That Quality Assurance Programs Are Reviewed on a Regular Basis
| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR1000.55] |
Affiliate I--FOOD AND DRUG ADMINISTRATION
Section OF Health AND HUMAN SERVICES
SUBCHAPTER J - RADIOLOGICAL HEALTH
(a) Applicability. Quality assurance programs every bit described in paragraph (c) of this section are recommended for all diagnostic radiology facilities.
(b) Definitions. As used in this department, the following definitions apply:
(1) Diagnostic radiology facility ways any facility in which an x-ray organization(south) is used in whatever procedure that involves irradiation of any function of the human being body for the purpose of diagnosis or visualization. Offices of individual physicians, dentists, podiatrists, and chiropractors, as well equally mobile laboratories, clinics, and hospitals are all examples of diagnostic radiology facilities.
(2) Quality balls means the planned and systematic actions that provide adequate conviction that a diagnostic x-ray facility will produce consistently high quality images with minimum exposure of the patients and healing arts personnel. The determination of what constitutes loftier quality will be made by the facility producing the images. Quality balls actions include both "quality command" techniques and "quality administration" procedures.
(three) Quality assurance programme ways an organized entity designed to provide "quality balls" for a diagnostic radiology facility. The nature and extent of this program will vary with the size and type of the facility, the type of examinations conducted, and other factors.
(4) Quality control techniques are those techniques used in the monitoring (or testing) and maintenance of the components of an x-ray organisation. The quality control techniques thus are concerned direct with the equipment.
(5) Quality assistants procedures are those management actions intended to guarantee that monitoring techniques are properly performed and evaluated and that necessary corrective measures are taken in response to monitoring results. These procedures provide the organizational framework for the quality assurance programme.
(6) Ten-ray system means an assemblage of components for the controlled production of diagnostic images with 10-rays. It includes minimally an x-ray high voltage generator, an 10-ray command, a tube-housing assembly, a beam-limiting device, and the necessary supporting structures. Other components that function with the arrangement, such every bit image receptors, epitome processors, view boxes, and darkrooms, are also parts of the system.
(c) Elements. A quality assurance program should contain the elements listed in paragraphs (c)(1) through (x) of this section. The extent to which each element of the quality assurance program is implemented should exist adamant by an analysis of the facility's objectives and resources conducted by its qualified staff or by qualified exterior consultants. The extent of implementation should be determined on the basis of whether the expected benefits in radiations exposure reduction, improved image quality, and/or financial savings will compensate for the resources required for the programme.
(1) Responsibility. (i) Responsibility and dominance for the overall quality assurance program as well equally for monitoring, evaluation, and corrective measures should be specified and recorded in a quality assurance transmission.
(ii) The possessor or practitioner in charge of the facility has primary responsibility for implementing and maintaining the quality assurance program.
(three) Staff technologists will generally exist delegated a basic quality assurance role by the practitioner in charge. Responsibleness for specific quality command monitoring and maintenance techniques or quality administration procedures may be assigned, provided that the staff technologists are qualified by training or experience for these duties. The staff technologists should besides be responsible for identifying problems or potential bug requiring actions beyond the level of their grooming. They should bring these bug to the attention of the practitioner in accuse, or his or her representative, so that help in solving the bug may be obtained from inside or outside the facility.
(iv) In facilities where they are available, physicists, supervisory technologists, or quality control technologists should have a major role in the quality balls program. Such specialized personnel may exist assigned responsibleness for twenty-four hour period-to-day administration of the programme, may carry out monitoring duties beyond the level of training of the staff technologist or, if desired past the facility, may save the staff technologists of some or all of their basic monitoring duties. Staff service engineers may too be assigned responsibility for certain preventive or cosmetic maintenance actions.
(v) Responsibility for certain quality control techniques and cosmetic measures may be assigned to personnel qualified by grooming or feel, such as consultants or industrial representatives, from exterior of the facility, provided there is a written agreement conspicuously specifying these services.
