NEMA XR 26-2012 Access Controls for Computed Tomography Identification Interlocks and Logs.pdf

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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 26-2012Access Controls for Computed Tomography: Identification, Interlocks, and Logs Copyright 2012 by National Electrical Manufacturers Association NEMA XR 26-2012 Access Controls for Computed Tomography: Identification,

2、 Interlocks, and Logs Published by: National Electrical Manufacturers Association1300 North 17th Street, Suite 1752 Rosslyn, Virginia 22209 www.nema.org Copyright 2012 by the National Electrical Manufacturers Association. All rights including translation into other languages, reserved under the Univ

3、ersal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. XR 26-3012 Page ii Copyright 2012 by National Electrical Manufacturers Association NOTICE AND DISCLAIMERThe information in this publicatio

4、n was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document. The Nationa

5、l Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have an inte

6、rest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information or the s

7、oundness of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, us

8、e of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular

9、 purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or sellers products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on be

10、half of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasona

11、ble care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake to polic

12、e or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this document shall not be attribu

13、table to NEMA and is solely the responsibility of the certifier or maker of the statement. XR 26-3012 Page iii Copyright 2012 by National Electrical Manufacturers Association FOREWORDThis first edition of this standard is intended to be used by medical imaging device manufacturers in the design and

14、manufacture of CT scanner equipment. This standard was developed by the CT Group of the X-Ray Imaging Section of the Medical Imaging however, they may be implemented and configured by a facility user with administrative privileges. The system shall record any such change in the log file and the oper

15、ator of record who made the change. 2.2 ACCESS AND AUTHORIZATION LEVELS The CT systems shall have at least three categories of access and authorization levels. These are scanning privileges, protocol privileges, and administrative privileges. Additional access levels may include service, application

16、s, engineering, or other privileges on the system. Each privilege shall be independent of each other and a user may be assigned one or multiple privileges. 2.2.1 Establishment of a User with Administrative PrivilegesThe manufacturers installation instructions shall require that prior to turnover of

17、the system, the field engineer/assembler obtain from the site at least one person to initially assign as a user with administrative privileges.Note: Manufacturers installation instructions should also advise sites to promptly set up the other clinical access privileges.2.2.2 List of Users The CT sca

18、nner shall be able to maintain a list of all users and their associated privileges. There shall be a unique identifier associated for each user. A user with administrative privileges shall be able to review and retrieve this list upon request. The scanner shall record all changes made to this list i

19、n the log file and the operator of record who made the change. The manufacturers information for users shall contain information to define users to adequately describe the operation and establish privilege assignments based upon facilities needs. 2.3 SYSTEM ACCESS In order to operate the CT system,

20、the system shall require that a user is logged on and authorized to use that system. This user shall be the operator of record. The system shall only allow one operator of recordto be logged on at a given time. In order to be authorized with administrative privileges or protocol privileges a passwor

21、d may also be required. 2.4 System Interlocks 2.4.1 Clinical ScanningThere shall be an interlock to preclude the clinical operation of CT equipment without entry of a user with scanning privileges. The operator of record at scan time shall be recorded for each exam. XR 26-3012 Page 4 Copyright 2012

22、by National Electrical Manufacturers Association 2.4.2 Saving of Clinical ProtocolsThere shall be an interlock to preclude establishing or saving a clinical protocol unless the operator has been assigned to have protocol privileges. The system shall record the operator of record, date and time, the

23、protocol identifier, and the parameters that changed (including both the new and previous values) in the log file. 2.4.3 Patient Identifier There shall be an interlock to prevent clinical operation of CT equipment without entry of a patient identifier. However, provision shall be made to allow scann

24、ing for trauma cases or other cases where the patient identifier may not be known. These cases shall be recorded in the log file with a unique exam identifier, date and time, and operator of record.2.4.4 Patient Height, Weight, Age and Gender The system shall also have the ability to enter patient h

25、eight, weight, age and gender for clinical scanning. In cases where the patient height/weight/age/gender entry is not known, failure to populate these fields shall not prevent scanning. 2.5 System Lock The system shall provide the ability to lock the user interface without loss of system state. Howe

26、ver, if the scan was in the confirmed/go/load status, the confirmed/go/load status shall not be maintained when the system is locked (i.e. system is no longer “armed” or in ready state). This lock shall be accomplished by user demand (manual lock). Any listed user shall be able to unlock the interfa

27、ce and become the operator of record with his/her associated privilege level. 2.6 Scanning for Unforeseen Circumstances, Emergency Access Means shall be provided to allow scanning under unforeseen circumstances when a qualified operator is unable to gain authorized access for clinical operation of t

28、hat system (e.g., when an operator is not entered into the system but is approved by the institution to perform the scan). In such cases, a field must be provided requiring the operator to enter his/her name before proceeding (this scenario is considered emergency access). This event shall be record

29、ed in the log file along with the operator name, date and time, and unique exam identifier. This event shall be highlighted such that it is easily identifiable for quality review. Additionally, when authorized under emergency access mode, the operator must re-enter his/her name before proceeding aft

30、er not more than five examinations. The manufacturers information for users shall contain information for maintaining an appropriate number of users with scanning privileges (and other privileges) to avoid these types of circumstances. 2.7 Log File Access to the log file shall be made available on d

31、emand for users with administrative privileges.Additionally, the system shall allow the user with administrative privileges to assign others with privileges access to the log file. A message shall be provided to the user before the log file becomes full instructing them to archive the file. The size

32、 of the log file shall be designed such that it is of sufficient size to contain logs for approximately 4 months of expected routine operation prior to archiving. The log file size shall be determined by the manufacturer based upon typical system use. A mechanism shall be made available XR 26-3012 P

33、age 5 Copyright 2012 by National Electrical Manufacturers Association such that the log file is preserved during, or archived prior to, any potential software updates, reloads or scanner de-installation. 2.8 Protocol Export The scanner shall have the capability to export protocols upon user request. NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION 1300 NORTH 17TH STREET, SUITE 900 ROSSLYN. VA 22209www.NEMA.orgTO ORDER ADDITIONAL NEMA STANDARDS VISITWWW.GLOBAL.IHS.COM OR CALL 1-800-854-7179/1-303-397-79565612_0514TB