Document expires June 2000
STANDING OPERATING PROCEDURE
Laboratory Computer Services Compliance with CAP
Accreditation Requirements
I. INTRODUCTION:
A. PURPOSE: To describe and review how the hospital and laboratory information system utilized by the Department of Pathology and Area Laboratory Services (DPALS), Landstuhl Regional Medical Center (LRMC), and subordinate medical treatment facilities (MTFs) is established, operated, maintained, and employed in manner which is in full compliance with requirements and recommendations of the College of American Pathologists (CAP).
B. SCOPE: This SOP applies to all personnel operating, maintaining, or otherwise using laboratory and hospital computer resources at LRMC to communicate and/or coordinate laboratory testing in support of patient care.
C. CLINICAL SIGNIFICANCE: The Composite Health Care System (CHCS) is a comprehensive and critical data communication system employed to automate every aspect of information management related to patient care at LRMC and subordinate medical treatment facilities. Adherence to the guidelines and requirements for accreditation of the College of American Pathologists is essential to ensuring that CHCS remains a reliable hospital and laboratory information system for providing suitable communication related to patient care.
II. PRINCIPLE: A list of questions with commentary is reviewed to assess adherence to and compliance with CAP accreditation requirements. Each organizational element subordinate to DPALS, LRMC, will ensure that the requirements reviewed herein are appropriately reflected in local written policies and procedures.
III. DETAILS:
A. Types Of Computer Services
[01.4217] Does the laboratory use a computerized laboratory information system (LIS), either on a stand-alone basis or as part of a hospital information system (HIS)?
YES. The Laboratory at LRMC employs a laboratory information system (LIS) module which is an integral part of the Composite Health Care System. The laboratory functionality of CHCS is referred to as CHCS-LAB.
[01.4218] Is the computer for the LIS used only by the laboratory?
NO. All aspects of health care and treatment are administered and executed through CHCS, not only by the medical laboratory, but by all other functionalities, including pharmacy, x-ray, patient appointments, patient administration, nutrition care, etc.
[01.4219] Is the laboratory computer a shared system, in-house (e.g., hospital computer shared by many departments)?
YES. CHCS is a shared, multi-module HIS which is used by workers in multiple functional areas.
[01.4220] Is the laboratory computer a shared system, regional (e.g., service company with multiple clients)?
YES. CHCS is an area-wide hospital information system which links together treatment and care delivery for Department of Defense (DoD) health care beneficiaries at over forty (40) DoD Medical Treatment Facilities (MTFs) throughout Europe (ref. figure "CHCS in Central Europe").
[01.4222] Does the institution have a computerized hospital information system (HIS)?
YES. Landstuhl Regional Medical Center hosts and employs the Composite Health Care System as its principle hospital information system (HIS). CHCS was developed and deployed under contract by the Science Applications International Corporation (SAIC). The system, including software and hardware, is owned entirely by the Department of Defense (DoD).
[01.4225] Is the LIS interfaced directly to other computer systems in the institution?
YES. Although CHCS is a stand-alone HIS which provides access to augmenting devices and software, either through direct mount or through a custom-developed interface, CHCS-LAB currently has direct interfaces with the Defense Blood Standard System (DBSS), which is the approved system for the automated management of blood services at LRMC; CoPath, which is the "commercial, off-the-shelf" software for the automation of all anatomic pathology services; and, a flexible laboratory instrument interface platform known as "DII" (Dynamic Innovations Incorporated).
B. Computer Configuration (Modules included in the LIS)
[01.4230] General clinical pathology (Chemistry, Hematology, Urinalysis, Immunology, etc.)?
YES. The CHCS general clinical pathology module at LRMC consists of Chemistry, Hematology, and Immunology.
[01.4235] Bar-coded specimen processing?
YES. Although there is a provision in CHCS for bar-coded operation throughout all phases of specimen management, testing, and reporting, bar-coded laboratory operation at LRMC is currently only in use for selected laboratory tests.
[01.4240] Quality control rules and statistics?
YES. CHCS-LAB has numerous routines for managing Quality Control checks and performing statistical analyses. Additionally, there is at least one microcomputer-based, stand-alone program used in the Lab to supplement process control in such areas as pipette calibration, control chart preparation, regression analyses, and report preparation.
[01.4245] Microbiology?
YES. The microbiology module of CHCS-LAB provides for comprehensive management of specimens, testing, and reporting for Bacteriology, Mycology, Parasitology, and Virology.
[01.4250] Transfusion medicine (Blood Bank)?
YES. The Defense Blood Standard System (DBSS) is the primary module used to automate Transfusion Medicine and other Blood Services at LRMC. As mentioned previoulsy, DBSS and CHCS are directly interfaced systems, and both systems have the capability to operate independently of each other during system interruptions to ensure continuity of services.
[01.4255] Anatomic pathology (any section)?
YES. CHCS-LAB is currently equipped with and configured to run CoPath, which is commercial, off-the-shelf software that provides for the management of all aspects of ordering, tracking specimens, testing, and reporting for Anatomic Pathology cases, and includes surgical and cytopathology cases.
C. Source Of Programs
[01.4260] In-house (laboratory and/or institution) development?
