A Case of Disclosure

From 1987 to early 2003, while I was chief of staff at the Lexington, KY VA Medical Center, we instituted a policy of full disclosure and fair negotiated compensation to anyone who had been injured by a medical error. No discretion was allowed and no case was too big or too small. It started without advance planning or training. We just did what was right and kept the patient at the center and didn’t stop until the patient was made whole (to the extent possible). Although I retired from the VA in 2003 (practicing now at the University of Kentucky) please don’t conclude that the VA policy ended then. It’s just that I can only vouch for what happened during the years mentioned above. We have previously described this program < http://annals.org/article.aspx?articleid=713181 >. In this short blog, I’d like to give a previously unpublished example illustrating how we operated. This was not a typical case and some readers might ask why we didn’t just let it alone. I will leave some clinical facts vague to avoid identification of the involved parties.

A man was admitted overnight for an oral surgery procedure. The surgery went well and the patient was discharged to the care of a relative the following day. He and his relative were instructed verbally and in writing how to care for the surgical site and what to do, and avoid doing, in the days following the operation. Within hours of discharge, the patient visited a bar and became drunk. The surgical site began bleeding profusely and he was returned emergently to the hospital having lost significant blood. Despite the efforts of the clinical staff, the patient died of complications a few days later.

On the surface, we first saw this as a case of extreme carelessness on the part of the patient who, by knowingly ignoring his post-operative instructions, caused his own death. However, we found evidence in his medical record that his alcoholism was known as was a past history of non-compliance. So, we assembled all the clinical staff involved in his case and asked whether they thought his care was appropriate or could have been handled better. I was somewhat anxious before this meeting, anticipating that the clinicians who had tried their best to treat this patient only to have it fall apart because of his irresponsible actions would perceive that they were being somehow blamed for the whole thing. Nevertheless, by the end of the meeting, the clinicians had acknowledged that they had known that the patient was poorly compliant and had an alcohol problem but they had nevertheless treated him as though he were an ordinary patient. They agreed that there had been other options and, on hindsight, could have declined to perform the procedure at all (it was elective) or could have done it and kept him hospitalized through the immediate postoperative period. Without letting the patient off the hook, they took some of the responsibility for the awful result that left a widow without a source of income.

Subsequent to this meeting, we contacted the widow, disclosed our findings and arranged to meet and negotiate a compensation amount based on the estimated monetary loss without losing sight of the patient’s shared responsibility. We believed that it was fair and a court would likely have seen it in a similar way.

It would have been so easy to let this thing lie. After all, it wasn’t really a medical error. The operation was indicated; there was no wrong site surgery, retained sponge or incorrect medication. The surgeons were qualified, skilled, and the trainees were well-supervised. But there was an error in judgement in that the staff hadn’t considered the patient’s known unreliability regarding his own care. Looking back at this, they recognized the lapse.

Medicine is hard and a doctor can feel like a juggler having to keep anything thrown at him in the air; balls, knives, water balloons; no errors allowed. But errors do happen inevitably and when they do, we mustn’t give ourselves a pass but instead admit the error, take care of the patient, cooperate in trying to make the patient or surviving relative whole, correct the systems or practices that contributed to the error and then move on without beating ourselves up. Hospital administrators and risk managers should take the lead to assure that communication is honest and complete and that everyone, including the clinicians, are cared for.

Can We Reduce Harm from Medical Care Itself?

M. Joycelyn Elders, MD – Former U.S. Surgeon General

When medical care itself goes awry, death and disability are absolutely the most awful outcomes that can happen. However, there are other significant losses.  The trust of patients in doctors, other health professionals, hospitals, and medical care itself can be diminished.   Doctors and medical staff can have their own doubt and disappointment in medical systems and in themselves.

Medical errors are significant problems in US hospitals.  There are too many; they occur too often, and many are preventable.

Medical errors are preventable events which either causes patient harm (an adverse event) or could have led to harm (a near-miss).  An adverse event occurs when patient receives medical care which causes harm to the patient. Adverse events are both preventable and non-preventable.  Ones which could have been prevented are considered medical errors.  Medical errors which can cause adverse events include an inaccurate or missed diagnosis of a disease, over treatment, physical or psychological injury, infections, pharmaceutical error and any other ailment which causes, pain, disability or requires further treatment.

Medical errors can occur anywhere in the healthcare system – hospitals, clinics, surgery centers, nursing homes, dialysis centers, pharmacies, or patient homes.  It may involve medical treatment, surgery, diagnosis, pharmacy, equipment, lab reports or other.  One in seven Medicare patients in hospitals experiences a medical error.(1)  There are numerous problems that occur too frequently during hospital stays, such as “adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, suicides, restraint-related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities” (IOM Report, 2000, Ref. 2).

