EHR Go-Lives Are Often Chaotic; One Area To Be Explored Is If This Go-Live Led To This Tragedy

EHR "go-lives" are particularly chaotic as staff adjusts to the new cybernetic governor of care.  Could the distractions have caused or contributed to the following tragedy?

http://www.cnn.com/2013/12/17/health/california-girl-brain-dead/

Family wants to keep life support for girl brain dead after tonsil surgery
By Tom Watkins and Mayra Cuevas, CNN
updated 4:32 PM EST, Wed December 18, 2013

The mother of 13-year-old Jahi McMath, who was declared brain dead Thursday, three days after undergoing surgery to remove her tonsils, said Tuesday that the family should make the call.

... The surgery, which occurred December 9 [at Children's Hospital & Research Center in Oakland, California - ed.], initially appeared to have gone well, said Sandy Chatman, Jahi's grandmother who is herself a nurse and saw the girl in the recovery room. "She was alert and talking, and she was asking for a Popsicle because she said her throat hurt," Chatman said.

But Jahi was then moved to the intensive-care unit, and her relatives were denied access to the eighth-grader for 30 minutes; when they finally were allowed to see her, they knew something was wrong. "Upon entry, they saw that there was way too much blood," Chatman said.

"We kept asking, 'Is this normal?'" Sealey said. "Some nurses said, 'I don't know,' and some said, 'Yes.' There was a lot of uncertainty and a lack of urgency."

Sealey said that when Chatman noticed that her granddaughter's oxygen levels were dangerously low, she called for help.

But Jahi went into cardiac arrest. The medical staff performed chest compressions to revive her and gave her clotting medications, but nothing worked.

The girl's brain was severely injured by lack of oxygen.  I am not commenting on the reported dispute regarding removing life support.

I am commenting on my concern about a possible contributory role of a new EHR.

At my Jan. 2, 2014 post "Doctors' Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems" (http://hcrenewal.blogspot.com/2014/01/doctors-dissatisfaction-with-ehrs-may.html) I wrote of the distractions that physicians reported were caused by EHR systems such as:

... current EHR technology interferes with face-to-face discussions with patients; requires physicians to spend too much time performing clerical work; and degrades the accuracy of medical records by encouraging template-generated doctors' notes.

I had also noted nurse's concerns of "inevitable" patient injury due to EHR distractions, such as at:

•  My July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" (http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html),

• my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, 

• my June 19, 2013 post "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" (http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html),  

• and at other posts citing similar nursing complaints.

The cases cited above involve the "EPIC" EHR, but similar issues arise will most of the current EHR sellers' products, which are unregulated.  

For instance see the ECRI Institute's Deep Dive study of EHR risk at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html. In a volunteer study (i.e., only a fraction of true incidents reported) of 36 ECRI PSO hospitals, 171 EHR-related "events" serious enough to cause harm were voluntarily reported in just 9 weeks.  8 of the "health IT events" were reported to have resulted in patient harm, and 3 were possibly related to patient deaths.  

From a press release from nurses at Affinity Medical Center (Ohio) on the nature of the problems:

... 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.” ... I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

An open letter from nurses at an Ohio hospital, Affinity, on EHR "threats to patient safety."  Click to enlarge.

The EPIC EHR apparently had just recently "gone live" at Children's Hospital Oakland.

From  "Children's Oakland completes Phase 1 of $89 million electronic records system", Nov 20, 2013 (http://www.bizjournals.com/sanfrancisco/blog/2013/11/childrens-oakland-89m-emr.html):

Children's Hospital & Research Center Oakland has completed the first phase of an $89 million Epic Systems Corp. electronic health records system that links inpatient operations and an oncology/hematology clinic.

Other outpatient clinics are expected to come online in March or April, spokeswoman Melinda Krigel told the Business Times.

... The project's overall cost, $89 million, includes hardware, software and other implementation costs, including a separate SoftLab system that interfaces with the main electronic medical records system, Krigel said.

The official "go-live" date was Nov. 5.

See also the Children's Hospital Oakland Annual Report at http://www.chofoundation.org/assets/files/2012-annual-report.pdf.  On page 21: 

... The Epic system will launch in November 2013 at Children’s inpatient facilities as well as in the Operating Room, the Emergency Department, the Day Hospital, and the Oncology/ Hematology Clinic.

I believe the possibility of clinicians being so distracted by computer data entry duties, and/or communications being impaired by the system's outputs, that this patient was left anoxic for a crucial period of time needs to be investigated.

In my view, in the differential diagnosis of clinical chaos in 2014, the chaos caused by healthcare IT needs to be a consideration.

