~tl s 20 \ ~ BY '2._. \- ''b~~"".s. ANALYST

BEFORE THE 8

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MEDICAL BOARD OF CALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS

STATE OF CALIFORNIA

11 In the Matter of the Accusation Against:

12 ALLEN THOMASHEFSKY, M.D.

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Post Office Box 3010 Santa Barbara, California 93130

Physician's and Surgeon's Cert~ficate G22085,

Respondent.

18 Complainant alleges:

Case No. 800-2015-012960

ACCUSATION

19 PARTIES

20 1. Kimberly K.irchmeyer (Complainant) brings this Accusation solely in her official

21 capacity as the Executive Director of the Medical Board of California (Board).

22 2. On March 15, 1972, the Board issued Physician's and Surgeon's Certificate number

23 G22085 to Allen Thomashefsky, M.D. (Respondent). That license was in full force and effect at

24 all times relevant to the charges brought herein and will expire on August 31, 2016, unless

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·-renewe-a: ·---------------- ------ ------ -- · ·---- ----- ------- -·-- ·- ------

JURISDICTION

27 3. This Accusation is brought before the Board under the authority of the following

28 provisions of the California Business and Professions Code (Code) unless otherwise indicated.

1

ACCUSATION NO. 800-2015-012960

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4. Section 2001.1 ofthe Code states:

"Protection of the public shall be the highest priority for the Medical Board of California in

exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the

public is inconsistent with other interests sought to be promoted, the protection of the public shall

be paramount."

5. Section 2002 of the Code states:

"Unless otherwise expressly provided, the term 'board' as used in this chapter means the

Medical Board of California. As used in this chapter or any other provision of law, 'Division of

·Medical Quality' and 'Division of Licensing' shall be deemed to refer to the board."


"The board shall have the responsibility for the following:

"(a) The enforcement of the disciplinary and criminal provisions of the Medical Practice

Act.

"(b) The administration and hearing of disciplinary actions.

"(c) Carrying out disciplinary actions appropriate to findings made by a panel or an

administrative law judge.

"(d) Suspending, revoking, or otherwise limiting certificates after the conclusion of

disciplinary actions.

"(e) Reviewing the quality of medical practice carried out by physician and surgeon

certificate holders under the jurisdiction of the board.

"(f) Approving undergraduate and graduate medical education programs.

"(g) Approving clinical clerkship and special programs and hospitals for the programs in

subdivision (f).

"(h) Issuing licenses and certificates under the board's jurisdiction.

··- --- "(i}Administering-theboa:rd's-continuing medical education progr~." ·


"(a) A licensee whose matter has been heard by an administrative law judge of the Medical

Quality Hearing Panel as designated in Section 11371 of the Government Code, or whose default

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has been entered, and who is found guilty, or who has entered into a stipulation for disciplinary

action with the board, may, in accordance with the provisions of this chapter:

"(1) Have his or her license revoked upon order of the board.

"(2) Have his or her right to practice suspended for a period not to exceed one year upon

order of the board.

"(3) Be placed on probation and be required to pay the costs of probation monitoring upon

order of the board.

"(4) Be publicly reprimanded by the board. The public reprimandmay include a '-

requirement that the licensee complete relevant educational courses approved by the board.

"(5) Have any other action taken in relation to discipline as part of an order of probation, as

the board or an administrative law judge may deem proper.

"(b) Any matter heard pursuant to subdivision (a), except for warning letters, medical

review or advisory conferences, professional competency examinations, continuing education

activities, and cost reimbursement associated therewith that are agreed to with the board and

successfully completed by the licensee, or other matters made confidential or privileged by

existing law, is deemed public; and shall be made available to the public by the board pursuant to

Section 803.1."


"The board shall take action against any licensee who is charged with unprofessional

conduct. In addition to other provisions of this article, unprofessional conduct includes, but is not

limited to, the following:

"(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the

violation of, or conspiring to violate any provision of this chapter.

"(b) Gross negligence.

·- - -·--"(c-) Repeated·negligentacts.··To-be·repeated;·-there·must be two··or more-negligent acts or··

omissions. An initial negligent act or omission followed by a separate and distinct departure from

the applicable standard of care shall constitute repeated negligent acts.

Ill

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"(1) An initial negligent diagnosis followed by an act or omission medically appropriate

for that negligent diagnosis of the patient shall constitute a single negligent act.

"(2) When the standard of care requires a change in the diagnosis, act, or omission that

constitutes the negligent act described in paragraph (1 ), including, but not limited to, a

reevaluation of the diagnosis or a change in treatment, and the licensee's conduct departs from the

applicable standard of care, each departure constitutes a separate and distinct breach of the

standard of care.

"(d) Incompetence.

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9. Section 2221.1 of the Code states:

"(a) The board and the Board of Podiatric Medicine shall investigate and may take

disciplinary action, including, but not limited to, revocation or suspension of licenses, against

physicians and surgeons and all others licensed or regulated by the board, or by the Board of

Podiatric Medicine, whichever is applicable, who, except for good cause, knowingly fail to

protect patients by failing to follow infection control guidelines of the applicable board, thereby

risking transmission of blood-borne infectious diseases from the physician and surgeon or other

health care provider licensed or regulated by the applicable board to patients, from patients, and

from patient to physician and surgeon or other health care provider regulated by the applicable

board. In so doing, the boards shall consider referencing the standards, regulations, and

guidelines of the State Department ofHealth Services developed pursuant to Section 1250.11 of

the Health and Safety Code and the standards, guidelines, and regulations pursuant to the

California Occupational Safety and Health Act of 1973 (Part 1 (commencing with Section 6300),

Division 5, Labor Code) for preventing the transmission ofHIV, hepatitis B, and other blood

borne pathogens in health care settings. As necessary, the board and the Board of Podiatric

·Medicine shall consult with the Board of Dental Examiners,·the Board of Registered Nursing; and

the Board of Vocational Nursing and Psychiatric Technicians, to encourage appropriate

consistency in the implementation of this section.

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"(b) The board shall seek to ensure that licentiates and others regulated by the board are

informed of the responsibility of licentiates to follow infection control guidelines and of the most

recent scientifically recognized safeguards for minimizing the transmission of blood-borne

infectious diseases.

10. California Code ofRegulations, title 16, section 1633, states:

"(a) Licensees shall follow the recommendations and the precautions set forth below,

hereby incorporated by reference, in order to minimize the transmission ofbloodbome pathogens

in health care settings. Adherence to these recommendations shall constitute the minimum

standard of infection control.

"(1) 'Recommendations for Preventing Transmission ofHuman Immunodeficiency Virus

and Hepatitis B Virus to patients During Exposure-Prone Invasive Procedures' from the U.S.

Centers for Disease Control Morbidity and Mortality Weekly Report, July 12, 1991, Vol. 40, No.

RR-8.

"(2) 'Update: Universal Precautions for Prevention of Transmission of Human

Immunodeficiency Virus, Hepatitis B Virus and Other Bloodbome Pathogens in Health-Care

Settings' from the U.S. Centers for Disease Control Morbidity and Mortality Weekly Report,

June 24, 1988, Vol. 37, No. 24·, pp. 377-382, 387-388.

"(3) 'Recommendations for Prevention ofHIV Transmission in Health-Care Settings' from

the U.S. Centers for Disease Control Morbidity and Mortality Weekly Report, August 21, 1987,

Vol. 36, No. 2S.

"(4) 'Guidelines for Preventing the Transmission ofBloodbome Pathogens in Health Care

Settings' from California Department of Health Services, May 1993.

"(b) In instances of conflict between differing Centers for Disease Control recommended

infection control practices, in publications (1), (2) or (3) above, the most recent recommendation

will-ptevait"··-· ---· ... ---·---- ... --· --- ----------·-- ------ ........ ·-·- ·- --- ... ··---··-·-- - ... ·--


"On or after July 1, 1996, no. physician and surgeon shall perform procedures in an

outpatient setting using anesthesia, except local anesthesia or peripheral nerve blocks, or both,

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1 complying with the community standard of practice, in doses that, when administered, have the

2 probability of placing a patient at risk for loss of the patient's life-preserving protective reflexes,

3 unless the setting is specified in Section 1248.1. Outpatient settings where anxiolytics and

4 analgesics are administered are excluded when administered, in compliance with the community

5 standard of practice, in doses that do not have the probability of placing the patient at risk for loss

6 of the patient's life-preserving protective reflexes.

7 "The definition of 'outpatient settings' contained in subdivision (c) of Section 1248 shall

8 apply to this section."

9 12. Section 1248 of the Health and Safety Code states:

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"For purposes ofthis chapter, the following definitions shall apply:

(a) 'Division' means the Medical Board of California. All references in this chapter to the

division, the Division of Licensing of the Medical Board of California, or the Division of Medical

Quality shall be deemed to refer to the Medical Board of California pursuant to Section 2002 of

the Business and Professions Code.

"(b)(1) 'Outpatient setting' means any facility, clinic, unlicensed clinic, center, office, or

other setting that is not part of" a general acute care facility, as defmed in Section 1250, and where

anesthesia, except local anesthesia or peripheral nerve blocks, or both, is used in compliance with

the community standard of practice, in doses that, when administered have the probability of

placing a patient at risk for loss of the patient's life-preserving protective reflexes.

"(2) 'Outpatient setting' also means facilities that offer in vitro fertilization, as defined in

subdivision (b) of Section 1374.55.

"(3) 'Outpatient setting'·does not include, among other settings, any setting where

anxiolytics and analgesics are administered, when done so in compliance with the community

standard of practice, in doses that do not have the probability of placing the patient at risk for loss

of_!he patient's life-p_r:e~~r~j11g prot~?ctiv_e refle:x;.e_s~

"(c) 'Accreditation agency' means a public or private organization that is approved to issue

certificates of accreditation to outpatient settings by the board pursuant to Sections 1248.15 and

1248.4."

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1 13. Section 1248.1 ofthe Health and Safety Code states:

2 "No association, corporation, finn, partnership, or person shall operate, manage, conduct, or

3 maintain an outpatient setting in this state, unless the setting is one of the following:

4 "(a) An ambulatory surgical center that is certified to participate in the Medicare program

5 under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act.

6 "(b) Any clinic conducted, maintained, or.operated by a federally recognized Indian tribe or

7 tribal organization, as defined in Section 450 or 1601 of Title 25 of the United States Code, and

8 located on land recognized as tribal land by the federal government.

9 . "(c) Any clinic directly conducted, maintained, or operated by the United States or by any

10 of its departments, officers, or agencies.

11 "(d) Any primary care clinic licensed under subdivision (a) and any surgical clinic licensed

12 under subdivision (b) of Section 1204.

13 "(e) Any health facility licensed as a general acute care hospital under Chapter 2

14 (commencing with Section 1250).

15 "(f) Any outpatient setting to the extent that it is used by a dentist or physician and surgeon

16 in compliance with Article 2.7 (commencing with Section 1646) or Article 2.8 (commencing with

17 Section 164 7) of Chapter 4 of Division 2 of the Business and Professions Code.

18 "(g) An outpatient setting accredited by an accreditation agency approved by the division

19 pursuant to this chapter.

