Directions for Submitting Comments

The REQUEST FOR STAKEHOLDER INPUT requires use of this written comments form. Include AFL No. 18-22 in the AFL box. The "Service" is Cardiovascular Surgery. The section number is 70435. Please e-mail the completed form to Here is some sample language to consider for inclusion in the form:

Thank you for the opportunity to submit stakeholder input regarding potential amendments to the California Code of Regulations, Title 22. As a cardiothoracic surgeon in California, I find the current requirements of CCR Title 22, Division 5, Article 6, 570435(b)(2) to be outdated and overly restrictive. I respectfully request changes to Title 22 that would allow me, as the primary surgeon, to determine the composition of my team based on the acuity of the patient and the competence of the available assistants.

California is the only state which precludes surgeons from determining the makeup of their cardiothoracic surgical team. The requirement that such a team be limited to three physician/surgeon assistants is overly prescriptive, and I ask that all references to the qualifications of those individuals assisting in the performance of the surgery be stricken from the regulation.

California has a shortage of trained cardiothoracic physician/surgeons. Allowing surgeons the flexibility to include qualified providers such as cardiothoracic surgical physician assistants (PAS) on their teams would reduce delays and provide better access to care for patients who are critically ill. The use of PAS in this role has been endorsed by the Society of Thoracic Surgeons (STS) and the American Association of Thoracic Surgery (AATS).

Attached, you will find an Executive Summary and other documents to support these changes.

6/19/2018 AFL 18-22 Request for Stakeholder Input In Amending CACH Cardiovascular Surgery Service and Cardiac Catheterization Laboratory Service ...

State of California—Health and Human

Services AgencyCalifornia Department of

Public HealthKAREN L. SMITH, MD, MPH EDMUND G. BROWN JR.

Director and State Public Health OfficerGovernor

AFL 18-22June 12, 2018

TO: General Acute Care Hospitals (GACHs)

SUBJECT; Request for Stakeholder Input in Amending GACH Cardiovascular Surgery Service and Cardiac Catheterization Laboratory Service Regulations

Ali Facilities Letter (AFL) Summary

The California Department of Public Health's Center for Health Care Quality (CHCQ) is seeking assistance in

amending GACH cardiovascular surgery service and cardiac catheterization laboratory service regulations

under

California Code of Regulations, Title 22, sections 70431 through 70439.

CHCQ is seeking input from interested stakeholders as part of the regulation development process to ensure

proposed regulations are consistent with other laws and regulations, modern hospital practices, and other

relevant standards, CHCQ has begun the process of revising regulations governing GACHs under California Code of

Regulations, Title 22. These GACH regulations include the following sections:

section 70431 Cardiovascular Surgery Service Definition section 70433 Cardiovascular Surgery Service General Requirements section 70435 Cardiovascular Surgery Service Staff

section 70437 Cardiovascular Surgery Service Equipment and Supplies section 70438 Cardiac Catheterization Laboratory Service section 70438.1 Cardiac Catheterization Laboratory Service—General Requirement section 70439 Cardiovascular Surgery Service Space

Instructions for Submitting Written Comments

Please submit your written comments by June 29, 2018 using the Written Comments Form. Stakeholders should

provide the section number they are addressing, their name, the name of the organization they represent, and

their comment or proposed text.

Please submit your response by email to CHCQRegulationsUnit@cdph.ca.gov, or you may also mail your commentsto:

California Department of Public Health

Center for Health Care QualityAttn: Regulations Unit, MS 3201

https://www.cdph.oa.govfPrograms/CHCQ/LCP/Pages/AFL- 18-22.aspx 1/2

6/1912018 AFL 18-22 Request for Stakeholder Input in Amending GACH Cardiovascular Surgery Service and Cardiac Catheterization Laboratory Service ...

P.o. Box 997377Sacramento, CA 95899-7377

Sincerely,

Original signed by Scott Vivona

Scott VivonaAssistant Deputy Director

Attachment: Written Comments Form

Center for Health Care Quality, MS 0512 P.O. Box 997377 Sacramento, CA95899-7377

(916) 324-6630 . (916) 324-4820 FAXDepartment Website (cdph.ca.gov)

Page Last Updated : June 18, 2018

https://www.cdph.ca.gov/programs/CHCQ/LCP/Pages/AFL-18-22.espx 2/2

Executive SummaryTitle 22 of the California Code of Regulations and Cardiovascular Surgery

Title 22 of the California Code of Regulations, Section 70435(b)(2) currently requires the surgical team for extracorporeal bypass to include a minimum of three surgeons. CCR Title 22, Division 5, Article 6,

"A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b)(l) above."

