January 1, 2008

Pennsylvania state laws and regulations that affect your medical practice

1. What is a diagnostic test?

Any medical service utilizing biomechanical, neurological, neurodiagnostic, radiological, vascular or any means, other than bioanalysis, intended to assist in establishing a medical diagnosis, for the purpose of recommending a course of treatment for the tested patient to be implemented by the treating practitioner or by the consultant.

2. What are the typical diagnostic uses for MR imaging?

(1) MR imaging has proven to be a useful tool in the diagnosis of the following:

(i) Brain, brain stem, spinal cord disorders and demylenating diseases;

(ii) Diffuse or infiltrating diseases of the liver and kidney;

(iii) Early changes in ischemia and infarction of heart tissue.

(2) Ovarian and uterine tissue can be imaged well through MR. Also, the process can be used to evaluate growth and development of a fetus.

(3) MR spectroscopy has potential application for in vivo analysis of biochemical processes in health and diseased tissue. Potential applications include the following:

(i) Determination of early chemical changes in evolving cerebral or myocardial infarctions;

(ii) Determination of the chemical nature and specific diagnosis of tumors throughout the body;

(iii) In vivo analysis of chemical parameters and changes in metabolic diseases of the liver and kidney;

(iv) In vivo analysis of early changes in multiple sclerosis;

(v) In vivo analysis of dementia-producing disorders such as Alzheimer's disease.

28 PA ADC § 401.11

3. Which related diagnostic modalities are permitted in hospitals offering MR?

(i) CAT full-body scanning;

(ii) Ultrasound;

(iii) Radionuclide scanning; and

(iv) Conventional X-ray, including, but not limited to, arteriography.

28 PA ADC § 401.11

4. Who is responsible for the operation of the MR facility and interpretation of the MR data?

A board-certified or board-qualified physician trained in MRI shall be responsible for the operation of the MR facility and interpretation of the MR data. This work shall be the full-time activity of that physician or other physicians delegated by that physician if they have been trained in MRI.

28 PA ADC § 401.11

5. What are the other staff requirements of an MR facility?

(a) The MR program staff shall include the specialty of radiology and subspecialists appropriate to the applications intended, including experience in computed tomograpy or nuclear medicine.

(b) MR facilities shall also directly provide a variety of medical subspecialty services which include, but are not limited to, oncology, neurology, internal medicine, pathology and radiology.

( c ) At least one staff person trained in cardio-pulmonary resuscitation (CPR) shall be on duty in the unit at all times.

(d) The facility shall have a program on image quality control of MR services and a program to calibrate and maintain its diagnostic equipment.

(e) The MR unit shall meet the standards recommended by the FDA.

28 PA ADC § 401.11

6. What are the requirements for acquisition of a Positron Emission Tomography (PET) scanner?

(a) Certificate of Need review for proposed PET scanners will be conducted using the following methodology:

PET Units = Population x (OH + PTCA + Epilepsy + Brain Tumor + Dementia) where:

OH (Open Heart) = 173/100,000 population

PTCA = 19/100,000

Epilepsy = 30/100,000

Brain Tumor = 18/100,000

Dementia = 34/100,000

Optimal Use Rate = 2,000 scans per year

(b) A site where PET services are proposed to be offered shall be a site where the following clinical services also are currently offered:

(i) An open heart surgery program that is approved by the Department of Health and where an average of at least 700 open heart cases per year during the most recent 3-year period were performed. In the interest of geographic distribution of PET services, the Department may waive this requirement in its consideration of an application from a hospital where at least 450 open heart cases were performed during the most recent 3-year period, if no other hospital in the same health planning area met the 700 case standard. The Department may also waive this requirement in its consideration of an application from a medical college;

(ii) A therapeutic cardiac catheterization service that is approved by the Department of Health and that includes a PTCA program; and

(iii) A full range of full-time, onsite related diagnostic modalities including conventional x-ray, full body computed tomography, ultrasound, magnetic resonance imaging and other radio-nuclide scanning.

28 PA ADC § 401.16

7. What are the staff requirements of PET services?

(a) A PET service shall be under the medical direction of a physician who is board certified in nuclear medicine or nuclear radiology, or trained and licensed in nuclear cardiology and has additional documented experience and training in PET technology, including radiochemistry. The physician shall be licensed by the Nuclear Regulatory Commission to possess radiopharmaceuticals and perform diagnostic procedures employing radiopharmaceuticals in human beings.

(b) Additional staff for a PET service shall include at a minimum the following staff as appropriate:

(i) A radiochemist trained at the master's or Ph.D. level in radiochemistry or radiopharmacy who also has a background in PET physics or radiochemistry and experience in radiopharmaceutical production;

(ii) A nuclear medicine technologist with training onsite or offsite in cyclotron operation and radiopharmaceutical production, and who will work under direction and supervision of the medical director; and

(iii) Two radiological technologists with documented training in radiology, nuclear medicine or MRI/CT scanning and who are able to provide support in the areas of PET imaging systems operation, patient preparation for PET studies and image analysis and processing.

28 PA ADC § 401.11

8. Are there operation requirements for PET services?

Yes. The PET service should be available for operation at least 8 hours per day, 5 days per week. Evening and weekend hours are encouraged as an aid to accessibility.

28 PA ADC § 401.11

9. What are the requirements for operation of diagnostic X-ray systems?

(a) An individual who operates an X-ray system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. There shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.

