Missouri Qualified Expert: Frequently Asked Questions

No. This rule has been an existing provision in the radiation safety rules for many years. To this point, it has only been implemented on a selective basis (hospitals, ambulatory surgery centers, portable x-ray suppliers, etc). In years past, as a public health service, DHSS employed a staff of radiation safety professionals to carry out some of these surveys at some facilities. However, conditions have changed, due to reduced workforce numbers, as well as a rapid evolution in technology that makes it increasingly difficult to maintain adequate training and expertise for public health staff members. These changing conditions now make it necessary to fully implement this rule statewide at all facilities utilizing radiation equipment, and transfer the required radiation safety requirements back to the equipment owners. References to Qualified Experts and requirements in the existing radiation safety rules (emphasis added): -19 CSR 20-10.010 (17) Qualified expert is an individual fitted by training and experience to perform dependable radiation surveys, to oversee radiation monitoring and to estimate the degree of radiation hazard. If the ability of a qualified expert is questioned, the department shall be the judge of his/her qualifications, in regard to which it may consider the testimony of other persons whom it deems expert. -19 CSR 20-10.030(1)…The [biennial] registration also shall give the name and address of the user(s) and the name and address of the qualified expert. -19 CSR 20-10.050(1) The user shall provide for radiation surveys and monitoring sufficient to assure compliance with other rules of this chapter. The radiation survey and monitoring shall be performed by, or under the direction of, a qualified expert using suitable instruments and methods for measuring radiation. -(2) Until an actual radiation survey can be performed, a written statement made by a qualified expert based on his/her analysis of the situation shall be acceptable as evidence of the absence of radiation hazard in a given area.

The basic QE survey requirements are spelled out in the existing rules. However, the language of the standards is less than overly descriptive. Therefore, the implementation expectations are largely based on presumptive standards already widely accepted in the radiation safety community; they are expectations of how the rule will be met. In general, we have described what we expect to see and if already in place, we would consider the requirement met. We have left considerable latitude to the professional judgment of the QE. In some cases, there may be alternative methods of compliance that are outside the presumptive standards. These methods, upon written request to the DHSS, may be examined to determine equivalency with the presumptive standards. The burden of evidence is on the petitioner requesting the alternative standard. In some cases, we have written (or will write) regulatory Interpretive Guidelines, which further detail and clarify how the rule is or will be interpreted and implemented. Presumptive standards may evolve over time due to introduction of new technology, protocol, or consensus view of professional bodies.

Yes. In the development of these presumptive standards, to identify common elements, DHSS reviewed both national radiation safety programs (CRCPD, ACR, AAPM), and programs from the following states: AR, FL, IA, IL, KS, KY, MD, NE, NJ, TX, VA, WV. The basis of this review in part represents what is referenced in 19 CSR 20-10.010(17) as “testimony of other persons whom [MRCP] deems expert.”

The registered radiation facility is responsible for arranging (and paying for) radiation safety surveys by a recognized QE, the frequency of which is dependent upon the facility Class (See Question 8).

–October 2012: Formal recognition process for Qualified Experts was initiated; we anticipate completing review of the bulk of existing QE applicants by early 2013. –December 2012: Mass mailing begins to all 4,700 registered facilities announcing the implementation of the QE survey process to be started January 1, 2014. As part of this announcement, we will make available to facilities a list of the current officially recognized Qualified Experts. At that time, we are also sending the announcement to installers, equipment vendors, and other associated stakeholders. — Calendar year 2013: Final year of most routine radiation safety surveys by DHSS staff. –January 1, 2014: Transition complete and fully implemented. Periodic surveys, dependent on facility class, will be required beginning on this date, staggered over the next six years. Another mass mailing is planned. In addition to periodic survey requirements for existing radiation facilities, all NEW radiation facilities beginning service on or after this date will have to meet these standards. The role of the MRCP will evolve, becoming more administrative and registration-driven. Regulatory actions for the MRCP will largely be based on survey findings of the Qualified Expert. MRCP (nonMQSA) onsite surveys will be further limited. We will conduct audit surveys and validation of surveys conducted by or under the direction of QEs. We will ensure that appropriate corrective actions are taken based on findings of the QE surveys. We will also perform onsite visits of problematic registrations, and facilities with poor compliance histories, as well as perform complaint investigations.

