Catheterization and Cardiovascular Interventions 86:655–663 (2015)
Core Curriculum Privileging and Credentialing for Interventional Cardiology Procedures James C. Blankenship,1* MD, MSc, Kenneth Rosenfield,2 MD, MS, and Henry S. Jennings III,3 MD Local institutional-specific credentialing and privileging for procedures is an important process for ensuring the quality of care provided by interventional cardiologists. Recently revised standards for coronary intervention and the blossoming of structural heart disease programs have generated controversy over these processes. How standards are set for credentialing and privileging is poorly understood by most interventional cardiologists, including those responsible for credentialing and privileging. Requirements from The Joint Commission dictate how credentialing and privileging is performed at hospitals they accredit. Physicians must be recredentialed every 2 years at each hospital, with privileges renewed at that time. Hospitals must review quality of physicians even more frequently using Ongoing Professional Practice Evaluations. Hospitals must also evaluate the performance of physicians when they join a hospital staff or when they begin performing new procedures using Focused Professional Practice Evaluations. Cardiology department directors and catheterization laboratory directors are responsible for recredentialing and reprivileging members of their departments. Individual physicians are responsible for cooperating with these processes, and for periodic recertification with specialty boards and governmental agencies. We provide specific guidance to help physicians navigate these processes. VC 2015 Wiley Periodicals, Inc. Key words: credentials; privileges; certification; accreditation; OPPE; FPPE
Interventional cardiologists lead the medical profession in monitoring the quality of care we provide. We owe it to our patients and other health care stakeholders [1,2]. Our specialty was one of the first to monitor quality of care, starting with the first and second National Heart, Lung, and Blood Institute Registries of 1977–1981 and 1985–1986 [3] and the Society for Cardiovascular Angiography and Interventions (SCAI) registry in the 1980s, leading to the American College of Cardiology Foundation (ACCF) National Cardiovascular Data Registry (NCDR) for coronary intervention in July of 1995. Participation in the NCDR CathPCI Registry has increased to about 90% of United States catheterization laboratories and the NCDR has spawned multiple other registries, most recently the Transcatheter Valve Therapy Registry. An even more important process for ensuring the quality of care provided by interventional cardiologists is local institutional-specific credentialing and privilegC 2015 Wiley Periodicals, Inc. V
ing for procedures. Recently, revised standards for coronary intervention [4] and the blossoming of structural heart disease programs have generated controversy 1
Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania 2 Department of Cardiology, Massachusetts General Hospital, Boston, Massachusetts 3 Vanderbilt Heart and Vascular Institute, Vanderbilt University School of Medicine, Nashville, Tennessee Conflict of interest: Nothing to report Correspondence to: James C. Blankenship MD MSc, Department of Cardiology 27-75, Geisinger Medical Center, 100 N Academy Avenue, Danville PA 17822. E-mail: [email protected] Received 15 September 2014; Revision accepted 14 December 2014 DOI: 10.1002/ccd.25793 Published online 2 April 2015 in Wiley Online Library (wileyonlinelibrary.com)
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over these processes [5]. Yet how standards are set for credentialing and privileging is poorly understood by most interventional cardiologists, including those responsible for credentialing and privileging [6]. The surgical and radiologic literature is replete with discussions of credentialing and privileging [7–11], and professional cardiology societies have published recommendations for credentialing for individual procedures [4,12–16]. However, few resources are available to interventional cardiologists facing credentialing/privileging issues. This article provides a brief summary of credentialing and privileging within the field of interventional cardiology. CERTIFICATION AND ACCREDITATION VERSUS CREDENTIALING AND PRIVILEGING
The term “certification” generally refers to status of individuals who have passed requirements of the American Board of Internal Medicine for Cardiovascular Medicine and/or Interventional Cardiology. Other organizations such as the American Board of Vascular Medicine offer certification in other fields practiced by interventional cardiologists. Many health care organizations consider “board certification” to be a required credential for physicians, but certification by an accrediting body by itself is not enough for any physician to be privileged at any hospital to perform procedures. The term “accreditation” refers to the status organizations seek by passing the requirements of an accrediting body. Common examples are “Chest Pain Center” accreditation by the Society of Cardiovascular Patient Care, “STEMI Receiving Center” accreditation by the American Heart Association’s Mission Lifeline, accreditation of individual catheterization laboratories by the Accreditation for Cardiovascular Excellence organization sponsored by the ACCF and SCAI, and The Joint Commission (TJC) accreditation for individual hospitals. “Credentialing” and “privileging” are often used interchangeably. “Credentialing” generally refers to the process of confirming a physician’s credentials and adding that specific practitioner to the medical staff of a hospital, health system, or insurance company physician panel. “Privileging” refers to the determination of whether a physician meets the standards required to perform specific procedures. HISTORICAL BACKGROUND TO CREDENTIALING AND PRIVILEGING
In the decades preceding the 1970s, specialty board certification was assumed to assure proficiency in pro-
cedures in that specialty’s domain. This evolved to the “laundry list” approach under which a practitioner would request privileges for specific procedures at the time of initial hospital credentialing, but which might continue indefinitely unless there was intervening evidence of poor quality, adverse outcomes, or incompetence. This approach created potential process and medico-legal liabilities for institutions and risks for patients. TJC addressed these concerns by requiring that recredentialing be performed periodically, with procedural privileging to be reviewed at the time of recredentialing. In 2007, TJC made significant fundamental changes to the credentialing and privileging process requirements by introducing the ongoing professional practice evaluation (OPPE) and the focused professional practice evaluation (FPPE) [17,18]. The OPPE requires all practitioners at a given institution to undergo regular (defined as a frequency of more than annually) review of the quality of their clinical performance and to be recredentialed every 2 years. It does not allow for exemptions due to board certification, experience, reputation, or “grandfathering.” The FPPE is a time limited focused review of the performance of a physician in one of three scenarios: [1] a new practitioner to an institution, [2] an established practitioner applying for a new privilege, and [3] an established practitioner in the circumstance of a perceived problem (“FPPE for cause”). Some institutions have struggled with implementation of these new requirements over the past several years. TJC has allowed latitude in allowing institutions to determine the specifics of what will be monitored for both OPPE and FPPE at their hospital. The intent of TJC has been to improve clarity, objectivity, and validity of competency standards, and to directly link the quality process to the credentialing/privileging process, which had previously been “siloed” in most institutions. Resources to aid institutions, credentialing/privileging bodies, and catheterization laboratory directors are available at www.jointcommission.org. CREDENTIALING
