decision after superior court remand the its ruling siva 2016-08-10 copy.pdfsiva arunasalam, m.d....
TRANSCRIPT
BEFORE THE MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA
In the Matter of the Accusation against:
SlY A ARUNASALAM, M.D.
Physician's and Surgeon's Certificate No. 066022
Respondent.
Case No. 09-201.1-220169
OAHNo. 2014010810
DECISION AFTER SUPERIOR COURT REMAND
In accordance with the Judgment Granting Administrative Writ of Mandamus issued on June 7, 2016, in the matter of Siva Arunasalam, M.D. v. Medical Board of California, Superior Court ofthc State of California for the County ofLos Angeles, Case No. BS 155396, and having considered the matter in light of the Court's ruling, the Medical Board of California hereby vacates and sets aside its decision dated April 9, 2015, and enters the following as its decision in the above-referenced matter:
The accusation is dismissed with prejudice.
A copy of the writ and the Court's ruling are attached.
IT IS SO ORDERED this lOth day of August, 2016.
Jamie ght, J.D., Chair Panel A
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l:Icnry R.,.Ferltrul11Jmte Bro'·N0.45130 Qennis 'l:l. Lee,. l State Ba~ No. 164}60 FP..NTON LA;';N ORQV¥'1 LLP 19!/Q S, Bundy j)r, 'if 777 Lns Angele~, CA 90025 Pho. ne ·(310)444-$244 Fnx (31 0) 444•5280
Attorneys for P~t1!ioner SfV AAR({MASALAM, M.D.
SUl'ERIOll. COURT OF THE STATE OF CAJ;WORNIA
PQR 11-!E COUNTY OF to$ANC!ELRS
SIVA ARONASALAM,M.D.,
Pi\titloner,.
v •.
MEDiCAL ~'lOARD OF CAl.!IIORNIA,
Rcspomll~nt.
l CASP.~O. HS!55396
[ll<:>n • .lames C. Chalfant, Dept. 851
ll'~$:.·h~.· . ·o. ].l'E.·l~T;'¥J>TORY WRIT OF MANDAMUS.
nept: 85 Hon. Jan1cs C. C!wlfan!, Judge
WHB,Rt!AS J•>dgment.grnntingl'etitioi\C.fs Petition was en!erc.d in. this t\ction, urde>'ttlg .
!hat n writ of ~dmlnislrl\tive mandrunu.~ h~ Issued fhnu this Coutt,
YOU AHH lll''-R.EBY C()MMANDED to do the fo!l<:>Will!l:
J. R¢Spootlenr is ordt-red to se\ us ide ]>etltioncr's pvhlic rcprimttnd in the Deaision
dut~d Apl'il !l, :1015, in thc ndminJstrutive rrroeceding entitled "In th!" Mutter ot'the ACCtLqafkm
Alli'in>i: Siva Arun~sal\int, M.D.," Casc.No. 09·:HHl·220 J 69, OAH No. 20 I 40 lOS l()
(".Respondent's Decision").
2;. Date:
3 JUL 2 B 2016
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Henry R.. Fenton, State Bar N<J. 4513{) Dennis E. Lee, State Bar No. l 64 360 FENTON LAW GROUP, LLP !990 S. Bundy Dr.,# 777 Los Angeles, CA 9002$ Phone (3 I 0) 444·5244 Fax (310) 444-5280
Attorneys for Petitioner SIVA ARUNASALAM, M.D.
SUPERJOR COURT OF THS STATE OF CALIFORNIA
FOR TilE COUNTY OF LOS ANGELES
SIVA ARUNASALAM, M.D.,
Petitioner,
v.
MEDICAL BOARD OF CALlFORN[A,
Respondent
CASBNO. BS1SS396 ByF
~n. J C. Challlmt, Dept. 85]
ff OSED) JUDGMENT 0 . TINO ADMINISTRATIVE WRJT OF MANDAMUS
Dept: 85 Hon. James C. Chalfant, Judge
This matter came regularly on April 28, 2016, for hallring in Department 85 of tile
Superior Court, the Honorable James C. Chalfant presiding. Henry R. Fenton appeared on
behalf of Petitioner Siva Arunl!l!alam, M.D. (•Petitioner"). Deputy Attorney General Harinder
Kapur appeared on behalf of Respondent Mediul Board of California ("Respondent" or "the
Board"). Having read and considered the papers and pleadings filed bY the parties and having
considered the oral argument of counsel with rl!l!pe:Ctlhereto, aad having $et forth a Tentative
Rulil'lg adopted as the ruling of the Court via Minute Order dated April28, 2016, the Court
1 !PROPOS1!D! JUDGMENT GRANTING I\OMINtS'rRI\1'1VE WRIT 01' MANI>AMUS
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• Siva Arunasalam v. Medical Board of California. BS 15 5396
• · ~~~~_officer/Clerk Tentative decision on peti · < • OH..a. Deputy
mandate: granted Mlcnaot Rivera
Petitioner Siva Arunasalam, M.D. ("Arunasalam") seeks a writ of mandate compelling Respondent Medical Board o(Califomia ("Board") to set aside its decision imposing discipline on Petitioner.
The court has read and considered the moving papers, opposition, and reply, and renders the following tentative decision.
A. Statement of the Case Petitioner Arunasalam commenced this proceeding on June 1, 2015. The verified Petition
alleges in pertinent part as follows. Petitioner is a physician licensed in California. On October 3, 2013, the Board filed an
Accusation against Petitioner pertaining to the care and treatment of five patients, W .S., P.P., B.R., M.R., and D.S-B. W.S. and P.P. were coronary patients, and B.R., M.R., and D.S·B. were carotid patients. The Board charged Petitioner with anprofessional conduct in the form of gross negligence, repeated negligent acts, and failure to maintain adequate or accurate medical records.
An administrative hearing was held and on April9, 2015, a Proposed Decision was issued by Administrative Law Judge Jonathan Lew ("ALJ"). The Decision held that no grounds existed to discipline Petitioner for gross negligence for his treatment and·care of all five patients. The Board failed to establish that Petitioner incorrectly interpreted the coronary angiogram, and did not demonstrate that Petitioner failed to document the neurological evaluations for B.R. and M.R. The ALJ further ruled that Petitioner maintained adequate and accurate medical grounds. However, the AU also found that Petitioner engaged in f!:peated negligent acts by performing carotid procedures on B.R., M.R., and D.S-B at a non-cardiac surgery hospital.
The Board adopted the Proposed Decision, but determined that the repeated negligent acts were only minor violations and did not warrant placing Petitioner on probation or requiring enrollment in remedial courses. Accordingly, only a public letter of reprimand was issued to Petitioner.
The Board's finding that Petitioner engaged in repeated negligent acts by performing carotid procedures at non-cardiac surgery facilities is not supported by the evidence. The weight of the evidence clearly demonstrates that Petitioner was unaware that he was prohibite.d from performing peripheral angiography and related procedures at Desert Valley Hospital.
B. §tandard of Review CCP section 1094.5 is the administrative mandamus prov1s1on which structures the
procedure for judicial review of adjudicatory decisions rendered by administrative agencies. Topanga Ass'n for a Scenic Community v. County of Los Angeles, ("Topanga") (1974) II Cal.3d 506,514-15.
CCP section 1094.5 does not in its face specify which cases are subject to independent r.:t· review, leaving that issue to the eourts. Fukuda y. City of Angels, (1999)20 Cal.4th 805, 811. In v' cases reviewing decisions which affect a vested, fundamental right the trial court exercises '
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• • independent judgment on the evidence. 6ixby v. Piemo, (1971) 4 Cal.3d 130, 143. See CCP § l 094.5 (c). An administrative decision imposing discipline on a professional licensee is decided under the independentjudgmentstandard. Griffiths v. SuperigrCQurt, (2002) 96 Cal.App.4th 757, 767.
Under the independent judgment test, "the trial court not only examines the administrative record for errors of law but also exercises its independent judgment upon the evidence disclosed in a limited trial de novo." !Q. at 143. The court must draw its own reasonable inferences from the evidence and make its own credibility determinations. Morrison v. ijousing Authority of the City of Los Angeles Board of Comml;;sionS)rs. (2003) 107 Cal.AppAth 860, 868. In short, the court substitutes its judgment for the agency's regarding the basic facts of what happened, when, why, and the credibility of witnesses. Guymon v. Board of Accountancy, (1976) 55 Cal.App.3d 1010, 1013·16.
However, "(i]n exercising its independent judgment, a trial court must afford a strong presumption of correctness concerning the administrative findings, and the party challenging· the administrative decision bears the burden of convincing the court that the administrative findings are contrary to the weight of the evidence." fukud!!, supra, 20 Cal.4th at 8!7. Unless it can be demonstrated by petitioner that the agency's actions are not grounded upon any reasonable basis in law or any substantial basis in fact, the courts should not interfere with the agency's discretion or substitute their wisdom for that of the agency. Bixby, supra, 4 Cal. 3d 130, 150·151; Bank of America v. State Water Resources Control Board, (1974) 42 Cal.App.3d 198, 208.
The agency's decision must be based on a preponderance of the evidence presented at.the hearing. Board of Medical Quality Assurance v. Superior Court, (1977) 73 Cai.App.3d 860,862. The hearing officer is only required to issue findings that give enough explanation so that parties may determine whether, and upon what basis, to review the decision. Topanga. supra, II Cal.3d 506, 514-15. Implicit in section !094.5 is a requirement that the agency set forth findings to bridge the analytic gap between the mw evidence and ultimate decision or order. Id. at 11.5.
An agency is presumed to have regularly performed its official duties (Ev. Code §664), and the petitioner therefore has the burden of proof. Steele v. Los Angeles County Civil Service Commission, (1958) 166 Cal.App.2d 129, 137. "[T)he burden of proof falls upon the party attacking the administrative decision to demonstrate wherein the proceedings were unfair, in excess of jurisdiction or showed prejudicial abuse of discretion. Afford y. PiewQ, (1972) 27 Cal.App.3d 682, 691.
C. Gqvl,lrni!Jg Law Business and Professions ("B&P") Code section 2234 provides that unprofessional conduct
includes, but is not limited to, certain enumerated conduct. Shea v, Board of Medical Exa.mjners, (1978) 81 Cai.App.3d 564, 575. One example of unprofessional conduct is repeated negligent acts, which is defined as "two or more negligent acts or omissions." B&P Code §2234(c).
"Unprofessional conduct is that conduct which breaches the rules or ethical code of a profession, or conduct which is unbecoming a member in good standing of a profession." !d. For licensing matters, negligence has been defined as a departure from the standard of care ·- a lack of ordinary care. Keen v. Prisinzano, (1972) 23 Cal.App.3d 275, 279. It is ''remissness in discharging known duties." Pollak v. Kinder, (1978) 85 Cai.App.3d 833, 839. As California ease law
.:S:· v• emphasizes, the standard of care applicable in reviewing the conduct of a physician is a question
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• • of fact that is "a matter peculiar! y within the knowledge of experts" and can only be established by expert testimony. NNV v. American Assn. of Blood Banks, (1999) 75 Cal.App.4th 1358, !385; Sin;!: v. Qwens, (1949) 33 Cal.2d 749, 753.
Cardiac catheterization labs in general acute care hospitals that do not provide cardiac surgery must meet the following conditions: (a) the hospital maintains a Current written transfer agreement with provisions for emergency and routine transfer of patients, provisions specifYing that cardiac surgery staff will be immediately available in an emergency, and provisions specifYing that the cardiac catheterization lab staff has responsibility for arranging transportation to the receiving hospitals. 22 CCR §70438.l(a). Only the fullowing diagnostic procedures may be performed in such a catheterization lab;(!) Right heart catheterization and angiography; (2) Right and left heart catheterization and angiography; (3) Left heart catheterization and angiography; ( 4) Coronary angiography; (5) Electrophysiology studies; and (6) Myocardial biopsy. 22 CCR §7043S.I(b). Violation of this requirement subjects a hospital to administrative penalties. 22 CCR §70951 et seq. No penalties are imposed for a minor violation. 22 CCR §70951(a)(l). A "minor violation" is a violation of law relating to the operation or maintenance of a hospital that has only a minimal relationship to the health and safety of hospital patients. 22 CCR §70952.
The Califoroia Department of Public Health ("CDPH" or "Department") is authorized to approve program flexibility requests for the temporary relocation of services and the use of interim space for hospital services under certain conditions on a case-by-case basis. Health & Safety Code §1276.05.
D. Statement of Facts 1. B!lckground On April 21, 2010, the Department issued an All Facility Letter ("AFL") notifying all
general acute care hospitals under its purview, including Desert Valley Hospital, that only "diagnostic procedures shall be perforo1ed in the [cardiac] catheterization laboratory" ("cath lab") in compliance with 22 CCR section 70438.l. AR 3246-47. The AFL stated that any hospital that wished to perform services other than those listed "must obtain approval of the Department prior to the provision of any other sarvice ... " AR 3247. If certain conditions were met, the CDPH would approve flexibility (flex) requests from the hospital to provide services other than those authorized in section 70438.1. AR 3246-47.
The Department issued a revised AFL to all general acute care hospitals on July 8, 2010. AR 3248. The AFL reminded hospitals "not providing cardiac surgery services" that they could only provide diagnostic procedures in the cath lab in compliance with 22 CCR section 70438.1. AR3249.
·Following receipt of the AFLs and "sometime fairly early in the process", Desert Valley Hospital applied for a flex for its cath lab. AR ISO. ·
In October 2011, prior to any flex being approved, Petitioner Arunasalam perf01med carotid procedures, which were outside the scope ofDVH's license, on three patients at DVH. See AR27. ,
On November 16, 2011, the Department. concluded a survey of the operations of Desert Valley Hospital, including its cath lab. AR 2678. As a result of the survey, DVH was cited for,
«• among other things, permitting non-emergent interventional procedures to be performed in the ...,., cardiac catheterization lab and not limiting the cath lab to diagnostic procedures as required by 22
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• • CCR section 70438.1. AR 2672.
Subsequently, in December 20 ll Desert Valley Hospital again applied for a flex to perform peripheral angiography in its cath lab. The flex was approved on March 19,2012 AR 2655,2665-66.
2. The Accusation On October 3, 2013, the Executive Director of Respondent Board filed an Accusation
against Petitioner Arunasalam. The Accusation charged Arunasalam with multiple causes for discipline, inc! uding gross negligence, repeated negligent acts, and failure to maintain adequate and accurate records in his care and treatment of five patients. AR 771-80. As pertinent, the Accusation alleged that Arunasalam was subject !o discipline under B&P Code section 2234(c) because he committed repeated negligent acts by performing procedures on five patients in a hospital which was not licensed for those procedures. AR 779.
The charges related to procedures performed by Petitioner on five patients. AR 774. On December 30,2010, Petitioner performed a left heart catheterization on patient W.S., followed by an emergency placement of a stent in the mid-left anterior artery. AR 775. On October 21,2011, Petitioner performed carotid stenting on patient B.R. AR 776. On June 23, 2011, and again on October 21, 2011, Petitioner performed carotid angiography on patient M.R. AR 777. On October 3, 2011, Petitioner performed cardiac catheterization on patient P.P., and then was forced to intervene with a balloon angioplasty. AR 778. On October 21, 2011, Petitioner performed a carotid angiogram on patient D.S·B. AR 779. It is undisputed that these procedures were interventional and not diagnostic in nature.