20 "(h) A setting, including, but not limited to, a mobile van, in which equipment is used to

21 treat patient~ admitted to a facility described in subdivision (a), (d), or (e), and in which the

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procedures perfonned are staffed by the medical staff of, or other healthcare practitioners with

clinical privileges at, the facility and are subject to the peer review process of the facility but

which setting is not a part of a facility described in subdivision (a), (d), or (e).

.. ·----·~ot~i!l~ ~I? this_s.e_c~on ~-h~l_l ~~liey_e_ an Y-s.~~!~ti<?.~!-~<?_ql<?!at_ion, fi[ffi, Plirtner~J:tip~ '?f .... ___ ...... .

person from complying with all other provisions oflaw that are otherwise applicable."

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1 14. Section 2052 of the Code states:

2 "(a) Notwithstanding Section 146, any person who practices or attempts to practice, or who

3 advertises or holds himself or herself out as practicing, any system or mode of treating the sick or

4 afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment,

5 blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition

6 of any person, without having at the time of so doing a valid, unrevoked, or unsuspended

7 certificate as provided in this chapter or without being authorized to perform the act pursuant to a

8 certificate obtained in accordance with some other provision of law is guilty of a public offense,

9 punishable by a fine not exceeding ten thousand dollars ($10,000), by imprisonment pursuant to

10 subdivision (h) of Section 1170 of the Penal Code, by imprisonment in a county jail not

11 exceeding one year, or by both the fine and either imprisonment.

12 "(b) Any person who conspires with or aids or abets another to commit any act described in

13 subdivision (a) is guilty of a public offense, subject to the punishment described in that

14 subdivision.

15 "(c) The remedy provided in this section shall not preclude any other remedy provided by

16 law."

17 15. Section 2264 of the Code states:

18 "The employing, directly or indirectly, the aiding, or the abetting of any unlicensed person

19 or any suspended, revoked, or unlicensed practitioner to engage in the practice of medicine or any

20 other mode of treating the sick or afflicted which requires a license to practice constitutes

21 unprofessional conduct."

22 16. California Code of Regulations, title 16, section 1360, states:

23 "For the purposes of denial, suspension or revocation of a license, certificate or permit

24 pursuant to Division 1.5 (commencing with Section 475) of the code, a crime or act shall be

·· --25 ·considered to be substantially-related to the qualifications;functimis or-duties of a person holding--

26 a license, certificate or permit under the Medical Practice Act if to a substantial degree it

27 evidences present or potential unfitness of a person holding a license, certificate or permit to

28 perform the functions authorized by the license, certificate or permit in a manner consistent with

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the public health, safety or welfare. Such crimes or acts shall include but not be limited to the

following: Violating or attempting to violate, directly or indirectly, or assisting in or abetting the

violation of, or conspiring to violate any provision of the Medical Practice Act."

17. Section 2266 of the Code states: "The failure of a physician and surgeon to maintain

adequate and accurate records relating to the provision of services to their patients constitutes

unprofessional conduct."

. FACTUAL ALLEGATIONS

18. On April2, 2015, the Santa Barbara County Public Health Department (SBCPHD)

notified the Board that Respondent's medical practice, located at 2320 Bath Street, No. 301,

Santa Barbara, California 93105, was closed after an inspection revealed poor infection control

practices. Six cases of Hepatitis C had been reported to SBCPHD and five of the six patients had

procedures performed in Respondent's office on September 4, 2014.

19. In his interview with the Board on September 29, 2015, Respondent acknowledged

that at least four patients were infected with Hepatitis C at his office.

A. Respondent admitted that ifhe was injecting patient with, for example, Dextrose (a

form of glucose), and needed more Dextrose, he would use a new needle but use the same syringe

to draw up more Dextrose.

B. Respondent acknowledged that patients were infected with Hepatitis C at his office

on September 4, 2014 and concluded, "the problem with these four patients that got hepatitis was

the reuse of the syringe that infected the bottle. When that bottle of lidocaine, which was a multi

use bottle was done, then no one else got hepatitis, but those four patients got hepatitis, which is

really bad."

INSPECTIONS OF RESPONDENT'S MEDICAL OFFICE BY SBCPHD

February 23, 2015 SBCPHD Announced Site Visit

---20:- On February 23; 2015, an announced site visit to Respondent's medical practice·-·

located at 2320 Bath Street, Santa Barbara, California was conducted by P.B., R.N., P.H.N., and

J.H., R.N., P.H.N., of SBCPHD. The purpose of the visit was to assess infection control practices

as part of a recent Acute Hepatitis C investigation. Respondent informed the SBCPHD that the

9

AGCUSATION NO. 800-2015-012960

1 only procedures conducted at his practice location were those specifically listed on the website at

2 www.ritdoc.net. A review of the website showed Respondent's practice offered medical

3 procedures, including among others, Prolotherapy, Platelet Rich Plasma Therapy (PRP), and

4 Autologous Adipose-Derived Stem Cell Therapy (ADSCT).

5 A. Respondent's office was composed of: a front area reception desk and waiting area, a

6 patient exam room, a centrifuge room 1, kitchen, and restroom.

7 B. Respondent's office staff consisted of Respondent and his daughter, S.L. Respondent

8 indicated that he was the only person who performed medical procedures in the office. S.L.

9 identified herself as the receptionist and claimed to have no role in medical procedures other than

10 cleaning the patient exam room.

11 21. At the time ofthe February 23, 2015, announced SBCPHD site visit, multiple

12 infection control breaches were observed, as follows:

13 A. There was a lack of written infection prevention policies or procedures.

14 B. Supplies necessary for adherence to standard precautions were not readily available.

15 Gloves were not observed in the centrifuge room or the kitchen. The box of gloves in the patient

16 exam room was in the back of a cupboard, behind other supplies.

17 C. Respondent did not maintain a log of needle sticks, sharps injuries, and other

18 exposure events.

19 D. Respondent did not have designated clean areas and designated dirty areas in his

20 work areas. Respondent prepared solutions and material for patient injections on the countertop

21 in the'patient exam room. Blood and adipose were mixed for Prolotherapy on the countertop next

22 to centrifuge in the centrifuge room.

23 E. The following clean items and dirty items were observed to be comingled in the same

24 area: multi-dose vials, clean syringes and needles, dirty syringes and needles, clean 4 x 4 cotton

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1 A centrifuge is a reusable medical device/machine that uses centrifugal force for separating substances of different densities, for removing moisture, or for simulating gravitational effects such as separating whole blood into its various components.

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swabs and dirty 4 x 4 cotton swabs. Respondent was observed handling clean and dirty items

interchangeably.

F. With respect to hand hygiene, there was no sink for hand washing in the patient exam

room. To wash his hands while in the patient exam room, Respondent was required to open the

door, leave the patient exam' room, wash his hands in the kitchen and return to the patient exam

room.

G. Injection safety was not practiced.

1. Injections were not prepared using aseptic technique in a clean area free

from contamination or contact with blood, body fluids, or contaminated equipment. The

centrifuge room lacked a designated clean area, designated dirty area and gloves. The kitchen

area next to the sink lacked a designated clean area, designated dirty area and gloves. The patient

exam room lacked a designated clean area and designated dirty area.

2. Respondent was observed re-entering multi-dose vials with the same

syringe used to inject the patient. The needle, however, was changed. Respondent explained that

he did not know a new syringe had to be used. He further explained that he did not believe that

blood got into the syringe. His regular practice was to only change the needle and to re-use

syringes between injecting a patient and re-entering multi-dose vials.

3. The rubber septum on medication vials was not consistently disinfected

with alcohol prior to piercing.

4. There were single dose medication vials and an IV bag partially full

indicating potential use for multiple patients.

5. Multi-dose vials to be used for more than one patient were kept in the

immediate patient treatment area on the countertop in the patient exam room instead of being kept

in a centralized medication area.

· -----·- ·---- -6'.----- Multi-dose-vials--were not discarded~- Respondent stated that the 100 ml

multi-dose vials of dextrose arid lidocaine solutions were discarded every morning, on a daily

basis; however, there were multiple opened and partially used vials in the kitchen refrigerator.

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Respondent indicated that he did not know why the vials were there and thought S.L. may have

refrigerated them because she sometimes assisted with cleaning the patient exam room.

7. There was no log or record of refrigerator temperatures in the kitchen

where medications were stored. It was not clear that the refrigerator was designated strictly for

medication storage.

H. There was a lack of written policies and procedures for routine cleaning and

disinfection of environmental surfaces. Both Respondent and S.L. confirmed that S.L. lacked

specific training on environmental cleaning and lacked a competency validation at the time she

was hired. There was a lack of written policies or procedures for decontamination of spills of

blood or other bloody fluids.

I. There was a lack of written policy and procedure to ensure that the centrifuge was

cleaned appropriately on a specified time frame. There was further a lack of record of cleaning it.

J. There were undated multi-dose medication vials in the kitchen refrigerator including

dextrose, lidocaine, glucosamine, and B 12.

SBCPHD's Follow Up Subsequent to February 23, 2015 Announced Site Visit

22. Following the February 23,2015, announced SBCPHD site visit, SBCPHD

conducted telephone follow up conferences with Respondent and S.L.

A. During multiple telephone conferences, S.L. stated that she did not participate in

medical procedures.

B. During a telephone conference with Respondent, he indicated that he does not

currently have nor has he ever had a partner in his medical practice.

23. A former patient of Respondent's reported to SBCPHD that Dr. A.K. was

Respondent's former partner.

24. Dr. A.K reported to SBCPHD that he shared office space and equipment with

Respondent until December 2014 when Dr. A.K. vacated the medical office .

Ill

Ill

25. Dr. A.K. also stated that S.L. assisted Respondent with procedures.

12


1 March 18,2015 SBCPHD Unannounced Site Visit

2 26. On March 18, 2015, an unannounced site visit to Respondent's medical practice was

3 conducted by C.D., M.D., M.P.H., Health Officer, and P.B., R.N., P.H.N., of the SBCPHD. The

4 purpose of the visit was to ensure that Respondent corrected the practices identified in the

5 February 23,2015, announced SBCPHD site visit, and that Respondent had a plan for

6 improvement in place to institute an infection control policy. Respondent permitted the

7 inspectors to observe a procedure and ask S.L. additional questions.

8 27. Respondent was observed performing a Prolotherapy procedure on a patient.

9 Respondent did not wash his h~ds before the procedure. When Respondent was asked about

10 failing to wash his hands before the procedure, Respondent stated that the sink was in the kitchen,

11 he did not want to walk back and forth and he believed that his hands were clean. Respondent did

12 not wear gloves.2 When Respondent was asked to wear gloves, he replied that he had been

13 practicing the same way without wearing gloves for over thirty (30) years and has never had a

14 patient report any problems. Respondent declined to wear gloves and used bare hands during the

15 procedure.