Credentialing is the process by which health care organizations ensure the quality of physicians with which they are associated. They do this by establishing standards, then checking to make sure their physicians meet these standards. Specific standards are set by each institution and will vary according to the idiosyncracies and mission of individual institutions. Sources of information for credentialing are listed in Table I and include educational and work history, practice history, malpractice history, regulatory background, criminal
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Credentialing for Interventionists TABLE I. List of Common Sources of Information for Physician Credentialing Medical school Internship/residency/fellowship Prior hospital affiliations Specialty and subspecialty board certification DEA (US Drug Enforcement Administration) National practitioner data bank Medicare/Medicaid sanctions (DHHS Office of Inspector General) State department of health (for licensing) State department of public welfare for child abuse clearance References (generally 3) Federation of State Medical Boards (FSMB) Medical liability insurance verification Background check with federal/state regulatory agencies: OIG, FDAA, GSA, etc.) Finger printing and FBI criminal history background check ECFMG (if applicable for foreign graduates) Interim CME requirements (institutionally defined)
TABLE II. The 6 Core Competencies 1. Patient Care. Provide care that is compassionate, appropriate, and effective treatment for health problems and to promote health. 2. Medical Knowledge. Demonstrate knowledge about established and evolving biomedical, clinical, and cognate sciences and their application in patient care. 3. Interpersonal and Communication Skills. Demonstrate skills that result in effective information exchange and teaming with patients, their families, and professional associates (e.g., fostering a therapeutic relationship that is ethically sound; uses effective listening skills with nonverbal and verbal communication; working as a team member and at times as a leader). 4. Professionalism. Demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations. 5. Systems-Based Practice. Demonstrate awareness of and responsibility to larger context and systems of healthcare. Be able to call on system resources to provide optimal care (e.g., coordinating care across sites or serving as the primary case manager when care involves multiple specialties, professions, or sites). 6. Practice-Based Learning and Improvement. Demonstrate ability to investigate and evaluate patient-care practices, appraise and assimilate scientific evidence, and improve practice of medicine.
record, records from the National Practitioner Data Bank, and reference checks. More recently, some hospitals and third party payers have introduced “economic credentialing” to exclude high cost physicians from their provider panels, generating extreme concern among physician providers [19,20]. The Joint Commission requires recredentialing every 2 years. Thus, TJC-accredited hospitals are required to check the status of credentials they require every 2 years for every practitioner. As noted above, TJC also requires an Ongoing Professional Practice Evaluation (OPPE) to be performed more often than yearly. The OPPE is a mechanism for evaluating the quality of work of physicians on a more regular basis than is provided by the recredentialing process. As with credentialing, the stand-
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ards used in the OPPE assessment are set by the health care organization, not TJC. Documentation of the results of recredentialing and OPPEs must be available for review by TJC. TJC, while it does not set the standards for credentialing, does enforce the adherence of institutions to the general standards they have set. Although the specific details of OPPE/FPPE are not “discoverable” from a strictly legal standpoint, they can be requested and accessed by TJC and CMS. PRIVILEGING
“Privileging” refers to the process of awarding the right to perform particular services and procedures to individual providers. As with credentialing, the standards for privileging are set by the organized medical staff at each institution. Recommendations by national bodies for standards for privileging may be followed but are not binding to local institutions. Reprivileging is performed every 2 years as part of the TJC recredentialing process. Procedural privileging occurs in three different forms during an interventional cardiologist’s career. The first is initial privileging, based on the scope of training before independent practice. The second is periodic reprivileging, intended to ensure ongoing high quality of care. The third is initial privileging for new procedures physicians wish to add to their repertoire. The privileging process should ensure that adequately trained physicians are allowed to perform services and procedures with adequate results. The awarding of privileges means that the physician can provide care before, during, and after procedures reflecting the six core competencies of patient care including medical knowledge, practice-based learning, interpersonal and communication skills, professionalism, system-based practice, and technical proficiency (Table II). INITIAL PRIVILEGING
Initial privileging should be based on training, board eligibility, and assessment of the physician by mentors during training. Board certification eligibility is generally considered a prerequisite for initial privileging, while recognizing that the term “board eligible” does not carry any official standing from the American Board of Internal Medicine. Board certification in a specialty does not imply expertise in performing all procedures within that specialty. Thus, training and experience in particular procedures must be assessed against standards for privileging for that individual procedure. These are
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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TABLE III. Steps for Developing an Evidence Based Ongoing Professional Practice Evaluation Step One: Complete a worksheet for each department and sometimes subspecialties within the department based on what is already being measured. Compare the list to the practitioner’s privilege list for specialties and subspecialties assigned to that department. You must be collecting data that relates to what they are privileged to perform. Step Two: If the list is inadequate, meet with the department chair or other appropriate medical staff member to add appropriate indicators. Develop a matrix of data sources. Again, using privilege list to make sure the data represents what the members are privileged to do. Step Three: Seek approval of the criteria by the appropriate medical staff leaders and/or committees. Step Four: Create the profiles from the indicator worksheet. Step Five: Define your timeframe for reporting the profile (i.e., 3/6/8 month time frame to easily merge with the TJC biennial institutional credentialing cycle Step Six: Develop a standard report format to and from the department chair to the quality department or the appropriate quality oversight group based on your institutional structure. Step Seven: Set up a process for the feedback to reach the database (file) of the individuals being considered for reappointment. Source: Monograph from LifePoint Hospitals, Brentwood TN 2008
determined by the individual institution, which should consider standards recommended by national professional associations. Recommendations of supervisors familiar with trainees should be considered in decisions regarding privileges to be granted to cardiologists entering clinical practice. In cases where quality is uncertain, conditional privileging may be granted contingent on completing a period of observation at the new institution. All trainees entering practice must undergo a FPPE which involves monitoring of quality for an institutionally defined period of time, usually 6 months, or a given number of procedures (which may be proctored at the institution’s discretion).