The scope of the required survey includes not only determination of full compliance with existing state rules and the FDA’s federal performance standard for radiation equipment as described in 21 CFR Parts 1010-1050, but also the Radiation Protection Law 192.430, which requires Radiation sources to be kept safe: “All sources of radiation shall be…used and kept so as to prevent all users thereof and all persons within effective range from being exposed to unnecessary radiation.” It is largely left to the professional judgment of the QE to apply generally-accepted professional standards of radiation protection to determine if radiological conditions are safe. Each QE can develop their own survey protocol, but are expected to follow generally-accepted standards of measuring radiation safety and radiation machine performance.

It depends on the situation, how the equipment is used, and the professional judgment of the Qualified Expert. The required radiation safety survey may include unit survey, area survey, or both. If the radiation machine is a medical machine used on human patients, then in almost all cases a unit survey testing variable parameters and performance of the machine will be necessary, because the patient is the member of the public most at risk for unnecessary radiation. This would include radiation not necessary to produce an optimal image or treatment, or radiation used in diagnostic exams performed so poorly (through either machine problems or user misuse) that the exam could likely lead to missed diagnoses. If the machine is not medical, then the exposure to the patient is not a consideration, and only occupational exposure and exposure to members of the general public is of significant concern. In this case an area survey may be more appropriate. For new medical facilities, both a unit survey and an area survey (to evaluate shielding, signage, etc) would probably be necessary. However, on surveys of that same facility in the future, if the equipment or usage of the area has not changed, an area survey may not be needed, although a unit survey would still be necessary to ensure that the equipment is still being maintained and used in a safe manner. In most cases, the evaluation of the Qualified Expert of the situation will determine what areas of radiation safety are most appropriate to be tested.

All radiation facilities must re-register their equipment every two years, and dependent on the facility Class, must have periodic radiation safety surveys by a QE performed. In determination of Class, MRCP considers likely public health hazards associated with various types of radiation-producing equipment, the facility workload, as well as the facility’s past compliance history, and based on hazard applies a staggered inspection period, taking into account other factors such as the impact on small entities, and the available population of likely QEs. The first full cycle of QE surveys will be phased in over several years. Facilities will be divided into Classes as follows:

Class A: Annual surveys: Licensed hospitals; Licensed Ambulatory Surgery Centers; any facility with the following type of equipment: CT (including dental facilities using CBCT), fluoroscopy, radiation therapy, mammography; Specifically Designated Facilities w/high risk equipment (some non-medical); or facilities with a history of radiation safety compliance problems, as determined by the MRCP. Note: Of the total 4,700 registered radiation facilities in Missouri, it is estimated that approximately 588 (13%) are Class A.

Class B: Biennial surveys: Routine x-ray, radiology, chiropractic, podiatry, CMS Certified Portable X-ray suppliers, and others designated by the MRCP. Note: Of the total 4,700 registered radiation facilities in Missouri, it is estimated that approximately 932 (20%) are Class B.

Class C: Four (4) year survey cycle: Facilities with services or equipment normally designated Class B, but providing written evidence of a very low workload: [300 or fewer exams/year (25 a month)], veterinary facilities without fluoroscopy or CT, others designated by the MRCP. Note: Of the total 4,700 registered radiation facilities in Missouri, it is estimated that approximately750 (16%) are Class C.

Class D: Six (6) year survey cycle:Dental offices without CBCT, Bone Density DEXA, non-medical facilities not Specifically Designated as Class A. Note: Of the total 4,700 registered radiation facilities in Missouri, it is estimated that approximately 2,410 (52%) are Class D.

In some cases, until an onsite radiation survey can be conducted by the QE, the QE may issue a written statement to the facility with a preliminary evaluation of probable radiation hazards, assessing to what degree additional testing or monitoring is necessary to assure safe use. In many (but not all) cases, this statement may be what is commonly referred to as a “radiation shielding plan.” QE’s should use generallyaccepted standards in the development of the written statement; i.e., various radiation shielding guidelines published by the National Council of Radiation Protection (NCRP). However, the QE is given considerable leeway to exercise his/her professional judgment in the formulation of recommendations in the written statement. The following are expectations of the written statement and initial survey, to be implemented January 1, 2014:

–New Class A facilities: Shielding plan evaluation and onsite survey of new facilities by QE prior to use.

