Int: First I wanted to give you these. It looks like you already have some information on us, but I wanted to give you--
Op: I said I didn't finish reading all of it so...
Int: Ok. This is just for your information later. It's a project abstract and then a description of the Therac case, and also two other cases that we're doing.
Int: You might've already seen on the web, so...
Op: Yeah, I just went to this one so far.
Int: Ok! I wrote up some questions for you, but I really wanted to leave our talk today pretty, pretty open and hear mostly what you have to say. We had talked about an hour, maybe forty-five minutes--
Int: To an hour, if that's all right with you.
Op: Sounds fine.
Int: Ok. So, and you know we're working on a grant from the National Science Foundation
Int: and the whole purpose of the project is to provide a website with historical cases that will help computer science instructors
Int: teach their students about ethics.
Int: So, the first case that we're putting up on the site is about the Therac-25
Int: that was the medical linear accelerator built by AECL, and I guess my first question for you today was whether you were an operator of one of those machines.
Op: I was an operator for Therac-4, it was called. Very similar to the Therac-25. It was just different equipment energy. My understanding was that the computer console portion that the therapists would control was similar in all their Therac equipment, so...
Int: That's interesting, be--
Op: I was told that I'd never see it to verify it,
Op: but that the console release was the same, the computer software, and that kind of thing.
Int: Interesting. We've read about a Therac-6, a Therac-20, and a Therac-25, but not the Therac-4, so it's interesting to hear about that.
Op: Yeah, I think it's labeled, and my understanding is that the company's labeling is just by their energy, and the one that I was working on at the time would have been in the, probably about 1983, so it was an older model, so maybe what you've found, I don't know for sure, but, might be that they didn't make that one anymore by that time.
Op: The trend in the field was to go to higher energy linear accelerators, so it might just be that those were becoming obsolete because nobody wanted a 4 MeV accelerator.
Int: ok. So that wasn't a dual mode.
Op: Nope. This one that I was on at the time was not. For photons, but it had electron capabilities, which was part of what the victims were...
Op: The issue was related to having both photon and electrons.
Op: So the one I was on was a dual mode, but not dual photon energy, correct.
Op: So sometimes that term might get used...I don't know how you're using it, but dual mode to me means photon and electrons...
Op: and then there's dual energy...
Op: that they have even nowadays, where they'll have like we have dual energy linear accelerators here now where they'll have 18 MeV and 10 MeV, let's say...
Op: for photons, and then they'll have electron energies, maybe 6 or 8 choices these days, so they're really different now even from then, but...
Int: That's helpful.
Op: What I can remember the one I worked on then was a single photon energy, but dual mode, where there're both photons and electrons.
Int: That's helpful. What was it like to operate?
Op: I actually liked it a lot back then, because for its time it was one of the first computerized linear accelerators. We also, this is again, the U of M was pretty advanced for its time, back then, and they had a Toshiba unit, a Cobalt teletherapy unit, and this, this Therac-4. And so of those 3, it was the most advanced of the 3 and the newest actually, because of its computerization. But now that I know what's happened, it's scares me to think, you know, sometimes companies sit back and wait and let other companies try out their computerized software and, you know, maybe they wanted to be on the cutting edge, make some money, be the first ones with a computerized linear accelerator, but then that could come back to haunt you, when all the bugs aren't out of the system, so. You know I liked it the best, and didn't realize any of this, you know, hadn't even thought about that as a young graduate, thinking of all the computer software glitches that could occur, and sometimes you think the more simple the better. You just have some manual buttons that run things instead of the computer, pushing the button on the computer, which runs the LA. So now that I think of it, now that I know what happened... So back then I liked it. It was really sophisticated, it made things easier. I think we were more efficient or productive on that particular machine. We seemed to be able to treat more patients. Quicker, yet still have the amount of time to spend with them talking like we did on the other machines. You know what I mean? So it didn't jeopardize any of that and it speeded things up so we'd have time for other things, in my opinion, back then.
Int: That would be positive.
Op: It was. [laughs] It was.
Int: How did you find out about the accidents?
Op: I think, I can't remember exactly. It could be one of two ways. I went to a national conference where I was, I attended a lecture that was given by a lawyer who actually had been a radiation therapist, and ... he handed out a newspaper article from the incident and talked about the issue of how many times therapists retried to get things to work when they'd get the malfunction faults, like the malfunction 54. They would try maybe 7 or 8 times and the whole intent of his lecture that I attended was how many times were too many, and you should have an institutional policy possibly saying maybe after 2 tries you do this or that, you call your physicist, you get the patient off the table, try it without the patient there, things like that that you should have an institutional policy. The difficult thing there we were thinking is not all places have physicists so. Here where I work and where I worked at the time I attended this meeting, you could just call the physicist and they'd take care of should you continue trying more attempts or should you get the patient off the table. You didn't feel like it was such a huge responsibility as a therapist to make these decisions, because there's so many other things that you're going to think about, oh we've got to stay on schedule, dadaduda, let's keep trying, let's deliver this in 12 increments instead of 1, just by continually clearing these faults. And this goes on today all the time.
Int: It does?!
Op: Oh yeah. We were talking about this this morning at the class I was teaching at. I brought this issue up: how many times do we keep trying. What institutional policy? And every place can have it's own policy. So anyways, that was one way I learned about it, was that lecture. I also know that when I came here and was talking to our physicist, when I first got a job here, and when I came here, I was talking to our physicist about this same issue and he said, "I've got an article about it," and we talked about it again, so it might have been through him that I first learned about it, but I'm remembering more this lecture that I attended at a national conference. And I think it was right around, you know, 1990, '91, so it had, it had happened quite a while before I even learned about it.
Int: and I think that, well let's see, there were accidents in '85 and '86, and then I know that they were written about then, but
Op: You know it was mostly Texas newspapers and things too. I'm surprised we didn't have more in our field. However, I didn't attend this national conference for the first time until 1989, so then it could have been that it was discussed pretty timely to those that were really doing this kind of work, but I would think there should have been some kind of alert notice that would've gone out. I was working at two pretty prestigious places, Abbot Northwestern and the University of Minnesota. I don't remember ever seeing any kind of alert to all of us.
Int: At the time of the accidents?
Op: Right. If you were working on a Therac piece of equipment, whether it was a 4 or a 25 or whatever, you'd think there would be some alert that comes out. I see these alerts now. Siemans, for example, we have Siemans equipment. They send alerts out: Medical alert. So-and-so reported this kind of a bug. Whatever it might be, it's not always software related. It can be hardware related. It can be Linear Accelerator (LA) related, and we'd make sure we'd read 'em and deliver 'em to staff. So at that time I do not recall any kind of alerts coming out.
Int: So you think it's changed?
Op: You know it could be that. It could be that the timeliness of when we replaced that LA compared to when these accidents occurred was right around the same time. So, we might not have been on the list to even get the alerts anymore, because they knew we were getting rid of our LA. Or the people that screen those alerts, like our physicists at the U of M, might have said, "We don't need to circulate these. We're not using that machine anymore," 'cause we got rid of that machine in '85.
Op: We were going into a new hospital, purchased new accelerators, it was just getting old. That kind of thing. The average life of a linear accelerator: most people say anywhere from 5 to 10 years.
Int: And then it's obsolete?
Op: That or they just don't function as well, because you get more and more of these faults as they just get old. So, just like a car kinda gets old, your oil lights start coming on a little more often, yeah, so that's kind of considered a time when it's time to replace them when they get that way. You know, having too many faults. Are these like the first time you heard some of this, 'cause I don't want to shock you either, but
Int: Ah, well, I want you to shock me.