REPRIVILEGING
Reprivileging is required by the Joint Commission every 2 years. It requires demonstration of current clinical competency, as reflected by board certification, volume of procedures, quality of results, results of interval OPPE (Table III), and other measures. Board certification should be considered a default requirement for reprivileging. All interventional cardiology certification is time limited, which raises questions of whether senior physicians who decline to recertify but have extensive experience should be denied privileges. Each institution will need to develop policy regarding this issue. Reprivileging should require evidence of procedural volume and quality as reflected both by effectiveness and safety. Procedural volume should be accurately reported by the hospital. Standards for volume should
reflect data on the relationship between volume and outcomes, where available. For most interventional cardiology procedures, this relationship is controversial [4,21] and difficult but not impossible [22] to demonstrate. Standards for volume should also reflect recommendations by professional societies. There is a consensus that annual volumes required for competency may change over a career, such that lifetime experience may compensate for lower annual volumes [21] although this, too, is controversial. There is a consensus that where volumes are low either because the procedures are low-frequency procedures (e.g., atrial septal defect percutaneous closure, or peri-valvular leak closure), or because the physician’s practice is a low-volume one, additional surveillance is appropriate to make sure that results are acceptable [12]. Procedural quality is harder to assess, but can be determined by results as reported to databases, hospital quality committees, and morbidity/mortality conferences. Interventional cardiologists should participate in the NCDR CathPCI Registry and other applicable NCDR registries. Catheterization laboratories should have active quality improvement committees and quality assurance programs that monitor the results of individual practitioners.
PRIVILEGING FOR NEW PROCEDURES OR NEW SKILLS
The process by which an experienced interventionist gains new privileges is determined by the local institution. For new devices or procedures, conditions may be set by the manufacturer (e.g., transcatheter aortic valve replacement) as well [16]. New privileging may require background experience in related procedures, in vitro experience (e.g., simulation training, animal laboratory training), experience assisting as a second operator, and/or experience under the supervision of a proctor for an institutionally defined number of procedures. When a physician performs a new procedure independently, a time-limited FPPE should be implemented to ensure procedures are performed safely and effectively. It may be prudent for the institution to mandate that a more experienced practitioner, if available, be present or available during procedures until the new practitioner has established a track record of excellence. Cardiologists must not begin to perform a new procedure independently without obtaining privileges. For example, in Pennsylvania, if the state department of health obtained evidence of a cardiologist performing a procedure for which they were not privileged, it would
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Credentialing for Interventionists
be categorized as an “infra-structure failure” with significant adverse consequences for the hospital. RESPONSIBILITY FOR CREDENTIALING AND PRIVILEGING
Healthcare organization credentialing departments are responsible for obtaining information used to credential physicians. The field of medical provider credentialing has a professional organization (The National Association of Medical Staff Services) whose members can become Certified Provider Credentialing Specialists by passing an examination. The Joint Commission places final responsibility for credentialing and privileging on the medical staff and the hospital board. In practice, this responsibility is diffused through many levels of a hospital’s hierarchy. Each level reports to the next higher level either a recommendation or a decision for, or against, giving a privilege. Typically, the cardiac catheterization laboratory director recommends privileges for an individual to the cardiology department or service line director, who decides to grant or not grant privileges. That decision goes to the credentials committee of the hospital medical executive committee. The credentials committee makes a recommendation to the medical executive committee, which reports a decision to the medical affairs committee of the hospital board. The medical affairs committee of the board recommends the privilege to the full board, which makes a final decision. TJC holds the hospital board ultimately responsible for privileging decisions and for ensuring the quality of physicians practicing there. When a practitioner disputes an adverse decision regarding a privilege, the appeal usually goes directly to the department director, and then to the medical executive committee, and finally to the hospital board. THE NATIONAL PRACTITIONER DATA BANK (NPDB)
The NPDB was established in 1990 to serve as a national clearing house for adverse actions against physicians. Reportable events include any malpractice suit payout, regulatory sanction, loss of license, sanction by Medicare of Medicaid, or health care related criminal convictions. Also reportable are any restriction or nonvoluntary loss of hospital privileges. Because any loss of privileges can effectively end a medical career, it behooves leaders to avoid actions that might inadvertently produce reportable events for physicians. The most common example would be
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when a provider requests a privilege at the biannual reprivileging period and the supervisor does not sign off on that privilege for any reason. If the reprivileging application goes forward without approval of one privilege, it counts as a “denied privilege,” with an obligation to report it to the NPDB. It is prudent to keep in mind that while the specific details of OPPE and FPPE are not reportable to the NPDB and not “discoverable” under the Health Care Quality Improvement Act of 1986, they still can be requested by TJC and CMS.
