Requirements to function as a first assistant surgeon for ...



[insert date here][Replace the following address with that of your local county Department of public health. This would be the same department that granted your second assist waiver for your cardiac surgery program]Eric Stone, Program ManagerHealth Facilities Inspection DivisionLos Angeles County Department of Public Health3400 Aerojet Avenue, Suite #323El Monte, California 91731CC:Ms. Jacqueline LincerCalifornia Department of Public HealthLicensing and Certification Division681 Parker St., Suite 200Orange, CA 92868[Send a copy, by email, to:] Keisha L. Pitts, JD Director, Constituent Organization Outreach & AdvocacyAAPA571-319-4357kpitts@RE:Program Flexibility for Section 70435(b)(2) of Title 22, California Code of Regulations To Whom It May Concern: Pursuant to 22 CCR Section 70129, please accept this request for program flexibility for Section 70435(b)(2) of Title 22 of the California Code of Regulations. Currently, critically ill cardiovascular surgery patients are facing delays in care due to a shortage of trained cardiac surgical assistants. This request aims to address that problem by allowing appropriately credentialed and privileged physician assistants (PAs) to act as first assistants during all cardiovascular operative procedures which require extracorporeal bypass.Section 70435(b)(2) currently requires the surgical team for extracorporeal bypass procedures to include a minimum of three surgeons. This rule was written in the early 1970’s before the wide-spread use of PAs in this role and does not consider modern advances in healthcare. As the healthcare landscape has changed tremendously since this rule was written, more efficient and appropriate methods for performance of extracorporeal bypass procedures have been implemented across the country. In 49 states, and the District of Columbia, these procedures allow for PAs as first assistants on the surgical team. California remains the sole state with a restriction such as this that precludes PAs from first assisting in procedures that require extracorporeal bypass. The utilization of PAs as fully capable assistants to cardiothoracic surgeons is also endorsed by the Society of Thoracic Surgeons and the American Association for Thoracic Surgery.We request program flexibility from the antiquated language in CCR Title 22, Section 70435(b)(2) to allow California licensed PAs with training and experience in cardiothoracic surgery to function as first assistants at [Insert your hospital name here]. The rule as written is problematic in instances where there is one surgeon and cases must be delayed or postponed due to the inability to find assistant surgeons trained in cardiovascular surgery, although PAs with this experience may be present. Additionally, while PAs are authorized to first assist in cases where patients are not on bypass, if the patient must be urgently transitioned to bypass, the surgical team then becomes non-compliant with the regulation. It is of note here 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). PAs that are appropriately credentialed and privileged in cardiothoracic surgery at [Insert your hospital name here] have a proven record of safety in the performance of these procedures as second assistants and as first assistants in cases where the patient is not on extracorporeal bypass. Specific responsibilities for PAs at this facility include closing the chest, harvesting of venous and arterial conduit for coronary artery bypass, and assisting the primary surgeon (the surgeon that must meet the requirements of subparagraph (b)(1) of the regulation) with cannulation and de-cannulation of the heart, to institute and withdraw extracorporeal bypass. Typically, the only portion of the procedure required by the regulation to be performed by a physician surgeon as first assistant surgeon is that portion of the procedure where the patient is actively on extracorporeal bypass. In a single-center study performed in California and published in 2012, the data demonstrated that PAs are equally as safe as their physician counterparts in performing as first assistant surgeons during these 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. This study confirmed what was already widely-known. There were no differences in patient outcomes when PA first assistants were used. [Replace the following two paragraphs with paragraphs that similarly describe your hospitals and the PAs who will be utilized as first assistants.]Providence Little Company of Mary is a community hospital with 317 beds serving the patients of Torrance and the surrounding beach communities. The heart surgery program at Little Company performs between 250 and 300 cases per year and is led by Dr. Li Poa, an expert in minimally invasive approaches and “off-pump” technique. Dr. Poa is the only full-time surgeon at Little Company and for each case requiring extracorporeal bypass (“on-pump”) a second surgeon must be invited to attend. This is typically a surgeon from a different hospital or the retired former director of the heart surgery program at Little Company.There are three PAs at Little Company with over thirty years of combined experience assisting during cardiothoracic procedures. Moreover, these PAs have practiced outside of California where they functioned as the first assistant surgeon for all cardiothoracic surgeries, on and off pump. Two of the PAs on staff have practiced in academia in the University of California Health System where they trained residents and fellows in cardiothoracic surgery. These PAs harvest conduit for coronary artery bypass and first assist at various steps throughout