16 28. In the patient exam room, eight open vials were observed on the countertop. The

17 . vials were all dated but some dates were illegible. The vials contained the following solutions:

18 (1) 1% Lidocaine, 50 cc, dated 3116, approximately~ full; (2) glucosamine, 30 cc, dark bottle,

19 dated 3114; (3) B12, date illegible; (4) Kenalog, date illegible; (5) 50% Dextrose, 50 cc,

20 approximately 1/3 full, date illegible; (6) 8.4% Sodium Bicarbonate, 50 cc, approximately Y2 full,

21 date illegible; (7) Sterile Water, 30 cc, approximately Yz full, date illegible; and (8) mixture of

22 2.5% I 25% I 25% dated 3114 (when Respondent was questioned about the ingredients of the

23 mixture he replied that it was "for Prolotherapy").

24 Ill

25 Ill

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2 At the time of Respondent's interview with the Board on September 29, 2015, he indicated that those in his specialty do not use gloves when performing PRP, but he is going to be using gloves from now on as advised by infection control specialists.

13


1 29. A single IV bag of 5% Dextrose IV dated 3/16 was observed being used. Respondent

2 explained that the single use IV bag was used as a multi-use bag in order to make dextrose

3 dilutions. He estimated one bag was used every three (3) days to treat more than one (1) patient.

4 30. With respect to the process of the Prolotherapy procedure observed, Respondent

5 cleaned a small area of the patient's left posterior lumbar region with an alcohol swab. He then

6 used his bare hands to palpate the injection site. He made approximately thirty (30) repeated

7 injections into the palpated region. The estimated blood loss was 1-2 cc. The blood on the

8 patient's back trickled onto the exam table. Without wearing gloves, Respondent used a 4 x 4

9 cotton swab to wipe the blood. He then tossed the soiled cotton swab onto the counter and wiped

10 his hands on his pants. After using his bare hands and a swab to wipe the patient's blood,

11 Respondent was observed handling multiple vials, the soiled 4 x 4 swab, and the patient without

12 wearing gloves or washing his hands. During the procedure, Respondent used a new syringe and

13 needle each time he aspirated fluid from a vial. He stated that he has stopped using the same

14 syringe, and was not previously aware of this standard of practice to use a new syringe each time.

15 He stated that he still believed that the blood could not get into the syringe, that he had always

16 changed needles and that SBCPHD's request to use a different syringe each time re-entering a

17 medication being used for multi-dose purposes was overkill.

18 31. There was no designated clean area and no designated dirty area on the counter

19 during the procedure. The clean items and dirty items were intermingled on the counter.

20 Respondent handled the vials immediately after using his bare hands and a swab to wipe the

21 patient's blood. After the patient left the exam room, Respondent left the exam room to wash his'

22 hands in the kitchen sink and then returned to the exam room.

23 32. SBCPHD then asked Respondent to wipe down the exam table. Respondent used a

24 Cl9rox bleach wipe from the supply cabinet to complete the request. Thereafter, Respondent was

-· 25 asked to describe the various medications injected during Prolotherapy; PRP, ·and ADSCT:· He - ·

26 explained that only dextrose and lidocaine are used in Prolotherapy. He stated that for ADSCT

27 and PRP, all necessary injectable solutions were enclosed in respective sterile kits, which were

28 housed in the centrifuge room near the centrifuge.

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33. Following the procedure, SBCPHD inspected the kitchen, kitchen sink, and the

centrifuge room, as follows:

A. Kitchen.

1. The medication refrigerator in the kitchen contained: one unopened

glucosamine sulfate 100 mg I ml Lot 03162015; three unopened Serostim 6 mg "For

Reconstitution;" and one opened and undated Serostim 6 mg "For Reconstitution," in liquid form,

approximately ~ full, about 2 cc of liquid.

2. Respondent stated that the Serostim vials (human growth hormones) were

for his personal use but also stated that he does administer hormone therapy to patients.

3. Respondent previously stated that only dextrose and lidocaine are used in

Prolotherapy; however, when asked about the glucosamine in the kitchen refrigerator, he stated

that he sometimes used it for Prolotherapy.

B. Kitchen Sink.

1. The kitchen sink was small with a small countertop area. S.L. indicated

that she leaves a white tray of prepared ADSCT injection materials (patient blood and fat) next to

the sink so Respondent can mix them for the next patient. A toothbrush was next to the kitchen

sink and S.L. confirmed that it was Respondent's personal toothbrush. When S.L. was asked

what she does with the leftover patient plasma and fat, she explained that it is squirted down the

kitchen sink. She stated that she tried to aim for the little holes in the drain so that the patient

plasma does not splatter as much. She discards emptied syringes in the kitchen trash. There were

no designated clean areas or designated dirty areas next to the sink. The clean vials awaiting the

next patient were close enough to the sink to feasibly be splattered.

C. The Centrifuge Room.

1. According to S.L., there were no protocols for when or how to clean the

centrifuge;-the--centrifuge had- never b-een:-clean:ed;-S.L. -completes one hundred percent (100%) of

patient specimen processing for PRP and ADSCT; S.L.'s training to operate the centrifuge

consisted of watching a 10 minute video provided by the centrifuge sales representative.

Ill

15


1 34. S.L., who did not have medical training or infection control training, stated that

2 processing specimens is not a medical procedure. She did not wear gloves while processing

3 specimens, was never asked by Respondent to wear gloves while processing specimens, and was

4 lUlaware that wearing gloves while processing specimens was standard practice.

5 35. S.L. was not offered the Hepatitis B vaccine as part of her employment with

6 Respondent.

7 36. S.L. explained her role in processing specimens.

8 A. For PRP, Respondent draws 50 cc of patient blood in the exam room and hands the

9 syringe to S.L., who then carries it to the centrifuge room to process for re-injection into the

10 patient.

11 B. For ADSCT, S.L. assists Respondent with fat aspiration in the exam room. S.L.

12 stated that she "hands [Respondent] things and helps out." She then processes the specimen in

13 the centrifuge room. The concentrated fat and concentrated platelet syringes are then placed next

14 to the sink in the kitchen for Respondent to mix together. Respondent then injects this mixture

15 back into the patient. S.L. disposes the leftover blood and fat, after the concentrate is removed,

16 down the kitchen sink. She describes it as "oily fat."

17 C. S.L. estimates that Respondent performs an average of one (1) ADSCT procedure per

18 month.

19 D. S.L. did not use the larger industrial sink in the hallway for disposal so that patients

20 would not see her squirt their "oily fat" down the sink. The patients could not see her do it in the

21 kitchen.

22 E. Despite multiple PRP and ADSCT procedures being performed on the same day, S.L.

23 had not labeled syringes with patient identifying information. She explained that patients arrive

24 in the morning to have specimens drawn and return in the afternoon for re-injection. S.L. ensures

· 25 that patienrsyringesare not inadvertently switcheda.nd·sne-"just keeps them straight."

26. 37. Multiple vials were observed to be sitting on the collllter next to the centrifuge and

27 stored in the nearby cabinet, not contained within a PRP or ADSCT kit. Since Respondent had

28 stated that all vials used for PRP and ADSCT were contained within the kits, S.L. was illlsure

16


' . --·i

1 why the vials were there. The vials appeared identical to those contained in the kits. They were

2 unopened and unlabeled.

3 38. Respondent's medical office did not have vital sign monitoring equipment.

4 A. At the time of Respondent's interview with the Board on September 29, 2015,

5 Respondent acknowledged tha~ he did not have a license or certificate to administer IV sedation

6 in his office and the last time he was certified in Advanced Cardiovascular Life Support was in

7 approximately 2000.

8 39. Respondent was asked about pain medications being administered prior to and during

9 procedures. He stated that some patients request to take oral pain medication before a procedure.

10 He did not mention IV sedation.

11 40. Respondent was a~ked if he knew of any Hepatitis C positive patients in his practice.

12 He responded that he did not know of any such patients in his practice, and he did not treat "those

13 types of people."

14 41. While Respondent maintained he did not have a medical partner, he shared office

15 space with Dr. A.K. for many years and Dr. A.K. vacated the premises in December 2014.

16 Respondent maintained that he and Dr. A.K. had separate medical practices, used separate

17 medicar supplies and medications and never assisted each other or shared patients.

18 42. At the time of the March 18,2015, unannounced site visit, Respondent had corrected

19 the following infection control breaches identified during the first inspection:

20 A. Multi-dose vials on the counter in the patient exam room were all dated.

21 B. Respondent used a new syringe to enter the multi-dose vial, though he stated that he

22 still did not believe any blood could get into the syringe and though he was complying, he

23 thought the request was overkill.

24 C. Respondent was in the process of having an infection control protocol written.

· 25 · ·- 4 3 ;·· · At the time of the March 18, 2015, unannounced site visit, Respondent coritiimed to· ··

26 have the following infection control breaches:

27 A. Lack of a designated clean area and designated dirty area in the patient exam room;

28 B. Lack of a designated clean area and designated dirty area in the centrifuge room;

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C. Lack of a designated clean area and designated dirty area in the kitchen;

D. Lack of proper infection control training for S.L., including OSHA bloodbome

pathogen training; and

E. Lack of vaccination against Hepatitis B for S.L.

44. At the time of the March 18,2015, unannounced site visit, the following newly

identified infection control breaches were made:

A. Neither Respondent nor S .L. wore gloves during the procedure or handling of patient

specimens.

B. Potential for contamination of clean medication vials with patient's blood during the

procedure.

C. Potential for contamination of surfaces (countertops, door handles, etc.) with patient's

blood during the procedure.

D. Potential for contamination of clean patient specimens next to sink by "oily fat" being

disposed of into the kitchen sink and splattering on patierit specimens.

E. Lack of labeling of syringes containing patient specimens, despite multiple PRP

procedures being performed on the same day.

F. Improper disposal of biological hazardous waste.

PATIENT CARE3

Patient C.W.

45. Respondent provided medical care, treatment and management to Patient C. W. as

follows:

A. April28, 2014, C.W., a 55-year-old male, presented to Respondent with complaints

oflow back and right hamstring pain. Respondent examined C.W. and assessed him as having

sacroiliac dysfunction. Respondent noted that he discussed the risks and benefits of Regenerative

Injection Therapy (RIT)4 with C.W., who then consented to-proceed. That same day, C.W.

3 Patients are referred to by initials or numbers to protect their privacy. 4 Regenerative injection therapy (RIT) is a treatment for chronic pain caused by unhealed injuries

around: cartilage, joints, ligaments, muscles and tendons. Types ofRIT include Prolotherapy and Platelet Rich Plasma (PRP).

18


1 underwent RIT. It was noted that the skin was prepped with Hibiclens, a skin cleanser and

2 antiseptic, four times and that sterile technique with gloves was used. C. W. was given a solution

3 ofD15 in both the iliolumbar and sacroiliac ligaments. He was instructed to return in six weeks.

4 B. On June 24, 2014, C.W. presented to Respondent with complaints oflow back pain

5 and a hamstring tear. C.W. underwent RIT of the low back. It was noted that the skin was

6 prepped with Hibiclens four times and that sterile technique with gloves was used. C. W. was

7 given a solution ofD20 with some P2G (phenol-glycerin-glucose) in both the iliolumbar and

8 sacroiliac ligaments. C.W. then underwent perineural subcutaneous injections of dextrose 5% in

9 the right hamstring, from the right buttock down to the right hamstring, mostly in the center of his

10 posterior thigh. C.W. was instructed to return as needed.

