A Right Royal Mess: EHRs and Royal Berkshire NHS Foundation Trust

Almost every theme I've written about for the past 15 years, at this blog and at my teaching site (link) regarding health IT mismanagement is present here:

A Right Royal Mess
    
ehealth INSIDER
12 February 2013

Newly released reports on Royal Berkshire NHS Foundation Trust’s implementation of Cerner Millennium show that many crucial issues were not addressed prior to go-live; and that the trust is continuing to face considerable operational and financial issues because of the system. Rebecca Todd reports.

Read it at the link above.

I feel this scenario is being repeated in many countries, including the U.S., with many different vendor products.  The industry's pathologies and self-serving memes are difficult to overcome.

As Orwell said:  "To see what is in front of one's nose needs a constant struggle."

But don't worry...you're perfectly safe.  Computers, after all, improve healthcare and are entirely beneficent, according to the pundits.  Every untoward event is a mere "anecdote."

-- SS

Addendum 2/15/13:  just to illustrate my point, there's also this:

Monitor blasts Rotherham's EPR programme
ehealth INSIDER
15 February 2013
Lis Evenstad 

The Rotherham NHS Foundation Trust has been found in significant breach of its terms of authorisation by Monitor, with its electronic patient record implementation identified as a key issue.

The trust this month admitted it was facing "persistant serious issues" with the deployment of its Meditech EPR including "clinician and staff acceptance and usability" ... “The trust has not managed EPR implementation in an effective way and significant operational and financial risks will remain until the trust has a robust and operationally effective EPR system." ... “It is unclear whether the trust has sufficient visibility over operational performance and quality issues, including incidents of patient harm,” it adds.

-- SS

Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post "Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?" I wrote:

 ... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:

(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act

... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software [see addendum below - ed.], such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.

Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.

The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).

In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR 

I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.

What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:

... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13.

The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission.

These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification.  An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website.  No "I didn't receive it" excuse is possible...

The facts about health IT "certification" are trivial to verify. 

As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "using certified EHR technology in compliance with federal law and regulations for Health Information Technology" was not possible at that time.  (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)

Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now knowingly lying to the Court in sworn filings, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.

The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence.

These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT.  I find this remarkable (but not surprising).

It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.

-- SS

Addendum:  Also pointed out in earlier filings was the fact that use of EMR's is not "required."   It seems the defense attorney, besides being a liar, has a thick skull.

-- SS

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes."  Health IT provisions are included.

This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’  PDF fulltext is located at this link:  http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf

With regard to health IT, the Act states the following.  A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine):

SEC. 618. HEALTH INFORMATION TECHNOLOGY.

(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.

(b) WORKING GROUP.—

(1) IN GENERAL.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).

(2) REPRESENTATIVES.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.

While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional hyper-enthusiasts, industry courtiers and opportunists.

I am actually not hopeful.

The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern.  As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified.

I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (link), with a national project (including CMS penalties for non-adopters) now several years underway.

Final thought:  if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a  "Food and Drug Administration Safety and Innovation Act" in 2012.

-- SS