Questions Key Words/Related Topics Inspector Instructions
Citation:
900.2(o)(2): Direct Supervision means that: During the performance of a mammography examination or survey of the facility’s equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey.
Discussion:
The goal of direct supervision is to provide reasonable assurance that any mistakes made by the radiological technologist or physicist being supervised are corrected before patients are irradiated or harm is done to the patient.
Personnel in training may work at facilities as long as they are under the direct supervision of a qualified individual.
For the performance of a mammography examination, direct supervision means that the supervisor is present to observe and correct, as needed, the performance of the trainee. This requires that the supervisor be in the examination room itself during the time the examination is being conducted. The goal of direct supervision is to provide reasonable assurance that any mistakes made by the trainee are corrected before the patient is irradiated or harm is done to the patient.
For the physics survey and/or mammography equipment evaluation, direct supervision means that the supervising medical physicist must have qualified under the Master’s or higher pathway 21 C.F.R. 900.12(a)(3)(i)(B)(3). and be present to observe and correct, as needed, the performance of the supervisee. This requires that the supervisor be in the room during the performance of the individual equipment tests to assure that any mistakes made by the supervisee are corrected before the test is completed. The supervisor must review any calculations made from, and any conclusions drawn from the test results, before those results are provided to the facility.
Furthermore, when conducting a physics survey, the supervisor and supervisee must jointly review the QC program records. The supervisor does not have to be present when the supervisee initially reviews the QC program records. However, the supervisor must review, discuss, confirm, and if necessary, correct the findings made by the supervisee prior to either the initial or final survey report being issued. 21 C.F.R. 900.12(e)(9).
The goal of direct supervision is to provide reasonable assurance that any mistakes made by the supervisee are corrected before the QC program review or tests are completed.
While an individual’s qualifications are still under evaluation, that individual may continue to provide mammography services to the facility in his or her area. Once it has been determined that an individual DOES NOT meet one or more of the initial personnel qualifications (e.g., a "No" answer has been entered in response to one or more of the initial qualification questions), that individual may lawfully provide mammography services to the facility only under the direct supervision of a fully qualified individual. The direct supervision must continue until such time as the individual meets the qualifications, at which time he/she may resume working independently.
Personnel who fail to meet a continuing requirement must also go under direct supervision as stated above. However, FDA may allow for a limited time exception to this rule when the imposition of direct supervision on the person failing to meet the continuing requirement would result in the facility having to cease providing mammography services.
Personnel who have not worked in mammography for some period of time after meeting the initial requirements may need to work under direct supervision when they return to mammography, if they do not meet the continuing experience or continuing medical education (CME) requirements. While under direct supervision, these personnel should obtain the necessary continuing experience and CME to requalify before resuming independent work in mammography. A facility may be cited during an inspection if such personnel work without supervision prior to obtaining sufficient hours of CME and continuing experience to meet the continuing requirements. Similarly, facilities should check to see that all new personnel meet all the appropriate requirements prior to letting them provide mammographic services independently. If these personnel are working independently and do not have the required continuing experience and CME, the facility may be cited for these problems.
No. As long as the facility is MQSA certified, there is nothing in the MQSA or FDA’s regulations that will interfere with training in mammography. Student technologists can receive classroom and practical training in a variety of ways. Student technologists who do not yet meet the requirements established under MQSA may perform actual examinations as part of the training so long as another technologist who does meet the MQSA requirements is present in the room to supervise (i.e. direct supervision) and, if necessary, corrects the student in the conduct of the examination. 21 C.F.R. 900.12(a)(2)(ii).
No. There are no requirements for general supervisory duties under the regulations. However, if a general supervisor, in addition to his/her general supervisory duties, also performs or directly supervises mammographic examinations or physics surveys, he/she must meet the appropriate requirements. 21 C.F.R. 900.12(a), (e)(9). (Note: the term "general supervisor," as used in this question, should not be confused with the other guidance referring to direct supervision).
The surveys performed to meet the initial experience and requalification requirements for the medical physicist must be performed under the direct supervision of a medical physicist who meets all the initial qualification and continuing qualification requirements (described in 900.12(a)(3)(i) and (iii)). NOTE: Medical physicists who qualify under the alternative initial qualification route (commonly known as the bachelors degree route), section 900.12(a)(3)(ii), cannot provide supervision of surveys performed for the purpose of meeting the initial experience requirement or reestablishing the continuing experience requirement.
No. While technologist B must be a qualified radiologic technologist, he/she does not have to include documentation showing that he/she is a qualified radiologic technologist.
No. While physicist B must be a qualified medical physicist, he/she does not have to include documentation showing that he/she is a qualified medical physicist.
Due to the large number of variables that may be involved, the status of the person being supervised will be determined on a case-by-case basis at the time such situations arise.
Personnel Radiologic Technologist Medical Physicist Direct Supervision General Supervisor Supervisory Duties Training Programs
Related Topics:
Medical Physicist Initial Experience
Reestablishing the Medical Physicist Continuing Experience Requirement
Radiologic Technologist Mammography Specific Training
Reestablishing the Radiologic Technologist Continuing Experience Requirement
Personnel who have met the initial requirements and are undergoing requalification after failing to meet the continuing requirements should not be considered trainees. Therefore, their names and associated information should be collected and recorded in the inspection record. The inspector should indicate the person’s requalifying status in the remarks section. When queried regarding requalifying personnel’s continuing requirements, the inspector should enter an "X."
Documentation: It will generally be sufficient if the technologist’s file contains a letter, table, or printout from each facility at which he or she performs mammography examinations, signed by a responsible facility official or the person performing the direct supervision. The document should state who provided the direct supervision and that the technologist performed a given number of examinations at that facility in a given time period. It is assumed that these numbers are based upon more extensive records, such as facility logs, that can be reviewed if there are any questions. The facility logs themselves can then be used as documentation. Provision of summary letters, tables, or printouts will speed up the inspection and rarely will the more detailed records be requested.
Documentation: It will generally be sufficient if the medical physicist’s file contains a letter, table, or printout from the surveying organization or each facility at which he or she performs mammography surveys, signed by a responsible organization or facility official or the person performing the direct supervision. The document should state who provided the direct supervision and that the medical physicist performed a given number of surveys of mammography facilities/units in a given time period. It is assumed that these numbers are based upon more extensive records, such as survey reports, that can be reviewed if there are any questions. The survey reports themselves can then be used as documentation. Provision of summary letters, tables, or printouts will speed up the inspection and rarely will the more detailed records be requested.