My concerns may be shown unfounded in this case (I hope they are), and the injuries the result of other factors.  In consideration of the reported complaints from other organizations, however, not conducting an impartial investigating of a role of the new EHR in this tragedy would be, in my opinion, cavalier.

-- SS 

Jan. 5, 2014 Addendum:

From a court document cached here:  http://www.cci.drexel.edu/faculty/ssilverstein/1230rrr.pdf , the following is written at p. 11-12:

... Originally the surgery was uneventful and MCMATH awoke from sedation in the recovery room speaking with hermother, Petitioner LATASHA WINKFIELD asking for a popsicle.  MCMATH was taken to the ICU and her mother was told to wait several minutes while they fixed her IV.

After being told several times that it would be just another 10 minutes, approximately 25-45 minutes after MCMATH was brought into the ICU, WINKFIELD went back and found her daughter sitting up in bed bleeding from her mouth.  It was evident that this had been transpiring for some time.  The nursing staff said “it was normal” and the mother stayed at the bedside as the bleeding grew increasingly worse.  The nurses gave WINKFIELD a cup/catch basin for MCMATH to bleed from her mouth into.  WINKFIELD asked for assistance and was told that this was normal and was given paper towels to clean the blood off herself and MCMATH.

The bleeding intensified to where copious amounts of blood were being expelled from MCMATH’s mouth and then nose.  MCMATH’s stepfather was also present and assisted in the attemps to stem/collect the blood.

Again, WINKFIELD asked for assistance, and a doctor, and was only given a bigger container to collect the blood and, later, a suction device to suction the increasing volume of blood.  The stepfather continued to suction while the mother went and got her mother, a nurse, to take over for her.  The grandmother saw what was happening and made multiple requests, and then a loud demand, for a doctor.

MCMATH shortly thereafter suffered a heart attack and fell into a comatose state.  She later was pronounced “brain dead”… 

"Heart attack" (i.e., primary myocardial infarction) in a 13-year-old sounds far less likely than exsanguination to the point of hypovolemic shock, severe hypotension, and cardiac arrest.  That such events transpired in an ICU, with family present and calling for help, suggests there were major clinician distractions of some sort at play.

A reader wrote me wondering if a new CPOE component could have caused delays in evaluation and treatment. When someone is dying, you simply cannot waste time 'clicking away', they wrote.

A reader also wrote me wondering if an EHR crash occurred at the time this patient was left with family to exsanguinate, causing clinical chaos.

That is a particularly interesting thought.  See the multiple posts at http://hcrenewal.blogspot.com/search?q=ehr+crash. 

In my opinion, these issues require investigation.

-- SS

Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (http://www.affinitymedicalcenter.com/) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.

See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples), and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html, along with links therein to other similar situations.

Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.

Here's the latest at Affinity Medical Center - an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013.  Images and text below:

Page 1 - click to enlarge (text is below)

Page 2 - click to enlarge (text is below)

The letter to the CNO states (emphases and comments in red italics are mine):

August 15, 2013

Mr. Osterman,

Nurses at Affinity Medical Center are pleased to see that you have responded to our request and provided additional Cerner education classes, but education was only one of many concerns. [I note that education cannot compensate for the toxic effects of bad health IT that is poorly designed and/or poorly implemented, and that it's legally the responsibility of a hospital to ensure all apparatuses implemented and the environment of care are themselves safe - ed.]

Since the implementation nurses throughout the hospital have brought many serious concerns to the attention of both yourself and other supervisors.  When nurses have reported these concerns they have been either ignored or dismissed. It is distressing that Affinity would so blatantly disregard the concern of their RN staff surrounding issues that concern patient safety.  It is clear to direct-care RNs that many of the problems that exist with Cerner are a direct result of the failure to include nurses in the planning stages. [Exclusion of enduser domain experts from health IT development, in 2013, is grossly negligent IMO - ed.]

Some of the concerns that nurses have brought to the attention of management include:

• Medication errors/scanning issues - perhaps the biggest concern of all RNs 
• RNs unable to access patient records for hours at  a time
• Incorrect descriptors and inaccurate drop-down menus
• Incorrect calculations in the I&O [fluid input and output, especially important in very ill patients - ed.] and MAP [mean arterial pressure, used to calculate drip rates of potent drugs that raise or lower blood pressure in critical care, among other things - ed.] portions of the chart 
• Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly
• Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency 

[It should be apparent that these 'issues' - some due to fundamental design flaws - are quite serious in terms of the harm they can cause, even with the exceptional and stressful RN hyper-vigilance their presence necessitates- ed.]
 
These threats to patient safety cannot continue.  It is only a matter of time before a communication error or a medication error lead to a serious complication for a patient.  These types of errors have the ability to harm every patient and must be addressed immediately. 