Op: this is really how it is. When you start to get so many faults and your track--your physicists, at least, I think, should be tracking your down time and all these faults. You'll start to see a pattern develop, and there'll come a point where it's a nuisance to us as well as we'll lose the patient's trust if this is happening where we don't even run 'em if we're getting this many faults. Yeah, we can struggle along and keep continuing treatment, but when they give these faults 3 or 4 times during everybody's treatment, we don't want to do that to anybody laying there, 'cause we'd lose their trust. We don't want that getting out in the community, saying, " Oh, gee, you know my treatment today, you know they had to start over 4 times to give me the same thing that yesterday took one attempt to give me." And so we don't want that out there, and nobody does. It's a tough decision to make 'cause they're very expensive, but there comes a time where you have to just say, "This machine is just having too many things occur. We aren't able to repair it to the point where we can get this to stop, so we're gonna pull the plug on it and get it out." That's kinda what usually the decision making process is on when it's time to replace 'em.
Int: One of the lessons I think they had hoped would be learned from Therac-25 accidents was to not rely on the software so much as far as safety interlock and machine shutdown, so I'm wondering if that's different now.
Op: I don't know at my level as a manager and a therapist by training, if I can answer that real well. You might need to get it from a physicist. What I can tell you is, I try to, like when I teach our new students, I try to have them think about that, because you're only as good, and you're trusting probably your physicists that have calibrated and commissioned that machine and made it ok to use, and as a therapist you know that there's daily, weekly, quarterly, annual checks that are required on LA to turn into the nuclear regulatory commission. So you trust that your physicists are doing those tests, and you have access to those if you want to see 'em, and I do that. And we as a group here in this department share that with all of our therapists so they can see, yeah, these tests have been done, and feel confident, but I still don't. I'm still putting my trust in someone else that that's been done. So, if there were a malfunction, such as this Therac-25 one on our equipment, I still know I'd get dragged into court at least to explain what I had done. Did I cursor her up, and did I change this, and when I got malfunction 54, how many times did I try, and, you know, those kinds of things. But I'd still have to defer most of that other stuff about, you know, the authorization that the equipment was safe would be really on the hands, or the shoulders, of the physicists, I think. And then ultimately then the medical director oversees the physicists, and so I know they scrutinize, the physicists take, and much more so probably than a therapist would. But we still think about it every day because of this incident, and we still teach our students we need to think about this. Don't trust your equipment. Don't trust your physicist, you know. You should always be double checking and questioning things, because, we teach that anyways you should question everything that comes out of the planning room to even administer that treatment. You know, you should question is this, does this prescription look correct or was the physician not thinking when they wrote this prescription, just like when a nurse would question a drug that's being administered in prescription for a drug. So we just kinda teach that anyways, and we never have more than, less than two therapists in a room, so that they're questioning each other. So it's just in this field in general, everybody's double-checking and triple-checking everybody. So the same thing should hold true with the equipment. You just shouldn't trust equipment. You shouldn't trust the people that are commissioning. You should question, I shouldn't say you shouldn't trust, that doesn't sound good, but you know you're putting your trust in 'em.
Int: I think it does.
Op: but yet you should question it, you know, question it always question. Don't ever think your questions are stupid. So that's kinda what we teach, and you know you have to have everyone that you're working with buy into that philosophy. I think we do that here. I don't know if everybody does it, but I think that's what you should do, personally. [laughs] Question, question, question, you know.
Int: I agree. What kind of educational background does an operator have?
Op: Ok. That's a really good question. That's a long answer. Here goes. There are approximately 102, or so, radiation schools in the country. There's 3 different types. Our national certifying agency and our professional society are working towards getting something to be standard, so that maybe there's one type of school in the future. As far as I know, the first radiation therapy school opened in 1978, or the first board exam at least opened in 197--was given in 1978. So there might have been schools before that time, but they weren't credentialling people by examination. So back to the types of schools, there's certificate programs, which are usually about 12 months in length. There's associate programs affiliated with certain colleges where people can get associate degree, and then there's four year bachelor programs, which is what we have here at Abbott. We're articulated with UW-LaCrosse. Once somebody finishes those programs, the program director has to sign off that the candidate, or that the student is eligible to take the boards, and that's administered by an agency here in Minneapolis called the American Registry of Radiologic Technologists. So then if they sit for that test and pass it, then they're considered entry-level therapist. And so, it could be that they've taken that training out of one of three of the methods or types of schools and then passed the board exam to become trained. Or to be classified as that. Then you have to keep up your credentials every year. To do that nowadays, just in the last five years, our credentialling agency, the ARRT, in St. Paul, has made it mandatory to have continuing education, which I think is great to a professional society in Albuquerque, New Mexico fought for that three years to make sure that they, they, you know... make sure that we all have 24 credits in two years before we can reregister our license, let's say, just like nursing, physicians, everybody else. It took us that long to fight to finally get that. So people now have sat for an exam, plus they have to keep up their training, to be able to say they're a registered therapist. The interesting thing I'll tell you about is that you don't have to employ registered therapists in the state of Minnesota, and so that's something we're fighting for on the federal level right now, so our professional agency is fighting for that. The weird thing is our agency that credentials schools and our agency that credentials us can't join on the bandwagon in that fight because it's really coming from our professional organization. And we've hired lobbyists at the Washington, D.C. level to get that to be standard where all x-ray operators and, x-ray machine operators, LA operators, anything dealing with ionizing radiation should have to have people be registered, but right now, for example, in the state of MN, people could walk in off the street and learn how to take x-rays and then sit for this exam that's a real basic exam that's offered through the MN Dept. of Health--Radiation Control Division. So, so much of this stuff is linked together. I've been involved, I mean I used to be president of our state society the year that we were trying to fight to get licensure to be mandatory in MN, and we didn't win. But we kinda went around the back door and got this exam at least possible through the MN Dept. of Health. So it's better than nothing. So at least the public can feel assured that there's some safety net there, but other states, I mean you can, I don't know where you can get this, but you could find out, I'd assume on the internet or through the ASRT, our professional agency in Albuquerque, which states require licensure, and then it's split up by nuclear medicine text, radiation therapy text, and diagnostic x-ray text. So some states have all 3, some states have one. In Minnesota, a radiation therapist could walk in off the street. There's no credentialing at all for radiation therapists in this state, but we have this minimum little exam at least for diagnostic x-ray text.
Int: So it all falls to the people hiring--
Op: We're getting there. It's just a huge project. You have to have the money to hire the lobbyists. I'll never forget the year we did that with two of the... we had a, you know... I'm forgetting the lobbyist's name. Wy Spanno. And then we had a DFL'r and a Republican that were fighting for this at the House and the Senate levels, and I went to so many committee meetings. And it just is like, you know... We eventually got it tacked on as a little rider to some other bill that didn't even have anything to do with it, because there's just... I don't know if you know much about how bills become laws, but by God [laughs], I learned. We just didn't have enough political clout, I guess, and money at the time, but, you know, there's something on the table for MN at least, but it's not near what I think it should be. I think there should be a federal law, and it should address diagnostic x-ray texts, radiation therapists, and nuclear medicine texts, in my opinion. That's that long answer that I told you... [laughs]
Int: Well that says a lot.
Op: But it's really interesting what goes on up there and the public probably doesn't know half of that. I remember going to my community, you know, my district caucus, to sell this thing, you know, to try to-- And that's what we were all trying to do. Any level we could get the word out there so the public knew what the issues was to have 'em help vote for this thing. So, that's what needs to take place. It's just a huge undertaking, and that's why we just finally went to the federal level. Cause all the states were just having so much difficulty, and I'd hear about this at our national meetings--what people were going through and how they kept getting it shot down, and every time a state would say, "Oh we got something," licensure, the whole room would, you know, thousands of people would get up and applaud because it was just a major thing, but even a little baby step in MN would be applauded. The federal level is where this has got to take place and the public has got to be better informed that this is what's going on, and they're just not. You know there just not informed.
