Wednesday, June 19, 2013

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.

Finally, medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the ECRI Deep Dive Study on Health IT harm at this link), ignores its clinicians over too-rapid deployment of health IT.

Also see newspaper article at

(The hospital management is extolling the safety of the new Cerner system.  What could possibly go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "MAUDE and HIT Risks: What in God's Name is Going on Here?" at or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at  Instead, unpaid bloggers do their work for them to protect patients....)

See this:

For Immediate Release - June 18, 2013
For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner.

The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.

Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients.
The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems.

Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  [Willful ignorance? - ed.] Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.

Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market.

“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. “The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.”

NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment. 

“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center

Inadequate Staffing
·        Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months.
·        The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.
·        They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.
·        The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.

Lack of training
·        Some nurses have received only one day of training.
·        Super-users have received no education or training in the system beyond what is provided to the other users.

Design flaws
·        Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting.
·        During one education session, the system crashed because 17 users at one time overloaded it.

Failure to consult nurses
·        Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency?

Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights.

The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.
CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission.

Michelle Mahon, RN
National Representative
National Nurses United

I believe the nurses should strike if their concerns are not heeded.

I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.

-- SS

6/20/13 addendum:

I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated explicitly that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?

-- SS

9/2/2013 addendum

The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.

-- SS


Anonymous said...

All should be reminded that Cerner's EHR devices have not been approved by the FDA as being safe, efficacious, or usable.

Yet, they are being sold throughout the USA at the behest of Congress (as are the EHR devices of the other vendors).

What is wrong with this picture?

Steve Lucas said...

It may be of interest to note that Affinity was able to purchase, in part, the assets of a non-profit hospital in Massillon to form this new entity. The old Doctor’s Hospital was a patient centered facility built with the support and donations of the community. There was a great deal of legal wrangling to achieve this transaction.

Nice when you can swoop in and take hard fought assets from those who have worked to make their community a nicer place.

Steve Lucas

Anonymous said...

Thanks for the well written article. Administration doesn't think the nurses know what we are talking about when we say we need more training and how this jeopardizes patient safety. But I wonder then why they hired us if they didn't value our skills and opinions. Affinity RN

Anonymous said...

The nurses are right. Been there amd done that. Mayhem and chaos rule for weeks after deployments of CPOE and yes, patients die from the neglect and delays in care.

Where are the doctors in all of this? Do they have yellow streaks down their backs?

InformaticsMD said...

Anonymous June 19, 2013 at 7:43:00 PM EDT said...

Administration doesn't think the nurses know what we are talking about when we say we need more training and how this jeopardizes patient safety.

Get it in writing, get it on tape, etc.

Considering reports such as that from the IOM (see midsection of post at and ECRI (as linked above in this post), I believe this definition may describe that attitude:

Criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)

-- SS

Anonymous said...

Ever since CPOE has been deployed at my hospitals, it has been a pain to have patients in the hospital and there has been a dumbing down of nurses. The nurses no longer know their patients or their problems when asked about them, because the information is all in the computer.

It is simply peachy for patient care when I ask the nurse for a patient's blood pressure (when they call about confusion in a medication schedule) and they have to log on (2 minutes) to tell me it is 210/110 mmhg, a reading in the EHR for hours, that the aid who worked the machine that took the blood pressure never told any one.

Anonymous said...

Kudos for the nurses to stand up to Cerner and the hospital.

These devices are known to kill patients, but neither the vendor nor hospitals want to know the truth. They always blame the user.

I urge you nurses to make more noise!

Anonymous said...

I have used cpoe for 6 years on three systems. All are different with complex idiosynchrasies. It is challenging to remember all of the random clicks needed to stop a certain monitor on a patient.

Today, I went through a counter intuitive clicking process that I will never remember.

The wasted profesional time is an outrage.
The cognitive disruption is an outrage.

All the worse since the outcomes have not improved, and costs have increased, $$$$$ going to enrich the vendors, at the expense of nurse, doctors, and the patients.

Go get em nurses. Stop this computer mediated crap care.

HITECH must be stopped. Vendors must be sued.


Anonymous said...

This is a one-sided article. Although I would agree that insufficient training, lack of clinician input (nurses, ancillary, physicians, etc) and lack of staffing are all ingredients for a go-live disaster, EHR systems are not all bad.

I've gone through several implementations and have been live with CERNER the past 6 years and it's been okay. Not perfect, but there is no perfect system. I have to say that EHR has given us more benefits than disadvantages. We've caught several near misses due to our EHR in place. You quoted IOM, but in fact, IOM (back in 1999) recommended information systems as a way to bridge the chasm and to improve patient safety.

Implementing systems is all about how you prepare, design, implement and maintain the system. This is an organic system that changes. It takes everybody to make it work. Just become you have a computer system in place, doesn't take your critical thinking away. A bad nurse will always be a bad nurse with or without computers. EHRs don't fix bad habits - they actually expose them more. This is the time you take advantage of cleaning the house and setting up new workflows.

Remember - you are the nurse. Not the computer. You're the one who went to school to be a nurse. You're the one who has the experience and the judgment to discern and to critically think. Don't give that up just because you are in front of a computer or using an EHR. It is a tool - just like any other medical device.

Whether you like it or not - EHR is here to stay. Us nurses should stop whining and get on with the program.

InformaticsMD said...

Anonymous August 20, 2013 at 11:24:00 said...

IOM (back in 1999) recommended information systems as a way to bridge the chasm and to improve patient safety ... I've gone through several implementations and have been live with CERNER the past 6 years and it's been okay. Not perfect, but there is no perfect system ... Remember - you are the nurse. Not the computer. You're the one who went to school to be a nurse. You're the one who has the experience and the judgment to discern and to critically think.

The 1999 IOM report is so outdated and so refuted, quoting it is ludicrous. Far less ludicrous is the IOM report of 2012 stating that health IT causes harms, but due to industry capture of the domain we don't know how much (i.e., we don't know if health IT does more harm than good). Readers, see midsection of post at for exact quotations.

The 2013 ECRI Deep Dive study showing 8 injurious and 3 possible deaths caused by 171 health IT mishaps, in a 9 week volunteer-reporting study from 36 PSO member hospitals, should be of great concern except to heartless bureaucrats with an 'IT-Over-All' agenda. Search this blog for it.

If you've gone through several implementations of commercial EHRs and find them "OK" I postulate you posted anonymously because you're either lying, or have a COI, or way outside the opinions of your peers.

You are correct - even with your perverse "nurses, bend over and stop complaining about safety" attitude - about nurses having gone to nursing school (and likewise physicians to medical school, residency and perhaps fellowship) to be more discerning and be more capable of critical thinking on clinical affairs.

Many of those critical thinkers are now saying "get this crap IT out of my clinic." Executives largely ignore them. Readers, see for instance the post at

This, too, shall pass, likely thanks to plaintiff and/or class action lawyers.

-- SS

InformaticsMD said...

By the way, the writings of August 20, 2013 at 11:24:00 above are not just perverse, but also deranged. They write:

"Don't give that up just because you are in front of a computer or using an EHR. It is a tool - just like any other medical device."

By your (il)logic, the medical device industry (and pharma too!) should be subject to the same level of regulation as the health IT "like any other medical device" industry - which is to say, none.


-- SS