The gamma knife is the best known system for radio surgery (RS). It allows non-invasive brain surgery to be performed in one session, with extreme precision. Based on preoperative radiological examinations, such as CT or MR scans and angiography, the gamma knife provides highly accurate irradiation of deep-seated targets in the brain, using a multitude of collimated beams of ionizing radiation with scalpel-like precision.

No surgical incision, no anesthesia
The uniqueness of the gamma knife (and RS surgery in general) is that no surgical incision is required. This serves to minimize risk to adjoining tissue, reduce the risk of surgical complications. It also eliminates the side effects and dangers of general anesthesia, which would be indispensable for the type of medical conditions it is used to target.
A gamma knife typically contains 201 cobalt-60 sources. Each is mounted in a circular array within a shielded system. The device aims gamma rays via a specialized helmet surgically fixed to the patient’s skull to a target point in the brain. The ‘blades’ of the gamma knife are the beams of gamma radiation programmed to target the lesion at the point where they intersect. In a single treatment session, beams of gamma radiation focus precisely on the lesion. Over time, most lesions slowly decrease in size and dissolve. The exposure is brief and only the tissue being treated receives a significant radiation dose, while the surrounding tissue remains unharmed.

Revolution for brain surgery
The gamma knife has revolutionized brain surgery. Over the last three decades, it has changed the landscape of neurosurgery – treating a range of conditions from brain tumours to vascular malformations with an unmatched level of accuracy. The gamma knife enables patients to undergo a non-invasive form of brain surgery without surgical risks, a long hospital stay or subsequent rehabilitation.
The gamma knife was officially named the Leksell gamma knife, after its lead inventor Lars Leksell, who developed the system in 1967 at the Karolinska Institute in Stockholm. Other key team members included Ladislau Steiner, a Romanian-born neurosurgeon and Borje Larsson, a radiobiologist from Sweden’s Uppsala University.

The CyberKnife
1990 saw the launch of another form of radio-surgical system based on linear accelerators. The best known of these is the CyberKnife, invented in the US by John R. Adler, a Stanford University Professor of Neurosurgery and Radiation Oncology. Unlike the gamma knife, the CyberKnife does not use radioisotopes. Instead, it uses a linear accelerator mounted on a moving arm to deliver X-rays, once again, to a very precise area. The CyberKnife does not use a frame to secure the patient. Instead, a computer monitors a patient’s position during treatment, using fluoroscopy. In other words, the CyberKnife allows for tracking a tumour, rather than fixing the patient. As it does away with a frame, its targets go beyond the brain.

Gamma knife and CyberKnife: Indications
Typically, a gamma knife is used to treat cancer that has metastasized to the brain from another part of the body, acoustic neuroma (a slow-growing tumour of the nerve connecting the ear and brain, pituitary tumours and non-cancerous brain tumours. Its application has also been extended to include certain blood vessel malformations, and fistulas, neuralgia and tremors due to Parkinson’s disease.

On its part, the different design of the CyberKnife allows it to also treat a host of other cancers (breast, kidney, liver, lung, pancreas, prostate and certain skin cancers. The CyberKnife is however, generally not used to treat non-cancerous brain tumours such as chordoma and meningioma.

Gamma knife and epilepsy: a European initiative
In recent years, the gamma knife has drawn attention due to its showing ‘some promise’ for treating certain types of epilepsy.
Attention to such possibilities however date back to 1993, when the first gamma knife treatment for temporal lobe epilepsy was performed at the Hopital Timone in Marseille, France. Just over 5 years later, Na Homolce Hospital in Prague followed with a four-year evaluation on the use of gamma knife in 14 mesial temporal lobe epilepsy (MTLE) patients.