SURRENDERING PRIVILEGES
Privileges to perform a service or procedure can be surrendered under several sets of circumstances. These are described in increasing order of adversarial action. A fundamental principle is that depending on how surrendering a privilege is handled, it may or may not be reportable to the NPDB. 1. Provider decides to surrender a privilege. When a cardiologist decides for any reason to stop performing a procedure in the absence of any quality concerns, it is easy to delete it from the set of privileges requested at the time of reprivileging. This is not reportable to the NPDB. 2. Quality issues lead to provider deciding to stop performing the procedure before the next reprivileging cycle. When there is evidence of inadequate quality, the provider and catheterization laboratory director may agree together that the provider should stop performing the procedure. If the overt reason for stopping performance of the procedure is poor quality, it is reportable. If a review of the provider’s practice determines that the provider is “ineligible” to continue to perform the procedure due to low volume or change in physical capability (e.g., deteriorating eyesight), it is not reportable. 3. Quality concerns lead to a focused professional practice evaluation (FPPE). If quality concerns arise, another option is to develop a FPPE which provides a method to evaluate the practitioner’s work and if necessary provide additional mentoring or training. At the end of the FPPE period (usually 6 months), if it is determined that the provider is performing adequately, then no further action is needed. If at the end of the FPPE it is determined that the provider has quality problems that have not been remediated, the privilege can be revoked, which must be reported to the NPDB.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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TABLE IV. Recommended Requirements for Performance of Interventional Cardiology Procedures Volume requirement for initial competence
Procedure
Volume requirement for maintaining competence
Percutaneous coronary interventions
250 while in training required for certification
100 over prior 2 years or log of 25 cases for recertification
Percutaneous coronary interventions Percutaneous coronary interventions for ST elevation myocardial infarction
Not available
Mitral valvuloplasty
5–10
50 percutaneous coronary interventions per year 11 Percutaneous coronary interventions for ST elevation myocardial infarction year (> 36 for facility) Not available
Percutaneous mitral valve repair
Not available
Not available
Transcatheter aortic valve replacement
100 Structural procedures lifetime or 30 left sided structural per year of which 60% should be balloon aortic valvuloplasty 10
20 per year (for program)
5
10 per year
30 carotid angiograms and 25 carotid interventions 100 diagnostic and 50 interventional peripheral procedures required for certification
Not available
Atrial septal defect/patent foramen ovale closure Alcohol septal ablation Carotid stenting Peripheral vascular procedures
Not available
10 per year
Not available
Source American Board of Internal Medicine (http://www.abim.org/certification/policies/imss/icard.aspx accessed May 24 2014 2013 ACCF/AHA/SCAI Clinical Competence statement [4] 2013 ACCF/AHA/SCAI Clinical Competence statement [4]
ACCF/AHA/SCAI 2007 Clinical Competence Statement [12] SCAI/AATS/ACCF/STS 2014 Operator and Institutional Requirements26 AATS, ACCF, SCAI, and STS expert consensus statement on operator requirements for transcatheter aortic valve replacement [16] ACCF/AHA/SCAI 2007 Clinical Competence Statement [12] 2013 ACCF/AHA/SCAI Clinical Competence statement [4] SCAI/SVMB/SVS [13] American Board of Vascular Medicine http://www.vascularboard.org/ cert_reqs.cfm accessed May 24, 2014
ACCF ¼ American College of Cardiology Foundation. AHA ¼ American Heart Association. SCAI ¼ Society for Cardiac Angiography and Interventions. AATS ¼ American Association of Thoracic Surgeons. STS ¼ Society of Thoracic Surgeons.
4. Involuntary surrender of privilege. If quality issues indicate a need to immediately stop a provider from performing a procedure and the provider is unwilling to stop, privileges can be withdrawn. This action is reportable to the NPDB and may lead to appeals and lawsuits. The following precautions should be taken by institutions and their governing bodies: (a) Document quality problems comprehensively and extensively. (b) Attempt remediation short of removing privileges and document these attempts. (c) Consult experts from the hospital’s human resources, legal, and quality departments and follow their recommendations. SPECIFIC RECOMMENDATIONS FOR PRIVILEGING FOR INTERVENTIONAL CARDIOLOGY
Recommendations for determining competency and privileging have been published for most interventional cardiology procedures (Table IV). In this respect the field of interventional cardiology is far ahead of most other medical specialties.
THE FUTURE OF INTERVENTIONAL CARDIOLOGY CREDENTIALING AND PRIVILEGING
These issues will arise in the near future: 1. Role of Simulation Training. Simulation training is rapidly improving. It is likely to serve increasingly large roles in initial training and perhaps in maintenance of expertise, particularly for low-volume procedures [23,24]. 2. Requirements for Recertification. Because all interventional cardiology board certifications are time limited, older practitioners may choose to avoid the expense and effort of recertification. There is no consensus on what effect expiration of certification should have on reprivileging. Additionally, new maintenance of certification policies of the American Board of Internal Medicine have established a new category termed “not participating in MOC”. The significance of this status is not established. 3. The Volume/Quality Relationship. The relationship of volume and quality is very controversial.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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TABLE V. Potential Problems with Privileging for Interventional Procedures and How to Solve Them Problem
Potential solution
Privileging processes and standards differ from one hospital to another. Many physicians practice at multiple hospitals, each with its own credentialing and privileging processes. Low volumes at one hospital may raise issues even for high-volume operators. Interventional cardiologists perform procedures shared by other specialties, so recommendations for privileging are developed by various coalitions of professional societies and published in many different venues. New procedures and technologies are being developed that require new privileging standards, which may change as technologies mature.
Physician leaders and administrators are reluctant to limit privileges of practicing physicians with poor outcomes or unprofessional behaviors Conflicts of interest may lead to lax standards for privileging, or lax enforcement of standards (e.g., no surgery on site hospitals with marginal PCI volumes) Competing practitioners may seeks to restrict privileges for political reasons, creating an inherent conflict of interest.
Ongoing professional practice evaluations are time consuming and require extensive data collection and evaluation
Additional research may further characterize the relationship for old and new procedures [4]. 4. Privileging for New Procedures. Structural heart procedures are professionally interesting and challenging; many interventional cardiologists will to perform them. However, requirements imposed by manufacturers, CMS, and hospitals will restrict privileging for these procedures. Controversy over appropriate requirements and restrictions on operator privileges are likely to increase [5]. 5. Institutional Consistency for Privileging Requirements. Catheter-based peripheral vascular interventions may be performed by interventional cardiologists, interventional radiologists, or vascular surgeons. Their different departments may establish very different OPPE/FPPE requirements for the same procedure. TJC has taken the position that within an institution, privileging requirements should be the same for all physicians performing that procedure, regardless of their specialty. It is likely hospitals will increasingly comply with this recommendation. 6. More detailed OPPE/FPPE processes. Most hospitals have implemented the 2007 TJC mandates at the level of the entire medical staff, or at the departmen-
Use recommendations from national societies or certifying boards where available. Encourage local hospitals to adopt the same standards Physicians should track their volumes and results and be ready to present aggregate volumes and outcomes resulting from practice at multiple hospitals. Physician leaders should scan the literature for new recommendations for privileging and insure institutional consistency across service lines.