–New Class B, C, & D facilities: Shielding plan and/or written statement from QE prior to use, and onsite survey within 90 days of beginning use of the radiation equipment.

–For existing facilities, if additional equipment (either new or used) is added between routine survey cycles, the facility will need a written statement from a QE prior to use of the equipment, assessing whether or not additional testing to assure safety is necessary, based on QE’s professional judgment. If so, onsite survey of new equipment will need to be done within 90 days. There is no specific format for the written statement, but it must be retained by the facility, and provided to the DHSS as evidence of compliance with registration requirements. Note: this is part of the requirement at 19 CRR 20-10.030 to notify the MRCP in writing of any change in conditions which could substantially increase the radiation hazards.

To some degree, the scope of the survey is determined by the professional judgment of the QE. State rule 19 CSR 20-10.030 requires that users notify the department of any change with respect to the radiation sources that will increase the potential for personnel exposure, so the department can determine any testing or monitoring needed. Our presumptive standard on compliance is as follows:

If radiation equipment of the same type, usage, and location is being replaced or repaired, DHSS recommends that the facility should contact a QE to consult whether the QE believes additional testing of the machine’s performance would be warranted. For example, if a facility has a routine radiographic machine in Room#1, and that machine is being replaced or repaired, it would be prudent to consult with a QE to determine if additional radiation safety testing should occur. In this case, the testing would likely not include an area survey.

If however, a facility is adding additional radiation machines or rooms, the facility must consult with a QE prior to the use of the equipment, assessing whether or not additional testing to assure radiation safety is necessary, based on the QE’s professional judgment. If so, onsite survey of new equipment will need to be done within 90 days. In this case, the testing would likely include not only a survey of the unit itself, but also an area survey as part of the unit survey. If the additional equipment is radiotherapy, mammography, fluoroscopy, or CT, the survey needs to be conducted prior to use.

Yes. The initial round of required QE surveys are tied to a specific “due by” date, as we stagger the timeframe over a 1-6 year period. However, facilities are also encouraged not to wait until the last minute, particularly if they do NOT have a QE on permanent retainer or employment status. If a hospital, for example, as a Class A facility is assigned 10/31/14 as a QE survey due date, that means that by said date, DHSS will be expecting a copy of survey results, but the survey itself can be completed at any point in the 12 months prior (10/31/13-10/31/14). By staggering the due dates over each month of a multiple year period, we hope to avoid an unmanageable rush at the end of each year as facilities make arrangements for QE surveys. Survey results will begin being due for submission to DHS for Class A facilities over a 12 month period beginning in 1/1/2014, for Class B a 24 month period beginning in 1/1/2015, for Class C a 48 month period beginning in 1/1/2016, and for Class D a 72 month period beginning in 1/1/2017.

Yes, as long as the facility meets the timeframes for survey as defined by their Class (See Question 8). For example, a hospital (Class A) may have one QE recognized for Therapy, and another for Diagnostic Radiology. The Hospital could arrange for the therapy QE and diagnostic QE to both perform annual surveys of the equipment for which they are Qualified Experts. It is the choice of the facility as to which QE or group of QE’s are utilized, as long as said individual(s) are officially recognized by DHSS as QE. Although permitted, a facility is not required to keep a QE on permanent retainer or contract; they may utilize a different QE each time a radiation survey is required, either due to the required time expiring, or the addition of equipment.

The owner of the x-ray equipment must make arrangements with a Qualified Expert recognized by DHSS, how this is arranged, whether contract, fee-for-service, formal employment, or on a pro bono volunteer basis is between the owner of the radiation equipment and a QE. In the situation you describe, those employees would indeed be able to perform the surveys, as long as they are recognized and approved as Qualified Experts by DHSS. DHSS will be auditing the work of all types of QE, regardless of the employment arrangements.

Not necessarily. It depends on several factors:

Question #2 of the FAQ indicates that much of what we’re basing the initial transition on are presumptive standards; circumstances we think will fit the majority of facilities. However, there are 4,700 facilities, and some of them are outliers that don’t fit neatly into a box. “Non-medical” equipment is frequently such an outlier, and Large Research University is another, where the usage of radiation is so varied that the determination of some things may need to be made on a case by case basis. As indicated in Question #2: “In some cases, there may be alternative methods of compliance that are outside the presumptive standards. These methods, upon written request to the MRCP, may be examined to determine equivalency with the presumptive standards. The burden of evidence is on the petitioner requesting the alternative standard.”

