A lab information system ("LIS") is a class of software that receives, processes, and stores information generated by medical laboratory processes. These systems often must interface with instruments and other information systems such as hospital information systems (HIS). A LIS is a highly configurable application which is customized to facilitate a wide variety of laboratory workflow models. Deciding on an LIS vendor is a major undertaking for all labs. Vendor selection typically takes months of research and planning. Installation takes from a few months to a few years depending on the complexity of the organization. There are as many variations of LISs as there are types of lab work. Some vendors offer a full-service solution capable of handling a large hospital lab's needs; others specialize in specific modules. Disciplines of laboratory science supported by LISs include hematology, chemistry, immunology, blood bank (Donor and Transfusion Management), surgical pathology, anatomical pathology, flow cytometry and microbiology. This article covers clinical lab which encompasses hematology, chemistry and immunology.
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Laboratory Information Systems are often part of an integrated informatics solution which involves many disparate applications. Use of an LIS is a critical piece of the clinical IT spectrum of systems and contributes significantly to the overall care given to patients. The LIS is used in inpatient and outpatient settings and in many cases is designed to support both. From an outpatient/ambulatory perspective, LIS interaction frequently begins after a physician has arrived at an initial diagnosis. For example, a patient enters the hospital looking pale and complaining of fatigue. The physician, suspecting anemia, might decide to order a complete blood count (CBC). In an inpatient setting when that patient is admitted into the hospital, the system is used to order tests, provide specimen processing assistance, receive the results from analyzers and deliver lab reports to the attending physician.
An order is placed in the system usually by a physician or laboratory scientist. The order or lab request contains a list of tests to be performed on one or more patient specimens (e.g., blood or urine). In many cases, each order is tracked with a unique identifier. This identifier (which is usually a number) is often referred to as Lab ID. In this hypothetical case, a CBC is ordered which is a panel of sub-tests including white blood cell count, red cell blood count and other blood-related tests.
A phlebotomist will be called on to collect the specimen(s) from the patient. Often, different specimens will be collected, so as to provide different tubes (each with a specific cap color) for each analyzer that will process the samples. In this case, the appropriate specimen (using a vacutainer tube with a lavender top) is taken from the patient and labeled with a bar code specimen label produced by the LIS. The LIS will print barcode labels (with the unique lab ID) for the draw tubes. In some cases, more advanced LIS products will also provide a unique identifier for each specimen. The newest of these systems are using RFID to eliminate human errors and automate the data capture. Serialized data through barcode or RFID provides the ability to track the specimen's chain of custody from the point it is taken from the patient to the point that it gets discarded. The specimen-accession-patient hierarchy is linked in a tree like numeric structure. In other cases,the patient is identified by a Lab ID linked to the patient's demographic record through the Hospital number.
After the specimen is collected, it is sent/brought to the lab for processing typically in a batch. This event should be recorded in the LIS. On reception of the specimen in the testing lab, either manual or automated lab work can begin. Many tests, such as CBCs or Chemistry profiles, are performed by automated analyzers.
Most LIS systems can be configured to download the specimen data to an analyzer either after the order is placed or when a specimen is received in a testing lab. When the specimen's barcode is read by the instrument, the unique ID from the specimen label is matched with the order previously downloaded to the instrument. This system is often called "Batch Download". A more efficient system is called "Host Query", where the instrument reads the barcode on the specimen and "queries" the LIS for the test orders. The LIS will be listening on a communication port for queries and will download the requests only when required. In cases where the LIS transmits data such as test orders or control messages to analyzers the communication is set up to be bi-directional.
When results of lab tests are available, they are entered into the system manually or automatically downloaded from an instrument. Once these results are double-checked by the Medical Laboratory Scientist or autoverified, they are released. Released results are often automatically printed or written on lab reports which are delivered to the attending physician or clinic. Results must be verified and released to attending physicians as soon as possible.
Lab Reports are the final output of all LIS systems and, in many cases, the primary LIS interaction with healthcare professionals outside the lab. The reports can either be printed or faxed in paper-based labs; they can be delivered via email or file in paperless labs. The degree to which an LIS supports customizable lab reports and flexibility in modes of delivery of results is one major factor in determining its success in the marketplace.
Laboratory Information Systems commonly support the following features:
In addition LISs commonly support the following:
There are many laboratory disciplines requiring the support of computerized informatics. These include: