Recommendations

30
Smith et al. 2005
ACC/AHA/SCAI Practice Guidelines
ACC - www.acc.org
AHA - www.americanheart.org
SCAI - www.scai.org
The Quality-Assessment Process
Quality assessment is a complex process that includes more
than mere tabulation of success and complication rates.
Components of quality in coronary interventional procedures
include appropriateness of case selection, quality of procedure
execution, proper response to intraprocedural problems,
accurate assessment of procedure outcome, and appropriateness
of postprocedure management. It is important to consider
each of these parameters when conducting a qualityassessment
review. A quality program performs appropriately
selected procedures that achieve risk-adjusted outcomes,
in terms of procedure success and complication rates, that are
comparable to national benchmark standards. Patient characteristics
that determine appropriateness are discussed elsewhere
in this document. Multivariate models that predict risk
have been published previously (43,47,305-308).
It is accepted that quality-assurance monitoring is best conducted
through the peer review process despite the political
challenges associated with colleagues evaluating each other.
There has been a considerable controversy surrounding
efforts to define standards, criteria, and methodologies for
conducting quality assessment. There are many challenges to
conducting this process in a fair and valid manner.
The cornerstone of quality-assurance monitoring is the
assessment of procedural outcomes in terms of success and
adverse event rates. Other components of quality-assurance
monitoring include establishment of criteria for assessing
procedure appropriateness and application of proper risk
adjustment to interpret adverse event rates. Because adverse
events should be rare, a valid estimate of a properly riskadjusted
adverse event rate generally requires tabulation of
the results of a large number of procedures. This adds an
additional challenge to the valid assessment of low-volume
operators and institutions. The responsible supervising
authority should monitor the issues outlined in Table 13
(309).
Initial Physician Operator Credentialing Criteria
The institutional credentialing committee should document
that an interventionalist wishing to initiate practice meets the
established training criteria, including those of the ACC Task
Force on Training in Cardiac Catheterization and
Interventional Cardiology (310-312). The ACC Training
Statement (312) for coronary invasive training requires a 3-
year comprehensive cardiac program with 12 months of
training in diagnostic catheterization, during which the
trainee performs 300 diagnostic catheterizations, with at least
200 of those as the primary operator. Interventional training
requires a fourth year of fellowship, during which the trainee
should perform more than 250 but not more than 600 interventional
procedures (312). The physician’s training program
director should certify that the candidate has completed
the program and has achieved the necessary competence
to perform coronary interventional procedures independently.
The certification should also include whether the candidate
has achieved requisite competence in related interven-
tional techniques such as rotational atherectomy, balloon
valvuloplasty, and closure of patent foramen ovale and atrial
septal defect.
It is recommended that an interventional cardiology operator
be certified by the American Board of Internal Medicine
in interventional cardiology. Ideally, board certification in
interventional cardiology should be required for credentialing.
The American Board of Internal Medicine certifying
examination in interventional cardiology has been administered
annually since 1999. As of the 2004 administration, a
total of 4718 individuals have been certified.
Privilege Renewal
Criteria for practitioner privilege renewal should be based on
both activity level and outcomes. The assessment process
should ascertain whether a physician operator’s activity level
is sufficient to maintain competence. In addition, the assessment
process should assess the appropriateness of the operator’s
case selection and compare the operator’s risk-adjusted
outcomes with established national benchmark standards
(310). This is discussed in depth in Section 4.2. Current
benchmark standards for mortality, complication rates, and
risk adjustment will be subject to future revision as procedure
technique is refined and newer data emerge. It is important
that institutions assist with these efforts by participating
in active database efforts to track clinical and procedural
information for individual operators and their institutions.
Outcome Data Tabulation and Reporting
Institutions performing PCI should gather data needed to
monitor their outcomes and should submit their data to a
national registry for benchmarking purposes. Institutions
should conduct meticulous record keeping that details the
cases performed-patient demographics and comorbidities,
Table 13. Key Components of a Quality-Assurance Program
Clinical proficiency
General indications/contraindications
Institutional and individual operator complication rates, mortality
and emergency CABG
Institutional and operator procedure volumes
Training and qualifications of support staff
Equipment maintenance and management
Quality of laboratory facility [See ACC/SCAI Expert Consensus
Document on Catheterization Laboratory Standards (309)]
Quality improvement process
Establishment of an active concurrent database to track clinical and
procedural information and patient outcomes for individual operators
and the institution. The ACC-NCDR ® or other databases are
strongly recommended for this purpose
Radiation safety
Educational program in the diagnostic use of X-ray
Patient and operator exposure
ACC indicates American College of Cardiology; CABG, coronary artery bypass graft surgery;
NCDR ® , National Cardiovascular Data Registry; and SCAI, Society for
Cardiovascular Angiography and Interventions.