American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards

A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents

T. M. Bashore, E. R. Bates, P. B. Berger, D. A. Clark, J. T. Cusma, G. J. Dehmer, M. J. Kern, W. K. Laskey, M. P. O'Laughlin, S. Oesterle, J. J. Popma, R. A. O'Rourke, J. Abrams, B. R. Brodie, P. S. Douglas, G. Gregoratos, M. A. Hlatky, J. S. Hochman, Sanjiv Kaul, C. M. Tracy & 3 others D. D. Waters, Jr Winters W.L., William L. Winters

Research output: Contribution to journalArticle

267 Citations (Scopus)

Abstract

A. The Cardiac Catheterization Laboratory Environment: Cardiac catheterizations are currently performed safely in hospitals with and without cardiac surgical backup. The latest information from the SCA & I lists >2,100 cardiac catheterization laboratories in the U.S. (including Puerto Rico and the Virgin Islands) (1). Of these, 72% provided on-site cardiac surgery (including 85% of those performing coronary intervention). Fifty-eight laboratories were located in nonhospital settings. In a hospital with cardiac surgery, essentially all patients with cardiovascular disease can undergo invasive studies safely. Full support services include not only cardiovascular surgery but also vascular surgery, nephrology and dialysis, neurology, hematology, and specialized imaging services (e.g., computed tomography, magnetic resonance imaging, and ultrasound). See Table 7 for assessment of proficiency criteria for individual operators and cardiac catheterization laboratories. In the hospital setting without cardiac surgery capability, many patients can undergo cardiac procedures safely. Exclusions for cardiac catheterization in this setting include patients with acute coronary syndromes, severe congestive heart failure, pulmonary edema due to acute ischemia, a high likelihood of severe multivessel or left main disease based on noninvasive testing, and severe left ventricular dysfunction associated with valvular disease. Certain elective therapeutic interventional procedures such as percutaneous coronary interventions (PCIs) and valvuloplasty should still be performed in facilities that provide cardiac surgical support. The ACC Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures and the ACC/AHA Guidelines for PCI Procedures (2,3) have addressed the issue of primary angioplasty for acute myocardial infarction in hospitals without cardiac surgery capability. Recent data suggest a lower mortality rate among patients undergoing primary angioplasty in higher-volume centers (4). Hospitals that perform primary angioplasty but are without on-site cardiac surgery capability must have a proven plan for rapid access (within 1 h) to a cardiac surgical operating room in a nearby facility with appropriate hemodynamic support capability for such a transfer. The procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (≥75 PCIs performed/year) and only in facilities performing a minimum of 36 primary PCIs/year. In accordance with the soon-to-be-published ACC/AHA guidelines for PCI (3), this committee does not endorse the performance of elective PCI in a facility without cardiac surgery capability. Patients are also being studied in freestanding laboratories (i.e., those that are not physically attached to the hospital). By definition a freestanding laboratory is one where quick transportation of a patient to a hospital by gurney is not possible. These patients clearly must be in stable condition and at the lowest risk for complications. It is vitally important to have mechanisms for backup and bailout in place to provide assistance should patients become unstable in this setting. Although a tertiary hospital serves as an appropriate means for providing proper oversight of a freestanding laboratory, recognized credentialing bodies approved by the local community may be able to provide appropriate oversight to ensure that all issues related to quality assurance (QA) are monitored and addressed. Interventional procedures of any kind should not be performed in a freestanding facility. B. Same-Day and Outpatient Cardiac Catheterization: With the decline in risk associated with cardiac catheterization, the performance of invasive procedures in the ambulatory setting has become more popular. However, prehospitalization may still be important in patients receiving anticoagulation therapy or in those with renal failure, diabetes, or a contrast allergy. Early discharge after the procedure may also be inappropriate for certain patients, including those with a procedure-related complication or hemodynamic instability. In addition, some patients are best observed overnight if severe disease is discovered (e.g., significant left main coronary artery disease or severe aortic stenosis) or in the presence of significant comorbid diseases that increase the risk of late complications. A general scheme is presented to help determine who should be excluded from early discharge after cardiac catheterization. C. QA Issues: Quality assurance starts with an assessment of clinical proficiency among the operators in the cardiac catheterization laboratory. This is surely one of the most difficult elements to assess, but issues of cognitive knowledge, procedural skill, clinical judgment, and procedural outcomes are all important. QA extends to the performance of the laboratory as a whole. A continuous quality-improvement (QI) program should also be included in the laboratory's overall design. One measure of outcome is the number of "normal" diagnostic cardiac catheterizations performed. "Normal" in this regard refers to no disease or insignificant (600 cases/year), and even then with mentoring. Low-volume operators in any other setting should not perform interventional procedures. The minimum case-load for operators performing pediatric catheterizations has not been established by data, although a caseload of 50/year has been suggested for individual operators. Pediatric cardiac catheterization laboratories often share space with adult procedural facilities. The pediatric catheterization laboratory should perform at least 75 procedures/year. Equipment maintenance and management remain an issue, and certain guidelines are provided. Each aspect of the radiographic system should be able to meet these performance expectations. The same is true for the physiological recorders and other specific devices used in the laboratories. A QI program must be in place. The keys are to develop variables that reflect the quality of care, to collect these variables in a systematic manner, to have a means for statistical analysis of the results, and to develop an approach to problem solving that involves feedback on the effectiveness of the solutions. These programs should provide ongoing educational opportunities for staff as well. The Committee also strongly encourages all laboratories to participate in a national data registry to help benchmark their results and provide an ongoing system for tracking complications.