Encouraging results from first study
A pioneering study on gamma knife and epilepsy at France’s Hopital Timone was published in 2000. It covered 25 patients with drug-resistant MTLE with 16 followed up for a period of over 24 months. Thirteen (81%) were seizure free, with two improved. The median latent interval from the gamma knife intervention to seizure cessation was 10.5 months (varying from 6 to 21 months), with two patients immediately becoming seizure free. No cases of permanent neurological deficit (except three cases of non-symptomatic visual field deficit), or morbidity, or mortality were observed.
Although the authors concluded that the ‘optimal parameters for treatment’ remain to be defined, as do studies on ‘dose-related efficacy, effectiveness over longer follow-up periods, and neuropsychological effects’, gamma knife interventions could be ‘a reasonable option,’ and its introduction into epilepsy treatment can reduce the invasiveness and morbidity.’

First and second follow ups to French study
The first five-year follow up to the above released its findings from France in 2004. It found a reduction in median seizure frequency, from 6.16 the month before treatment to 0.33 at 2 years after treatment. In two years, as many as 65% of patients (13 of 20) were seizure free. Five patients reported transient depression, headache, nausea, vomiting, and imbalance. There was ‘no permanent neurological deficit reported except nine visual field deficits.’ Finally, no neuropsychological deterioration was observed two years after treatment and the ‘quality of life was significantly better than that before surgery.’
A second follow-up, in 2008, noted that the gamma knife was ‘an effective and safe treatment for mesial temporal lobe epilepsy.’ Results, it found were ‘maintained over time with no additional side effects. Long-term results compare well with those of conventional surgery.’ The findings remained encouraging, with the mean delay for appearance of the first neuroradiological changes at 12 months. However, all patients who had been initially seizure free experienced a relapse of isolated aura or complex partial seizures during the crucial tapering of the antiepileptic drug. Restoration of medication resulted in good control of seizures.

Efforts in the US: focus on caution
In 2009, one of the first major multi-centric US studies on the gamma knife and epilepsy, led by a team from the University of California, San Francisco, reported three-year outcomes using radiosurgery (RS) for unilateral MTLE.
The authors found seizure remission rates comparable with those reported for open surgery. There were also ‘no major safety concerns with high-dose RS compared with low-dose RS.’ However, they called for additional research to determine whether RS ‘may be a treatment option for some patients with mesial temporal lobe epilepsy.’
Caution was again urged the next year when the US research group noted that RS was a promising treatment for intractable MTLE. However, they also observed ‘that the basis of its efficacy is not well understood…’ The researchers, however, minced no words in their observation that ‘Temporal lobe stereotactic radiosurgery resulted in significant seizure reduction in a delayed fashion which appeared to be well-correlated with structural and biochemical alterations observed on neuroimaging. Early detected changes may offer prognostic information for guiding management.’

Growing interest and availability in US
Nevertheless, there is growing interest across the US in using the gamma knife for epilepsy.
Its potential is highlighted (albeit, to varying degrees) by top facilities such as the Mayo Clinic and other leading hospitals like the University of California at San Francisco. On the other side, the University of Pittsburgh Medical Center explicitly specifies the gamma knife for treatment-resistant epilepsy. An active programme of use is also announced by St. Louis Children’s Hospital, for ‘certain epileptogenic lesions,’ corpus callosotomies as well as hypothalamic hamartomas – a benign plume-like malformation that causes a syndrome characterized by treatment-resistant epilepsy.
Some smaller centres in the US are also describing the Gamma Knife as ‘giving patients with epilepsy another option for treatment.’

Europe seemingly lags US
Although France pioneered studies into the use of the gamma knife in epilepsy, interest in Europe still lags that being shown in the US. One reason may also be that other efforts in Europe have been evidently unsuccessful. For example, a four-year study in the late 1990s in the Czech Republic on using the gamma knife in epileptic patients concluded: ‘Radiosurgery with 25, 20, or 18-Gy marginal dose levels did not lead to seizure control in our patient series, although subsequent epilepsy surgery could stop seizures.’ On the other hand, higher doses were associated with the risk of brain edema, intracranial hypertension, and a temporary increase in seizure frequency.

The ROSE study
Both in the US and Europe, the outlook on using Gamma Knife in MTLE is clearly one of cautious optimism.
Trials conducted to date seem to show mixed results, or do not provide researchers enough conviction, as yet.
For the moment, attention remains focused on an ongoing multi-centre trial called ROSE (Radiosurgery or Open Surgery for Epilepsy). The randomized, double blind trial is funded by the US National Institutes of Health, and is being conducted at 13 centres in the US and the prestigious All India Institute of Medical Sciences in New Delhi.

