Lab Soft News

Lab Analytics Emerges as Hot Area for Software Development

A very hot area of interest in the healthcare IT world these days is lab analytics, a type of business intelligence (BI) software. Under ACA, labs will be under extreme pressure to operate more efficiently and this requires a constant flow of operational metrics. Lab analytic software grabs information from the LIS and tweaks it to indicate the need for change, usually to improve business performance. The results are displayed in the form of a dashboard. This reminds me of the early days of specialized lab outreach software. The incumbent LISs vendors were unable or uninterested in developing comprehensive solutions of this type, allowing smaller software companies to move into the void.

The three lab analytic vendors I have identified thus far are Visiun, hc1.com, and Viewics. Major LIS vendors such as Sunquest, Cerner, and SCC Soft generally provide their own lab analytic modules which are sometimes excellent but sometimes inadequate by today's standards. A colleague has told me that analytic software provided by Epic is "lousy" as it pertains to an EHR dashboard, which may be the reason that the company recently announced an agreement with an Dimensional Insight (see: Dimensional Insight Announces Business Intelligence Vendor Agreement with Leading Healthcare EMR Software Company). Below is an excerpt from the article:

Dimensional Insight, a leader in business intelligence (BI) solutions in healthcare, ...announced that it has entered into an agreement that enables enhanced integration and support of The Diver Solution (Diver) with Epic. For healthcare providers, reimbursements are increasingly tied to quality measures and performance monitoring and analytics. Providers use Dimensional Insight's business intelligence and analytics to derive meaning from clinical, operational and financial data and gain insight into how costs, resources, quality and outcomes are interrelated and how actions impact results.....Florida-based Lee Memorial Health System, a 1,300 bed system handling 1 million patient contacts each year across its four acute care and two specialty care hospitals, is an example of a joint customer benefiting from this partnership. 

Here's a cut-and-paste from the Dimensional Insight website (see: Healthcare Business Intelligence) with examples of some of the different types of reports that the company provides:

OPERATIONS:

Staffing; Strategic Planning; Utilization

CLINICAL:

Physician Scorecarding; Quality; Patient Satisfaction; Outcomes

FINANCE:

Budget Denials Management; General Ledger Payroll Analysis; Product Line Analysis

As readers of this blog know, my attitude toward Beaker, the LIS developed by Epic, is that it's an immature system but on a fast developmental path. However, a number of pathology departments, some quite complex (see, for example, Allina Health Begins a Phased Rollout of Epic's Beaker LIS), are in the process of installing it. If and when these departments seek a lab analytic solution, I suspect that Dimensional Insight would not have the experience to provide a product that would satisfy them and certainly not at the level of the three lab analytic companies cited above. One point of possible confusion for lab professionals is that Dimensional Insight often refers to itself as DI. This should not be confused with Data Innovations (DI), a company well known in the lab world. 

Rapidly Approaching Deadlines for the Pathology Informatics Summit 2014

Pathology Informatics Summit 2014 is rapidly approaching. The conference will be held on May 13-16, 2014, at the Wyndham Grand in downtown Pittsburgh. This is the only conference of the year devoted exclusively to a broad swath of pathology informatics. There will be a separate track devoted to the practice of informatics in both clinical and anatomic pathology. New this year is a third track for long presentations of the best research abstracts submitted to the conference organizers. The entire conference schedule is available at the its web site for review. A total of 26 exhibitors will participate and will be located in a single large ballroom. For any vendors who are considering participation in PI Summit, there are still a couple of tables available.

Of importance is that the early-bird registration ends tomorrow, April 30, 2014.  Register now to get the reduced registration price on $875, including all workshops. You will also need to book your room by Friday, May 2, 2014, to receive the special conference room rate at the Wyndham. A block of rooms will be held at the rate of $184, plus taxes of 14%, under the name Pathology Informatics 2014 until this time.  The availability of rooms cannot be guaranteed at this rate after Friday.