Int: I certainly didn't know...
Int: anything about it.
Op: Ya. So, if you want more...I can get ya it. You can look that up on the internet too, I'm sure there's web sites that'll help ya ta know what's going on out there with that, but it's just not enough yet. We're still fighting that one.
Int: Wow. So your nametag says RTT. What does that stand for?
Op: Right. It stands for Registered Technologist, and then the T should really be in parentheses, and they goofed here. It stands for therapy. And so there's a RT(R), an RT(M), there's several of 'em. RT(R) would be radiographer, RT(M) would be mammographer. Then there's a RT(QM), which stands for a quality management board exam was sat for. So all these things in parentheses after our initials for Registered Technologist stand for the board exams you would've sat for. There's a CT and MRI, which, MRI doesn't use radiation. There's still other issues on protecting the public as far as being a qualified operator to get diagnostic films that a radiologist can read out to make a proper diagnosis. There's still that issue there to protect the public from.
Int: But then training for the specific machines would happen at the hospital, because all different places use different machines.
Op: Right, so, exactly. So the programs that are set up, the hundred and two or however many, approximately a hundred in the United States at this present time, always affiliate with the clinical site. You have to get your school accredited, you have to have so many hours of clinical training, clinical competency, where someone's testing out on certain things. In this field, you know, you have to test out on how to be able to set up a patient for breast cancer, lung cancer, Hodgkin's disease and all the different cancer types. And then your clinical component as well as your didactic or classroom training has to be signed off on by your program director to sit for this exam. The difficult part is trying to get that exam to measure your clinical performance, your training. Now in Canada I know that their clinical component of their board exam, their actually performing things and someone has to watch them doing things on a LA. In the United States, your board exam is strictly a computerized, 200-question test. But they're trying to have people that write the questions focus them on clinical scenarios. But I still actually sit on the committee that writes the questions as well as I've sat on the committee that takes the questions and makes the tests. So there's two different committees at our national certifying agency in St Paul, the ARRT. And that process is difficult to get the clinical component evident in an exam. That's 200 questions, 3 hours. But I would sure, I would assume nursing has the same thing in our country, you know, how do you watch a nurse administer a drug when you're taking a test at a computer screen, you know? So I think Canada's kind of got the right idea there. And I don't know how many years they've had their exams set up that way, but I met people in 1989 that told me about it, so I would assume it's been going on for years, so that's an important part. And testing somebody on do they have the knowledge of how to run an accelerator and really seeing 'em do it are really two different things in my opinion.
Int: So it really, it falls to you as the person in charge of training to make sure that all your operators here are...
Op: Right. Right. Yep. And so your program director that's signing off saying these people yep they're competent to sit for the exam... that clinical component I think it the key thing that the program directors are signing off on. It's really on their shoulders.
Int: So you're a program director here?
Op: I used to be. I'm not now. I used to be at the U of M, and then I used to be here, and then I've just had too much going on, so I had to give to somebody else. But I at least know what's involved with signing off on that because I've done that in the past. It's pretty similar today. I think I quit doing that in '95, so not that long ago.
Int: So what are your duties here at Abbott?
Op: Right now I'm a manager here, so and I still teach class for our school, and so I still am teaching students both in the classroom and in the clinical setting on the machine, and I still cover for our staff that do the treatments, so I still just an hour ago was doing a treatment, and pushing a button to deliver the treatment, so I still do that. I still feel like I keep in touch with it, I guess.
Int: Do the companies, you said now you work with Scimed?
Op: Siemans, they're called.
Int: Siemans. Do they provide a lot of assistance as far as training and documentation, or how do they compare to AECL.
Op: Boy, they're all different as far as how much training they give you, and it's actually something sometimes you have to pay for, which is sometimes a deciding factor when people make the decision on how much training...
Int: Yeah, that shocks me.
Op: It's really frustrating. But I can't say that with AECL, I was, I was not on board when they first got that machine, because you only get it when you first get the machine, and then from that point on every year after, if you get a new employee, you are doing the hands-on training, so you're passing it on.
Int: Did they give any, did AECL give any books or documentation?
Op: I would assume they would've, just because I know what was going on back then, but I just wasn't part of the, recipient to that because I was on board 7 years after they got that machine, so I was getting it from the staff, as a student and as an operator then. Now, we do that, with our Siemans equipment, I know what we had here on board, and yes they do leave several binders that show you how to operate the machine as well as five days of on-site training by an application specialist. And I believe they have about 5 for the Siemans company and I think the other major company manufacturing LAs is Varian. I don't know if you've heard of them. So right now Varian and Siemans are pretty much the biggies. Then there's the Phillips company, which got bought out by Electa, is probably like number 3, and Mitsubishi is still selling LA as well out of Japan, so I think those are like the 4 that I can think of right now, today, that are as big as AECL back in 1985 when this happened. They were probably number 3 back then. There was Varian, Siemans, probably AECL. Right now its still Varian and Siemans kind of neck and neck. Anyways, they all have about the same number of application specialists, depending on how many accelerators they sell that year. So that if they sell twice as many all of a sudden, then they'll beef up their application specialists and get those people ready to go out in the field then and train all of us. So it's usually, you know, average of 4 to 5 days. You barter when you buy a LA for the training time if it's gonna be over and above that, or sometimes we've had pieces of equipment, not LA, but if we're gonna have more than two people get trained you have to go to their site to train. Then you have to pay for it yourself, so a lot of the bartering goes on depending upon if they come to your site or if you go to their site, and who pays for it. And I think it's kind of hokey, hokey stuff, in my opinion. But we have to pay $7000 to get our person trained just because we got a computer over here but the training site is out there and it's something we're bartering for so let's say, "Oh, we don't want software upgrades for free. We're gonna take training instead." These are like bargaining tools that the companies use. You know if I could change anything I'd love to change that. I think that's ridiculous. But you know we're stuck. Our hands are tied. These companies with all the money, you know. Our hands are tied. We have to do, you know, we look at what our needs and if we think trainings more important, we'll pay for it, so it depends on the institution.
Int: But it could be possible for a clinic, especially in MN where the operators don't have to be certified to have uncertified operators and then cutting costs on training...
Op: Could be, could be. Now LA, what this accident occurred on, are much better than some of the other pieces of equipment that deliver radiation treatments. There's other things that, um, high dose rate units, there's planning computers that aren't really delivering the radiation but they're gonna drive the LA later. Those are the ones where these companies are sticklers on this training stuff being a bartering tool and costing money. Ultimately, we're on this era right now that you won't even be able to fathom what's going on in this field. I don't say that, you know, to knock you 'cause you don't have the knowledge--
Int: No. I understand.