The trial takes up the hypothesis ‘that radiosurgery is as safe and effective as temporal lobectomy in treating patients with seizures arising from the medial temporal lobe.’ It randomizes patients to either technique and is due to compare seizure remission, cognitive outcomes, and cost. The trial will not only measure outcomes (determined during the course of the final year of a 3-year follow-up period). It will also pay attention to interim measures concerning patient safety, quality of life etc., and compare these between the two groups. The eventual aim is to guide physicians to direct patients between traditional and RS techniques matched to patient characteristics.

It is now clear that casualties after the November 2015 terror attacks in Paris were reduced by a superbly conceived and coordinated response.
While 130 people died in the tragedy, another number deserves attention, too. As many as 302 people were wounded, several seriously. They were triaged, treated on site and then shifted to hospital. Of these, two died during transport and another two in the first 10 days after admission. In other words, the casualty rate in the aftermath of terror was less than 1.5%.

by Ashutosh Sheshabalaya and Antonio Bras Monteiro

Plan Blanc – a collaborative blueprint for disaster medicine
Much of the credit for such an achievement goes to France’s ‘Plan Blanc’ (White Plan), created to respond to disasters. In Paris, the White Plan was activated within an hour after the first incident, namely the bomb explosions at the Stade de France. It mobilized some 40 hospitals, 200 operating rooms, 22,000 beds and 100,000 health professionals.
The White Plan is essentially a collaborative blueprint for disaster medicine. Although its conceptual roots go back several decades, November 2015 was the first time it was put to use.
The White Plan effectively places the entire French hospital system on a war footing, with the ability to pool resources on demand. It establishes a lean/quick-response command, control, communication and information system, mobilizing and synchronizing hospital/clinic bed and staff availability to anticipated victim inflows, postponing chronic surgeries and interventions while readying operating rooms, and providing rolling plans for augmenting resources – both human and material. The White Plan also establishes a specialized unit for informing families and communicating with the media.

No surprise about French leadership
According to us, France is among the world’s best prepared countries to deal medically with the aftermath of a terrorist attack. This laurel should be no surprise, given that the concept of ‘disaster medicine’ (médecine de catastrophe) was developed in the 1980s by three French physicians – René Noto, Alain Larcan and Pierre Huguenard. The French Society of Disaster Medicine/Société Française de Médecine de Catastrophe (SFMC) was founded in 1983.

Emergency medicine versus disaster medicine
Both emergency medicine and disaster medicine deal with the kind of challenges seen in Paris: gunshot wounds, blast wounds caused by explosions with organ and tissue damage, contusion and embolisms, multiple penetrations, pulmonary damage, and last but not least, shock.
The key difference between the two, however, involves the subject for medical attention. In emergency medicine, the subject is an individual patient, while disaster medicine deals with a group of patients. Disaster medicine begins on site and, given extreme constraints in human resources and equipment, is devoid of any element of personal medical care. It also uses specialized equipment, such as portable ultrasound and minimalist lightweight stretchers, while first responders are trained to improvise – for instance, carrying patients by their arms and legs. All this was evident in Paris.

Specialized military medical practices
What also was seen in Paris was a full range of specialized techniques. Some of these are derived direct from military medicine – hemorrhage control with tourniquets, hypotensive resuscitation and hypothermia prevention.
Another battlefield practice deployed in Paris (and debated subsequently by clinicians in many other countries) was to let the blood pressure of thoracic primary blast injury victims fall to levels which avoided exsanguination, but not below that required to maintain perfusion.

