Archive for the ‘Infection control’ Category

Report Card on Failing Hospitals: Prince George’s Hospital Center Tops ‘Complications’ List

Tuesday, April 12th, 2011

From the Editor (Brian Nash):

The following is the first of many blogs-to-come by our new associate lawyer, Jason Penn. Read about Jason’s background and enjoy reading his first venture into the blogosphere of medicine-law-healthcare.

By: Jason Penn

Prince George’s Hospital Center finds itself at the top of yet another dubious list.  With 4 out of every 1,000 patients experiencing a complication, Prince George’s Hospital has failed to meet a target for the prevention of complications set by the Maryland Health Services Cost Review Commission.

The penalty for Prince George’s Hospital?  The hospital’s ‘rate increase’– or how much the hospital can charge for services rendered — will be lowered by $890,000 for next year.  The State uses a payment-related methodology to reduce the frequency of hospital-based complications.  The State of Maryland has the authority to establish hospital payment levels applicable to both private insurance companies and public insurers such as Medicare and Medicaid.  The methodology links payments to hospital performance on a list of 52 acquired conditions.  These conditions are complications that are unlikely to be a consequence of the natural progression of an underlying disease.  The program seeks to eliminate some of the most serious and injurious patient complications in Maryland’s 47 acute care hospitals:  bed sores, infections, accidental punctures or cuts during medical procedures, strokes, falls, delivery with placental complications, obstetrical hemorrhage without transfusion, septicemia, collapsed lungs and kidney failure.

The Maryland Hospital Acquired Conditions Initiative, begun in 2009, is an effort to tie financial incentives and penalties to how well hospitals perform in reducing life threatening, dangerous and preventable complications.  Maryland’s motivation in starting the initiative is not pure; rather, as the Commission’s name suggests, it is a cost savings measure.  Patient safety taking an apparent backseat, the Commission recognized that many of the complications that occur in the hospital setting are costly, to the tune of $521 million in 2010.

Prince George’s Hospital Center is not alone, however.  Eight other Maryland and Washington D.C. area hospitals will face penalties for complications.  Doctors Community, Washington Adventist, Montgomery General, Shady Grove Adventist, University of Maryland Medical Center, St. Joseph Medical Center, and Civista Medical Center of Cumberland, Maryland have been penalized due to their failure to meet targets for the prevention of complications.  Those hospitals will lose a combined $2.1 million in the amount they can charge patients, according to a story first reported by Kaiser Health News.

The Commission’s Executive Director Robert Murray noted in a news release that in fiscal year 2008, the Commission estimated preventable, hospital-based complications were seen in “55,000 of the State’s total 800,000 inpatient cases,” representing $522 million in hospital payments that could have potentially been avoided.  The number of complications is staggering:  The University of Maryland Medical System had an observed number of complications of 1223 cases; Prince Georges Hospital had 553; while Montgomery General Hospital had 304 listed.  All three hospitals were worse than the state average.

In the original Kaiser Health article, Mr. John O’Brien, president of Prince George’s Hospital noted that “the problem mainly lies in how the hospital tracks, codes and reports data, not in patient care.”

One thing seems certain – Prince George’s Hospital is failing.  The numbers certainly suggest that it is failing in its patient care responsibilities yet Mr. O’Brien reports that it is merely a “failure of its tracking system.”  If, theoretically, it is as Mr. O’Brien says – that the tracking system is faulty, how does he conclude that the system is creating false positives and is not underreporting the errors?  The common thread is clear.  Prince George’s and other local hospitals are failing, either at tracking untoward events or at patient care and likely injuring their patients in the process.

The truly frightening aspect is that there are an untold number of patients that were irreparably harmed by these complications.  At first blush, the State’s attempt is laudable, clearly designed to hit the hospitals in their wallets for its misgivings.  The penalties notwithstanding, the State’s initiative offers no mechanism to compensate the victims of these hospital complications.  Every indication is that the injured patients and their advocates are left to pursue alternative avenues to obtain compensation for these so-called “complications.”


Spinal Epidural Abscess: A basic primer

Friday, March 11th, 2011

Epidural abscess compressing the spinal cord -courtesy of

In a previous blog, I introduced the topic of neck and back pain which can have a host of causes, most of which are mechanical.  This blog attempts to explore an infectious etiology of neck and back pain that can be potentially devastating, resulting in paralysis and even death.

