WSR 16-16-016

PROPOSED RULES

[Filed July 21, 2016, 2:24 p.m.]

Preproposal statement of inquiry was filed as WSR 13-09-041.

Title of Rule and Other Identifying Information: Chapter 246-226 WAC, Radiation protection—Computed tomography, establishes a new chapter of rules for the safe and effective use of computed tomography (CT) X-ray systems for diagnostic purposes.

Hearing Location(s): Department of Health, Town Center 3, Room 224, 111 Israel Road S.E., Tumwater, WA 98511, on September 7, 2016, at 10:00 a.m.

Date of Intended Adoption: September 14, 2016.

Submit Written Comments to: Michelle K. Austin, P.O. Box 47820, Olympia, WA 98504-7820, e-mail https://fortress.wa.gov/doh/policyreview, by September 7, 2016.

Assistance for Persons with Disabilities: Contact Michelle K. Austin by August 31, 2016, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will establish requirements in a new chapter of rules for the safe and effective use of CT X-ray systems for diagnostic purposes.

Reasons Supporting Proposal: The use of CT technology has grown in recent years in the number of units, the frequency of prescribed scans, and most importantly, the amount of radiation used. The proposed rules are intended to reduce occupational and patient radiation exposure and help prevent overexposure incidents in Washington state that have occurred in other states in recent years.

Statutory Authority for Adoption: RCW 70.98.050 and 70.98.080.

Statute Being Implemented: Chapter 70.98 RCW.

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Dan Van Gent, 111 Israel Road S.E., Tumwater, WA 98511, (360) 236-3231.

There are two hundred thirty-five hospitals and clinics (facilities) in Washington state using approximately four hundred CT X-ray systems. Currently, anyone using a CT X-ray system must register with the department of health (department) as required by chapters 70.98 RCW and 246-224 WAC, Radiation protection—Radiation machine assembly and registration. Under the generally applicable X-ray requirements for the healing arts established in chapter 246-225 WAC, Radiation protection—X rays in the healing arts, the department inspects registered CT X-ray systems for the health and safety of operators and the public. During inspections, the department notes if the registrant is accredited. If so, the department reviews the last medical physicist survey and records typical doses for head and body scans. The department is proposing rules to establish requirements in a new chapter for the safe and effective use of CT X-ray systems for diagnostic purposes. The proposed rules include requirements for facilities, equipment, staffing, operation and maintenance, records, and reporting requirements, which, collectively, are intended to reduce radiation exposure to the public and help prevent incidents of overexposure of patients and staff.

National Perspective: The use of CT technology has grown in recent years in the number of units, the frequency of prescribed scans, and most importantly, the amount of radiation used. In an October 8, 2009, Initial Communication, the United States Food and Drug Administration (FDA) acknowledged that two hundred six patients had been accidentally exposed to excess CT-generated radiation at the Cedars-Sinai Medical Center in California over an eighteen month period beginning February 2008. At least forty-four more CT-generated radiation overdose incidents were subsequently discovered at Glendale Adventist Medical Center and at Providence St. Joseph Medical Center in Burbank, California. A number of patients at Huntsville Hospital in Alabama were also exposed to excessive CT-generated radiation. The majority of these excess radiation exposures caused injurious adverse health effects. These findings resulted in adoption of strict rules for CT exams and procedures with stringent upper limits on acceptable radiation doses delivered during CT exams by the state of California radiation authority.

As CT technology advanced rapidly, professionals in the industry became aware that children were often times receiving standard adult CT-generated radiation doses. The doses were not adjusted for the smaller body sizes and shapes of pediatric patients and their increased sensitivity to radiation. Failure to adjust CT-generated radiation doses for children often results in radiation exposures three to four times greater than necessary for pediatric patients. For this and other reasons, several states in addition to California have created CT X-ray system rules including Oregon, Minnesota, Colorado, Utah, Michigan, Nebraska, and Ohio.

Further investigation by the FDA through 2010 revealed that approximately three hundred eighty-five patients nationwide were exposed to excess amounts of radiation during CT brain perfusion scans at six different hospitals. This finding resulted in the FDA adopting a nationwide initiative to reduce unnecessary radiation exposures resulting from CT and other X-ray imaging procedures.1 However, there are currently no federal rules for any type of patient CT imaging procedures using gantry-style CT X-ray systems.

1http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm.

Washington State Perspective: In 2005, two professional medical physicists recognized as qualified experts by the department X-ray program found and reported CT patient safety concerns in forty-three facilities surveyed in our state. When compared to the American College of Radiology's (ACR) recommended dose index reference levels, sixty percent of the facilities had higher than recommended dose index values for CT head exams, and more than four percent of the facilities had higher than recommended adult abdomen CT dose index values.

In February 2012, at a CT seminar in Tacoma, one of the same two medical physicists pointed out to the audience of CT operators, radiologists, and hospital administrators that he personally was aware of two recent CT patient overexposures that occurred in our state. He went on to say that the state of Washington has no regulations controlling the use of CT.