Original languageEnglish (US)
Pages (from-to)2170-2214
Number of pages45
JournalJournal of the American College of Cardiology
Volume37
Issue number8
DOIs
StatePublished - Jun 15 2001
Externally publishedYes

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Advisory Committees
Cardiac Catheterization
Consensus
Angiography
Percutaneous Coronary Intervention
Thoracic Surgery
Angioplasty
Guidelines
Pediatrics
Quality Improvement
Catheterization
Transportation of Patients
Stretchers
Hemodynamics
Maintenance
Credentialing
Benchmarking
Puerto Rico
Equipment and Supplies
Clinical Competence

ASJC Scopus subject areas

  • Nursing(all)

Cite this

American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards : A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. / Bashore, T. M.; Bates, E. R.; Berger, P. B.; Clark, D. A.; Cusma, J. T.; Dehmer, G. J.; Kern, M. J.; Laskey, W. K.; O'Laughlin, M. P.; Oesterle, S.; Popma, J. J.; O'Rourke, R. A.; Abrams, J.; Brodie, B. R.; Douglas, P. S.; Gregoratos, G.; Hlatky, M. A.; Hochman, J. S.; Kaul, Sanjiv; Tracy, C. M.; Waters, D. D.; Winters W.L., Jr; Winters, William L.

In: Journal of the American College of Cardiology, Vol. 37, No. 8, 15.06.2001, p. 2170-2214.