Anticipating frictions
Although considerable attention was paid to the White Plan, other Plans too rolled into place in the immediate aftermath of the first attack in Paris. Taken together, they highlight how potential conflicts on roles and responsibilities, jurisdiction etc. between different sets of professionals, in a period of extreme personal and systemic stress, had been anticipated, with interdisciplinary protocols already in place to minimize confusion between the police, the fire brigade, ambulance drivers, physicians and other hospital staff as well as the media and the public.
The police, for example, provided perimetric security and crowd control, taking charge of  clearing and organizing pathways to and from incident scenes. The fire brigade was responsible for victim search and extraction as well as certain types of emergency first aid. Though based in principle at field stations, doctors and nurses attended on site as and when required to the severely wounded, conducting triage and handing over patients for transport to ambulance drivers. On their part, specialist Red Cross teams had set up counselling services for victims and their families by midnight – in other words, within just 2-3 hours of the attacks.
The impact of such preparation cannot be under-estimated. In many cases, it allowed BRI special police forces to ignore pleas for help from victims, without disrupting their conscience or composure. Knowing that qualified medical professionals would shortly be taking responsibility for the wounded, the armed intervention teams instead concentrated on their job – to neutralize the terrorists.
All this, it must be underlined, was undertaken in the face of anticipated dislocations due to a strike by thousands of medical professionals protesting a health reform bill in the French Parliament on the very same day as the terrorist attacks. The strike was subsequently called off.

Other plans also implemented
The Alpha Red Plan is designed to deal with extreme emergencies at multiple sites. It sets up an ad-hoc, quick-operational chain of command which pools the full range of emergency services. These include public and private ambulances, the fire brigade and civil protection as well as the Red Cross – to provide evacuation and support. Hospitals outside the region are also placed on standby, if required.
In an interview with the ‘New England Journal of Medicine’, France’s Director-General for Health, Benoit Vallet, said that he had activated emergency protocols in areas outside Paris, including a request for helicopters to be on standby to transport victims. Vallet also noted that military hospitals treated some of the victims: “[Their] surgeons’ experience in war surgery was, unfortunately, exactly what was needed.”
The Red Plan focuses on pre-hospital care in the field. It is based on the principle of extracting and grouping the injured in a field medical facility, triaging them and then providing care on a need basis. Care is based on prioritizing treatment to what is strictly necessary for survival, managing extreme pain and transporting victims without worsening their condition.
Indeed, a key factor behind the success of the Paris response in November was the pre-hospital system. Within an hour of activation of the Red Plan, eight coordinating units dispatched 45 medical teams – each consisting of a doctor, a paramedical assistant and a driver – to six incident sites.

Lessons from France: the US case
The lessons from the French response to terror are being studied in many parts of the world. One of the first questions being asked is whether other countries would have managed as well.

Such a topic seems to be particularly charged in the US, for several reasons.
A key hurdle is that it is not easy to compare the US and French disaster response systems. The US system is built around mainly private hospitals, and is bottom-up and decentralized, while the French system is based largely on public sector hospitals, and is top-down and centralized.
Nevertheless, critics of hospital disaster preparedness in the US complain that decentralization simply means far too many federal initiatives, which leaves considerable scope for confusion about  lines of authority and responsibility in a crisis.

The US National Disaster Medical System
The point organization for overseeing a US federal medical response to disaster is the National Disaster Medical System (NDMS). NDMS is staffed by more than 8,000 civilian volunteer medical personnel. It is tasked with supplementing medical professionals and equipment should local medical resources become overwhelmed. It also has the responsibility to move injured patients to areas unaffected by a disaster.
NDMS was originally under the Department of Health and Human Services (HHS) but was moved as a result of the 9-11 terror attacks to the Federal Emergency Management Agency (FEMA), which is part of the Department of Homeland Security.
After Hurricane Katrina in 2005, amidst allegations of mismanagement, NDMS was removed from FEMA and sent back to HHS, where it now remains parked within the Office of Preparedness and Emergency Operations (OPEO). OPEO is responsible for developing operational plans, analysis and training to respond to public health emergencies and acts of terror.

HHS versus Homeland Security: Turf wars and more
It is evident that there is room for considerable conflict between OPEO and NDMS’s original parent, FEMA. One of the supra-entities tasked with overseeing a disaster response is The National Response Framework, a multi-agency initiative run by FEMA for the Department of Homeland Security.
As Beltway insiders know, the rivalry between Homeland Security and HSS is considerable.