Physician leaders should scan the literature for recommendations for privileging new procedures, be sure that physicians have appropriate experience before starting them, and perform focused professional practice evaluations to monitor results. Document extensively. Remediate practice patterns or behaviors when possible. Consult human resource, quality, and legal departments regarding appropriate actions. Physicians must put patient interests first, balancing enforcement of reasonable standards against mitigating circumstance. Physician leaders (e.g., cath lab directors and cardiology department directors) must fulfill the role of trusted “honest brokers.” Consideration may need to be given to an impartial outside third agency in certain circumstances. Implement routine data collection and practice evaluation programs so that data and evaluations are produced automatically at periodic intervals. Utilize data that is already being tracked, and just change the frequency of monitoring to a time frame
Core Curriculum Privileging and Credentialing for Interventional Cardiology Procedures James C. Blankenship,1* MD, MSc, Kenneth Rosenfield,2 MD, MS, and Henry S. Jennings III,3 MD Local institutional-specific credentialing and privileging for procedures is an important process for ensuring the quality of care provided by interventional cardiologists. Recently revised standards for coronary intervention and the blossoming of structural heart disease programs have generated controversy over these processes. How standards are set for credentialing and privileging is poorly understood by most interventional cardiologists, including those responsible for credentialing and privileging. Requirements from The Joint Commission dictate how credentialing and privileging is performed at hospitals they accredit. Physicians must be recredentialed every 2 years at each hospital, with privileges renewed at that time. Hospitals must review quality of physicians even more frequently using Ongoing Professional Practice Evaluations. Hospitals must also evaluate the performance of physicians when they join a hospital staff or when they begin performing new procedures using Focused Professional Practice Evaluations. Cardiology department directors and catheterization laboratory directors are responsible for recredentialing and reprivileging members of their departments. Individual physicians are responsible for cooperating with these processes, and for periodic recertification with specialty boards and governmental agencies. We provide specific guidance to help physicians navigate these processes. VC 2015 Wiley Periodicals, Inc. Key words: credentials; privileges; certification; accreditation; OPPE; FPPE
Interventional cardiologists lead the medical profession in monitoring the quality of care we provide. We owe it to our patients and other health care stakeholders [1,2]. Our specialty was one of the first to monitor quality of care, starting with the first and second National Heart, Lung, and Blood Institute Registries of 1977–1981 and 1985–1986 [3] and the Society for Cardiovascular Angiography and Interventions (SCAI) registry in the 1980s, leading to the American College of Cardiology Foundation (ACCF) National Cardiovascular Data Registry (NCDR) for coronary intervention in July of 1995. Participation in the NCDR CathPCI Registry has increased to about 90% of United States catheterization laboratories and the NCDR has spawned multiple other registries, most recently the Transcatheter Valve Therapy Registry. An even more important process for ensuring the quality of care provided by interventional cardiologists is local institutional-specific credentialing and privilegC 2015 Wiley Periodicals, Inc. V
ing for procedures. Recently, revised standards for coronary intervention [4] and the blossoming of structural heart disease programs have generated controversy 1
Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania 2 Department of Cardiology, Massachusetts General Hospital, Boston, Massachusetts 3 Vanderbilt Heart and Vascular Institute, Vanderbilt University School of Medicine, Nashville, Tennessee Conflict of interest: Nothing to report Correspondence to: James C. Blankenship MD MSc, Department of Cardiology 27-75, Geisinger Medical Center, 100 N Academy Avenue, Danville PA 17822. E-mail: [email protected] Received 15 September 2014; Revision accepted 14 December 2014 DOI: 10.1002/ccd.25793 Published online 2 April 2015 in Wiley Online Library (wileyonlinelibrary.com)
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over these processes [5]. Yet how standards are set for credentialing and privileging is poorly understood by most interventional cardiologists, including those responsible for credentialing and privileging [6]. The surgical and radiologic literature is replete with discussions of credentialing and privileging [7–11], and professional cardiology societies have published recommendations for credentialing for individual procedures [4,12–16]. However, few resources are available to interventional cardiologists facing credentialing/privileging issues. This article provides a brief summary of credentialing and privileging within the field of interventional cardiology. CERTIFICATION AND ACCREDITATION VERSUS CREDENTIALING AND PRIVILEGING
The term “certification” generally refers to status of individuals who have passed requirements of the American Board of Internal Medicine for Cardiovascular Medicine and/or Interventional Cardiology. Other organizations such as the American Board of Vascular Medicine offer certification in other fields practiced by interventional cardiologists. Many health care organizations consider “board certification” to be a required credential for physicians, but certification by an accrediting body by itself is not enough for any physician to be privileged at any hospital to perform procedures. The term “accreditation” refers to the status organizations seek by passing the requirements of an accrediting body. Common examples are “Chest Pain Center” accreditation by the Society of Cardiovascular Patient Care, “STEMI Receiving Center” accreditation by the American Heart Association’s Mission Lifeline, accreditation of individual catheterization laboratories by the Accreditation for Cardiovascular Excellence organization sponsored by the ACCF and SCAI, and The Joint Commission (TJC) accreditation for individual hospitals. “Credentialing” and “privileging” are often used interchangeably. “Credentialing” generally refers to the process of confirming a physician’s credentials and adding that specific practitioner to the medical staff of a hospital, health system, or insurance company physician panel. “Privileging” refers to the determination of whether a physician meets the standards required to perform specific procedures. HISTORICAL BACKGROUND TO CREDENTIALING AND PRIVILEGING
In the decades preceding the 1970s, specialty board certification was assumed to assure proficiency in pro-
cedures in that specialty’s domain. This evolved to the “laundry list” approach under which a practitioner would request privileges for specific procedures at the time of initial hospital credentialing, but which might continue indefinitely unless there was intervening evidence of poor quality, adverse outcomes, or incompetence. This approach created potential process and medico-legal liabilities for institutions and risks for patients. TJC addressed these concerns by requiring that recredentialing be performed periodically, with procedural privileging to be reviewed at the time of recredentialing. In 2007, TJC made significant fundamental changes to the credentialing and privileging process requirements by introducing the ongoing professional practice evaluation (OPPE) and the focused professional practice evaluation (FPPE) [17,18]. The OPPE requires all practitioners at a given institution to undergo regular (defined as a frequency of more than annually) review of the quality of their clinical performance and to be recredentialed every 2 years. It does not allow for exemptions due to board certification, experience, reputation, or “grandfathering.” The FPPE is a time limited focused review of the performance of a physician in one of three scenarios: [1] a new practitioner to an institution, [2] an established practitioner applying for a new privilege, and [3] an established practitioner in the circumstance of a perceived problem (“FPPE for cause”). Some institutions have struggled with implementation of these new requirements over the past several years. TJC has allowed latitude in allowing institutions to determine the specifics of what will be monitored for both OPPE and FPPE at their hospital. The intent of TJC has been to improve clarity, objectivity, and validity of competency standards, and to directly link the quality process to the credentialing/privileging process, which had previously been “siloed” in most institutions. Resources to aid institutions, credentialing/privileging bodies, and catheterization laboratory directors are available at www.jointcommission.org. CREDENTIALING
