The themes in the letter will be familiar to readers of Healthcare Renewal.
A PDF copy of the letter can be downloaded by clicking below, and the text follows.
Here is the text, along with several comments:
August 11, 2011
The Honorable Kathleen Sebelius
Secretary
U.S. Department of Health and Human Services
200 lndependence Avenue, S.W.
Washington, DC 20201
Via Facsimile: 202. 690.7380
Dear Secretary Sebelius:
The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology.
On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015.
One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s Pittsburgh Post-Gazette [a series, actually, here and here- ed.] cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs.
[You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.]
The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. [I wrote about that here - ed.]
A modern, well-equipped office is critical to the practice of medicine, and health IT offers promise to all medical professionals. [But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork.
We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness.
[Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law, as I wrote here, but better late than never - ed.]
As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented.
[I have been calling for this for years now - ed.]
Sincerely,
Renee Ellmers
Chairwoman
Subcommittee on Healthcare and Technology
House Committee on Small Business
I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's background from Wikipedia:
In 1990, she graduated with a Bachelor of Science degree in Nursing. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.
The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see here and here). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter here.
-- SS
It is about time that lawmakers question the integrity of the devices on which $ billions are being spent.
ReplyDeleteThere is reason to believe that if these devices were subjected to the lowest range of standards used by the FDA to approve a medical device, the CPOE and decision support components would not make it on grounds of absent safety benefit, absent efficacy, and poor usability.
However, the vendors' EHRA was clever. They had HIMSS, its wealthy trade group create CCHIT with shared leadership, to certify the HIT devices' features and provide the illusion that "certification" equated to FDA approval.
Thus, here we are.
Thousands of doctors and nurses are being required to use devices (and create work-arounds for the impediments) that have zero assessment for safety, efficacy, and human factors, and NO FDA approval.
Nothing to see here, move right along please .....
ReplyDeleteI do not see the big deal. There are just thousands of errors and defects. No sweat! Good for the economy.
ReplyDeleteThe vendors are trying their best to maximize their profits without killing too many patients. If they had to spend hours and hire workers in order to report the errors, deaths, injuries, near misses, and defects, they would have to increase their work force by approximately 25%.
This effort would be a job creation program. Great for the patients and great for the economy.
"Nothing to see here..." Errr, not exactly. He must be talking about the smoke and mirrors of the HIT industry that obfuscates the adverse events from its systems, blames the users, and creates a facade around the tue dangers of its products. Ellmers is courageous to do what she did. There goes her campaign support from the vendors and HIMSS advocacy.
ReplyDeleteOn the other side of the coin, will EHRs help centralize patient information and allow for easier exchange of patient info between doctors (coordinated care)? Will it perfect? No. Will it be an improvement? Yes. Could it lead to improved patient-doctor interactions? Perhaps. http://whatstherealcost.org/video.php?post=five-questions
ReplyDeleteUnknown (with an empty blogger profile) said...
ReplyDeleteWill it be an improvement? Yes. Could it lead to improved patient-doctor interactions? Perhaps.
Could the risks outweigh the benefits? Maybe.
Even FDA admits we simply don't know, but you seem willing to roll the technology out nationally in a grand experiment based on hope.
Remind me about how that attitude fits in with modern medical ethics such as outlined here:
45 CFR 46 Protection Of Human Subjects
Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)
The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Nuremberg Code Directives for Human Experimentation
World Medical Association Declaration Of Helsinki
If you can't, then why not volunteer to be an experimental subject to any experiment some prominent professor somewhere wants to conduct, and free him/her from the obligations of research subjects protections and informed consent.
After all, they're a prominent professor, no harm could come to you.
-- SS
The vendors are trying their best to maximize their profits without killing too many patients.
ReplyDelete