CEO SUMMARY: It’s a laboratory regionalization project without precedent because of its worldwide scale. Within the Armed Forces, laboratorians are working to seamlessly integrate laboratory test data generated by laboratories within the Army, Navy, Air Force, and Veterans Administration. LOINC is the tool used to link participating laboratories. The eventual goal is to create a universal medical record for all American service personnel and their dependents.
EDITOR’S NOTE: This is the first of a two-part feature on how pioneering laboratory organizations are using LOINC (Logical Observation Identifier Names and Codes) to standardize laboratory test data on a major scale.
THREE YEARS AGO military laboratorians launched the ultimate laboratory regionalization program, one that involves all laboratories in the American military system and Veterans Administration across the globe.
This ambitious undertaking is built around a simple goal: to create a unified laboratory system, using LOINC (Logical Observation Identifier Names and Codes), so specimens could be referred to any laboratory worldwide operated by the Army, Air Force, Navy, and Veterans Administration. Because referred testing is a part of this project, Laboratory Corporation of America and Quest Diagnostics Incorporated are also participating.
Importance Of Lab Test Data
“Since acronyms are integral to military operations, the lab data integration part of this project is known as G-LIT (Global Laboratory Interoperability Project),” observed Thomas A. Robillard, Colonel, U.S. Air Force and Flight Commander of Pathology and Clinical Laboratories at Keesler Air Force Base in Ocean Springs, Mississippi. Robillard is one of the leaders of the G-LIT initiative.
“Because of its unique mission, military medicine has specific needs,” noted Robillard. “Not only are service personnel moved anywhere in the world on short notice, but they may often find themselves in harm’s way. To do the best possible job, military medicine is working to develop an electronic medical record for every serviceman and dependent that will literally follow these individuals anywhere they travel.”
Like their counterparts in civilian medicine, military planners quickly recognized that laboratory test data is the major part of most people’s medical record. Thus, to create a complete and accurate electronic medical record, a major first step was to develop a way for each laboratory operated within the military to feed lab test data to a central repository in a universal format. As primary reference testing sources, LabCorp and Quest Diagnostics must also have that same capability.
“The military’s effort to develop an effective electronic medical record is quite complex,” stated Gregory Craigmiles, Captain, U.S. Navy, Medical Service Corps, DoD Center for Clinical Laboratory Medicine, Rockville, MD. “There are approximately 23 ‘eGov’ initiatives being pursued as government-wide objectives. The Office of Management and Budget assigned each initiative to a ‘managing partner’ department or agency.
“The Department of Health & Human Services (HHS) was designated as managing partner for the ‘Consolidated Health Informatics’ eGov initiative, or ‘CHI’,” he continued. “HHS identified the Centers for Medicare & Medicaid Services to lead the work. The Department of Defense is one of several lead partners in this initiative, along with the Department of Veterans Affairs, National Institutes of Health, Centers for Disease Control and Prevention, and Indian Disease Control and Prevention, and Indian Health Service. The laboratory goal in this initiative is to standardize laboratory test results, successfully operationalize the process, maintain a high level of security for the data, reduce costs, and increase efficiency.”
“LOINC, with its universal identifiers for laboratory and other clinical observations, was chosen to be the standard for lab test data files,” explained Craigmiles. “HL-7 was selected as the electronic interface format standard and the CHCS generic interface system is used for data encryption. When we started on this initiative we had no idea of the complexity and size of the LOINC files. For instance, the LOINC master index currently contains 30,598 standardized names and codes for tests and clinical measurements descriptors.
“In our project, we have mapped about 6,100 LOINC codes to about 8,600 standard test file records in CHCS,” he continued. “We utilized the most commonly-used descriptors, as we wanted to make it easier to manage. The level of complexity as well as the use of the multiple legacy LIS systems proved to be an eye-opening experience.”
Using SNOMED To Map Anatomic Path Tests
STANDARDIZING TEST NOMENCLATURE for anatomic pathology and microbiology procedures are the most complex part of the military’s lab test standardization project.
Mapping AP procedures is proving to be the biggest challenge and Robillard’s team has not set a date for when this effort will begin. “This will be an even bigger undertaking than the clinical side,” explained Air Force Colonel Thomas A. Robillard. “Presently most of our larger lab sites use SNOMED codes for all aspects of the specimen, whereas the smaller sites use only ICD-9 codes. We are still evaluating how to standardize our AP informatics. However, we may convert all the sites to SNOMED and utilize that as the initial process and later integrate SNOMED with LOINC.”
Microbiology is a different story. “So far we’ve got a 70% success rate in mapping micro,” stated Robillard “But its complexity forced us to engage microbiology specialists to help us map the micro LOINC codes.
