LABORATORY INFORMATION SYSTEM

LABORATORY INFORMATION SYSTEM

What is LIS (Laboratory Information System)

Ø  Computerized information management system designed for laboratories Manages lab data from sample log-in to reporting

Ø  Interfaces with analytical instruments

Ø  Sorts and organizes data into various report formats

Ø  Stores data for future reference and use

Information Available from LIMS

Ø  Project, Sample, and Test documentation

Ø  Sample tracking history within laboratory

Ø  Reporting results (hardcopy, electronic file)

Ø  Financial information by test, client, dates

Ø  Information on productivity

LIS FEATURES

Ø  Patient registration and report printing

Ø  Barcode printing

Ø  Instrument interfacing

Ø  Inventory management

Ø  Training

Ø  Interconnecting central lab with centers

Ø  SMS and email of reports

Standards for Laboratory Information Systems

Laboratory Information System Validation

The laboratory must maintain documented validation data for the LIS. All steps and results of validation must be documented and available for review.

v  Document the installation of new computer programs when first installed. Any changes or modifications to the system must also be documented, and the laboratory director or designee must approve all changes before they are released for use.

v  Document testing of all possible anticipated permutations of processes (for example, entry of normal, abnormal low, abnormal high, critical and absurd results).

v  Document testing and validation of all calculations that are performed by an LIS.

v  Document the validation of all data transmitted from the LIS to other computer systems and their output devices.

v  Document the verification of reference ranges and comments as well as actual testing results.

v  Document a validated emergency preparedness system.

Generation of Reports

v  The LIS must be capable of generating accurate and complete copies of study-participant results.

v  The laboratory must be capable of reprinting a complete copy of archived study-participant test results. –

v  Results must include original reference ranges and interpretive comments.

v  Results must include any flags or footnotes that were present in the original report.

v  Results must include the date of the original report.

v  Stored study-participant result data and archival information must be easily and readily retrievable within a time frame consistent with study/trial needs (e.g., within 24 hours).

Audit Trails

Computer time-stamped audit trails must be used by the LIS. The laboratory must ensure that, when individual tests from a single test order (e.g., multiple tests with same accession number) are performed by separate individuals and the test result is entered into the LIS, the system must provide an audit trail to document each person involved (includes sequential corrections made to a single test result).

If auto-verification is used, then the audit trail must reflect that the result was verified automatically at a given time and date.

Access and Security

v  The laboratory must ensure that LIS access is limited to authorized individuals.

v  Documentation must be maintained indicating that all users of the computer system receive adequate training both initially and after system modification.

v  The laboratory’s LIS policies must define those who may only access study- participant data and users who are authorized to enter study-participant results or modify results

v  The laboratory must establish user codes to permit only specifically authorized individuals to access study-participant data or alter programs. –

v  A user code is typically assigned to each employee upon employment or at the point of completion of training.

v  All employees who will use the system should have a user code that is linked to an appropriate level of access, as determined by his/her job requirements.

v  The system typically maintains active employees’ access codes as a database from which hard-copy reports may be created.

v  User access codes should be inactivated upon termination of an employee. The user code, once inactivated, should not be used for another employee.

v  User codes must not be shared with coworkers.

v  The security of the system must be sufficient to prevent unauthorized personnel from installing software. Unauthorized installation of software may expose the system to a security breach, virus, worm, or spyware.

Documentation

v  The laboratory must maintain a written SOP for the operation of the LIS and should follow these guidelines:

v  Procedures must be appropriate and specific to the day-to-day activities of the laboratory staff as well as the daily operations of the Information Technology staff. Current use of LIS must match policy and procedure documents.

v  The purpose of the computer program, the way it functions, and its interaction with other programs must be clearly stated.