In a previous note, I mentioned that the digital pathology footprint for the conference will be particularly strong this year (see: Digital Pathology Well Represented at Pathology Informatics Summit 2014). This is encouraging because this industry segment seems to have been in the doldrums for a while. I am anxious to see much greater deployment of these systems so that digital pathology can start to catch up with the success of digital radiology. This might also be an opportune time to consider joining the Association for Pathology Informatics (API), the only medical society totally focused on this speciality area within pathology. 

A Competitive Threat to U.S. Healthcare in the Cayman Islands?

I have posted a number of articles about medical tourism whereby Americans travel abroad for (hopefully) high quality, low cost care. I have remarked more than once that a key aspect of medical tourism has been to provide an incentive for U.S. providers to operate more efficiently and in a more cost-competitive way. Healthcare reform in the form of, say, the ACA is also pushing hospitals in this same direction. It turns out that medical tourism is getting closer to home -- Narayana Health is opening a hospital in the Cayman Islands. The chairman of the company, Dr. Devi Shetty, has pioneered heart surgery in India for $1,600 a case (see: Why the future of health care can be found in the Cayman Islands). Below is an excerpt from the article:

...[M]ore than 2,000 attendees from around the world gathered under a large tent to celebrate the opening of a new 104-bed hospital [in the Cayman Islands] .Why all the fuss? Because this new facility is the work of Narayana Health chairman and India’s most renowned heart surgeon, Dr. Devi Shetty....Narayana is internationally regarded as a low-cost, high-quality health care provider. Its newest hospital, Health City Cayman Islands, is the organization’s first development outside of India. It has American health care providers watching closely and anxiously. Narayana Health positioned to deliver quality care to Americans. At the end of 2013, Narayana Health was operating 18 hospitals across 14 cities in India. With a laser focus on efficiency and quality, the average Narayana cardiac hospital performs 40 heart surgeries a day for less than $1,600 a case. That’s about 2 percent of the average heart surgery cost in the U.S. with outcomes that rival the best American facilities. With the first phase of the Cayman Island hospital completed in February, Dr. Shetty plans to expand Health City Cayman Islands to 2,000 beds over the next decade....In the United States, there is about 1 hospital bed per 333 people. The Grand Cayman Island has about 50,000 residents. When Dr. Shetty completes his expansion plans, his newest hospital will feature 1 bed per 25 Grand Cayman residents. It doesn’t take a heart surgeon to see Dr. Shetty is thinking way beyond the Caymans. Given the hospital’s close proximity to Miami, Dr. Shetty must be planning to attract patients from the United States. That would certainly explain the 5-star hotel he built next door with a foot bridge connecting the two world-class structures.Today, Health City Cayman Islands focuses on cardiac and total joint surgery. It will add cancer care and transplant services in the near future. Plans are already underway to construct an international medical school and a variety of high-quality residency training programs. 

Self-insured companies are beginning to point their employees in the direction of "super-regional' hospitals for major surgical procedures such as hip replacement (see: Patients Encouraged to Travel for Surgical Procedures by Their Employers). Many such hospitals have become so experienced at performing such procedures that they can "wring out" inefficiencies and quote a lower, and fixed, price for them. In so doing, they "undercut" the smaller hospitals that may be located in the patient's home communities. The patients participating in such programs often enjoy a quality advantage based on their willingness to travel some distance and the company derives a cost benefit. 

With the launching of Narayana Health in the Cayman islands, the low cost, high quality competition could get even stiffer for hospitals in the U.S. Traveling to the Cayman islands may not be as daunting as a trip to India or Singapore. Narayana, I am sure, will also package some sort of recuperation option with their surgical procedures at little additional cost for the insuring company because their base cost for the procedure will be so much lower than in American hospitals. The burden that Narayana will need to overcome in order to attract more U.S. patients will be to prove that its quality and standards are comparable to that of U.S. hospitals. My guess is that it will not be hard for the company to obtain such data quickly given their large anticipated  patient volume. With such data in hand, they can then begin to market to the huge U.S. market to the north.

The Diversity Gap in Clinical Trials; Can It Be Closed?