Research output: Contribution to journalArticle

Bashore, TM, Bates, ER, Berger, PB, Clark, DA, Cusma, JT, Dehmer, GJ, Kern, MJ, Laskey, WK, O'Laughlin, MP, Oesterle, S, Popma, JJ, O'Rourke, RA, Abrams, J, Brodie, BR, Douglas, PS, Gregoratos, G, Hlatky, MA, Hochman, JS, Kaul, S, Tracy, CM, Waters, DD, Winters W.L., J & Winters, WL 2001, 'American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents', Journal of the American College of Cardiology, vol. 37, no. 8, pp. 2170-2214. https://doi.org/10.1016/S0735-1097(01)01346-8
Bashore, T. M. ; Bates, E. R. ; Berger, P. B. ; Clark, D. A. ; Cusma, J. T. ; Dehmer, G. J. ; Kern, M. J. ; Laskey, W. K. ; O'Laughlin, M. P. ; Oesterle, S. ; Popma, J. J. ; O'Rourke, R. A. ; Abrams, J. ; Brodie, B. R. ; Douglas, P. S. ; Gregoratos, G. ; Hlatky, M. A. ; Hochman, J. S. ; Kaul, Sanjiv ; Tracy, C. M. ; Waters, D. D. ; Winters W.L., Jr ; Winters, William L. / American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards : A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. In: Journal of the American College of Cardiology. 2001 ; Vol. 37, No. 8. pp. 2170-2214.
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abstract = "A. The Cardiac Catheterization Laboratory Environment: Cardiac catheterizations are currently performed safely in hospitals with and without cardiac surgical backup. The latest information from the SCA & I lists >2,100 cardiac catheterization laboratories in the U.S. (including Puerto Rico and the Virgin Islands) (1). Of these, 72{\%} provided on-site cardiac surgery (including 85{\%} of those performing coronary intervention). Fifty-eight laboratories were located in nonhospital settings. In a hospital with cardiac surgery, essentially all patients with cardiovascular disease can undergo invasive studies safely. Full support services include not only cardiovascular surgery but also vascular surgery, nephrology and dialysis, neurology, hematology, and specialized imaging services (e.g., computed tomography, magnetic resonance imaging, and ultrasound). See Table 7 for assessment of proficiency criteria for individual operators and cardiac catheterization laboratories. In the hospital setting without cardiac surgery capability, many patients can undergo cardiac procedures safely. Exclusions for cardiac catheterization in this setting include patients with acute coronary syndromes, severe congestive heart failure, pulmonary edema due to acute ischemia, a high likelihood of severe multivessel or left main disease based on noninvasive testing, and severe left ventricular dysfunction associated with valvular disease. Certain elective therapeutic interventional procedures such as percutaneous coronary interventions (PCIs) and valvuloplasty should still be performed in facilities that provide cardiac surgical support. The ACC Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures and the ACC/AHA Guidelines for PCI Procedures (2,3) have addressed the issue of primary angioplasty for acute myocardial infarction in hospitals without cardiac surgery capability. Recent data suggest a lower mortality rate among patients undergoing primary angioplasty in higher-volume centers (4). Hospitals that perform primary angioplasty but are without on-site cardiac surgery capability must have a proven plan for rapid access (within 1 h) to a cardiac surgical operating room in a nearby facility with appropriate hemodynamic support capability for such a transfer. The procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (≥75 PCIs performed/year) and only in facilities performing a minimum of 36 primary PCIs/year. In accordance with the soon-to-be-published ACC/AHA guidelines for PCI (3), this committee does not endorse the performance of elective PCI in a facility without cardiac surgery capability. Patients are also being studied in freestanding laboratories (i.e., those that are not physically attached to the hospital). By definition a freestanding laboratory is one where quick transportation of a patient to a hospital by gurney is not possible. These patients clearly must be in stable condition and at the lowest risk for