Op: I just mean I can't even fathom it myself, what's going on. But we're at this era in radiation therapy that some people are considering is comparable to when CT came out in radiology. You remember how big that was. Or when MRI came out. And so we're in this process where we're doing some planning on these computers because of 3 dimensional software now. So this issue's gonna be huge, and we won't be able to [laughs] I don't know how we're ever gonna track what we were doing then, let alone back when this accident happened, how difficult it was to figure out what went wrong. So with 3-d software, everything was 2-d back then, we were treating from front and back and left and right and real simple parallel pulse fields we called it. With this 3-d software, and I keep pointing to that thing cause that's what's gonna do it, that's the stuff where all the people have to go to get training and pay $7000 to get it. That's gonna be driving the LA eventually, and we've already got the link for our new accelerator set up. So through cyber space it downloads all this information 3 dimensionally and the way they're, why they're relating it to what CT was is because now we can instead of just giving radiation straight out of the machine all the dose throughout the whole square field is even, from left to right edge and top to bottom and front to back. Now you can actually insert little devices that are driven by this computer to the LA that will make it like we're painting with radiation so we've got spots of this square now that are gonna get a higher amount, maybe in the middle or maybe less over here 'cause there's a lens of an eye and less over here 'cause the spinal cord is in the way. We can do that now with this 3-d software running the linear accelerators. So this issue is going to come up again. It's gonna scare the heck outa me and the FDA that approves the software to run these accelerators I hope to God is doing their job really well, that's all I can say, you know, because I'll never know. Again, we're all going to be trusting that these companies that sell the software to run the machines three dimensionally now and do all this fancy stuff like CT--we're gonna trust that the FDA caught all the bugs in the software or the company's working with the FDA then. And it's way more complex than back in those days when this incident occurred, and that was a software bug. Basically it was a software bug.
Int: It was two, actually two software bugs, but one of the big problems back in those days was that while companies were required to report to the FDA, clinics were not. So, AECL, even though I think they were possibly at fault in a number of ways with that, didn't even know about some of the accidents because, until much later, because they were never told.
Op: Sure. That's true too. You got both things going on, you know. So, I think we're better today than then as far as reporting so these alerts come out, the one component.
Int: Are clinics required now to report?
Op: Oh, yes. Yeah. Any kind of thing that you find that you think is a funny fluke in the software. I hope everybody, you know that they're, I mean, you know even though you're required, there's gonna be people that are still gonna choose not to do it 'cause the paper trail that you have to deal with when you submit something like that. But hopefully there's enough reputable radiation ecology in the field that those things are important to protect the public, and we don't want any of that bad ink that happened in the '85. I think we're all pretty good about that, but I mean I got this tiny little network of people that when you go to a national conference that's all you're basing this on is that you think people are genuinely honest and yes they are going to take the time and know that they're going to have a huge month's worth of paper trail because they, they've submitted something like that, you know.
Int: And they submit to the FDA or to...
Op: I think like we, Siemans would be us if we found a little bug that we're suspicious something funny's going on. However, there's other ways to report, like if you have an error that you found made. Whether it's an error that's from the equipment, that would go one way, to Siemans, and then they'd report. But if we made an error, a technical error on somebody's treatment, we're responsible to report. And again, it's only, it's gonna be as good as, the system will only be as good as the honesty of the people reporting, so that's something. But you can go to, there's a governmental report that comes out every quarter where you can read the errors that occurred in radiation therapy centers. So if somebody, you know, made an error or somebody discovered an error, whether it was intentional or not. So let's say I was supposed to treat your, right breast and I treated your left breast, and that happened about two years ago where somebody went through a whole course of radiation therapy the wrong breast, for example, down in Florida. That should be reported to the government, and then the government publishes that report for the public. So I know that is out there for that mechanism. The software or hardware bugs that we may find or suspect, we'll report to Siemans, someone'll come out and test something, and then Siemans will report it. That's where I don't know who they report it to. I'm sure it's a government agency, but I don't know if it's the FDA...
Int: AECL? They worked with both FDA and Canada's equivalent of the FDA.
Op: Ok. But what about like the nuclear regulation commission in the United States? Do they have a similar agency up there? Cause I would think that's part of the loop, you know, the FDA here doesn't really control radiation, the NRC does.
Int: And what about the Center for Devices and Radiological Health?
Op: That's, that would be another one.
Int: And but they're part of FDA?
Op: That I don't know either but I often see things coming from them. So that would be...I...
Int: I think they're part of FCA.
Op: you know what, I think that's where Siemans would report.
S, Op: yep.
Int: I think they're FCA.
Op: I think that's so if Siemans suspected it. A software bug or something like what happened here.
Op: And so they... The only thing I can say is I don't see us talking about that very often. You know I think when you buy a LA and maybe your applications person is coming doing your training to your staff, that would be a good thing that they should teach, and I've never heard that. I know it 'cause I know how the system works.
Int: like how it works.
Op: Yeah. And we teach our students that 'cause I've been in this long enough, or whatever. The physicists have been around for twenty years, so they're real good about saying, "If you notice something funny, make sure you tell me." But I would think the companies that sell you the accelerators would promote that more, and they don't. You know. So I think that would be something we could improve upon as a community working with accelerators. I don't remember one application specialist ever teaching that, that I can think of. And I think that would be something the company would really want to do to cover their butts, you know.
Int: You would think.
Op: You'd think they'd just have a form saying here if you ever notice anything funny, fill this out, fax it to us. You know what I mean. 'Cause you could just do something real quickly. Or you, they could have a website where you could go and report all that.
Int: And they don't.
Op: Maybe I just don't know about it because they have, maybe they have it, but they haven't taught us about it, you know what I mean. And I would think that would be just a real quick, easy way. I mean you wouldn't want to tell them every little thing, but you should have a system in your department where if you suspect something as a therapist, I'd bring it to my physicist or whomever would be in charge and have them test it without a patient in the room, and then if they think it's really a bug, they should just be able to get on the website for Siemans and tell them they've discovered this. You know, something really quick. And I just don't know if they're, if that exists and they're not telling us... That's what I mean--the education component I think we're lacking on. You know, I think there could be way more promotion with those that are getting new machines and getting training, that the applications people should be promoting that kind of thing. Constantly saying if you get this fault and, you know, whatever, challenging 'em and making 'em think about it, 'cause they're covering their equipment then, you know. Anyways, that's my high horse on that one. [laughs]
Int: Ok. Well when the test, the operator from Texas-- is it operator or therapist, what's the best?
Op: Well, it's radiation therapist today. Couple years ago it was radiation therapy technologist, and operator's fine too. I think the lay person would understand operator much easier. 'Cause people think of the therapist sometimes as the physician. And they're actually called radiation oncologist--that's the doctor's name. So operator's just fine, but if you're gonna speak to someone by title you usually say radiation therapist.
Int: Ok. Well the operator from Texas testified in one of the cases that she was told during training that she could never hurt anyone with Therac-25. That it was impossible. That there were too many safety interlocks for that to happen. So I'm wondering if during your training on the Therac-4, did anyone ever tell you, you know, this--
Op: I've heard similar comments like that.
Op: But I don't think I've heard 'em since this incident, to tell you the truth, and we actually, I think we teach just the opposite.
Int: Now, so that's changed.
Op: Yeah, I mean, I think the whole issue of, you know we all trusted what was going on was safe back then, and yet there were so many detection systems, but when things became computerized, a lot of that just went out the door, in my opinion. When it was the manual, for example, when I used to run a Cobalt machine, as a student and then finally as a therapist, I think maybe in that case, I would've even felt more comfortable with someone telling me that or teaching me that. 'Cause I knew that if the source didn't go back in the machine, I could see that by a manual system, and I could go in and get the patient out of the room. But even then, the patient would've gotten overdosed if the source didn't go back in the lead safe, let's say. I don't know how much you know about Cobalt machines, but the point was that it's a more simple machine and it was a manual system where if this rod stuck out or this light didn't go off... So, I wouldn't, I couldn't even, I wouldn't even need to rely on the light getting burnt out. There was a rod. The only thing that could've gone wrong was, again, the rod might have malfunctioned, and, so that, you know, even then there, I knew, and I was taught that even that, that would be the one last thing that could fail us, right? So as machines have gotten more and more complex... I don't know if we can say that anymore, however I know we tried to tell patients this that ask, 'cause patients do ask. Patients are getting more and more knowledgeable with what's going on out there, because of the internet, I think. That's just changed everything and how we educate people. It might be also that the baby boomers are coming up to, now, the point getting cancer, and I think they were a type of generation that sought out information more. Whereas the generation that in the past had been getting cancer was... I don't know what was before, they used to call 'em, the World War II, what was the, what do they label that generation? They're more the type--
Int: Tom Brokaw says the greatest generation, and I've heard that more now.