It all adds up, resulting in 10 percent of all US deaths being due to or associated with medical errors.

Medical errors are the third leading cause of death in the US(3, 4, 5).  Only heart disease and cancer exceed the number of deaths caused by medical error.

The National Institute of Medicine Report in 1999, “To Err Is Human” stated that 98,000 hospital patients die each year from preventable medical errors.(2)  Other more recent reports suggest that the number may be over 200,000 (3, 4, 5) or even as high as 400,000 (5) , based on the point estimates.  There are 35,416,020 hospital admissions each year.  The point estimate for the data is 0.71 percent of all hospital admissions die (6)

In addition to the approximately 1000 deaths per day in hospitals around the US, there are about 10,000 cases of serious complications resulting from medical errors that occur each day.

Medical errors cost this country a staggering amount – billions of dollars each year in hospitals nationwide, which includes the expense of additional medical care, lost productivity at work and home, disability and premature death, lost income and household productivity, and disability. (6)

The aim is to increase patient safety in American hospitals, and to get to “0” harm.  In order to get to “0,” we must know how to prevent harm.  In order to have a safety culture, we must have a:
•    A culture of open reporting,
•    A just culture,
•    A learning culture and 4) An informed culture.
The key to safety is to collaborate, be transparent, and be consistent.  In order to be transparent, we must:
•    Have early learning,
•    Steal good ideas and share them,
•    Work as partners,
•    Mentor and all be teachers and
•    All be learners.  We must have early prevention training, high reliability, accept human errors and medical errors. Respond quickly. We have to be timely, standardized, and have a quick response.  Be optimistic.  Focus on safety.

There are significant problems, such as ideology.  Ideology is multifactorial. Acknowledge that errors happen.  Recognize that they happen.  Share in the fact that they happen.  Be transparent. Hospitals must be willing to commit resources to reduce errors.  We all must speak up for safety and error prevention.

The incidence of death by medical errors is the equivalent of one 747 jet airplane crashing every day with no survivors.  Put in that way, we would all be aghast at the loss; people would be demanding attention to the problem.  But the loss due to medical errors is quiet and isolated, one location at a time, one person at a time 187,000 to 400,000 times per year.

While to err is indeed human, and to forgive may be divine, in this case it is time for us to stop Americans from having to forgive so many medical errors.  It is up to medical professionals to recognize the enormous loss and get to work to eradicate death and disability due to medical error.


  1.  Department of Health and Human Services, Office of the Inspector General. Adverse Events in Hospitals: National Incidence among Medicare Beneficiaries. Washington, DC; 2010, Available at:  http://oig.hhs.gov/oei/reports/OEI-06-09-00090.pdf
  2. Kohn LT, Corrigan JM, and Donaldson MS, Editors; Committee on Quality of Health Care in America; Institute of Medicine  Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press, 2000. doi:10.17226/9728.  http://www.nap.edu/catalog/9728/to-err-is-human-building-a-safer-health-system
  3. Makary, M.A., Daniel, M. “Medical error—the third leading cause of death in the US.” BMJ 2016;353:i2139
  4. The Leap Frog Group. About the score.   http://www.hospitalsafetyscore.org/your-hospitals-safety-score/about-the-score
  5. James JT. A new, evidence-based estimate of patient harms associated with hospital care.  J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.  Accessed from http://journals.lww.com/journalpatientsafety/Fulltext/2013/09000/A_New,_Evidence_based_Estimate_of_Patient_Harms.2.aspx
  6. Healthcare IT News. Erin McCann. “Deaths by Medical Mistakes Hit Records.” July 18, 2014.  http://www.healthcareitnews.com/news/deaths-by-medical-mistakes-hit-recordshttp://www.healthcareitnews.com/news/deaths-by-medical-mistakes-hit-records, accessed on July 18, 2016.

The incidence of MRSA infections in the United States: is a more comprehensive tracking system needed?

The effectiveness of MRSA control strategies in the United States is unclear due to discrepancies in the systems used to track MRSA infections, according to  a recent article published in Antimicrobial Resistance & Infection Control. Dr. Kevin Kavanagh, Board Chairman of Health Watch USA  and a team of policy researchers reviewed various tracking systems used in the United States to monitor MRSA infection rates.

The researchers found that the tracking systems gave conflicting results because they studied data that had different baselines, and were from differing patient populations, geographic areas and healthcare systems.

Data from the National Healthcare Safety Network (NHSN) for 2015 (last year data is available) showed an increase in the rate of MRSA infections, which approximated the 2010 to 2011 baseline rate, while Veterans Health Administration (VA) hospitals reported excellent control, with over an 80% reduction in MRSA infections.