Clinical trials are essential for assessing the safety and efficacy of new drugs and new drug combinations. Despite their importance, there are flaws in how subjects are selected for such trials. Here's a quote from the Wikipedia about this issue: "In the US, the elderly constitute only 14% of the population, while they consume over one-third of drugs, Seniors are often excluded from trials because their greater health issues and drug use complicate data interpretation. Women, children and people with unrelated medical conditions are also frequently excluded (see: Clinical trial)." Another significant problem is that there is insufficient racial diversity among clinical trial subjects (see: Closing The Diversity Gap In Clinical Trials). Here's another article about this problem (see: Closing The Diversity Gap In Clinical Trials). Here is an excerpt from this first article:

...[M]ost of the clinical trials conducted in this country suffer from a pronounced lack of diversity. Minority populations are consistently underrepresented....This diversity gap can lead to sub-optimal development of new medicines and can further exacerbate minority health disparities. According to the Food and Drug Administration, while African-Americans represent 12 percent of the total U.S. population, they comprise just 5 percent of clinical trial participants. Hispanics account for 16 percent of the total population but just 1 percent in trials. A new study... shows that...non-whites comprise fewer than 5 percent of participants in NIH-supported studies....African-American men are twice as likely as their white counterparts to die from prostate cancer. Yet they represent just 4 percent of prostate cancer clinical trial participants....

There are a variety of reasons for the low rate of clinical participation among ethnic communities. Some are distrustful of clinical trials or understandably wary of sharing the most intimate details of their health in a clinical trial setting....There can be other practical matters that interfere....Transportation to and from clinical sites can be prohibitively expensive for some potential participants. Others can’t afford to miss work.The pharmaceutical industry recognizes that these issues can and must be addressed and is playing a lead role in forging solutions....Lilly has launched a first-of-its-kind program to train, mentor and equip minority investigators to conduct clinical trials that are well-designed and relevant to minority populations. For example, we have found that people are much more likely to volunteer for a trial if their contact person is familiar with their culture....

As someone who was a member of an institutional review board (IRB) tasked with the protection of subject enrolled in clinical trials, I can comment that there was always exquisite sensitivity about the possibility of subtle coercion in the selection of subjects. Here's a paragraph from the AMA about this topic (see: Subject Selection for Clinical Trials):

Ethical considerations in clinical research have traditionally focused on protecting research subjects. These protections may be especially important for those from socioeconomically disadvantaged populations who may be more vulnerable to coercive pressures. The benefits from altruism that result from participation in research, particularly for severely chronically ill persons, may justify equitable consideration of historically disadvantaged populations such as the poor. 

So, for example, it is generally impermissible to pay subjects for participation in clinical trials other than to reimburse them for expenses, such payments constituting a form of coercion for someone of limited means. However, more affluent or more educated candidates for a clinical trial may be better able to take time away from work than others. Perhaps even more important is that more educated subjects may be less suspicious about representations that are made to them about the goals of a research project. Also, more educated people may have physicians who will make an added effort to identify suitable clinical trials for them or may even be conducting trials. Many of the barriers to diversity in clinical trials relate to societal issues that will not be solved overnight but we need to continue working in this direction.

Financial Challenges for Non-Profit Hospitals; Lab Budget Reductions Anticipated

Hard times are coming for non-profit hospitals and, in my opinion, particularly for pathology and the clinical lab contained within them (see: Ratings Agencies Go Negative on Not-for-Profit Hospitals for 2014; Their Projections Signal Fewer Resources for Hospital-based Clinical Laboratories) Below is an excerpt from this article:

Tough financial times are ahead for not-for-profit hospitals, according to the projections of multiple rating agencies. Financial analysts attribute this to an extended period of massive and disruptive change. This is not good news for hospital-based clinical laboratory managers and pathology groups. Big Three credit-rating agencies...echoed a common theme in their 2014 outlooks for not-for-profit hospitals, which represent 60% of the nation’s hospitals. Environmental pressures will suppress revenue growth, while fresh cost-cutting measures will become increasingly harder to find....Revenue growth at not-for-profit hospitals will fall to roughly 3% to 3.5% in 2014....This compares to a growth rate of 5.2% in fiscal year 2012.