Petitioner filed a notice of defense (AR 784), and the administrative hearing look place on January !2, 13. 14, 15, 20, 21, and 22, 2015, before the ("ALJ"). AR 5.
3. Testimpny of Dr, Otto Steven Otto, M.D., testified on behalf of the Board. AR 50-94. He is the Chief Medical
Consultant for the Department's Licensing and Certification Program. AR 50. · A hospital that does not have a cardiovascular surgery program is limited !{) the six
diagnostic procedures pursuant to section 70438.1. AR 59, 69. The Department has authority to flex or alter particular regulations for a particular hospital under a particular set ofeircumstances. AR 53. A hospital can request a flex of the regulation to expand the procedures that could be performed at its facility, including peripheral studies, carotid, and other vascular studies. AR 60. Dr. Otto helped to author the AFL's regarding the flex of the state regulations for cardiac catheterization labs. AR 53.
ln late 2011, the Department conducted a survey at Desert Valley Hospital. AR 61, 63. During that survey, CDPH became aware that earotid procedttres and studies were being performed at the hospital. AR 71. · Desert Valley Hospital was not licensed to perform carotid procedures regardless of whether they were part of a study unless the study had been approved by CDPH. AR 72. None of the carotid studies at Desert Valley Hospital had been approved by the Department. AR 74. ·
4. Tgtimony of Lena Resurreccion LenaResurreccion, RN., testified on behalfoftheBoard. AR 95-141. She is the Distriet
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• • Manager for the Department's Licensing and Certification Program. AR 95. In 2010 and 2011, Desert Valley Hospital did not perform cardiovascular surgery and was not licensed to perform carotid angiograrns in its cath lab. AR 113, 135. Following a survey, Desert Valley Hospital was cited for performing interventions in the cath lab when it was not licensed to do so. AR 105, 111, 2637-3 8, 2671-72.
In December 2011, Resurreccion received and reviewed a request from Desert Valley Hospital for a variance in the services that could be performed in the cath lab. AR 99. The flex was approved in March 2012. AR I 03, 134, 2665-67. Desert Valley Hospital was approved for cardiovascular surgery on March 20, 2012. AR 134.
5. Testimony of Dr. Peterson Margeret Peterson, Ph.D., testified on bebalf of the Board. AR 142-188. Dr. Peterson has
been tbe Chief Executive Officer of Desert Valley Hospital since March 2009. AR 154. Dr. Peterson could not recall the exact date that Desert Valley Hospital received the AFL,
but believed it was around December 2010 or early 2011. AR 151, 183. Following receipt of the AFL and "sometime fairly early in the process", Desert Valley Hospital applied for a flex for its oath lab. AR 150-51. Dr. Peterson did not recall receiving a response from CDPH. AR 150.
The cath lab performed -multiple types of procedures, including peripheral and coronary interventions. AR 156, 172-73, 183. Prior to receipt of the AFLs, it was standard practice throughOut the state for cath Jabs to perform peripheral elective angiography and angioplasty procedures, AR 183. A November 2009 written policy expressly approved carotid angiography
· at Desert Valley Hospital, and this policy was conveyed to the cardiologists and physicians on staff. AR 167-68.1 In 2009, no one at Desert Valley Hospital ever told Arunasalam he was not permitted to do carotid procedures or emergency con:mary procedures at Desert Valley Hospital. AR 171. Once the AFL came out, a memo was circulated at Desert Valley Hospital to notify the staff to perform only the listed procedures. AR 185. Staff complied by limiting themselves to the restrictions in the AFL after the memo was circulated. AR 188.
Arunasalam was approved by Desert Valley Hospital to do carotid angioplasty training for other physicians and instructed other physicians in a 2009 carotid course. AR 169-70. No medical staff raised any issue with Arunasalam whether he could perform the procedures in the carotid course. AR 170. Other cardiologists also performed coronary interventions in the cath Jab. AR 166.
6. Expert Testimony of Dr. Acbeatel . Roger J. Acheatel, MD. testified as the Board's expert. AR 193-323. The majority of Dr.
Acheatel' s testimony related to whether Petitioner's treatment of five patients met the standard of care. AR 193-257.
Regarding the issue of repeated negligence, Dr. Acheatel understood that Desert Valley Hospital was not licensed to perform the type of procedures that Petitioner pmformed on the five patients at issue. AR 258, 272. Dr. Acheatel opined that "[a] facility that,'s not licensed to do a procedure, those procedures should not be done at those facilities." AR 258. If Petitioner had
r.r.• 1 The Medicare/Medicaid Center also approved carotid artery stenting (a peripheral ':::' procedure) for Desert Valley Hospital. AR 4212.
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• • been given privileges by Desert Valley Hospital to perform cardiac procedures, Dr. Acheatel would "withdraw that criticism" because it would be within the standard of care if Petitioner reasonably believed he was permitted to perform the proeedure. AR 258,272,275.
7. Testimony of Christine Bethel Christine Bethel ("Bethel"), R.N., testified as Petitioner's witness. AR 328· 76. She has
been the cath lab charge nurse at Desert Valley Hospital since 2009. AR 329. In that capacity, Bethels' duties included "(s]cheduling and policies and procedures and stats. That sort of thing." AR 329.
A doctor must be credentialed by Desert Valley Hospital to perform procedures in the cardiac catheterization lab. AR 338. Petitioner was credentialed by the hospital to perform carotid angiograms and angioplasties, peripheral angiograrns and an_gioplasties, and coronary angiograms and angioplasties. AR 338. Bethel did not know of any restrictions placed by Desert Valley Hospital on Arunasalam that would have prevented him from performing coronary or peripheral interventions. AR 349.
In late 2011, the cath lab staff was told they could not perform peripheral angiograms or angioplasty. AR 346. The Department's survey personnel informed her that peripheral angiograrns or angioplasties could not be performed in the cath lab because Desert Valley Hospital was not licensed to perform those services in the cath lab and they had to be performed in radiology. AR 348-49. Petitioner Arunasalam complied with this restriction, as did all other staff. AR 347.
8. Petitioner Arunasalam's Testimony Petitioner Arunasalarn testified in pertinent part as follows. He first received staff
privileges at Desert Valley Hospital in 1995. AR 586. His privileges at the hospital include admitting patients, consulting for cardiology and cardiovascular, and all aspects of interventional cardiology, including peripheral interventions, coronary interventions, and carotid interventions. AR587.
He was head of cardiology and the cath lab in 2008. AR 588. In 2008, the cath lab was limited to emergent procedures for coronary interventions because< Desert Valley Hospital did not have surgical back-up for cardiac surgery. AR 588. There were no restrictions on peripheral interventions, nor for cardiac angiography (which is diagnostic). AR 589. Each year, he performs approximately 800 coronary angiographies and an average of 20 to 30 carotid interventions. AR 586-87. .
9. The Board's Decision In April20!5, the AU issued his Proposed Decision. AR S. The AU found that it was
undisputed that Petitioner had no authority to perform carotid angiography or interventional stents at Desert Valley Hospital prior to March 19,2012 because it was a non-cardiac surgery hospital. AR 27. Petitioner performed unauthorized procedures on three patients prior to that date. AR 27.
· Until 2010, Desert Valley Hospital believed it was authorized to perform peripheral angiography and related interventions. AR 27. In 2010, DVH received the Department's AFL
ai· instructing it cease performing any procedures in the cath lab other than the limited· diagnostic ~' procedures listed. AR 28. At that time, the AU concluded that Petitioner was on constructive a:·. "-'' 6
• • notice that peripheral angiography was not authorized. AR 28.
The AU concluded that Petitioner had a duty as an interventional cardiologist to inquire or clarify whether the hospital had authorization to perform peripheral angiography. AR 28. The fact that charge nurse Bethel knew sometime in 2011 that peripheral angiography was unauthorized only highlight~ this fact AR 28·29. Petitioner did not inquire or clarify, and his performance of unauthorized carotid procedures in 2011 on patients B.R., M.R., and D.S·B fell outside the standard of care. AR 29. While Petitioner performed the procedures openly and during a period when the hospital believed the procedures were authorized, Petitioner was on constructive notice and knew or should have known that peripheral angiography and related procedures was outside the standard of care. AR 29. The unauthorized procedures on three patients therefore were outside the standard of care. AR 29.
The ALJ sustained only one cause for discipline against Petitioner ·- repeated negligent acts-- as to three patients. AR 37. Petitioner Arunasalam had performed "carotid procedures in 2011 at Desert Valley Hospital on patients B.R., M.R. and D.S-B., at a time Desert Valley Hospital was still a non-cardiac surgery hospital." AR 37. All of the other causes for discipline were unfounded. AR 35-38. Based on this conclusion, there was cause to discipline Petitioner's license under B&P Code section 2234(c), and the AU reconunended that Petitioner receive a written public reprimand. AR 37-38.
The Board adopted the Proposed Decision. AR 4.
E. Analysis Petitioner Arunasalam seeks a writ of mandate compelling the Board to set aside its
decision finding that Petitioner committed:repeated negligent acts and imposing a written public reprimand. Petitioner argues that the weight of the evidence does not support (a) the admission of , the two AFLs, and (b) the Board's fmding that he breached the standard of care when he performed peripheral interventional procedures that could not be performed at Desert Valley Hospital.
1. The Hospital's Knowledge of the AFL§ . Petitioner contends that neither be nor Desert VaHey Hospital were aware of any limitations
on peripheral procedures until late 2011 or 2012, after the procedures at issue occurred. Dr. Peterson could not recall when she received the first AFL, only that it was sometime in late 2010 or 2011. Bethel testified that tha cath lab received notice of the procedure restrictions in late 20 II or early 2012, at which point all staff complied with the restrictions. AR 346-47. Petitioner performed the procedures in question in Ortober 2011, and he argues that neither he nor Desert Valley Hospital had notice of the procedure restnchoiiS. Pet. Op. Br. at 3·5; Reply at 2·4.
Qn April21, 2010, the Department issced the first AFL. The Depru.iment issued a revised AFL on July'S, 2010. While she could not recall the exact date that the first AFL was received, believing it was aro~nd December 2010 or early 2011, Dr. Peterson testified that she reviewed and acted upon it. AR 151, 183. "Sometime fairly early in the process" Desert Valley Hospital applied for a flex from the AFL's restrictions. AR 150·51. Dr. Peterson did not recall receiving·a response from CDPH. AR 150. A,fter receiving the Department's November 2011 su!l,~y, Desert Valley Hospital again applied for a flex to perform peripheral angiography in its catlJI!lb in
ac·· December 201!. The flex was approved on Ma1ch 19,2012. AR 2655,2665:66. · ..,., As a threshold issue, Petitioner objects to the AFLs as unauthenticated and incompetent. ~
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• • Reply at 2. He notes that they were not addressed to Desert Valley Hospital, but to "General Acute Care Hospitals" and further argues that they were "probably not received until late 2011 or 2012. Pet. Op. Br. at 3. A writing may be authenticated by its content or by the recipient's reply, Evid. Code§§ 1420·21. The AFLs are authenticated by their content, by Dr. Peterson's testimony, and by the actions of Desert Va!Jey Hospital.
While the precise date of Desert Valley Hospital's receipt of the AFLs is unknown, the hospital applied for a flex sometime "early in the process." It seems likely that this was 2010, and most certainly it was applied for well before Petitioner performed his October 2011 procedures. This is true because the hospital applied for a second flex shortly after Petitioner performed his procedures - the second flex application was triggered by the November 2011 results of the Department's survey.
The weight of the evidence supports the Board's finding that Desert Valley Hospital had actual notice of the AFLs, probably in 20 I 0 and no later than early 201 L
2. Standard of Care Petitioner contends that the Board expressly acknowledged that Petitioner did not violate
the standard of care in his performance of carotid procedures, and therefore .could not find him guilty of negligence. AR 28. Petitioner characterizes his violation of22 CCR section 70438.1 as a "technical violation" that should not constitute a breach of the standard of care and also contends that the Board's finding of negligence is inconsistent with its finding that he did not breach the standard of care in performing the procedures. Pet. Op. Br. at 6.
It is true that the Board found that P!!titionerdid not violate the standard of care with respect to the medical need for, or the manner in w'litch he pertormea, the carotid procedures, but there is nothing inconsistent between this conclusion and the finding lbi£ Petiboner was negligent for performing the services at an unauthorized hospital. The performance of a procedure m a hospital no! hcensed to pertorm them 1s not, as Pebhoner claims, a mere technical violation. Part of the standard of care requires a physician to select a venue for treatment that will ensure the patient's safety. AR 28. Patient safety can be compromised when certain cardiac procedures are performed in a hospital without a cardiac surgery center. This fact is recognized in 22 CCR sectlon 70438.1 's requirement that the cath lab have procedures for emergency transport of patients even when performing diagnostic procedures. 22 CCR §70438.1 (a).2
Petitioner argues that Board's expert, Dr. Acheatel, admitted that Petitioner did not breach the standard of care if Desert Valley Hospital gave him privileges to perform the carotid procedures.3 Pet. Op. Br. at 7.
2 Petitioner notes that Desert Valley Hospital followed the requirements of 22 CCR section 7048.1. Pet. Op. Br. at 6. This is true, but irrelevant. The restrictions permit a hospital to perform diagnostic procedures, and there is tto dispute that Desert Valley Hospital (and Petitioner) were authorized to perform diagnostic procedures.
3 Petitioner argues that, even if he should have known about the restrictions, the legislative scheme imposes administrative penalties for a violation against hospitals, not individuals, and does not eyen penalize hospitals for a minot violation. Mot. at 4·5. Petitioner is correct, but he was not
. charged with violating 22 CCR section 70348.1. He was charged with violating B&P Code section :::;:; 2234(c) through repeated negligence in performing procedures at an unlicensed facility. See AR ~
.<!:• 8 "-''
"" 1-.....:' a:• ,_.. o:·
• • Dr. Acheatel opined that it would be a breach of the standard of care to perform a procedure
at a facility that is not licensed for that procedure. AR 258. He qualified this opinion by stating that, if it was reasonable for Petitioner to believe that he was permitted to perform the procedure, then he would not violate the standard of care in doing so. AR 258. Dr. Acheatel stated that if Desert Valley Hospital gave Petitioner privileges to perform these procedures, then it would be reasonable for Petitioner to believe he was permitted to perform them. ML
Prior to the AFLs, it was standard practice in the ·State to perform peripheral elective angiography and angioplasty proceduras. AR 183: That was no longer true after the AFLs were issued. By early 2011, Desert Valley Hospjtal had actual notice thai it could not perform these interventional procedures in its cath lab.