“To get a final answer, many micro procedures must scale down through numerous levels,” added Robillard. “As well, the specimen may contain more than one organism, so this can get pretty complex. Negatives are easy; it’s the positive results that take lots of discrete steps, such as the separate steps needed to evaluate antibiotic susceptibilities. Computer interfaces are harder with microbiology. And don’t forget we must cross all 103 sites and the private sector labs.”
“Corporate help for this government project has been considerable,” said Robillard. “Science Applications International Corporation (SAIC) modified the software for us from the original Composite Healthcare System of the DOD and also the software from the Decentralized Hospital Computer Program of the VA. This then provided us with a common base to work from. In working with SAIC, LabCorp, and Quest Diagnostics, we’ve discovered a common agreement among the government and the private sector about the necessity to standardize the healthcare process. That common purpose helped make headway on our lab data standardization project.”
Colonel Robillard spoke on LOINC and the military’s lab regionalization program at the Executive War College in May 2000. Since then, his team has made considerable strides in the laboratory standardization program. “We are currently doing simulations of integrated lab test data feeds from multiple labs by using mirror images of data in the system,” observed Robillard.
Alpha Testing To Begin
“By this fall, we should to be ready for alpha testing with live data. We will have the capability to validate our LOINC code mapping and see it in action. This will involve laboratories at least seven sites across several states,” he continued. “Our criteria was to include large laboratories with smaller feeder sites, like several mini-networks. All military divisions and the VA are represented, allowing us to check the accuracy of data flowing back and forth within the networks and across services, covering about 2,000 lab tests.
“The seven lab sites we select for the alpha test of our LOINC project will involve about three million tests per year,” said Robillard. “When we fully implement this system in all participating labs, we anticipate handling about 45 million tests. Keep in mind that this is only clinical pathology and each test may have numerous descriptors.”
The impending live test represents the fruits of two years labor by Captain Craigmiles and his team. It’s been a massive effort to standardize all laboratory files and map them using the LOINC nomenclature. Standardization mapping is 70% complete.
Lots Of Resources
“LOINC provides a good tool for mapping lab test files,” noted Craigmiles. “But it required considerable resources to get to our current mapping level. Mapping lab tests through LOINC would have gone faster had we been able to start off with a new computer system,” added Craigmiles, “but we had to use the legacy systems already in use at 103 lab sites in the United States and other countries.
“This project proceeded in several steps,” he continued. “First, the DoD team developed the Laboratory Standard File and submitted it to SAIC. The Standard File provided laboratory test order names and associated LOINC component result descriptors for use by all DoD laboratories. SAIC modified CHCS to incorporate the Standard File and required LOINC fields. Second, SAIC, working with the individual sites, performed a system-wide conversion to implement the Laboratory Standard File. The next step will include validation of the Standard File and mapped LOINC components during the upcoming G-LIT alpha test.
“We’ve mapped several different types of tests. It’s required many talented laboratorians in our DoD labs who volunteered their time to get us to the point we are today. Chemistry and hematology were a snap compared to microbiology. Some of the immunology and cell marker tests hepatitis panels were more time consuming, as were the more complex molecular tests.
Mapping Across Labs
“When you have to map across the test catalogs of all laboratories and ensure they are identical, that is where the labor needs climb at a logarithmic pace,” noted Robillard noted. “We didn’t track time on this project with precision, but we did have eight people working full-time on this project and several of them put in many extra hours. Lots of correlations had to be done between different labs to validate that we had accurately mapped their test catalogs.
“Even though we are 70% complete, we must do ongoing updates to include the many new tests released every month,” added Robillard. “Another problem is that LOINC does not have codes for all the new tests in proteomic and genomic testing. To address this, the DOD works with Clem McDonald, M.D. of the Regenstrief Institute in Indianapolis, Indiana to add new codes to the sys- tem. He is Chairman of the LOINC Laboratory Committee.”
Standardized Lab Data
“Progress towards our goal of standardized laboratory test data has been steady,” stated Craigmiles. “We finally have a system in which each lab result record will have a standard analyte name, measured property, timing, type of sample, type of scale, and methodology (where relevant). LOINC provides for all these parameters, and is very specific.
“We anticipate that this is the base for future data mining,” he continued. “Present data mining is problematic as there is no true standardization when crossing data across several laboratories. Our vision is to be data mining our global laboratory records within three to five years.”
Besides the obvious benefits if supporting a universal patient medical record, the military’s G-LIT project will generate sizable labor savings and a reduction of errors. Robillard and Craigmiles expect labor savings will come from order entry, billing and rekeying of information. Such savings should become measurable within six to 12 months. Increased consistency with file maintenance will also be a big improvement.