Credentialing is the process by which health care organizations ensure the quality of physicians with which they are associated. They do this by establishing standards, then checking to make sure their physicians meet these standards. Specific standards are set by each institution and will vary according to the idiosyncracies and mission of individual institutions. Sources of information for credentialing are listed in Table I and include educational and work history, practice history, malpractice history, regulatory background, criminal
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Credentialing for Interventionists TABLE I. List of Common Sources of Information for Physician Credentialing Medical school Internship/residency/fellowship Prior hospital affiliations Specialty and subspecialty board certification DEA (US Drug Enforcement Administration) National practitioner data bank Medicare/Medicaid sanctions (DHHS Office of Inspector General) State department of health (for licensing) State department of public welfare for child abuse clearance References (generally 3) Federation of State Medical Boards (FSMB) Medical liability insurance verification Background check with federal/state regulatory agencies: OIG, FDAA, GSA, etc.) Finger printing and FBI criminal history background check ECFMG (if applicable for foreign graduates) Interim CME requirements (institutionally defined)
TABLE II. The 6 Core Competencies 1. Patient Care. Provide care that is compassionate, appropriate, and effective treatment for health problems and to promote health. 2. Medical Knowledge. Demonstrate knowledge about established and evolving biomedical, clinical, and cognate sciences and their application in patient care. 3. Interpersonal and Communication Skills. Demonstrate skills that result in effective information exchange and teaming with patients, their families, and professional associates (e.g., fostering a therapeutic relationship that is ethically sound; uses effective listening skills with nonverbal and verbal communication; working as a team member and at times as a leader). 4. Professionalism. Demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations. 5. Systems-Based Practice. Demonstrate awareness of and responsibility to larger context and systems of healthcare. Be able to call on system resources to provide optimal care (e.g., coordinating care across sites or serving as the primary case manager when care involves multiple specialties, professions, or sites). 6. Practice-Based Learning and Improvement. Demonstrate ability to investigate and evaluate patient-care practices, appraise and assimilate scientific evidence, and improve practice of medicine.
record, records from the National Practitioner Data Bank, and reference checks. More recently, some hospitals and third party payers have introduced “economic credentialing” to exclude high cost physicians from their provider panels, generating extreme concern among physician providers [19,20]. The Joint Commission requires recredentialing every 2 years. Thus, TJC-accredited hospitals are required to check the status of credentials they require every 2 years for every practitioner. As noted above, TJC also requires an Ongoing Professional Practice Evaluation (OPPE) to be performed more often than yearly. The OPPE is a mechanism for evaluating the quality of work of physicians on a more regular basis than is provided by the recredentialing process. As with credentialing, the stand-
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ards used in the OPPE assessment are set by the health care organization, not TJC. Documentation of the results of recredentialing and OPPEs must be available for review by TJC. TJC, while it does not set the standards for credentialing, does enforce the adherence of institutions to the general standards they have set. Although the specific details of OPPE/FPPE are not “discoverable” from a strictly legal standpoint, they can be requested and accessed by TJC and CMS. PRIVILEGING
“Privileging” refers to the process of awarding the right to perform particular services and procedures to individual providers. As with credentialing, the standards for privileging are set by the organized medical staff at each institution. Recommendations by national bodies for standards for privileging may be followed but are not binding to local institutions. Reprivileging is performed every 2 years as part of the TJC recredentialing process. Procedural privileging occurs in three different forms during an interventional cardiologist’s career. The first is initial privileging, based on the scope of training before independent practice. The second is periodic reprivileging, intended to ensure ongoing high quality of care. The third is initial privileging for new procedures physicians wish to add to their repertoire. The privileging process should ensure that adequately trained physicians are allowed to perform services and procedures with adequate results. The awarding of privileges means that the physician can provide care before, during, and after procedures reflecting the six core competencies of patient care including medical knowledge, practice-based learning, interpersonal and communication skills, professionalism, system-based practice, and technical proficiency (Table II). INITIAL PRIVILEGING
Initial privileging should be based on training, board eligibility, and assessment of the physician by mentors during training. Board certification eligibility is generally considered a prerequisite for initial privileging, while recognizing that the term “board eligible” does not carry any official standing from the American Board of Internal Medicine. Board certification in a specialty does not imply expertise in performing all procedures within that specialty. Thus, training and experience in particular procedures must be assessed against standards for privileging for that individual procedure. These are
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TABLE III. Steps for Developing an Evidence Based Ongoing Professional Practice Evaluation Step One: Complete a worksheet for each department and sometimes subspecialties within the department based on what is already being measured. Compare the list to the practitioner’s privilege list for specialties and subspecialties assigned to that department. You must be collecting data that relates to what they are privileged to perform. Step Two: If the list is inadequate, meet with the department chair or other appropriate medical staff member to add appropriate indicators. Develop a matrix of data sources. Again, using privilege list to make sure the data represents what the members are privileged to do. Step Three: Seek approval of the criteria by the appropriate medical staff leaders and/or committees. Step Four: Create the profiles from the indicator worksheet. Step Five: Define your timeframe for reporting the profile (i.e., 3/6/8 month time frame to easily merge with the TJC biennial institutional credentialing cycle Step Six: Develop a standard report format to and from the department chair to the quality department or the appropriate quality oversight group based on your institutional structure. Step Seven: Set up a process for the feedback to reach the database (file) of the individuals being considered for reappointment. Source: Monograph from LifePoint Hospitals, Brentwood TN 2008
determined by the individual institution, which should consider standards recommended by national professional associations. Recommendations of supervisors familiar with trainees should be considered in decisions regarding privileges to be granted to cardiologists entering clinical practice. In cases where quality is uncertain, conditional privileging may be granted contingent on completing a period of observation at the new institution. All trainees entering practice must undergo a FPPE which involves monitoring of quality for an institutionally defined period of time, usually 6 months, or a given number of procedures (which may be proctored at the institution’s discretion).
