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Accreditation of nuclear cardiology laboratories: An educational process
EDITORIAL POINT OF VIEW Accreditation of nuclear cardiology laboratories: An educational process Frans J. Th. Wackers, MD President, Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories The Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL) was founded in 1997 with the aim of first developing a voluntary peer-review accreditation program for nuclear cardiology imaging facilities. The writing of the Essentials and Standards and the application for nuclear cardiology laboratories was completed in the fall of 1998 and then tested successfully in 5 pilot laboratories.1 In 1999 the general nuclear medicine and positron emission tomography programs were launched. In 2001 the American College of Nuclear Physicians/Society of Nuclear Medicine (ACNP/SNM) accreditation program for general nuclear medicine merged with the ICANL to form one single ICANL accreditation organization for both nuclear cardiology and general nuclear medicine.2 With this merger, a mandatory laboratory site visit was added to the accreditation process. The ICANL quickly gained recognition as a valuable means of evaluating the quality of nuclear cardiology/nuclear medicine services. Experts who themselves went through the process of laboratory accreditation review each application. Accreditation is granted on the basis of two independent reviews and site visit findings. Accreditation is for 3 years and re-accreditation is required. ICANL accreditation already is linked to reimbursement for nuclear cardiology services provided by cardiologists in a number of states (eg, Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, and Wisconsin); it can be anticipated that more states will follow. SUBMISSION OF APPLICATION Accreditation by the ICANL is by no means an easy process. An application consists of three components that From Yale University School of Medicine, Section of Cardiovascular Medicine, New Haven, Conn. Reprint requests: Frans J. Th. Wackers, MD, Yale University School of Medicine, Section of Cardiovascular Medicine, 333 Cedar St, PO Box 208017, New Haven, CT 06520-8017. J Nucl Cardiol 2003;10:205-7. Copyright © 2003 by the American Society of Nuclear Cardiology. 1071-3581/2003/$35.00 ⫹ 0 doi:10.1067/mnc.2003.39
document the structure, processes, and outcomes of an imaging facility. Evaluation of the structure requires documentation of the training, credentials, licenses, and continuing medical education credit hours of the medical and technical staff. A description of the physical facilities and a listing of imaging and nonimaging equipment are required. Evaluation of the processes requires submission of written documentation of all imaging and nonimaging procedures and policies. The outcomes are evaluated on the basis of submission of technical quality assurance data, raw digital image data, processed images, and copies of written reports. Even for a well-organized laboratory, it may take 3 to 4 months to assemble a complete application. After submission to the ICANL, two independent reviewers evaluate each application with particular emphasis on the “end product” (ie, images and reports) and a site visit is conducted (Figure 1). The written reviews and site visit report are submitted to the ICANL Board of Directors for final decision. The Board of Directors has the option to make one of three decisions: grant, delay, or deny accreditation. Delay usually entails a request for further clarifications and/or recommendations for changes of certain elements in the application that were judged to be deficient. When the requested additional information has been submitted and reviewed, accreditation may be granted. DELAYED ACCREDITATION As of November 2002, 718 laboratories obtained the ICANL Essentials and Standards documents, thereby indicating interest in applying for accreditation. Currently, 179 laboratories at 232 sites are ICANL-accredited (Figure 2). Since 1999, a total of 214 laboratories submitted complete applications. After review, accreditation was granted without delay to 143 imaging facilities (67%); for 71 laboratories (33%), the decision was delayed. Ultimately, 69 of these laboratories were granted accreditation after submission of additional material; accreditation was denied to 2 laboratories. Figure 3 shows the increase in applications over the 4-year period and also illustrates the increasing proportion of facilities for which accreditation was delayed because 205
206
Wackers Accreditation of nuclear cardiology laboratories
Figure 1. Process of accreditation through ICANL. Each application is first checked for completeness at the ICANL office. Two reviewers (one physician and one technologist) then independently review the application. In addition, a limited site visit is conducted with a focus on imaging and nonimaging quality control and radiation safety practices. Recommendations by the reviewers and site visitor are evaluated by one half of the ICANL Board of Directors (BOD). The decision to grant, delay, or deny accreditation is communicated to the applicant laboratory, followed by a detailed letter of critique. In cases in which the decision is appealed, the other half of the Board of Directors considers the application de novo.