In 2005, a then-confidential report prepared for the Secretary of Homeland Security evaluated US disaster medical readiness. The 103-page report found that “the nation’s medical leadership works in isolation, its medical response capability is fragmented and ill-prepared to deal with a mass casualty event and … HHS lacks an adequate medical support capability for its field operating units.”

NDMS was specifically targeted, as lacking the medical leadership and oversight “to effectively develop, prepare for, employ, and sustain deployable medical assets,” relying on an overtaxed volunteer network and experiencing “critical shortfalls in doctrine, training, logistics support and coordination” with other emergency responders and federal agencies.

ER capacity shortfalls in the US ‘truly alarming’
The impact of such inter-departmental rivalry and the seriousness of the allegations drew the attention of a Congressional Committee a few years later. The Committee chose a very specific target, namely emergency room (ER) capacity in cities considered to be at greatest risk of a terror attack.
Its findings, released in May 2008, were described as “truly alarming”. The hospitals surveyed did not have “sufficient ER capacity to treat a sudden influx of victims from a terrorist bombing.” The situation in Washington DC and Los Angeles were described as being “particularly dire.”
Aside from capacity, the Congressional investigation also revealed what appeared to be “a complete breakdown in communications between the Department of Homeland Security and the Department of Health and Human Services.” When the Committee requested information on hospital emergency surge capacity, “neither department was able to produce a single document.”

In France, some ironies too
There are several lessons to be learned from the French response to the November 13 terror attacks. The most salutary one brims with irony.
The French ‘system’, in the Anglo-Saxon mind, is believed to be statist, bureaucratic, top-heavy and inflexible. The White Plan response in November was based largely on the Parisian APHP, Assistance Publique – Hôpitaux de Paris, Europe’s largest hospital system.
Many critics have questioned the concept of the APHP, particularly its enormous size, as “an obstacle to adaptation in a rapidly changing technological, medical, and social context.” However, the rapid response of the APHP after the Paris terror attacks negates such criticism.
According to APHP Director General Martin Hirsch: “We sensed … that the size of the [APHP] could be an advantage in times of disaster. This advantage has now been demonstrated. No lack of coordination has been identified. No leakage or delay has occurred. No limit was reached.”
“At no time during the emergency was there a shortage of personnel.”

The authors
Ashutosh Sheshabalaya and Antonio Bras Monteiro
SolvX Solutions
Email: office@solvx.com

SolvX provides security and risk consulting services out of offices in Europe, the Middle East and Asia

Point-of-care testing (POCT) refers to diagnostic tests which are performed physically close to a patient, with the results obtained on site. They are conducted at primary care centres and at hospital bed sides (increasingly, in emergency departments and intensive care units, too).
POCTs are also used in the field in settings such as natural or man-made disasters, and accompanied by telemedicine, in patients’ homes.

Saving time and space
While traditional diagnostic tests involve taking patient specimens, transporting them to a laboratory for analysis and then returning the results to a physician, POCTs cut out both the transport and laboratory. As a result, they provide quicker turnaround time (TAT), sometimes near-instantaneously.
In the past, the traditional laboratory-centric process was unavoidable due to the sheer size of equipment required for diagnostic tests. In recent years, technology developments – especially in terms of miniaturization – have made it possible to perform a growing number of tests outside of the laboratory. One recent book on biomedical engineering (D. Issadore and R.M. Westervelt (eds.), Point-of-Care Diagnostics on a Chip, Biological and Medical Physics, Biomedical Engineering’, Springer-Verlag, Berlin 2013) notes the array of sophisticated, low-power and small ‘microfilters, microchannels, microarrays, micropumps, microvalves and microelectronics …. integrated onto chips to analyse and control biological objects at the microscale’, that have made decentralized diagnostics possible.

