2014 Meeting of Mid-Atlantic States Radiation Control Programs March 25, 2014

Transcription

1 2014 Meeting of Mid-Atlantic States Radiation Control Programs March 25, 2014

2 Interpreting Physicians

3 Final Requirements for Interpreting Physicians Meet Initial Qualifications License Certification OR two/three months training 40/60 hours CME 240 patient exams 8 hours new modality training Maintain Continuing Education Teach or earn 15 CEUs in 36 months Maintain Continuing Experience Interpret at least 960 Mammograms in 24 months

4 Interpreting Physician Initial Qualification Overview INTERIM Met before 4/28/99 Need valid license (any state) Need one of the following: ABR, AOBR, or RCPSC Two months training Need 40 hours CME (attestation allowed if obtained prior to 10/1/94) Need 240 patient exams in any 6 month period (attestation allowed if completed prior to 10/1/94) 8 hours new modality training FINAL Met after 4/28/99 Need valid license (any state) Need one of the following: ABR, AOBR, or RCPSC Three months training Need 60 hours Category 1 CMEs, of which 15 were earned in the past three years Need one of the following: 240 patient exams in prior 6 month period Certified at first allowable time- 240 patient exams in the last two years of residency 8 hours new modality training

5 Interpreting Physician Initial Requirements State Licensed A physician who is state licensed or state approved in one State is qualified to interpret mammograms in any other State under MQSA.

6 Interpreting Physician Alternative to Board Certification For physicians who are not board certified, they must obtain either 2 months (interim) or 3 months (final) training. Formal training is a structured documented education program that includes mammographic interpretation, academic course work, and/or continuing medical education

7 Interpreting Physician Alternative to Board Certification Some of the ways that formal training requirements may be met and documented include the following: A letter or other documentation from the physician s residency program documenting that the physician has met the 3 months of training in mammography. For purposes of meeting the training requirements, FDA considers 3 months to equal 12 weeks, which also equals 420 hours (35 hours x 12 weeks). The 3 months of training can occur any time during the residency program and does not have to be in one continuous block of time. Documented CME in mammography totaling 420 hours that may include certificates, letters, etc. These CME units must be category I. *Attestation may not be used to document that the interpreting physician satisfies the alternative to board certification

8 Interpreting Physician Final Initial Qualifications 60 hours CME The interpreting physician shall have a minimum of 60 hours of documented medical education in mammography, which must include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution.

9 Interpreting Physician Initial Qualifications- 240/6 months Have interpreted, under direct supervision, 240 mammographic examinations in the 6 months immediately prior to qualifying as an interpreting physician OR if the physician passed his/her certifying board in diagnostic radiology at the first allowable time the 6 month period could have been anytime in the last two years of the residency program.

10 Interpreting Physician Initial Qualifications Most common method to demonstrate initial qualifications are met is with residency letter Alternative method is to demonstrate each individual requirement has been met (i.e., patient logs for 240 exams, CME certificates totaling 40/60 hours)

11 Sample Residency Letter Interim

12 Sample Residency Letter Final

13 Residency Letter- Acceptable?

14 Residency Letter- Acceptable?

15 Residency Letter Acceptable?

16 Residency Letter Acceptable?

17 Residency Letters What should you do if, inspecting a facility with a physician new to that facility, you find a residency letter with issues but the letter has been previously accepted at other facilities and the IP has been reading for many, many years? Explain issue to facility, have IP try to obtain acceptable residency letter. If IP cannot obtain acceptable residency letter, contact your auditor. Last resort is to contact MQSA Hotline.

18 Residency Letters

19 Dr. J Initial Qualifications Facility presented this residency letter for Dr. J Is this an acceptable residency letter?