There has been one unintended management consequence from this LOINC project. “When you define your computer files, you are also defining your business practices,” stated Robillard. “As a result, we’ve gained new insights into our own lab organization as well as that of the commercial laboratories. This is pointing us to new areas of improvement.
“Moreover, as our labs begin to speak the same language of LOINC, we expect reductions in testing,” he added. “This will reduce lab test costs. In particular, as a serviceman goes from one location to another, the physician will have a better understanding of what tests have already been completed. This is particularly useful in the more complex testing areas such as hepatitis and molecular testing.
More In-House Testing
“We also anticipate that our LOINC-based capability will allow us to bring more testing in-house,” Robillard predicted. “Our hub labs will be better positioned to service smaller labs in our system. All this will mean savings for the U.S. government. We don’t have the numbers yet, but we will closely monitor the savings.”
Second phase projects include the concept of one central repository for all laboratory records. “This is still a few years into the future,” offered Robillard. “But we have started work on OOT (Object-Oriented Technology) as a way to bring all the clinical data together for the physician and support the fully-integrated continuum of care.
“A couple of key concepts dominate our OOT philosophy,” he continued. “One, it will allow us to encapsulate procedures and data. Two, it can support polymorphisms across objects containing data. Third, all this can be associated with hierarchical relationships.
“This will be the ultimate system, and by partnering we are making these things happen,” said Robillard. “The future is paperless, and LOINC and OOT are tools to help us accomplish this. As for total centralization of lab testing services across the globe, we are still in the planning stage and we may still decide to use the hub-and- spoke network system.”
These are advantages of LOINC. But what about disadvantages? “LOINC currently cannot support front-end standardization,” points out Robillard. “That requires requires human intervention and a learning curve to standardize the ordering selection of tests. We are training people at all 103 laboratory sites to handle this function. Because of all the cultures involved, both nationally and internationally, it can get quite complicated. Also just like the private sector, staff turnover further complicates this effort.”
One of Robillard’s tips for success in this whole process is to train a medical laboratory person to become an information specialist. “You need the files built the right way the first time,” he said. “It is difficult to train an informatics person to be a lab person.”
The military’s effort to standardize lab test data across 103 individual laboratories is ambitious, but it demonstrates that the healthcare system wants such standardization. Participation by LabCorp and Quest Diagnostics in the G-LIT program gives them a head start on this important capability.
Are other laboratories using LOINC as a path to standardization? Yes! Mayo Medical Laboratories and ARUP Laboratories are mapping their test files. North of the border, labs in British Columbia and Ontario are adopting LOINC codes province-wide. These projects demonstrate the importance of standardized laboratory test data.
Lessons Learned From LOINC: Important Implementation Advice
THREE YEARS OF HARD KNOCKS and tough experience have marked the military’s effort to standardize lab test data across multiple laboratory sites. Air Force Colonel Thomas A. Robillard and Navy Captain Gregory Craigmiles offer advice and lessons learned on using LOINC.
- Train a medical technologist to work on the file structure of LOINC. Get them to be familiar with the lab database and the use of LOINC.
- LOINC codes are not intended to transmit all possible information about a test, they are to identify the test result. However, a message source code can be more specific; e.g. result code—blood culture; and sample—pump blood.
- Each LOINC record corresponds to a single test result. The record includes specifications for the analyte, the property measured timing, the type of sample, the type of scale (e.g. quantitative, nominal, or narrative), and method when relative. It also contains information on the amount, route, and timing of physiologic or pharmacologic challenges.
- Verify that laboratory requisitions correctly reflect what is being ordered in LOINC. By using LOINC there is more specificity of test order and this forces retraining of test ordering patterns for more specificity and “sameness” of test ordering across sites. It requires retraining all personnel in both ordering the test and data entry.
- LOINC and SNOMED collaborate to ensure a consistent, unambiguous clinical reference that uses the strengths of each. This will take significant effort to update all lab sites, as some labs may still use ICD-9 codes. Linking the two supports the goal of an integrated continuum of care.
- Limitations of LOINC are in fine details. The code will not define the instrument used in testing, fine details about the site of collection, whether stat or routine, who verified the result, the size of the sample collected or the place of testing; e.g. lab or bedside.
- Output must be intelligible for the user. Close scrutiny of the output is important, as there is significant detail in the coding, however, much of this information is not needed to make a clinical decision.
- Most file-mapping issues of laboratory procedures are most easily addressed by those that work in the laboratory, not by informatic specialists.