The issue is whether Pe itio w or should have known about the peripheral procedure restrictiOnS. ehtioner had a duty to inquire Whet er e proce UfCS were aut 0 I rt V~ lrospital. This duty stems from the standard of care, which can only be provided through. expert testimony.4 NNV v. American Assn. of Blood Bll.!ll<§, supra, 75 Cal.App.4th at 1385; Sinz v. Owens, 33 Cal.2d at 753. Dr. Acheatel's testimony supports the conclusion that Petitioner had a duty to inquire whether Desert Valley Hospital was authorized to perform elective peripheral interventional procedures in its cath lab, and to receive that information before conducting the
. peripheral procedures. As an interventional cardiologist .. and a senior one at that •• Petitioner had a resrnsibility to his patients to inquire and ensure that peripheral procedures we~g performed jn an authi:iiiWJ yeng~. =•
So far, so good. But Petitioner had permission to perform these procedures in the cath lab. Prior to 2009, the standard practice throughout the state was for cath labs to perform peripheral elective angiography and angioplasty procedures. AR 183. A November 2009 written policy expressly approved carotid angiography at Desert Valley Hospital, and this policy presumably had bee(l conveyed to Petitioner. See AR 167-68.
The issue becomes whether after 2009 Petitioner had a continuing duty to inquire of Desert Valley Hospital about its cath lab authorization, or otherwise to stay abreast of the Department's policy letters governing cardiac procedures, to ensure there had been no change in that permission. Dr. Acheatel did not opine that the standard of care im osed a continuing duty to inquire, and his ojmuon at e 1 toner wou d not in rase if he reasona y un ers o at he had such privileges (AR 275) suggests that Petitioner had no such continuing duty. Thus, Petitioper CO.J4ld reasonably rely on the 2009 written awroval unless .he had reason to believe there had been ~ change. - Nor is there any support for a duty for Petitioner to unilaterally to stay abreast of the
Department's policy letters for hospital procedures. The simple fact that Desert Valley Hospital sent a 2009 memorandum to staff and pertinent physicians expressly approving carotid angiography (AR 167-68) shows that a cardiologist may fairly rely on Desert Valley Hospital to
3 7, 779. The tack of administrative penalties for an individual is not relevant to whether Petitioner was negligent.
4 Although the Board's decision refers to constructive notice (AR 28), constructive notice may be defined as the implication or inference of notice as a matter of law. The proper basis for
IX· deciding whether Petitioner breached the standard of care is whether he had a duty to inquire, not ""' constructive notice . . ,
'" 9
• • stay abreast ofthis information and inform its cardiologists and staff about changes in permissible procedures at the hospital.
Did Petitioner have reason to know that the policy for peripheral procedures had changed? The only evidence supporting Petitioner's reason to know of a change are the facts that (1) Desert Valley Hospital had actual notice of the AFLs, probably in 2010 and no later than early 2011, and (2) Dr. Peterson's testimony that the hospital sent a memo to staff after the AFL carne out that the could perform only the listed procedures. AR 185.
This memo was not included in the record and no reason was iven for that failure. Nor is there any tes 1mony a ou s a e, o er t 1IUl a general reference to e ac t it was issued after the AFL. The court would draw an inference that the memo must have been issued in early 2011 except for the facts that (a) Dr. Peterson testified that staff complied with the memo by limiting themselves to the restrictions in the AFL (AR 188), and (b) Bethel testified that the cath lab staff was told after the Department's survey in November 2011 that they could not perform these procedures and they, Petitioner, and other cath lab physicians complied (AR 346). Collectively, this testimony undermines a conclusion that the memo was issued before Petitioner performed the October 2011 peripheral procedures. Without the memo, the court cannot conclude that Petitioner knew about a change in Desert Valley Hospital policy for peripheral procedures in the cath lab. He reasonably was entitled, therefore, to continue to rely on the 2009 written policy that permitted him to perform carotid angiography.5
In sum, the weight of the evidence shows that Petitioner was authorized in a 2009 written memorandum to perform carotid angiography at Desert Valley Hospital. The standard of care permitted him to reasonably rely on this memorandum until he was notified differently. When he performed the October 2011 procedures, Petitioner did not know that had been a change in the ·authorization for carotid procedures at Desert Valley Hospital's cath lab. Therefore, he did not breach the standard of care. 6
F. !;onelusion
5 Petitioner's status as a former head of the cath lab who performs 20 to 30 carotid interventions each year (AR 586-87) is evidence that it may have been unreasonable for him not to have known about the change in policy. But Dr. Acheatel did not testify about this issue under the standard of care.
6 The Board's opposition addresses attorney's fees under Goveroment Code section 800 because, although they were not addressed in Petitioner's moving papers, attorney's fees were sought in the Petition. See Opp. at 9. Petitioner's reply also addresses the issue. Reply at 5.
Since attorney's fees were not sought in Petitioner's notice of motion or memorandum of. supporting authority, the issue is walved. Petitioner could, however, seek attorney's fees in a post· judgment motion, and therefore the court will address the issue now. The Board's decision that Petitioner breached the standard of care by performing unauthorized procedures at Desert Valley Hospital was not arbitrary and capricious evell though it was unsupported by the weight of the evidence. See !:Jalaco Engineering Co. v, South Central Coast !&eg.ional Commission, (1986) 42
""' Ca1.3d 52, 79. The Board gave serious consideration to the evidence and its rationale for v• Petitioner's breach of a duty to inquire is not arbitrary. The request for attorney's fees is denied.
10
• • The petition for writ of mandate is granted. A writ shall issue directing the Board to set
aside Petitioner's public reprimand. Petitioner's counsel is ordered to prepare a proposed writ and judgment, serve 1hem on the
Board's counsel for approval as to form, wait 10 days after service fur JmY objections, meet and confer if there are objections, and then submit the proposed judgment and writ along with a declaration stating' the existence/non-existence of any unresolved objections. An OSC re: judgment is set for June 9, 20!6 at 9:30a.m.
"'' VI
" '"'' "-'' 11 .,
"'' ""' ,_ ""'
BEFORE THE ME.DICAl, BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA
In the Matter of the Accusation Against: ) ) )
SIVA ARUNASALAM, M.D. ) Case No. 09-2011-220169 ) ) OAH No. 2014010810
Physician's and Surgeon's ) Certificate No. G 66022 )
) Respondent. )
)
DECISION
The attached Proposed Decision is hereby adopted by the Medical Board of California, Department of Consumer Affairs, State of California, as its Decision in this matter.
This Decision shall become effective at 5:00p.m. on May 8, 2015.
IT IS SO ORDERED April9, 2015.
MEDICAL BOARD OF CALIFORNIA
BEFORETI-IE MEDICAL BOARD OP CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA
In the Matter of the Accusation Against:
SIVA ARUNASALAM, M.D. Victorville, California 92395
Physician's and Surgeon's Certificate No. 066022
Respondent.
Case No. 09-201!-220169
OAHNo. 2014010810
PROPOSED DECISION
This matter was heard before Administrative Law Judge Jonathan Lew, Office Of Administrative Hearings, on January 12,2015, in Riverside, Callfomia; and thereafter on January 13 through 15, and 20 through 22,2015, in San Bernardino, California.
Harinder K. Kapur, Deputy Attorney General, represented complainant.
Henry R. Fenton, Attorney at Law, represented Siva AI'Unasalam, M.D., who was present.
The case was submitted for decision on January 22, 2015.
FACTUAL FINDINGS
1. Kimberly Kirchmeyer (complainant) brought the Accusation solely in her ·official capacity as the Executive Director of the Medical Board of California (Board).
2. On June 19, 1989, the Board issued Siva Arunasalam, M.D. (respondent) Physician's and Surgeon's Certificate No. G66022. The certificate was current at all times pertinent to this matter. It will expire on July 31, 20 I 6, if not renewed. There has been no prior disciplinary action taken against this certificate.
1
Background
3. Respondent is an interventional cardiologist. The Accusation charges him with violations of the Medical Practice Act in connection with his care and treatment of five
---··· --·-patients;-·Eln-two-patients;-respondentperfonned""f'.oronary-procedurcs;-spccltlcaHy,-left-hcart--catheterization and angiography, followed by an intervention (stent placement/balloon angloplasty). On three patients, respondent performed carotid procedures; specifically, angiography followed by stenting on two of the three carotid patients.
4. Complainant alleges that respondent engaged in unprofessional conduct in the form of gross negligence and repeated negligent acts, and that he failed to maintain adequate or accurate records. Fo1· all five patients, complainant al!eges that respondent performed an intervention in a facility not ltcensed for such procedures. For the two coronary patients, complainant further contends that respondent failed to document a pre-procedural consultation describing the recommendation for angiography and possible intervention, and alternatives, benefits, and risks of performing an intervention at a facility that was not licensed for such intervention. Complainant also believes respondent failed to properly interpret the coronary angiograrns, and proceed with proper treatment options.
For the three carotid patients, complainant contends that respondent failed to document any neurological evaluation and/or finding.~, and alternatives, benefits, and risks of performing a procedure at a facility that was not licensed for such an intervention.
5. Respondent contests these allegations. He believes that his pre-procedural consultations with each patient are well documented and provide for informed consent in every case, including recommendations for angiography and possible intervention an.d alternatives, benefits and risks associated with each procedure. He contends the two coronary interventions were emergent situations consistent with the hospital's emergency protocols, and therefore an exception to !he limitation on performing coronary interventions, He averred that be engaged in the carotid angiography/interventions at a time when he understood that such procedures were permitted at the hospital.
Jlollowing a summary of respondent's professional background and experience, and the procedures authorized to be perfonned in the catheterlz,atlon laboratory at Desert Valley Hospital, the specific Accusation allegations and defenses will be discussed.
6. ~sional Background. Respondent completed an M.D. /Ph.D. program at Emory University School of Medicine In Atlanta, Georgia. He completed his residency in Intemal Medicine through Harbor-UCLA Medical Center, and his fellowship in Internal Medicitle (C1'itical Care Medicine) through Cedars-Sinai Medical Center. Respondent also completed a separate fellowship in Cardiology at Cedars-Sinai Medical Center.
Respondent holds certifications f:i·om the American Board of Internal Medicine (ABIM) in Internal Medicine, Cardiovascular Disease, and lntervent.ional Cardiology.
2
Respondent's professional activities include membership in the American Heart Association, Alpha Omega Alpha, and the San Bernardino Medical Society.
Respondent is the Director and Attending Cardiologist at High Desert Heart Institute ____ ,in Victorville, Cal~rnia. He_ obtain~'!_ ho~pita~p~vileges at several area}l()~J'.jtals including __ ,_~,,
DeserrValley Hosp1t8J (2005 to present), Victor Vifiey Community Hospital (2003-2004), St. Mary Regional Medical Center (1999-2003), and Barstow Community Hospital (1999-200 1 ). Respondent estimates that he performs approximately 800 diagnostic angiographies per year, 40 percent of which are followed by some type of cardiac intervention. His staff privileges at Desert Valley Hospital include all aspects oflnterventional cardiology including carotid angioplasty and percutaneous transluminal coronary angloplasty. His Desert Valley Hospital privileges also include coronary, peripheral and carotid stent placements.
7. Desert Valley Ca!bLab Services. From December 1, 2010, to November30, 2011, Desert Valley Hospital was licensed to perform cardiac catheterization services. During the same time period, Desert Valley Hospital was a non~cardlac surgery hospital. Cath Labs are nevertheless authorized to operate in non-cardiac surgery hospitals provided certain conditions are satisfied. These include the hospital having in place: I) provisions for emergency and routine transfer of patients; 2) provisions which &-pecizy that cardiac surgery staff and facilities shall be immediately available to patients upon notification of an emergency; and 3) provisions which specifY that the cath lab staff have responsibility for arrat1ging transportation to the receiving hospitals. (Cal. Code Regs., tit. 22, § 70438.1, subd. (a).) Cath labs are furthor limited to specific 1:ypes of diagnostic procedures that can be performed. Thus, the regulations provided for only the following diagnostic procedures to be performed in Desert Valley's cath lab over the period in question:
(l) Right heart catheterization and angiography. (2) Right and left heart catheterization and angiography. (3) Left heart catheterization and angiography. (4) Coronary angiography. ( 5) Electrophysiology studies. (6) Myocardial biopsy.
(Cal. Code Regs., tit. 22, § 70438.1, subd. (b).) Hospital cath labs arc licensed by the California Department of Public Health (CDPH). Under certain conditions, CDPH is authorized to approve program flexiblllty (flex) requests fbr services other than those specified in section 70438.1, subdivision (b). (Health & Saf. Code,§ 1276.05.) Desert Valley did make a flex request to perform carotid angiographies in late 2011. CDPH made additional requests for more info11nation before :finally approving Desert Valley Hospita:t's request to perform peripheral angiography on March 19, 2012. Desert Valley Hospital was not authot·ized to perform carotid angiography or lnterventlonal stents prior to its being granted permission to perfo~m peripheral angiography on March 19, 2012.
8. Margaret Peterson, Ph.D., was the ChiefExccutive Officer ofDesert Valley Hospital between 2009 and March 2014. She testified at hearing. She confirmed that in
2010, Desert Valley Hospital received an AH :Facilities Letter (AFL) from CDPH, reminding all general acute care hospitals not providing cardiac surgery services of the limited diagnostic procedures that could he performed in cath labll under California Code of Regulations, title 22, section 70438.1. Prior to receipt of the AF.L, she was under the
-~mistaken.undc~standin~that-per:ipheral-angi oplasties could-beperfotmed.in Desert-V-alley--··-····--·· -Hospital's cath lab on an elective basis. In response to the AFL alert, Desert Valley Hospital made the flex request to perform peripheral angiography. The flex request was also in response to being cited by CDPH for performing unauthorized procedures. Contemporaneous with the flex request, Desert Valley Hospital also worked with CDPH to expand into and become approved as a cardiovascular surgery hospital. Dr. Peterson believes this request was merged with the flex. request to perform peripheral angiography. Both reque.~ts were approved by CDPH in March 2012.
Prior to 2010, neither Desert Valley l-Iospitalnor Dr. Peterson advised respondent that there were any rustrictions or any issue about him performing earotid angiographies or anglopla.~ties in. the cath lab. Respondent even provided training on these procedures to other physicians in the cath lab over this period. He was never advised of any issues about training other physicians. After receiving the 2010 AFL alert, Dr.I>eterson alerted cath lab staff in Desert V ailey Hospital not to perform unauthorized procedures. Respondent presumably received notice at that time.
9. Emergent Coronary Services Exception. Notwithstanding the limitation on diagnostic procedures to be performed In the cath lab, coronary interventions may be performed in cath labs when emergent situations arise. In such cases, reference is made to the hospital's approved policy and guidelines as to what constitutes an "emergent situation." Desert Valley Hospital's Policies and Procedures include "Guidelines for Performing Cardiac Diagnostic and Emergent Coronary lntorventions." These guidelines were formulated in July 2007, and revised in February 2012. Of particular relevance to tbis case, the guidelines set forth circumstances when a percutaneous coronary intervention (PC!) may be performed In documented emergent s)tuations where a patient scheduled for routine diagnostic studies becomes unstable during the procedure as evidenced by:
a. Acute EKG changes during the procedure.
b. Active chest pain refractory to medical management during the procedure
c. Hemodynamic instability during the procedure.