For procedures that require extracorporeal bypass, primary surgeons should be allowed to choose their cardiovascular surgical team. A primary surgeon is well qualified to determine the appropriate assistants for the procedure. Delays in care can occur when there is one surgeon, yet no available assistant surgeons trained in cardiovascular surgery, although PAS (physician assistants) with this experience may be available. Hospitals often have to find alternative ways to work around to address this problematic rule. If a workaround is necessary to provide critical care to patients, then the underlying administrative rules that have not kept pace with modern approaches to the delivery of healthcare need to be revised. California's rules governing PA practice, Title 16 section 1399.541, specifically allow PAS to act as first assistant during surgery.

In 49 states, and the District of Columbia, PAS may act as first assistants on the cardiovascular surgical team—without a distinction between cases that require bypass and those that do not. California remains the sole state with a restriction that precludes PAS from first assisting in procedures that require extracorporeal bypass. It is of note that the rules currently allow PAS to first assist on cases that do not require bypass, which are indisputably more difficult than the cases where PAS are unable to first assist based on Section 70435(b)(2).

The California Department of Public Health (CDPH) has the option to issue "Authorizations for Program Flexibility" to allow individual hospitals to apply for "waivers" to a specific regulatory requirement. Currently, CDPH has refused to grant requests for program flexibility from Section 70435(b)(2) for PAS to serve as first assistants on the surgical team when a patient is on bypass. CDPH has commonly granted waivers to allow PAS to act as second assistant. Only Kaiser San Francisco has had a waiver to authorize PAS to first assist while a patient is on bypass.

Recently the California Department of Public Health has started a process to update outdated regulations as it relates to Cardiac Surgery. A request for stakeholder input was sent to all acute care hospitals which will be followed by a request for public input. It is our intention to use this process to update the regulations to allow the primary surgeon to choose the make-up of the surgical team.

Patients are ill-served when qualified providers are limited in care by archaic regulation. This regulation is inconsistent with modern practice and should be amended.

Title 22 Regulation Sections Referenced in All Facilities Letter No. 18-22

The California Department of Public Health's Center for Health Care Quality (CHCQ) is seeking assistance in amending general acute care hospital (GACH) cardiovascular surgery service and cardiac catheterization laboratory service regulations under California Code of Regulations, Title 22, sections 70431 through 70439.

5 70431. Cardiovascular Surgery Service Definition.

Cardiovascular surgery service means the performance of laboratory procedures for obtaining physiologic, pathologic and angiographic data on patients, and cardiovascular operative procedures, each supported by appropriate staff, space, equipment and supplies. It is the intent of this definition that the two aspects of this service shall not exist separately.

5 70433. Cardiovascular Surgery Service General Requirements.

(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate, These policies and procedures shall include provision for at least:

(1) Definitions of qualifications of physicians for privileges to perform cardiovascular laboratory catheterization procedures and/or surgery.

(2) Regular review of case management, both preoperatively and postoperatively.

(3) Collection, processing and retrieval of data on all patients to include at least: diagnosis, procedure performed, pathophysiologic, angiographic, morbidity and mortality data.

(4) Recommendations regarding equipment used, procedures performed and staffing patterns in the catheterization laboratory and cardiovascular surgery units.

(b) The responsibility and the accountability of the service to the medical staff and administration shall be defined.

(c) An adequate service base shall support the provision of these services, Recommended minimums are:

(1) 260 cardiac catheterizations per year.

(2) 150 cardiovascular procedures requiring extra corporeal bypass per year.

(d) The cardiovascular surgical service shall be available at all times for emergencies.

(e) Supportive diagnostic services with trained personnel shall be available and include, where appropriate, electrocardiography, vectorcardiography, exercise stress testing, cardiac pacemaker station, echocardiography, phonocardiography and pulse tracings,

(f) An intensive care service with respiratory care capabilities shall be provided by the hospital, (g)

An animal laboratory is recommended as support for the cardiovascular surgery service.

(h) A cardiac rehabilitation program should be integrated with the cardiovascular surgery service for early identification of the patient who can profit thereby.

(i) All persons operating or supervising the operation of X-ray machines shall comply with the requirements of the Radiologic Technology Regulations, Subchapter 4.5, Chapter 5, Title 17, California Administrative Code.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.

5 70435. Cardiovascular Surgery Service Staff.

(a) Cardiovascular catheterization laboratory.

(1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification in cardiology by either the American Board of Internal Medicine or the American Board of Pediatrics or have equivalent experience and training. He shall be responsible for:

(A) Implementing established policies and procedures,

(B) Supervision and training of all personnel, including in-service training and continuing education.

(C) Assuring proper safety, function, maintenance and calibration of all equipment.

(D) Maintaining a record of all angiographic procedures performed.

(2) A physician who is certified or eligible for certification by the American Board of Radiology with special training or experience in cardiovascular radiology shall be available to the cardiovascular surgery service staff.

(3) Two persons (registered nurses or cardiovascular technicians) shall assist during the performance of all cardiac catheterization procedures. These personnel shall be trained in the use of all instruments and equipment and shall be supervised by a physician.