20 Dr. J Initial Qualifications The residency letter in the previous slide was not acceptable- did not include 2 months training, 40 CME hours or 240 patient exams Facility presented this attestation

21 Dr. J Initial Qualifications Attestation in previous slide is unacceptable because Dr. J attested he met initial qualifications after 10/1/94 Facility presented this residency letter- is this acceptable? * Note the dates- Dr. J could have attested since his initial training was completed prior to 10/1/94

22 Dr. J Initial Qualifications Facility has 1 tomosynthesis and 1 FFDM unit Established that Dr. J is ABR certified, 40 CME hours, 240 patent exams (Qualified prior to 10/1/94) Dr. J presents 8 hours of tomosynthesis training Can Dr. J begin interpreting mammograms for this facility?

23 Continuing Experience Interpret 960 mammograms in 24 months Effective 24 months (2 years) after meeting the initial requirements The 24 months are calculated back from Inspection date Date of the previous calendar quarter Any date between the two ore than one survey of a specific facility within a 10-month period or a specific unit within a 60-day period.

24 Interpreting Physicians Requalification Requirements Continuing experience Interpret under direct supervision EITHER 240 examinations OR enough to bring total to 960 / 24 months (6 month exemption period) Continuing education Bring total continuing education credits up to 15 CME units / 36 months

25 Interpreting Physicians Requalification- Case Example Dr. X- initially qualified in 06/2008; however, did not maintain continuing experience or education. He was hired by a facility in January, 2013 and completed an ACR course on 02/02/2013 in which he read 377 mammograms under direct supervision. Between 2/2/13-8/2/13, Dr. X read another 418 mammograms, bringing his total to 795. Between 8/2/13-10/15/13, Dr. X did not read any mammograms. The facility was inspected on 10/31/13, and this physician was found to have read a total of 1006 mammograms (he read 211 mammograms between 10/16-31/13). Should the facility be cited?

26 Case Example Answer: YES The physician did not successfully complete the requalification process and read the balance of 960 exams in the 6 month requalification period and prior to reading independently The physician should have began the requalification process again on 8/2/13

27 Case Example The facility argued that according to the PGHS, since he obtained 960 reads prior to the inspection they should not have been cited. This is not a maintenance issue, it is a requalification issue.

28 Medical Physicists

29 Final Requirements for Medical Physicist Meet Initial Qualifications State License or Approval; or Certified Degree Requirement Contact Hours Experience Conducting Surveys New Modality Training Maintain Continuing Education Teach or earn 15 CEUs in 36 months Maintain Continuing Experience Survey 6 units/2 facilities in 24 months Requalification

30 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

31 Initial Requirements - Option 1 For physicists with a Master s degree or higher Masters Degree in a Physical Science [chemistry, radiation (medical and health physics), engineering with 20 semester hours in physics] Certified OR State Licensed/State Approved 20 Contact Hours Training in Surveys Experience in Conducting Surveys (1 facility & 10 units) Under Direct Supervision after 4/28/99 New Modality Training [8 hours] (if applicable)

32 Initial Requirements - Option 2 For physicists with only a Bachelor s degree Met the alternative initial requirements before 4/28/99: Bachelors Degree in a Physical Science [chemistry, radiation science (medical and health physics), engineering, 10 semester hours in physics] Certified OR State Licensed OR State Approved 40 Contact Hours Training in Surveys Experience in Conducting Surveys (1 facility & 20 units) New Modality Training [8 hours] (if applicable)

33 Initial Requirements - Option 2 For physicists with only a Bachelor s Degree Medical physicists qualifying under this alternative cannot supervise others, such as trainees or those reestablishing qualifications, in conducting surveys to meet the continuing experience requirement.

34 Formal Education Question: I have a degree in a physical science obtained at a non-us institution. Is that acceptable toward meeting the degree requirement? Answer: A degree from a non-us institution is acceptable if the physicist can provide information showing that his or her foreign degree is accepted by an accredited US institution, the Committee on Accreditation of Medical Physicists Education Programs (CAMPEP), World Education Testing, or by one of the professional certifying bodies approved by FDA.

35 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

36 Physical Science Question: There are a variety of sub-specialties and corresponding degrees within the physical sciences listed in the definition. Do they all meet the requirements for a physical science degree or only certain ones? Answer: Degrees that are in one of the specialties or sub-specialties of physics, chemistry, and engineering meet the requirements for a physical science degree. All sub-specialties in radiation science that involve study or use of radiation may be considered as a radiation science degree and thus a physical science degree.