11 C. On September 4, 2014, C.W. presented to Respondent with sacroiliac ligament

12 dysfunction. He was noted to have had ''very good luck" with his two Dextrose treatments, but

13 fell and in the past week or so, has had terrible pain and an antalgic gait (a gait that develops as a

14 way to avoid pain while walking). The patient underwent a PRP Injection. It was noted that the

15 skin was prepped with Hibiclens and that sterile technique was used. It was noted that C.W. was

16 injected with PRP solution in both the iliolumbar and sacroiliac ligaments as well as in the facet

17 areas ofL4-5 and L5-S1, bilaterally.

18 D. On February 10,2015, C.W. presented to Respondent with complaints oflow back

19 pain. He was given Demerol 50 mg and Versed 4 mg intramuscularly and then underwent RIT of

20 the low back. It was noted that the skin was prepped with Hibiclens and sterile technique was

21 used. C.W. was given a solution ofD15 with some Kenalog in both the iliolumbar and sacroiliac

22 ligaments. He was noted to have been "mostly all better" by the time he got up off the table. He

23 was instructed to return as needed.

24 E. Respondent did not document vital signs for C.W. at the time he administered

... 25

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procedural sedation. ·

Patient F .S.

27 46. Respondent provided medical care, treatment and management to Patient F.S. as

28 follows:

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1 A. F.S., a then 58-year-old female patient, initially presented to Respondent in December

2 2005, with complaints of bilateral knee pain. Respondent recommended injection therapy. In

3 addition, Respondent reviewed F.S.'s blood tests and diagnosed her with hyperthyroidism,

4 following a review of her blood work, which reflected a thyroid stimulating hormone (TSH) of

5 4.77 (normal noted to be .3 to 5.5), free T4 of 1.0 (normal noted to be 0.8 to 1.7) and free T3 of

6 2.7 (normal noted to be 2.3 to 4.2). Respondent started F.S. on Armour thyroid medication on

7 December 20,2005.

8 B. On January 5, 2006, Respondent injected F.S.'s left knee and continued her thyroid

. 9 medication. He recommended blood tests in about 6 weeks and returning for knee and ankle

10 injections as needed.

11 C. On February 27,2006, F.S. was seen by Respondent for left ankle and right knee

12 injections. Respondent also reviewed F.S.'s blood work. He increased her thyroid medication of

13 Armour thyroid 90 mg every day to 120 mg every day.

14 D. On May 4, 2006, F.S. was seen by Respondent for knee injections. He also noted that

15 F.S. has been doing very well on Armour thyroid 120 mg every day. She was instructed to return

16 as needed.

17 E. On May 27, 2006, F.S. was seen by Respondent for an injection into the articular

18 space of both knees. Her last blood tests showed a free T3 equaling 4.4., which was noted to be

19 "perfect" and she was continued on Armour thyroid 120 mg every day.

20 F. On July 21,2006, Respondent noted that F.S. was doing well on Armour thyroid 120

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mg every day. She was noted to have osteoarthritis of both knees and was given another injection

into both knees. She was instructed to return as needed.

G. On February 6, 2007, F.S. presented to Respondent at which time he noted that she is

doing great on Armour thyroid 120 mg every day and had been doing well with glucosarnine

injections, \Vith her last one· in July 2006.-·Respondent gave F.S. an injectiorfofD25 and· · ·- -·- ----

glucosarnine into both knees and instructed her to return as needed.

H. On February 7, 2008, F.S. presented to Respondent at which time he noted that she

was doing great on Armour thyroid 120 mg every day and she had been doing well with the

20

ACCUSATIONNO. 800-2015-012960

1 osteoarthritis ofher knees. Respondent noted that F.S. was given neural therapy in the usual

2 pattern and then given a solution ofD25 and glucosarnine into each knee articular space. She was

3 instructed to return as needed.

4 I. F.S. presented to Respondent on March 12, 2009, at which time, she had PRP injected

5 into her right knee articular space and said that she may return for the other knee. It was also

6 noted that she was on Armour thyroid and doing well.

7 J. F.S. presented to R,espondent on December 3, 2009, at which time, he noted that her

8 hypothyroidism was doing great on Armour thyroid 120 mg a day, plus other bio-identical

9 hormone replacements. She was noted to have left knee arthritis and left ankle osteoarthritis. She

10 was given IV sedation, including 50 mg Demerol and 1 mg Versed, and "this was probably too

11 much for her." Thereafter, she was given a solution ofD20 and glucosamine in the right knee

12 articular space, left knee articular space, left knee lateral collateral ligament, and left tibiotalar

13 joint.

14 K. F.S. presented to Respondent on December 11,2009, at which time, it was noted that

15 he gave her 20 mg ofKenalog into her left tibiotalar joint and a solution ofD15 in the left fibular

16 head.

17 L. F.S.'s chart from Respondent's office reflects that on February 3, 2010, Armour

18 thyroid was not available at the pharmacy, and instead, Respondent prescribed compounded

19 T3T4, 120 mg once a day for a year. On May 10,2010, Respondent prescribed Thyroid 120 mg

20 to be taken once a day for four months.

21 M. F. S. presented to Respondent on January 13, 2011, with complaints of knee arthritis

22 and left ankle osteoarthritis. She was injected with a solution ofD15 and glucosamine along the

23 lateral joint line and ligaments of the fibular head bilaterally. She was also given a solution of

24 D15 in the lateral ankle ligaments and the tibiotalar joint of the left ankle.

·· 25 - N. ·· F.S. presented to Respondent on August 18,2011, with arthritis of the knees and-

26 osteoarthritis of the ankles. F.S. was given IV sedation with Demero150 mg and Versed 2 mg.

27 She then under went knee injections. It was noted that the skin was prepped with Hibiclens and

28 ///

21


1 sterile technique was used. She was given a solution ofD25 and glucosamine into the

2 subacromial space bilaterally, as well as, into her tibiotalar joints bilaterally.

3 0. F.S. presented to Respondent on Aprill5, 2013, with complaints ofknee and left

4 ankle pain. F.S. underwent right and left knee injections. It was noted that her skin was prepped

5 with Hibiclens and sterile technique was used. She was given a solution of D25 and glucosamine

6 in the right knee, at the lateral joint line fibular head ligaments, and in the left knee medial and

7 lateral joint line and articular space. She also underwent a left ankle injection. It was noted that

8 the skin was prepped with Hibl.clens and sterile technique was used. She was given a solution of

9 D25 and glucosamine in the tibiotalar joint, sinus tarsi, and anterior talofibular ligament.

10 P. F.S. presented to Respondent on June 23,2014, with complaints ofleft knee pain.

11 She underwent an RIT injection of the left knee. It was noted that her skin was prepped with

12 Hibiclens four times and that sterile technique with gloves was used. She was given a solution of

13 D15 in the lateral collateral ligament on the left and in the fibular head ligaments on the left. Her

14 medical records reflect that she underwent another RIT injection of the left knee. It was noted

15 that her skin was prepped with Hibiclens four times and sterile technique was used. She was then

16 given a solution of D 15 in the anterior talofibular ligament. She was then given a solution of D25

17 in the lateral joint line. Respondent noted "[a]fter the injection she did well, but she had a foot

18 · drop, secondary to the Xylocaine around the peroneal nerve and we waited almost 2 hours until

19 . she was able to walk out of the office." F.S. was instructed to return as needed.

20 Q. F.S. presented to Respondent on November 7, 2014, with complaints ofleft knee

21 pain. She was given a PRP injection of the left knee. It was noted that her skin was prepped with

22 Hibiclens 4 times and that sterile technique with gloves was used. She was given a PRP solution

23 2 m1 into the fibular head ligaments. She was then given a 3 ml solution ofPRP into the medial

24 joint line and articular space. It was noted that F.S. would keep in touch with Respondent by

· · · 25 email and phone. ·-

26 R. F.S. presented to Respondent on February 11,2015, with complaints ofleft knee pain.

27 It was noted that she had PRP on her left knee on November 7, 2014, and was doing better

28 overall, but has had pain since the injection. She used an anti-inflainmatory medication, Mabie

22


1 7.5 mg, which helped with the pain. Respondent noted talking to F.S. about PRP and healing.

2 F.S. was instructed to return in. 4-8 weeks for a second PRP, as needed.

3 S. Respondent did not document vital signs for F .S. at the time he administered

4 procedural sedation.

5 Patient#l

6 47. Respondent provided medical care, treatment and management to Patient #1 as

7 follows:

8 A. In 2012, Patient # 1. presented to Respondent for PRP therapy to her left medial joint

9 line. She was given IV sedation with Demerol 50 mg and Versed 3 mg and was noted to have

10 tolerated it well. She was draped in a sterile manner, infiltrated with a Xylocaine epinephrine

11 solution and then 3 ml offat was aspirated from her left flank area Respondent noted that he was

12 assisted by S.L. and Dr. A.K. Patient #1 's skin was prepped with Hibiclens, with sterile

13 technique noted. PRP was noted to have been prepared in a sterile manner, the PRP and fat were

14 mixed, then injected into her medial joint line and articular space of the left knee. Respondent .

15 gave the patient Vicodin and Diazepam and indicated that he would follow her carefully by email

16 and telephone.

17 B. Respondent did not document vital signs for Patient # 1 at the time he administered


19 Patient #4


21 follows:

22 A. In September 2013, Patient #4 presented to Respondent for PRP. She had previously

23 been seen on August 12,2013. Respondent noted that Patient #4 was to undergo PRP injection of

24 the right knee. It is noted that her skin was prepped with Hibiclens and sterile technique was

· 25 used, including sterile-gloves·:- Patient #4 was given 3 m1 of a PRP solution in the anterior hom-

26 and body of the medial meniscus of the right knee. It is further noted that she had Vicodin, an

27 ///

28 ///

23


1 opioid analgesic, and Hal cion, 5 a benzodiazepine, before she presented to the office and was

2 "very anesthetized."

3 B. Respondent did not document vital signs for Patient #4 at the time he administered


5 Patient #7


7 follows:

8 A. Patient #7 presented to Respondent on August 17, 2012, with complaints of right

9 shoulder pain and right knee pam. He was given IV sedation witl;t Versed 3 mg, with no

10 Demerol, and fell asleep. He underwent a right shoulder RIT injection. It was noted that the skin

11 was prepped with Hibicens and sterile technique was used. Patient #7 was then given a solution

12 ofD15 into the right shoulder supraspinatus tear. He also underwent a right knee RIT injection

13 and was given "some D25 and glucosamine" in the lateral joint line and articular space.

14 B. Patient #7 presented to Respondent on February l3, 2013, for bilateral knee injections

15 and a right shoulder injection. ·He was given Versed 4 mg intravenously. With respect to the

16 knee injections, his skin was prepped with Hibiclens and sterile technique was used. He was

17 given a solution of PRP I ADSCT in the medial and lateral joint line and articular space of the right

18 knee as well as in the medial joint line and anterior hom of the medial meniscus of the left knee.