the procedures, typically before and after the use of extracorporeal circulation and on cases performed off-pump. Further evidence to support this request is contained in the following paragraphs:The proposed alternative meets the intent of the regulation while providing safe and adequate care.Intent of Regulation: The apparent intent of 22 CCR 70435(b)(2) is to ensure patient safety by assuring the surgical team has a minimum of three providers that are appropriately trained and qualified to safely perform the procedure. Problem: The inability to use PAs as first assistant surgeons for cardiac cases impacts patients negatively. Smaller community hospitals where cardiac surgery is performed are typically served by a two-surgeon team. Should one of those surgeons be unavailable (e.g. ill, away at a conference, vacation, or even in situations where multiple urgent or emergent cases present themselves simultaneously), arrangements must be made to have another cardiac surgeon brought in from outside the practice to first assist cases. These programs typically have fully trained and qualified PAs that could function in this role.Proposed alternative: Authorize physician assistants (PAs) to first assist during extracorporeal bypass surgery. Supporting Evidence that PAs are appropriately trained and qualified to safely perform the procedure: [Provide a bullet item for each PA requesting privileges to function as a first assistant surgeon similar to those listed below.]Edward A. Ranzenbach, PA-C, MPAS, CAQ-CVTS, DFAAPA, FAPACVS is a PA with over 18 years of experience. He has a Masters in Cardiothoracic Surgery and a Certificate of Additional Qualification (CAQ) in Cardiovascular Thoracic Surgery. PA Ranzenbach has 19 years of direct experience first assisting during cardiothoracic surgeries, including those requiring extracorporeal bypass, in and out of California.Gerard Francisco, PA-C, has over 12 years experience with majority of that experience first assisting cardiothoracic surgeries off pump as well as those requiring extracorporeal bypass.Tiffany Schaffer, PA-C, has over four years of experience. Ms. Schaffer started her cardiothoracic surgical career in a state that allowed PAs to first assist in cases requiring extracorporeal bypass.The PAs curriculum vitae detailing their training, experience and qualifications to perform the procedure are attached as Addendum A. 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 surgery. 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. The law has not kept pace with modern technology when the use of alternatives, approaches, or techniques meets the intent of the law.22 CCR 70435 (b)(2) is documented as having been adopted in the early 1970’s and has not been revised since that time. The delivery of healthcare, and specifically the performance of cardiovascular surgeries requiring extracorporeal bypass has changed tremendously since the rule was written. This law undoubtedly has not kept pace with modern technology and alternative approaches to the performance of cardiovascular surgery that clearly meet the intent of the law. The article, Physician Assistants in Cardiothoracic Surgery: A 30-Year Experience in a University Center published in the Annals of Thoracic Surgery in January 2006 states the following:“Over the past 30 years, the role of our PAs at Emory University has expanded and their utilization in the operating room has greatly increased. The cardiothoracic PA has a significant amount of autonomy in the operating room and performs the critical task of harvesting the greater saphenous veins or radial arteries (utilizing open or endoscopic techniques) for use as a bypass conduit as an essential component of almost every coronary bypass procedure. After preparation of the bypass conduit, the PA either first or second assists during the remainder of the case, including tasks of providing cardiac retraction, closure of the incisions in the lower extremity, assist in cannulation and decannulation, and closure of the chest. They function primarily as surgical first assistants, especially at CLH, where there remains a discrepancy in the number of cases performed and number of cardiothoracic residents available. The PA is the ideal first assistant in these settings, as they are trained specifically to meet the needs of the staff surgeon and are knowledgeable of the surgeon’s idiosyncrasies. As expected, the exact role of the PA is determined by their clinical experience and the discretion of the attending cardiothoracic surgeon.The usefulness of the PAs in each of our hospital situations cannot be overestimated. The PA has enabled us to expand our services without jeopardizing patient care. In the operating room, they have functioned in the roles of first and second assistants and have allowed us to increase our surgical volume without increasing the number of residents and fellows. With long-term job commitment, the PAs’ own technical skills have become very refined, and they are superb assistants to staff surgeons and surgical residents.”The full text of this article can be viewed at (05)01220-8/pdf 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 of Physician 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 11th, 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.” Advancements in medicine and clinical standards of practice including standards adopted in other states and by nationally recognized professional associations should be considered by CDPH. Advancements in medicine and clinical standards are evident by the fact that PAs regularly first assist during extracorporeal bypass in every state except California. In fact, California is the only state that does not allow PAs to first assist during surgeries requiring extracorporeal bypass. Interestingly, California’s administrative rules governing PA practice specifically allow PAs to act as first assistant during surgery. 