Journal of Nuclear Cardiology March/April 2003
Figure 3. Number of laboratories evaluated by the ICANL from 1999 to 2002. The proportion of laboratories that received immediate accreditation (n ⫽ 143) and that received delayed accreditation (n ⫽ 71) is shown overall, as well as over the years. The proportion of laboratories with delayed accreditation increased over time.
tation after several unsuccessful re-submissions. The increasing number of delayed submissions most likely results from two factors: (1) The laboratories that sought accreditation during the first years of the ICANL’s existence were most likely self-selected and high-quality laboratories. (2) With increasing experience of reviewing laboratories, reviewers became more discriminating about certain aspects of the operation and management of nuclear imaging facilities that should be improved before granting accreditation. LESSONS LEARNED FROM ACCREDITATION
Figure 2. Type of laboratories with ICANL accreditation. The majority of laboratories are located in private offices or hospitals. The remaining facilities are freestanding nuclear cardiology laboratories or in imaging centers. There were also a few mobile laboratories.
one or more components of the operation of the laboratory were deficient and required correction. In 2002 the accreditation of 47% of laboratories was delayed because of deficiencies in the application. However, over this 4-year period, only 2 laboratories were denied accredi-
As reported previously, with state-of-the-art equipment, most laboratories are capable of routinely generating high-quality SPECT images. However, many laboratories were noted to be deficient in two aspects: the quality of procedural protocols and the quality of reports to referring physicians. (See also www.icanl.org.3) The importance of high-quality reports has been addressed previously.4 From the time the ICANL published report templates, subsequent applications demonstrated more uniform and better-quality reports. Good-quality and detailed procedure protocols are also of importance because they reflect the degree of organization and standardization of a laboratory. Laboratories usually develop unique ways to perform procedures while remaining within standardization boundaries. Technologists often rewrite image acquisition protocols to accommodate local conditions and preferences. The purpose of written procedure protocols and policies is to ensure reproducibility of results and consistency of quality over
Journal of Nuclear Cardiology Volume 10, Number 2;205-7
an extended period of time. Lack of written procedure protocols or policies may result in inconsistent and/or poor quality. AN EDUCATIONAL PROCESS AND CONTINUING QUALITY IMPROVEMENT The ICANL accreditation process was designed, in part, as an educational effort. Experts in the field of nuclear cardiology and nuclear medicine wrote the Essentials and Standards with quality assurance and continuing quality improvement in mind. A laboratory that has received ICANL accreditation has been demonstrated to be in substantial compliance with the Essentials and Standards. This means that minimal standard criteria of quality were met. There clearly is always room for improvement in some aspects of the daily operation of a laboratory, even in the best of laboratories. A critique letter describing point by point what reviewers noted as imperfections and weaknesses accompanies the Certificate of Accreditation. When a laboratory applies for re-accreditation 3 years later, reviewers look for evidence of improvement with regard to these points as compared with the previous application. The ICANL accreditation program has become a well-accepted means for accreditation of nuclear laboratories. It can be anticipated that in the near future, more and more health care organizations will require ICANL accreditation for reimbursement for nuclear cardiology procedures by cardiologists. This will doubtlessly result in increasing numbers of applications. Although, understandably, one may be dismayed by the increasing regulation of practice, it may be of some reassurance that the ICANL accreditation program was designed by expert practicing physicians and technologists who set reasonable minimal standards for acceptable quality. In addition, the focus of evaluation is on the “end product,” that is, the overall quality of services provided.
Wackers Accreditation of nuclear cardiology laboratories
207
The accreditation program also is an excellent means for monitoring what constitutes “real” daily practice of nuclear cardiology: whether guidelines are being followed, and if not, what deviations exist and which may be acceptable. The program also provides a unique means by which to identify educational needs for individual laboratories, as well as for the entire nuclear cardiology community. A good example of this was the observation of a lack of standardization of nuclear cardiology reports. This observation resulted in the publication of an ICANL position statement on goodquality reports and the publication of sample templates.4 This same issue was then addressed in lectures at national and local meetings. At present, reviewers have observed noticeable improvement in quality and uniformity of reports in new applications. This is an illustration of the potential of laboratory accreditation as an instrument for continuing quality improvement. Ultimately, by the approach of focusing on individual laboratories, accreditation and re-accreditation of imaging facilities may have a far-reaching impact on the overall quality of nuclear cardiology services in years to come. Accreditation is an educational process.