19 In his right shoulder, he was injected with a solution ofPRPIADSCT in the infraspinatus and

20 supraspinatus tendon attachment.

21 C. Respondent did not document vital signs for Patient #7 at the time he administered


23 Patient #8

24 50. Respondent provided me<;lical care, treatment and management to Patient #8 as

- 25 follows: ·

26 Ill

27

28 5 Throughout his typewritten progress notes, Respondent identified Halcion as "Halcyon."

24


1 A. Patient #8 presented to Respondent on May 7, 2011. She was noted to have been

2 seen twice previously with complaints of neck and low back pain and had injections in several

3 places. Patient #8 underwent injections in her high neck around C1, C2 and C3 as well as in her

4 low back in the areas of her sacroiliac joints and around the coccyx. The injections were then

5 followed with a solution ofD15 in the lateral mass ofC1, C2 and C3, in the posterior inferior

6 iliac spine and the sacrotuberous ligaments at the coccyx.

7 B. On September 27, 2012, Patient #8 presented to Respondent with neck and low back

8 pain. She was given PRP injections into her neck and low back. With respect to sedation,

9 Respondent made the followin~ notation in Patient #8's chart: "Because she didn't really want to

10 feel pain, I gave her Demerol20 mg and Versed 3 mg IV. She did great through the treatment,

11 but got dizzy and nauseated when she tried to get up. She lied [sic] around for about 20 minutes

12 and then was fine to go home."

13 C. When Patient #8 presented to Respondent on February 9, 2013, for treatment. She

14 was given Xylocaine before her RIT injection to the low back and was instructed to return in 6

15 weeks-or sooner, as needed.

16 D. Patient #8 presented to Respondent on March 16,2013, with complaints of neck and

17 low back pain. She underwent RIT injections to her neck and low back. She again was given

18 Xylocaine for anesthesia. She was instructed to return in 6 weeks or sooner, as needed.

19 E. Patient #8 presented to Respondent on April20, 2013, with complaints of neck and

20 low back pain. She was given a Percocet about an hour before her injections. Following skin

21 preparation with Hibiclens and sterile technique, she was given a solution ofD15 in the C6 facet

22 down to T4lateral mass bilaterally, lamina, and midline interspinous ligaments in the neck. She

23 was given a solution ofP2G in the iliolumbar and sacroiliac ligaments of the low back. She was

24 instructed to return in 6 weeks or sooner, as needed.

25 F. ··- On June 8, 2013; Patient #8 presented to Respondent for injections of the neck and ·

26 low back. It was noted that her skin was prepped with Hibiclens and sterile technique was used.

27 With respect to the neck RIT injection, she was given a solution of D 15 in the lateral mass,

28 lamina, and interspinous ligaments from C6 down to T4. With respect to the low back RIT

25


1 injection, she was given a Ravin solution6 and P2G in both the iliolumbar and sacroiliac

2 ligaments. She was instructed to return as needed.

3 G. On August 10, 2013, Patient #8 presented to Respondent for low back and neck

4 injections. She was noted to have taken a Percocet prior to arriving and was "a little nauseated

5 from the Percocet." With respect to the low back RIT injection, she was given a solution ofD20

6 in both the iliolumbar and sacroiliac ligaments. With respect to the neck RIT injection, she was

7 given a solution ofD15 and a small amount ofP2G in the lateral mass and lamina from C6 down

8 to T4. She was instructed to return as needed.

9 H. Respondent did not document vital signs for Patient #8 at the time he administered


11 Patient#9


13 follows:

14 A. In 2011, Respondent treated Patient #9 for shoulder pain. Prior to Patient #9's

15 procedure, he was given IV sedation with Demerol37 mg and Versed 2 mg. He then underwent

16 an injection ofD15 along the infraspinatus and supraspinatus attachments in his right shoulder.

17 He was instructed to return as needed.

18 B. In 2012, Patient #9 was seen for mid-back pain on three occasions. On each of the

19

20

21

22

23

24

- 25

26

27

28

three visits,' Patient #9 was given IV sedation with Demerol 50 mg and Versed 3 mg. Likewise,

for each visit, it was noted that the skin was prepped with Hibiclens with sterile technique. On

one occasion, Patient #9 wasgiven a solution ofKenalog 40 mg suspended in 10 ml ofXylocaine

throughout the midline interspinous ligaments and lamina bilaterally from Tl 0 through L2. On

the second occasion, he was then given a solution ofKenalog 40 mg, diluted in 10 ml of

Xylocaine, along the lateral mass, lamina, and interspinous ligaments at Tl 0 through L 1. On the

third·occasion, he was given ~rPRP injection in the T6, T7 midline interspinous ligaments, and -

Ill

6 Respondent's typewritten progress note reflects the use of a "Ravin solution." Complainant is unaware of any such solution. ·

26


1 lamina bilaterally, as well as, in the Tll, Tl2, and L1 interspinous and supraspinous ligaments,

2 and lamina bilaterally.

3 C. In 2013, Patient #9 returned with thoracic and right groin pain. He was given IV

4 sedation with Demerol50 mg and Versed 3 mg. Thereafter, his skin was prepped with Hibiclens

5 with sterile technique. With respect to the thoracic PRP injection, he was given a PRP solution

6 from T11, Tl2, and L1 interspinous and supraspinous ligaments, and lamina bilaterally. With

7 respect to the right groin PRP injection, he was given a PRP solution along the right pelvic ramus

8 at the attachment of the adductors. He was instructed to return as needed.

9 D. Respondent did not document vital signs for Patient #9 at the time he administered


11 Patient #10

12 · 52. Respondent provided medical care, treatment and management to Patient #10 as

13 follows:

14 A. Patient #10 presented to Respondent on April 8, 2008, with complaints oflow back

15 pain. Patient #10 was given IV sedation, including 50 mg ofDemerol and 2 mg ofVersed, and

16 was noted to tolerate it well. ffe was then given a solution ofP2G and Morrhaute in both his

17 iliolumbar and sacroiliac ligaments as well as in the facets ofL4-5 and L5-S1 interspinous

18 ligaments. Patient # 1 0 was instructed to return as needed.

19 B. Patient # 10 next presented to Respondent on August 20, 2009, with a tear and

20 impingement of his supraspinatus tendon. He was given a Pybus solution7 and D20 with

21 ultrasound guidance into the supraspinatus tendon attachment and subacromial space.

22 C. Patient #10 presented to Respondent on November 15, 2010, at which time he

23

24

25

26

27

28

complained of neck pain. He was given IV sedation, including 50 mg ofDemerol and 2 mg of

Versed, and was noted to have tolerated it well. Patient #1 0 was then given neck injections of a

Pybus' solution and D15 ill the Cl facet down to TJlateral mass bilaterally, lamina, and midline

interspinous ligaments, the medial superior border of the right scapula, and the lateral right

7 Respondent's typewritten progress note reflects the use of a "Pybus solution." Complainant is unaware of any such solution.

27


1 scapular board. He also received a 10 mg injection ofKenalog in the subacromial space of the

2 right shoulder. He was instructed to return as needed.

3 D. Patient #10 presented to Respondent on December 14,2010, at which time it was

4 noted that he had good benefit from his November 15,2010 injection. He was given IV sedation,

5 including 50 mg ofDemerol and 3 mg ofVersed, and was noted to have tolerated it well. Patient

6 #10 was then given neck injections of a Pybus solution and D15 in the C1-2lateral mass

7 bilaterally; the sub-occipital base; the C4 facet down to T4lateral mass bilaterally, lamina and

8 midline interspinous ligaments; the medial superior border of the right scapula; and the lateral

9 scapular border on the right. Patient #10 also received an injection ofD15 and glucosamine in

10 the first metacarpophalangeal joint of his left toe and a small amount ofKenalog in his left elbow.

11 E. Patient #10 was seen by Respondent on March 22,2012, with complaints of having a

12 lot of trouble with his right shoulder and thoracic pain secondary to heart surgery. He was given

13 IV sedation with Demerol 50 mg and Versed 2 mg, and was noted to have tolerated it well. He

14 was then given a RIT injection in the right shoulder. It was noted that the skin was prepped with

15 Hibiclens and sterile technique was used. He was then given a solution ofD15 in the

16 supraspinatus tendon of the right shoulder with ultrasound guidance and in the T1 through T4

17 lateral mass bilaterally, lamin~ and midline interspinous ligaments. He was instructed to return

18 as needed.

19 F. Patient #10 presented to Respondent on February 12,2013, with complaints of neck

20 and upper back pain. Respondent's impression was that Patient # 10 had adjacent segment

21 dysfunction, probably at CS-6, above his prior cervical fusion. Respondent recommended

22 injection therapy to stabilize that segment. Patient #10 was given IV sedation with Demerol50

23 mg and Versed 3 mg, and was noted to have tolerated it well. He was given an RIT injection in

24 the neck. It was noted that the skin was prepped with Hibiclens and sterile technique was used.

25 Patient #10 was placed in the side lateral position and given a solution ofD15 in the right side

26 lateral mass from C3 through C7. He was then placed in a prone position and the lateral mass

27 was injected from C3 through T8 lateral mass on the right lamina, and midline interspinous

28 ligaments. He was instructed to return in four weeks or sooner as needed.

28


1 G. Respondent did not document vital signs for Patient #10 at the time he administered


3 STANDARD OF CARE

4 53. Reusing Syringes. The standard of medical practice in California is to never reuse

· 5 needles or syringes because of the risk of transmission of infectious material.

6 54. Use of Standard Precautions While Injecting Patients. The standard of medical

7 practice in California is to use standard precautions for the care of all patients, regardless of their

8 diagnosis or presumed infection status. Standard precautions include the use of hand washing and

9 appropriate personal protective equipment such as gloves, gowns, and masks whenever touching

10 or exposure to patient's body fluid is anticipated.

11 55. Practice ofProce~ural Sedation. The standard of medical practice in California for

12 procedural sedation requires that the clinician be trained and experienced in procedural sedation,

13 that equipment necessary to perform the procedure and manage the airway be present, and that

14 the patient be monitored carefully throughout the procedure. This monitoring includes

15 measurement of the patient's blood pressure, heart rate, and respiratory rate at frequent, regular

16 intervals, as well as, continuous monitoring of the patient's oxygen saturation and end-tidal

17 carbon dioxide level.

18 A. Procedural sedation (previously called conscious sedation) involves the use of

19 medicines to help the patient relax (a sedative) and to block pain (an analgesic) during a medical

20 or surgical procedure. A clinician who practices procedural sedation must have an in-depth

21 knowledge of the relevant drugs, including their mechanism of action, doses, side effects, and

22 reversal agents. The clinician also must be well-versed in advanced cardiovascular life support,

23 including airway management.

24 B. Procedural sedation typically is performed by anesthesiologists, emergency medicine

25 physidans;cfitical care specialists, nurse i:ipeCialistS~-·a:nd physicians with specialized training in:

26 procedural sedation. It is recommended, though not absolutely required, that one clinician

27 performs the procedure while another clinician provides the procedural sedation and carefully

28 ///

29


1 monitors the patient's clinical status. This monitoring includes measurement of the vital signs

2 and oxygen status as outlined above.