10. There was some question as to when the above guldellnes were approved. However, the record in this case also contains documentation ofCDPH issuing a revised hospital license to Desert Valley Hospital on April21, 2004. As part ofthls process, Desert Valley Hospital develop<.>Ai policies and procedures for its cath lab which defmed the circumstances when it may be appropriate to perform a PCI on an emergency basis at the cath lab. These circumstances included the following:
4
a. Patient has been waiting for 24 hours oi more for a receiving facility for PCI;
b. There exists an immediate PCI due to a critical corenary ---~-------·--···· ~les~ion, but there are no beds available at two facilities contacted
· -- ..... the time after diagnostic coronary angiogram perforn1ed;-···--·-·--..--··-·····-···· ..
c. Patient has acute myocardial infuret (MI), wlth or without ST-segment elevation. and hemodynamically unstable;
d. Patient with )Jllstable anglna/non·Q wave Ml refractory to optimal medical management complicated by dysarrhythmias, hypotension, refractorY chest pain or pump failure;
e. Patient with high grade lesion with less than TIMI Ill flow with continued ST -segment changes;
f. Patient with unstable dysarrhythmias;
g. Patient with contraindication(s) for fibrinolysis;
h. Patient with history of CABG (coronary artery bypass graft)/not a candidate for CABO surgery; or
i. Need for emergent pre-operative clearance.
Coronary Pati.ents
Patient WS
1 I. Patient Histon::. WS had been seeing respondent sinee 1999. He had a history of hypercholesterolemia, hypertension, coronary artery disease, premature ventricular · contractions (PVC) and supraventricular tachyarrhythmia for which rcspondont prescribed medications and recommended conservative treatment. On May 24, 2007, respondent performed a selective left and right coronary angiography, v~ntriculogram, and right lliac angiography. WS presented with exertlonal chest pain and an abnormal treadmill test at that time. The angiogram indicated "small vessel disease, typical diabetic vasculopathy." The left anterior descending (LAD) artery had mild diffuse disease with about 20 percent narrowing in the mid-LAD portion. Respondent noted that WS's estimated ejection fraction was 55 percent. 1 . WS 's discharge diagnoses included acute coronary syndrome, diabetes,
1 Ejection fraction is the fraction of outbound blood pumped from the heart with each heartbeat, and serves as a general measure of a person's cardiac function. Ejection fraction is calculated by dividing the volume ejected by the heart (stroke volume) by the volume ofthe filled heart (end-diastolic volume).
5
hypertension and hyperlipidemia. Respondent did not believe WS had significant heart disease at that time and opted to pursue a course of aggressive risk modification for WS.
On June 18, 2009, WS underwent cardiac screening of the coronary arteries. His total . ···-- --···- . calclum~~core was- 661-,-placing-him iMhe-70..peraontile-rankJ-R08pQndent-intGPJ'li'Cted this--------- -·-·
test result as indicating extensive atherosclerotic plaque burden with a high likelihood (> 90 percent) of at least one significant coronary stenosis.
By November 10, 2010, respondent noted that WS was having slight increases in PVCs and premature atrial contractions (PAC), and was at high risk of developing atrial fibrillation. He recommended that a stress test and echocardiography be performed.
12. On December 10, 2010, WS underwent a Cardiolite stress test. 3 This test indicated an increased inferior defect. His ejection fraction was measured at 46 percent. Respondent reconunended that WS undergo left heart catheterization (LHC) at that time. The LHC was scheduled for December 30, 2010.
13. December 30,2010 Procedure. WS was age 72 when he underwent the LHC at Desert Valley Hospital. Re,qpondent provided the following sununary of the December 30, 20 tO LHC in his operative report:
score.
During coronary angiogram, it was noted that the patient had heavy calcification throughout the left anteril!r descending artery with filling defect in the proximal segment, sluggish flow, TIMI4 grade 2 flow with dye hang-up in the proximal segment
2 That means 30 percent ofthe males at the ages 71 and older had a higher calcium
3 A Cardiolite stress test determines if the coronary arteries are supplying the heart with enough blood. The cardioHte is injected through a vein in the ann. The blood can·ies the radioactive tracer to the heart muscle and through the coronary atteries. A nuclear medicine camera detects and produces an image of the tracer's distribution in the heart.
4 The Thrombolysis in Myocardial Infarction (TIMJ) risk score a.,sesses the risk of death and ischemic events in patients experiencing unstable angina or a non-ST elevation myocardial infarction. It forms a basis for therapeutic decision making. "TIM! Grade Flow" is a scoring system from 0 to 3 referring to level.~ of coronary blood flow asse.~sed during percutaneous coronary angioplasty, and is generally defined as follows:
• TIMI 0 flow (no perf.U.~ion) refers to the absence of any antegrade flow beyond a coronary occlusion.
• TIMI 1 flow (penetration without perflls1on) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
6
and the mid segment consistent with severe aneurysmal dilatation of the artery as well as from high-grade narrowing In the mid LAD of about 90%. It is an eccentric lesion. Because ofthe above presentation with thrombus, sluggish flow, and a
__ -····-···----------· . £.!.1!.~~-~~-f~~as felt~at th~£.~!ien~~~-d. .. l:lnd=::e::<rg"i'o'cc'--__ _ emergent ang10p1asty. '1ne patient underwent appropriate angioplasty with stent placement, however, developed perforation distal to the stent and essentially had cardiac · tamponade.5 Pericardiocentesis6 was performed, however, we were unable to rescue the patient, the patient went into asystole and eventually died.
Medical Expert Opinions - WS
14. Complainant's Medical Expert. Accusation allegations relating toWS's care and treatment include respondent: 1) failing to properly interpret the coronary angiogram and proceeding with the proper treatment options; 2) performing an intervention in a facility not licensed for such a procedur8; and 3) failing to document a pre-procedural consultation describing the recommendation for angiography and pqssible intervention, and alternatives, benefits, and risks of performing an intervention at a facility that was not licensed for such an intervention. In support of such allegations, complainant relies largely upon the testimony of its expert witness, Roger J. Acheatel, M.D., J.D., M.S., F.A.C.C.
15. Dr. Acheatel attended UCLA School of Medicine. He did hfs residency ln Internal Medicine at Cedars-Sinai Medical Conter, Los Angeles, and his fellowship in Cardia logy at the same Medical Center. He ls ABIM certified in both Internal Medicine and Cardiovascular Diseases. He is not board certified in tntervent!onal Cardiology. Dr. Ascheatel is a Follow with the American College of Cardiology, and a member of the American Heart Association. He is affiliated with Palomar Medical Center, Department of Cardiology, in Escondido, California; and also Pomerado Hospital, Department of Cardiology, in Poway, Californla. From 1987to present, Dr. Acheatel has practiced as a cardiologist with Escondido Cardiology Associates, Inc. He previously practiced as a cardiologist with No11:h County Cardiac Center in Escondido, and at Cedars-Sinai Medical Center in Los Angeles. Dr. Acheatel woo Chief of Staff at Pomerado Hospital between 2011
·-·······--------------------------'------, TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete
tilling of the distal territory.
• TIMI 3 is normal flow which :fills the distal coronary bed completely.
5 Cardiac tamponade is pressure on the heart muscle which occurs when the pericardia! space fills up with fluid faster than the pericardia! sac can stretch.
6 Pericardiocentesis is a procedure where fluid is aspirated from the pericardium (the sac enveloping the heart).
7
and 2013, In 2012, he was Palomar Medical Center's Physician of the Year and its Cardiology Unit Physician ofthe Year, He estimates that 90 percent ofhls current practice is clinic!~], He pertbrms up to 80 interventional cardiology procedures per year, almost all coronary. He does not perform carotid Interventions.
16. Dr. Acheatel reviewed patient records for WS and other patients In this case, as well CD Images and anglo grams of all cardiovascular procedures. He also reviewed a transcript of respondent's November 28, 2012 interview with the Board, and investigation records by Steven Otto, M.D., medical consultant for CDPH. Dr. Acheatel noted CDPH's concern that procedures were being performed at Desert Valley Hospital that were not within the approved procedures to be performed in the cath lab at that facility. Dr. Acheatel believes that the only emergency procedure that was permitted to be performed at Desert Valley Hospital "was for a patient that presented with an acuteST-segment elevation MJ (STEMI)." He noted: "In that instance, it was permissible to allow coronary artery angioplasty and stent placement, but only in that instance." Dr. Acheatel prepared a report elated June 26, 2013, summarizing his opinion about the .care and treatment respondent provided WS.
17. Dr. Acheatel noted that during respondent's November 2&, 2012 interview, he acknowledged taking in patients for diagnostic angiography with "a high likelihood of having a narrowing that requires intervention." Respondent further indicated in that interview that WS fell into a category of "very hlgh risk" for coronary artery disease and an event. Thus, knowing before the procedure that WS very likely required coronary angloplasty or bypass surgery, Dr. Acheatel believes respondent had no business performing an angiography at Desert Valley Hospital. He noted that "lt should have been done at a center where the patient could have gone to intervention percutaneously or, if necessary, for bypass surgery, neither of which procedure was authorized at Desert Valley Hospital at that time." Nor does Dr. Acheatel believe that respondent was faced with an emergency situation at the time U1at he determined to perform the percutaneous coronary intervention on MS. Dr. Acheatel explained:
Dr. Arunasalem's contention la that the patient developed an emergency situation in the course of diagnostic angiography. However, there is no verification of this and, in fact, the cath Jab chronology indicates that the patient was having no pain during the diagnostic procedure. This patient could have been placed on the appropriate anticoagulation and then transferred to a facility that was authorized to do this procedure. It wa~ only in the course of doing the procedure, which was not an authorized procedure, that the patient became highly unstable due to the perforation of the artery and resultant tamponade and was not in a facility which was equipped to handle such an eventuality.
18. Dr. Acheatel bolstered hls opinion with his own observations ofWS's coronary angiogram. He is in marked disagreement with the degree of occlusion reported by
respondent. Respondent had earlier described the stenosis in the LAD as being 99 percent during his interview with the Board. Dr. Acheatel's reading of the angiogram Is that while it showed significant stenosis, it was much less than 99 percent. Respondent further. described the blood flow in the LAD as being "TIMl·2 sluggish flow." Dr. Acheatel found the flow through the LAD to be TIMI-3 flow, with no restriction In brisk flow. Dr. Acheatel's
-- - ··cnaracterfziitfon -also matched thaf contarneCfiii ffie }:ii·ooeoiire Toil' or the -cardiac·- --- .... ··- .. --- -- . -catheterization procedure. The log entry was made by a non-physician technician. It described the pre-TIMI flow as "complete and brisk flow/compl~e perfusion." Dr. Acheatel also noted respondent's earlier description ofWS having chest pains. The record, in fact, contains repeated entries of"denies chest pain" prior to· the intervention. And it was only after the PCI and placement of a wire and stent in the LAD that WS began to develop chest pain. Dr. Acheatel noted that this was understandable ''since the wire caused a perforation in the artery, resulting in extravasation of blood in the pericardia! space and the resultant deterioration of the patient's status."
Dr. Acheatel summarized his opinion regarding an emergent situation as follows:
}t is my medical opinion that Dr. Arunasalem hss exaggerated the severity of the lesion, the finding ofTIMI-2 flow, the prest,'llce of thrombus, and the existence of chest pain prior to intervention, all to justify proceeding with whst he considered to be the need for emergency intervention. In fact, the emergency wa.~ caused by the intervention. There was no emergency prior to the intervention.
19. Dr. Acheatel was also critical of respondent's recordkeeping in this case, which he characterized as "remarkably poor." He elaborated as follows:
Dr. ArtUlrulalem 's ol't1ce notes do not reflect a visit with the patient post Cardiolite testing to go over the result.~ and go over his recommendations. There is no indication that he described the procedure to the patient or gave him the alternatives to go forward with angiography. The hospital chart shows no preprocedure admission and history or consultation, which meant that there was no documentation of an adequate consent obtained from the patient by the physician.
[f.l ... NJ
It is also necessary to re-emphasize the very scanty medical records to support going forward with this procedure. Anytime such a procedure is to be performed, there should be substantial documentation of the patient's history, medical testing being done, physical examination of the patient, and then discussion of the rationale for the procedure. Most importantly, there should
be discussion of the informed consent obtained from the patient by the physician doing the procedure. That consent should entail description of the procedure, its benefits, alternatives, and most Importantly the risks; None of these are evident in the
-- -· -- -·------- -- - records supplied,--cithet' by the outpatient-chart of-EWS)or--the------- -- . --------- --- -· --inpatient record at Desett Valley Hospital.
20. Dr. Acheatel opined that respondent's decision to proceed with the percutaneous coronary intervention on WS following diagnostic angiography was an extreme departure from the standard of care. He believes no medical emergency justified such intervention. Dr. Acheatel churacteri7..ed respondent's recordkccping and lack of documentation of informed consent to be simple departures from the standard of care.
21. Remondent's Medical Experts. Reginald G. M. Abraham, M.D., and Ernst Schwarz, M.D., testified as medical expert witnesses on behalf of respondent.
Dr. Abraham is a cardiovascular and !boracic surgeon, He at~ended St. George's University School of Medicine in Grenada, and pursued his residency in general surgery at Yale University School of Medicine, including work as a Post-Doctoral Fellow in GI Surgical Research and Yale Clinical Fellow in !he Emergency/Surgery Departments. Dr. Abraham continued his general surgery residency at Sound Shore Medical Center, New York Medical College. He then completed a Cardio!horacic Resident/Fellowship at SUNY Buffalo. He became Board cettified in both Surgery and Thoracic S1.1rgery, and is a Fellow of the American College of Surgeons (FACS), American College of Cardiology (FACC), and American College of Chest Physicians (PCCP). Between A1.1gust 2004 and May 20 I 0, Dr. Abraham was the Director ofthe Cardia Vascolar S1.1rgery at Fountain Valley Regional · Hospital and Medical Center. He practices in all aspects of cardiac, vascular, !boracic, oncology and vascular surgery, including cndovascular surgery. Between December 2011 and December 2012, he was !he Medical Director Cardiac Surgery at Desert Valley Hospital. He currently practices in Orange County.
Dr. Ab,.iuJ.am has served over the years on a number of committees at Fountain Valley Regional Hospital, and is a member of nun1crous professional societies and associations. He has conducted numerous cardin thoracic workshops and courses. Dr. Abraham has published extensively, with his curriculum vitae detailing 55 peer-reviewed publication.s6ournal articles and two book chapters. Dr. Abraham has reviewed and/or performed thousands of coronary and carotid angiograms and interventions.
22. Ernst Schwarz, M.D., Pb.D., also testified on behalf ofrespondent. Dr. Schwarz did his medical training through the University ofVienna, Austria, and PhillppsUniversity, Marburg, Germany. He did his residency in Internal Medicine and Cardiology at Community Hospital, Eschwcgtl, Germany. Dr. Schwar.~: then pursued a Fellowship in Internal Medicine andCardiolngy at RWTH University Hospital, Aachen, Germany, as well a Research Fellowship at the Heatt Institute, Good Samaritan Hospital, Division of Cardiology, University of Southern California. Dr. Schwarz is Board certified in Internal
10
MediCine, Cardiology, Cardiovascular Diseases, and Advanced Heart Failure/Transplant Cardiology.