(4) A biomedical engineer shall be available for consultation as required.

(5) An electronic technician shall be available where required.

(b) Cardiovascular operative service.

(1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery, He shall be responsible for:

(A) Implementing established policies and procedures.

(B) Training and supervising the nurses and technicians in special techniques.

(C) Training and supervising the clinical perfusionists.

(2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above.

(3) Anesthesia for cardiovascular procedures shall be administered by a physician who is certified or eligible for certification by the American Board of Anesthesiology.

(4) A physician who is certified or eligible for certification in cardiology by the American Board of Internal Medicine should be a member of the surgical team and should assist in monitoring the patient.

(5) Clinical perfusionists shall operate the extracorporeal equipment under the immediate supervision of the cardiovascular surgeon or cardiologist.

70437. Cardiovascular Surgery Service Equipment and Supplies.

(a) Cardiovascular catheterization laboratory equipment and supplies shall include but not be limited to:

(1) X-ray machine

(2) Image intensifier.

(3) Pulse generator,

(4) Camera.

(5) Spot film device.

(6) Videotape viewing equipment of fluoroscopic procedures.

(7) Magnetic tape recording and playback equipment.

(8) Motor driven cardiac table.

(9) Cinefiuorography and radiography equipment.

(10) Monitoring and recording equipment.

(11) Pressure transducers.

(12) Equipment for determining cardiac output,

(13) Equipment for exercising patients during procedures.

(14) Equipment for determining oxygen saturation, hemoglobin, blood gas analysis and pH.

(15) Appropriate cardiac catheters and accessory equipment.

(16) Resuscitation equipment.

(b) Cardiovascular operating room equipment and supplies shall include but not be limited to:

(1) Monitoring and recording equipment for:

(A) Electrocardiograms.

(B) Pressures.

(C) Coronary blood flow.

(D) Cardiac output.

(E) Patient temperature.

(2) Blood gas analyzer.

(3) Heart-lung machine with oxygenator.

(4) Device for rapid cooling and heating of the patient,

(5) DC defibrillator.

(6) Magnetic tape recording equipment.

(7) Suction outlets, piped in air and oxygen and tanks of gas including mixtures of oxygen and carbon dioxide.

(8) All other necessary equipment and supplies as required in an operating room.

5 70438. Cardiac Catheterization Laboratory Service.

Cardiac catheterization laboratory service shall be organized to perform laboratory procedures for obtaining physiologic, pathologic and angiographic data on patients with cardiovascular disease.

5 70438.1. Cardiac Catheterization Laboratory Service -General Requirements.

The cardiac catheterization laboratory service may be approved in a general acute care hospital which does not provide cardiac surgery provided the following requirements are met:

(a) The hospital shall maintain a current written transfer agreement as specified in Section 1255 of the Health and Safety Code, which shall include all of the following:

(1) Provisions for emergency and routine transfer of patients.

(2) Provisions which specify that cardiac surgery staff and facilities shall be immediately available to the patient upon notification of an emergency.

(3) Provisions which specify that the cardiac catheterization laboratory staff shall have responsibility for arranging transportation to the receiving hospitals.

(b) Only the following diagnostic procedures shall be performed in the catheterization laboratory:

(1) 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.

(c) The hospital shall comply with all of the requirements of Sections 70433(a), (b), (c)(l), (e), (i), (j), 7043%) and 704376).

5 70439. Cardiovascular Surgery Service Space.

(a) Catheterization laboratory space shall include:

(1) A minimum floor area of 40 square meters (450 square feet) for the procedure room.

(2) A minimum floor area of 9 square meters (100 square feet) for each of the following:

(A) Control, monitoring and recording equipment.

(B) X-ray power and controls.

(C) Work room.

(D) Dressing rooms for doctors and nurses.

(b) Cardiovascular surgery space shall include:

(1) Operating rooms that comfortably accommodate 12 persons and all necessary equipment with a minimum floor area of 60 square meters (650 square feet).

(2) Work room.

(3) Pump work room,

(4) Adequate storeroom.

* - AAPAJanuary 18, 2017

Ms. Jacqueline LincerCalifornia Department of Public HealthLicensing and Certification Division681 Parker St., Suite 200Orange, CA 92868

Electronic DeliveryUSPS First Class

Dear Ms. Lincer:

The American Academy of PAS (AAPA) is the national professional organization for PAS (physician assistants). In this capacity, AAPA represents a profession of more than 1 15,000 PAS across all medical and surgical specialties, in all 50 states, the District of Columbia, U.S. territories and the uniformed services.

It has come to our attention that requests for program flexibility from California's Code of Regulations, Title 22, Section 70435(b)(2) to allow PAS to first assist during extracorporeal bypass surgery are being uniformly denied by the California Department of Public Health (CDPH). Section 70435(b)(2) requires the surgical team for extracorporeal bypass procedures to include a minimum of three surgeons. This type of restrictive rule, specifically for extracorporeal bypass procedures, exists only in California and is outdated and unnecessary. In every other state, PAS perform as first assistants during this procedure.