Op: Right. They didn't seek out the information as much. If their doctor recommended radiation therapy, they didn't question it, they just did it. Well that generation is kinda moving through now and baby boomers are coming in, so they are challenging the information. So patients ask that, and when we tell them, "Well the machine goes through 94 checks before it delivers a treatment," and we've got three categories of faults that we as a therapist can see on the screen. Now I don't tell a patient that, but I know when it's sending out the signal to test the treatment before it'll run, and it'll come back to me before I even turn the machine on. So, that part you're feeling good about about the computer, but yet, you know, that can still fail. And so I don't think people are teaching therapists anymore not to, just, believe the computers and believe the equipment, like they used to. And it might just be because more and more of these accidents and little safety alerts are coming out now that we're hearing about. Because the equipment's getting more and more complex. It's just unbelievable.
Op: It's scary, you know. So, I don't remember ever getting taught that way where I was. But I tend, you know, I'll just, I think in MN we're, I know where we all train, and just, you know, the history of radiation therapy community in MN, almost everybody got their training at the U of M--doctors, physicists, and therapists. Now it's branched out much more so in the last 5 to 10 years, but all of us having had our training there... I can actually even tell you about a individual that I would say has had the philosophy that has influenced all of us to have this kind of questioning philosophy and, the patient comes first type of philosophy, which is, you know, of course, but where we just won't train people by saying you accept this as it is. It's black or white. We didn't have that training philosophy at the U of M. So this doctor I want to talk about is Doctor Seymour Lovit, who is kind of considered like the, one of the grandfathers of radiation therapy, and so, so many of us coming out of that training program, now branching out and starting our own training programs... Hopefully we've upheld that kind of philosophy where, at least in MN, it's really something I think I can speak to. But I don't know what goes on in the rest of the country, you know. I'm in my own little world here in MN, but I at least know the network amongst ourselves. I still think that's, that philosophy's been upheld, where we question it. We don't teach a student that you should just think your machine is safe. Because we know that's been proven otherwise.
Int: Back at the time that these accidents occurred with Therac-25, the machines, the messages that came back to the operator didn't make sense. It would say something like Malfunction 54 or some other type of malfunction or just some numbers or a word. So there wasn't really a lot given to the operator from the computer as far as what might be going wrong, and also the company didn't provide any kind of simple key or a translation, and I'm wondering if that was your experience with the Therac machine you worked on and whether you think that might, whether Siemans is doing a better job right now.
Op: I know Siemans is doing a better job. When I use that machine...
Int: The Therac?
Op: [nod] when I was fresh out of school, I know there were some keys, but they were really really basic back in those days, you know, I mean there's 94 faults now. And I have a grid that I can look at, and then they're categorized so I can kinda have an idea what's going on and make a judgement--ok, I'm not gonna keep pushing this button to keep overriding this, you know.
Int: So you can still override?
Op: You can still override. Some things, not all. There's even mechanisms where a physicist can come and go into a different mode called service, and go through this it's a diagnostic system where he can see or she can see what the faults were and why, how often they occurred and when, where everything was as far as the parameters of the equipment, when it happened, to see if it's linked to, you know, maybe the machine being down at 90 degrees instead of zero, the weight of something is pressing on a wire, you know, even that kind of stuff. Back then, I can't tell you how much was available to me as an operator. I know there were some things, you know, right above the machine that would cover the stuff. I could grab a training manual, but, you know, now we've got 4 binders and pages of the stuff because it's gotten more complex. I know there were still things that would occur that would not be answered or addressed by the binders, and I have still had that even now. I've been operating a machine where it quits on me in the middle of a treatment, doesn't tell me why, and usually it's, you know, I was told when I was trained it'll always give me a reason. A fault will be at the bottom... 94 things that are all categorized by software, hardware, and LA faults, ok? I've still run the machine where no fault has come up and it stops on me, and I don't know why. And that drives me crazy. That makes me think there's still software bugs out there happening.
Int: So what's the procedure now--
Op: when that happens?
Int: for Siemans, I guess you'd contact them.
Op: I report it to our physicists, they'll try to duplicate it, they'll report it even if they can't duplicate it. Our service engineer or a Siemans service engineer will come and try to duplicate it. They'll eventually tell us back have they been able to or not, and what they've done about it. They can't duplicate some of that stuff. So, you don't know if it's a power surge because somebody turned on an air conditioner in the Piper building that caused it, 'cause they can't duplicate it. Or not. So some of it there's still some, you know, loodoodoodoo, stuff that goes on out there in cyberspace that we can't answer.
Int: Was it different back in the '80s?
Op: The process where I was on that Therac-4 was very similar. If we'd get a fault we couldn't explain, we'd call someone. We were very fortunate we had physics staff right on site, service engineers right on site. And could call in and have a corporate service engineer that was in an hour. Now, so, I felt good about--
Int: Corporate AECL?
Op: Yep. We could've if we needed to. Depending on their district and how many service guys they'd have per state, let's say. Siemens we could get a guy in an hour and a half, Varium it might have taken a day to get somebody from California, so it depends on the equipment. You have a different service contract with each company, and they even spell out how quickly they can respond, how much they'll charge you, all that kind of stuff. But some places choose to have in-house people trained on the equipment, because that can be a savings, a cost saving, and it can be more convenient to have somebody there quickly. So we have both, and most places will do that. They'll have one guy trained on some of the basics, but they'll go out, again, you pay for it, but they'll go out to the Siemans corporate headquarters in Palo Alto, California, have a five week training course on LA operation and repair. And so they can do some of the basics. Anything they get stuck on they'll call in the Siemans gentleman. So it's very similar even back then. I can just say that the books and binders and things that I'd go to when I had a fault weren't as well-written, let's say.
Int: Back then, mh hm.
Op: And we were trained more, much more thoroughly, I think, I've trained much more thoroughly on that, because I went through the applications training on these new machines. But the people that were training me on the job that were the therapists that were my colleagues didn't do as much of that as I think we do nowadays. They just said here's how you run it. They didn't really go over the inner workings of when malfunctions would occur as much. We're really focused on the patient care aspect, the technical component of accurately delivering treatment. And we tend, as therapists, to leave the on-the-job training stuff about the machine to the physics staff and the service engineers, and that just wasn't a component of my training on the machine. It was a component of my training in the classroom. So there's some part of us that knows that you've gotten some of that in the classroom, but yet you're responsible to teach 'em the idiosyncrasies of that machine or that company's machine when you're on the job learning with someone. So I didn't get a lot of that, no.
Int: Ok. Did AECL charge? It sounds like Siemans charges to have someone come and look at something?
Op: I don't know back then what they charged, if they did charge. Most of the service contracts are set up where you have a one-year warranty--anything's for free. After that you choose. Do you want to continue a service contract for $140,000 a year, and I'm sure it's more than that now. I would guess it's probably up to, who knows, $180,000 a year. Or you can get a minimal contract and then overtime is more. Which everybody has overtime, 'cause you're running a machine from 7:30 to 4:30. The only time service guys can come in are when you're done with your patients, to work on things, if it at least functions to get you through the day. And again, you have to make the decision where if it's sluggish and you're running poorly and you're, you know, pressing the button seven times to get one course of treatment...
Int: The override?
