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to permit evaluation of the performance of the facility's x-ray system(s) in terms of the standards for image quality established by the facility (as described in paragraph (c)(4) of this section) and compliance with applicable Federal and State regulatory requirements. The maintenance program should include corrective maintenance to eliminate problems revealed by monitoring or other means before they have a serious deleterious impact on patient care. To the extent permitted by the training of the facility staff, the maintenance program should also include preventive maintenance, which could prevent unexpected breakdowns of equipment and disruption of departmental routine.

(i) The parameters to be monitored in a facility should be determined by that facility on the basis of an analysis of expected benefits and cost. Such factors as the size and resources of the facility, the type of examinations conducted, and the quality assurance 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 will vary somewhat from facility to facility, every diagnostic radiology facility should consider monitoring the following five key components of the x-ray system:

(a) Film processing.

(6) Basic performance characteristics of the x-ray unit.

(c) Cassettes and grids.
(d) View boxes.
(e) Darkroom.

(iii) Examples of parameters of the above-named components and of more specialized equipment that may be monitored are as follows:

(a) For film processing:
An index of speed.
An index of contrast.
Base plus fog.
Solution temperatures.
Film artifact identification.

(6) For basic performance characteristics of the x-ray unit:

(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 x-ray output.
Focal spot size consistency.
Half-value layer.
Representative entrance skin exposures.

(2) For image-intensified systems:
Resolution.
Focusing.
Distortion.
Glare.
Low contrast performance.
Physical alignment of camera and colli-
mating lens.

(3) For radiographic x-ray units: Reproducibility of x-ray output. Linearity and reproducibility of mA sta

tions. Reproducibility and accuracy of timer sta

tions. Reproducibility and accuracy of kVp sta

tions. Accuracy of source-to-film distance indica

tors.
Light/x-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.

(4) For automatic exposure control 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 light output with time. Consistency of light output from one box to

another. View box surface conditions.

(e) For darkrooms: Darkroom integrity. Safe light conditions.

() For specialized equipment:

(1) For tomographic systems: Accuracy of depth and cut indicator.

Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Platness of cassette.
Representative entrance skin exposures.

(2) For computerized tomography:
Precision (noise).
Yontrast scale.
ligh and low contrast resolution.
Alignment.
Lepresentative entrance skin exposures.

(iv) The maintenance program should nclude both preventive and corrective spects.

(a) Preventive maintenance. Preventive naintenance should be performed on a egularly scheduled basis with the goal of preventing breakdowns due to equipnent failing without warning signs deectable by monitoring. Such actions lave been found cost effective if reponsibility is assigned to facility staff nembers. Possible preventive maintelance procedures are visual inspection of the mechanical and electrical char.cteristics of the x-ray system (covring such things as checking condiions of cables, watching the tomoraphic unit for smoothness of motion, ssuring cleanliness with respect to pilling of contaminants in the examnation room or the darkroom, and lisening for unusual noises in the movng parts of the system), following the nanufacturer's recommended procelures for cleaning and maintenance of he equipment, and regular inspection nd replacement of switches and parts hat routinely wear out or fail. The rocedures included would depend upon he background of the staff members vailable. Obviously, a large facility vith its own service engineers can do nore than an individual practitioner's office.

(6) Corrective maintenance. For maxmum effectiveness, the quality assurince program should make provision, us described in paragraph (c)(5) of this lection, for ascertaining whether poential problems are developing. If poential or actual problems are deected, corrective maintenance should De carried out to eliminate them before hey cause a major impact on patient are.

(4) Standards for image quality. Standards of acceptable image quality should be established. Ideally, these should be objective, e.g., acceptability limits for the variations of parameter values, but they may be subjective, e.g., the opinions of professional personnel, in cases where adequate objective standards cannot be defined. These standards should be routinely reviewed and redefined as needed, as described in paragraph (C)(10) of this section.