37 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

38 License and Certification A medical physicist who is state licensed or state approved in one State is qualified to conduct surveys in any other State under MQSA. However, MQSA permits States to have more stringent requirements than the MQSA standards. If these regulations exist, the medical physicist must meet its requirements in order to practice under state regulations.

39 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

40 Contact Training Hours Time spent in the actual performance of surveys can be used to meet the survey contact hours requirement. As guidance, however, no more than 4 hours for each facility survey and 2 hours for each unit survey should be counted toward the required total hours of training.

41 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

42 Initial Experience No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. After April 28, 1999, experience conducting surveys must be acquired under the direct supervision of a medical physicist qualified with a Master s.

43 Option 1 Option 2 Masters or higher In a Physical Science 20 Semester hours in physics Certified State Licensed State Approved 20 Contact training hours in surveys Experience in conducting surveys 1 Facility & 10 Units New Modality Training 8 hours Bachelors (prior to 4/28/99) In a Physical Science 10 Semester hours in physics Certified State Licensed State Approved 40 Contact training hours in surveys Experience in conducting surveys 1 Facility & 20 Units New Modality Training 8 hours

44 New Modality Training Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, the physicist must receive at least 8 hours of training in surveying units of the new mammographic modality.

45 New Modality Defined as any modality other than one for which the physicist received training to qualify under Examples Physicist trained in Screen/Film, then Digital is a new modality Physicist trained in Digital, then Screen/Film is a new modality.

46 New Modality Training The 8 hours of training in the new mammographic modality requirement is not limited to hands on with the mammography unit. The training can be didactic (classroom), on line, hands-on, etc.

47 Computed Radiography (CR) vs Digital While the systems have significant physical differences, FDA treats them the same from an MQSA regulatory standpoint. All personnel using a (CR) system must have completed at least 8 hours of training specific to digital mammography prior to using the new CR system on patients.

48 Any other new modalities? On February 11, 2011, FDA approved Hologic, Inc. to market its Selenia Dimensions 2D Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) system. This DBT is the first mammography system that provides 3D images of the breast for breast cancer screening and diagnosis.

49 Digital Breast Tomosynthesis (DBT) Because DBT is a new mammographic modality, the medical physicist must obtain at least 8 hours of DBT training This is in addition to 8 hours of digital training Record of this training remains with their initial qualifications for life

50 Acceptable Documentation Initial Requirements Certificate (from ABR or ABMP) Original or copy of certificate Confirming letter from certifying board Original or copy of pocket-card Confirming letter from ACR State License or Approval (by a State) Original or copy of current State license or approval; showing expiration date Confirming letter from State licensing board

51 Acceptable Documentation Initial Requirements Degree (Master s or Bachelor s) in a Physical Science Original or copy of diploma Confirming letter from college or university FDA Approval Letter Semester Hours (20/10) in Physics College or university transcripts Confirming letter from college or university FDA Approval Letter

52 Acceptable Documentation Initial Requirements Contact Hours (20/40) Training in Surveys Attestation (only for training obtained before 10/1/94) Letter or other document from training program CMEs/CEUs in mammography or medical physics Letter or other document confirming in-house or formal training FDA Approval Letter Training gained performing surveys (supervised after 4/28/99) Facility surveys may count up to 4 hours each Unit surveys may count up to 2 hours each

53 Acceptable Documentation Initial Requirements Experience in Conducting Surveys [1 facility & 10/20 units] Attestation (only for experience obtained before 10/1/94) Copy or cover sheet of survey done Letter from facility documenting performance of surveys (supervised after 4/28/99) Listing from company providing physics survey services FDA Approval Letter

54 FDA Approval Letter Upon request, FDA's Division of Mammography Quality Standards (DMQS) will review a medical physicist's credentials to determine whether or not the physicist meets the initial requirements under the MQSA regulations. After the review, DMQS will send the physicist a letter identifying the initial requirements that he or she meets. The physicist can then provide this letter to the mammography facilities he or she serves.