16 CCR section 1399.541(i)(2). A physician assistant may also act as first or second assistant in surgery under the supervision of a supervising physician.Standards in other states: The following job descriptions for PAs in cardiovascular surgery in other states include first assisting in all cardiovascular surgeries. See job description for PA in cardiovascular surgery in Virginia posted June 18, 2017: . Screen shot included in Addendum B. See job description for PA in cardiovascular surgery in Maryland posted February 7, 2017: (Click here for link to web posting). Screen shot included in Addendum C. See job description for PA in cardiovascular surgery in New Jersey. See Item 4 under Cardiothoracic Operating Room duties. See job description for PA in cardiovascular surgery in Minnesota posted April 18, 2017. See job description for PA in cardiovascular surgery in Florida. Biography for PA in cardiovascular surgery in Wisconsin that includes first assisting: a survey of PAs working in cardiovascular surgical settings, 94.5 percent of PAs reported they first assist in surgery. Standards adopted by nationally recognized professional associations:The Association of PAs in Cardiovascular Surgery (APACVS) communicated its position that PAs should be allowed to first assist in cardiothoracic surgeries that require extracorporeal bypass to CDPH via a letter of support submitted to CDPH from 2017. APACVS has provided information to CDPH in support of this position in the past. The Society of Thoracic Surgeons issued an endorsement statement in 2003 regarding appropriate standards for PA scope of clinical duties in a cardiothoracic practice. The statement states “The duties performed by a physician assistant under the supervision of a cardiothoracic surgeon may include… 2) first assisting in surgery.” The American Association for Thoracic Surgery issued an endorsement statement in 2004 regarding appropriate standards for PA scope of clinical duties in a cardiothoracic practice. The statement states “The duties performed by a physician assistant under the supervision of a cardiothoracic surgeon may include… 2) first assisting in surgery.” To ensure appropriate instruction and training in a postgraduate setting by a supervising cardiothoracic surgeon, which may be augmented by clinical rotations in cardiothoracic surgery, postgraduate apprenticeship programs, CME programs specific for cardiothoracic surgery, or technical skills workshops specific to cardiothoracic surgery. The PAs at [Insert your hospital name here] have satisfied all of the items listed above. Their biographies and curriculum vitae are attached in Addendum A. To provide evidence and documentation indicating how the proposed alternative will be carried out to ensure safe and adequate care. A detailed protocol for PAs as first assistants in cardiothoracic surgery is attached as Addendum D. Additional InformationThe 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.”As this request indicates, PAs are nationally recognized as safe, qualified first assistants for procedures requiring extracorporeal bypass. The request further indicates that PAs in cardiovascular surgery at [Insert your hospital name here] are a safe, qualified and experienced group of providers that should be allowed to perform as first assistants for extracorporeal bypass procedures. Granting this request will increase access to this critical procedure for patients by allowing appropriately credentialed and privileged PAs to function as the first assistant surgeon for all cardiothoracic surgeries. Specifically, by authorizing program flexibility for this rule, the primary surgeon will have the flexibility to choose the surgical team, based on the acuity of the patient and competence of the available assistants. Based upon the aforementioned, we respectfully request that [Insert your hospital name here] be granted a program flexibility waiver to Section 70435(b)(2) of Title 22, California Code of Regulations to authorize California licensed PAs, practicing in full compliance with the PA Practice Act and rules in California Business and Professions Code, Division 2, Chapter 7.7 and California Code of Regulations Title 16, Division 13.8, who are granted privileges to do so by the facility, be authorized to act as first assistants when patients are on extracorporeal bypass. We appreciate your consideration of this request. If we can provide any further information that will assist in the consideration of this request, please do not hesitate to contact us.Respectfully Submitted,[Insert the name and address of the director of cardiothoracic surgery or other responsible individual or agency as a signature block here.]Addendum A[Provide a curriculum vitae for each PA, seeking to act as a first assistant surgeon for cardiac surgery, in this addendum]Addendum BAddendum CAddendum DThis addendum defines a policy that will need to be adopted by your hospital to credential the PAs for cardiothoracic surgery first assisting privileges. It requires that the PAs have a minimum number of documented cases both as second assistant surgeon and first assistant surgeon. Alternatively, the PAs may be fellow members of the APACVS or have taken and successfully completed the CAQ process from the NCCPA, specifically for cardiothoracic surgery. Documentation must be maintained by the hospital that the PAs have completed the required postgraduate training and