....Expenses grew faster than revenues for a second year in a row at not-for-profit hospitals....Not-for-profits have struggled to cut costs in an effort to improve margins. At the same time, these hospitals recognize they must reposition themselves in order to succeed in the new value-based reimbursement environment. That means they continue to invest in information technology and to expand physician practices as a source of referrals....Uncertainties following implementation of the Patient Protection and Affordable Care Act (ACA) will present additional challenges for not-for-profit hospitals going forward....Expanding Medicaid rolls will augment patient volumes. However,....,analysts are pessimistic that these increases will be enough to boost profits.

....Many not-for-profit hospitals have already implemented the most easily achievable cost-cutting measures....Now they are looking for options to push cost savings even further. Some strategies being considered include best practice definition and implementation, as well as clinical integration and productivity. However, some organizations will face roadblocks. Inadequate technology capabilities and cultural inability to achieve consensus could impede needed cost-saving initiatives.....The fact that multiple financial rating agencies predict tougher financial times ahead for a large number of not-for-profit hospitals is not good news for the clinical laboratory professionals and pathologists who work in these hospitals. Among other things, it means that medical laboratory budgets will continue to shrink and lab managers will be asked to do more with fewer resources.

When finances get tight, executives of non-profit hospitals tend to target the labs first for cuts. The perception is that the labs can absorb budget reductions without too much pain. This "logic" is based partly on the high degree of automation in the labs as well as the fact that they provide ancillary services without a direct relationship to patient admissions. All this despite the fact that pathology and the labs commonly account for only about five or six percent of the operating budget of most hospitals. This also despite the fact that hospitals will be facing a greater patient load coupled with the deployment of expensive new EHRs. Here's an article that details about the effect of EHRs on hospital budgets (see: EHR Jobs Boom: 8 Hot Health IT Roles). Below, for me, is the key quote from the article:

Electronic health records have fueled a growing career specialty. Consider these in-demand health IT jobs. Electronic Health Records (EHRs) have created a burgeoning genre of health IT jobs. While health IT once accounted for between 5% and 10% of a hospital's IT budget, it now represents 25% to 35%, Kevin Holloran, a director in Standard & Poor's nonprofit healthcare group told Beckers Hospital Review (see: EHRs and Health IT Projects: Are They Battering Hospitals' Financial Profiles?). A large portion of that money goes toward EHRs -- both in terms of technology and people.

So the budget for hospital IT, EHRs specifically, is at least triple what it used to be. This money needs to some from somewhere and the labs will undoubtedly be one of the first stops.

What's Wrong with Healthcare Software; Response to the Fallows Article

James Fallows wrote an article for The Atlantic about EHRs (see: Why Doctors Still Use Pen and Paper). You may want to browse this original article which is very interesting. He wrote a number of follow-up pieces and then an eighth one that quotes some of the email that he has received in response to the original article (see: The Electronic-Medical-Records Email(s) of the Day, No. 2). In this last one, he quotes an email from an IT consultant. Here is a truncated list of the observations about healthcare software in the email to Fallows:

• Software companies in "vertical" markets have never been magnets for top programming talent...
• Nowhere is the lack of star talent more glaringly obvious than in user-interface design....I am staggered by the sheer number of clicks required to get through even the simplest of screens, and there are far too many screens.
• Counterintuitively, some of the most physician-UNfriendly interfaces I've seen were designed by physicians....
• The back-turned-to-the-patient issue is an easy...[problem] to solve: use a tablet, or a laptop on a rolling stand, and face the patient....
• Nuance Communications has a virtual lock on the voice-recognition market, and they exploit it in ways that I frankly find appalling....Dragon Medical...[software costs] $1500. The only real difference between ...[the regular premium product] and Medical is a pre-trained vocabulary....
• Data interchange between competing EMRs is laughable. There are national and international standards for this (HL7, CCR/CCD, etc.), but no EMR company takes this seriously - they generally do an OK job of exporting data but are completely clueless about importing it....