The VA tracking system is not comparable to that of the NHSN and the VA does not report to the NHSN. Smaller, rural hospitals are not required to use the NHSN, so their data may be missed.  In addition, the NHSN only measures bloodstream infections, a subset of total MRSA infections.

Dr Kavanagh said: “Even though the observed increase according to the NHSN data may be artifactual due to changes in the tracking method, the United States is nowhere near on track for meeting the 2020 U.S. Dept. of Health and Human Services’ goal of a 50% reduction.”

Firm and effective mandates are needed to control MRSA.  Two which have been extensively discussed in the literature are universal chlorhexidine bathing versus screening and isolation/decolonization. Many facilities are implementing universal bathing along with hand hygiene to control MRSA.  The VA uses a methodology which also stresses hand hygiene but in addition implements facility-wide surveillance and isolation of MRSA carriers.

Dr Kavanagh said: “Hand washing is an important intervention, but it is not the most important in preventing the spread of MRSA.  In many ways it is a backup measure.  If a staff member’s hands at any time becomes contaminated with MRSA, then there has already been a failure in containment and control and without an effective tracking system determining the comparative effectiveness of the two interventions will be difficult at best.”

A comprehensive well-functioning tracking system which encompasses all types of healthcare facilities is also needed to monitor for the emergence of new antibiotics resistant organisms. Facilities will need to commit significant resources to patient safety, as well as provide and support adequate staffing to implement effective infection control, according to the authors.

The article can be downloaded from:   https://aricjournal.biomedcentral.com/articles/10.1186/s13756-017-0193-0

Preventable Hospital-Related Mortality Approximates 200,000 Each Year

In a recent article published in the Journal of Patient Safety, patient advocates stress that the patient context (age, illness and life choices) should be dissociated from medical errors and preventable mortality and not used as reasons to mitigate their occurrence.   In addition, all too often, studies regarding health system performance in other countries, such as Canada and England with centrally controlled, uniform healthcare systems are extrapolated to the disjointed non-centralized system of the United States.

Dr. Kevin Kavanagh, lead author and Board Chairman of Health Watch USA, stressed that their calculations of preventable hospital-related mortality were based upon two well-controlled studies and are in line with other researchers.  The authors’ calculated an annual rate of 163,156 preventable hospital deaths each year in the United States. When combined with diagnostic errors, non-captured events and deaths after hospitalization, it can be projected to approximate 200,000 preventable deaths annually, which is inline with a number of other studies.

The authors’ stated: “Advocates are not calling to prevent problems for which solutions are not known but calling to implement known solutions to prevent all too common problems.  What ties the occurrence of preventable adverse events and mortality together is the willingness and determination of facilities to adopt a culture of safety and invest in patient safety.”

“Even if the (preventable hospital mortality) rate from medical errors is not the 163,156 that we have projected but is as low as the 25,000 per year based on the United Kingdom’s NHS data, that equates to approximately 5 potentially preventable deaths per year per hospital in the United States or 1 every 2 to 3 months. In addition, one could argue that this figure should be doubled by accounting for deaths from diagnostic errors. In what other industry would such a record be tolerated, let alone defended? Would the airline industry and public ever tolerate even a single preventable airline crash?  We can and must do better.”

View YouTube Video:  https://youtu.be/ktjh8EmO9QU 

Download Journal of Patient Safety article regarding preventable hospital mortality:

Preoperative Patient & Surgeon Mutual Protection Agreement

Enhancing Patient & Occupational Safety and Reducing Professional Liability:

According to the CDC, sharps injuries and exposure to blood and blood-borne pathogens during surgery are alarmingly frequent events, occurring approximately 1000 times per day in the United States.1 Because these adverse events are mostly preventable by the use of safety engineered surgical devices and safe surgical techniques, they should be viewed as never eventswhich pose a serious occupational health risk for surgical care providers and for patients who may become infected. In fact, multiple instances of transmission of HIV, hepatitis C, hepatitis B and other infections have been documented following exposure of surgical care providers and patients to each others blood.2,3,4,5

Recognizing the need for the mutual protection of surgical care providers and patients, the American College of Surgeons has recommended that blunt tipped suture needles be used as the method of choice for closing fascia and muscle (incision closure).6 Every other surgical organization has endorsed this recommendation.7 This best safe practice, among others, is also mandated by federal regulations, including the Needlestick Safety and Prevention Act of 20008, OSHA, NIOSH, the CDC and the FDA. Prudent recommendations by surgical organizations include wearing two pair of gloves (double gloving) to prevent blood exposures, using a “Neutral Zone”, also known as “Safe Zone” or “Hands-free Passing”, for safer transfer of sharps between OR team members, instead of hand-to-hand passing, and using safety scalpels (scalpels with shielded or retracting blades) wherever possible (except where they may interfere with visibility of the operative site or otherwise compromise surgeon performance and patient care) and that all members of the surgical team wear appropriate personal protective equipment (eye and face protection, etc.).