Op: Exactly. We make the decision we don't want to continue that and we down it. But it could still sluggishly limp along if you choose that. So anyways, there's different contracts available, different prices, different companies
(switch tape sides)
Op: 8am if we when we're warming it up the machine and testing it at 7am before we start treating patients, he may not get here until 9, so we have to make the decision. Down the machine and treat everybody on one machine, and then we tag team and try to quickly get our patients in so they're not waiting forever and we still stay on schedule.
Int: Do you feel like the administration at the hospital has the same goal as far as patient treating as the treatment staff or as the therapy staff does?
Op: I do. Here at this institution. I don't know how others would answer that, but part of my job, kinda being the middle person too, is making sure that I educate them on what is happening, so the squeaky wheel gets the oil, you know. If we're having major machine problems and it's just getting ridiculous then I can tell them how many patients have complained, and I really try to bring that forth on the staff complaints for that matter too. They don't feel it's safe or whatever. So I can bring that to our administrator or manager and relate it to the cost issue. You know it's usually going to boil down to cost. Do we want to spend the money to have the overtime for the service engineer to get this thing fixed so we don't lose patients. 'Cause in the long run, we'll have a cost issue that way. We'll lose revenue. Because patients won't come here 'cause we'll lose their trust. So I really see that as my role--trying to get that into some kind of concrete form that administration can buy is tough. I've gotta show how many patients this has affected, what kind of money that would bring in, and have it, icky, you know I have that icky feeling it all relates to money. But yet the experience and the reputation and all that is the part that I really can sell, you know, I've gotta get the numbers for 'em, but I don't even like that part. I can sell the patient concerns, I can get Dr. Kim to get on the phone and call my manager and say, "You know, this is really bad." We've had this, we've had patients come from other institutions telling us the same thing, so we know what it's like. Somebody'll come here and say, "I think they made an error on me. Can you look through my records? I don't want to have any more treatments over there. Can I come here?" I mean this just happened two weeks ago. So this goes on out there. So that part is a easy sell to administration, then, if you have that kind of thing going on. But, you know, you have to, I don't just say it unless it happens, too. I have to have some facts. And so, if I do my job well, yes they'll buy in. And I don't think I very often have too hard a sell. But I know other managers have a hard sell on this issue. I can tell you what's caused some of this is the balanced budget act in 1997 that went through is killing all of us in health care right now. And so, Medicare, which 65% of the patients in this department are Medicare, and how they choose to reimburse us is really the thing that's killing a lot of hospitals when these issues come up. You have these decisions to make that indirectly the government's controlling. It's just, that's a whole nother path we can go down, a whole nother topic, that, it's huge.
Int: So there is pressure to keep patients going through, and you know, so would you--
Op: Yeah. It's just sad that it comes down to the financial stuff sometimes. I think we here are lucky that we're financially maybe one of the more stable hospitals so that decisions can be made based on safety and not, you're financial dollar signs don't even enter in. And I don't think we'd ever compromise anything. If it did come down to a dollar sign, you know, the patient safety would come first and the legal issues... Of course any institution knows in the long run you can shoot yourself in the foot if you didn't listen to these things. But I know that some managers have a real hard time with this and I, networking with colleagues I hear this.
Int: At other hospitals?
Op: Yeah. It's just horrible. I think the private clinics, or the free-standing clinics have less of an issue with this, with money, but yet they're the ones that may be putting so many patients through kind of on assembly line kind of system that, depends on the physicians running the group in that case, are they, I hate to say it, but you know are they greedy for the money or not is gonna be the issue. Now in an institution like this one...
Int: And this is more publicly funded, is that right, or what's the difference?
Op: Well we're non-profit, a non-profit organization, which can help and hurt you, I mean, you know, so. It's just a tough issue, you know, we're gonna be more affected by the governmental issues than, in that case, 'cause reimbursement's gonna be different than if we stay in the clinic. So all those issues relate to this issue in that sense, and if it boils down to the money versus, you know, somebody making a decision, "ok, I'm gonna make that linear accelerator limp along one more year cause we don't have the capital this year for it," and who knows if some of the little faults and little idiosyncrasies of that machine aren't gonna ultimately end up in one of these situations, you know.
Int: And so in those, in those kind of places, too, where money may be a little bit more valued than safety, would an operator probably not be encouraged to keep reporting those malfunctions, or...
Op: They might. They might truly get to where they just think they're beating a dead horse, and they'll give up, you know. And that's again another thing you almost have to teach the students those issues. That you don't want 'em to give up, you want 'em to keep badgering those issues and keep bring them up. Or eventually people get so frustrated they'll leave, 'cause they're afraid to be part of it. I know people have left institutions because they're afraid to be part of what's going on when that happens.
Int: It's just unsafe?
Op: Yeah. They don't feel like it's safe. I remember when this, when I told you I first think I learned about this issue, from the lawyer that had been the therapist and he said he was interviewing other therapists not related to this issue about what their practices are, to find out what is the common, what is the norm, what is the standard. Since there isn't any federal laws on this. What is the standard on how many times you should keep overriding these faults. There's, he said, that there were people that came forth with things that were haunting him and going on in this field that they were shocked to learn about. People overriding things with, we have little jumper cables that you can attach onto some of the computer boards to override things. And he said one of the people that he interviewed, I don't even know how he got the person's name or whatever, but it was totally unrelated. He just wanted to find out, his goal was to find out what's the standard in this field. Kinda like what you're doing. He said he was just haunted by some of the stories he'd hear. And so of course then I heard this at this meeting, and I, you know, you do hear about this stuff, and, I don't think the public does, but...
Int: Not as much.
Op: So those are the decisions, somebody made the decision that they'd override this or that with these little jumper cables, they call'em jumpers, 'cause they didn't have the money to buy a new machine or whatever the issue was, they didn't have the...
Int: Or pay for the service.
Op: Or maybe the service guy couldn't come for two days or, you know, who knows what was going on.
Int: And you lose two days of patients.
Op: Yeah! And that's what goes on out there. They make the decision to keep treating patients when really things probably should be looked at, and I think if patients knew that they'd say, "No way, not me." Would you? I mean, I'd say forget it if I knew some of this stuff. [laughs]
Int: You know, makes me pretty nervous! You know.
Op: I'm mean really I think the best thing if you were a public consumer in this field would be really to check all this stuff out. And knowing what I know, I'd do it. And I would send any of my family members here, but I know that there's places out there I wouldn't, 'cause I hear these stories. And if I didn't know the reputation of the place, I'd investigate it, and the public needs to be educated on that. Students need to know before they get out there and do this stuff--what goes on out there, you know.
Int: What kind of training happens where.
Op: Yep, exactly. And I think our national agency that accredits programs is very very good about how, when, you know, like, when joint commission accredits a hospital, we have a joint commission that accredits a school. I think they're very very good at how they scrutinize the training to make sure this isn't going on, but they're not responsible to go back behind the machine and see if there's jumper cables back there either, you know what I mean. They're making sure that the students get the right training, but the government would be the one that would have to make sure the institution is doing the proper thing with the LA. And the agency that would govern that, I'm assuming, would be the nuclear regulatory commission, and the physicists reporting and how they do things. Well they can walk in your door and everything can look fine, but an hour later... just like, you know like the Department of Health coming around to a restaurant to check for sanitary conditions. Well a week later it could be a whole nother story. So we have OSHA that could look at some of our things, we have the NRC that can walk in without an announcement, you know, an announced visit, and you can be fine one day and the next not, you know. So, that's the tough thing, you know, are you doing what you say you're doing when they're here for their visit. Are you doing it every day? Are you living and breathing the stuff every day, you know. That's what I think is important. So, here I go again [laughs] I'm on my high horse.
Int: And training people to, you know when you train your operators to insist on that.