(vi) In large facilities, responsibleness for long-range planning of quality assurance goals and activities should exist assigned to a quality assurance committee as described in paragraph (c)(9) of this department.
(2) Buy specifications. Before purchasing new equipment, the staff of the diagnostic radiology facility should make up one's mind the desired operation specifications for the equipment. Initially, these specifications may be stated in terms of the desired performance of the equipment, or prospective vendors may be informed solely of the functions the equipment should be able to perform and asked to provide the performance specifications of items from their equipment line that tin can perform these functions. In either case, the responses of the prospective vendors should serve as the basis for negotiations to establish the final buy specifications, taking into account the state of the fine art and balancing the need for the specified performance levels with the cost of the equipment to run into them. The terminal purchase specifications should exist in writing and should include performance specifications. The availability of experienced service personnel should as well exist taken into consideration in making the terminal purchase decisions. Any understandings with respect to service personnel should be incorporated into the purchase specifications. Afterwards the equipment is installed, the facility should conduct a testing program, as defined in its buy specifications, to ensure that the equipment meets the agreed upon specifications, including applicative Federal and State regulatory requirements. The equipment should not be formally accustomed until whatever necessary corrections have been made by the vendor. The purchase specifications and the records of the acceptance testing should be retained throughout the life of the equipment for comparison with monitoring results in order to assess continued acceptability of performance.
(3) Monitoring and maintenance. A routine quality command monitoring and maintenance system incorporating country-of-the-art procedures should exist established and conducted on a regular schedule. The purpose of monitoring is to allow evaluation of the performance of the facility's 10-ray organization(s) in terms of the standards for image quality established by the facility (as described in paragraph (c)(iv) of this section) and compliance with applicable Federal and State regulatory requirements. The maintenance plan should include cosmetic maintenance to eliminate problems revealed past monitoring or other means before they accept a serious deleterious touch on patient care. To the extent permitted by the training of the facility staff, the maintenance program should too include preventive maintenance, which could forestall unexpected breakdowns of equipment and disruption of departmental routine.
(i) The parameters to exist monitored in a facility should exist determined by that facility on the ground of an analysis of expected benefits and cost. Such factors as the size and resource of the facility, the blazon of examinations conducted, and the quality balls problems that have occurred in that or similar facilities should be taken into account in establishing the monitoring system. The monitoring frequency should also be based upon need and can be different for different parameters.
(ii) Although the parameters to be monitored volition vary somewhat from facility to facility, every diagnostic radiology facility should consider monitoring the post-obit 5 key components of the ten-ray organisation:
(a ) Moving-picture show processing.
(b ) Basic performance characteristics of the x-ray unit.
(c ) Cassettes and grids.
(d ) View boxes.
(eastward ) Darkroom.
(iii) Examples of parameters of the above-named components and of more specialized equipment that may be monitored are every bit follows:
(a ) For motion picture processing:
An index of speed.
An alphabetize of contrast.
Base of operations plus fog.
Solution temperatures.
Film artifact identification.
(b ) For bones operation characteristics of the x-ray unit of measurement:
(1 ) For fluoroscopic x-ray units:
Table-top exposure rates.
Centering alignment.
Collimation.
kVp accuracy and reproducibility.
mA accuracy and reproducibility.
Exposure time accuracy and reproducibility.
Reproducibility of ten-ray output.
Focal spot size consistency.
Half-value layer.
Representative archway skin exposures.
(2 ) For image-intensified systems:
Resolution.
Focusing.
Baloney.
Glare.
Low dissimilarity performance.
Physical alignment of camera and collimating lens.
(3 ) For radiographic 10-ray units:
Reproducibility of x-ray output.
Linearity and reproducibility of mA stations.
Reproducibility and accurateness of timer stations.
Reproducibility and accuracy of kVp stations.
Accuracy of source-to-film altitude indicators.
Light/10-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.
(four ) For automatic exposure command devices:
Reproducibility.
kVp compensation.
Field sensitivity matching.
Minimum response time.
Backup timer verification.