I would like to make some comments about the idea of healthcare as a vertical market. I agree with the correspondent that most EHR software is pretty bad and also extremely expensive. I agree that part of the problem is that it's not developed by the "top programming talent." However, if you look at smaller niche markets within the larger medical software market like LISs and RISs, the software is generally good and "reasonably" priced. So, the question arises about how the EHR market differs from the LIS/RIS/PACS market. The following differences come to my mind:

• Departmental systems, at least in the past, have been shopped for by the same personnel who were actually going to use them on a daily basis, In the case of LISs for example, they have always been chosen by pathologists and medical technologists on the basis of optimal functionality. They would never choose a system that would not serve them well because it would harm their productivity (and job security). In the case of EHRs these days, they are largely chosen by the hospital C-suite, mainly non-physicians, who will never use them on a daily basis. Hospital executives make a show of obtaining clinician and nurse input into EHR selection decisions but it's largely a sham.
• The LIS and RIS markets have always been competitive with a number of companies vying for market share. At least for the higher end of the EHR market, there are only several players with Epic currently closing most contracts for large hospitals. There is little bargaining room for a contract with Epic.
• We now have the federal government distorting the EHR market with financial incentives to deploy systems and regulatory requirements governing the products themselves. The federal government does not particularly like to interact with small businesses such as solo medical practitioners so it's helping to drive them out of business. The IT costs alone make the idea of a solo practice very difficult. Thats part of the reason an increasing number of physicians are converting their practice to models such as concierge and direct primary care (see: Concierge medicine). If physicians opt out of government and health insurance company payments, they avoid many of the onerous restrictions on their practices.

Pertaining to the need for lab professionals to select LISs with optimum functionality, the Association for Pathology Informatics (API) now provides a LIS Functionality Assessment Toolkit that can be downloaded at no cost from the API web site.

Distracted Diagnostics: Is This Really a Problem?

In a recent note, a guest blogger, Nial Toner, raised the issue of what I will call distracted diagnostics for the purpose of this discussion (see: Cloud Computing in Digital Pathology: Addressing Some Pressing Needs). Here is a paragraph from his note making reference to the fact that some pathologists working on digital cases away from their normal office might feel stressed or unfocused:

Some pathologists may be skeptical about working from many different locations and believe that system settings may affect how they deal with their daily case workload. The key argument here is that the pathologist working in his or her office environment is more likely to stay focused and therefore make more accurate diagnoses.

This is a very interesting point. We all understand the hazards of distracted driving and have seen cars weaving about with the driver holding a cell phone to his or her ear. Many states have outlawed the practice as unsafe. By the way, I purposely chose the term distracted diagnostics because the issue is even more relevant for the radiologist than the pathologist, digital images being more widely available in radiology. 

I am thinking about a pathologist or radiologist interpreting images in a home office, perhaps alternating between household tasks and professional work. Increasingly common may even be the scenario of the review of a surgical pathology case or a radiology study with a cell phone, ducking out of a restaurant or party. Distraction has always been one of the known challenges of telecommuting.

On the other hand, it may be relevant here to ask whether the notion of distracted diagnostics is a red herring? Clinicians take cell phone calls all of the time wherever they are located. They frequently provide critical clinical advice with their hand over one ear to block out ambient noise in a restaurant. No one considers this a problem. In fact, we consider it appropriate and necessary.

I found a reference to distracted doctoring on the web site of a malpractice lawyer. Here, cell phones and browsing social media sites were highlighted as common distractions for physicians and other health professionals in hospital settings (see: Find out how a Tennessee medical malpractice lawyer can help). Here is a quote from the web page:

Doctors are without question busy during their day. Certain distractions are unavoidable due to the nature of their work. Other distractions are unnecessary in an operating room or examining room:

• Socializing
• Answering a cell phone
• TextingSurfing the internet
• Checking social medial sites

Distracted doctoring is more common than people might think. In fact, the ECRI Institute, an organization that researches ways to improve safety and quality of patient care, listed “caregiver distractions from smartphones and other mobile devices” as No. 9 on a top 10 list of health technology hazards for 2013. Stories have surfaced of doctors wearing headsets and making a personal phone call during a procedure.