education. That documentation is attested to by the supervising surgeon. There is a grandfather clause for PAs prior to January 1 of 2017. This attestation by the supervising surgeon is designed to be portable, that is, the PA does not have to repeat the required case counts and education for each hospital where they are privileged. Requirements to Credential as a First Assistant Surgeon for Cardiac Surgery in the State of California at [insert your hospital name here]Requirements to function as a first assistant surgeon for cardiac surgeryThe following subsections define the requirements to function as a first assistant surgeon for cardiac surgery at [Insert your hospital name here]. Completion of these requirements in and of itself is not an authorization to function in this role. LicensureIt is a requirement that the credentialed physician assistant be a graduate of an accredited PA program, that they are certified by the National Commission on Certification of Physician Assistants (NCCPA), and that they are licensed in the state of California.Training and experienceClassically, PAs have always gained experience in specialty training, including surgery, through mentorship by a supervising physician. Alternatively, PAs may undergo additional postgraduate formal education through accredited residency programs. In keeping with this model, the following training and experience requirements are defined:Completion of 50 cases as a second assistant surgeon for cardiac surgery OR graduation from an accredited postgraduate surgical residencyFive proctored cases as a first assistant surgeon for cardiac surgeryDocumentation of 50 completed cases as a second assistant surgeon will require a letter from the PA’s supervising surgeon. Documentation of five proctored cases as a first assistant surgeon in cardiac surgery will also require a letter from the PA’s supervising surgeon. Documentation of graduation from an accredited surgical residency will be by diploma or certificate from the residency program. For PAs entering the cardiac surgery specialty after January 1st , 2017, the cases required must be logged to include the date of service, the type of surgery assisted, and the supervising surgeon. Op notes from the logged cases must be available in either printed or electronic form,Alternatively, the documentation requirements of item 1 from the above list can be satisfied by a certificate as a Fellow member of the APACVS, or by a certificate of additional qualification (CAQ) in cardiovascular and thoracic surgery by the NCCPA. Attainment of these certificates from these organizations have required the PA to demonstrate training and experience that exceeds the requirements of this paragraph and the Fellow level of membership in the APACVS has been endorsed by the STS. A copy of that endorsement is attached.The required documentation shall be maintained by the hospital and be available for inspection by the state. Letters from surgeons attesting to the case requirements, and case logs shall be transferable between hospital programs.BackgroundSection 1399.541(i) of Title 16 of the California Code of Regulations (CCR) authorizes the physician assistant to act as a first or second assistant in surgery under the supervision of the supervising physician. Throughout the history of cardiothoracic surgery in California, PA’s have been further restricted from operating as a first assistant surgeon, for cardiac surgery cases requiring extracorporeal bypass, by Section 70435(b)(2) of Title 22 of the California Code of Regulations. This paragraph requires the surgical team for extracorporeal bypass procedures include a minimum of three surgeons and, up till now, PAs have only been waivered to act as second assistant surgeons. When considering this further, this is a restriction not only on the PA but also on the surgeon who is restricted in forming the team that they think is most appropriate for their patient’s surgery. Moreover, these restrictions can cause delays in care due to a shortage of trained cardiac surgical assistants and requests for waivers of this Title to 22 requirement have not, to date, been entertained by the state. The use of PAs as first assistant surgeons in cardiac surgery has been fully endorsed by the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgery (AATS), the California Academy of Physician Assistants (CAPA), the American Academy of Physician Assistants (APPA), and the Association of Physician Assistants in Cardiovascular Surgery (APACVS). Those endorsements are attached to this document.In a single-center, retrospective case study performed in California and published in 2012, the data demonstrated that PAs are equally as safe as their physician counterparts in performing as first assistant surgeons during these 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. This study confirmed what was already widely-known. There were no differences in patient outcomes when PA first assistants were used. The training and experience of the PAs who functioned as first assistants in this study are used here as a basis for those training and experience requirements necessary for waiver of the restrictions of Title 22. Those PAs meeting these minimum requirements should have the confidence of the surgeon, hospital administration, the state of California, and most importantly, the patient that they can act under the supervision of the primary surgeon to provide safe and effective care in this role.Attachments:STS Endorsement of PA PracticeAATS Endorsement of PA PracticeSTS Endorsement of Post Graduate Training and Fellow Member Status ................
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