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"Laboratory Information System (LIS" Laboratory Information System (LIS)

OBJECTIVE To ensure that all components of the LIS meet ISO 15189 standards for high quality patient care.

"Critical Elements" Critical Elements for which the Laboratory Director must have authority and responsibility include: reliability of data output for patient management accuracy of calculations appropriateness of reference intervals confidentiality of data preservation of records

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Components Environment Procedure Manual System Security Data Entry and Reports Data Retrieval and Storage Hardware and Software System Maintenance Interfaces Network

ENVIRONMENT Is the computer facility and equipment clean, well‑maintained and adequately ventilated with appropriate environmental control? Is fire‑fighting equipment (extinguishers) available? Are all wires and computer cables properly located and/or protected from traffic? Is the computer system adequately protected against electrical power interruptions and surges?

PROCEDURE MANUAL Are procedure manuals clearly documented, complete and readily available to all authorized users? Is there documentation that laboratory computer procedures are reviewed at least annually by the Laboratory Director or designee?

PROCEDURE MANUAL Are there documented procedures for the preservation of data and equipment in case of an unexpected destructive event (e.g. fire, flood), software failure and hardware failure?

SYSTEM SECURITY Are major computer programs protected to prevent alteration or destruction? Are there explicit documented policies that specify who may use the computer system to enter or access patient data, change results, change billing or alter programs?

SYSTEM SECURITY Are computer access codes (security codes, user codes) used to limit access to only those functions the individuals are authorized to use? Is the security of access codes maintained (e.g. deleted when employees leave, not posted on terminals)?

DATA ENTRY AND REPORTS Are manual and automated result entries verified before final acceptance and reporting by the computer? If the laboratory employs autoverification procedures for tests performed on any instrument(s), is there documentation that the laboratory has validated the autoverification process against rules prescribed by the Laboratory Director before implementation? e.g.   LDL must be less than Total Cholesterol    The sum of LDL & HDL must be less than total          cholesterol

DATA ENTRY AND REPORTS Is there documentation that the autoverification process has been tested at least annually, and whenever there has been a change to the system? Is there documentation that calculations performed on patient data by the computer are periodically reviewed?

DATA ENTRY AND REPORTS Does the Laboratory Director review and approve the content and format of all computer‑generated patient reports at least annually?

DATA ENTRY AND REPORTS 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, does the system provide an audit trail to document each person involved?

DATA ENTRY AND REPORTS If point‑of‑care testing results are entered into the LIS, are they verified, and is the person performing the test, as well as the person verifying data entry, uniquely identified by an appropriate audit trail?

DATA ENTRY AND REPORTS Are result entries checked against a defined range of expected results to detect absurd values before reporting? Is there a documented system to ensure that all revised reports for previously reported incorrect (erroneous) patient results are identified as revised, corrected, or amended on all forms of patient reports (paper, video displays, etc.)?

DATA ENTRY AND REPORTS When a revised report is issued, are the original information and changed information reported together? When there are multiple sequential corrections of a single test result, are all corrections listed in sequential order, including dates and results of corrections made on subsequent reports?

DATA ENTRY AND REPORTS Are both original and revised patient results retained for at least 2 years? Does the system provide for comments on specimen quality that might compromise the accuracy of analytic results (e.g. hemolyzed, lipemic)?

DATA ENTRY AND REPORTS Is there an adequate system to identify all individuals who have modified patient data, control files, or computer programs?

DATA RETRIEVAL AND STORAGE Can archived patient result data be retrieved rapidly (less than 4 hours) when necessary? Can a complete copy of archived patient test results be reprinted, including original reference ranges and interpretive comments?

DATA RETRIEVAL AND STORAGE When multiple identical analyzers are used, are they uniquely identified such that a test result may be appropriately traced back to the instrument performing the test?

DATA RETRIEVAL AND STORAGE Is the data storage capacity of the computer system sufficient to meet the patient care needs of the organization? Are storage data media (e.g. tape reels, disk cartridges) properly labeled, stored and protected from damage and unauthorized use?

DATA RETRIEVAL AND STORAGE Is there a documented system to prevent loss of patient result data in case of hardware or software failure? Are automatic alarms that alert computer operators of imminent problems monitored and tested periodically?

HARDWARE AND SOFTWARE Is there a documented schedule and procedure for regular maintenance of hardware and software either by maintenance contracts or documented in-house procedures? Is there evidence of ongoing evaluation of system maintenance records?

HARDWARE AND SOFTWARE Is there a documented system to verify the integrity of the system after restoration of data files? Is there documentation of responses to error messages during the system backup?

HARDWARE AND SOFTWARE Is there a documented record of all hardware and software modifications? Is there documentation that the Medical Director or designee approves all changes, additions and deletions in programs, the test library, and major computer functions before they are released?

HARDWARE AND SOFTWARE Is there documentation that programs are adequately tested for proper functioning when first installed and after any changes or modifications have been made?

HARDWARE AND SOFTWARE Is there documentation that all users of the computer system receive adequate training initially, after system modification, and after installation of a new system? Is there a responsible person (e.g. Computer System Manager) in the laboratory who is notified of significant computer malfunction?

SYSTEM MAINTENANCE Is downtime for maintenance scheduled to minimize interruption of service? Are there documented procedures to ensure data integrity and uninterrupted delivery of laboratory services during partial or complete downtime and recovery of the system, such that patient results are reported in a prompt and useful fashion?

SYSTEM MAINTENANCE Are there documented procedures for the changes in laboratory functions necessary during the partial or complete shutdown and recovery of systems that interface with the laboratory system? Is there a documented record of unscheduled downtime, system degradation (i.e. increased response time), or other computer problems that includes reasons for failure and corrective actions taken?

SYSTEM MAINTENANCE Is emergency service for both computer hardware and software available at all necessary times? In the judgment of the laboratory Medical Director, does the computer system meet patient care needs?

INTERFACES If the system uses an interface to populate data into another computer system, is a documented encoding and transmission scheme such as HL-7 utilized? As applicable, are reference ranges and units of measure for every test transmitted with the patient result across the interface?

INTERFACES Are acceptable transmission limits established for data throughput by the interface engine, and is this parameter periodically monitored and recorded? If data in other computer systems can be accessed through the LIS (e.g., pharmacy or medical records), are there documented policies to prevent unauthorized access to that data through the LIS?

INTERFACES If the facility uses a public network (such as the Internet) as a data exchange medium, are there adequate network security measures in place to ensure confidentiality of patient data? Is there a documented system in operation to periodically verify that patient results are accurately transmitted from the point of data entry (interfaced instruments and manual input) to all types of patient reports (both paper and video displays)?

NETWORKS Is there periodic monitoring of network performance and availability to all sites? Is the network equipment accessible, well-maintained, and adequately labeled, showing which devices are using a specific port?

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