In This Issue of Update…

NPC Web Page Now in Operation

NPC is proud to announce yet another way we can communicate with our clients:

http://www.npc-link.com

Sign on and see what we’ve got. Your comments and suggestions are welcome.

In addition, NPC consultants now have easy to remember E-mail addresses:

Dave Close

dave@npc-link.com

Peggy Horgan:

peggy@npc-link.com

Bob Kobistek

bob@npc-link.com

Mike Lairmore

mike@npc-link.com

Sharon Long

sharon@npc-link

Now what could be easier than that?

Computer Generated Software & YEAR 2000 COMPLIANCE

By Michael W. Lairmore

Over the past several months, NPC clients have expressed concern regarding the operability and future use of software driven products through the year 2000. These concerns focus on the effects the transition to the year 2000 will have on computer generated dose calibrators, multi-channel analyzers, wipe test counters and uptake probes. Specific concerns relate to the accuracy of data, when using dates and times for decay correction calculations.

Due to the number of manufacturers providing computer-generated instrumentation, this article will be limited to an analysis of Capintec systems.

When discussing the Year 2000 compliance, representatives from Capintec have sorted company products in three categories:

1. Systems functionally compliant through the year 2000.

2. Systems not affected by Year 2000 Compliance.

3. Systems unable to handle the transition.

1. Software driven products listed below are programmed to perform decay correction calculations through the year 2060:

CRC-15

CRC-15R

CRC-15 BETA

CRC-35

CRC-50

BETA-C

CAPTUS 500

CAPTUS 600

CAPTUS 2000

CAPRAC

CAPRAC R

In regards to the Capintec CRC-35R, the system’s software version will determine if transition to year 2000 is possible. If the system has Software Revision 2.17 (or earlier version), the system will be unable to calculate next day and/or future dose measurements made between December 31, 1999 to January 1, 2000.

This problem can be corrected with the installation of Revision 2.18. Individuals interested in receiving a software upgrade should contact Capintec Inc.

The Captus 2000 is currently unable to perform decay correction calculation on reference sources calibrated in the year 2000. Capintec has indicated that this problem will be corrected in the future. Software upgrades will be provided at no charge to the customer. The software revision will be completed within 3 - 4 months.

2. Earlier versions of CAPINTEC instruments are not CPU driven and do not perform time and/or date related functions. These products will not be affected by Year 2000 Compliance. These instruments are listed below:

CRC-2N

CRC-4

CRC-5

CRC-6

CRC-7

CRC-7R

CRC-7BT

CRC-8

CRC-10

CRC-10R

CRC-10 RBC

CRC-10BC

CRC-12

CRC-12R

CRC-16

CRC-17

CRC-22NB

CRC-120

CRC-120R

CRC-127

CRC-712R

CRC-712M

192 Electrometer 174 Electrometer

3. The following instruments will be unable to handle the transition from 1999 to year 2000.

CRC-30 CRC-30BC CAPTUS 1000

These models use only the last two digits of the year for decay correction calculations. These instruments will calculate accurately prior to and after the year 2000. During the transition, these instruments will not correctly calculate dose information.

Capintec recommends that CAPTUS 1000 users upgrade to Windows based CAPTUS 2000. For clients using the Capintec CRC-30 and/or CRC-30BC, it was recommended that the CRC-15R and CRC-35R be considered as replacement models.

If additional questions arise, please contact your NPC consultant and/or Capintec representative.

The New Landauer Personnel Dosimeters

By Bob Kobistek

Some users of Landauer personnel dosimetry badges may have been surprised when their familiar Gardray film badges were substituted with the new Luxel badges. Actually, according to Landauer, this should not have been a surprise to anyone, because, if your badges were changed, you were notified by mail prior to the change. According to Landauer, however, I was not the only customer to file his letter before fully digesting what was happening.

If you were surprised to see a box of Luxel badges on your desk, you will also be surprised to know that your badges may now have a read bi-monthly read frequency. Now there are two things you should know: 1) Bimonthly badges are not appropriate for NRC compliance, some state regulations, and just good radiation safety practices, and 2) You can still have everything the old way, but you have to tell Landauer. You can go back to monthly frequency; you can even go back to the old Gardray badges. But you have to tell Landauer.

The new Luxel badges are technologically superior to the old film badges, but it still would be wise to review your current status since it may have changed without your knowledge. If you are unsure about your badges, frequencies, availabilities, and costs, you should call Landauer customer service at 800-323-8830.

Entrance Skin Exposure

By Bob Kobistek

NPC X-ray clients are familiar with the Entrance Skin Exposure (ESE) charts that our consultants provide as part of their annual survey reports. These clients are also familiar with the bold-type results that occasionally appear in the reports indicating a technique that needs adjustment. Several questions are frequently raised by these charts, and in this article I hope to answer the following: 1) why do we compute ESE’s? 2) What is an entrance skin exposure? 3) What do you do when an ESE is out of range?