I don't know whether distracted diagnostics is really a problem. It might be worth a study, perhaps starting with digital radiology. 

Cloud Computing in Digital Pathology: Addressing Some Pressing Needs

This is a guest blog by Nial Toner of PathXL, a vendor of cloud-based digital pathology systems. I asked him to discuss the benefits of cloud computing in digital pathology and barriers to its deployment. There will be some emphasis placed on digital pathology at the upcoming Pathology Informatics Summit 2014 (see: Digital Pathology Well Represented at Pathology Informatics Summit 2014)--BAF

In digital pathology, cloud computing can help to deliver cost effective healthcare and also help to manage the growing amount of data that is generated by the technology. Cloud computing provides many benefits but also some drawbacks. The benefits of cloud computing in digital pathology are the following:

• Cloud computing makes data and images accessible anywhere in the world. For pathologists this brings the benefit of working from any location. Furthermore, pathologists can collaborate on a global scale, enabling them to share images and annotations to get a second opinion instantly, allowing for faster diagnosis
• Some digital pathology software companies host their products entirely in the cloud (SAAS). Customers who use such software benefit from having access to the most up-to-date versions of it without having to upgrade or install it manually. In addition time and money are saved because the data is stored in a secure external hub. 
• Cloud computing provides a central repository, holding all virtual slides and data that can be easily accessed and viewed by any authorized person.

Despite these benefits, some reservations and barriers to using cloud technology in digital pathology persist and include:

• Some pathologists may be resistant to new technology, having used the same methods throughout their careers and achieved a comfort level with them.
• Many pathologists are also apprehensive about storing sensitive information externally where it may be susceptible to hackers or be lost. In response, most cloud computing vendors will offer enterprise-class firewalls as well as a dedicated VLAN. 
• Some pathologists may be skeptical about working from many different locations and believe that system settings may affect how they deal with their daily case workload. The key argument here is that the pathologist working in his or her office environment is more likely to stay focused and therefore make more accurate diagnoses.

While the benefits are substantial, cloud computing has yet to make any major inroads in pathology. Despite this, cloud computing in support of digital pathology is increasingly being used for medical education and in research settings. The future for cloud technology does look bright and the value of cloud computing for the healthcare industry has been predicted to reach $5.4 billion by 2017. We are all increasingly adapting to a mobile world and digital pathology will make a major contribution to this goal.

UCLA Teams Up with Chinese Partner in Development of a New Esoteric Lab

I have posted previous notes about U.S. academic pathology departments and LIS vendors entering into various types of business arrangements with Chinese businesses. One involved the UPMC pathology department providing second opinions for surgical pathology cases to KingMed Diagnostics three year ago (see: UPMC Enters China Market for Second Opinions in Surgical Pathology Cases). Another involved the establishment of a global pathology network by PathCentral, a cloud-based AP-LIS, with participation by China-based Kindstar Globalgene Technology (see: PathCentral Debuts Agnostic Global Pathology Network). About three years ago, Mayo Clinic also signed a collaboration agreement with Kindstar (see: Mayo Clinic Signs Strategic Collaboration Agreement with Wuhan Kindstar Globalgene Technology, Inc. (Kindstar)). Here's a quote from that article:

...Kindstar offers 750 tests in specialties including hematology, oncology, genetics, infectious diseases, and cardiovascular disease. Through the collaboration with Mayo Clinic, Kindstar will expand its test menu offerings, promoting high-quality diagnostic and therapeutic care for the people of China by providing patients and physicians the broadest access to advanced esoteric testing services.