complications. It is vitally important to have mechanisms for backup and bailout in place to provide assistance should patients become unstable in this setting. Although a tertiary hospital serves as an appropriate means for providing proper oversight of a freestanding laboratory, recognized credentialing bodies approved by the local community may be able to provide appropriate oversight to ensure that all issues related to quality assurance (QA) are monitored and addressed. Interventional procedures of any kind should not be performed in a freestanding facility. B. Same-Day and Outpatient Cardiac Catheterization: With the decline in risk associated with cardiac catheterization, the performance of invasive procedures in the ambulatory setting has become more popular. However, prehospitalization may still be important in patients receiving anticoagulation therapy or in those with renal failure, diabetes, or a contrast allergy. Early discharge after the procedure may also be inappropriate for certain patients, including those with a procedure-related complication or hemodynamic instability. In addition, some patients are best observed overnight if severe disease is discovered (e.g., significant left main coronary artery disease or severe aortic stenosis) or in the presence of significant comorbid diseases that increase the risk of late complications. A general scheme is presented to help determine who should be excluded from early discharge after cardiac catheterization. C. QA Issues: Quality assurance starts with an assessment of clinical proficiency among the operators in the cardiac catheterization laboratory. This is surely one of the most difficult elements to assess, but issues of cognitive knowledge, procedural skill, clinical judgment, and procedural outcomes are all important. QA extends to the performance of the laboratory as a whole. A continuous quality-improvement (QI) program should also be included in the laboratory's overall design. One measure of outcome is the number of {"}normal{"} diagnostic cardiac catheterizations performed. {"}Normal{"} in this regard refers to no disease or insignificant (600 cases/year), and even then with mentoring. Low-volume operators in any other setting should not perform interventional procedures. The minimum case-load for operators performing pediatric catheterizations has not been established by data, although a caseload of 50/year has been suggested for individual operators. Pediatric cardiac catheterization laboratories often share space with adult procedural facilities. The pediatric catheterization laboratory should perform at least 75 procedures/year. Equipment maintenance and management remain an issue, and certain guidelines are provided. Each aspect of the radiographic system should be able to meet these performance expectations. The same is true for the physiological recorders and other specific devices used in the laboratories. A QI program must be in place. The keys are to develop variables that reflect the quality of care, to collect these variables in a systematic manner, to have a means for statistical analysis of the results, and to develop an approach to problem solving that involves feedback on the effectiveness of the solutions. These programs should provide ongoing educational opportunities for staff as well. The Committee also strongly encourages all laboratories to participate in a national data registry to help benchmark their results and provide an ongoing system for tracking complications.",
author = "Bashore, {T. M.} and Bates, {E. R.} and Berger, {P. B.} and Clark, {D. A.} and Cusma, {J. T.} and Dehmer, {G. J.} and Kern, {M. J.} and Laskey, {W. K.} and O'Laughlin, {M. P.} and S. Oesterle and Popma, {J. J.} and O'Rourke, {R. A.} and J. Abrams and Brodie, {B. R.} and Douglas, {P. S.} and G. Gregoratos and Hlatky, {M. A.} and Hochman, {J. S.} and Sanjiv Kaul and Tracy, {C. M.} and Waters, {D. D.} and {Winters W.L.}, Jr and Winters, {William L.}",
year = "2001",
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language = "English (US)",
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TY - JOUR