(5) Evaluation. The facility's 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

X-ray system(s) to determine whether corrective actions are needed to adjust the equipment so that the image quality consistently meets the standards for image quality. This evaluation should include analysis of trends in the monitoring data as well as the use of the data to determine the need for corrective actions on a day-byday basis. Comparison of monitoring data with the purchase specifications and acceptance testing results for the equipment in question is also useful.

(ii) 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, examination of equipment repair and replacement costs, subjective evaluation of the radiographs being produced, occurrence and reasons for complaints by radiologists, and analysis 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 most useful and may also provide information of value in the first level of evaluation. Such studies can be used to evaluate potential for improvement, to make corrections, and to determine whether the corrective actions were effective. The number of rejects should be recorded daily or weekly, depending on the facility's analysis of its needs. Ideally, the reasons for the rejection should also be determined and recorded. Should determining these reasons be impossible on a regular basis with the available staff, the analysis should be done for a 2-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, any difficulties detected, the corrective measures applied to these difficulties, and the effectiveness of these measures. The extent and form of these records should be determined by the facility on the basis of its needs. The facility should view these records as a tool for maintaining an effective quality assurance program and not view the data in them as an end in itself but rather as a beginning. For example, the records should be made available to vendors to help them provide better service. More importantly, the data should be the basis for the evaluation and the reviews suggested in paragraphs (c)(5) and (10) of this section.

(7) Manual. A quality assurance manual 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 as providing essential information:

(i) A list of the individuals responsible for monitoring and maintenance techniques.

(ii) A list of the parameters to be 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.

(iv) A brief description of the procedures to be used for monitoring each parameter.

(v) A description of procedures to be followed when difficulties are detected to call these difficulties to the attention of those responsible for correcting them.

(vi) A list of the publications in which detailed instructions for monitoring and maintenance procedures can

be found. Copies of these publications should also be readily available to the entire staff, but they should be separate from the manual. (Publications providing these instructions 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 be kept. The facility staff should also determine and note in the manual the length of time each type of record should be kept before discarding

(viii) A copy of each set of purchase specifications developed for new equipment and the results of the acceptance 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 assumed and continuing education 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 most desirable type of training. The use of self-teaching materials can be an adequate substitute for supervised instruction, especially in continuing education programs, if supervised instruction is not available.

(9) Committee. A facility whose size would make it impractical for all staff members to meet for planning purposes should consider the establishment of a quality assurance committee whose primary function would be to maintain lines of communication among all groups with quality assurance and/or image production or interpretation responsibilities. For maximum communication, all departments of the facility with x-ray equipment should be represented. The committee may also be assigned policy-making duties such as some or all of the following: Assign quality assurance responsibilities; maintain acceptable standards of quality; periodically review program effectiveness, etc. Alternatively, the

luties of this committee could be asigned to an already-existing comaittee such as the Radiation Safety ommittee. In smaller facilities, all taff members should participate in the ommittee's tasks. The Quality Assurnce Committee should report directly o the head of the radiology departnent, or, in facilities where more than ne department operates x-ray equipnent, to the chief medical officer of he facility. The committee should heet on a regular basis.

(10) Review. The facility's quality asurance program should be reviewed by he Quality Assurance Committee and/ r the practitioner in charge to deteraine whether its effectiveness could be mproved. Items suggested for incluion in the review include:

(i) The reports of the monitoring and naintenance techniques to ensure that hey are being performed on schedule und effectively. These reports should be 'eviewed at least quarterly.

(ii) The monitoring and maintenance echniques and their schedules to enure that they continue to be appropriate and in step with the latest develJpments in quality assurance. They should be made current at least annuully.

(iii) The standards for image quality jo ensure that they are consistent with the state-of-the-art and the needs and resources of the facility. These standards should be evaluated at least annually.

(iv) The results of the evaluations of the effectiveness of the quality assurance actions to determine whether changes need to be made. This determination should be made at least annually.