We compute ESE for three reasons. First, ESE calculations are required by JCAHO standards. Entrance Skin Exposure charts must be on file and must contain ESE information for all commonly-performed views. The ESE’s may be interpolated, but must be based on measurements.

Many of our clients are not JCAHO accredited, which brings us to reason number two. During State of Ohio inspections, the inspector will measure the ESE for a few standard techniques. The State of Ohio has prepared a list of expected ranges. You will not be cited if an ESE is out of range, however the inspector will note the fact in his/her report.

Many of our clients are not located in Ohio, which brings us to the third reason. It’s a useful QA tool. Comparing your ESE values with national averages and watching for trends helps your physicist spot problems.

So what is an "entrance skin exposure?" It is the exposure, measured in milliroentgens, on the central axis of the X-ray beam, at the point in space at which the beam would enter a patient if a patient were present. The X-ray machine is set up using the technique factors for a standard size patient, and the measurement is made "free in air." "Free in air" means that no phantom is used so there is no backscatter. If a patient or phantom were present, the exposure would be higher because of scatter.

ESE should not be confused with absorbed dose (measured in rads) or dose equivalent (measured in rem). These two quantities are of interest when talking about radiation effects. If one exam has a higher ESE than another exam, it does not necessarily mean that the one with the higher ESE "gave the patient more radiation." The actual amount of energy absorbed by the patient depends on a lot of other factors such as kVp, patient thickness, and anatomical region being imaged.

If your physicist tells you that one or more ESE calculations is out of range, you should attempt to adjust your technique factors to bring the ESE into the proper range. Bear in mind that being out of range doesn’t always mean "too high." Your physicist may also tell you that it is too low. Low ESE may be a sign of overdeveloping or simply that you are not getting the image quality you should be getting.

And, of course, you can always call Bob or Peggy with any questions or to help you adjust your techniques.

 

NRC 1998 Fees, Final

By David Close

The NRC has announced its fees for its Fiscal Year 1998. Most annual fees and amendment fees will stay the same or decrease slightly. The fees were published in the June 10, 1998 Federal Register. The effective date is August 10, 1998. Selected fees for FY 98 are listed below along with the FY 97 fees. The NRC’s fiscal year begins on Oct. 1. The fees listed below are unchanged from those proposed in April. This information may be useful to you in your budgetary processes.

 

Annual Fee

Amendment Fee

License Type

FY 97

FY 98

FY 97

FY 98

7A Medical Teletherapy

10,300

10,300

400

390

7B Medical Broad Scope

23,500

23,500

740

710

7C Nuclear Medicine

4700

4700

460

450

3P Small Commercial Uses

1700

1700

350

340

Small Business Entities

400 or 1800

400 or 1800

N/A

N/A

Power Reactors

2,978,000

2,980,000

-------

-------

Texas Radiation Conference

By Danny Harris

The Texas Department of Health, Bureau of Radiation Control is sponsoring a TEXAS RADIATION REGULATORY CONFERENCE in Austin, Texas on August 17 and 18, 1998. The seventh radiation regulatory conference will provide an opportunity for the regulated community, licensees and registrants, to receive updated information on the uses of radiation. The conference will focus on changes to regulating radiation in Texas as a result of state legislative actions, federal mandates and radiation issues demanding regulatory attention. An increased number of displays on a variety of radiation topics will also be featured.

Topics scheduled for the agenda include Mammography, Transportation, Medical Rules, X-ray Rules, and Medical Radiologic Technologist issues. The conference provides an opportunity to ask questions and gain insight into the operations of the Bureau of Radiation Control. Most of the inspectors and other regulatory personnel usually attend the conference.

Continuing education credits are authorized for technologists attending this conference. Please make plans to attend. Notifications, which were mailed in mid-June, should have been received by each licensee or registrant; however, if you have not received such notification, please call the Bureau of Radiation Control at 512 834-6688 and ask for Jan Endahl or Cindy Cardwell. The conference will be held at the Austin North Hilton, which can be reached at 512 451-5757 or at the Hilton Reservation number 1 800 347-0330. Discounted rates of $70.00 per night are being offered.

NRC License Terms

By David Close

In the June 10, 1998 Federal Register, the NRC announced it is amending Part 35 of its regulations. This amendment deletes the 5-year term limit for medical licensees from 35.18. The term limits will now be set by policy at up to 10 years. Most other licensees already had term limits set by the 10-year policy. Some licenses will have a term of less than 10 years, although most medical licensees will have the 10-year expiration date. The effective date of this amendment is July 10, 1998. NPC was one of five commenters to support the proposal.

NARM Licensing in Ohio

By David Close

On June 2, 1998, a NARM Symposium was held in Columbus, Ohio. The meeting was sponsored by several organizations (ORMUG, OHA, ODH). Most of the presentations were by members of the Ohio Department of Health, Bureau of Radiation Protection. The symposium focused on the issues of licensing radioactive material in Ohio; new Ohio regulations for radioactive material users; inspection and licensing fees; and the status of the Agreement State process. There was some opportunity for the attendees to provide feedback to State personnel. NPC was represented by Sharon Long and David Close. The following identifies some of the topics discussed.