T1 - American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards

T2 - A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents

AU - Bashore, T. M.

AU - Bates, E. R.

AU - Berger, P. B.

AU - Clark, D. A.

AU - Cusma, J. T.

AU - Dehmer, G. J.

AU - Kern, M. J.

AU - Laskey, W. K.

AU - O'Laughlin, M. P.

AU - Oesterle, S.

AU - Popma, J. J.

AU - O'Rourke, R. A.

AU - Abrams, J.

AU - Brodie, B. R.

AU - Douglas, P. S.

AU - Gregoratos, G.

AU - Hlatky, M. A.

AU - Hochman, J. S.

AU - Kaul, Sanjiv

AU - Tracy, C. M.

AU - Waters, D. D.

AU - Winters W.L., Jr

AU - Winters, William L.

PY - 2001/6/15

Y1 - 2001/6/15

N2 - A. The Cardiac Catheterization Laboratory Environment: Cardiac catheterizations are currently performed safely in hospitals with and without cardiac surgical backup. The latest information from the SCA & I lists >2,100 cardiac catheterization laboratories in the U.S. (including Puerto Rico and the Virgin Islands) (1). Of these, 72% provided on-site cardiac surgery (including 85% of those performing coronary intervention). Fifty-eight laboratories were located in nonhospital settings. In a hospital with cardiac surgery, essentially all patients with cardiovascular disease can undergo invasive studies safely. Full support services include not only cardiovascular surgery but also vascular surgery, nephrology and dialysis, neurology, hematology, and specialized imaging services (e.g., computed tomography, magnetic resonance imaging, and ultrasound). See Table 7 for assessment of proficiency criteria for individual operators and cardiac catheterization laboratories. In the hospital setting without cardiac surgery capability, many patients can undergo cardiac procedures safely. Exclusions for cardiac catheterization in this setting include patients with acute coronary syndromes, severe congestive heart failure, pulmonary edema due to acute ischemia, a high likelihood of severe multivessel or left main disease based on noninvasive testing, and severe left ventricular dysfunction associated with valvular disease. Certain elective therapeutic interventional procedures such as percutaneous coronary interventions (PCIs) and valvuloplasty should still be performed in facilities that provide cardiac surgical support. The ACC Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures and the ACC/AHA Guidelines for PCI Procedures (2,3) have addressed the issue of primary angioplasty for acute myocardial infarction in hospitals without cardiac surgery capability. Recent data suggest a lower mortality rate among patients undergoing primary angioplasty in higher-volume centers (4). Hospitals that perform primary angioplasty but are without on-site cardiac surgery capability must have a proven plan for rapid access (within 1 h) to a cardiac surgical operating room in a nearby facility with appropriate hemodynamic support capability for such a transfer. The procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (≥75 PCIs performed/year) and only in facilities performing a minimum of 36 primary PCIs/year. In accordance with the soon-to-be-published ACC/AHA guidelines for PCI (3), this committee does not endorse the performance of elective PCI in a facility without cardiac surgery capability. Patients are also being studied in freestanding laboratories (i.e., those that are not physically attached to the hospital). By definition a freestanding laboratory is one where quick transportation of a patient to a hospital by gurney is not possible. These patients clearly must be in stable condition and at the lowest risk for complications. It is vitally important to have mechanisms for backup and bailout in place to provide assistance should patients become unstable in this setting. Although a tertiary hospital serves as an appropriate means for providing proper oversight of a freestanding laboratory, recognized credentialing bodies approved by the local community may be able to provide appropriate oversight to ensure that all issues related to quality assurance (QA) are monitored and addressed. Interventional procedures of any kind should not be performed in a freestanding facility. B. Same-Day and Outpatient Cardiac Catheterization: With the decline in risk associated with cardiac catheterization, the performance of invasive procedures in the ambulatory setting has become more popular. However, prehospitalization may still be important in patients receiving anticoagulation therapy or in those with renal failure, diabetes, or a contrast allergy. Early discharge after the procedure may also be inappropriate for certain patients, including those with a procedure-related complication or hemodynamic instability. In addition, some patients are best observed overnight if severe disease is discovered (e.g., significant left main coronary artery disease or severe aortic stenosis) or in the presence of significant comorbid diseases that increase the risk of late complications. A general scheme is presented to help determine who should be excluded from early discharge after cardiac catheterization. C. QA Issues: Quality assurance starts with an assessment of clinical proficiency among the operators in the cardiac catheterization laboratory. This is surely one of the most difficult elements to assess, but issues of cognitive knowledge, procedural skill, clinical judgment, and procedural outcomes are all important. QA extends to the performance of the laboratory as a whole. A continuous quality-improvement (QI) program should also be included in the laboratory's overall design. One measure of outcome is the number of "normal" diagnostic cardiac catheterizations performed. "Normal" in this regard refers to no disease or insignificant (600 cases/year), and even then with mentoring. Low-volume operators in any other setting should not perform interventional procedures. The minimum case-load for operators performing pediatric catheterizations has not been established by data, although a caseload of 50/year has been suggested for individual operators. Pediatric cardiac catheterization laboratories often share space with adult procedural facilities. The pediatric catheterization laboratory should perform at least 75 procedures/year. Equipment maintenance and management remain an issue, and certain guidelines are provided. Each aspect of the radiographic system should be able to meet these performance expectations. The same is true for the physiological recorders and other specific devices used in the laboratories. A QI program must be in place. The keys are to develop variables that reflect the quality of care, to collect these variables in a systematic manner, to have a means for statistical analysis of the results, and to develop an approach to problem solving that involves feedback on the effectiveness of the solutions. These programs should provide ongoing educational opportunities for staff as well. The Committee also strongly encourages all laboratories to participate in a national data registry to help benchmark their results and provide an ongoing system for tracking complications.