REPRIVILEGING
Reprivileging is required by the Joint Commission every 2 years. It requires demonstration of current clinical competency, as reflected by board certification, volume of procedures, quality of results, results of interval OPPE (Table III), and other measures. Board certification should be considered a default requirement for reprivileging. All interventional cardiology certification is time limited, which raises questions of whether senior physicians who decline to recertify but have extensive experience should be denied privileges. Each institution will need to develop policy regarding this issue. Reprivileging should require evidence of procedural volume and quality as reflected both by effectiveness and safety. Procedural volume should be accurately reported by the hospital. Standards for volume should
reflect data on the relationship between volume and outcomes, where available. For most interventional cardiology procedures, this relationship is controversial [4,21] and difficult but not impossible [22] to demonstrate. Standards for volume should also reflect recommendations by professional societies. There is a consensus that annual volumes required for competency may change over a career, such that lifetime experience may compensate for lower annual volumes [21] although this, too, is controversial. There is a consensus that where volumes are low either because the procedures are low-frequency procedures (e.g., atrial septal defect percutaneous closure, or peri-valvular leak closure), or because the physician’s practice is a low-volume one, additional surveillance is appropriate to make sure that results are acceptable [12]. Procedural quality is harder to assess, but can be determined by results as reported to databases, hospital quality committees, and morbidity/mortality conferences. Interventional cardiologists should participate in the NCDR CathPCI Registry and other applicable NCDR registries. Catheterization laboratories should have active quality improvement committees and quality assurance programs that monitor the results of individual practitioners.
PRIVILEGING FOR NEW PROCEDURES OR NEW SKILLS
The process by which an experienced interventionist gains new privileges is determined by the local institution. For new devices or procedures, conditions may be set by the manufacturer (e.g., transcatheter aortic valve replacement) as well [16]. New privileging may require background experience in related procedures, in vitro experience (e.g., simulation training, animal laboratory training), experience assisting as a second operator, and/or experience under the supervision of a proctor for an institutionally defined number of procedures. When a physician performs a new procedure independently, a time-limited FPPE should be implemented to ensure procedures are performed safely and effectively. It may be prudent for the institution to mandate that a more experienced practitioner, if available, be present or available during procedures until the new practitioner has established a track record of excellence. Cardiologists must not begin to perform a new procedure independently without obtaining privileges. For example, in Pennsylvania, if the state department of health obtained evidence of a cardiologist performing a procedure for which they were not privileged, it would
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be categorized as an “infra-structure failure” with significant adverse consequences for the hospital. RESPONSIBILITY FOR CREDENTIALING AND PRIVILEGING
Healthcare organization credentialing departments are responsible for obtaining information used to credential physicians. The field of medical provider credentialing has a professional organization (The National Association of Medical Staff Services) whose members can become Certified Provider Credentialing Specialists by passing an examination. The Joint Commission places final responsibility for credentialing and privileging on the medical staff and the hospital board. In practice, this responsibility is diffused through many levels of a hospital’s hierarchy. Each level reports to the next higher level either a recommendation or a decision for, or against, giving a privilege. Typically, the cardiac catheterization laboratory director recommends privileges for an individual to the cardiology department or service line director, who decides to grant or not grant privileges. That decision goes to the credentials committee of the hospital medical executive committee. The credentials committee makes a recommendation to the medical executive committee, which reports a decision to the medical affairs committee of the hospital board. The medical affairs committee of the board recommends the privilege to the full board, which makes a final decision. TJC holds the hospital board ultimately responsible for privileging decisions and for ensuring the quality of physicians practicing there. When a practitioner disputes an adverse decision regarding a privilege, the appeal usually goes directly to the department director, and then to the medical executive committee, and finally to the hospital board. THE NATIONAL PRACTITIONER DATA BANK (NPDB)
The NPDB was established in 1990 to serve as a national clearing house for adverse actions against physicians. Reportable events include any malpractice suit payout, regulatory sanction, loss of license, sanction by Medicare of Medicaid, or health care related criminal convictions. Also reportable are any restriction or nonvoluntary loss of hospital privileges. Because any loss of privileges can effectively end a medical career, it behooves leaders to avoid actions that might inadvertently produce reportable events for physicians. The most common example would be
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when a provider requests a privilege at the biannual reprivileging period and the supervisor does not sign off on that privilege for any reason. If the reprivileging application goes forward without approval of one privilege, it counts as a “denied privilege,” with an obligation to report it to the NPDB. It is prudent to keep in mind that while the specific details of OPPE and FPPE are not reportable to the NPDB and not “discoverable” under the Health Care Quality Improvement Act of 1986, they still can be requested by TJC and CMS.
SURRENDERING PRIVILEGES
Privileges to perform a service or procedure can be surrendered under several sets of circumstances. These are described in increasing order of adversarial action. A fundamental principle is that depending on how surrendering a privilege is handled, it may or may not be reportable to the NPDB. 1. Provider decides to surrender a privilege. When a cardiologist decides for any reason to stop performing a procedure in the absence of any quality concerns, it is easy to delete it from the set of privileges requested at the time of reprivileging. This is not reportable to the NPDB. 2. Quality issues lead to provider deciding to stop performing the procedure before the next reprivileging cycle. When there is evidence of inadequate quality, the provider and catheterization laboratory director may agree together that the provider should stop performing the procedure. If the overt reason for stopping performance of the procedure is poor quality, it is reportable. If a review of the provider’s practice determines that the provider is “ineligible” to continue to perform the procedure due to low volume or change in physical capability (e.g., deteriorating eyesight), it is not reportable. 3. Quality concerns lead to a focused professional practice evaluation (FPPE). If quality concerns arise, another option is to develop a FPPE which provides a method to evaluate the practitioner’s work and if necessary provide additional mentoring or training. At the end of the FPPE period (usually 6 months), if it is determined that the provider is performing adequately, then no further action is needed. If at the end of the FPPE it is determined that the provider has quality problems that have not been remediated, the privilege can be revoked, which must be reported to the NPDB.