(c ) For cassettes and grids:
(1 ) For cassettes:
Film/screen contact.
Screen condition.
Light leaks.
Artifact identification.
(2 ) For grids:
Alignment and focal distance.
Artifact identification.
(d ) For view boxes:
Consistency of lite output with time.
Consistency of low-cal output from one box to another.
View box surface conditions.
(e ) For darkrooms:
Darkroom integrity.
Safety calorie-free conditions.
(f ) For specialized equipment:
(one ) For tomographic systems:
Accuracy of depth and cutting indicator.
Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Flatness of cassette.
Representative entrance pare exposures.
(2 ) For computerized tomography:
Precision (noise).
Contrast scale.
High and low dissimilarity resolution.
Alignment.
Representative entrance peel exposures.
(iv) The maintenance plan should include both preventive and cosmetic aspects.
(a ) Preventive maintenance. Preventive maintenance should be performed on a regularly scheduled basis with the goal of preventing breakdowns due to equipment failing without warning signs detectable by monitoring. Such actions take been found cost effective if responsibility is assigned to facility staff members. Possible preventive maintenance procedures are visual inspection of the mechanical and electric characteristics of the x-ray system (covering such things as checking conditions of cables, watching the tomographic unit of measurement for smoothness of motion, assuring cleanliness with respect to spilling of contaminants in the examination room or the darkroom, and listening for unusual noises in the moving parts of the organisation), following the manufacturer'due south recommended procedures for cleaning and maintenance of the equipment, and regular inspection and replacement of switches and parts that routinely wear out or fail. The procedures included would depend upon the groundwork of the staff members bachelor. Plainly, a large facility with its own service engineers tin do more than an individual practitioner's part.
(b ) Corrective maintenance. For maximum effectiveness, the quality assurance plan should brand provision, as described in paragraph (c)(5) of this section, for ascertaining whether potential problems are developing. If potential or actual bug are detected, corrective maintenance should be carried out to eliminate them before they cause a major bear on on patient care.
(four) Standards for image quality. Standards of acceptable paradigm quality should be established. Ideally, these should be objective, eastward.g., acceptability limits for the variations of parameter values, but they may be subjective, eastward.g., the opinions of professional personnel, in cases where adequate objective standards cannot be divers. These standards should exist routinely reviewed and redefined as needed, every bit described in paragraph (c)(ten) of this section.
(v) Evaluation. The facility'south quality assurance program should include means for two levels of evaluation.
(i) On the first level, the results of the monitoring procedures should be used to evaluate the performance of the ten-ray system(due south) to make up one's mind whether cosmetic actions are needed to adjust the equipment so that the image quality consistently meets the standards for epitome quality. This evaluation should include analysis of trends in the monitoring data also equally the use of the data to determine the need for corrective actions on a twenty-four hour period-by-day basis. Comparison of monitoring data with the purchase specifications and acceptance testing results for the equipment in question is also useful.
(two) On the second level, the facility quality assurance program should also include means for evaluating the effectiveness of the program itself. Possible means include ongoing studies of the retake rate and the causes of the repeated radiographs, exam of equipment repair and replacement costs, subjective evaluation of the radiographs being produced, occurrence and reasons for complaints by radiologists, and assay of trends in the results of monitoring procedures such as sensitometric studies. Of these, ongoing studies of the retake rate (reject rate) and its causes are often the near useful and may besides provide information of value in the beginning level of evaluation. Such studies tin be used to evaluate potential for improvement, to make corrections, and to make up one's mind whether the corrective actions were effective. The number of rejects should be recorded daily or weekly, depending on the facility's assay of its needs. Ideally, the reasons for the rejection should as well exist determined and recorded. Should determining these reasons be incommunicable on a regular basis with the available staff, the analysis should exist washed for a ii-calendar week period after major changes have occurred in diagnostic procedures or the x-ray system and at least semi-annually.
