By Grace Robinson,2014-03-29 07:01
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    Multiple solutions for laboratory information systems (LIS) exist. Traditional systems have a local “host” database (i.e., the computer hardware and software) serving the information needs of the laboratory; the laboratory is the only “user.” In the current environment, the host is often physically remote from the laboratory and in fact the host may have multiple user laboratories. Many of the Computer Services questions may apply to host, user, or both, depending on how information services are organized in the laboratory. For laboratories which do not have host functions on site, the inspector should mark nonapplicable questions. However, the laboratory is responsible for ensuring that the provider of host functions meets CAP requirements (see GEN.42165, below).

The questions in this section do NOT apply to the following:

    1. Desktop calculators

    2. Small programmable technical computers

    3. Purchased services such as the Quality Assurance Service or Laboratory

    Management Index Service of the College of American Pathologists

    4. Micro computers used solely for word processing, spreadsheets, or similar single

    user functions

    5. Dedicated microprocessors or workstations that are an integral part of an analytic


**REVISED** 03/30/2005

GEN.42165 Phase II YES

    The components of the LIS are located at a facility other than the one under this CAP accreditation number, there is evidence that the remote facility complies with CAP requirements for host LIS functions.

    NOTE: The computer facility has been provided a copy of this Checklist, and has satisfactorily addressed the contents of the Computer Facility section, and all other pertinent items, with documentation provided to the laboratory director and the CAP inspector.

GEN.42457 Phase II YES

    In the judgment of the laboratory director, the functionality and reliability of the computer system (hardware and software) is adequate to meet the needs of patient care.

    NOTE: Patient and laboratory data should be available online for 1 year. The LIS server can store about 10 year’s data for all department of laboratory medicine.




    This section applies to laboratories where the computer facilities are housed. If the computer facilities are located at another site, mark these 4 questions and continue with the LIS/Computer Procedure Manual section.

GEN.42750 Phase I YES

    The computer facility and equipment is clean, well-maintained and adequately ventilated with appropriate environmental control.

    NOTE: The computer facilities are located in the place period cleaned, well maintained, and environmentally controlled...

GEN.42800 Phase II YES

Fire-fighting equipment (extinguishers) is appropriate for electrical components available.

NOTE: Appropriate fire extinguishers have prepared.

GEN.42850 Phase I YES

All wires and computer cables are properly located and/or protected from traffic.

    NOTE: All wires and computer cables have been enlaced and properly located. **REVISED** 03/30/2005

GEN.42900 Phase II YES

    The computer system is adequately protected against electrical power interruptions and surges.

    NOTE: UPS has been used for LIS server and Periodic testing UPS to ensure protection of data. We will check UPS regularly.




GEN.42950 Phase II YES

    LIS/computer procedures are clearly documented, complete and readily available to all authorized users.

    NOTE: Procedures are appropriate to the level of use of the system, and encompass the day-to-day activities of the laboratory staff as well as the daily operations of the Information Technology staff.

**NEW** 03/30/2005

GEN.42975 Phase II YES

There is a procedure for the support of the computer system.

    NOTE: The laboratory have a procedure outlining the support of the system, including local maintenance, vendor support and emergency contact information.

GEN.43000 Phase II YES

    There is documentation that laboratory computer procedures are reviewed at least annually by the laboratory director or designee.

NOTE: The director of every Lab sign and carefully reviewed.




**NEW** 03/30/2005

GEN.43011 Phase II YES

There is documentation of all hardware modifications.

NOTE: There is record that notes all hardware modifications.

GEN.43022 Phase II YES

    There is documentation that programs are adequately tested for proper functioning when first installed and after any modifications, and that the laboratory director or designee has approved the use of all new programs and modifications.

    NOTE: When the programs have already been tested for functioning when first installed and any modifications. Laboratory director has approved.

**NEW** 03/30/2005

GEN.43033 Phase II YES

Customized programs are appropriately documented.

NOTE: Customized programs are already monitored.

GEN.43044 Phase II YES

    There is an adequate tracking system to identify all persons who have added or modified software.

    NOTE: All persons who have added or modified software are monitored and it can be examined in


GEN.43055 Phase II YES

    There is documentation that all users of the computer system receive adequate training initially, after system modification, and after installation of a new system.

    NOTE: All persons of the computer system must been trained before they use LIS.

GEN.43066 Phase II YES

    There is a responsible person in the laboratory that is notified of significant computer malfunction.