[This is not theoretical or unlikely.  Such an error led to my own mother's crippling injuries and death, and to injuries and deaths in numerous other cases of which I am aware through my legal work - ed.]

We ask that you set up a meeting with a delegation of RNs from our Facility Bargaining Council to discuss the concerns that nurses have documented on 'Technology Despite Objection' forms [complaint forms about use of technology with objections - ed.] and make a plan to fix these life-threatening problems.

You may set up a meeting by contacting Pam Gardner, RN at [redacted] or our National Representative  Michelle Mahon, RN.  [For the National Nurses United labor union, http://www.nationalnursesunited.org/, with close to 185,000 members nationwide - ed.]  We look forward to hearing from you.

The letter is followed by the signatures of about 70 nurses.

I am informed by a Union rep in mid-November 2013, 3 months after the date of this letter, that (emphasis mine):

Nurses there are continuing to document the problems and concerns that they are experiencing.  I have attached a letter sent to the CNO at Affinity signed by nearly 70 RNs.  This is a pretty significant number of nurses especially in light of the fact that managers stole the circulating letter two times to prevent nurses from signing on.  The response to this letter was…….nothing.  The nurses have been ignored yet again. [Ellipsis in the original, I did not redact - ed.] 

It is clear the administration of this healthcare system has been explicitly put on notice of likely if not imminent danger to patients by multiple qualified experts, its own RNs.  If they do not act and patient harm occurs, it is my belief criminal negligence charges could be merited.

I also highly doubt patients are informed of these EHR system 'issues' and have been afforded the opportunity to give informed consent to the use of these computer systems in their care, or to go elsewhere for treatment.

These problems are repeating themselves over and over across this country and others, but many clinicians, especially those not protected to some degree by a labor union, do not speak out due to fear of retaliation.

Let's hope the nurses who signed this letter don't get their complaints plastered to their foreheads, as some were threatened with as in the aforementioned post.

-- SS

How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!

At my June 19, 2013 post "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" (http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html) I noted what appeared to be an imperial hospital leadership recklessly and negligently ignoring their own nurses' concerns about safety of a new EHR system implementation.

Now there's this at IndeOnline.com:

"Judge orders Affinity to bargain with union" (http://www.indeonline.com/news/x1808710525/Judge-orders-Affinity-to-bargain-with-union?zc_p=1)

CANTON (OH) — July 2, 2013

A judge ruled Affinity Medical Center violated federal labor laws and ordered the hospital to bargain with the registered nurses’ union and reinstate a nurse fired for union activity.

Affinity says it will appeal the decision.

National Labor Relations Board Administrative Law Judge Arthur Amchan issued a 36-page ruling Monday based on a hearings held April 29 through May 5 in Cleveland.

The National Nurses Organizing Committee-Ohio, an affiliate of National Nurses United, filed several labor complaints against Affinity and its parent company, Community Health Systems. The complaints cited the hospital’s refusal to bargain with the union, which was certified last year.

... The judge ordered the hospital to reinstate Ann Wayt, an orthopedic nurse for 23 years, with back pay and restitution of benefit or pension losses, and withdraw efforts to have Wayt’s nursing license pulled by the Ohio State Board of Nursing. Wayt was fired in September and never had been disciplined before that month.

“I was confident that the truth would come out,” Wayt said in a statement. “The judge has spoken for me. I want to thank the community, the nurses at Affinity, and the nurses across the country for their support.”

The judge also ordered the hospital to stop firing, disciplining or otherwise discriminating against other registered nurses.

Mentioned in the article is this:

The judge also ruled that the hospital must end threats and other acts of retaliation against nurses who submit objection forms to the employer documenting assignments they believe are unsafe. The hospital also must stop denying access to the hospital of union representatives ... Two weeks ago, nurses filed an unfair labor practice charge with the NLRB after requesting that the hospital delay a launch of the new electronic health record system, citing inadequate training and short staffing.

The nurses began to file objection forms related to the EHR.

What really caught my eye was this:

... In his ruling, the judge found one Affinity manager violated labor laws by threatening to plaster the objection forms on the forehead of any employee who submitted one. That same manager also began scrutinizing patient charts more closely, stated how much she would enjoy disciplining a prominent union supporter and retaliated against employees by reducing the number of nurses in the intensive-care unit [to make others work harder, patient safety be damned, apparently - ed.], according to the ruling.

I dislike stating the obvious, but this manager, a clear bully, is a danger to patient safety and clinician esprit de corps, and needs - at best - sensitivity training, ethics education and perhaps a psychiatric exam.

-- SS

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 http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, 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 http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF.

(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 http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html.  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

mmahon@nationalnursesunited.org

234-207-6706

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 http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html) - 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