California's regulations allow for rule exceptions to be made for specific facilities through requests for program flexibility.2 However, CDPH has refused to grant requests for program flexibility from Section 70435(b)(2) for PAS to serve as first assistants on the surgical team. We are greatly concerned with the refusal to grant a waiver of prograll) flexibility to allow PAS to first assist during extracorporeal bypass surgery. Physicians in California desire to work with PAS as first assistants during extracorporeal bypass, similar to their colleagues throughout the country. CDPH's denial of requests for program flexibility for PAS as first assistants during extracorporeal bypass lacks any basis in data, research or California statutory intent and merely appears to unnecessarily restrict competition.

PAS Regularly First Assist During Extracorporeal Bypass in Every State Except California Throughout the United States, PAS routinely work as first assistants during extracorporeal bypass procedures. In fact, California is the only state that does not allow PAS to first assist during extracorporeal bypass procedures. California's Health and Safety Code does not contain any provisions regarding the composition of the surgical team for extracorporeal bypass surgery nor any intent that the team should be limited to physicians as first assistants.

CCR Title 22, Division 5, Article 6, "A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph I ) above," 2 CCR Title 22, Division 5, Article 2, 70]29.

2318 Mil' Road, suite 1300, Alexandria, VA 22314 P 703.836.2272 703.684.1924 aapa@aapa.org vvww.aapa.org

The problematic rule language in California's Title 22, Section 70435(b)(2) was implemented in 1971, when the PA profession was less than 5 years old, and had only been established as a profession in California for one year. It is foreseeable that rulemakers at the time may not have contemplated or been familiar with this new group of healthcare professionals, PAS, when drafting the rule. Since that time, PAS have become widely used as first assistants during extracorporeal bypass procedures throughout the rest of the country.

Since 1996, CDPH has only granted Kaiser Permanente San Francisco a program flexibility waiver allowing PAS at that facility to first assist during bypass procedures- the same role that is now being inexplicably denied by CDPH. In addition, PAS in California can first assist during cardiac procedures that do not require bypass, which are indisputably more difficult than the procedures on which PAS are being denied the ability to first assist.

There is no Data to Indicate PAS Are Unqualified to First Assist or Pose a Risk to Patients Aside from the waiver issued to Kaiser Permanente San Francisco in 1996, CDPH has refused to grant further waivers allowing PAS to first assist during extracorporeal bypass procedures, with no basis in patient risk or provider lack of qualifications.

The Federal Trade Commission (FTC) weighed in on state law and regulatory restrictions on PAS that lack evidence of public health or safety concerns in a December 2016 letter to the Iowa Department of Public Health and stated the following:

"Even well-intentioned laws and regulations may include unnecessary or overbroad restrictions, including those that may limit competition or frustrate the development of innovative and effective models of team-based health care. Such undue restrictions on health care services can raise costs or prices to patients or third-party payers, limit access to important health care services, or both, without providing countervailing consumer protection benefits."

"When analyzing competition in various health care professions, FTC staff consistently recommend that policy makers carefully examine purported safety justifications for restrictions on health care practitioners — especially when the scope of practice for one health care profession overlaps to some degree with that of another profession over which it exercises supervisory authority. We have recommended that state legislators, regulators, and other policy decision makers:

• Evaluate what, if any, pertinent evidence exists to maintain or add scope-of-practice restrictions;

• Evaluate whether purported health and safety justifications are well founded; and• Consider whether less restrictive alternatives would protect patients without imposing undue

burdens on competition and undue limits on patients' access to health care services"

"Consistent with patient safety, however, we have urged regulators and legislators to consider whether removing unnecessary practice restrictions for non-physician providers may promote competition and benefit patients."

3See, Comment from FTC to Iowa Department of Public Health (Dec. 2016), https://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-comment-

O American Academy of PAS

professional„licensuredivision-iowa-department-public-health-regardingproposed/vl 70002 ftc staff comment_to iowa dept of_public_health ] 2-21-16.pdf

Additionally, in a single-center study performed in California under the emergency clause and published in 2012, the data demonstrated that PAS are equally as safe as their physician counterparts in performing as first assistant surgeons during extracorporeal bypass procedures. Nine different performance factors and twenty-six complications, including thirty-day mortality, were analyzed in two cohorts; those cases first assisted by an MD or DO surgeon and those cases first assisted by a PA. The study concluded that there were no differences in patient outcomes when PA first assistants were used.