    NOTE: Prof. Liang and Peng, Lecturer Wu are the routine system administrator of LIS.

**REVISED** 03/30/2005

GEN.43077 Phase II YES

    The laboratory information system has been validated for blood banking/transfusion medicine activities.

    NOTE: Blood banking/transfusion system has been used for some time, and the LIS has been validated at initial installation, and when a change is made to the system.

GEN.43088 Phase II YES

    There is a documented process to verify the integrity of the system (operating system, applications and database) after restoration of data files.

    NOTE: The computer system have been checked after restoration of data files to ensure that no inadvertent alterations have occurred that might affect clinical result reporting. The laboratory director is responsible for determining verification procedure(s) appropriate to the laboratory.




**NEW** 03/30/2005

GEN.43099 Phase II YES

Downtime for maintenance is scheduled to minimize interruption of service.

    NOTE: Downtime for maintenance is scheduled at 8:00 pm in Saturday or Sunday.

GEN.43110 Phase II YES

    There is a documented schedule and procedure for regular maintenance of hardware and software either by maintenance contracts or documented in-house procedures.

    NOTE: There is a document that regulates the maintenance schedule of hardware and software.

**NEW** 03/30/2005

GEN.43121 Phase II YES

Service and repair records are available for all hardware and software.

NOTE: All Service and repair of hardware and software must be recorded.

GEN.43132 Phase II YES

There is evidence of ongoing evaluation of system maintenance records.

    NOTE: Hardware manufacturers have a standard maintenance schedule that must be documented. In addition, regularly scheduled maintenance has been documented for printers etc.




    The following questions concern unauthorized users. If a system is vulnerable, steps should be taken to prevent unauthorized access.

GEN.43150 Phase II YES

    There are explicit documented policies that specify who may use the computer system to enter or access patient data, change results, change billing or alter programs.

    NOTE: Policies has been defined those who may only access patient data and users who are authorized to enter patient results, change results, change billing, or alter computer tables or programs.

    **REVISED** 03/30/2005

GEN.43200 Phase I YES

Computer access codes (security codes, user codes) are in place to limit individuals’ access to

    those functions they are authorized to use and the security of access codes is maintained (e.g.,

    inactivated when employees leave, not posted on terminals).

    NOTE: The laboratory has established security (user) codes to permit only specifically authorized individuals to access patient data or alter programs. A system that allows different levels of user access to the system based on the user's authorization is desirable and usually provides effective security.

**NEW** 03/30/2005

GEN.43262 Phase I YES

    Policies and procedures are in place to prevent unauthorized installation of software on every computer used by the laboratory.

    NOTE: Laboratory computers often serve multiple functions. Many of these computers are connected in a network. The security of the system in our laboratory is sufficient to prevent the casual user from installing software. Such unauthorized installation may not allow to operating system. Every operating system must procedures to restrict certain users from installing software.

GEN.43325 Phase II N/A

    Our Lab do not use a public network, such as the Internet as a data exchange medium, there are adequate network security measures in place to ensure confidentiality of patient data.

    NOTE: Our lab does not connect to public network. Also, systems is in place to protect network traffic, such as "fire walls" and data encryption schemes.

**NEW** 03/30/2005

GEN.43387 Phase II N/A

The laboratory has procedures to ensure consistent with HIPAA?

    NOTE: The Health Information Portability and Accountability Act (HIPAA) is a federal law requiring protection of patients’ health care information. The law requires maintenance of confidentiality when patient data is transmitted between two organizations. Also, organizations must establish appropriate relationships between sender and receiver of patient data to ensure that the information will be used as intended.

The laboratory must periodically monitor compliance with HIPAA.




**REVISED** 03/30/2005

GEN.43450 Phase II YES

    There is documentation that all calculations performed on patient data by the computer are reviewed annually, and when a system change is made that may affect the calculations.

    NOTE: Errors can be inadvertently introduced into established computer programs. Calculations, algorithms, and/or rules involving reportable patient results is rechecked and documented to ensure accuracy.

    When calculations are performed by an LIS shared by multiple laboratories, we review at one location and each individual laboratory have a copy of the review documentation. Any calculations specific to an individual laboratory’s methodology is reviewed by that laboratory and the

    documentation of that review is available.

GEN.43600 Phase I YES

System data tables are set up to detect absurd values before reporting.

