Keywords:
quality, commission, conference, supervision, standard
Every percutaneous coronary intervention (PCI) program must have a quality improvement committee that routinely performs the following: (a) a review of quality processes and outcomes with risk adjustment, (b) peer review of difficult or complicated cases, and (c) individual operator assessment including random case reviews. This 2011 PCI Guidelines class I recommendation from the American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) has been recognized as essential by providers and administrators for nearly two decades. However, variations in program implementation may impact effectiveness. All facilities should have an independent catheterization laboratory quality program and not just perform quality assurance (QA) as a subset of a hospital-wide program; physician participation, essential to the QA process, should be mandatory; administrative support must be adequate to support data collection/entry. Without requirements for “how to do quality” and limited methods for assessing an individual QA program, assuring quality in one’s catheterization laboratory QA program can be challenging. This chapter will review the necessary steps for effective QA implementation. In concert with prior editions, the assurance of quality as it relates to documentation and patient safety will also be reviewed in this chapter.
Quality improvement/assurance
Quality care in the cardiac catheterization laboratory requires each program to evaluate its performance through a meaningful continuous quality improvement (CQI) process providing program evaluation, deficiency identification, methods for remediation, and final reassessment. SCAI has been a leader in this area, publishing its first guidelines on quality nearly 25 years ago. SCAI’s quality efforts have continued since with position papers and the living document, 2011 Catheterization Laboratory Quality Improvement Tool Kit (SCAIQIT), designed to assist individual laboratories in this quality effort.
CQI is an iterative method to evaluate operational approaches and to remedy deficiencies beyond the isolated assessment of adverse outcomes; peer review is an essential component of this process. CQI requires a dedicated physician champion, a staff champion, a quality improvement committee specific to the catheterization laboratory, and full support from hospital administration. Increasingly recognized, the interconnectivity of quality of care, cost effectiveness, and reimbursement ramifications require this integral partnership. However, only through active, nonpartisan, nonpunitive physician participation will this process be beneficial to the operator, staff, hospital administration, and ultimately the patient by continually improving processes and efficiencies, which will, in turn, improve outcomes.
Six elements for a CQI program include (1) establishing the Quality Committee, (2) identifying quality indicators, (3) systematic data collection using standard definitions, (4) benchmarking of data with appropriate analysis and peer review, (5) implementation of a plan to correct deficiencies with follow-up, and (6) appropriate use of conferences for case review and education. ( Table 11.1 )
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Quality committee
The QI process starts with a committee of physicians, staff, and hospital administration. This should be established just for the cardiac catheterization laboratory to address issues specific to the laboratory. Although it is essential that this committee interact with other committees within the hospital, the cardiac catheterization laboratory director should chair this committee with specific QA staff from the catheterization laboratory. Physician and staff “champions” are required for this process to be effective.
In addition to the interventional cardiologists, the composition of a PCI CQI committee may include noninvasive cardiologists, primary care physicians, catheterization laboratory nurses, technologists, and hospital administrators. Rotation of members and lead should be in conjunction with department chairs or the hospital medical director. In small PCI programs, all active staff interventionists may be included. In larger laboratories, a formal and fair process for selecting and replacing members must be devised. An expert in interventional cardiology with established credibility, often the catheterization laboratory director, should chair this committee with a dedicated staff lead. Interaction with hospital risk management is required to assure appropriate confidentiality. However, this is an independent group whose goal is quality in the laboratory. Interaction with all subspecialties should be established to assure all aspects of patient care within the laboratory are covered.
The CQI Committee’s responsibilities are outlined in Table 11.2 . Patient safety is the central purpose of the CQI process. The quality program should monitor clinical outcomes, complication rates, compliance with policies and procedures both internal as well as those from external regulatory and/or accrediting bodies, and patient satisfaction. The committee must be nonpunitive and behave equitably and transparently to ensure fairness to the operator, quality for the patient, and credibility for the committee. The CQI committee should meet at regular intervals but be available for ad hoc meetings if necessary. External reviews should be requested when deemed appropriate.
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Identification of quality indicators
The key to assessing quality is to identify appropriately and measure quantitatively and qualitatively indicators directly and indirectly involved in the delivery of patient care. Three indicators will be discussed for organizational purposes: Structural, Process, and Outcomes.
Structural indicators are objective, easy to collect, and often established beyond the confines of the catheterization laboratory. Structural indicators are considered by hospital privileging or staff credentialing/recredentialing and include: medical training, licensure, board certification, procedure volume, and participation in conferences/continuing medical education. The method for credentialing and the ongoing assessment of proficiency must be developed in accordance with local governance policies and professionally developed standards. The granting of privileges by healthcare systems is within the legal and ethical purview of these institutions. Establishing a minimum standard limits confrontation when physicians are either inadequately trained or fail to maintain required qualifications. Operator procedural volume is a weak and inconsistent measure of quality and should not be used as a quality indicator in isolation. Institutional volume is a better programmatic predictor of outcomes but does not supersede actual outcomes.
Process indicators reflect patient evaluation and management, appropriateness of a procedure, and treatment adherence to guidelines ( Table 11.3 ). The key to the quality assurance program is to evaluate the environment leading up to a specific outcome and not merely to react to the metric. Because of the qualitative component of these measures, they are more challenging to assess, less objective, and prone to potential observer bias. However, these indicators are helpful in working through the entire process from protocols, to staffing, to turnover of the room, and to patient length of stay. Assessing these indicators allows a more complete analysis of outcomes in the QA process.
| Direct Patient Care-Related Indicators |
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| System Specific Indicators |
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| Guidelines Driven Indicators |
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| Cost Related Indicators |
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