Dr. Schwarz is Founder and President of"Dr. Schwarz Medical InstiMe of California," and past Medical Director of Pacific Heart Medica! Group. He was Chief
··· · · ·-- ·"MearcammceroftfieHea:rt Insiffute ·ofSoulfiemCiilifom1a-:-or: Scbwarzwas·an)\ttenafiig····· ·- · Cardiologist at different facilities including Fallbrook Hospital, Fallbrook, California; Inland Valley Medical Center, Wildomar, California; Rancho Springs Medical Center, Murletta, California; Menifee Hospital, Menifee California; Lorna Linda University Medical Center, Murietta, California; and Valley Presbyterian Hospital, Van Nuys, California.
Dr. Schwarz has had a number of aeadernlc appointments. He is a Clinical Professor of Medicine, David Geffen School of Medicine, UCLA, and Professor ofMedic.ine, Cedars Sinai Medical Center. He has served In the past as Professor of Medicine, University of Texas School of Medicine. He was Director of the Cardiology Clinics at the University of Texas, as well Director of the University's Heart Failure and Transplantation, and Heart Failure Fellowship Program. He earlier served as an Associate Professor ofMedicinc, RWTH University Hospital, Aachen, Germany.· He worked there in various capacities including as Faculty, Consultant Cardiologist, Interventional Cardiologist, Clinical Supervisor, Director pfHeart Failure & T!llllllplant Program, Director ofCardio· physiological Research, and Interim,Supervisor for the Coronary Care/Intensive Care Units. Dr. Schwarz holds professional memberships in a number of European, German, Saudi and American associations. He has been a reviewer for nearly 40 scientific journals or member of editorial boards, including the New England .Journal of Medtcine, American Journal of Cardiology, American Heart Journal and Cardiology. He has lectured extensively and been principal or co-investigator on numerous heart studies. He has authored 150 publications/journal articles dating back to 1989, as well books and book chapters.
Dr. Schwarz estimates that he currently performs up to 500 diagnostic cardiac procedures amiually, and approximately 150 coronary interventions pery!;l!ll'.
23. Dr. Abraham's Testimon_y. Dr. Abraham reviewed patient records for WS and other patients in this case, as well CD images and angiograms of all cardiovascular procedures. He noted in particular the December 10,2010 Cat•diolite Stress Test results, and Vi'S 's 46 percent ejection fraction meru.'Ul'e at that time. This was a vary significant decline from previous measures, which had held fairly steady to that point. For example, a cardiac stress test on November 1, 2002, measured his ejection fraction at 55.7 percent; a nuclear stress test on February 24, 2006, measured his ejection fraction at 53 percent; and the May 24, 2007 angiography procedure measured his ejection fraction at 55 percent. While WS's ejection fraction was measured by different methodologies depending upon the procedw'll, the same thing was measured in each instance. Dr. Abrahan1 noted that at most, the different methodologies would result in differences of one or two percent, so comparing the ejection fraction measuren1ents over time was appropriate.
11
Dr. Abraham attached further significance toWS's calcium scores measured on June 18, 2009. He characterized WS's plaque burden and calcium risk score as "very high" and suggestive of greater than 90 percent likelihood of at least one significant coronary stenosis. He explained that plaque burden results from calcification within the blood vessels until they
· -become .. friable and-ocGhaded. 1'he.alfecred.-vessel-be~:omes-a-'!casto£itself'.' .and-there-is-a .. ----diminution of blood flow. Dr. Abraham notGd that the calcium score is part of a well-established algorithm with significant clinical value. In thl..~ case he believes WS 's high calcium score suggested that he .had ''porcelain eggshell-like" vessels that would have precluded bypass surgery.
Finally, Dr. Abraham compared electrocardiograms (EKGIECG) of WS on December 10, 2010, and one done preoperatively nearer the time of the procedure. He noted dyltamlc flattening of the T ·waves over this short time period, suggesting poor blood flow to the heart and that WS was undergoing an ischemic episode. Dr. Abraham ophted that WS was very likely having both ongoing ischemia and a silent myocardial infarction (Ml), essentially an interruption in blood flow to the coronary arteries without the usual ·signs and symptoms of a heart attack, and often associated with diabetes, This was an ongoing event. Dr. Abraham noted that respondent described it as Acute Coronary Syndrome in the diagnostic Impression portion of his December 30, 2010 Short Stay History and Physical Examination of WS. At that point, such diagnosis could only be confirmed or ruled out by performing the coronary angiogram,
24. Dr. Abraham reviewed the December 30, 2010 LHC images for WS, including all CD images and anglograms. He observed multiple points of stenosis in the LAD. There was haziness within the contrast with alternate dark, light, dark coloration along the·vessel. This indicated a lot of plaque in the LAD, which Dr. Abraham described as 90 percent narrowing in aneurysmal sections of the LAD. Dr. Abraham described various matters as he went through WS's angiograms. Contrast dye was repeatedly "hung up" in stenotic areas at the midpoint of the LAD, even after the dye had washed out- suggestive of a lot of plaque and a "highly diseased vessel." Dr. Abraham described very diminished blood flow downward in the LAD. He characterized such flow as TIM! -2. Dr. Abraham opined that WS presented as a patient wlth ongoing symptoms. He believes WS's vessels were far too friable, and when considered along with his calcium score, hyperlipidemia, and diabetes, he was not a candidate for and was precluded from bypass surgery,
Dr. Abraham opined that given WS' s presentation at the time of the angiogram, he was a patient at high ri~k and that coronary intervootion was "immediately necessary." He believes that the conglomeration of events considered- the observed poor blood flow, high calcium scores, high plaque burden, decline In ejection fraction, and EKG!ECG resultsplaced WS at "exponential risk" for a sudden cardiac event or death. Dr. Abraham opined that both cot•onary angioplasty and stenting were justified under such circumstances. He believes there was an immediate need for such intcrvootion in this case,
25. Dr. Schwarz's Testimony. Dr. Sehwarz concurred with Dr. Abraham's opinion regarding the need for irumediat.e Intervention following WS's December 30, 20!0
12
I
angiogram. He opined that prior to this procedure WS presented a~ having a high probability for developing coronary artery dise~e. He based this on WS's cllnical presentation at the time of his December 10,2010 Cardiolite Stress Test (hyperlipidemia/hypercholesterolemia, . hypertension, PVC/PAC, etc.), the decline in his ejection fraction to 46 percent, his calcium score indicating extensive plaque burden, and the more recent dynamic changes in his EKG,
-- ·· ··---·- -- speclfically-thc-uprightT •wave-folhlwed by-flattening;-Dr~ SchW!!J'Z.bt}"!tevestlwlmter~--·-·-· ---·· · changes were suspicious for myocardial ischemia,
During the coronary angiogram, respondent had noted that WS had heavy calcification throughout the LAD with filling defect in the proximal segment, sluggish flow, TIMI grade 2 flow with dye hang-up in the proximal segment and the mlc! segment consistent with severe aneurysmal dilatation of the artery, as well as from high-grade narrowing in the mid LAD. Dr. Schwarz noted that heavy plaque burden may have caused a no reflow phenomenon and that in this case IntcgrUJin was administered to WS to prevent further clot burden, consistent with respondent finding a :reductl.on in flow caused by clot material. lntegrlllin is used to address inadequate perfusion into distal portions, and to prevent fragmentation of clots that might lodge in smaller vessels. In short, respondent acted consistent with his angiographic findings at the time of the proceduret lending credence to his having formulated medical judgments at that time, and not as after the fact rationalizations.
26. Dr. Schwarz eoncurred with respondent that because of the above presentation with thrombus, siuggish flow, and a tilling defect, WS should undergo emergent angloplasty, He reviewed the December 30, 20 I 0 LHC images for WS, including all CD images and anglograms. He noted some reduction in blood flow in th.e proximal section of the .LAD, and a lack of contrast flow and reduced flow within aneurysmal portions of' the LAD. He characterized the flow as TIMI·2. Dr. Schwarz opined that WS presented at that time as an unstable patient with potential for abrupt closure ofthe .LAD. Dr. Schwarz explained that the· observed occlusions could have led to a heart attack and potential death, and that he would have intervened and proceeded with angiop!asty "right away.» Dr. Schwarz .further noted that WS presented a~ having ongoing myocardial ischemia, critical stenosis, and a flow limiting lesion wi1h vulnerable plaque. There w~ abnormal blood flow in his LAD, and there were concerns related to the significant drop in his ejection fraction. Dr. Schwarz believes respondent made an ad hoc decision that was in WS's best interest. He would not have transferred WS to another facllity.at that time because WS wa.~ not stable. Dr. Schwarz characterized WS ~ being in a potentialli tb-threatening situation at the time respondent determined to proceed with angioplasty. He further noted the rehttive low risks associated with angioplasty, the mortality being below two percent, and 1.3 percent in 1he United States,
27. Regarding respondent's documentation of informed consent for WS, Dr. Schwarz opined ~at his practices were "absolutely" within the standard of care. He noted that respondent used a standard informed consent form, simillll' to that which he uses at UCLA. Dr. Schwarz is unaware of any additional requirement for a physician to make a separate chart entry in patient medical records indicating that an Informed consent discussion occurred. He opined that it is enough that the patient sign an informed consent form, and
13
that respondent was not required to separately chart the fact of any "discussion of the consent obtained from the patient by the physician doing the procedure" as suggested by Dr. Acheatel. Having the patient and physician sign the informed eonsent is all that is needed to comply with documentation requirements for informed consent.
-·~······---·-··-~-------- ................... ,~ ~---------------~·.-"----·---------~-------- .. ----- -·- --RegiU'ding WS, Dr. Schwar<~ opined that the emergency Intervention did not require a
sepiU'ate signed informed consent form. A non:emergency intervention would have t-equired transfer ofWS to a different facility. An emergency intervention required the physician to discuss the procedure with the patient just prior to the intervention, but no additional consent form. In this case, WS ·would have been conscious after the angiogram, as only moderate sedation would have been administered at the site of the catheter. Respondent was permitted to obtain oral informed consent from WS under these circumstances.
28. WS Discussion. Respondent followed WS as both his primiU'y care physician and cardiologist from 1999. His testimony regarding WS's history is as set forth in I'indlngs ll through 13, and his diagnostic impressions and rationale for intervening are consistent with that testified to by Dr. Abraham and Dr. Schwarz. Respondent noted in particular that the CIU'diolite Stt·ess Test finding of increased inferior defect was "very ominous" given the 1 O·polnt decline in WS's ejection fraction. The BKG changes from the baseline and the STwave flattening suggested to him that something dynamic was occurring, most likely ischemia. He believes he correctly interpreted the angiogram as representative of:TIMI-2 flow. At hearing he explained that WS had 90 percent narrowing of the LAD, of a Type C acentric long nature, whlch represented a situation where the IU'tery might close more abruptly. 7 Respondent noted that he administered two different anticoagulants during the diagnostic angiogram (Angiomax and Integri!lin) as "very aggressive" measures prior the intervention. He disagrees with the staff ohiU't entry that WS had complete and brisk flow, and "complete perfusion." Those were not his assessments at the llrile. He noted that once he had administered the anticoagulant to WS he needed to continue with the intervention. He believed that WS was at high risk of abrupt closure following angiography and to stop the anti-coagulant would have been ill-advised. He noted that WS was already on maximum medical management, and that the risks and benetits ofhoth the LHC angiogram, and later the intervention, were explained by him toWS. Respondent noted that the rupture in this case occurred as soon as he put the stent in place, and that it is not common for such ruptures to occur. He estimates that he bas performed approximately 6,000 balloon and stent procedures over the past 20 yeiU's, and that ruptures have occurred only four times over this same period.
29. The testimony of Dr. Abraham, Dr. Schwarz and respondent IU'e consistent and persuasive that WS presented with an emergent situation at the time of the December 30, 2010 LHC and angiogram such that he was at high risk a_nd coronery intervention became immed.iately necessiU'y. The conglomeration of events considered- the observed poor blood flow, high calcium scores, high plaque burden, decllne in ejection fraction, and dynamic
7 In eontt·ast, a Type A narrowing is symmetric ( equicentric ), and a Type B narrowing is acentdc short. Such occlusions are supposedly less prone to abrupt closure.
14
BKGIECG results - placed WS at "exponential risk" for a sudden cardiac event or death. Dr. Abraham and Dr. Schwarz opined that both coronary angiopiasty and stenting were justified under such eireumstsnces. Both reviewed the December 30, 2010 LHC images for WS, including all CD images and angiograrns. Their observations and opinions were consistent and well-explained at hearing. The reduction in blood flow in the proximal section of the
-----LAD; ruiiltrie lacroi cori1fasrflow and-redi.iced-flow witfilil aneurysmar p<irtionsofUleTAD ___ -- ---were consistent with TIMI-2 flow. Both Dr. Schwarz and Dr. Abraham opined that WS presented as an unstable patient with potential for abrupt closure of the LAD. The BKG changes strongly suggested a dynamic situation. Both Dr. Schwarz and Dr. Abraham opined that the observed occlusions could have led to a heart attack and potential death, and both indicated that they would have Intervened and proceeded immediately with angioplasty.
That Dr. Abraham and Dr. Schwarz bring rather impressive credentials as expert witnesses in the area of cardiology, as set forth in Findings 21 and 22, has also been considered in lending credence to their opinions.
30. The testimony of Dr. Acheatel on the question of whether an emergent situation arose was not as persuasive. He believes that respondent "exaggerated the severity of the lesion, the tlnding ofTIMI·2 flow, the presence of thrombus, and the existence of chest pain prior to intervention, ... »8 However, the severity of the lesion was detailed above by Dr. Abraham and Dr. Schwarz. There were strong indications that WS was at risk of abrupt closure of the LAD. Dr. Acheatel's reading of the angiogram was that there was TIMI-3 flow, or "no restriction in brisk flow." That there was disagreement among the four cardiologists viewing the same angiogram was somewhat surprising. TIMI. flow is an objective measure and characterization of the flow of blood tlu·ough a vessel. Dr. Abraham, Dr. Schwarz and respondent provided consistent descriptions and explanations of where and to what degree there was reduced flow through the LAD, and such was consistent with the definition ofTIMI-2 flow. It is also perceptible to a lay observer viewing the angiograms. In contrast, Dr. Acheatel'~ characterization of no restriction in brisk flow flnds less · angiographic support. Nor was the presence of thrombus an after-the-fact exaggeration as suggested by Dr. Acheatel. Respondent's actions in administering Angiomax (both bolus and drip), followed by Integrillin, are strong indication of his diagnostic impre.~sions at that time. -
The medical evidence supports a finding that WS presented as an unstable patient. Dynamic changes in his EKG were suggestive of an ongoing myocardial ischemia. In addition, WS presented as having critical stenosis and a flow-limiting lesion with vulnerable plaque. There was abnormal blood flow in his LAD, and there were concerns related to the significant drop in his ejection fraction. Respondent determined that transfer to another facility at that time was ill advised. WS was .not stable, Both Dr. Abraham and Dr. Schwarz characterized WS as being in a potential life--threatening situation at the time respondent determined t<l proceed with angioplasty.
8 Respondent has acknowledged that his earlier interview statements regarding chest pain were made in error.
!5
31. For all the above reasons the medical expert testimony of Dr. Abraham and Dr. Schwarz is persuasive that WS presented with an emergent situation at the time of the December 30, 20 l 0 LHC and angiogram such that coronary intervention became immediately necessary. Complainant, through the medical expert l'eport and testimony of
~ _. _ _ _______ .O.rJ.!~&.he~le!,.ha~JJ!ll p~!lliJ.li!lleJ~.t.and.k!Jl'!Y.incing.med!cal. e.v.idencc..othetwise. ___ ---···-···· _. __ ..