In 2012, Anthony Furnary, MD, a senior cardiothoracic surgeon and chief operating officer of Starr-Wood Cardiac Group in Oregon wrote in the Journal of the American Academy ofPhysician Assistants (JAAPA)

"At first CVPAs [Cardiovascular PAS] were used almost exclusively in the operating room as second assistants to supplement and assist the cardiovascular fellows we trained As our own integrated international fellowship program waned after the attacks of September 1 Ith, the role of our CVPAs increased dramatically, They began to assume the role of first assistant in the CVOR on all operations. Coronary artery bypass grafts, valves, aortic dissections, redo surgeries, thoracotomies—you name it, and they rose to the challenge and did it, Our PAS now do almost everything we surgeons do: consults, ICU rounds, floor rounds, insertion of chest tubes, removal of balloon pumps - the list goes on and on."5

The Society of Thoracic Surgeons and the American Association for Thoracic Surgery issued endorsement statements in 2003 and 2004, respectively, stating that "The duties performed by a physician assistant under the supervision of a cardiothoracic surgeon may include... 2) first assisting in surgery."

In a survey of PAS working in cardiovascular surgical settings, 94.5 percent of PAS reported they first assist in surgery. This demonstrates that PAS are widely regarded and competent providers, in the role of first assistant in cardiovascular surgery and maintain a high level of confidence among the cardiovascular surgeons they work alongside.

PAS as First Assistants in Extracorporeal Bypass Procedures Increases Patient Access to Critical CareAccess to critical extracorporeal bypass procedures is delayed or postponed when teams are unable to find an available assistant cardiovascular surgeon. In California, physicians commonly encounter delays of patient care when no surgeon is available to first assist, although a PA with experience first assisting in these procedures in other jurisdictions is available. For example, PAS in California may first assist on bypass patients at the David' Grant USAF Medical Center at Travis Air Force Base. When these same PAS help fill staffing shortages at a local non-military hospital, they are unable to first assist on a procedure on which they were legally authorized to first assist just a few miles away.

When surgeons operate with teams with whom they routinely practice, anesthesia and surgery times can be reduced. This decreases risk for patients and costs for the healthcare system. A chief PA at a prominent university hospital moved to California to join the surgeon they worked with who had accepted a position as chief surgeon at the hospital. Although the PA previously first assisted with the physician on bypass procedures, since moving to California, they no longer can do so.

O American Academy of PAS

4 Ranzenbach E, Poa L, Puig-Palomar M, et al The safety and efficacy of physician assistants as first assistant surgeons in cardiac surgery, JAAPA 2012 Aug;25(8):52.5 Furnary, A, The Cardiovascular Physician Assistant: The Angel in the Room. JAAPA 2012 Aug; 25(8) p. 18. 6 Lee, J„ Cooper, J., Lopez, E.C., et al. Survey on Utilization of Nonsurgeon Practitioners in Cardiothoracic Surgery. Surgical Physician Assistant 2000;6(11).

In a time when more patients are seeking care, combined with the looming physician shortage, it is imperative for regulators and others to be more inclusive and recognize the necessity to efficiently utilize all qualified providers of care. Primary surgeons should be allowed to choose their cardiovascular surgical team based on the acuity of the patient and the competence of the available assistants. Failing to timely perform an extracorporeal bypass procedure when an experienced team is available that includes PAS as first assistants unnecessarily jeopardizes patient lives.

Utilizing PAS as first assistants during extracorporeal bypass procedures increases access to care by increasing the number of available first assistants, thus eliminating scheduling delays for patients in critical need of the procedure.

In conclusion, we find no rational basis for CDPH's denial of requests •Ibr program flexibility for PAS to first assist during extracorporeal bypass surgery. It is well established that PAS safely and competently perform as first assistants during extracorporeal bypass procedures in every other state in the United States, as well as the District of Columbia, and in California at Kaiser San Francisco and Travis Air Force Base. Furthermore, there is no distinct difference in the performance of extracorporeal bypass procedures that is unique to California to justify being the only state to prohibit PAS from first assisting when the patient is on bypass.

California has failed to keep up with the rest of the country by adhering to a 46 year old rule that was written before the PA profession was well established. Strict adherence to this outdated rule fails to consider the tremendous advances in healthcare over the last 50 years. CDPH's denial of waivers unnecessarily restricts innovative and efficient new models of team based care that could reduce costs for patients and the healthcare system and reduce inefficiencies.

Requests for program flexibility for PAS as first assistants under 22 CCR 70435(b)(2) do not appear to be given fair consideration of the unique facts and data presented by each applicant. As a result, CDPH's across the board denial of PAS as first assistants during extracorporeal bypass procedures represents a bureaucratic road block that restricts competition as it flatly disregards the direct experience and competency of the PAS at the facility, the lack of cardiovascular surgeons available for the procedure and the risk to patients caused by delays of care.

