[snip]

Thanks to John Steiner and Wild2K.com for sharing this AMA conference overview...

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MARCH 18, 1999
TO: DAVE GEHANT
FR: DAVE HIBBARD

RE: AMA CONFERENCE ON Y2K

"THE YEAR 2000 PROBLEM: GUIDELINES FOR PROTECTING YOUR PATIENTS AND PRACTICE"

* The American Medical Association (AMA) is putting on seminars around the country on the Y2K problem in an attempt to educate and prepare physicians. I attended one of the first of these seminars held in Denver, on Friday, March 12, at my own expense, using my own CME time. This was an excellent conference and I want to share what I learned at this conference because it impacts both the hospital and the CMA.

* It might be a good idea for Joe MacDonald to attend one of these seminars after he has had a chance to digest the material in this letter. His attendance would be one more piece of documentation that the hospital has done everything it reasonably can to be ready for Y2K.

* I am providing you with copies of the workbook which was provided to us, plus a copy of my notes and other materials given to us.

*The presentation was by the law firm of Foley & Lardner, which has been hired by the AMA to develop these materials and put on these seminars. The following points were made:

1. The Y2K problem is real and significant and could have serious impact on patients, hospitals and medical practices unless corrective action, as recommended by the AMA, is taken.

2. There is an emerging "Standard of Care" for dealing with the Y2K problem which the AMA is defining and passing along to physicians and hospitals. The implication throughout this seminar was that if this Standard of Care is not met by hospitals, physicians, and medical practices, then not only might patients be harmed, but the hospitals and physicians would be legally liable (civilly and/or criminally) for failure to take adequate corrective action to protect these patients. The lawyers pointed out that unfortunately, there are a host of lawyers gearing up to bring suite against physicians and hospitals who are not in compliance, who have not done their homework, who have not documented "Due Diligence" in pursuing this "Standard of Care" re: Y2K.

As the workbook "The Year 2000 Problem: Guidelines for Protecting Your Patients and Your Practice" points out (p.2):

"In order to avoid a court or arbitration finding that you or your practice were negligent with respect to Year 2000 risks, the efforts made in your practice to identify, correct, and/or avoid such risks must be determined by the court or arbitration tribunal to have been reasonable, considering what other businesses were doing to address the problem at the time and the circumstances of your particular practice."

" Because some Year 2000 problems likely to be present in a physician practice could be very serious or even life-threatening, the legally required stand of care for addressing these problems will be high."

"Despite the fact that the year 2000 is fast approaching, the required standard of care for a properly designed and executed Year 2000 compliance program is still evolving. Consequently, any specific determination as to whether your efforts conform to the legally required standard of care will include an examination of the content and status of your compliance efforts at various dates and the resources allocated to your effort at each of these junctures. What is seen as reasonable now many be viewed as insufficient by mid-1999."

3. Re: the biomedical devices, they stated that the key is to show that you did everything humanly possible to find out about the reliability of these devices. In addition to contacting/writing the various vendors for letters re: reliability, there are other steps which must be taken and must be documented:

* Access the FDA's web site (www.FDA.gov) and download all the information they have on each biomedical device. The FDA now has a list of devices which are definitely NOT Y2K compliant/reliable. This information should be kept in a Due Diligence File, and every 6 to 8 weeks throughout the remainder of the year, this web site should be revisited and the information downloaded again, because it will be constantly updated by the FDA.

* " A recent FDA advisory warns that Hewlett-Packard's 43100A/43200A External Defibrillator and Invivo Research Inc.'s Multiparameter Patient Monitor have internal clock and date printout problems."

The hospital MUST visit the web site to satisfy the Standard of Care according to the lawyers who made this presentation.

* Almost all vendors now have web sites which provide information about the Y2K reliability of their devices. Each hospital should visit each of these web sites and down load that information, and do so every 6 to 8 weeks, since this information will also be updated as the year progresses. The lawyers pointed out that some vendors have certified their devices as being compliant, and then changed their minds, thus it is imperative that these vendors be researched periodically. This information should also be kept in this Due Diligence File (DDF).