(v) The quality assurance manual should also be reviewed at least annually to determine whether revision is needed. (44 FR 71737, Dec. 11, 1979) $ 1000.60 Recommendation on adminis

tratively required dental x-ray examinations. (a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after careful consideration of the dental or other health needs of the patient, that is, when the patient's dentist or physi

cian judges them to be necessary for diagnosis, treatment, or prevention of disease. Administratively required dental x-ray examinations are those required by a remote third party for reasons not related to the patient's immediate dental needs. These x-ray examinations are usually a source of unnecessary radiation exposure to the patient. Because any unnecessary radiation exposure should be avoided, third parties should not require dental x-ray examinations unless they can demonstrate that such examinations provide a direct clinical benefit to the patient, and the patient's dentist or physician agrees with that assessment.

(b) Some examples of administrative x-ray examinations that should not be required by third parties are those intended solely:

(1) To monitor insurance claims or detect fraud;

(2) To satisfy a prerequisite for reimbursement;

(3) To provide training or experience;

(4) To certify qualifications or competence.

(c) This recommendation is not intended to preclude dental x-ray examinations ordered by the attending practitioner, based on the patient's history or physical examination, or those performed on selected populations shown to have significant yields of previously undiagnosed disease. This recommendation is also not intended to preclude the administrative use by third parties of dental radiographs that are taken on the order of the patient's dentist or physician as a necessary part of the patient's clinical care.

[45 FR 40978, June 17, 1980)

PART 1002-RECORDS AND

REPORTS

Subpart A-General Provisions

Sec. 1002.1 Applicability. 1002.2 [Reserved) 1002.3 Notification to user of performance

and technical data. 1002.4 Confidentiality of information. 1002.7 Submission of data and reports.

Subpart B-Required Manufacturers' (b) Manufacturers, dealers, and dis

Reports for Listed Electronic Products tributors of electronic products are 1002.10 Product reports.

subject to the provisions of part 1002 as 1002.11 Supplemental reports.

set forth in table 1 of this section, on1002.12 Abbreviated reports.

less excluded by paragraph (c) of this 1002.13 Annual reports.

section, or unless an exemption has

been granted under $ 1002.50 or $ 1002.51. Subpart C-Manufacturers' Reports on

(c) The requirements of part 1002 as Accidental Radiation Occurrences

specified in table 1 of this section are 1002.20 Reporting of accidental radiation oc- not applicable to: currences.

(1) Manufacturers of electronic prod.

ucts intended solely for export if such Subpart D-Manufacturers' Records

product is labeled or tagged to show 1002.30 Records to be maintained by manu- that the product meets all the applicafacturers.

ble requirements of the country to 1002.31 Preservation and inspection of

which such product is intended for exrecords.

port. Subpart E-Dealer and Distributor Records

(2) Manufacturers of electronic prod

ucts listed in table 1 of this section if 1002.40 Records to be obtained by dealers

such product is sold exclusively to and distributors.

other manufacturers for use as compo1002.41 Disposition of records obtained by dealers and distributors.

nents of electronic products to be sold 1002.42 Confidentiality of records furnished to purchasers, with the exception that by dealers and distributors.

the provisions are applicable to those

manufacturers certifying components Subpart F-Exemptions From Records and

of diagnostic X-ray systems pursuant Reports Requirements

to provisions of g 1020.30(c) of this chap1002.50 Special exemptions.

ter. 1002.51 Exemptions for manufacturers of (3) Manufacturers of electronic prod

products intended for the U.S. Govern- ucts that are intended for use by the ment.

U.S. Government and whose function AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j, or design cannot be divulged by the 360hh-360ss, 371, 374.

manufacturer for reasons of national SOURCE: 38 FR 28625, Oct. 15, 1973, unless security, as evidenced by government otherwise noted.

security classification.

(4) Assemblers of diagnostic x-ray Subpart A-General Provisions equipment subject to the provisions of

$ 1020.30(d) of this chapter, provided the $ 1002.1 Applicability.

assembler has submitted the report reThe provisions of this part are appli- quired by $ 1020.30(d)(1) or (d)(2) of this cable as follows:

chapter and retains a copy of such re(a) All manufacturers of electronic port for a period of 5 years from its products are subject to $1002.20.

date.
TABLE 1-RECORD AND REPORTING REQUIREMENTS BY PRODUCT

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