Op: Yes! And that's really, I mean, that's human characteristics. That's having a personality type that you select and to be training to even be students in this program that're gonna be honest people. That if they make a mistake, they know they could lose their job over it, but you gotta bring it forth. You know, you have to. You might have overdosed a patient and you can adjust for it the next day, you know. 'Cause it's important to bring, if you made an error, it's important to bring it forth, you know. Or bring it to me, and I'll bring it to the doctor, if they're afraid to, you know? But that's, to get, how do you, how do you really pick through, on a one-day interview, the kinds of students you're gonna have in your training program to get those types of people that have those personality characteristics, you know.
Int: Does overdosing still happen with the LA?
Op: Oh sure. Yep. People still, there's still human mistakes that are made no matter how many are checking things and how much is computerized...
Int: Just do the incorrect dose...
Op: There's still a certain component that manually has to get entered. So whether it's that computer driving our LA, it's a human element that we have to enter the data. Some of it gets sent over from out CT scanner, through cyberspace, and we have to check that that got done properly before we do anything, so yep, there's still errors that occur. I just got one this morning. And we, you know, I think the best thing to do so that people come forth is make it a process where you're really sure that you don't have any initials on who did what, just that somebody's bringing it forth. We even bring our actual and our potential errors forth. If we catch something that we caught before we treated. 'Cause we're using it as a learning experience so that we report that quarterly here in our department and share that with our staff. So we're saying we had this many of this type, and this many of this type and what do we think, you know, on the form it says, "what do you think we could do to prevent it." Sometimes it's just we're too busy! Less volume, more staff, you know might even be the issue. I haven't seen that in a while, luckily. 'Cause that would be my job, you know, make sure that that's not on those forms. Might just be so-and-so was off this day and the physicist checking wasn't as knowledgeable, or, you know, whatever. Could be things like that. Could just be it was just oversight; somebody missed it; a nine and a eight got transposed or whatever. But we're trying to learn from it. Hopefully there's recommendation on how to improve it so the error doesn't occur again you can really focus your efforts on that instead of pointing fingers on who did what. That's one of the most difficult things, I think, in this field is that people are so quick to point fingers at the errors and hopefully, you're working for physicians that aren't like that, and, you know, again, this Dr. Levitt over at the U of M that trained so many of us in MN, trained the doctor that I've got as my medical director now, is just wonderful about, you know, we'll bring it to the group, we'll point out the error. We'll try to do it the week it happened, or whatever. We have weekly meetings, of course, that. And he's good about telling the patient what we did and helping them to understand what went wrong, so that we can make up for it or subtract for it, or whatever. But I think that's really really important that, you know, nobody's afraid then to bring out an error. Just like you don't want to be afraid if your machine's malfunctioning. You don't want to withhold that just so you can get done with your day's schedule, 'cause you know if you bring up a malfunction, it's gonna mean you're gonna get behind schedule, because someone's gonna come in and look at it, you're gonna have patients out in the waiting room complaining that they're waiting. It takes time for all this to happen, and you have to decide, you know, that's more important, that's more important that you bring it out. Instead of thinking your personal oh I want to get out of here by 4 o'clock stuff, you know what I mean. You just don't know.
Int: But here that's considered more important to do, whereas other places you just don't know.
Op: It might not be. That's right. That's a tough thing though, to get all your employees to buy into that philosophy. You know, you really, really have to just promote that all the time, and you have to walk the walk and talk the talk, you know, yourself. Practice what you preach. Whatever cliche you want to call it, I mean you really do. You don't want to say one thing and do another and then have somebody else observe that and go, "Well, gee, then I'm not gonna do that next time. I'm just gonna say forget it. I'm not gonna report this fault, 'cause I wanna get out of here at 4 o'clock today," whatever, you know, when really you think it's something you should have somebody take a look at. You know, it's a judgement call, it really is.
Int: Do you feel that it would be important for the designers of the software that runs these machines to know what it's like to do your job?
Op: Oh, yeah. Oh, yeah. And do they? No. Do they? I don't even think they have a clue. I never hear that they get, that therapists get invited when software design comes out. I think I would hear that. I think I have a pretty good network of what's going on. I know they ask us technical design, major, like, LA component issues, like where to place this button or that button. I've never heard of a therapist getting involved in software design. Doesn't mean it doesn't happen, but I just think I would've heard about it.
Int: Have you ever met anyone that's been a designer?
Op: I have at the Siemans, I went and did a plant tour and I saw their research and development division and met some other staff. I know the mechanism that Siemans has when we were told if we don't like something, go ahead and tell your sales rep. I know we had some design things we didn't like, and they never went any farther. The sales rep actually, oh, this is a bad story, the sales rep brought it to the corporate headquarters and we never got our issue resolved so we just forked up the money ourselves to change the design. And even that is risky, 'cause then you could say that if you change the design of something and it malfunctions, they Siemans can say they're not legally responsible anymore.
Int: Sure. So you had someone else change it.
Op: We had something, yep, that we hated so much that we changed it, and we took that upon ourselves to then be legally liable for it, and then that sales rep got fired. I don't think he, I know he didn't get fired over that issue, but it makes you wonder, sometimes, it really makes you wonder. 'Cause he was the type of sales rep that was always bringing in the customers' concerns, and bringing it to the research and development office. So that mechanism exists, but when I experienced that with that particular sales rep, and then I saw the outcome. It makes me wonder. That was Siemans back in 1989, and I don't want to say anything bad about Siemans, 'cause I think they're a really good company, and I think they changed that, but I don't know how they did it, but I think they changed it. I just think, I think, yes, to get a therapist more involved in the software design would be good 'cause I think right now we're only involved in the real hardware component of the LA, not hardware of the computers even.
Int: Is the, is the design of Siemans, it's a dual mode also with the different levels of--
Op: Dual mode and dual energy, yep.
Int: Is it on a turntable design, like, Therac-25 had a turntable design, and that was one of the problems.
Op: Yeah, ah, no, um not that I, you know what, I should know that and I don't. And the reason I'm fumbling with that is because we got a new machine and there's an old model, and I can't recall the new model. I could get that information, though, I mean, at least as a therapist I know I could get that information.
Int: Ok. I was just, just curious.
Op: I want to say it's a sliding tray. Are you familiar with that design?
Int: Not, what, no. Not as much as...
Op: Ok, it's instead of the turntable, or the, what was it called?
Int: Turntable design.
Op: Did you get to see what that looks like?
Int: We had a diagram of it.
Op: Ok, so it just kind of turns around in a circle. You know the component that is going in underneath the electron gun is the component they were talking about that didn't go into place on this case.
Int: Yes. Yes.
Op: I think Siemans has this sliding tray. So it's the same kind of thing. An electron scattering foil will go in, or a photon target, which looks like a witch's hat, we call it, it's kind of like a cone shape. And I've seen that, and I'm pretty sure the new Primus that we've just got has the sliding tray component. So, I know that part of that design of the Siemans was because of that error also, because that thing going around always detected something was there. It was a continual thing. Sliding tray's either in or out. You know what I mean? So that was wise somebody designed it that way, is what I've heard. It's either there or it's not there. If it's half way there, it's still telling you it's half way but it's not all the way in place.
Int: it's not there. Right. That was part of the problem.
Op: and there's backup, right, there's backup systems even to that. You know they have a backup to the backup on certain components of the machine where they really want to make sure that that is detected. That's one of the most crucial components, was what that error was about.
Int: Yes. I think that on the Therac-25 even the FDA and I think the Canadian equivalent of FDA was asking for a retro fit where they had a separate detector of the placement for the position of the turntable, and it wasn't implemented.
Op: Right. And you know maybe someone made that decision because of a money issue. Who knows, you know? I mean it's just the same thing as like the airlines and all their issues. And I saw at least one of the cases about the airline things, and I can only imagine.