(6) Records. The program should include provisions for the keeping of records on the results of the monitoring techniques, whatever difficulties detected, the corrective measures practical to these difficulties, and the effectiveness of these measures. The extent and course of these records should be adamant by the facility on the basis of its needs. The facility should view these records as a tool for maintaining an constructive quality assurance programme and not view the data in them every bit an terminate in itself but rather as a starting time. For case, the records should be made available to vendors to assist them provide better service. More than importantly, the data should exist the basis for the evaluation and the reviews suggested in paragraphs (c)(five) and (10) of this section.
(seven) Manual. A quality assurance transmission should be written in a format permitting convenient revision as needed and should be made readily available to all personnel. The content of the manual should be determined by the facility staff, but the following items are suggested equally providing essential information:
(i) A list of the individuals responsible for monitoring and maintenance techniques.
(ii) A list of the parameters to exist monitored and the frequency of monitoring.
(iii) A description of the standards, criteria of quality, or limits of acceptability that have been established for each of the parameters monitored.
(4) A cursory description of the procedures to be used for monitoring each parameter.
(v) A clarification of procedures to be followed when difficulties are detected to telephone call these difficulties to the attention of those responsible for correcting them.
(six) A list of the publications in which detailed instructions for monitoring and maintenance procedures can be constitute. Copies of these publications should also be readily available to the entire staff, but they should be carve up from the transmission. (Publications providing these instructions tin can usually be obtained from FDA or private sources, although the facility may wish to make some modifications to meet its needs more effectively.)
(vii) A list of the records, with sample forms, that the facility staff has decided should exist kept. The facility staff should besides decide and annotation in the transmission the length of time each blazon of record should be kept before discarding.
(8) A copy of each prepare of purchase specifications developed for new equipment and the results of the credence testing for that equipment.
(8) Training. The program should include provisions for appropriate training for all personnel with quality assurance responsibilities. This should include both training provided before the quality assurance responsibilities are causeless and continuing pedagogy to keep the personnel up-to-date. Practical experience with the techniques conducted under the supervision of experienced instructors, either in the facility or in a special program, is the well-nigh desirable blazon of training. The use of self-pedagogy materials tin can be an adequate substitute for supervised didactics, especially in continuing educational activity programs, if supervised didactics is not available.
(9) Committee. A facility whose size would brand information technology impractical for all staff members to meet for planning purposes should consider the establishment of a quality assurance committee whose master office would exist to maintain lines of communication among all groups with quality assurance and/or prototype product or interpretation responsibilities. For maximum communication, all departments of the facility with x-ray equipment should be represented. The committee may too be assigned policy-making duties such as some or all of the following:
Assign quality assurance responsibilities; maintain acceptable standards of quality; periodically review plan effectiveness, etc. Alternatively, the duties of this committee could exist assigned to an already-existing committee such every bit the Radiations Safety Commission. In smaller facilities, all staff members should participate in the committee's tasks. The Quality Assurance Committee should report directly to the caput of the radiology section, or, in facilities where more than 1 department operates x-ray equipment, to the main medical officeholder of the facility. The committee should come across on a regular footing.
(10) Review. The facility's quality balls programme should be reviewed by the Quality Assurance Committee and/or the practitioner in accuse to determine whether its effectiveness could be improved. Items suggested for inclusion in the review include:
(i) The reports of the monitoring and maintenance techniques to ensure that they are existence performed on schedule and effectively. These reports should be reviewed at to the lowest degree quarterly.
(ii) The monitoring and maintenance techniques and their schedules to ensure that they proceed to be appropriate and in step with the latest developments in quality assurance. They should be made current at to the lowest degree annually.
(3) The standards for image quality to ensure that they are consistent with the state-of-the-fine art and the needs and resource of the facility. These standards should be evaluated at least annually.
(4) The results of the evaluations of the effectiveness of the quality assurance deportment to determine whether changes need to exist made. This conclusion should be fabricated at least annually.
(5) The quality assurance transmission should likewise be reviewed at least annually to determine whether revision is needed.
[44 FR 71737, Dec. eleven, 1979]
Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=1000.55