The spine is a complicated structure involving bones, discs, ligaments, muscles, blood vessels and nerves.  It’s two main functions are to provide axial support for the upright stature of the human body and fluid movement of the body parts while also protecting or housing a critical component of the central nervous system, the spinal cord. Oversimplified, the spinal cord is a conglomeration of nerve fibers that act as the “information highway” between the peripheral nerves supplying sensory and motor function to the body parts and the brain. The spinal cord transmits chemical messages from the brain, telling the body what to do and how to function, even functions we are not conscious of doing (digestion, breathing, etc.), and it receives input from all of our senses and interprets the data.  Without the spinal cord or if the spinal cord is affected by an injury, there is disconnect; we lose feeling and movement as well as control of some of our normal unconscious body functions.  The location of the spinal cord damage dictates the level at which the disconnect occurs.  To help you understand the anatomy of the spine, here’s a short video describing the basic anatomy of the spine.



An epidural abscess is a collection of pus that occurs as the result of an infectious process involving any part of the  spinal cord from the base of the head to the tailbone; the abscess is located within the protective boney compartment housing the spinal cord, the spinal canal, and the thick outer covering of the spinal cord, the dura.  The dura is comprised of 3 layers, the outer one being very tough, the middle one being very vascular, and the inner one being very “tender.”

Signs and Symptoms:

In the early stages of the infection, a patient will often complain of neck or back pain very specific to the location of the infection, but the pain can be referred due to nerve root irritation.  As the infection grows, it spreads along the axial plane of the spinal canal, but the pressure and swelling of the purulent collection also tends to compress the spinal cord, resulting in numbness, tingling and functional loss below the level of the compression.  This progression can be indolent or rapid, depending on both the virulence of the pathogen and the person’s immune system.  Without emergent treatment, the pus collection can “choke off” the spinal cord and its blood supply, leading to permanent spinal cord injury and paralysis.

How does the infection get there?

Patients who have undergone spinal surgery are at an increased risk of these types of infections, especially during the immediate post-operative period.  Surgical wounds can become infected allowing bacteria to track deep into the tissues and the spine through the operative plane.  If hardware (spinal instrumentation) has been used, these man-made devices become reservoirs or fomites for attachment of the bacteria, and it is extremely difficult to eradicate bacterial pathogens from the hardware.

The bloodstream is another source of migration for bacterial pathogens from peripheral sites (infected gums, endocarditis, bladder infection, skin abscesses/boils) to the spine.  Individuals particularly at risk are those with depleted immune systems (e.g. diabetics, patients with auto-immune diseases on chronic steroids, HIV, etc.) and IV drug abusers (directly inject materials into veins).  Having spinal hardware from a previous spine surgery will increase the risk of seeding to that instrumented site should bacteria become blood-borne.

Direct inoculation can occur if  poor technique is utilized during epidural spinal injections or epidural anaesthesia.  There can also be contiguous spread from adjacent infected tissues (e.g. diskitis, osteomyelitis).

What are the most common pathogens?

Staph aureus, a common skin pathogen, is the most common cause.  It is known to cause skin abscesses/boils, wound infections, sinus infections, bladder infections and even pneumonia!  The relatively recent incidence of MRSA (a very resistent variety of Staph aureus) in the community has changed the way medicine treats common skin ailments; its effect on the incidence and treatment of epidural abscesses has yet to be determined.  If an epidural abscess is suspected, antibiotic coverage for MRSA is now automatically included in the initial treatment due to the bacterial virulence and resistance to treatment.

E. coli ( a common bowel pathogen and cause of bladder infection), fungi (like yeast), and even Mycobacterium tuberculosis are also causes of epidural abscess.  One can also contract mixed infections with aerobic and anaerobic bacteria, depending on the source of the infection (intra-abdominal abscess, perforated appendix).

How is an epidural abscess diagnosed?

The clinician must have a high index of suspicion and keep an open mind.  A thorough history often leads to clues such as recent fevers, a recent skin abscess or cellulitis, IV drug abuse, recent dental extraction or procedure, and neck or back pain without a specific inciting incident.  Physical examination of the patient often reveals point tenderness directly over the affected area of the spine, worse with percussion or tapping on the boney prominences, and often worse in the recumbent position.

Visualization of the spine is best accomplished with an MRI of the spine (above, below and including the tender area); it is non-invasive and very detailed regarding the soft tissues.  Patient weight can be a factor in accessing these machines; they often have a maximum weight limit of 300 lbs.  Many morbidly obese patients, who often have type II diabetes, are at risk for epidural abscesses; they often have to be transported to external facilities for “open MRI” studies.  Claustrophobia can also be a restricting factor, often requiring patient sedation or anaesthesia.  Excruciating pain while lying flat can also be prohibitive.  An alternative study to visualize the spinal cord is a CT-myelogram during which the epidural space is accessed with a spinal needle and dye is injected for visualization under computed tomography.  The CT-myelogram is a higher-risk study and can also be limited by a patient’s weight and sensitivity to contrast dye.  A lumbar puncture should NOT be done since it can lead to spinal cord herniation and permanent spinal injury.

What is the treatment for an epidural abscess?