One of the presumptive standards that may differ on a case-by-case basis is the initial assignment of Facility Class. Based on the type of equipment, a facility may look like (and be presumed to be) Class A, but taking other factors into account, it may be more appropriate to make it a Specifically Designated Facility in another Class. In this specific case, the medical equipment is not used on humans and there is a significant degree of routine oversight by radiation safety personnel, so there is a case to be made that this is actually more of a Class C or D facility. Although we are certainly concerned with occupational exposure, from a public health standpoint, we are even more concerned with patient exposure and to members of the general public. As a point of comparison, this is similar to presumptive designation of Class C for veterinarian offices. Although the equipment is similar to medical, it is not used on humans. In a sense, it is closer to a research or non-medical application that would typically be Class D. However, over many years of field surveys, we have found that many vet facilities provide minimal training to their operators, and often the vet techs end up holding the animals and stand near (or in) the primary radiation field during the exam. In this case, the occupational exposure, and possibility of unnecessary exposure is of higher risk than most non-medical applications. For this combination of reasons, veterinarian facilities will normally be considered Class C. Following the same logic, an argument could be made that the University could more reasonably (and from a public health risk standpoint) be considered a Class C or D.

Initial Classification of facilities are made based on our presumptive standards, and the information we currently have in our database. However, as indicated in Question #2, each facility will also be afforded an opportunity to request in writing that an alternative standard be applied, one that provides an equivalency of public health protection for the operator, patient, and general members of the public. If, upon review, DHSS concludes that the alternative standard is adequate, we will consider the requirement met. As always, the burden of showing this rests on the person or facility applying for the alternative standard.

Equipment being brought into the state must be registered at least four (4) days prior to entry. The owner/user should attach registration information and evidence of the most recent survey completed in the state where the equipment is normally housed. DHSS may require survey prior to use, or within 30 days, if the machine is to be used in excess of 30 days within Missouri.

No, survey time frames are based on the Class (see Question 8) of the entire registered facility as a whole, which is dependent on the most significant potential radiological public health hazard registered to the facility, or past compliance history issues. In the case above, this would be considered a Class A facility, and all radiation producing equipment in the facility would need to be surveyed annually.

There are four (4) Pathways available to determine official recognition of Qualified Expert status:

A. Pathway 1: Approval by a Nationally-recognized Certifying body:

  • The American Board of Radiology; or
  • The American Board of Medical Physics; or
  • The Canadian College of Physicists in Medicine; or
  • The American Board of Health Physics.

OR

B. Pathway 2: Masters or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university.
-AND (2-A) documentation of a minimum of one (1) year of full time training and one (1) year professional, clinical and/or technical full time work experience under appropriate supervision.
-AND (3-B) Evidence of at least two (2) radiation surveys in the last two (2) years.

OR

C. Pathway 3: Bachelor’s degree with 30 credit hours in physical or biological sciences or mathematics from an accredited college or university.
-AND (3-A) Four (4) years of applied radiation protection experience, of which at least one (1) year shall include applicable survey experience under supervision acceptable to the Department.
-AND (3-B) Evidence of at least two (2) radiation surveys in the last two (2) years.

OR

D. Pathway 4: Alternative Standard/Recognition by Petition. Petitioner for Recognition does not meet the qualifications of paths 1,2, or 3; however, as an alternative, professes and can demonstrate to the department that the petitioner is competent to act in the category(ies) for which they are applying, via equivalent educational, professional, clinical, technical, employment, or relevant experience, or have equivalent certification to the certifying agencies named above. Petitioner will submit third party documentation of education and experience or certification, and explain how that is applicable and equivalent to meet the intent of the Qualified standard. Burden of evidence is on the petitioner.
-AND (4-A) Four (4) years of applied radiation protection experience, of which at least one (1) year shall include applicable survey experience under supervision acceptable to the Department.
-AND (4-B) Evidence of at least two (2) radiation surveys in the last two (2) years.