* Each vendor is required to file information with the Securities and Exchange Commission (SEC) on a quarterly basis, including Y2K compliance, and the SEC web site should be visited and this information down loaded and put into the DDF, and yes, this information should be down loaded every 6 to 8 weeks for the remainder of the year. (It seems like a lot of work, but the lawyers who made this presentation stated categorically that if these steps were not taken, and if the hospital ever had a law suit, then the absence of this material, even when the AMA had recommend it, would be taken as negligence on the part of the hospital!)

4. Every conversation, every decision about Y2K should be written down and included in this DDF, showing the thought processes you went through in preparing your hospital or medical practice for Y2K. They want you to make a paper trail which documents the efforts you have made to get all the information possible and then act on that information for the protection of the patients which the hospital serves.

5. They are advising that any implantable device be considered an "experimental device" when the year 2000 arrives, and patients should sign "informed consent" forms which point out that because of Y2K this device may fail and the patient must be aware of that.

6. They are recommending that all elective surgery for the first 2 to 3 weeks of 2000 be moved up to 1999, or delayed until later, allowing the hospital staff to exert full surveillance of the hospital functions and corrective action if such is needed.

7. They are recommending to individual physicians that they NOT admit patients to the hospital electively after the turn of the century, and admit only when really necessary.

8. They brought up the issue of having patients admitted to the ICU sign an "informed consent" form which would discuss the possibility that the devices in the ICU might fail and result in harm to the patient, but the AMA is not yet recommending this step. The point is, however, that they are considering recommending doing this, so the hospital must continue to monitor this issue. If the AMA comes out with a definite recommendation to this effect, the hospital needs to be aware of this.

9. Obtaining letters from vendors stating that their device is Y2K compliant is not sufficient. The hospital must obtain from the vendors "complete, detailed documentation which states specifically what they did.....the detailed steps they went through to determine that their device was Y2K compliant." Did they look at other dates as well as 01-01-2000?

10. If you are having difficulty getting meaningful information from your vendor, it is time to have your lawyer send them a letter.

11. Obviously, don't buy anything new unless it is Y2K compliant.

12. Managed Care companies may use Y2K as an excuse to delay payment for services. Medicare may not be ready to pay for services. The GAO (Government Accounting Office) has stated that Medicare is "lying" about its readiness.

13. If false billing claims are submitted to Medicare because of Y2K problems with our computers, the hospital will be legally liable. I am personally concerned about this because if claims are submitted by the CMSO which have my name on them, then I may be legally (criminally) at fault. What is my legal liability here?

14. Copic is giving a presentation for physicians on Y2K preparedness at Avista Hospital on Wednesday, April 14. BCH should contact Copic and schedule a similar presentation to be held at BCH.

15. Testing devices is one of the most important steps for compliance, yet, there are very real "Arguments Against Testing."

"Users may be unable to perform comprehensive tests themselves

* Overly simplistic tests may lead to false sense of security

* More comprehensive tests are in all likelihood beyond the capability of most health care practitioners and organizations

* Testing may cause damage to, or otherwise affect, the functionality of the device. In this case, liability may be created, rather than avoided, by testing

* Testing may void existing warranties or violate license or maintenance and support agreements

* If it is possible to test, it is preferable to obtain consent or assistance from the manufacturer, which prevents them from saying you violated or harmed the device

* With larger and more important devices, (MRI, CT) you should get the vendor to come out to your institution and certify the devices

* KEY: if you are unsure of the compliance status, DO NOT USE IT

16. Regional Cooperation.

The AMA is urging hospitals and physicians offices to share what they have learned and how they are preparing with other hospitals and other physicians offices. Get the 3 local hospitals' Y2K Preparedness Committees to start working together, sharing information and the work load. One hospital could research these few medical devices (including getting all the web page down loading), the next hospital could take the next few devices, etc. That way no one hospital has to do all the work, it can be shared. The other point here is that each hospital can show that they were attempting to maximize their readiness by seeking information from other sources (the other hospitals). Such sharing also falls into the realm of community sharing and good will.

CONTINGENCY PLANNING: HOSPITAL & CLINICS (CMA OFFICES)

1. The AMA seminar presenters stressed the need for written contingency plans for all aspects of the hospital and clinic operations. We spent an hour doing just that.