(b) A chart, which specifies the techniques for examinations performed with the system, shall be provided in the vicinity of each diagnostic X-ray system's control panel. This chart shall include information pertinent to the particular examination, such as:

(1) The patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

(2) The type and size of the film or film-screen combination;

(3) The type of grid, if any;

(4) The type and location of placement of patient shielding–for example, gonad, and the like;

(5) For mammography, indication of kVp/target/filter combination; and

(6) Source to image receptor distance to be used, except for dental intraoral radiography.

( c ) Written safety procedures and rules shall be available at a facility, including restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with the rules.

(d) Except for patients who cannot be moved out of the room, only the staff and ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. The following apply for individuals other than the patient being examined:

(1) Individuals shall be positioned so that no part of the body will be struck by the useful beam unless protected by at least 0.5 millimeter lead equivalent material. The lead equivalent of the material is to be determined at 60 kV.

(2) All persons required for the medical procedure shall be protected from the stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be so positioned that the persons are not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.

(3) A patient who cannot be removed from the room shall be protected from the stray radiation by protective varriers of at least 0.25 millimeter lead equivalent material unless the shield would compromise the health of the individual or shall be so positioned that the patient is not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.

(4) No individual, other than the patient being examined, may be in the useful beam, unless required to conduct the procedure.

(e) During diagnostic procedures in which the gonads are in the useful beam, gonad shielding of at least 0.5 millimeter lead equivalent shall be used for patients except for cases in which this would interfere with the diagnostic procedure.

(f) An individual may not be exposed to the useful beam except for healing arts purposes or as authorized for research. An exposure shall be authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

(1) Exposure of an individual for training, demonstration or other nonhealing arts purposes;

(2) Exposure of an individual for the purpose of healing arts screening except as authorized by the Department of Health.

(g) If a patient or image receptor requires auxiliary support during a radiation exposure the following apply:

(1) Mechanical holding devices shall be used when the technique permits;

(2) The human holder shall be protected; and

(3) An individual may not be used routinely to hold image receptors or patients.

(h) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

(i) The screen and film system used shall be spectrally compatible. Defective screens may not be used for diagnostic radiological imaging.

(j) With the exception of intraoral dental radiography, film may not be used without intensifying screens for routine diagnostic radiological imaging.

(k) The registrant shall have a quality assurance program. This quality assurance program shall be documented and be in accordance with guidelines established by the Department of Environmental Protection (DEP) or by another appropriate organization recognized by the DEP. At a minimum, the quality assurance program shall address repeat rate; image recording; processing and viewing; and maintenance and modifications to the quality assurance program. Records shall be maintained by the registrant for inspection by the DEP for 3 years. The DEP's guidelines and a list of recognized organizations will be maintained and made available on the DEP's website and on request.

(l) Neither the X-ray tube housing nor the collimating device may be hand-held during the exposure.

25 PA ADC § 221.11

10. What are the records requirements for operation of X-ray systems?

The registrant shall maintain records of surveys, calibrations, maintenance and modifications performed on the X-ray systems including the names of persons who performed the services. The registrant shall keep these records for inspection by the Department of Environmental Protection for 5 years.

25 PA ADC § 221.12

11. What information must be submitted by persons requesting approval to conduct healing arts screening?

(a) The Department of Environmental Protection (DEP) will consider efficacy as a factor in evaluating healing arts screening procedures. In its review, the DEP will consider national medical organization consensus statements as well as peer reviewed scientific and medical literature that addresses the efficacy of the proposed screening procedures. The review may also consider relevant information from appropriate federal agencies. For procedures that result in an individual organ dose or deep dose equivalent greater than 1 mSv (100 mrem) to a screened individual, the DEP will consult with the Department of Health (DOH) for assistance in reviewing the efficacy of the proposed procedures but the final decision will remain with the DEP. The DOH will have access to all relevant materials when rendering its review.

(b) A person requesting that the DEP approve a healing arts screening program shall submit in writing the following information for evaluation by the DEP. If information submitted to the DEP becomes invalid or outdated, the registrant shall immediately notify the DEP.

(1) The name and address of the applicant and, if applicable, the names and addresses of agents within this Commonwealth;

(2) The diseases or conditions for which the X-ray examinations are to be used;

(3) The description in detail of the X-ray examinations proposed in the screening program;

(4) A description of the population to be examined in the screening program – age, sex, physical condition and other appropriate information;

(5) An evaluation of all known alternate methods that could achieve the goals of the screening program and why these methods are not used in preference to the proposed X-ray examinations;

(6) An evaluation by a qualified expert of the X-ray systems to be used in the screening program. The evaluation shall show that the systems satisfy the requirements of this article. The evaluation shall include a measurement of patient entrance exposures and calculation of the maximum shallow dose, deep dose equivalent and organ dose from the X-ray examinations to be performed;

(7) A description of the diagnostic X-ray quality control program;

(8) A copy of the technique chart for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined;

(9) The qualifications of all individuals who will be operating the X-ray systems;

(10) The qualifications of the physician who will be supervising the operators of the X-ray systems. The extent of supervision and the method of work performance evaluation shall be specified.

(11) The name, address and qualifications of the individual who will interpret the screening procedure results;

(12) A description of the information and procedure for advising the individuals screened of the potential for false positive or negative results and the implications for the patient; the procedure for recording informed consent for the procedure following disclosure of this information; and the procedure for advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and further medical needs indicated;

(13) A description of the procedures for the retention or disposition of the diagnostic images, data and other records pertaining to the X-ray examination; and

(14) An approximation of the frequency of screening activities and duration of the entire screening program.

25 PA ADC § 221.13

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.