There are two schools of thought regarding treatment.  One school favors emergent surgical debridement of the abscess along with intravenous antibiotics; this also allows for identification and sensitivity testing of the organism.  The other school suggests that intravenous antibiotics alone can be sufficient if no signs of spinal cord impingement are present; if symptoms progress to the development of neurologic symptoms, then surgery becomes more urgent.

What is the prognosis in epidural abscess?

Prognosis depends on the patient’s underlying medical condition and the degree of spinal cord involvement at the time of diagnosis/intervention.  Obviously, the earlier the intervention and treatment, the better the prognosis; hence, I favor surgical debridement as soon as possible.  Delays in diagnosis often lead to permanent and life-altering neurologic damage and functional loss or even death.  These delays and the permanent neurologic sequellae suffered often become the basis for medical malpractice litigation.

FDA warning to healthcare professionals: use sterile prep pads!

Tuesday, February 8th, 2011

Sterile Prep Pads

On February 1, 2011, the FDA issues a News Release about the use of non-sterile alcohol prep pads in certain clinical situations.

“Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery.”

This reminder/warning was issued in the wake of a recall on January 5th of all lots of alcohol prep pads and swabs manufactured by The Triad Group of Hartland, Wisconsin citing concerns about the product’s potential contamination with Bacillus cereus, a bacterium that can be harmful to humans.

While I guess we all need reminders now and then, do healthcare professionals really use non-sterile pads for pre-procedure prep when sterile technique is called for? Isn’t this basic training?

We have heard over and over again about the problems with infection control in medical facilities. Isn’t this a basic way to improve infection control – using sterile prep pads when doing open or penetrating skin procedures? Oh my!

While we in law deal with the end-result of failures to use “sterile techniques” – including the basic concept of using sterile pads - is this really such a problem in the healthcare industry that the FDA needs to remind providers to use the right kind of pad?

A number of our readers are members of the healthcare profession. Tell us – please, is this really a problem in the industry? Are there not basic protocol, stock control, safety measures in place that deal with this apparent problem? The rest of our readers either have been a patient or have a family member who’s been a patient; have you ever encountered a problem with an infection because your provider used the wrong type of prep pad?

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Sepsis – Simple steps in ER saves lives

Thursday, October 7th, 2010

Following summer headlines citing extensive hospital deficiencies in screening a fatal illness known as sepsis, there is some good news out of Kaiser Permanente this week.

Sepsis as defined by Wikipedia as a serious medical condition affecting the whole body. As we know, it can even be fatal. Sepsis is caused when a harmful infectious organism invades the body. Invasion can occur through the blood, urine, lungs, skin, or body tissue. The body reacts with an inflammatory response that is characterized by fever or low body temperature, low blood pressure, and an increasing high white blood cell count.  In earlier times the condition was commonly called “blood poisoning”.

As the patient becomes sicker, the body becomes overwhelmed by an acid called lactate acid. It is formed as a result of lowered oxygen to organs and tissue resulting in a condition known as lactic acidosis. As the condition progresses, the body eventually can not overcome the acidosis and low tissue oxygen perfusion. Death ensues often despite aggressive medical treatment.

Kaiser reported 17 participating hospitals in Northern California began using a 6-step diagnostic and treatment tool known as a “sepsis bundle” in 2008 to rapidly diagnose and treat sepsis. Using this new tool and computerized medical records, Kaiser found the patient death rate improved significantly from 25% to 11%, the patients’ hospital stays were 3 days shorter, and $36 million was saved.

However, just the day before Kaiser released their data, another article in FierceHealthcare – daily news for healthcare executives - listed infections add an average 19 days to a hospital stay with a cost per patient of $43,000. This study was published by the Agency for Healthcare Research and Quality who concluded that 12% of all infections were classified as sepsis. Two months ago, Fierce Healthcare reported excerpts from new research published in the Archives of Surgery by a surgeon named Laura Moore practicing at Houston’s Methodist Hospital. Dr. Moore performed a retrospective review of 364,000 general surgery patients registered in the American College Of  Surgeons National Surgical Quality Improvement Database. Sepsis occurred in 2.3% totaling 8,372 patients.  She also wrote mortality from sepsis has doubled in the last 20 years. Sepsis is the leading cause of death in general surgery ICU’s.

In December 2008, the European Society of Critical Care Medicine, the International Sepsis Forum, and the Society of Critical Care Medicine launched the Surviving Sepsis Campaign. Sepsis is estimated to kill 1,400 people worldwide each day. Mortality rates from severe sepsis are rated as high as lung, breast, and colon cancer. The campaign wrote severe sepsis is expected to grow at 1.5 % annually with an additional 1 million cases per year in the USA by 2020. The campaign sited the cause for this is due to the aging population and increasing invasive medical procedures. HIV and cancer rates are increasing, which will also impact severe sepsis rates.