Now comes news that UCLA has signed a business agreement with Centre Testing to operate an esoteric  lab in Shanghai with a special focus on molecular and genetic testing (see: UCLA signs agreement with Centre Testing to create clinical laboratory in Shanghai). Here is an excerpt from the article:

The University of California and UCLA Department of Pathology have signed an agreement with Centre Testing International Corp., a Chinese firm, to create a company that will operate a clinical laboratory in Shanghai. The new lab will support clinical trials and enhance medical care for Chinese patients with cancer and other diseases. The new company, CTI-Pathology/UCLA Health, is jointly owned by CTI and the University of California. The 25,000-square-foot facility - the first of its kind in China - will offer genetic and molecular diagnostics and other sophisticated tests that exceed the scope of the average lab in China, and UCLA pathologists will train Chinese lab specialists to accurately interpret the tests....The partnership is the first between a Chinese company and a U.S. academic medical center to create a specialized laboratory in China. ....UCLA will oversee management of the laboratory to ensure that its operations meet international standards for quality, and CTI will provide capital funding and marketing expertise. 

This deal between UCLA and Centre strikes me as being unusual in a couple of  ways. First, the new lab will focus on clinical trials as well as molecular and genetic testing. These are areas in which an academic lab like UCLA could have special expertise that would be of great value in the Chinese market. China is now one of the major sites for clinical trials because of the reduced cost of managing trials there but also because the Chinese market for prescription drugs is becoming one of the largest in the world (see: Clinical Trials Increasingly Move Offshore, Many to China; China's pharmaceutical industry -- Poised for the giant leap -- pdf). A second point is that Centre Testing International (CTI) is a testing, inspection, certification, and consulting firm but not a hospital or clinical laboratory. CTI is providing capital and marketing expertise for the project but UCLA will totally oversee management of the laboratory. This a  different scenario than an American academic facility providing expertise on a case-by-case or referral basis to a Chinese lab or hospital. 

Experience with Autoverification in a Core Clinical Chemistry Lab

Autoverification is the process by which LIS-based rules are used to verify clinical laboratory test results without any manual intervention. It's a process that all sophisticated clinical labs need to adopt, particularly for routine chemistry and hematology tests, to decrease labor costs and test turn-around-times (TATs). A recent article in the on-line Journal of Pathology Informatics described autoverification in the chemistry core lab at the University of Iowa Hospitals (see: Autoverification in a core clinical chemistry laboratory at an academic medical center). Below is an excerpt from the results portion of the abstract:

The autoverification rate for tests performed in the core clinical chemistry laboratory has increased over the course of 13 years from 40% to the current overall rate of 99.5%. A high percentage of critical values now autoverify. The highest rates of autoverification occurred with the most frequently ordered tests such as the basic metabolic panel ..., albumin (99.8%), and alanine aminotransferase (99.7%). The lowest rates of autoverification occurred with some therapeutic drug levels...and with serum free light chains (kappa/lambda), mostly due to need for offline dilution and manual filing of results. Rules also caught very rare occurrences such as plasma albumin exceeding total protein (usually indicative of an error such as short sample or bubble that evaded detection) and marked discrepancy between total bilirubin and the spectrophotometric icteric index (usually due to interference of the bilirubin assay by immunoglobulin (Ig) M monoclonal gammopathy).... Our results suggest that a high rate of autoverification is possible with modern clinical chemistry analyzers. The ability to autoverify a high percentage of results increases productivity and allows clinical laboratory staff to focus attention on the small number of specimens and results that require manual review and investigation.

Delving back in my memory of a few decades ago, I recall some degree of anxiety involving the CAP inspection of our labs in relation to our use of autoverification rules. There was a requirement at that time that a medical technologist must "manually" verify each batch of test results prior to release to ensure that they were "reasonable" or some equivalent word. One of the technologists in our hematology lab had a burning interest in autoverification and had succeeded in that goal such that most of the routine hematology tests were being autoverified.

The autoverification rules for hematology tests must accommodate to a large number of patients with very high or low white blood cell and platelet counts. This was accomplished by taking into account the "delta" between the current day's value for a patient and that of a previous day. Patients with high WBC counts today probably had high counts yesterday. I seem to recall that the lab was achieving autoverification rates for hematology routine tests in the range of about 70-80%. We worried that our use of autoverification rules might get us into trouble during an inspection. We decided that we had adopted a modern approach to workflow and would just explain this to our inspector if need be.