Int: It was a military chip, involving cutting costs and testing. They were cutting costs on the testing.
Op: Yep. And so I know, we have, on the console as a therapist you see what you entered in and you see a backup and another backup, so you can see all three of these, and when you test it in the morning, you're testing the backups too. So, on the sliding tray issue there's like a microswitch that would tell you when it's in place, and then there's usually a backup to that. You might have a microswitch fault, and it's telling you, ok, the machine won't run 'cause that microswitch is broken, and there's no way it'll let you run and override that. We don't want to.
Int: You can override that?
Op: I don't know that. I hope to God, no. But you know, you never know with those jumper cable deals, if someone would jimmy one of those computer boards that has that microswitch fault on it, you never know. I can't say that for sure. I don't know that.
Int: In other places they do that?
Op: I know there's people that override certain things with jumper cables. I don't know what exactly.
Op: Not here. Nope. No way. [laughs] No way. We just do not do that. But, I was leading to, like the microswitch deal: you can have switches that go out and if you feel your components are in place, you could override those switches. I've seen us do that on certain components of the machine that would not overdose the patient, but would, we would not be, how do I describe this to you... Are you familiar with what blocks are, blocking, trays? Have you learned any of that?
Op: You can, ok, I'll see if I can describe this ok to you. There's, the radiation'll come out of the machine in either a square or rectangular shape right now. And you, the physician'll design something that we fabricate called a serabin block that would shape the field, maybe stopsign shaped or any configuration you need to, and then you fabricate these lead or serabin alloy blocks that are about 8cm thick. Well then these get mounted on a tray, like a plastic little lucite tray, it's about 1/2 a cm thick, and then you slide it into the machine. Well there's a microswitch then that'll sense that that block is in place, and now companies have even gone so far as to code the tray so that you don't use somebody else's tray inadvertently on, you know, Mr. Jones's block on Mr. Smith, which can happen. So that can be some of the errors that still occur in this field. And now they've coded the trays.
Int: And so the treatment would be in the wrong shape.
Op: Right. Exactly. You could completely miss something. You could shield something you needed to treat, or whatever. That can still happen. Well, there's microswitches to those trays, for example, that you can stick a piece of tape on and override. And I've, we've done that here. But you know you have to sit and think how much of this are you going to tolerate. Well, maybe for a couple hours you put a piece of tape on it, and you say, "Can you get the Siemans guy here by noon?" Or now we have a service guy that could fix it immediately. So there's certain things that, as an institution, you could say are override. I don't even know if that's so good, you know, 'cause we can't overdose the patient by not having the block in, but yet we could incorrectly shield or treat something we shouldn't, so, in a sense, it's indirectly, yeah, you're overdosing or underdosing then, you know what I mean? So those kinds of things can still be done, and, yes, we have done those here. We're not anymore, but that would, you know, in the early '90s we had these microswitches that we'd put tape on and things.
Int: So part of the importance of doing that correctly is having the right training too.
Op: Yep. What things are going to be ok to do, and then, if you're going to do that and say for two hours we're going to treat this way, that would be 8 patients, until the service guy gets in, you have to make sure everybody's alerted, and you, you know, you could still make a mistake, but maybe you just have that little reminder that you alerted each other, the therapists your working with, that you gotta check to make sure you have the right block in. Or you even have a block in, if you're suppose to have a block in, you know, if you're gonna make that decision. And you know errors could still occur. They really could. So that's the scary thing. That still goes on. I shouldn't tell you that, 'cause you're never gonna wanna have radiation therapy if you ever needed to, but, you know what I mean?
Int: Well I suppose if I needed it, I would take the risk, but I think that's part of medical treatment today. And I also think that's part of the danger of computers, in a way, although I think it's getting better now, is that back in the '80 and less today people just think, "Well, it's a computer. It can't make a mistake."
Op: Yeah. I know. And you gotta remember who designed that software was a human being.
Int: Exactly right.
Op: Did they think of every possible scenario to test. And how do you, you know what is the exponential function of how many scenarios there are to test, you know what I mean? It's huge.
Int: I think with Therac that was, one of the lessons learned was that just assume that you can't think of every possible scenario and build in hardware safety interlocks. And that's what Therac was missing. But the earlier versions of Therac, Therac, probably Therac-4, Therac-6, Therac-20, there were hardware safety interlocks that stopped massive overdose in one way or another. But with Therac-25, it's my understanding that those were taken out and only hardware safety remained.
Op: Wow. Now did you find out why they took 'em out? Was it a financial thing?
Int: They were, I'm not sure, part of our problem is that we don't really have any access to AECL records. We have articles. There's a professor at MIT who's written about, and we've got permission to reprint some of her writing about this. But we don't really have access to their records directly, so we don't know if it was cost driven. I know that part of what made Therac-25 attractive was that it was a sleeker design; it was much smaller.
Op: That saves costs for construction for people purchasing it, you know, so maybe they chinzt on some things to make it smaller, you know, you never know. Gol that's spooky.
Int: It's hard to know.
Op: Well remember when we talked on the phone I mentioned that any of the physicists that were around at that time I bet would have that information. To know what was, why did they take out that component. I would bet you could find that out, yet, if you guys were really interested in getting that. The physicist that works here used to be on the Board of, I think it's called the Board of Chancellors, at the America College of Radiology, and their, the physicians and the physicists national organizations have those committees that, I would bet, just the people that were serving at that time would've been involved in all this, so they may have some of that. They may not have it in writing, but they'd at least remember it, and you'd have to take the verbal. Or some of them may have it all in writing, and know what the issue was back then. It's probably tougher 'cause it's a Canadian company, and so if it was in the United States, the ACR--American College of Radiology--involved, I don't know. They might have looked to them for expertise, to hear how we would've handled things in the United States, but I bet someone, that if you uncovered, you know, if you guys dig deep enough, I bet you'll find somebody that would know that.
Int: That's interesting.
Op: Yeah. 'Cause the physicists are really heavily involved with the equipment and commissioning and approving of equipment, design of equipment, and.... Yeah, it's huge.
Int: When we talked on the phone you mentioned creepy when you were referring to AECL and their machines. You felt that way about AECL, do you feel that way right now?
Op: Only because of this incident.
Int: Because of this?
Op: Yeah. I hadn't before. I mean I liked the machine before that time. I thought it was really, like I said, it was one of the first computerized machines that I had worked on--the only one. So I thought it was great. The second one I worked on was by the Phillips Company, out of England. I loved that one too. Mainly because at the time there was such a shortage of therapists. I remember working all alone for my first two years, almost, out of training, 'cause we were just short. They just, there weren't enough schools, it was kind of a new field. And so I could work faster and still have, still feel like I was giving the same accuracy to the patient, and still having time to spend with them then. You know, so, dinging around with all this other technical stuff and not having time to spend with them when I was working alone, it was stressful back then. I'll never forget it. So that was just my opinion of it, what I was able to do for productivity and spending time with the patient.
Int: Looks like we've gone, we've gone a long time. I really appreciate your time.
Op: Oh this is fun. It's kind of interesting. I hope I haven't scared you to death so any, that ever comes down to, you know, in need, I mean, just really the education to go and seek it out if you ever have a family member or anybody that needs treatment, really scrutinize the place they're going.
Int: And I think, I think you're absolutely right. And I think that's important no matter what you.... My son had hernia surgery when he was one and a half and we ended up going to Children's West, which was great, but, you know we talked to a lot of people, we visited...
Op: Yeah. Find out how many surgeries the surgeons have done, you know, exactly. People just don't do enough of that.
Int: They're starting.
Op: We're getting better, all of us, but, yeah. It's just amazing. I mean I wouldn't want to put my hands in somebody that'd only done five of 'em you know.