Impact on efficiency, outcomes – and costs
Such time savings can have a dramatic impact on downstream clinical efficiency and patient outcomes. In many cases (although not universally or under all circumstances), they also save costs.
For example, POCT can reduce revenue losses due to workflow delays of test-dependent medical procedures – such as disruptions in magnetic resonance imaging (MRI) or computer tomography (CT) queue. This is not a rare occurrence, and delays in radiology testing have been shown to extend total length of stay in the emergency department (ED).

From lab downscaling to targeted solutions
Early POCTs were based on the simple transfer of traditional methods from a central laboratory, accompanied by their downscaling to smaller platforms. At a later stage, unique, innovative assays were designed specifically for POCT (such as the rapid streptococcal antigen test). This was accompanied by the development of wide arrays of POCT-specific analytic methods, ranging from the simple (such as pH paper for assessing amniotic fluid) to the ultra-sophisticated (for example, thromboelastogram for intra-operative coagulation assessment).
Today, the typical POCT test arsenal includes cardiac biomarkers, hemoglobin concentrations, differential complete blood count (CBC), blood glucose concentrations, coagulation testing, platelet function, pregnancy testing as well as tests for streptococcus, HIV, malaria etc.

Beside and near-bedside POCT
POCT devices are used in a wide range of healthcare settings. They can be divided into two broad groups, depending on size and portability – bedside and near-bedside.
Bedside POCT devices are smaller, usually hand-held, and offer the greatest mobility. Due to their compact nature they are often more specialized and limited in overall functionally. Many are enclosed in test cassettes (such as easy-to-use membrane-based strips) and based on portable, sometimes handheld, instruments. This family of POCT requires only a single drop of whole blood, urine or saliva, and the tests can be performed and interpreted by a general physician in minutes. Nevertheless, some of them can be quite sophisticated.
New POCTs for early detection of rheumatoid arthritis, for example, require only a single drop of whole blood, urine or saliva, and can be performed and interpreted by any general physician within minutes. Two of the earliest efforts in this area were made in Europe. The first, from Sweden’s Euro-Diagnostica detects antibodies to CCP, while Rheuma-Chec from Orgentec in Germany combines two biomarkers – rheumatoid factor and antibodies to MCV. These tests are targeted at primary care.

Near-bedside (or neighbourhood) devices are larger and typically located in a designated testing area. They provide higher calibration sensitivity and quality control and are used for more complex diagnostic tests than their smaller bedside counterparts.
They are themselves also far more complex, with high degrees of automation in comparison to their bedside POCT counterparts. This automation contributes to the increased speed and ease-of-use of the devices. However, it also leads to challenges in training users.

The imperatives of turnaround time
As mentioned, the principal interest in POCT is to reduce turnaround time (TAT) – the duration between a test and the obtaining of results which aid in making clinical decisions. The impact of this has been profound in the emergency department.
Already in 1998, a randomized, controlled trial in the A&E department of a British teaching hospital assessed the impact of POCT on health management decisions. The results, published in British Medical Journal’ in 1998, found that physicians using POCT reached patient management decisions an average of 1 hour and 14 minutes faster than patients evaluated through traditional means.

Use in emergency departments
Though the bulk of POCT is conducted by primary care physicians, one of its fastest growing users has been hospital EDs, which the British Medical Journal’ study hinted at almost 20 years ago.
POCT’s relevance for emergency departments is multi-faceted.
In the ED, prolonged wait times and overcrowding directly correlate to reduced patient satisfaction and adverse clinical outcomes. Several European countries have regulations on length-of-stay time targets in EDs, requiring that patients must transit through four to 8 hours. Though there are several factors at play here, no one would argue that reducing the delay between sample collection and test results can enable healthcare professionals to arrive at quicker decisions and increase patient throughput. POCTs make this possible.
One study in Switzerland evaluated adding POCT to B-type natriuretic peptide levels for ED patients presenting acute dyspnea as their primary symptom. POCT was not only associated with significant decreases in time to treatment initiation, but was also associated with a shorter length of stay and a 26percent reduction in total treatment costs.
Another study on D-dimer POCT in the ED found a 79percent reduction in TAT compared to central laboratory testing and resulted in shorter ED lengths of stay and reduced hospital admissions, while a randomized study in coagulopathic cardiac surgery patients found that POCT-guided hemostatic therapy led to reduction in transfusion and complication rates, and improved survival.