3 C. All equipment necessary to perform the procedure and manage the airway should be

4 available at the bedside while procedural sedation is being performed. Such equipment includes

5 suction to manage oral secretions or vomiting, airway adjuncts (such as a bag-valve mask and

6 oral/nasal airways), and equipment to perform endotracheal intubation. Intravenous access (an IV

7 line) should be established, and reversal agents and resuscitation medications should be available.

8 56. Appropriate treatment of thyroid disease. The standard of medical practice in

9 California is to treat thyroid disorders appropriately, as under treatment or over treatment can

10 have significant adverse consequences. Hypothyroidism is diagnosed when the thyroid

11 stimulating hormone (TSH) is elevated and levels ofT3 and/or T4 hormones are low.

12 57. Assisting or providing patient care. The standard of medical practice in California

13 is for only licensed individuals to assist in or provide patient care.

14 58. Documentation of injections. The standard of medical practice in California is to

15 document the site of injections and to indicate the type and dos~ of medication injected.

16 FIRST CAUSE FOR DISCIPLINE

17 (Gross Negligence- Reusing Syringes)

18 59. Respondent is subject to disciplinary action under section 2234, subdivision (b), of

19 the Code, section 2221.1 of the Code, and California Code of Regulations, title 16, section 1633,

20 in that he engaged in gross negligence by reusing syringes, putting patients at risk of transmission

· 21 of infectious material, including Hepatitis C virus infection in multiple patients. Complainant

22 refers to and, by this reference, incorporates herein, paragraphs 18 through 44 and 53, above, as

23 though fully set forth herein. The circumstances are as follows:

24 A. Needles and syringes should not be reused because of the risk of transmission of

25 infectious material. While it is preferable to use single use vials of medication to reduce the risk

26 of contamination, if a multi-use vial of medication is being used, only sterile syringes and needles

27 should be used to draw up medications. Respondent repeatedly reused syringes to draw up

28 medications contained in multi-use vials.

30


1 B. On April2, 2015, SBCPHD notified the Board that Respondent's medical practice,

2 located at 2320 Bath Street, No. 301, Santa Barbara, California 93105, was closed after an

3 inspection revealed poor infection control practices. Six cases of Hepatitis Chad been reported to

4 SBCPHD and five of the six patients had procedures performed in Respondent's office on

5 September 4, 2014.

6 C. In his interview with the Board on September 29, 2015, Respondent acknowledged

7 that at least four patients were infected with Hepatitis C at his office.

8 1. Respondent admitted that if he was injecting patient with, for example,

9 Dextrose (a form of glucose), and needed more Dextrose, he would use a new needle but use the

10 same syringe to draw up more Dextrose.

11 2. Respondent acknowledged that patients were infected with Hepatitis C at

12 his office on September 4, 2014 and concluded "the problem with these four patients that got

13 hepatitis was the reuse of the syringe that infected the bottle. When that bottle of lidocaine,

14 which was a multi-use bottle was done, then no one else got hepatitis, but those four patients got

15 hepatitis, which is really bad."

16 D. At the time of the February 23,2015, SBCPHD announced site visit, multiple

17 infection control breaches were observed, including comingling of clean syringes and needles

18 with dirty syringes and needles.

19 E. At the time of the February 23, 2015, SBCPHD announced site visit, it was observed

20 that injection safety was not practiced.

21 1. Injections were not prepared using aseptic technique in a clean area, free

22 from contamination or contact with blood, body fluids, or contaminated equipment. The (\.

23 centrifuge room lacked a designated clean area, designated dirty area and gloves. The kitchen

24 area next to the sink lacked a designated clean area, designated dirty area and gloves. The patient

· 25 exam room lacked a designated clean area and designated dirty area. ·

26 2. Respondent was observed re-entering multi-dose vials with the same

27 syringe used to inject the patient. The needle, however, was changed. Respondent explained that

28 he did not know a new syringe had to be used. He further explained that he did not believe that

31


1 blood got into the syringe. His regular practice was to only change the needle and to reuse

2 syringes between injecting a patient and re-entering multi-dose vials.

3 3. The rubber septum on medication vials was not consistently disinfected

4 with alcohol prior to piercing.

5 4. There were single dose medication vials and an IV bag partially full

6 indicating potential use for multiple patients.

7 5. Multi-dose vials to be used for more than one patient were kept in the

8 immediate patient treatment area on the countertop in the patient exam room instead of being kept

9 in a centralized medication area

10 6. Multi -dose vials were not discarded. Respondent stated that the 100 ml

11 multi-dose vials of dextrose and lidocaine solutions were discarded every morning, on a daily

12 basis; however, there were multiple opened and partially used v_ials in the kitchen refrigerator.

13 Respondent indicated that he did not know why the vials were there and thought S.L. may have

14 refrigerated them because she sometimes assisted with cleaning the patient exam room.

15 7. There was no log or record of refrigerator temperatures in the kitchen

16 where medications were stored. It was not clear that the refrigerator was designated strictly for

17 medication storage.

18 60. Respondent's acts and/or omissions as set forth in paragraphs 18 through 44 and 53

19 above, whether proven individually, jointly, or in any combination thereof, constitute gross

20 negligence pursuant to section 2234, subdivision (b), of the Code, section 2221.1 of the Code, and

21 California Code ofRegulations, title 16, section 1633. Therefore cause for discipline exists.

22 SECOND CAUSE FOR DISCIPLINE

23 (Gross Negligence- Failure to Use of Standard Precautions When Injecting Patients)


·· 25 the Code, section 2221.r of the Code, and California Code of Regulations, title 16, section 1633,

26 in that he engaged in gross negligence by failing to use standard precautions when injecting

27 patients. Complainant refers to and, by this reference, incorporates herein, paragraphs 18 through

28 44 and 54, above, as though fully set forth herein. The circumstances are as follows:

32 ACCUSATION NO. 800-2015-012960

1 A. Standard precautions must be used for the care of all patients, regardless of their




5 B. Respondent has been observed in his practice:

6 1. not washing his hands before performing a Prolotherapy procedure on a

7 patient;

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

2.

3.

not wearing gloves while performing a Prolotherapy procedure;

wiping patient blood that had trickled on to the patient exam table with a

soiled cotton swab, throwing the soiled swab on the counter and wiping his ungloved hands on

his pants; and

4. handling multiple vials and soiled swabs without wearing gloves or

washing his hands.

C. At the time of the February 23, 2015, SBCPHD announced site visit, it was observed

that standard precautions were not practiced.

1. There was a lack of written infection prevention policies or procedures.

2. Supplies necessary for adherence to standard precautions were not readily

available. Gloves were not observed in the centrifuge room or the kitchen. The box of gloves in

the patient exam room was in the back of a cupboard, behind other supplies.

3. Respondent did not maintain a log of needle sticks, sharps injuries, and

other exposure events.

4. Respondent did not have designated clean areas and designated dirty areas

in his work areas. Respondent prepared solutions and material for patient injections on the

countertop in the patient exam room. Blood and adipose were mixed for Prolotherapy on the

coUn.tertop ·next to centrifuge in the centrifuge room.

5. The following clean items and dirty items were observed to be comingled

in the same area: multi-dose vials, clean syringes and needles, dirty syringes and needles, clean

Ill

33


1 4 x 4 cotton swabs and dirty 4 x 4 cotton swabs. Respondent was observed handling clean and

2 dirty items interchangeably.

3 6. With respect to hand hygiene, there was no sink for hand washing in the

4 patient exam room. To wash his hands while in the patient exam room, Respondent was required

5 to open the door, leave the patient exam room, wash his hands in the kitchen and return to the

6 patient exam room.

7 7. There was a lack of written policies and procedures for: routine cleaning

8 and disinfection of environmental surfaces; decontamination of spills of blood or other bloody

9 fluids; and ensuring that the centrifuge was cleaned appropriately on a specified time frame.

10 D. At the time of the March 18,2015, SBCPHD unannounced site visit, it was observed

11 that standard precautions were not practiced.

12 1. Respondent did not wash his hands before performing a Prolotherapy

13 procedure on a patient and did not wear gloves for the procedure. He cleaned a small area of the

14 patient's left posterior lumbar region with an alcohol swab and then used his bare hands to palpate

15 the injection site. He made approximately thirty (30) repeated injections into the palpated region.

16 The estimated blood loss was 1-2 cc. The blood on the patient's back trickled onto 1;}le exam

17 table. Without wearing gloves, Respondent used a 4 x 4 cotton swab to wipe the blood. He then

18 tossed the soiled cotton swab onto the counter and wiped his hands on his pants. After using his

19 bare hands and a swab to wipe the patient's blood, Respondent was observed handling multiple

20 vials, the soiled 4 x 4 swab, and the patient without wearing gloves or washing his hands. There

21 was no designated clean area and no designated dirty area on the counter during the procedure.

22 The clean items and dirty items were intermingled on the counter. Respondent handled the vials

23 immediately after using his bare hands and a swab to wipe the patient's blood.

24 2. There was a lack of: a designated clean area and designated dirty area in

25 the patient exam: rooin;·a designated clean area and designated dirty area in the centrifuge room;

26 and a designated clean area and designated dirty area in the kitchen.

27 3. There was a lack of proper infection control training for S.L., including

28 OSHA bloodbome pathogen training.

34


1

2

4.

5.

There was a lack of vaccination against Hepatitis B for S.L.

Neither Respondent nor S.L. wore gloves during the procedure or handling

3 of patient specimens.

4 6. There was potential for contamination of clean medication vials with

5 patient's blood during procedures.

6 7. There was potential for contamination of surfaces ( countertops, door

7 handles, etc.) with patient's blood during procedures.

8 8. There was potential for contamination of clean patient specimens next to

9 sink by "oily fat" being disposed of into the kitchen sink and splattering on patient specimens.

10 9. There was a lack of labeling of syringes containing patient specimens,

11 despite multiple PRP procedures being performed on the same day.

12 10. There was improper disposal of biological hazardous waste.



15 negligence pursuant to section 2234, subdivision (b), of the Code, section 2221.1 of the Code, and

16 California Code of Regulations, title 16, section 1633. Therefore cause for discipline exists.

17 THIRD CAUSE FOR DISCIPLINE

18 (Gross Negligence- Use of Procedural Sedation)


20 the Code, section 2216 of the Code, and California Code of Regulations, title 16, section 1633, in

21 that he engaged in gross negligence by administering procedural sedation to Patients C.W., F.S.,

22 #1, #4, #7, #8, #9 and #10. Complainant refers to and, by this reference, incorporates herein,

23 paragraphs 18 through 52 and 55, above, as though fully set forth herein. The circumstances are

24 as follows:

25 ···--A· ·Respondent's medical office did not have vital sign monitoring equipment at the time

26 of the March 18,2015, SBCPHD unannounced site visit.

27 B. Respondent did not have a license or certificate to administer N sedation in his

28 office.

35


1 C. Respondent had not been certified in Advanced Cardiovascular Life Support since

2 approximately 2000.