    NOTE: Our lab set up a system data tables to check the result against a defined reportable range and critical values for the test, and the appropriate number of decimal places are present. When the value of patients is over reportable range, the computer will give some alerts.

GEN.43750 Phase II YES

    The system provide for comments on specimen quality that might compromise the accuracy of analytic results (e.g., hemolyzed, lipemic).

NOTE: The system will provide for comments on specimen quality to the user.

GEN.43800 Phase II YES

    There is an adequate system to identify all individuals who have entered and/or modified patient data or control files.

    NOTE: 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 provide an audit trail to document each person involved. For example, a single accession number having orders for electrolytes and a lipid panel may have testing done by two or more individuals. The laboratory is able to identify the responsible personnel who performed each test and posted the data. This includes sequential corrections made to a single test result.

    With point-of-care testing, if the individual performing the test is different than the individual entering test data into the LIS, both are uniquely identified by the system and retrievable by audit trail.

**NEW** 03/30/2005

GEN.43812 Phase I YES

    The laboratory has a process to ensure appropriate routing of patient test results to physicians.

    NOTE: During the course of their medical care in a health care system, the location of a patient may change multiple times. Patient test results are routed to the responsible physician(s) regardless of patient location.

GEN.43825 Phase II YES

    Manual and automated results are entered verified before final acceptance and reporting by the computer.

    NOTE: Data entered into the computer system either manually or by automated methods is reviewed by an authorized individual who verifies the accuracy of the input data before final acceptance and reporting by the computer. They are checking the result against the reportable range and critical values for the test. Depending on the local environment, this may or may not require a second person. Verification procedures generate an audit trail.

GEN.43837 Phase II YES

    There are documented procedures to ensure reporting of patient results in a prompt and useful fashion during partial or complete downtime and recovery of the system.

    NOTE: There is a Procedure for Emergency Service of LIS during partial or complete downtime and recovery of the system.




GEN.43900 Phase II YES

    A complete copy of archived patient test results can be reprinted, including original reference ranges and interpretive comments, including flags or footnotes that were present in the original report, and the date of the original report.

    NOTE: Stored patient result data and archival information are easily and readily retrievable within a time frame consistent with patient care needs.

GEN.43920 Phase I YES

    When multiple identical analyzers are used, they are uniquely identified such that a test result is appropriately traced back to the instrument performing the test.

    NOTE: The system will identify the analyzer and show the origin analyzer to the user.

**NEW** 03/30/2005

GEN.43933 Phase I YES

    The laboratory has a process to monitor computer system performance, to ensure that the data storage capacity and performance of the system are sufficient to meet the patient needs of the organization.

    NOTE: We set and monitor thresholds for acceptable storage capacity, average response time and system resource utilization. Laboratory data is available on-line for a reasonable period of time, which determined by the needs of the organization.

GEN.43946 Phase II YES

    There are documented procedures for the preservation of data and equipment in case of an unexpected destructive event (e.g., fire, flood), software failure and/or hardware failure, and

    these procedures allow for the timely restoration of service.

    NOTE: These procedures include (but are not limited to) steps to limit the extent of the destructive event, protocols for periodic backing up and storing of information, procedures for off-site storage of backup data, and protocols/procedures for restoring information from backed up media. The procedures specifically address the recoverability of patient information. Changes to hardware and software commonly are reviewed and reevaluation of these documented procedures. The procedures specifically address the physical environment and equipment.

GEN.43972 Phase II YES

    Emergency is service for both computer hardware and software available at all necessary times.

    NOTE: There is a Procedure for Emergency Service of LIS for both hardware and software.

GEN.44000 Phase II YES

Storage data media (e.g., tape reels, disk cartridges) are properly labeled, stored and

    protected from damage and unauthorized use.

NOTE: There is a record for storage and label of media data.

GEN.44100 Phase II YES

    Computer error messages are that alert computer users of imminent problems monitored and the error messages are responded system tested periodically.

    NOTE: Computer error messages come in many forms, and usually signify an event that requires immediate attention to rectify a situation. Examples of error messages include system errors, low disk space warnings, database validation errors, exceeding environmental limits, etc. There is a person responsible for acknowledging the message, a defined system of notification, and response to the situation. The error message response process is periodically tested.

GEN.44150 Phase II YES

    There is documentation of responses to any error messages during the system backup.

NOTE: The error messages will be record in log during system backup.

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