Ohio is in the process of developing rules for the use and licensing of radioactive material. Some rules have been developed, but more need to be developed. Proposed rules can be viewed on the ODH web page. Draft rules need to be requested from the ODH.

Licensing of Ohio facilities for NARM has begun. It has been a learning experience for all parties, including ODH personnel. While there have been some difficulties in the licensing process, many have been resolved. All Ohio facilities should be licensed by this time next year.

The Bureau is hiring staff for licensing and inspection. They appear to be behind schedule in staffing.

Inspection of facilities against the new Ohio regulations has begun. Since June 1997, Ohio facilities have been required to comply with NRC regulations for the use of NARM. Ohio inspectors have been inspecting against these requirements. It has been a learning experience for the inspectors.

ODH is proceeding in its attempt to make Ohio an Agreement State. Their goal is to complete the process by Jan. 1, 1999. ODH feels they can reach this goal if all goes well. The impression of many of the symposium attendees is that ODH is behind schedule; that they will remain behind schedule; that the ODH schedule is unrealistically optimistic; and that the Jan. 1 target date will not be met. Many of the attendees are opposed to Ohio becoming an Agreement State at the present state of affairs. We will continue to monitor this process.

When Ohio becomes an Agreement State, NRC licenses will become Ohio licenses. The licensee will be required to pay the annual license fee within 30 days of the transition. An amendment (with an amendment fee) will be needed to combine the old NRC license and the Ohio NARM license into one Ohio license. The alternative is to maintain two separate Ohio licenses, with full license fees for each.

NRC Proposes a Complete Revision of 10 CFR Part 35

By Sharon Long

The Nuclear Regulatory Commission intends to completely revise the rules and regulations governing the medical use of byproduct material (10 CFR Part 35). The proposed new rules represent major changes in regulatory philosophy and intend to make Part 35 a more " risk-informed, performance based regulation that focuses on those medical procedures that pose the highest risk, from a radiation safety aspect, with a subsequent decrease in the oversight of low-risk activities. The following is the NRC’S new Part 35 Medical Policy Statement. The full Part 35 Draft Document is available on our web page at by clicking here.

Draft recommendations for revision of NRC's 1979 Medical Policy Statement for regulating the medical uses of radioisotopes.

MEDICAL POLICY STATEMENT

  1. The NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public.
  2. The NRC will not intrude into medical judgments affecting patients except as necessary to provide for the radiation safety of workers and the general public.
  3. NRC will, where justified by the risk to the patients, regulate the radiation safety of patients to assure that the physician's prescription is correctly delivered.
  4. The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety.

New Ohio Regulations

By Bob Kobistek

Effective June 1, 1998, the new State of Ohio regulations regarding facilities with X-ray equipment went into effect. NPC hospital customers who use NPC for their X-ray consulting were sent an Alert letter, summarizing the new rules.

While the Alert letter is a summary of the rules, the following is a list of highlights:

Rule 3701:1-38-03 covers the registration process.

Rule 3701:1-38-04 covers inspections.

Rule 3702:1-66-03 covers Certified Radiation Experts (CRE). Here’s where your NPC consultant comes in. Several NPC consultants have submitted applications for CRE status in Diagnostic Radiology and Mammography. Every hospital is required to hire a CRE in each relevant specialty (X-ray, mammography, and therapy) to oversee their QA program.

Rule 3701:1-38-06 describes the Quality Assurance Program. Here’s where the work comes in. Every registrant must set up a QA program. Hospitals must have a CRE oversee the QA program. Each hospital must form a QA committee that meets quarterly. The CRE will review the QA program quarterly and test the equipment annually. Quarterly reports will be sent to the committee, and annual reports must be filed with the State.

Non-hospital registrants have fewer requirements, but their not totally off the hook. Non-hospitals still have to set up and document a QA program, but they are not required to form a QA committee. NPC is currently working on a similar Alert letter to be sent its to non-hospital X-ray clients in Ohio.

As I mentioned earlier, this list merely scratches the surface. But rest assured that your NPC X-ray consultants are busy working on studying and understanding the new rules. We will be in contact with all our hospital clients to assist in complying with the new rules. If there are any questions, please call Bob at 888-456-5255 or Peggy at 440-498-9810.

When the music stops…pick an 800 number!

By Bob Kobistek

Less than one year after I announced a change in my 800 number, I’m announcing another change. Unfortunately, my 800 number was given to someone else – someone not associated with NPC. So, I’ve gotten a new 800 number: 888-456-5525. This is not a direct line into my voice mail like my previous 800 number; it is a line directly to my office. When I am out of my office, calls are forwarded to my cell phone, pager, or voice mail as appropriate.

I apologize for any inconvenience.