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TABLE IV. Recommended Requirements for Performance of Interventional Cardiology Procedures Volume requirement for initial competence
Procedure
Volume requirement for maintaining competence
Percutaneous coronary interventions
250 while in training required for certification
100 over prior 2 years or log of 25 cases for recertification
Percutaneous coronary interventions Percutaneous coronary interventions for ST elevation myocardial infarction
Not available
Mitral valvuloplasty
5–10
50 percutaneous coronary interventions per year 11 Percutaneous coronary interventions for ST elevation myocardial infarction year (> 36 for facility) Not available
Percutaneous mitral valve repair
Not available
Not available
Transcatheter aortic valve replacement
100 Structural procedures lifetime or 30 left sided structural per year of which 60% should be balloon aortic valvuloplasty 10
20 per year (for program)
5
10 per year
30 carotid angiograms and 25 carotid interventions 100 diagnostic and 50 interventional peripheral procedures required for certification
Not available
Atrial septal defect/patent foramen ovale closure Alcohol septal ablation Carotid stenting Peripheral vascular procedures
Not available
10 per year
Not available
Source American Board of Internal Medicine (http://www.abim.org/certification/policies/imss/icard.aspx accessed May 24 2014 2013 ACCF/AHA/SCAI Clinical Competence statement [4] 2013 ACCF/AHA/SCAI Clinical Competence statement [4]
ACCF/AHA/SCAI 2007 Clinical Competence Statement [12] SCAI/AATS/ACCF/STS 2014 Operator and Institutional Requirements26 AATS, ACCF, SCAI, and STS expert consensus statement on operator requirements for transcatheter aortic valve replacement [16] ACCF/AHA/SCAI 2007 Clinical Competence Statement [12] 2013 ACCF/AHA/SCAI Clinical Competence statement [4] SCAI/SVMB/SVS [13] American Board of Vascular Medicine http://www.vascularboard.org/ cert_reqs.cfm accessed May 24, 2014
ACCF ¼ American College of Cardiology Foundation. AHA ¼ American Heart Association. SCAI ¼ Society for Cardiac Angiography and Interventions. AATS ¼ American Association of Thoracic Surgeons. STS ¼ Society of Thoracic Surgeons.
4. Involuntary surrender of privilege. If quality issues indicate a need to immediately stop a provider from performing a procedure and the provider is unwilling to stop, privileges can be withdrawn. This action is reportable to the NPDB and may lead to appeals and lawsuits. The following precautions should be taken by institutions and their governing bodies: (a) Document quality problems comprehensively and extensively. (b) Attempt remediation short of removing privileges and document these attempts. (c) Consult experts from the hospital’s human resources, legal, and quality departments and follow their recommendations. SPECIFIC RECOMMENDATIONS FOR PRIVILEGING FOR INTERVENTIONAL CARDIOLOGY
Recommendations for determining competency and privileging have been published for most interventional cardiology procedures (Table IV). In this respect the field of interventional cardiology is far ahead of most other medical specialties.
THE FUTURE OF INTERVENTIONAL CARDIOLOGY CREDENTIALING AND PRIVILEGING
These issues will arise in the near future: 1. Role of Simulation Training. Simulation training is rapidly improving. It is likely to serve increasingly large roles in initial training and perhaps in maintenance of expertise, particularly for low-volume procedures [23,24]. 2. Requirements for Recertification. Because all interventional cardiology board certifications are time limited, older practitioners may choose to avoid the expense and effort of recertification. There is no consensus on what effect expiration of certification should have on reprivileging. Additionally, new maintenance of certification policies of the American Board of Internal Medicine have established a new category termed “not participating in MOC”. The significance of this status is not established. 3. The Volume/Quality Relationship. The relationship of volume and quality is very controversial.
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TABLE V. Potential Problems with Privileging for Interventional Procedures and How to Solve Them Problem
Potential solution
Privileging processes and standards differ from one hospital to another. Many physicians practice at multiple hospitals, each with its own credentialing and privileging processes. Low volumes at one hospital may raise issues even for high-volume operators. Interventional cardiologists perform procedures shared by other specialties, so recommendations for privileging are developed by various coalitions of professional societies and published in many different venues. New procedures and technologies are being developed that require new privileging standards, which may change as technologies mature.
Physician leaders and administrators are reluctant to limit privileges of practicing physicians with poor outcomes or unprofessional behaviors Conflicts of interest may lead to lax standards for privileging, or lax enforcement of standards (e.g., no surgery on site hospitals with marginal PCI volumes) Competing practitioners may seeks to restrict privileges for political reasons, creating an inherent conflict of interest.
Ongoing professional practice evaluations are time consuming and require extensive data collection and evaluation
Additional research may further characterize the relationship for old and new procedures [4]. 4. Privileging for New Procedures. Structural heart procedures are professionally interesting and challenging; many interventional cardiologists will to perform them. However, requirements imposed by manufacturers, CMS, and hospitals will restrict privileging for these procedures. Controversy over appropriate requirements and restrictions on operator privileges are likely to increase [5]. 5. Institutional Consistency for Privileging Requirements. Catheter-based peripheral vascular interventions may be performed by interventional cardiologists, interventional radiologists, or vascular surgeons. Their different departments may establish very different OPPE/FPPE requirements for the same procedure. TJC has taken the position that within an institution, privileging requirements should be the same for all physicians performing that procedure, regardless of their specialty. It is likely hospitals will increasingly comply with this recommendation. 6. More detailed OPPE/FPPE processes. Most hospitals have implemented the 2007 TJC mandates at the level of the entire medical staff, or at the departmen-
Use recommendations from national societies or certifying boards where available. Encourage local hospitals to adopt the same standards Physicians should track their volumes and results and be ready to present aggregate volumes and outcomes resulting from practice at multiple hospitals. Physician leaders should scan the literature for new recommendations for privileging and insure institutional consistency across service lines.
Physician leaders should scan the literature for recommendations for privileging new procedures, be sure that physicians have appropriate experience before starting them, and perform focused professional practice evaluations to monitor results. Document extensively. Remediate practice patterns or behaviors when possible. Consult human resource, quality, and legal departments regarding appropriate actions. Physicians must put patient interests first, balancing enforcement of reasonable standards against mitigating circumstance. Physician leaders (e.g., cath lab directors and cardiology department directors) must fulfill the role of trusted “honest brokers.” Consideration may need to be given to an impartial outside third agency in certain circumstances. Implement routine data collection and practice evaluation programs so that data and evaluations are produced automatically at periodic intervals. Utilize data that is already being tracked, and just change the frequency of monitoring to a time frame