References 1. Wackers FJTh. Blueprint of the accreditation program of the Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories. J Nucl Cardiol 1999;6:372-4. 2. Wackers FJTh. ICANL and ACR nuclear medicine accreditation: a comparison. J Nucl Med 2000;41:26N-28N. 3. Intersocietal Commission for the Accreditation of Nuclear Laboratories Web site. Available at: http://www.icanl.org. Accessed “Sample reports” at http:/www.icanl.org/samples.htm. 4. Wackers FJTh. Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL) position statement on standardization and optimization of nuclear cardiology reports. J Nucl Cardiol 2000;7:397-400.
document the structure, processes, and outcomes of an imaging facility. Evaluation of the structure requires documentation of the training, credentials, licenses, and continuing medical education credit hours of the medical and technical staff. A description of the physical facilities and a listing of imaging and nonimaging equipment are required. Evaluation of the processes requires submission of written documentation of all imaging and nonimaging procedures and policies. The outcomes are evaluated on the basis of submission of technical quality assurance data, raw digital image data, processed images, and copies of written reports. Even for a well-organized laboratory, it may take 3 to 4 months to assemble a complete application. After submission to the ICANL, two independent reviewers evaluate each application with particular emphasis on the “end product” (ie, images and reports) and a site visit is conducted (Figure 1). The written reviews and site visit report are submitted to the ICANL Board of Directors for final decision. The Board of Directors has the option to make one of three decisions: grant, delay, or deny accreditation. Delay usually entails a request for further clarifications and/or recommendations for changes of certain elements in the application that were judged to be deficient. When the requested additional information has been submitted and reviewed, accreditation may be granted. DELAYED ACCREDITATION As of November 2002, 718 laboratories obtained the ICANL Essentials and Standards documents, thereby indicating interest in applying for accreditation. Currently, 179 laboratories at 232 sites are ICANL-accredited (Figure 2). Since 1999, a total of 214 laboratories submitted complete applications. After review, accreditation was granted without delay to 143 imaging facilities (67%); for 71 laboratories (33%), the decision was delayed. Ultimately, 69 of these laboratories were granted accreditation after submission of additional material; accreditation was denied to 2 laboratories. Figure 3 shows the increase in applications over the 4-year period and also illustrates the increasing proportion of facilities for which accreditation was delayed because 205
206
Wackers Accreditation of nuclear cardiology laboratories
Figure 1. Process of accreditation through ICANL. Each application is first checked for completeness at the ICANL office. Two reviewers (one physician and one technologist) then independently review the application. In addition, a limited site visit is conducted with a focus on imaging and nonimaging quality control and radiation safety practices. Recommendations by the reviewers and site visitor are evaluated by one half of the ICANL Board of Directors (BOD). The decision to grant, delay, or deny accreditation is communicated to the applicant laboratory, followed by a detailed letter of critique. In cases in which the decision is appealed, the other half of the Board of Directors considers the application de novo.
Journal of Nuclear Cardiology March/April 2003
Figure 3. Number of laboratories evaluated by the ICANL from 1999 to 2002. The proportion of laboratories that received immediate accreditation (n ⫽ 143) and that received delayed accreditation (n ⫽ 71) is shown overall, as well as over the years. The proportion of laboratories with delayed accreditation increased over time.
tation after several unsuccessful re-submissions. The increasing number of delayed submissions most likely results from two factors: (1) The laboratories that sought accreditation during the first years of the ICANL’s existence were most likely self-selected and high-quality laboratories. (2) With increasing experience of reviewing laboratories, reviewers became more discriminating about certain aspects of the operation and management of nuclear imaging facilities that should be improved before granting accreditation. LESSONS LEARNED FROM ACCREDITATION
Figure 2. Type of laboratories with ICANL accreditation. The majority of laboratories are located in private offices or hospitals. The remaining facilities are freestanding nuclear cardiology laboratories or in imaging centers. There were also a few mobile laboratories.