We strongly encourage you to fairly evaluate the data and information provided in support of PA qualification and competency as first assistants during extracorporeal bypass procedures and to cease the blanket denial of requests for program flexibility from 22 CCR

Sincerely,

Ann Davis, MS, PA-CVice President, Constituent Organization Outreach & Advocacy

O American Academy of PAS

cc: Dr. Karen Smith, Director, California Department of Public HealthJean lacino, Deputy Director, Center for Health Care QualityVirginia Yamashiro, Chief of Field Operations, Licensing and Certification

Steve Gottesfeld, PA-C, Vice President, Association of PAS in Cardiovascular Surgery Joe Jacquot, Esq., Foley & Lardner LLP

O American Academy of PAS

Association ofPhysician Assistants in Cardiovascular Surgery

April 25, 2017

Ms. Jacqueline LincerCalifornia Department of Public Health Licensing and Certification Division681 Parker st., suite 200 Orange, CA 92868

Dear. Ms. Lincer:

On behalf of the Association of PAS in Cardiovascular Surgery (APACVS), we would like to express our support for PAS being authorized to first assist during procedures when patients are on extracorporeal bypass. At the request of Dr, Steven Otto, we have previously shared information with the California Department of Public Health on this topic. It appears, though, that this is still a barrier for PAS in California.

Since 1967, PAS have provided surgical first assistance during cardiac surgery, as well as providing care in alt areas of adult and congenital cardiac surgery. PAS as first assistants during cardiac surgery is nationally accepted and has become the standard of care in 49 states, the District of Columbia and the Federal Government. Oddly, California is the only state that has any regulatory restriction for the use of PAS as surgical first assistants during procedures where the patient is on extracorporeal bypass. APACVS regularly surveys our members from across the U.S. on a range of services they perform and 88 percent report that they regularly first assist during cardiac surgical procedures. This number has remained consistent for over 10 years.

California's regulatory requirement that surgical teams for extracorporeal bypass procedures be comprised of three surgeons is a major barrier to patient access to care. The requirernent prevents individual cardiac surgeons from determining the level of surgical assistance needed to safely perform a particular cardiac surgical procedure.

To date, the APACVS has received multiple contacts from surgical groups throughout the State of California that would like to utilize PAS as first assistants during procedures where the patient is on extracorporeal bypass. These groups are comprised of surgeons in California who understand the capabilities and skills of PAS. We routinely hear from PAS who have relocated to California from other states and have a long career first assisting during cardiac surgery and are now unable to do so because of the requirement in Title 22 Section 70435(b)(2) of California's Code of Regulations.

Without any data indicating there is a patient safety risk, and considering that PAS are first assisting during procedures where the patient is on extracorporeal bypass daily around the country, APACVS is concerned with the appearance of

5()0 C..,umtn.i.ngs Center Suite • Beverly, MA 01913Phone: Well)'. www.apacvg.org

anti-competitive underpinnings in refusing to grant waivers to PAS. Under California law, PAS could not legally perform in this role if they were not competent to do so.

APACVS is committed to safe, reliable surgical first. assistance by PAS that will increase access to these critical procedures for patients entrusted to our care. As such, APACVS is willing to assist the California Department of Public Health in developing a regulatory change that would authorize PAS to first assist in procedures when the patient is on extracorporeal bypass. In the meantime, we encourage the approval of waivers for clearly qualified applicants to first assist during these procedures until permanent or temporary rules are adopted.

Sincerely,

David E. Lizotte, Jr. MPAS, PA-c, FAPACVS

President, APACVS

50() (jumrnings (jenter Suite Beverly, 01 (M 5 Phone: 978027 -833() Web: www.apacvs.or.g

AMERICAN ASSOCIATION FOR THORACIC SURGERY

2004-2005

President Tirone E. Davld, M.D.Toronto. Ontario

President-Elect Richard A. Jonas, M.D.Boston. Massachusetts

Vice PresidentBruce W. Lytle, M.D. Cleveland, Ohio

SecretaryIrving L. Kron, M.D.Charlottesville, Virginia

Treasurer Alec Patterson, M.D. St. Louis, Missouri

Editor

Andrew S, Wechsler, M.D.Philadelphia, Pennsylvania

Councillors Joel D. Cooper, M.D.St. Louis, Mlssouri

O, Howard Frazier, M.D.Houston, Texas

D. craig Miller, M.D.

Stanford. Callfornla

Hartzell V. Schaff, M.D.Rochester, Minnesota

David J. Sugarbaker, M.D. Boston, Massachusetts

Marko l. Turlna, M.D.Zurich, Switzerland

Executive Director Robert P. Jones, Jr., Ed.D.Beverly, Massachusetts

June 8, 2004

Joseph H. Cooper, PA-CPresident of APACVSNational Headquarters P.O. Box 4834Englewood, Colo. 80155.

Dear Mr. Cooper:

I am pleased to inform you that the AATS Council, at its annual meeting in Toronto, enthusiastically endorsed the attached "Physician Assistant Endorsement Statement" recommended by Dr. Neal D. Ron.

We thank you for the extraordinary efforts the APACVS has made to the specialty.