Accordingly, it was not established that respondent fililed to properly Interpret the coronary angiogram and proceed with proper treatment options as alleged in the Accusation. Respondent did perform a coronary intervention in a facility not licensed at the time for such a procedure as alleged in the Accusation. However, his actions fell within tl1e recognized exception for emergent coronary circumstances. Finally, it was not established that respondent's practice and documentation related to informed consent for WS fell outside the standard of care.
Patient PP
32. j?atient History. On September 28, 2011, PP was admitted to Desert Valley Hospital with complaints of chest pain. At that time PP was age 59, and was Incarcerated at a federal correctional facility. He had a history of coronary artery disease, congestive heart failure, diabetes, and hypertension. Upon admission, myocardia1 infarction was ruled out and PP reported feeling better. He underwent a Card!olite scan which showed evidence of ischemia. Based upon ilie abnormal Cardiolite scan, he wa.~ refe11·ed to respondent. On September 30, 2011, respondent saw PP for the first time. He recommended left heart cathetetization and angiogram, which was scheduled for October 3, 20 11 .
.33. October.3, 2011 Procedure. On October 3, 2011, PP underwent cardiac cailieterization. The angiogram revealed that the major coronary arteries were intact, and that there was high-grade stenosis of the obtuse marginal artery 3 (OM3) and obtuse marginal artery 4 (OM4). OM3 and OM4 are small branches of the left circumflex system, which are small vessels. Respondent chose to intervene on these lesions with balloon artgioplasty. The balloon angioplasty on OM3 went well. However, during the OM4 intervention, there was a perforation of the vessel. The plan was to stop the anticoagulation with the hope that the artery would seal itself without further extravasation of blood Into the pericardia! space. PP became unstable with pericardia! effusion, tamponade, and a ·requirement for pericardiocentesis. PP was thereafter transferred to another hospital where he underwent stemotomy,9 draining of the pericardia! effusion, and placement of a patch. Thereafter, PP did well. In his operative report, respondent explained the rationale for perfonning angioplasty emergently:
Following the angiogram, it was felt that the patient had 99% narrowing of OM3 and OM4. There is a small veasel, small targets not amenable to any bypass surgery. Circumflex artery was a dominant vessel. OMl, OM2, and circumflex itself in the
9 An incision into or through the sternum;
16
A V groove were without significant disease. Left anterior descending artery also did not show any significant disease, although the first diagonal artery of the LAD had previous stent placement and it was chronically occluded. Because ofthe
····---·- · ··------~:i·~t~~~e :1.~~~~~~b~~f~~~%~:~\~~dbecause the size ofthe vessel, it was felt that the patient should undergo angioplasty emergently. He was having chest pain while he was in the catheterlzatiou laboratory as well. Right coronary artery wus a non-dominant vessel as well.
Medical Expert Opinions - PP
34. Complrunant'§ Medical Expert. Accusation allegations relating to PP'.s care and treatment include respondent: 1) performing an intervention in a facility not licensed for such an intervention; and 2) failing to document any findings and alternatives, benefits, and risks of performing a procedure at a facility that was not licensed for such a procedure. In support of such f.~llegations, complainant relies largely upon the medical expert testimony of Dr. Acheatel.
3 5. Dr. Acheatel reviewed patient records for PP, as well CD images and angiograms of all cardiovnscular procedures. He also reviewed .a transcript of respondent's November 28,2012 interview with the Board. Dr. Acheatel opined tha.tPP's medical records and chart do not ref1ect the high level of instability that respondent described in his earlier Interview with the Board. Nor does he believe that PP was on maximal medical therapy with regard to doses of medication ns well as types of medications. Dr. Acheatel considered the medical regimen that PP was on, including both beta and calcium-channel blockers. He noted, however, that PP was not on nitrates, aod "certainly could have been on IV nitroglycerin." Dr. Acheatel questioned whether respondent made rea:sonable attempts to transfer PP to a hospital where the coronary intervention could be performed. He noted that PP was at Desert Valley Hospital from September 28 to October 3, 2011, a period when PP. was "unstable" and when respondent was unable to effectuate transfer to another hospital. Yet, when PP developed pericardia! effusion, tamponade, and a requirement for pericardiocentesis - a situation where PP was truly unstable- re.~pondent was able to effectuate transfer to St. Mary's HospitaL Dr. Acbeatel believes that respondent planned to perfonn the intervention from the beginning. He does not believe that there was an emergency situation as PP had already been in the hospital for five days, aod ifthere was truly an emergency the procedure would have been performed earlier. Dr. Acheatel summarized his opinion regarding respondent's care and treatment of PP as follows:
As mentioned, the documentation in the chart is woefully i.nadequate to sustain claims of marked instabillty requiring emergency intervention. It is my medical opinion that tbis patient was planned to have angiography as a matter of course and not as a matter of emergency. This opinion, in conjunction
17
with the poor recordkccping, the lack of adequate consent, failure to document appropriately, and performance of a procedure that did not seem to be emergent at a facility that was not licensed to perform interventions, all combine to result in a
· · · ·· · .... ...-- · ........... ___ conclusion-that: the care· ofthis·!latientrepresents· an -Extreme .. _, ___ ------- - ---- .. - -Departure From the Standard of Care.
36, Respond!lnt's Medical Experts. Dr. Abraham reviewed the patient records for PP, as well CD images and angiograms of all cardiovascular procedures. The report after a stress test performed on September 30, 2011, indicated that PP had «probability oflnducible Ischemia." A treadmill nuclear stress te&t thatPP underwent that same day confirmed "Ischemia affecting the inferior wall." Dr. Abraham characterized this as a definitive diagnosis. On admission, PP complained of "heavy pressure feeling across the chest radiating to his left arm accompanied by shortness of breath lasting up to 15 minute period of time." He had a history of known coronary artery disease, and had had a previous myocardial infarction. PP had had eight stonts placements in the past. On admission his diagnoses il1Cluded: 1) chest wall pain syndrcmelcostochondrltis syndrome; 2) chest pressure suggestive of angina with previous history of coronary artery disease, previous old myocardial infarction, and previous stents; and 3) chronlc congestive heart failure with possible acute diastolic exaeorbation; 4) diabetes, insulin dependent; and 5) hyperlipidemia.
On October 1, 2011, a Physician Order Sheet reference to a blood draw test for Troponln, an Ml marker, suggested to Dr. Abraham tbat l'P was having chest pain and active heart issues. Dr. Abraham explained that when a patient continues to have chest pain three days following hospital admission, as PP did, such "unrelenting symptoms" needed to be addressed. Cardiac catheterization is usually performed to improve the situation. Dr. · Abrahan1 reviewed the October 3, 2011 angiograms. He confirmed that PP had coronary artr:ry disease consistent with diahetcs in OM3 and OM4, with significant stenosis and a lot of calcific material. He explained that because they were small vessels, angioplasty was appropriate. The small vessels were not amenable to 9ypass surgery. Dr. Abraham opined that emergency intervention needed to be done at that time.
37. Dr. Schwar'l concurred. He noted PP's history of preexisting coronary attery disease ai1d prior placement of eight stents. Angiography showed greater than 90 percent stenosis of OM3 and OM4. Given the angiogram results, the objective signs of ischemia, ~nd PP's continued chest pain, Dr. Schwarz indicated that he would have intervened at that time on both occlllSions. Dr. Schwarz opined that this was an emergency situation requiring respondent to intervene "right away." He explained that angiography conftrmed two relatively large vessels with critical stenosis. Intervention was necessary at that time because a rupture could lead to ischemia or myocardial infarction. Tne danger is especial.ly so for diabetics because they may be asymptomatic.
38. J:'P DbcussiQ.Q. Respondent indicated that he proceeded with angioplasty because PP had ongoing chest pain despite maximum medical management at the hogpital. He noted that PP was on nitroglycerin and beta blockers and was still experiencing ongoing
18
chest pain. He earlier indicated that PP was also on around-the-clock narcotic pain management. Tn his Board intetview respondent explained that even small diagonal arteries (OM3 and OM4) can cause "excruciatlrig pain." Respondent believes PP was on maximum medical management prior to the October 3, 20lllntervention. Respondent's decision to intervene was also informed by the angiogram showing 99 percent narrowing in both OM3
---and.OM4.--Respondent chameterized·them as·critical ~fype·C occlusions;-·He-hau·s~d-l'P -·- - --on anticoagulants, which he believes weighed in favor of more immediate intervention. Respondent indicated that calls had been placed _to other area hospitals that day and that he had been advised that no beds were available for PP's transfer. Respondent considered the angloplasty to be an emergent procedure a.t that time based on: I} PP's ongoing chest pain; 2) his asses.~ment following angiography that the lesiom were serious; 3) the unavailability of area hospital beds; and 4) his judgnient that his having started PP on anticoagulants favored intervention at that time.
39. The medical evidence supports a fmding that PP presented as an unstable patient. Although he had been hospitalized for five days prior to the intervention, he continued to experie11ce chest pain. Dr. Abraham considered such unrelenting symptoms as . strong indication that something needed to be done "to improve the situation." Dr. Acheatel's suggestion thatPP had not benefited from maximum medical management looked largely to increases/changes in dose or type of medications. Respondent indicated, however, that PP had been on beta blockers, nitroglycerine and narcotic pain medications without relief of symptoms. It does appear that PP had ongoing ischemia involving the Inferior wall, and that his on.going symptoms suggested dynamic heart issues. Such supports his medical judgment that PP was not in a stable condition. Angiography confirmed the serious natl.lre of the lesions, which respondent described as 99 percent narrowing in both arteries.
Respondent determined that transfer to another facility at that time was not an option, and he provided the rationale tor going forward with angioplasty. Both Dr. Abraham and Dr. Schwarz characterized PP as requiring immediate intervention. Dr. Schwarz explained that intervention was necessary at that time because a rupture could lead to ischemia or myocardial infarction, particularly in a diabetic patient who may otherwise be asymptomatic.
40. For all the above reasons the medical expert testimony ofDr. Abraham and Dr. Schwarz is consistent and persuasive thatPP presented with an emergent situation at the time of the October 3, 201langiogram and subsequent coronary lntcJ'Ventlons. Complainant, through the medical expert report and testimony of Dr. Achcatel, has not presented clear and convincing medical evidence otherwise.
Respondent did perform a coronary intervention in a facility not licensed at the time for such a procedure as alleged in the Accusation. However, hls actions fell within the recognized exception for emergent coronery cireuntstances.
Discussion of whether respondent failed to document in PP's medical records any findings, and altematives, benefits, and risks of performing a procedure at a facility that was
19
not licensed for such a procedure is deferred for now, but will be considered later as partof a more general discussion relating to all patients in this case.
Carotid Patients
Accusation allegations regarding the three carotid patients are similar. Their histories and complainant's contentions are briefly summarized below. Discussion of specific allegations relating to performance of unauthorized carotid procedures, neurological examinations, informed consent, and medical recordkeeping will then be considered in a broader context, incorporating all three, and sometimes all five patients.
PatientBR
41. Patient History. BR was seen by respondent on October 21,2011, with an <!dmitting diagnosis of cerebrovascular accident (CVA), also known as stroke. She was age 78 at that time. BR had a history of coronary artery disca..,e and she had had a stcnt placed In her right coronery artery ln 1997. Her medical history also included signlflcant hypertension, poorly controlled despite multiple medications, as well as a history of peripheral vascular disease. Respondcot dictated a History and Medical Examination report on her discharge, the extent of which history indicated: ''history of severe le:l't carotid artery. Patient with TIA:10-like symptoms. Currently the patient is doing well."
BR underwent a carotid angiogram which showed a high-grade leU internal carotid stenosis. Respondent performed carotid &'tenting at which time BR became hypotensive and bradycardic.
42. Complainant's Contentions. Accusation allegations relating to BR are that: I) respondent performed an intervention in a flleility not licensed for such a procedure; and 2) failed to document any neurological evaluationlltldlor fmdings, and alternatives, benetits, and risks of performing a procedure at a facility that was not licensed for such intervention. Such relate to respondent's performance of an intervention (carotid Mgiogram/~'tenting) in a facility not licensed for such intervention, but not to the manner in which he performed the actual intervention.
43. Dr. Acheatel is critical ofre.~pondent's reeordkeeping in this case. He noted in pru'tlcular respondent's failure in the Admission History to describe the CVA or related sympt()ffiS in any detail. He opined that the standard of care .is for there to be a neurological evaluation in such cases. Dr. Acheatel found no documentation of informed consent where respondent deseribed the procedure with its attendant risks, benefits and alternative.~. He further.understood that Desert Valley Hospital was not licensed to peri:brm carotid angiography or cartotid stenting. Dr. Achcatelsummarized the issues in BR's case as follows i11 his June 26, 2013 report:
10 Transient ischemic attack, or TIA, is a transient episode of neurologic dyslimction caused by ischemia without acute infarction (tissue death).
20
First, there is very poor medical rocordkecping. There is no indication in the Hlsto.ry and Physical of the patient's symptoms although there is indication of a cerebrovascular accident. There is no neurologic exam which would describe what the
____ Jl\!UXQI_Qgll.f!!Itil.l.4)!1g_s_ '!~~!-~urt!t_e.!It!Ore, in the Admission History and Physical, there is no indication-olcor!.Seni l:'or tfie---··----- ···· · ··------ · - -procedure to be performed. This is also the case in the office vi&'it notes. Sub.'ltantial documentation is lacking.
With regard to the procedure itself; there is still the issue as to whether Desert Valley Hospital at this period of time was authorized to perforn:i carotid angiography and carotid stenting. As alluded to above, U1ere is evidence that these procedures were not authorized to be done at this time. What is interesting, however, is the fact that there are procedure forms fi·om the hospital indicating carotid angiography and stenting, which would indicate the hospital was not cognizant of the fact that these procedures were not within the hospital's licensure at that time.
In my medical opinion, if, in fact, the hospital were to be found licensed to perform iliesc procedures, then Dr. Arunasal em's evidence of poor recordkeeping and lack of obtaining informed consent would also be considered an Extreme Depruture From the Standard of Care.
Patient MR
44. l?atientHlst"Oty. On June 20, 2011, MR; an 81-yea.r-otd man, was admitted to Desert Valley Hospital with acute onset ofleft-sided weakness, dragging ofhis left foot while ambulating and falling. His admitting diagnosis was CVA versus TIA. On June 23, 2013, respondent performed carotid angiography and PTCA 11 stenting of the right internal carotid artery. The rigl1t intemal carotid artery was desoribed as having 100 percent subtotal occlusion with stent placement and residual less than 20 percent stenosis, with Jess than TIMI-3 grsde flow post procedure and no visualization of the cerebral circulation. The left internal cll!'otid artery was described as having 95 percent eccentric st.enosis. MR underwent repeat angiography.in October 2011, due to symptoms of weakness on the right side. In an office note dated October 7, 2011, respondent noted under his impression section: "Thus patient is with dense tight hemiparesis secondary to left sided CV A secondary to chronic left sided carotid artery stenosis. Now with mild symptoms of further weakening on the right slde."