AB - A. The Cardiac Catheterization Laboratory Environment: Cardiac catheterizations are currently performed safely in hospitals with and without cardiac surgical backup. The latest information from the SCA & I lists >2,100 cardiac catheterization laboratories in the U.S. (including Puerto Rico and the Virgin Islands) (1). Of these, 72% provided on-site cardiac surgery (including 85% of those performing coronary intervention). Fifty-eight laboratories were located in nonhospital settings. In a hospital with cardiac surgery, essentially all patients with cardiovascular disease can undergo invasive studies safely. Full support services include not only cardiovascular surgery but also vascular surgery, nephrology and dialysis, neurology, hematology, and specialized imaging services (e.g., computed tomography, magnetic resonance imaging, and ultrasound). See Table 7 for assessment of proficiency criteria for individual operators and cardiac catheterization laboratories. In the hospital setting without cardiac surgery capability, many patients can undergo cardiac procedures safely. Exclusions for cardiac catheterization in this setting include patients with acute coronary syndromes, severe congestive heart failure, pulmonary edema due to acute ischemia, a high likelihood of severe multivessel or left main disease based on noninvasive testing, and severe left ventricular dysfunction associated with valvular disease. Certain elective therapeutic interventional procedures such as percutaneous coronary interventions (PCIs) and valvuloplasty should still be performed in facilities that provide cardiac surgical support. The ACC Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures and the ACC/AHA Guidelines for PCI Procedures (2,3) have addressed the issue of primary angioplasty for acute myocardial infarction in hospitals without cardiac surgery capability. Recent data suggest a lower mortality rate among patients undergoing primary angioplasty in higher-volume centers (4). Hospitals that perform primary angioplasty but are without on-site cardiac surgery capability must have a proven plan for rapid access (within 1 h) to a cardiac surgical operating room in a nearby facility with appropriate hemodynamic support capability for such a transfer. The procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (≥75 PCIs performed/year) and only in facilities performing a minimum of 36 primary PCIs/year. In accordance with the soon-to-be-published ACC/AHA guidelines for PCI (3), this committee does not endorse the performance of elective PCI in a facility without cardiac surgery capability. Patients are also being studied in freestanding laboratories (i.e., those that are not physically attached to the hospital). By definition a freestanding laboratory is one where quick transportation of a patient to a hospital by gurney is not possible. These patients clearly must be in stable condition and at the lowest risk for complications. It is vitally important to have mechanisms for backup and bailout in place to provide assistance should patients become unstable in this setting. Although a tertiary hospital serves as an appropriate means for providing proper oversight of a freestanding laboratory, recognized credentialing bodies approved by the local community may be able to provide appropriate oversight to ensure that all issues related to quality assurance (QA) are monitored and addressed. Interventional procedures of any kind should not be performed in a freestanding facility. B. Same-Day and Outpatient Cardiac Catheterization: With the decline in risk associated with cardiac catheterization, the performance of invasive procedures in the ambulatory setting has become more popular. However, prehospitalization may still be important in patients receiving anticoagulation therapy or in those with renal failure, diabetes, or a contrast allergy. Early discharge after the procedure may also be inappropriate for certain patients, including those with a procedure-related complication or hemodynamic instability. In addition, some patients are best observed overnight if severe disease is discovered (e.g., significant left main coronary artery disease or severe aortic stenosis) or in the presence of significant comorbid diseases that increase the risk of late complications. A general scheme is presented to help determine who should be excluded from early discharge after cardiac catheterization. C. QA Issues: Quality assurance starts with an assessment of clinical proficiency among the operators in the cardiac catheterization laboratory. This is surely one of the most difficult elements to assess, but issues of cognitive knowledge, procedural skill, clinical judgment, and procedural outcomes are all important. QA extends to the performance of the laboratory as a whole. A continuous quality-improvement (QI) program should also be included in the laboratory's overall design. One measure of outcome is the number of "normal" diagnostic cardiac catheterizations performed. "Normal" in this regard refers to no disease or insignificant (600 cases/year), and even then with mentoring. Low-volume operators in any other setting should not perform interventional procedures. The minimum case-load for operators performing pediatric catheterizations has not been established by data, although a caseload of 50/year has been suggested for individual operators. Pediatric cardiac catheterization laboratories often share space with adult procedural facilities. The pediatric catheterization laboratory should perform at least 75 procedures/year. Equipment maintenance and management remain an issue, and certain guidelines are provided. Each aspect of the radiographic system should be able to meet these performance expectations. The same is true for the physiological recorders and other specific devices used in the laboratories. A QI program must be in place. The keys are to develop variables that reflect the quality of care, to collect these variables in a systematic manner, to have a means for statistical analysis of the results, and to develop an approach to problem solving that involves feedback on the effectiveness of the solutions. These programs should provide ongoing educational opportunities for staff as well. The Committee also strongly encourages all laboratories to participate in a national data registry to help benchmark their results and provide an ongoing system for tracking complications.

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