Sincerely,

Irving L. Kron, M.D.Secretary

900 Cummings Center, Suite 221-U, Beverly, Massachusetts 01915, (978) 927-8330 / FAX: (97b) 524-8890E-Mail: aats@prrl.com / www.aats.org

April 14, 2017

Ms. Jacqueline LincerCalifornia Department of Public Health Licensing and Certification Division681 Parker st., suite 200 Orange, CA 92868

Dear Ms. Lincer:

The California Academy of PAS (CAPA) is the state professional PA organization that advocates on behalf of the almost 11,000 PAS licensed in California to ensure optimal PA practice and utilization in California. We understand the California Department of Public Health is evaluating whether PAS should be authorized to first assist during procedures when patients are on extracorporeal bypass. In support of our mission and vision of full integration of PAS into every aspect of California's healthcare, we strongly support PAS as safe, competent first assistants in these procedures.

It is well established that when PAS practice at the top of their education, training and experience there is an increase in patient access to safe, high-quality healthcare, Currently in California, PAS are unable to first assist during procedures when patients are on extracorporeal bypass due to an outdated administrative rule in California's Code of Regulations, Title 22, Section 70435(b)(2). The rule, written in 1971, requires the team for extracorporeal bypass procedures to be comprised of three surgeons.

We understand that this rule has led to delays in access to care for patients when no physician is available to first assist. PAS are an integral part of cardiothoracic surgical teams and there is a strong desire by cardiothoracic surgeons to utilize PAS as first assistants during these procedures. An immediate solution to this problem is for CDPH to grant waivers from 22 CCR 70435(b)(2) authorizing PAS as first assistants.

Across the United States, PAS that worl< in cardiothoracic surgery regularly perform a wide range of duties including: conduit procurement for coronary artery bypass surgery; first assisting in surgery; arterial line placernent; central line placement; Swan Ganz catheter placement; thoracentesis; placernent of, and removal of, intra-aortic balloons; placement and removal of chest tubes; and pre and postoperative patient care,

231B SOUTI„I FAIRVIEW STREET, SANTA ANA, CA 92704 PI-ONE n 4,427.0321 FAX n CAPANET.ORG

Ms. Jacqueline LincerApril 14, 2017Page two

Countless PAS working in cardiothoracic surgery outside of California are first assisting during procedures when patients are on extracorporeal bypass. CAPA finds no distinct difference in the performance of this procedure that is unique to California and supports PAS in California being authorized to first assist during these exact same procedures as they would be allowed under the law in every other state.

California's rules governing PA practice require PAS to perform only those medical services they are competent to perform and consistent with the PA's education, training and experience. Further, the rules require PAS to consult with e physician regard!ng any procedure that exceeds the PAS level of competence. 2 The cardiothoracic surgeon is the team lead during these procedures and is responsible for determining the skill level of the PA in order to ensure that all clinical duties are performed safely and competently,

As an ardent advocate for PAS being authorized to practice to the full extent of their education, training and experience, CAPA strongly encourages the California Department of Public Health to grant waivers authorizing PAS to practice as first assistants durlng procedures where the patient is on extracorporeal bypass. We further support revising Title 22 of California's Code of Regulations to authorize PAS as first assistants.

Very truly yours,

Roy Guizado, PA-CPresident

of THORActQ

THE SOCIETY OF THORACIC SURGEONS633 N. SAINT CLAIR STREET, SUITE 2320

51399.540

&tQblished

CHICAGO, ILLINOIS 60611-3658Phone: 312/202-5800Fax: 312/202-5801E-mail: sts@sts.orgWeb: http://www.sts.org

PresidentROBERT A. GUYTON

First Vice PresidentPETER C. PAIROLERO pairolem.peteGmayo.edu

Second Vice President SIDNEY LEVITSKY slevitsk@caregroup.harvard.edu

Secretary GORDON F, MURRAY gmurray@hsc.wvu.edu

Treasurer DOUGLAS J. MATHISEN dmathisen@partners.org

Immediate Past President WILLIAM A. BAUMGARTNER wbaumgar@csurg.jhmi.jhu.edu

International Director TORKBL H.J. ÅBERG secretary@eacts.norrnod.se

Directors-at-LargeJOHN W, BROWN

JEFFREY P. GOLD jpgold@montefiore.org LESLIE J. KOHMAN kohmanl@upstate.edu

CONSTANTINE MAVROUDIScmavroudis@childrensmemorial org MEREDI'PH L. scorr mlscottl@earthlink.net DOUGLAS E. WOOD dewood@u.washington.edu

Editor L. HENRY EDMUNDS, JR. hankedmunds@uphs.upenn.edu

Historian W. GERALD RAINER wrainer$jh82b@pol.net

Executiæ Director & General Counsel ROBERT A. WYNBRANDT rwynbrandt@3ts.org

PHYSICIAN ASSISTANT ENDORSEMENT

STATEMENT

The Society of Thoracic Surgeons supports the use of physician assistants, working under the supervision of cardiothoracic surgeons, in the practice of cardiothoracic surgery. Physician assistants should be credentialed by their local hospital and have received appropriate instruction and training in all procedures and all clinical duties performed under the supervising physician. The duties performed by a physician assistant under the supervision of a cardiothoracic surgeon may include, but are not limited to, the following: 1) conduit procurement for coronary artery bypass surgery; 2) first assisting in surgery; 3) arterial line placement; 4) central line placement; 5) Swan Ganz catheter placement; 6) thoracentesis; 7) placement of, and removal of, intraaortic balloons; 8) placement and removal of chest tubes; and, 9) pre and postoperative patient care.