11 Percutaneous transluminal coronary angioplasty (PTCA) Is performed to enlarge the lumen of a sclerotic coronary artery.
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45. Complainant'§ Cgnteutlons. Accusation allegations relating to MR are that: 1) respondent performed an lntervention in a facility not licensed for such a procedure; and 2) failed to document any neurological evaluation andlot• findings, and alternatives, benefits, and risks of performing n procedure at a facility that was not licensed for such intervention,
- -Again,.su~h-relate to-respondenf~performan~-of an lnt!!l'VentiGn (carotid--. --- . -- ----- -·- --· ... anglography/stentlng) in a facility not licensed for such intervention, but not to the manner in which he performed the actuallntervention.
46. Dr, Acheate! raises similar criticisms regarding respondent's medical recordkeeping in this case. He noted that MR's records do not indicate that respondent had done a preoperative consultation 011 this patient and consequently there was no evidence that an informed consent was obtained from MR or his family. Dr. Acheatel idetltifi.ed a hru;dwritten note dated June 23, 2011, which stated "increased risk ofLC bleedingi discussed with family concerning bleeding risk." However, this note was prepared after the angiography and stenting procedure. Dr. Acheate! also indicated that there were en·ors in respondent's medial recordkeeping. For example, one of respondent's note.~ made reference to an October 21, 20 11 repeat angiography, but such note predated the actual procedure by two weeks (October 7, 201 J ). He is further critical of respondent's physical examination not including a neurological examination. Dr. Acheatel opined:
This again rel]ects what is a recurring theme with regard to Dr. Arunasalem's recordkeeping, which reflects wrong infomtation and lack of appropriate documantation of symptoms and fmdings. Consequently, based on these findlngs, as well as the procedure being performed in a facility not licensed for these procedures, I conclude that the care ofthL~ patient represents Extreme Departure From the Standard of Care.
Patient DSB
47, Patient History. On October 10,2011, DSB, a 76·year-old woman, waB referred to respondent for consultstion with symptoms of numbness in her arm and carotid artery duplex scan fmdings of 65 to 70 percont luminal narrowing. DSB had a history of diabetes, nephropathy, retinopathy, chro11ic obstructive pulmonary disease, hypertension and hypcrlipideml.a. Respondent saw her following a referral for carotid artery angiography and pos~lble stenting. Respondent documented that DSB had mild right-sided weakness and presented "signs, symptoms, complex ofhlgh-grade narrowing of the carotid artery by carotid ultrasound done at Desert Valley Hospital." His diagnostic impression indicated "findings consistent with carotid artery stenosis and TIA-Hke symptoms and patient to undergo angiography."
48. Qomplainant'ltCQntent!on~. Dr. Acheatel reviewed respondent's medical records related to DSB. He noted that respondent's consultation did not "reflect that he described his impression of the patient, with a description ofhis recommendations for angiography and possible intervention. He did not describe the benefits, alternatives, and
22
risks of the procedure in order to obtain informed consent." Dr. Acheatel also found that a procedure note incorrectly idcmtified two physician observers as performing the procedure on DSB. Dr. Acheatel summarized his opinion regarding respondent's care and treatment of DSB as follow~:
- ··········· --. - _ ....... --,!"his case,'as'was the case'\viththe'previouii carotid-cases, . -indicates that the patient was not adequately consented for the procedure, the procedure note is in error with regard to the physician performing the procedure, and the procedure was done at a facility that was not licensed to perlbrm either carotid angiography or carotid artery stenting at the time the procedure was performed. Consequently, as with the other cases, based on these findings, this represents an Extreme Departure From the. Standard of Care.
Unauthorized Carotid Procedures
49. At the time re.~pondent performed the carotid procedures in 2011 on patients BR, MR and DSB, Desert Valley Hospital was still a non-cardiac surgery hospital. By regulation, it was limited to specific types of diagnostic procedures that could be performed in its cath lab. (Cal. Code Regs., tit. 22, § 70438.1, subd. (b).) Respondent had no authority to perform carotid angiography or intcrventional stents at Desert Valley Hospital prior to CDPH granting the hospital permission to perform peripheral angiography on March 19, 2012. Tills is undisputed. He wa.~ not authorized to perform the procedures he did on BR, MR and DSB at Desert Valley Hospital.
50. Respondent noted that he was given staff privileges to perform all aspects of intervcntional cardiology at Desert Valley Hospital since 2004, and no limitation was imposed on his performing peripheral interventions including carotid angiography and stenting. With regard to coronary interventions, he did understand that he was limited to right and left heart catheterization and angiography, and coronary angiography, in the absence of an emergent situation. Respondent further explained that documentation of all procedures he perfonned in Desert Valley Hospital's oath lab was open and readily accessible to hospital administr!!tion and CDPH at all times. He denies being aware or ever being told that he could not perform peripheral angiography in the cath lab. He provided onsite training to other physicians on carotid procedures at Desert Valley Hospital. The hospital used informed consent forms that were specific to carotid procedures. From around 2004 to 2012, respondent even participated in an FDA, Medicare ar1d Institutional Review Board (IRB) - approved carotid stenting trial involving approximately 200 carotid patients, including some in this ease.
Up until 2010, Desert V ailey HOl!pital beli()ved it was authorized to perform peripheral angiography and related interventions on an elective basis in its cath lab. As earlier noted, it was not untll2010 that Desert Valley Hospital received an All Facilities
23
Letter (AFL) from CDPH, reminding all general acute care hospitals not providing cardiac surgery set'Vices of the limited diagnostic procedures that could be performed in cath labs. Desert Valley Hospital made its successful flex request to perform peripheral angiography in response to the AFL and its being cited by CDPH for performing unauthorized procedures .
. .. .... Importantly, aftel; reeelvingthe 2010 AFL alett, Desert Valley. Hospital CEO-Dr ,.Peterson .. - -- .... alerted cath lab staff not to perform unauthoriz.ed procedures. Respondent was on constructive notice from that time that peripheral angiography wa., not authorized.
51. Respondent contends that this is not a physician standard of care issue, and that .the limitations on procedures that could be performed in the cath lab are based rather on hospital-directed regulations. Neither respondent's judgment regarding medical indications for carotid procedures, nor the manner in which he peti'ormed the carotid procedures on BR, . MR and DSB have been criticized. But respondent's suggestion that this is therefore not a standard of care case is mistaken.
A standard of care Is a formal diagnostic and treatment process a doctor will follow for a patient with a certain set of symptoms or a specific illness. That standard will follow guidelines and protocols that experts would agre-e with as most appropriate, also called "best practice." Because standard of care looks to the treatment of patients, this 6f necessity
, includes treatment at an authorized hospital. Desert Valley Hospital fell within the class of California hospitals described at that time as general acute care hospitals not providing cardiac surgery services. Because it was a non-cardiac surgery hospital, it was limited to peti'orming only certain diagnostic procedures In its oath lab. Rellpondent understood this. He knew, for example, that any intervention following hoart catheterization and angiography could only be justified by emergent circumstances. This is tacit recognition that patient safety may be compromised when certain interventions are performed in non-cardiac surgery hospitals. In ·fuct, oath labs are authorized to operate in non-cardiac surgery hospitals only if they h!lve in place: I) provisions for emergency and routine transfer of patients; 2) provisions which specify that cardiac surgery staff and facilities shall be immediately available to patients upon notification of an emergency; and 3) provisions which specifY that the cath lab staff have responsibllity tot· arranging tran.~portation tci the. receiving hospitals. (Cal. Code Regs., tit. 22, § 70438.1, subd. (a).) In short, the venue where certain procedures such as peripheral angiography/stooting arc performed falls well within the treatment process an interventional cardiologist must follow. It was therefore a standard of care issue for respondent to perform peripheral angiography and related procedures only in an authorized setting. He failed to do so.
The regulations impose strict limitations on the types of procedure,q that can be performed in cath labs in non-cardiac surgery hospitals. As an interventional cardiologist, respondent was responsible for knowing these limitations. (Cal. Code Regs., tiL. 22, § 70438.1, subd. (b).) I)crlpheral angiography is not included as one of these procedures. Respondent had a duty to inquire and/or clarifY whether Desert Valley Hospital had received separate authorizntion from CDPH to perform this procedw·e. He fulled to do so. 'I11e fact that eath lab charge nurse Christine Bethel was aware sometime in 2011 that peripheral
24
angiography was not authorized highlights the importance of respondent, as the interventional cardiologist, also being aware.
52. For the above reasons, respondent's performall<:e of carotid procedures in . _2_01 )_at J?~ie.!! Yal!ey_Hospital on pJiti5ll).!il1?.R. Ml~,JI!ld.P.!l~. at_IHime . ..Y!llln..PJl~.!lri_Y~J~y ____ ..
Hospital was st!ll a non-cardiac surgery hospital, fell outside the standard of care. However, such was not an extreme departure from the standard of care. Dr. Acheatel conceded that he would withdraw any such criticism if it was reasonable for respondent to believe he was permitted to perform such procedures. In this case, respondent performed such proeedures openly and over a period of time when the hospital also believed such procedures were authorized. However, after the hospital and its oath lab were placed on notice in 2010 that such procedures were not allowed, respondent was on constructive notice that performing peripht.wal engiography in the cath lab was unauthorized. He knew or should have known from that time that performing peripheral angiography and related procedures was outside the standard of care. Accordingly, his perfonning such procedures on BR, lvlR and DSB constituted repeated depar\ures from the standard of care, i.e., repeated negligent acts.
Neurological ExamJnatkms
53. At hearing, complainant conceded that respondent performed and documented his neurological evaluation and! or findings with regard to DSB, and withdrew such criticism. This all~tion relates only to patients BRand MR.
54. Patient BR. Dr. Acheatel opined that neither respondent's History and Physical Examination for BR, nor his offiee notes described any neurologic symptoms. He explained that it is the standard of care for a patlent with a history of CV A to conduct a neurologic examination and to document neurologic findings. (Finding 43.) Respondent contends that he did conduct a neurological examination for BR. For example, he noted that on the admitting history and physical examination report he dictated, he referenced the fact that BR had "TIA like symptoms." Respondent explained that he could only have made this admitting diagnosis by performing a neurological examination. Although the typewritten report Wt\s dictated following her discharge, he noted that his comments were taken directly from contemporaneous handwritten notes written at ihe time of BR's admission. Such were contained in the record. Respondent made a further handwritten and signed entry in BR's hospital progress notes on October 22, 2011, which made reference to her having no _ "ne1.1rologic" symptoms. 11lis was one day after the procedure.
BR was referred to respondent by her primary care physician, William Jacobson, M.D. Importantly, her medical records on refemu indicated that she was also under the care of neurologist Noel C. Bernales, M.D. BR was seen by Dr. Bernales on July 12,2011, and again on August 16, 2011. Dr. Bemales prepared neurological reports after both visits, which were contained in BR's medical records, The August 16, 20 ll report described BR's neurological symptoms including "generalized parestheslas and numbness affecting limbs, more so the legs, more recently affecting the arms also." Dr. Bernal e.~ diagnosed BR with
25
underlying peripheral polyneuropathy, with superimposed carpal tunnel syndrome bilaterally. lie planned to follow up with her ln three months. .
Respondent. was aware ofBR's examinations by Dr. Bernales, and the neurological .. rep.orts.after.examinat!on ... He lndicatcd.that he deferred.to.Dv.-Elernales's-neurological- -- --· "''- -
findings. He ell:plalned that he could not do any better regarding the neurological examination, noting: "What more as a cardiologist am I to do?'i
Dr. Schwarz opined that it was wilhln the standard of care for respondent to have relied as he dld on patient BR's medical records as a whole in documenting her neurologieal condition.
5 S. Patient MR. Complainant is critical of respondent's record of physical examination ofMR not including a neurological examination. Christine Bethel, a registered nurse and the Charge Nurse since 2009ln Desert Valley Hospital's cath lab, testified at hearing. Ms. Bethel reviewed patient records which confirm that she was present during the October 2011 procedures for both BR and MR. Ms. Bethellndlcaled that she and other cath lab nurses performed neurological examinations on the carotid patients as part ofthe Choice Study protocols, and that documentation ofsame was maintained separately from the patient
. tnedical records.
Importantly, Peter C. Lue, M.D., dictated neurologic findings on MR upon his earlier hospital admission on June 20, 2011, and of which respondent was aware. Dr. Lue indicated at that time that: "The patient is able to follow commands, but he has left upper extremity and left lower extremity weakness, although he is able to move them. He does have a left facial droop. He does have left-sided neglect." MR's admitting diagnoses at that time included "Acute right-side~ cerebrovascular accident." Respondent performed two carotid angiographies on MR, the first on June 23, 2011. Dr. Schwarz opined that respondent's reliance upon the neurological findings of Dr. Lue, documented only three days earlier, in MR 's medical records was within the standard of care.
56. Respondent's reliance upon the neurological examinations of Dr. Bernales and Dr. Lue, performed respectively on patients BRand MR, was within the standard of care. Dr. Bernales is a neurologist. He parformed two neurological examinations which were contained in BR's medical records and about which respondent was aware. Dr. Lue performed and documented his neurological examination on MR three days before respondent performed the first carotid angiography in June 20 11. And Ms. Bethel teatified credibly that she routinely performed neurological examinations on carotid patients when she participated in the carotid procedures in the oath lab. For these reasons it was not established by clear and convincing evidence that respondent failed to perform/document a neurological examination and/or findings for carotid patients BRand MR.
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Documentation of Informed Consent
57. For all patients, complainant alleges that respondent failed to document informed consent where he described the procedures to be performed with attendant risks,
~---henetits,.and alternatives .. (See. Findings 19. and.20.)_As noted earlter_withregat:d.to . .W.S,_Dr. ___ .. Acheatel opined that the hospital chart showed no pre-procedure admission and history or consultation, which riwant that there was no documentation of an adequate consent'obtained by the patient by respondent. Dr. Acheatel believed there should he a separate patient chart entry, indepelldent of any signed informed consent form, indicating that the physician described the procedure, its benefits and risks, and alternatives to the patient. In contrast, Dr. Schwarz was unaware in his experlence of any additional requirement for a physician to make a separate chart entry in patient medical records indicating that an informe.d consent discussion ocaurre~. He credibly opined that it is enough that the patient sign an informed consent form, and that respondent was not required to separately chart the fact of any "discussion of the consent obtained from the patient by the physician doing the procedure." Dr. Schwarz was persuasive that having the patient and physician sign the informed consent form is all that is needed to comply with documentation requirements for informed consent. (See Finding 27.)
58. For every patient, respondent used an informed consent form from Desert Valley Hospital entitled "Authorization for and Consent to Surgery for Special Diagnostic or Therapeutic Procedure.~." Paragraph 6 of the form provides space for the physician to detail the recommended operation or procedure. For WS, for example, the handwritten entry provided that he was to undergo: "Left Heart Catheterization, Selective Coronary Angiography, Left Ventriculogram." The Informed consent form had separate spaces for physician and patient signatures. Above the physician signature line is the following language:
lNFORMED CONSENT I, the undersigned physician, hereby certify that l have discussed the procedure named above with this patient and/or family/conservator/guardilm, including the risks and benefits of the procedure, any adverse reaction.~ that may reasonably be expected to ocour, any alternative efficacious methods of treatment which may be medically viable and any research or economic interest I may have regarding the treatment.