55 FDA Approval Letter

56 Acceptable Documentation Initial Requirements New Modality Training (if applicable) Attestation (only for training/experience with investigational units prior to 10/1/94 and or experience with such units between 10/1/94 & 4/28/99) Mammography modality-specific CME/CEU certificates CME/CEU certificates plus agenda, course outline or syllabus Confirming letters from CME/CEU granting organization Letters, certificates, or other documents from manufacturers or other formal training courses Letter from facility where experience was obtained documenting experience in the new mammographic modality

57 Continuing Experience Perform at least 2 facility surveys with a total of at least 6 units in 24 months Effective 24 months (2 years) after meeting the initial requirements The 24 months are calculated back from Inspection date Date of the previous calendar quarter Any date between the two ore than one survey of a specific facility within a 10- month period or a specific unit within a 60-day period.

58 Acceptable Documentation - Continuing Experience Copy of cover sheet of survey Letter from facility or listing from company providing the physics survey services documenting the performance of survey(s)

59 Continuing Education Teach or earn at least 15 CME/CEU Credits/36 months Courses taught may only be counted once/36 months Effective 36 months after meeting the initial requirements The 36 months are calculated back from Inspection date Date of the previous calendar quarter Any date between the two

60 Acceptable Documentation - Continuing Education CME/CEU certificates Confirming letters from CME/CEU granting organizations Letters, certificates, or other documents from manufacturers or other formal training courses

61 Re-qualification Requirements Continuing Experience Physicists who fail to maintain their continuing experience requirements must complete a sufficient number of surveys under direct supervision to achieve a total of 2 facilities & 6 units in the previous 24-month period before resuming independent work. Continuing Education Physicists who fail to maintain their continuing education requirements must complete a sufficient number of CMEs/CEUs to achieve a total of 15 in the previous 36-month period.

62 Acceptable Documentation - Re-qualification Continuing Experience - same as what is needed to meet the initial or continuing experience requirements, except that documentation must show that experience was obtained under direct supervision. Continuing Education - same as what is needed to meet the continuing education requirements.

63 Medical Physicist Example

64 Medical Physicist Example

65 Medical Physicist Example

66 Medical Physicist Example

67 Medical Physicist Example What is the start date for this physicist? Are there any documents missing?

68 Radiologic Technologists

69 Final Requirements for RT Must meet Initial Qualifications License or Certificate, AND Mammography Training Requirement New Modality Training Maintain Continuing Education Teach or earn 15 CEUs in 36 months Maintain Continuing Experience Perform at least 200 Mammograms in 24 months Requalification

70 Radiologic Technologist Initial Qualification Overview INTERIM Met before 4/28/99 Need one of the following: General radiography license (any State) General certification (ARRT(R) or ARCRT) Need one of the following: 40 hours of mammography training ARRT (M) CA Mammography Certification AZ Mammography Certification NV Mammography Certification Completion of prior FDA accepted course or training **attestation is allowed if training completed prior to 10/1/94 FINAL Met after 4/28/99 Need one of the following: General radiography license (any state) General certification (ARRT)(R) Need all of the following: 40 hours of mammography training including the following subjects: Breast Anatomy Physiology Positioning/Compression QA/QC Breast Implants 25 supervised patient exams (up to 12.5 hours can be counted toward the 40 hours, but must be documented)

71 Initial Qualifications for Radiologic Technologist Interim and Final Be licensed to perform general radiographic procedures in any State, or Have general certification from an FDA approved body: American Registry of Radiologic Technologist (ARRT), or American Registry of Clinical Radiography Technologist (ARCRT), AND

72 Initial Qualifications for RT Interim Mammography Training At least 40 hours of training in mammography ARRT Mammography Certificate-ARRT (M) California Mammography Certificate Arizona Mammography Certificate Nevada Mammography Certificate FDA accepted course (see PGHS) TIP Attestation acceptable if training was obtained prior to 10/1/94