3 D. Respondent was the only person who performed medical procedures in his office.

4 E. On February 10, 2015, Respondent administered Demerol and Versed

5 intramuscularly to Patient C.W. prior to RIT injection therapy.

6 F. On August 18, 2011, Respondent administered IV sedation with Demerol and Versed

7 to Patient F.S. prior to injection therapy.

8 G. On December 3, 2009, Respondent administered IV sedation with Demero1 and

9 Versed to Patient F.S. prior to injection therapy, noting that the IV sedation was "probably too

10 much for her."

11 H. In 2012, Respondent administered IV sedation with Demerol and Versed to Patient #1

12 prior to PRP therapy to her left medial joint line.

13 I. In September 2013, Respondent noted that prior to administering PRP therapy,

14 Patient #4 had Vicodin and Halcion before she presented to the office and was "very

15 anesthetized."

16 J. On August 17, 2012, Respondent administered IV sedation with Versed, with no

17 Demerol, to Patient #7 prior to RIT therapy, and he "fell asleep."

18 K. On September 27,2012, Respondent administered IV sedation with Demerol and

19 Versed to Patient #8 prior to PRP injections "because she really didn't want to feel pain."

20 L. In 2011,2012 and 2013, Respondent administered IV sedation with Demerol and

21 Versed to Patient #9 before administering injection therapy.

22 M. In 2010,2012 and 2013, Respondent administered IV sedation with Demerol and


24 N. Respondent failed to document the vital signs of Patients C.W., F.S., #1, #4, #7, #8,

25 #9 and #1 0 ·at the time he administered procedural sedation to each of them.



28 ///

36


1 negligence pursuant to section 2234, subdivision (b), of the Code, 2216 of the Code, and

2 California Code ofRegulations, title 16, section 1633. Therefore cause for discipline exists.

3 FOURTH CAUSE FOR DISCIPLINE

4 (Gross Negligence- Treatment of Patient F.S.'s Thyroid Disease)


6 the Code in that he engaged in gross negligence in the treatment of Patient F .S.' s thyroid disease.

7 Complainant refers to and, by this reference, incorporates herein, paragraphs 46 and 56, above, as

8 though fully set forth herein. The circumstances are as follows:

9 A. The standard of medical practice in California is to treat thyroid disorders

10 appropriately, as under treatment or over treatment can have significant adverse consequences.

11 Hypothyroidism is diagnosed when the TSH is elevated and levels ofT3 and/or T4 hormones are

12 low.

13 B. In 2005, Respondent diagnosed Patient F .S. as "very hypothyroid" despite normal

14 TSH, normal free T4, and normal free T3 and started Patient F.S. on supplemental thyroid

15 hormones.

16 C. Respondent continued to prescribe thyroid hormone therapy through 2010 even

17 though prescribing thyroid hormone to a patient who does not need it can have adverse cardiac

18 effects such as atrial fibrillation and can have negative effects on bone mineral density.

19 66. Respondent's acts and/or omissions as set forth in paragraphs 46 and 56, above,

20 whether proven individually, jointly, or in any combination thereof, constitute gross negligence

21 pursuant to section 2234, subdivision (b), of the Code. Therefore cause for discipline exists.

22 FIFTH CAUSE FOR DISCIPLINE

23 (Repeated Negligent Acts)

24 67. Respondent is subject to disciplinary action under sections 2234, subdivision (c), of

25 the Code, and California Code ofRegulations, title 16, section 1633, in that he engaged in

26 repeated acts of negligence by reusing syringes, putting patients at risk of transmission of

27 infectious material, including Hepatitis C virus infection in multiple patients; failing to use

28 ///

37


1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

standard precautions when injecting patients; providing procedural sedation in the treatment of

Patients C.W., F.S., #1, #4, #7, #8, #9 and #10~ and, treatment ofPatient F.S.'s thyroid disease.

Complainant refers to and, by this reference, incorporates herein, paragraphs 18 through '66,

above, as though fully set forth herein. The circumstances are as follows:

A. Needles and syringes should not be reused because of the risk of transmission of

infectious material. While it is preferable to use single use vials of medication to reduce the risk

of contamination, if a multi-use vial of medication is being used, only sterile syringes and needles

should be used to draw up medications. Respondent repeatedly reused syringes to draw up

medications contained in multi-use vials.

B. On April2, 2015, SBCPHD notified the Board that Respondent's medical practice,

located at 2320 Bath Street, No. 301, Santa Barbara, California 93105, was closed after an

inspection revealed poor infection control practices. Six cases of Hepatitis C had been reported to

SBCPHD and five of the six patients had procedures performed in Respondent's office on

September 4, 2014.

C.. In his interview with the Board on September 29, 2015, Respondent acknowledged

that at least four patients were infected with Hepatitis C at his office.

1. Respondent admitted that if he was injecting patient with, for example,

Dextrose (a form of glucose), and needed more Dextrose, he would use a new needle but use the

same syringe to draw up more Dextrose.

2. Respondent acknowledged that patients were infected with Hepatitis C at

his office on September 4, 2014 and concluded "the problem with these four patients that got

hepatitis was the reuse of the syringe that infected the bottle. When that bottle of lidocaine,

which was a multi-use bottle was done, then no one else got hepatitis, but those four patients got

hepatitis, which is really bad."

D. -·Atthetime·ofthe February·23, 2015, SBCPHD announced site visit, multiple

infection control breaches were observed, including comingling of clean syringes and needles

with dirty syringes and needles.

Ill

38


1 E. At the time of the February 23, 2015, SBCPHD announced site visit, it was observed

2 that injection safety was not practiced.

3 1. Injections were not prepared using aseptic technique in a clean area free

4 from contamination or contact with blood, body fluids, or contaminated equipment. The

5 centrifuge room lacked a designated clean area, designated dirty area and gloves. The kitchen

6 area next to the sink lacked a designated clean area, designated dirty area and gloves. The patient

7 exam room lacked a designated clean area and designated dirty area.

8 2. Respondent was observed re-_entering multi-dose vials with the same

9 syringe used to inject the patient. The needle, however, was changed. Respondent explained that

10 he did not know a new syringe had to be used. He further explained that he did not believe that

11 blood got into the syringe. His regular practice was to only change the needle and to reuse

12 syringes between injecting a patient and re-entering multi-dose vials.

13 3. The rubber septum on medication vials was not consistently disinfected

14 with alcohol prior to piercing.

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4. There were single dose medication vials and an IV bag partially full

indicating potential use for mu~tiple patients.

5. Multi-dose vials to be used for more than one patient were kept in the

immediate patient treatment area on the countertop in the patient exam room instead of being kept

in a centralized medication area.

6. Multi-dose vials were not discarded. Respondent stated that the 100 ml

multi-dose vials of dextrose and lidocaine solutions were discarded every morning, on a daily

basis; however, there were multiple opened and partially used vials in the kitchen refrigerator.

Respondent indicated that he did not know why the vials were there and thought S.L. may have

refrigerated them because she sometimes assisted with cleaning the patient exam room.

7. · There was no log or record of refrigerator temperatures in the kitchen ·

where medications were stored. It was not clear that the refrigerator was designated strictly for

medication storage.

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1 F. Standard precautions must be used for the care of all patients, regardless of their




5 G. Respondent has been observed in his practice:

6 1. not washing his hands before performing a Prolotherapy procedure on a

7 patient;

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2. not wearing gloves while performing a Prolotherapy procedure;

3. wiping patient blood that had trickled on to the patient exam table with a

soiled cotton swab, throwing the soiled swab on the counter and wiping his ungloved hands on

his pants; and

4. handling multiple vials and soiled swabs without wearing gloves or

washing his hands.

H. At the time of the February 23, 2015, SBCPHD announced site visit, it was observed

that standard precautions were not practiced.

1. There was a lack of written infection prevention policies or procedures.

2. Supplies necessary for adherence to standard precautions were not readily

available. Gloves were not observed in the centrifuge room or the kitchen. The box of gloves in

the patient exam room was in the back of a cupboard, behind other supplies.

3. Respondent did not maintain a log of needle sticks, sharps injuries, and

other exposure events.

4. Respondent did not have designated clean areas and designated dirty areas

in his work areas. Respondent" prepared solutions and material for patient injections on the

countertop in the patient exam room. Blood and adipose were mixed for Prolotherapy on the

countertop ·next to centrifuge in the centrifuge room. ·

5. The following clean items and dirty items were observed to be comingled

in the same area: multi-dose vials, clean syringes and needles, dirty syringes and needles, clean

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4 x 4 cotton swabs and dirty 4 x 4 cotton swabs. Respondent was observed handling clean and

dirty items interchangeably.

6. With respect to hand hygiene, there was no sink for hand washing in the

patient exam room. To wash his hands while in the patient exam room, Respondent was required

to open the door, leave the patient exam room, wash his hands in the kitchen and return to the

patient exam room.

7. There was a lack of written policies and procedures for: routine cleaning

8 and disinfection of environmental surfaces; decontamination of spills of blood or other bloody

9 fluids; and ensuring that the centrifuge was cleaned appropriately on a specified time frame.

10 I. At the time of the March 18,2015, SBCPHD unannounced site visit, it was observed

11 that standard precautions were not practiced.

12 1. Respondent did not wash his hands before performing a Prolotherapy

13 procedure on a patient and did not wear gloves for the procedure. He cleaned a small area of the

14 patient's left posterior lumbar region with an alcohol swab and then used his bare hands to palpate

15 the injection site. He made approximately thirty (30) repeated injections into the palpated region.

16 The estimated blood loss was 1-2 cc. The blood on the patient's back trickled onto the exam

17 table. Without wearing gloves, Respondent used a 4 x 4 cotton swab to wipe the blood. He then

18 tossed the soiled cotton swab onto the counter and wiped his hands on his pants. After using his

19 bare hands and a swab to wipe the patient's blood, Respondent was observed handling multiple

20 vials, the soiled 4 x 4 swab, and the patient without wearing gloves or washing his hands. There

21 was no designated clean area and no designated dirty area on the counter during the procedure.

22 The clean items and dirty items were intermingled on the counter. Respondent handled the vials

23 immediately after using his bare hands and a swab to wipe the patient's blood.

24 2. There was a lack of: a designated clean area and designated dirty area in

25 the patient exam room; a designated clean area and designated dirty area in the centrifuge room; · · r

26 and a designated clean area and designated dirty area in the kitchen.

27 3. There was a lack of proper infection control training for S.L., including

28 OSHA bloodbome pathogen training.

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1 4. There was a lack of vaccination against Hepatitis B for S.L.

2 5. Neither Respondent nor S.L. wore gloves during procedures or handling of

3 patient specimens.

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6. There was potential for contamination of clean medication vials with

patient's blood during procedures.

7. There was potential for contamination of surfaces ( countertops, door

handles, etc.) with patient's blood during procedures.

8. There was potential for contamination of clean patient specimens next to

sink by "oily fat" being disposed of into the kitchen sink and splattering on patient specimens.

9. There was a lack of labeling of syringes containing patient specimens,

despite multiple PRP procedures being performed on the same day.