Note: “grandfathering” in recognition by Petition. Evidence should include documentation that the petitioner was actively engaged in radiation safety activities, and had a reasonable history of conducting surveys of the type they are requesting recognition for, prior to 1/1/2013. After that date, requirements for recognition will more likely default to the non-alternative presumptive standards described in Pathways 1,2 or 3.

Yes. QE status will be renewed every two (2) years. Renewal will primarily be based on:
–Continued Experience: Evidence of at least 2 applicable radiation safety surveys in the last 2 years in the recognized modality/specialty.
–Continued Education: Upon renewal, evidence of approved credits pertinent to the recognized area(s) of expertise.

Most likely yes, depending on the scope of the survey(s) reviewed. After initial recognition, when QE status is renewed in two years, at that point, we will likely not allow review only, but will expect ongoing education & experience, to include surveys. However, for initial recognition of QE status, since this is new process, we will take this situation of supervising individuals and review of work into account. For those that qualify for recognition via Path 1, we are not requiring that evidence initially, but will on reapplication. We will apply a similar standard in this specific instance. However, we would ask for some specific details about your role as a supervisor or reviewer; for example, a letter from a superior or the owner of the firm describing expectations in terms of review of surveys, surveys have performed in the past (outside the two year window), how many surveys you reviewed and signed off on over the last two years.

— Recognition as a Qualified Expert may be denied or revoked due to problems regarding the reliability of the consultation/survey(s) resulting from:
–Falsification of data/information, either on the application for recognition or survey/consultation documents;
–Negligence in the performance of radiation consultation/surveys such that significant errors result;
–Utilization of methods or procedures that do not conform (when applicable) to existing accepted professional standards (such as those described in documents published by AAPM, ACR, or other recognized standards);
–Lack of adequate oversight/direction of individual(s) performing tests or gathering data under review/signature of the QE;
–Failure to provide adequate survey documentation to the MRCP upon request;
–Failure to provide adequate evidence of initial or (upon re-registration every two years) continuing professional education and experience.
–Other problems that impact on the reliability of the consultation services provided by the Qualified Expert.

What does the language in 19 CSR 20-10.050(1) mean that states the QE must utilize “Suitable Instruments & Methods” to conduct the radiation safety survey?
–Survey equipment used to measure radiation safety should be used as the manufacturer indicates, following generally-accepted professional standards, and calibrated per manufacturer specifications.
–Suitable Methods means that the QE should follow accepted professional standards & protocol for radiation equipment evaluation; i.e., follow guidelines published by recognized professional organizations such as AAPM, ACR, etc. QE’s are allowed significant leeway to develop and alter survey protocols, depending on their professional judgment and the individual circumstances of the facility. However, they should be prepared to scientifically justify any deviations from common radiation safety protocol.

–Survey of Class A facilities must be conducted personally by a Qualified Expert, or under their direct supervision (on site, in the building, available to observe and correct for training purposes).
–Survey of Class B, C, D facilities may be conducted by QE or under their direction. The QE can utilize another individual to conduct measurements and gather data for the survey, but the QE is ultimately responsible for the quality and oversight of the survey process, including protocol & measurements. In addition, the results must be reviewed and approved by the QE, and the QE must provide a signed report summarizing the results of the survey.
–Both the survey frequency & level of QE supervision take into account public health risk, as well as recognizing existing numbers of QE’s available to handle expanded workload & responsibility.

For Class A facilities, the radiation surveys must be conducted directly by the QE, or under their direct supervision while onsite (for training purposes). However, for Class B, C, and D facilities, the data & measurements for the radiation safety survey may be gathered under the direction of the Qualified Expert (QE determines survey protocol, reviews results, and produces a signed final report summarizing findings and recommendations). For those individuals the QE may use to assist in collecting data and making measurements, there are no formal standards. The QE is free to utilize whomever they choose, but are required to provide adequate training and oversight of those individuals, as well as review the data and create the signed report of findings and recommendations under the signature of the QE.