Appropriate instruction and training for physician assistants in postgraduate settings should be provided by the supervising cardiothoracic surgeon. This instruction and training can be augn•nented by clinical rotations in cardiothoracic surgery while the physician assistant was in PA school, by postgraduate apprenticeship programs—either affiliated with an educational institution or in a private-practice setting, by continuing medical education programs specific for cardiothoracic surgery, or by technical skills workshops specific for CT surgery.

The supervising cardiothoracic surgeon is responsible for determining the skill level of the physician assistant in order to help ensure that all clinical duties are performed safely and competently.

The Society does not intend for this endorsement statement to supersede any applicable local or state law or regulation, or any local or state credentialing or regulatory authority or agency. It should be used only as a guide to what are generally considered appropriate and acceptable standards for the physician assistant's scope of clinical duties in a cardiothoracic practice,

This document is not intended to exclude any other non-physician clinical staff employed by or supervised by the CT surgeon from perfonning any appropriate clinical duty performed under the supervision of the cardiothoracic surgeon.

Adopted by the Board ofDirectors of The Society of Thoracic Surgeons: May 4, 2003

2004-2005

PresidentTirone E. David, M.D.Toronto. Ontario

President-Elect Richard A. Jonas, M.D.Boston, Massachusetts

Vice PresidentBruce W. Lytle, M.D. Cleveland, Chlo

SecretaryIrving L. Kron, M.D.Charlottesviile, Virginia

TreasurerAlec Patterson, MD.St. Louls, Missouri

Editor

Andrew S. Wechsler, M.D.Philadelphia, Pennsylvania

Councillors Joel D. Cooper, M.D.St. Louis, Missouri

O. Howard Frazier, M.D.Houston, Texas

D. craig Miller. M.D.Stanford, California

Hartzell V. Schaff, M.D.Rpchester, Minnesota

David J. Sugarbaker, M.D. Boston, Massachusetts

Marko l. Turina, M.D.Zurich, Switzerland

Executive Dlrector Robert P. Jones, Jr., Ed.".Beverly, Massachusetts

PHYSICIAN ASSISTANT ENDORSEMENT STATEMENT

The American Association for Thoracic Surgery supports the use of physician assistants, working under the supervision of cardiothoracic surgeons, in the practice of cardiothoracic surgery. Physician assistants should be credentialed by their local hospital and have received appropriate i_nstnlction and frainingin all procedures and all clinical duties performed under the supervising physician. The duties performed by a physician assistant under the supervision of a cardiothoracic surgeon may include, but are not limited to, the following: 1 ) conduit procurement for coronary artel-y bypass surgery; 2) first assisting in surgery; 3) arterial line placement; 4) central line placement; 5) Swan Ganz catheter placement', 6) thoracentesis; 7) placement of, and removal of, intra- aortic balloons; 8) placement and removal of chest tubes; and, 9) pre and postoperative patient care.

Appropriate instruction and training for physician assistants in postgraduate settings should be provided by the supervising cardiothoracic surgeon. This instruction and training can be augmented by clinical rotations in cardiothoracic surge1Y while the physician assistant was in p A school, by postgraduate apprenticeship programs-either affiliated with an educational institution or in a private-practice setting, by continuing medical education programs specific for cardiothoracic surgery, or by technical skills workshops specific for CT surgery.

'Ihe supervising cardiothoracic surgeon• is responsible for determining the skill ••levgl of the physician assistant in order to help ensuie that all clinical duties are performed safely and competently,

The Association does not intend for this endorsement statement to supersede any applicable local or state law or regulation, or any local or state credentialing or regulatory authority or agency. It should be used only as a guide to what are generally considered appropriate and acceptable standards for the physician assistant's scope of clinical duties in a cardiothoracic practice,

This document is not intended to exclude any other non-physician clinical staff employed by or supervised by the CT surgeon from performing any appropriate clinical duty performed under the supervision ofthe cardiothoracic surgeon,

900 Cummings Center, suite 221-U, Beverly, Massachusetts 01915, (978) 927-8330 1 FAX: (978) 524-8890E-Mail: aats@prri.com I www.aats.org

AMERICAN ASSOCIATION FOR THORACIC SURGERY