The department found many of the conditions that could contribute to the findings described above during inspections of CT X-ray systems over an eighteen month period beginning in 2013. Examples of findings include inadequate attention to protocol password protection, no designation of a responsible radiologist to oversee protocol selection, and no guidance for retakes which may lead to overexposure.

Approach to Rule Making: On January 1, 2012, Centers for Medicare and Medicaid Services began requiring all nonhospital facilities using CT to be accredited by either the ACR or the Intersocietal Accreditation Commission in order to receive medicare reimbursement. This accreditation requirement leaves a gap in complete accreditation since it does not apply to hospitals and facilities that do not receive medicare reimbursement. The proposed rules will create consistent statewide requirements for all facilities using CT X-ray systems for diagnostic purposes that are compatible with medicare standards. By establishing CT X-ray system requirements in rule, the department seeks to improve patient and operator safety.

To develop the proposed rules, the department used a collaborative rule-making approach. The department developed an initial draft rule based on recommendations from an advisory committee made up of experts in the field of CT. The advisory committee was composed of a representative cross-section of doctors, radiologic technologies, radiation medical physicists, nurses, and hospital administrators from both urban and rural facilities. The advisory committee met six times over nineteen months beginning in July 2013. The department further refined the rules for proposal based on an extensive informal review and comment period held in July 2015.

The department surveyed all two hundred thirty-five registrants (entities with registered CT X-ray systems in the state). The department also surveyed three medical physicist groups that provide service to registrants in the state to assess the potential cost of the proposed rule. The survey asked questions about each of the proposed sections and asked participants to identify if they already comply with the proposed rules, or if not, to provide cost estimates to comply. Table 1 below shows the cumulative cost of the proposed rules for the twenty-two respondents. For more information about the specific rule sections, please refer to the significant analysis that the department developed for this proposed chapter.

The department assumes that no businesses will lose sales or revenue by implementing the proposed rules.

SECTION 4: Analyze whether the proposed rule may impose more than minor costs on businesses in the industry.

As defined in chapter 19.85 RCW, and based on the information above, the proposed rule or portions of the proposed rules may impose more than minor costs on businesses in the industry. The remainder of this document meets the requirements of RCW 19.85.030 and 19.85.040.

Based on cost estimates received from survey respondents, the department assumes many of the costs of the proposed rule are comparable regardless of business size. Therefore, the department assumes the proposed rules are likely to impose a disproportionate impact on small businesses.

Modifications to the proposed rules were made to balance the burden of reporting injuries with the necessity to improve patient safety and reduce the incidence of medical errors (CT events) that contribute to injuries. These changes include exempting registrants who include CT events in another department-approved coordinated quality assurance program from the event reporting requirements. The proposed exemption allows small business to take advantage of existing reporting processes rather than creating a new process for the purposes of the proposed rules alone.

Though the proposed rules follow national standards quite closely, they were modified to reduce staffing requirements established in national standards to balance patient safety with patient access to services in rural and acute access areas of the state. This is also an important modification to be consistent with department authority related to the regulation of health professionals.

Overall, the department is proposing rules that provide the least burdensome requirements that still protect occupational and public health and safety.

As described in Section 1: Approach to Rule Making, the department worked closely with an advisory committee to develop the proposed rules. The advisory committee included representatives from both urban and rural areas specifically to include small business perspectives in the development of the proposed rules. In addition, the advisory committee began development of the proposed rules from the basis of national standards and medicare reimbursement requirements specifically to create consistent statewide requirements for all facilities, including small businesses that currently receive medicare reimbursement for services and assumedly meet those requirements. The department further refined the rules for proposal based on an extensive informal review and comment period and cost survey which included all registrants and outreach to facilities in rural and acute access areas of the state.

The department assumes no jobs will be created or lost as a result of the proposed rules.

A copy of the statement may be obtained by contacting Michelle Austin, P.O. Box 47820, Olympia, WA 98504-7820, phone (360) 236-3250, e-mail Michelle.Austin@doh.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Michelle Austin, P.O. Box 47820, Olympia, WA 98504-7820, phone (360) 236-3250, e-mail Michelle.Austin@doh.wa.gov.

July 21, 2016

John Wiesman, DrPH, MPH

Secretary

Chapter  246-226  WAC

Where:
	Z = Position along a line perpendicular to the tomographic plane;
	D(z) = Dose at position z;
	T = Nominal tomographic section thickness;
	N = Number of tomograms produced in a single scan.
	And:
	The dose profile is centered around z and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

Where:
	k = A constant, a normal value of 1,000 when the Hounsfield scale of CTN is used;
	μx = Linear attenuation coefficient of the material of interest;
	μw = Linear attenuation coefficient of water.

Where:
	= Linear attenuation coefficient of the material of interest;
	μw = Linear attenuation coefficient of water;
	s = Standard deviation of the CTN of picture elements in a specified area of the CT image.

CT Procedure	Phantom Size	Dose Limit: CTDIvol (mGy)
Adult head	16 cm	80
Adult abdomen	32 cm	30
Pediatric head (one year old)	16 cm	40
Pediatric abdomen (40 pounds)	16 cm	20