From ACS to pregnancy tests, and overcrowding
Favourable perspectives on POCT in the ED have strengthened over time. One recent study in Critical Care’ found POCT increased the number of patients discharged in a timely manner, expedited triage of urgent but non-emergency patients, and decreased delays to treatment initiation. The study quantitatively assessed several conditions such as acute coronary syndrome (ACS), venous thromboembolic disease, severe sepsis and stroke, and concluded that POCT, when used effectively, ‘may alleviate the negative impacts of overcrowding on the safety, effectiveness, and person-centeredness of care in the ED.’
A great deal of attention has been given to the use of POCT in emergency settings for screening patients who presented with symptoms of acute coronary syndromes (ACS). The rapid identification and treatment of ACS patients is critical.
Due to the time-sensitive nature of ACS, reduced TATs can offer a clear advantage. POCT has been shown to increase the speed at which positive cases of ACS are accurately identified, allowing physicians the ability to admit and initiate treatment at a faster rate than previously possible. Decreased TATs also can result in the earlier identification of negative cases of ACS, thereby increasing the number of successful discharges, and allowing for more efficient use of hospital resources .

The ICU and POCT
Unlike the ED, the use of POCT in intensive care units is still in its infancy. In 2013, researchers at Germany’s Klinikum rechts der Isar in Munich sought to retrospectively investigate whether POCT predicted hospital mortality in over 1,500 ICU admissions. The results were mixed. Lactate and glucose seemed to independently predict mortality. So did some forms of metabolic acidosis, especially lactic acidosis. However, anion gap (AG)-acidosis failed to show any use as a biomarker.
One of the most important areas for POCT focus in the ICU consists of sepsis – which is directly correlated to poor outcomes. ICU patients often have other ongoing disease processes whose biomarkers are shared with sepsis, such as raised white blood cell count and fever. More crucially, many ICU patients are already on antibiotics at admission, making microbiological cultures redundant.

POCT as part of health management strategy
Overall, POCTs have an impact and make most sense when utilized as part of an overall health management strategy which enhances the efficiency if clinical decision-making. Indeed, the rapid TAT provided by POCT allows for accelerated identification and classification of patients into high-risk and low-risk groups, improving quality of care and increasing clinical throughput.
POCT results are often available in minutes. However, decreased TATs on their own mean nothing, until they provide clinical pathways means to impact on workflow. The latter varies widely across healthcare settings.

Differences in practice
Such a scenario is by no means straightforward. In Europe, for example, POCT use is highly irregular and differs greatly between institutions and countries. Though differences in operating procedures are natural by-products of institutional cultures, there are some oversight and quality control issues which healthcare leaders must address to take maximum advantage of POCT.
Answers to the above are not a question of if’ but when’.

Regulation – the future ?
The future of POCT may well be shaped by regulators, and their response to the kind of pressures mentioned above.
In Europe, POCT devices are regulated under the 1998 European Directive 98/79/EC on in vitro diagnostic medical devices, which became operational in 2001. POCT devices are not specifically mentioned or referred to in this directive, and at the European level, coverage of POCT is referred by international standard ISO 22870:2006, used in conjunction with ISO 15189 which covers competence and quality in medical laboratories.
In the US, CLIA88 (Clinical Laboratory Improvement Amendments of 1988) provided a major impetus for growth in POCT. The rules, published in 1992, expanded the definition of laboratory’ to include any site where a clinical laboratory test occurred (including a patient’s bedside or clinic) and specified quality standards for personnel, patient test management and quality.
One of CLIA88’s biggest contributions to POCT growth was to define tests by complexity (waived, moderate complexity and high complexity control), with minimal quality assurance for the waived category.
CLIA88 has been followed by US federal and state regulations, along with accreditation standards developed by the College of American Pathologists and The Joint Commission. These have established POCT performance guidelines and provided strong incentives to ensure the quality of testing.