one or more components of the operation of the laboratory were deficient and required correction. In 2002 the accreditation of 47% of laboratories was delayed because of deficiencies in the application. However, over this 4-year period, only 2 laboratories were denied accredi-
As reported previously, with state-of-the-art equipment, most laboratories are capable of routinely generating high-quality SPECT images. However, many laboratories were noted to be deficient in two aspects: the quality of procedural protocols and the quality of reports to referring physicians. (See also www.icanl.org.3) The importance of high-quality reports has been addressed previously.4 From the time the ICANL published report templates, subsequent applications demonstrated more uniform and better-quality reports. Good-quality and detailed procedure protocols are also of importance because they reflect the degree of organization and standardization of a laboratory. Laboratories usually develop unique ways to perform procedures while remaining within standardization boundaries. Technologists often rewrite image acquisition protocols to accommodate local conditions and preferences. The purpose of written procedure protocols and policies is to ensure reproducibility of results and consistency of quality over
Journal of Nuclear Cardiology Volume 10, Number 2;205-7
an extended period of time. Lack of written procedure protocols or policies may result in inconsistent and/or poor quality. AN EDUCATIONAL PROCESS AND CONTINUING QUALITY IMPROVEMENT The ICANL accreditation process was designed, in part, as an educational effort. Experts in the field of nuclear cardiology and nuclear medicine wrote the Essentials and Standards with quality assurance and continuing quality improvement in mind. A laboratory that has received ICANL accreditation has been demonstrated to be in substantial compliance with the Essentials and Standards. This means that minimal standard criteria of quality were met. There clearly is always room for improvement in some aspects of the daily operation of a laboratory, even in the best of laboratories. A critique letter describing point by point what reviewers noted as imperfections and weaknesses accompanies the Certificate of Accreditation. When a laboratory applies for re-accreditation 3 years later, reviewers look for evidence of improvement with regard to these points as compared with the previous application. The ICANL accreditation program has become a well-accepted means for accreditation of nuclear laboratories. It can be anticipated that in the near future, more and more health care organizations will require ICANL accreditation for reimbursement for nuclear cardiology procedures by cardiologists. This will doubtlessly result in increasing numbers of applications. Although, understandably, one may be dismayed by the increasing regulation of practice, it may be of some reassurance that the ICANL accreditation program was designed by expert practicing physicians and technologists who set reasonable minimal standards for acceptable quality. In addition, the focus of evaluation is on the “end product,” that is, the overall quality of services provided.
Wackers Accreditation of nuclear cardiology laboratories
207
The accreditation program also is an excellent means for monitoring what constitutes “real” daily practice of nuclear cardiology: whether guidelines are being followed, and if not, what deviations exist and which may be acceptable. The program also provides a unique means by which to identify educational needs for individual laboratories, as well as for the entire nuclear cardiology community. A good example of this was the observation of a lack of standardization of nuclear cardiology reports. This observation resulted in the publication of an ICANL position statement on goodquality reports and the publication of sample templates.4 This same issue was then addressed in lectures at national and local meetings. At present, reviewers have observed noticeable improvement in quality and uniformity of reports in new applications. This is an illustration of the potential of laboratory accreditation as an instrument for continuing quality improvement. Ultimately, by the approach of focusing on individual laboratories, accreditation and re-accreditation of imaging facilities may have a far-reaching impact on the overall quality of nuclear cardiology services in years to come. Accreditation is an educational process.
References 1. Wackers FJTh. Blueprint of the accreditation program of the Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories. J Nucl Cardiol 1999;6:372-4. 2. Wackers FJTh. ICANL and ACR nuclear medicine accreditation: a comparison. J Nucl Med 2000;41:26N-28N. 3. Intersocietal Commission for the Accreditation of Nuclear Laboratories Web site. Available at: http://www.icanl.org. Accessed “Sample reports” at http:/www.icanl.org/samples.htm. 4. Wackers FJTh. Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL) position statement on standardization and optimization of nuclear cardiology reports. J Nucl Cardiol 2000;7:397-400.