73 Initial Qualifications for RT Final Mammography Training At least 40 hours documented supervised training in Mammography, including: Breast Anatomy, Physiology, Positioning and compression, QA/QC Techniques, Imaging of patients with breast implants TIP Technologists may use their ARRT(M) certification as proof of meeting the 40 hours ONLY if issued after 11/1/2001

74 Initial Qualifications RT Final Perform a minimum of 25 mammography exams under direct supervision of an MQSA qualified individual Facility or teaching program must provide a signed letter or other document(s) on official letterhead indicating: the trainee performed at least 25 examinations under the direct supervision of a qualified RT the inclusive dates during which time the training was given the name of the individual(s) supervising the performance of the 25 exams signature of a responsible official of the facility or training program

75 Initial Qualifications RT Final General rule for determining training hours for the performance of Mammography exams Training programs can include the actual time spent performing supervised examinations toward the 40 hour total. As guidance, however, no more than 12.5 hours of the required 40 should come from the performance of examinations. In those cases where training was obtained from more than one entity, each entity must provide its own letter documenting those areas that it covered. The total of all letters must meet the requirement. TIP Cannot use the performance of mammograms alone to meet the training requirement.

76 ARRT(M) Certification Final Technologists cannot use their ARRT(M) certification ONLY as proof of meeting the initial training if ARRT(M) was issued between the dates of 4/28/99-10/31/2001. ARRT(M) certification may be used as proof of meeting initial training if issued after 11/1/2001.

77 Initial Qualifications RT Final 8 Hours Training in each new Mammographic Modality Before an RT may begin performing mammographic exams independently, they must have 8 hours of training in each mammographic modality TIP Mammographic Modality- Technology for radiography of the breast; e.g., digital, screen-film, tomosynthesis MRI and Ultrasound are not Mammographic Modalities because they are not radiography of the breast.

78 Example 1

79 Example 1

80 Example 1

81 Example 1 What is the start date for this technologist? Are there any documents missing?

82 Example 2

83 Example 2

84 Example 2

85 Example 2 What is the start date for this technologist? Are any documents missing?

86 Continuing Education Final Participate in continuing education related to the diagnosis or treatment of breast cancer Teach or earn at least 15 CEUs in 36 months TIP A taught course can only be counted once in the 36 month period, even if taught multiple times.

87 Continuing Education Final Acceptable Documentation: Certificates, letters or other documents from granting organizations, manufacturers, or qualified authorities Agendas or similar documents of course or other educational activities (if needed, these agendas will allow personnel to use the limited attestation policy to document the amount of CEUs in each mammographic modality) Future- FDA has requested granting organizations to identify on their certificates the amount of modalityspecific education

88 Continuing Experience Final Perform at least 200 mammography exams in 24 months: The RT must meet this requirement following the second anniversary date of the end of the calendar quarter in which the initial requirements were completed. The RT will be allowed at least 24 months to perform their first 200 mammography exams. After that time the 24 months will be a floating period counted back from, at the facilities choice: the date of inspection, the date of the last day of the previous calendar quarter, or any date in between.

89 Continuing Experience Final Acceptable Documentation Letter, table, or printout from each facility at which the RT performs mammography, signed by a responsible facility official Any method used should document the total number of exams at a given facility in a given time period Facility logs can be reviewed, if any questions

90 Requalification Final Continuing Experience RTs who fail to maintain their continuing experience requirements must perform a minimum of 25 mammography exams under the direct supervision of a qualified RT before resuming independent performance of mammography. After requalifying, they are still responsible for maintaining their 200 exams in 24 months. TIP 6 month exemption period- once an RT re-qualifies, they will be exempt from this requirement for 6 months from their re-qualification date.

91 Requalification Final Continuing Education RTs who do not meet the continuing education requirements requalify by obtaining a sufficient number of continuing education units to bring their total to at least 15 units in the previous 36 months.

92 Continuing Education & Experience Should you tell a technologist to stop performing mammograms if they do not meet the continuing education or experience at the time of the MQSA inspection?

93 Questions?