2. Look at those things that can cause the most harm to patients and create a contingency plan that will deal with these issues. Have a written protocol in each office and in the hospital of what will be done, make sure that testing is done of that contingency protocol, and have ONE person in charge of monitoring how the plan will work.

3. They are recommending that each medical office have a meeting ASAP where the entire staff comes together and brainstorms about how to handle patients if worse case scenarios happen, e.g., the power is off, there is no water, sewers are not working, etc. Then write all of this down and keep it in a Contingency File for each office.

For The Family Medical Center of Louisville this might include:

* If the power goes out on Saturday, Jan. 1, 2000, having someone responsible for moving the thousands of dollars of vaccines and refrigerated biologicals to BCH for adequate continued refrigeration (vs. buying a battery or getting a generator).

* Having emergency electrical generation capacity at the Community Medical Center (CMC) and transporting all of our patients there for treatment where they have light, and heat. Does the CMC in this scenario need to stock extra water for washing hands, flushing toilets, etc., or have other supplies on hand?

* Having an inventory of all the biomedical equipment in our office and its compliance.

* Looking at the billing if there is no power (do we go back to the pegboard?)

* Printing out before 1-1-2000 a hard copy of the patient daily schedules if we cannot access our computers. Having a scheduling book on hand just in case.

* Checking our oxygen sources and crash kits prior to the end of the year to make sure they are up to date, have no outdated materials, are complete, etc.

* Establish some way of communicating with each other (doctors & staff) if the power is down. If the phones won't work, will the cell phones? Will the pagers work? At midnight everyone needs to page themselves to make sure their pagers are working. communication tree needs to be established and everyone needs to know how to make it work.

* Should BCH have a tank truck of gasoline in the parking lot at BCH for the use by physicians so they can get back and forth to work, in the event that the gas stations are unable to pump gas?

* What arrangements have been made for continued biohazard waste pickup?

* All of these plans need to be written up and put into a Contingency File, and there should be monthly or so meetings to update the information in this file. These plans should be made and written up depending on the days without essential services: what are the plans for Day 1, Day 2, Day 3....... into 2 or 3 weeks. The AMA presenters stated this should be a priority and should be taken seriously in order to ensure the safety of patients and to minimize legal liability.

* Each medical office should consider giving patients handouts which give instructions for patients who are on electricity dependent systems at home (oxygen concentrators, respirators, etc.) for dealing with prolonged power outages. Should the patient have their own back up battery, or generator system, or should they go to their nearest hospital and hook into that hospitals' power supply, or should they have tank oxygen supplied to them by the oxygen company?

* Each medical office should consider giving patients handouts suggesting that patients have a least a one month extra supply of critical medications on hand in case the normal distribution lines fail. In the case of Managed Care companies, this may require prior authorization for getting more than one month of medications at a time, sometime toward the end of the year.

As more information becomes available to me I will update you on this matter.

Note: I would be pleased to work with Denise Anderson on preparing the individual physician offices for a worst case scenario.

[/snip]

-- Critt Jarvis (critt@critt.com), March 23, 1999

Answers

So Wake Medical Center is following standard industry practice by relying on websites and vendor certifications. Meanwhile, BellSouth is testing every single device. Even the Raleigh News & Observer is going to run an operation test during the third week of August of all devices by setting all clocks forward to Dec. 31 and doing a full production run of an 8 page test paper which will be processed and printed during a mock midnight rollover. Do I see some misplaced priorities here? (At least on the part of the medical establishment?)

-- Puddintame (dit@dot.com), March 23, 1999.

Critt...nice catch. Thanks for posting this.

-- Lobo (Hiding@woods.com), March 23, 1999.

In this document the gentleman posts ;

5. They are advising that any implantable device be considered an "experimental device" when the year 2000 arrives, and patients should sign "informed consent" forms which point out that because of Y2K this device may fail and the patient must be aware of that.

Folks the health industry is in a critical situation, they can't test and the manufactures are not responding in a forthright manner. Plus they have the legal eagles looking over their shoulders. For more on this matter and others may I suggest the RX2000 listserve archive. http://www.rx2000.org/data/forms/listserv.htm Go there and type compliance in your "find" Y2K is real and very untrivial

Good luck and stay healthy

Brian

-- Brian (imager@ampsc.com), March 24, 1999.