QE’s should indicate his/her areas of Expertise, and upon request be able to provide evidence of both training and experience for each specific type of equipment for which they are requesting Qualified Expert status. Expertise in the following areas will be recognized:

  1. Health Physics Consultation
  2. Shielding Design
  3. Routine Radiographic (Medical/Chiropractic/Podiatric/x-ray machines
  4. Mammography (qualifications must conform to the FDA’s MQSA requirements.)
  5. Fluoroscopy/interventional radiology
  6. CT
  7. Bone Density/DEXA
  8. Non-medical/Industrial/Academic/Research
  9. Veterinary Radiology (machine type similar to medical, but public health risk is occupational only).
  10. Dental (non-CBCT)
  11. Therapy/Linear accelerators
  12. OTHER radiation safety expertise: applicant will be asked to describe specifics more fully

Once the initial population of Qualified Experts is identified, and applications for QE status processed, DHSS will provide ongoing and routine communication with the QE community through the MRCP website, individual contact, and periodic direction via e-mail and/or ListServ, beginning sometime in 2013. An ongoing partnership and dialog with the QE community will be important during of this transition, not only with individual QE’s, but with formal representatives and professional entities of the radiation safety/health physics community, such as local chapters of the AAPM and HPS.

Yes. As noted on the application for recognition as a Qualified Expert, to claim the area of expertise in mammography, the applicant must demonstrate that he/she conforms to the federal requirements to be a medical physicist under the FDA’s Mammography Quality Standards Act (MQSA). Many physicists have already had their initial qualifications approved in Missouri to be a mammography physicist in years past. However, that approval as a physicist was only based on a review of the initial qualifications. To be recognized as a Qualified Expert in mammography, the applicant must also conform to the continuing qualification requirements, namely education (15 CEUs in the last 36 months) and experience (2 facilities & 6 units in the last 24 months). This documentation must be provided as part of the QE application if you are claiming an expertise in Mammography. Since Qualified Expert status must be renewed every two years, once you are registered as a QE, we will request updated continuing education and experience at each renewal (at a minimum). However, your QE certificate will be the only document you need to show at mammography facilities in Missouri (other state’s requirements may differ). For your reference, the federal requirements for mammography physicists may be found on the FDA’s MQSA website at: http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm

Yes. While true that in years past we had an informal registration process for physicist approval, most notably for mammography, the formal recognition process for Qualified Expert has been refined, and some of the expectations are different or expanded. We are requesting additional information, and our presumptive standards have been updated. Also, previously the approval was a one-time occurrence. The revised presumptive criteria for recognition of a Qualified Expert will now also require regular continuing education & experience. If we reviewed credentials in the past, we should still have those in file, and part of those existing files may be used to document certain elements of QE qualifications. However, since QE recognition is an entirely new process, we need updated and complete applications for recognition. It is typically safer to err on the side of too much documentation rather than too little. Also note that past approval focused primarily on mammography. It is now being significantly expanded to encompass many more areas of expertise. (Although claiming Expert status in mammography STILL requires that all FDA standards of qualifications and documentation be met and documented.)

Yes. QE’s will enjoy considerable freedom to develop and utilize his/her own survey protocol. However, as part of the expectation of recognition of Qualified status, the QE will be required to use a standardized survey summary results form, consistent across all facility Class types. They will also be asked to provide to DHSS, upon conclusion of the required radiation safety survey, basic information about the survey so that DHSS staff can track and follow up on problems as needed. The form will be developed by DHSS and available on the MRCP website early in 2013. It will include basic information about the survey such as:
–Facility identification
–Who performed the survey (data collection, as well as final QE conclusions/recommendations)
–Date survey completed
–Listing of Radiation Equipment Reviewed (to ensure that all facility radiation equipment was surveyed)
–Summary of Results for each machine reviewed [(1)No problems, (2)Minor issues/suggestions to improve quality or reduce unnecessary exposure, (3)Significant Problems/Safety issue]
–The QE will be expected to provide the Radiation Safety Summary Results Form to MRCP within thirty (30) days after completion of the survey. We will review the results and QE recommendations, and seek additional information as needed (corrective actions, etc) from the facility, to ensure that facilities correct any significant problems found.

There is no regulatory mandate that an individual physicist or radiation safety consultant be recognized as a Qualified Expert. The mandate is on the radiation facility itself. Each registered facility must utilize a recognized Qualified Expert to conduct their periodic radiation safety surveys. If you are contracted as a physicist with a facility, but are not registered and recognized as a QE, the facility will have to utilize someone else who IS a recognized QE to provide the periodic radiation safety survey.