Technical Support and Preparedness

v  The laboratory must have a documented back-up system and accompanying procedure for the LIS based on the following guidelines in an effort to maintain integrity of data and reduce impact and severity of unscheduled downtimes and destructive events:

v  The laboratory must have a procedure outlining the technical support staff and/or vendor for the system including emergency contact information.

v  Documented procedures and disaster-preparedness plan must exist for the preservation of data and equipment in case of an unexpected destructive event (e.g., fire, flood) or software failure and/or hardware failure, allowing for the timely restoration of service.

v  Documented procedures must exist to ensure reporting of study-participant results in a prompt and useful fashion during partial or complete LIS downtime, to include: –

v  Steps to prevent the corruption and/or loss of active data

v  Procedures for periodic backing up and storing of information

v  Procedures for off-site storage of back-up data

v  Procedures for restoring information from backed-up media

v  The LIS should be run in a closed environment, as much as is practical, to protect participant confidentiality.

v  The Application of the GLP Principles to Computerised Systems

v  The following considerations will assist in the application of the GLP Principles to computerised systems outlined above:

Inventory management

Ø  Record as the supplies come

Ø  Record reagents used as testing is done

Ø  The difference is inventory

Ø  Check it against average usage and order if necessary

Ø  Use 2D barcode provided by the manufacturer.

Ø  Scan reagents as they arrive

Ø  LIS tells about lot and bottle use

Ø  Define re-order level

Ø  Reagent lot and bottle (Date and time of first use)

Quality management

Ø  We are expected to run 2 levels control for common tests

Ø  30 X 2 ie. 60 values obtained

Ø  Print , feed the values

Ø  Plot charts

Ø  If the day starts at 9:30 when to take corrective action and when does the work begin ?

Advantages of LIMS Use

Ø  Fewer transcription errors & faster processing with direct instrument uploads

Ø  Real time control of data quality with built in QC criteria

Ø  Direct report generation meeting specific client requirements

Ø  Direct electronic reporting to clients or direct client access to data

Disadvantages/Concerns

Ø  Customization of LIMS/interfaces required for specific lab/client needs

Ø  Adequate validation to ensure data quality

Ø  Data integrity and confidentiality, especially when clients have direct access to data

Ø  Limited interface between lab & field computer systems

SEPSIS BIOMARKER: CURRENT CONCEPT

Sepsis biomarkers: Current Concept

Lactate, C-reactive protein (CRP), and procalcitonin (PCT) are commonly used for classification and management of septic patients. Lactate is used to assess tissue perfusion and is elevated with tissue hypoxia caused by hypoperfusion in severe sepsis and septic shock but not in early sepsis. The SSC guidelines recommend measuring lactate within three hours after sepsis is suspected; a lactate > 4 mmol/L warrants fluid resuscitation. If initial concentration is above that cut-off, lactate is remeasured within a few hours to evaluate response to therapy. Patients achieving a lactate clearance > 10% have better prognoses.

CRP and PCT are both inflammatory biomarkers, widely investigated for sepsis diagnosis. CRP is an acute-phase reactant elevated in many inflammatory conditions. PCT, the precursor of the thyroid hormone calcitonin, is also increased in the systemic inflammatory response to infection. The Food and Drug Administration-approved PCT testing is indicated in conjunction with other laboratory and clinical findings for the diagnosis of bacterial infection and sepsis in critically ill patients. Overall, most studies indicate superior clinical utility (sensitivity and specificity) of PCT over CRP for the identification of sepsis among patients with systemic inflammation. The concentration of PCT correlates with severity of disease, while CRP is not helpful for stratification.

The utility of PCT remains controversial and it is not universally adopted in clinical practice. Both CRP and PCT are listed among the inflammatory variables that serve as criteria to diagnose sepsis, but the SSC guidelines state that the ability of PCT or CRP to discriminate between non-infectious and infectious SIRS has not been demonstrated, and they issue no recommendations for utilization of either biomarker to identify infected patients among those with systemic inflammation. The SSC guidelines endorse PCT as a tool for antibiotic stewardship. In adults, low PCT concentrations can be used to direct cessation of antibiotics in critically ill patients; however, high PCT concentrations should not be used to intensify antibiotic therapy. The utility of PCT is still unknown in pediatric patients and neonates. PCT-guided antimicrobial therapy reduces antibiotic use without benefits in morbidity and mortality.

In sum, lactate, PCT, and CRP are helpful markers to manage patients with suspected sepsis by providing prognostic information and guiding therapy, but they have limited diagnostic utility in sepsis and no role at the early stages of sepsis.