Paragraph 3 of the informed consent form contains the following patient-directed language:
To make sure that you fully understand the operation or procedure, your physician will fully explain the operation or procedure to you before you decide whether or not to give consent. If you have any questions, you are encouraged and
27
expected to ask them. Your signature on this form Indicates that: (1) you have read and understood the information provided in this form, (2) the operation or procedure indicated on the back of this form, its risks, benefits and alternatives have
... --···-· ----·- been adequately.ex:plainedto.yotJ-by.your-physiclan, (J)-you -· -have had a chance to ask questions, (4) you have received all of the information you desire concerning the operation or procedure, and (5) you authorized and consent to the performance of the operation or pt•ocedure and the anesthesia or sedation.
Above the patient signature line is the following language:
I, [patient name], acknowledge that my doctor has explained to me that 1 will have an operation, diagnostic or treatment procedure. My doctor has explained the risks of the procedure, advised me of alternative treatments and told me about the expected outcome and what could happen if my condition remained untreated. I also undet:lltand the anesthe.,ia services are needed so that my doctor can perform the operation or procedure.
59. Respondent testified that it is his practice in coonection with every interventional cardiology procedure to have a discussion with the patient in which he describes the procedure andlor intervention, its benefits and risks, and alternatives. Both respondent and his stat'f engage in this process. He noted that for most cardiology diagnostic procedures/interventions, he personally explains to patients that the risks include bleeding, infection, rupture, stroke or death. For coronary procedures performed prior to 2008, the informed consent form made reference to possible interventions such as stents. Since 2008, however, afler CDPH clarified to Desert Valley Hospital that coronary interventions could only be done cmergently, the Informed consent form no longer referenced such Interventions. In those cases respondent obtaiUIJ verbal consent to emergent interventions. He ave.rred that he did so orally for both WS and PP. He did obtain a signed informed consent form from . both WS and PP tor tile coronary angiographlc procedures. Respondent forgot to sign his name on the informed consent form for WS.
For the three carotid procedures, respondent explained the risks and benefits ofthe procedure to each patient. The three patients were all participants in a Choice carotid stenting study. The study protocol required the doctor to "explain to yon, separately, the risks of your carotid stenting procedure." Respondent indicated that he did so for patients BR, MR and DSB. The medical records tbr BR, MR and DSB all contained signed informed consent forms.
60. BR signed the informed consent form on October 18, 2011, at 2:00p.m. The procedure was described as "Carotid Angiogram, Possible Angioplusty, Possible Stent." The
28
form was not signed by respondent There is a notation on the physician signature Une indicating that it was "Authenticated by SivaArunasalam, MD on 11/15/2011.. .. " Respondent believes that it is within the standard of care to later authenticate his having earlier engaged in an informed consent patient discussion. The event log for the October 21, _Z_Ql.Lmo_c~lro:eon_BB f).lrtherJn4!~~!l~ l;hati!UQ;lO f\.m,_"!?ll!i~!l!\ltl_rP~i?~d _______________ _ Understanding of Procedure." There Is another reference in the event log at 10;10 a.m. to "Consent signed and on chart." Finally, there is a reference at 10:22:52 a.m. to "Patient has been informed of the risks and benefits." This is consistent with tha testimony of cath lab charge nurse Christine Bethel that Informed consent was confirmed for every carotid patient.
MR signed the informed consont form on October 21,2011, at 10:00 a.m. The procedure was described as "Carotid Angiogram, Possible Angioplasty, Possible Stent." Respondent signed the form that same date. The event log for the October 21, 2011 procedure. on MR further it1dicates !hat at 11:43 a.m., "Patient Verbalized Understanding of Procedure" and that "Consent signed and on chart." The event log indicated that re.~pondent arrived at 12:16 p.m. This was followed by a reference. at 12:17:08 indicating, "PreProcedure assessment By Physician: No Change in patient cond." And a subsequent reference at 12:18:08 indicating, "Patient has been informed of the risks and benefits."
DSB signed the informed consent form on October 21,2011, at7:45 a.m. The procedure was described as "Carotid Angiogram with Possible Angioplasty Possible Stent." Respondent signed the form. The event log for the October 21, 2011 procedure on DSB further Indicates that at 9:11 a.m., ''Patient Verbalized Understanding ofProcedurc'' and that "Consent signed and on chart." This was followed by a reference at 9:20: 19 indicating, "Pre· Procedut'e assessment By Physician: No Change in patient cond." And a subsequent reference indicating, "Patient has been informed of the risks and benefits."
61. The above matters have been considert:d in finding that raspondent, for each patient, did document a pre-procedural eo!)Sultation describing the recommendation for angiography and possible intervention, and alternatives, benefits and risks of performing the procedures/interventions. Respondent's documentation of same in the patient records for WS, PP, BR, MR and DSB fell within the standard of care. The testimony and opinion of l)r. Acheatel was not persuasive otherwise. Complainant did not establish by clear and convincing evidence that respondent failed to perform/document alternatives, benefits and risks of performing procedures/interventions fur these five patients.
Medical Recordkeeping
62. Complainant has generally alleged that respondent failed to maintain adequate and accurate records in the care and treatment of patients WS, PP, BR, MR and DSB. The allegations were largely based upon the specific accusation allegations relating to lack of documentation of a pre-procedural consultation with documentation of informed consent, respondent's purported failure to perform/document a neu!'ological examination and/or findings for carotid patient.~ BRand MR, and specific instances of inaccurate or missing
29
' documentation in patient records. The allegations relating to documentation of neurological examinations and informed consent have already been discussed in Findings 53 to 61. Dr. Acheatcl identified other examples of medical recordkeeping errors related to dates, missing signatures and other instances of"poor reeordkeeping." Such were the exception, not the
.. ..ru.LeL Respondentgenerally maintained adequate andaccll.l'llte.medical records.for.all.flv.e _ ...... ~ patients in this case. Dr. Schwan found respondent's medical recordkeeping to be within the standard of c!ll'e as it related to documentation of both neurological examinations and informed consent. He explained why sep!ll'ate documentation of respondent having engaged in discussion of informed consent was unnecessary. Respondent's patients all signed an informed consent form. In addition, there is separate documentation of his pre-procedural discussion of informed consent for all three carotid patients. Respondont has further identified separate ontries in patient medical records indicating when and what neurological examinations were performed.
63. Dr. Schwarz reviewed the patient medical records in this case. He noted that respondent's patient medical records provided adequate documentation of his medical/clinical fmdlngs, reasons/indications for each procedure and patient outcomes. Dr. Schww" opined that respondent's documentation was "more than adequate" and that his general medical recordkeeplng did not deviate from the stand!ll'd of CIU'e.
Respondent's medical records for WS IU'e instructive. ').'hey detail WS's history of treatment and care by respondent from 1999, including numerous reports and studies following the different diagnostic procedures perfurmed on him through the December 30, 2010 procedure. Respondent's operative reports for both the May 24, 2007 and December 3 0, 20 1 0 c!ll'diao catheterization procedures on WS provide detailed and accurate information on each step taken duilng the course of the procedures/interventions, as well his thinking on the medical indications for doing so. (See Finding 13.) Simlllll'ly, respondent's October 3, · 2011 separate operative reports for PP's clll'diac catheterization and pcriclll'diocentosls procedures set forth both the indications and procedural steps for the procedures in some detail.
64. The above matters have been considered ln finding that re,qpondent generally maintained adequate and accurate medical records in the o!ll'e and treatment of each of the five patients in this case. Respondent's documentation of his care and treatment of WS, PP, BR, MR and DSB fell within the standard of care. The testimony and opinion ofDr. Acheatel was not persuasive otherwise. Complainant did not establish by clcar and convincing evidence that respondent failed to maintain adequate or accurate medical records for these five patiimts.
Disciplinary Considerations
65. Respondent has no other history of disciplinary action by the Bo!ll'd. The two more serious allegations in this case related to eoron!ll'y patients WS and PP. In both cases respondent well explained the emergent circumstances and indication.~ for performing the
30
coronary interventions that he did while at Desert Vailcy Hospital's cath lab. His clinical judgments in both cases were reasonable and strongly supported by medical experts Dr. Abraham and Dr. Schwart:. The medical opinion of Dr. Acheatel was not persuasive otherwise. In addition, Accusation allegations 1'elatlng to respondent's documentation of informed oonsont, neurological examinations and medical recordkeeping were neither
-- supported nor established "by clear and ·convUiCing evfaence. ··- . ... ... . -· --·-. . . -. . .. . . .
66. Respondent's performance of carotid procedures in 2011 at Desert Valley Hospital on patients BR, MR and DSB, at a tlmc when Desert Valley Hospital was still a non-cardiac surgery ho$pital, full outside the standard of care. He performed such procedures openly .and over a period oftime when the hospital also believed such procedures were authorized. However, after the hospital and Its oath lab were phiced on notice in 2010 that such procedures were not allowed, respondent was on constructiv~ notice that performing peripheral angiography in the cath lab was unauthorized. He knew or should have known from that time that performing peripheral angiography and related procedures was outside the standard of care. Accordingly, his performing such procedures on BR, MR and DSB constituted repeated departures ft'Om the standard of care, i.e., repeated negligent acts. ·
67. Such repeated negligent acts are deemed minor violations that do not require placing respondent on probation. Respondent's clinical judgments regarding the medkal indications for the carotid procedures und the manner in which they were performed have not been criticized. He acknowledged and understands that peripheral angiography and stenting procedures were not authorized at the time he performed the procedures on the three patients. . Given these circumstances, probation wHI serve no public interest. Nor would enrollment and successful completion of a clinical course or tralning program be necessary in this case. l'or these several reasons it is recommended that the Board issue a public letter of reprimand to respondent. Such is appropriate discipline in this case.
LEGAL CONCLUSIONS
l. Business and Professions Code section 2234 provides that the Board shall take action against any licensee found to have engaged in unprofessional conduct. Under section 2234, 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 [Chapter 5, the Medical Practice Act]. .
(b) Gross negligence,
( o) Repeated negligent act.~. To be repeated, thoro must be two or more negligent acts or omissions. An initial negligent act or
31
omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.
{!)_An initial negligent diagnosis followed.by.ru1 act or_ ... omission medically appropriate fur that negligent diagnosis of the patient shall conlltitute 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.
2. Business and Professions Code section 2266 provides: "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."
3. Respondent had a duty to engage in medical practice, including interventional cardiology, with fue degroo of learning and sklll ordinarily possessed by a reputable physician practic.in.g in the san1e or similar locality ood under similar circumstances. He Wll8
further obligated to use reasonable diligence and his best judgment in fue exercise of his professiotml skill and in the application of hi.~ learning, in an effort to accomplish the purpose for which he was engaged. A failure to fulfill such duty is negligence. (Keen v. Prislmano (1972) 23 Cal.App.3d 275, 279; Hv/fman v. Lundquist (195;) 35 Ca1.2d 465, 473.) A physician is not necessru·Uy negligent because of errors in judgment or because efforts prove unsuccessfuL A physician is negligent only where the error in judgment or lack of success is due to a failure to perform any of the duties required of reputable members ofthe medical profession practicing under similar ciroumstances. (Norden v. Hartman ( 195 5) 134 Cal.App.2d 333, 337; B!ackv. Caruso (196Q) 187 Cai.App.2d 195.) A lack of ordinary care defines negligent conduct. Gross negligence, however, is defined by an error or omission that is egregious and flagrant. "Or9ss negligence ha.~ been said to mean the wru1t of even scant cru·e or an extreme departure from the ordinary standard of conduct,'' (Van Mete:r v. Bent Com;truction Co. (1946) 46 Cal.2d 588.)
4. No cause for disciplinary action exillts under Business and Professions Code section 2234, subdivision (b), by reason of the Juatters set forth in Findings 21 through 26, 28 through 31, 36 through 40, and 49 through 61. Respondent was not grossly negligent in connection with his care and treatment of patients WS, PP, BR, MR and DSB,
For coronary patients WS and PP, it was not established that respondent failed to properly interpret the coronary ru1giogram, and then proceed with the proper treatment
32
options. The medical expert testimony of Dr. Abraham and Dr. Schwarz is consistent and persuasive that WS and PP presented with emergent situations at the time of their LHCs and subsequent coronary interventions. Complainant, through the medical expert report and testimony of Dr. Aeheatel, has not presented clear and convincing medical evidence otherwise. The burden is on complainant to demonstrate that respondent engagedin gross
.. negligel1cie-:- In the.Se proceedings-the aegree- of proof required -is clear anl CO!lVincing-- - . -· evidence to a reasonable certainty. (Ettinger v. Board of Medical Quality Assurance (1982) 135 Cal.App.3d 853.) The application of this higher standard of proof is justified where vested rights are at stake- the revocation or suspension of a physician's and surgeon's cel'tificate in this case. Complainant has not met this burden here.
For patients BR and MR, it was not established that respondent failed to document any neurological evaluation and/or findings. For all patients, it was not established that respondent failed to document alternatives, benefits and risks of performing a procedure.
5. Cause for disciplinary action exists under Business and Professions Code section 2234, subdivision (c), by reason ofthc matters set forth in Findings 49 through 52. It was established that respondent engaged in repeated negligent acts; specifically, his performance of carotid procednres in 2011 at Desert Valley Hospital on patients BR, MR and DSB, at a time when Desert Valley Hospital was still a non-cardiac surgery hospital. From around 201 0, respondent knew or should have known that performing peripheral angiography and related procedures was not permitted at Desert Valley Hospital. Consequently, performing such procedures at the hospital was outside the standard of care. Accordingly, his performing such ptoced1,lres on BR, MR and DSB constituted repeated departures from the standard of care, and therefore repeated negligent acts.
6. No cause for discipline existS under Business and Professions Code section 2266, by reason of the matters set forth in Findings 62 through 64. Respondent generally maintained adequate and accurate medical records in the care and treatment of each ofthc five patients in this case.
7. Business and Professions Code set.'i:ion 2221.05 provides:
(a) Notwithstanding subdivision (a) of Section 2221, the board may issue a physician's and surgeon's certificate to an applicant who has committed minor violation.~ that the boarcl deems, in its discretion, do not merit the denial of a certificate or require probationary statllll under Section 2221, and may concurrently issue a public letter of reprimand.
(b) A public letter of reprimand issued concurreqtly with a Physician's and s\lrgeon's certificate shall be purged threeyeru·s fi·om the date of iss\lance.
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(c) A public le1ter ofreprhnand issued pursuant to this section shall be disclosed to an inquiring· member ofthe public and shall be posted on the board's Internet Web site.
- (d) Nothing in this section shall be·construed·to affeet the · board's authority to issue an unrestricted license.
The matters set forth in Findings 65 through 67 have been considered iri determining that the appropriate discipline in this case is for the Board to issue a public letter of reprimand to respondent.
ORDER
Respondent Siva Arunasalam, M.D., shall receive a written public reprimand for his repeated negligent actions per Legal Conclusion 5. Should the Board so elect, this decision shall serve as that reprimand.
DATED: March 5, 2015
.1La ~ THAN LEW !Strative Law Judge
Office of Administrative Hearings
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