10. There was improper disposal ofbiological hazardous waste.

J. Respondent's medical office did not have vital sign monitoring equipment at the time

of the March 18, 2015, SBCPHD unannounced site visit.

K. Respondent did not have a license or certificate to administer IV sedation in his

office.

L. Respondent had not been certified in Advanced Cardiovascular Life Support since

approximately 2000.

M. Respondent was the only person who performed medical procedures in his office.

N. On February 10,2015, Respondent administered Demerol and Versed

intramuscularly to Patient C.W. prior to RIT injection therapy.

0. On August 18,2011, Respondent administered IV sedation with Demerol and Versed

to Patient F.S. prior to injection therapy.

P. On December 3, 2009, Respondent administered IV sedation with Demerol and

Versed to-Patient "F:S. prior to injection therapy;noting that the IV sedation was "probably too

much for her."

Q. In 2012, Respondent administered IV sedation with Demerol and Versed to Patient #1

prior to PRP therapy to her left medial joint line.

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1 R. In September 2013, Respondent noted that prior to administering PRP therapy,

2 Patient #4 had Vicodin and Halcion before she presented to the office and was "very

3 anesthetized."

4 S. ·On August 17,2012, Respondent administered IV sedation with Versed, with no

5 Demerol, to Patient #7 prior to RIT therapy, and he "fell asleep."

6 T. On September 27,2012, Respondent administered IV sedation with Demerol and

7 Versed to Patient #8 prior to PRP injections "because she really didn't want to feel pain."

8 U. In 2011,2012 and 2013, Respondent administered IV sedation with Demerol and


10 V. In 2010,2012 and 2013, Respondent administered IV sedation with Demerol and


12 W. Respondent failed ~o document the vital signs of Patients C.W., F.S., #1, #4, #7, #8,

13 #9 and # 10 at the time he administered procedural sedation to each of them.

14 X. The standard of medical practice in California is to treat thyroid disorders

15 appropriately, as under treatment or over treatment can have significant adverse consequences.

16 Hypothyroidism is diagnosed when the TSH is elevated and levels ofT3 and/or T4 hormones are

17 low.

18 Y. In 2005, Respondent diagnosed Patient F.S. as "very hypothyroid" despite normal

19 TSH, normal free T4, and normal free T3 and started Patient F.S. on supplemental thyroid

20 hormones.

21 Z. Respondent continued to prescribe thyroid hormone therapy through 2010 even

22 though prescribing thyroid hormone to a patient who does not need it can have adverse cardiac

23 effects such as atrial fibrillation and can have negative effects on bone mineral density.

24 68. Respondent's acts and/or omissions as set forth in paragraphs 18 through 66, above,

25 whether proven individually, jointly, or in any combination thereof, constitute repeated acts of

26 negligence pursuant to sections 2234, subdivision (c), of the Code, and California Code of

27 Regulations, title 16, section 1633. Therefore cause for discipline exists.

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1 SIXTH CAUSE FOR DISCIPLINE

2 (Incompetence)

3 69. Respondent is subject to disciplinary action under section 2234, subdivision (d), of

4 the Code, and California Code ofRegulations, title 16, section 1633, in that he was incompetent

5 by reusing syringes, putting patients at risk of transmission of infectious material, including

6 Hepatitis C virus infection in multiple patients; failing to use standard precautions when injecting

7 patients; providing procedural sedation in the treatment of Patients C.W., F.S., #1, #4, #7, #8, #9

8 and #10; and treatment of Patient F.S.'s thyroid disease. Complainant refers to and, by this

9 reference, incorporates herein, paragraphs 18 through 68, above, as though fully set forth herein.

10 70. Respondent's acts and/or omissions as set forth in paragraphs 18 through 68, above,

11 whether proven individually, jointly, or in any combination thereof, constitute incompetence

12 pursuant to section 2234, subdivision (d), of the Code, and California Code of Regulations, title

13 16, section 1633. Therefore cause for discipline exists.

14 SEVENTH CAUSE FOR DISCIPLINE

15 (Aiding and Abetting the Unlicensed Practice of Medicine)


17 the Code, and California Code ofRegulations, title 16, section 1633, in that he engaged in aided

18 and abetted the unlicensed practice of medicine. Complainant refers to and, by this reference,

19 incorporates herein, paragraphs 18 through 44, 47, and 57, above, as though fully set forth herein.

20 The circumstances are as follows:

21 72. Only licensed individuals are to assist in or provide patient care. The following acts

22 and omissions of Respondent constitute the aiding and abetting the unlicensed practice of

23 medicine:

24 A. At the time of the March 18, 2015, an unannounced site visit to Respondent's medical

25 practice, S.L., who was identified as Respondent's daughter and receptionist, indicated that she

26 completes one hundred percent (1 00%) of patient specimen processing for PRP and ADSCT, as

27 follows:

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1 1. For PRP, Respondent draws 50 cc of patient blood in the exam room and hands

2 the syringe to S.L., who then carries it to the centrifuge room to process for re-injection into the

3 patient.

4 2. For ADSCT, S.L. assists Respondent with fat aspiration in the exam room. S.L.

5 "hands [Respondent] things and helps out." She then processes the specimen in the centrifuge

6 room. The concentrated fat and concentrated platelet syringes are then placed next to the sink in

7 the kitchen for Respondent to mix together. Respondent then injects this mixture back into the

8 patient. S.L. disposes the leftover blood and fat, after the concentrate is removed, down the

9 kitchen sink.

10 B. For the PRP therapy performed on Patient #1 in 2012, Respondent noted that he was

11 assisted by S.L.

12 C. Dr. A.K. stated that S.L. assisted Respondent with procedures.

13 73. Respondent's acts and/or omissions as set forth in paragraphs 18 through 44, 47, and

14 57, above, whether proven individually, jointly, or in any combination thereof, constitute aiding

15 and abetting the unlicensed practice of medicine pursuant to section 2052, subdivision (b), of the

16 Code, and California Code of Regulations, title 16, section 1633. Therefore cause for discipline

17 exists.

18 EIGHTH CAUSE FOR DISCIPLINE

19 (Employment of an Unlicensed Person)

20 74. Respondent is subject to disciplinary action under section 2264 of the Code, and

21 California Code of Regulations, title 16, section 1633, in that he employed an unlicensed person

22 to practice of medicine. Complainant refers to and, by this reference, incorporates herein,

23 paragraphs 18 through 44, 47, 57, 72, and 73 above, as though fully set forth herein. The

24 circumstances are as follows:

25 75. Only licensed individuals are to assist in or provide patient care. The following acts

26 and omissions of Respondent constitute the aiding and abetting the unlicensed practice of

27 medicine:

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1 A. At the time of the March 18,2015, an unannounced site visit to Respondent's medical

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practice, S.L., who was identified as Respondent's daughter and receptionist, indicated that she

completes one hundred percent (100%) of patient specimen processing for PRP and ADSCT, as

follows:

1. For PRP, Respondent draws 50 cc of patient blood in the exam room and hands

the syringe to S.L., who then carries it to the centrifuge room to process for re-injection into the

patient.

2. For ADSCT; S.L. assists Respondent with fat aspiration in the exam room. S.L.

"hands [Respondent] things and helps out." She then processes the specimen in the centrifuge

room. The concentrated fat and concentrated platelet syringes are then placed next to the sink in

the kitchen for Respondent to mix together. Respondent then injects this mixture back into the

patient. S.L. disposes the leftover blood and fat, after the concentrate is removed, down the

kitchen sink.

B. For the PRP therapy performed on Patient #1 in 2012, Respondent noted that he was

assisted by S.L.

C. Dr. A.K. stated that S.L. assisted Respondent with procedures.

17 76. Respondent's acts and/or omissions as set forth in paragraphs 18 through 44, 47, 57,

18 72, and 73 above, whether proven individually, jointly, or in any combination thereof, constitute

19 aiding and abetting the unlicensed practice of medicine pursuant to section 2264 of the Code, and

20 California Code of Regulations, title 16, section 1633. Therefore cause for discipline exists.

21 NINTH CAUSE FOR DISCIPLINE

22 (Failure to Maintain Adequate and Accurate Records)

23 77. Respondent is subject to disciplinary action under section 2266 of the Code for failing

24 to maintain adequate and accurate records relating to his care and treatment of Patients C.W.,

25 F.S., #1, #4, #7, #8, #9, and #10. Complainant refers to and, by this reference, incorporates ··

26 herein, paragraphs 45 through 52, 55 and 58, above, as though fully set forth herein. The

27 circumstances are as follows:

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1 78. The standard of medical practice in California is to document the site of injections

2 and to indicate the type and dose of medication injected. Respondent did not adequately

3 document the injections that he administered to patients.

4 A. Regarding Patient C.W., Respondent failed to document the quantity of

5 medication/solution being injected.

6 B. Regarding Patient F.S., Respondent failed to document the quantity of


8 C. Regarding Patient #1, Respondent failed to document the quantity of


10 D. Regarding Patient #7, Respondent failed to document the volume ofthe


12 E. Regarding Patient #8, Respondent failed to document the volume of the


14 F. Regarding Patient #10, Respondent failed to document the volume of the


16 79. Respondent failed to document the vital signs ofPatients C.W., F.S., #1, #4, #7, #8,

17 #9 and # 10 at the time he administered procedural sedation to each of them.

18 80. Respondent's acts and/or omissions as set forth in paragraphs 45 through 52, 55 and

19 58, above, whether proven individually, jointly, or in any combination thereof, constitute the

20 failure to maintain adequate records pursuant to section 2266 of the Code. Therefore cause for

21 discipline exists.

22 DISCIPLINARY CONSIDERATIONS

23 81. To determine the degree of discipline, if any, to be imposed on Respondent,

24 Complainant alleges that on or about August 18,2015, Respondent, who is licensed to practice

· 25 medicine in the State of Oregon, entered into an Amended Interim Stipulated Order with the

26 Oregon Medical Board to vol~tarily cease performing injections other than immunizations and

27 cease retrieving or processing blood and tissue from patients, and to cease using scheduled

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1 medications parenterally prior to an office visit, pending the completion of the Oregon Medical

2 Board's investigation of his ability to safely and competently practice medicine in Oregon.8

3 PRAYER

4 WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged,

5 and that following the hearing, the Medical Board of California issue a decision:

6 1. Revoking or suspending Physician's and Surgeon's Certificate Number G 22085,

7 issued to Allen Thomashefsky, M.D.;

8 2. Revoking, suspending or denying approval of his authority to supervise physician

9 assistants, pursuant to section 3527 of the Code;

10 3. If placed on probation, ordering him to pay the Board the costs of probation

11 monitoring; and

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4. Taking such other and further action as deemed necessary and proper.

14 DATED: ,January 5, 2016

15 Executive Director Medical Board of California

16 Department of Consumer Affairs State of California

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Complainant

LA2015603728

8 Previously, on Aprill4, 2015, Respondent had entered into an Interim Stipulated Order with the Oregon Medical Board to voluntarily cease performing injections other than immunizations and cease retrieving or processing blood and tissue from patients pending the completion of the Oregon Medical Board's investigation into his ability to safely and competently practice medicine in Oregon.

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