Sepsis varies greatly in its progression and symptoms seen in each patient. This makes early diagnosis and treatment challenging for even the best ICU physicians. Symptoms such as fever, rapid pulse rate, and respiratory difficulty are commonly seen in a host of other medical conditions. Obtaining an accurate diagnosis can take precious time. In an effort to improve the diagnosis and survival rates, the campaign challenged to USA hospitals to adopt and implement a “sepsis bundle” program and begin reducing mortality by 25% over the next 5 years.

So what is a sepsis bundle? The Surviving Sepsis Campaign chose medical therapies called “elements” designed to give physicians worldwide a framework to standardize sepsis practices. Their specific intent was to reduce the chaotic approaches seen in many clinical settings. The campaign founders consolidated world medical care data and practices that had shown clear positive impact on outcomes. They challenged critical care physicians to choose a grouping of these elements based on their patient population. Next,  physicians were to apply their individualized “sepsis treatment bundle” and  study the outcomes by using the campaign’s measurement database. By choosing to delete an element(s), the hospital would be classified as non-compliant and their performance data would likely show poorer outcomes.

In the sepsis resuscitation bundle, there were 5 critical elements. In the sepsis management bundle there were 4 elements.  So neither bundle is too complicated or intricate to put into medical practice. Now two years later, those early hospitals that accepted the challenge and implemented a sepsis bundle program are publishing their success data. Another fine example was published by Barry Evans, RN, MSN, Adult Critical Care Data Coordinator at the University of Rochester/Strong Health.

Kudos to Kaiser Permanente California, Strong Health, and all the other critical care services who accepted the 2008 challenge for US patients and are making it happen. Can’t wait to see the campaign’s worldwide end data in 2013!

Newborn Mortality Rate Significantly Higher in Home Births – Are Home Births Worth the Risk?

Friday, July 16th, 2010

A recent study published by the American Journal of Obstetrics & Gynecology suggests that there is a significant increase in the newborn mortality rate in cases of planned home births when compared to hospital deliveries. The study conducted by Joseph R. Wax. M.D. included data from 342,056 planned home births and 207,511 planned hospital deliveries. The data was collected from a number of industrialized Western nations. Researchers found that:

Although rare, newborn deaths occurred in 0.2% of the total planned home births included in the analysis, compared with 0.09% of the total planned hospital births. Among infants born without any birth defects, the rates were 0.15% vs. 0.04%, respectively.

These findings suggest that, in cases of home birth, the newborn mortality rate was almost twice as high when compared to hospital deliveries and almost tripled in cases involving newborns with congenital abnormalities. One explanation for these findings is that newborns have less medical intervention, which can result in respiratory distress and failed resuscitation.

This data is particularly surprising considering that most women, who participated in home births, had fewer overall obstetrical risk factors (e.g., obesity, previous pregnancy/delivery complications, c- sections). Additionally, the study also suggests that while the newborn mortality rate increased in cases of home births, the mothers were less likely to develop a number of complications, including infections, perineal/vaginal lacerations, bleeding, and retained placentas.

For many women, the decision to proceed with a home birth vs. a hospital delivery is not an easy one. It is usually motivated by a number of factors, such as preconceived notions about medical care, family history, and opinions regarding c-sections, among many other things. If you are expecting, whatever you do, make an educated decision about your delivery.

New federal study finds ‘lax infection control’ at same-day surgery centers

Tuesday, June 15th, 2010

There was an astounding report in last week’s Yahoo! News concerning a new federal report advising that recent investigations of same-day or ambulatory surgical centers (ASC’s) in this country revealed many of these surgi-centers have ‘serious problems’ with infection control.  

“These are basic fundamentals of infection control, things like cleaning your hands, cleaning surfaces in patient care areas,” said lead author Dr. Melissa Schaefer of the Centers for Disease Control and Prevention. “It’s all surprising and somewhat disappointing.”

According to Yahoo! News, the inspections were performed at 68 ambulatory surgical-centers in Maryland, North Carolina and Oklahoma. Using new audit tools, inspectors followed at least one patient throughout the visit. Their findings: 67% of the centers had at least one ‘lapse’ in infection control; 57% of these centers were cited for ‘deficiencies.’

What is even more shocking is that some of the centers that were visited had not been inspected in 12 years!

State agencies have the main responsibility for making sure centers comply with  federal standards, but states often fall behind.

Just how difficult or complicated are these ‘federal infection controls’? They are available online at the Electronic Code of Federal Regulations. Section 416.51 is the relevant section of Title 42: Public Health.

(a) Standard: Sanitary environment. The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

These acceptable standards are set-out in a host of available resources. Perhaps the best known of these are the Heathcare Infection Control Guidelines of the CDC’s Advisory Committee (HICPAC).

Apparently, it would serve many of these ASC’s – among others – to read them – or – if they have read them, to follow them!