In spite of these wide-ranging regulations and recommendations, compliance with these proven effective safe practices by surgical team members – especially surgeons – is sporadic at best.9 At a time when preventable medical harm to patients appears to be out of control and widely reported by the media, it seems appropriate that patients and patient safety advocates take steps to encourage surgeons to simultaneously protect their patients as well as themselves and their surgical team members. To that end, a novel variation of the standard surgical consent form has been developed by a coalition of surgeons, worker safety advocates and patient safety advocates The resulting “Preoperative Patient and Surgeon Mutual Protection Agreement” is designed to insure surgeons’ compliance with safe practices that protect everyone in the OR. Both the patient and the surgeon would receive a copy of the form signed by the surgeon.

Along with the protection afforded against exposure to bloodborne pathogens, additional stipulations of this safety, quality and compliance tool would have surgeons agree to: personally perform the proposed surgery (or specify who will perform which parts of the procedure), be board certified and credentialed to perform the procedure, be physically present during the surgical “time out” and personally mark the operative site(s), and attest to preoperatively explaining and discussing with the patient all alternatives to surgery, including the “wait and see” approach. Additionally, if a medical device is to be implanted, the surgeon would agree to supply the patient with the name, brand, serial number and manufacturer of the device, and if a non-hospital employee such as a device or pharmaceutical manufacturer representative is to be present during the procedure, the patient will be made aware, written permission will be obtained, and the names of the non-hospital employee and his/her employer will be provided.

Finally, if during the procedure there is an injury to the surgeon or anyone assisting the surgeon (collectively called “Care Providers”) involving a sharp instrument (a “sharps injury”) and the injured Care Provider’s hand re-contacts the patients tissues, both the patient and the injured Care Provider (surgeon or other assistant) would be tested for the blood borne pathogens HIV, hepatitis C and hepatitis B, and other pathogens where appropriate. Test results would be given to the patient and the injured care provider and would otherwise remain privileged and confidential; no one would share test results with anyone by any means of communication without the express written consent of the patient or care providers who were tested.

A prototype for the “Preoperative Patient and Surgeon Mutual Protection Agreement” referenced above is available for anyone’s inspection. Facilities could modify it to suit their particular needs. Widespread implementation of this tool would protect patients and care providers alike from preventable exposure to blood and bloodborne pathogens, reduce incorrect surgery and other medical errors, and limit professional liability through improved compliance with best safe practices

As Hippocrates suggested, the goal is to protect patients from preventable harm. This new tool does that while protecting surgical care providers from occupational risk and potential liability. This is clearly a win-win for patients, surgeons and facilities. Facility risk managers may reflexively take an opposing view but if they really think about it, the logical conclusion should be that it should be implemented expeditiously at every surgical facility. For more information on this “Preoperative Patient and Surgeon Mutual Protection Agreement” and to download a copy, go to www.healthwatchusa.org/surgeonsconsent/

Mark S. Davis, MD

Gynecologic Surgeon and Obstetrician
Author:  “Advanced Precautions for Today’s OR; The Operating Room Professional’s Handbook for the Prevention of Sharps Injuries and Bloodborne Exposures, 2015 Digital Edition” and
“Irresponsible: What Surgeons Won’t Tell You and How to Protect Yourself, 2015 Digital Edition”


1. CDC Estimate of Annual Sharps Injuries http://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html

2. Transmission of HIV Infection During Invasive Dental Procedures in Florida https://www.cdc.gov/mmwr/preview/mmwrhtml/00014428.htm

3. Probable transmission of HIV from an orthopedic surgeon to a patient in France. http://www.ncbi.nlm.nih.gov/pubmed/9890844

4. Transmission of HIV-1 from an obstetrician to a patient during a caesarean section. http://www.ncbi.nlm.nih.gov/pubmed/16511424

5. Transmission of hepatitis C virus by a cardiac surgeon. http://www.ncbi.nlm.nih.gov/pubmed/8569822

6. Statement on Sharps Safety – American College of Surgeons. https://www.facs.org/about-acs/statements/58-sharps-safety

7. Council on Surgical & Perioperative Safety

8. Needlestick Safety and Prevention Act https://www.osha.gov/needlesticks/needlefaq.html

9. Increase in sharps injuries in surgical settings versus nonsurgical settings after passage of national needlestick legislation.  http://www.ncbi.nlm.nih.gov/pubmed/20347743