NO. As mentioned previously, all software development and hardware configuration was/is accomplished under contract between the Department of Defense and duly selected contractors. This is the only authorized path for software development and use on the system. Although there is considerable flexibility in the way the system is employed locally to accomplish the work of medical treatment and health care, there is no in-house development of programs.
[01.4265] Purchased package (software only)?
NO. CHCS was developed and deployed as a comprehensive hardware and software
system.
[01.4270] Purchased package (hardware and software)?
YES. CHCS was developed and deployed as a comprehensive hardware and software
system.
[01.4272] Whether or not the laboratory data center is located within the laboratory, is there an actively followed policy in place, locally signed and approved by the director to ensure that a copy of the system administration manual, all software updates, downtime log, maintenance log, and backup/restore procedures are kept locally and regularly updated?
YES. The policies, procedures, manuals, and other documentation of the CHCS Program Office and Information Management Division, LRMC, will be reviewed annually (minimum) to ensure that the following documentation is available (kept locally ) and updated regularly :
a. The system administration manual
b. All software updates
c. Downtime log
d. Maintenance log
e. Backup/restore procedures.
D. Environment
[01.4275] Is the computer facility and equipment clean, well-maintained and adequately ventilated with appropriate temperature and humidity control?
YES. The Composite Health Care System is homed on Ward 9D (Bldg 3767) of LRMC, in an especially prepared and maintained environmental room. Environmental controls include access control, carefully defined and monitored air-conditioning (temperature and humidity), and routine cleaning and tidying.
[01.4280] Is fire-fighting equipment (extinguishers) available?
YES. Fire extinguishers and alarms are located near the main computer room as indicated on the Fire and Evacuation Plan for Ward 9D (appendix 2).
[01.4285] Are all wires and computer cables properly located and/or protected from traffic?
YES. All wires and cables connecting monitors, instruments, and other devices to CHCS are located inside of cable runs, wall spaces, and ceilings such that they are concealed from traffic and other involvement with passersby.
[01.4290] Is the computer system adequately protected against electrical power interruptions and surges?
YES. All computer and communications equipment located in the large computer room on Ward 9D is connected to a 75 kilowatt uninterruptable power system (UPS) which, in turn, is connected to an emergency electrical power generator. In the event of an interruption in mains current, the UPS protects CHCS from power loss during the split second required for the emergency generator to automatically switch into operation. Upon restoration of mains power, the UPS again holds the system while switching back to normal operation.
E. Procedure Manual
[01:4295] Are procedure manuals clearly written, complete and readily available to all authorized users?
YES. Procedure manuals for all laboratory users are provided to the work area in the form of the CHCS Laboratory Reference Manual and supplementary SOPs. The basic procedural instructions provided in the Laboratory Reference Manual are used in conjunction with task-specific SOP's to provide full, work-area guidance.
[01:4300] Is there documentation that laboratory computer procedures are reviewed at least annually by the laboratory medical director or designee?
YES. Responsibility will be delegated in memorandum, "Renewal of Laboratory Automation System Office Assignments". Review and approval memo (signed by delgates) will be attached to appropriate SOPs.
[01:4305] Are there written procedures for the preservation of data and equipment in case of fire, software failure and hardware failure?
YES. The written procedures of the CHCS Operations staff will be used to provide guidance on the preservation of data and equipment in case of fire, software failure, and hardware failure. Copies of these procedures are maintained in the Customer Support Center of the LRMC Information Management Division (located on Ward 9D).
F. System Security
[01:4310] Are major computer programs protected to prevent alteration or destruction?
YES. Access to CHCS and ancillary programs and routines is tightly defined and controlled through account privileges set up by a CHCS software specialist in accordance with established security policies.
[01:4315] Are there explicit written policies that specify who may use the computer system to enter or access patient data, change results, change billing or alter programs?
YES. Access to all data and program options is controlled through the assignment of appropriate User Keys to different Provider Classes as outlined in the procedural guidance of the CHCS Project Office.
[01:4320] Are computer access codes (security codes, user codes) used to limit access to only those functions the individuals are authorized to use?
YES. All users are assigned privilege keys, menus, and menu option based on the type of hospital location where they are assigned, as specified in conventions established by the CHCS Project Office. Because of this, Laboratory users only see Laboratory menus and Pharmacy users only see Pharmacy Menus. Additionally, clerks see only clerk options, technicians see technician and clerk options, and supervisors see all options.
[01:4325] Is the security of access codes maintained (e.g., deleted when employees leave, not posted on terminals)?
YES. Every CHCS user is issued a unique set of Access and Verify codes when his account is first activated. Upon receipt of these codes, the new user receives a security briefing and signs a statement acknowledging his responsibility to protect private, confidential, and sensitive information.
[01:4330] If data in other computer systems can be accessed through the LIS (e.g., pharmacy or medical records), are there explicit written policies to prevent unauthorized access to that data through the LIS?
YES. Access to all data and program options is controlled through the assignment of appropriate User Keys to different Provider Classes as outlined in the procedural guidance of the CHCS Project Office. Comprehensive guidance has also been established (e.g.,Army Regulation 40-66, CHCS Mail Man messages and elsewhere).
[01:4332] Is there a documented protocol in place to effectively ensure that confidential patient data are accessible only by those healthcare personnel that are entitled to review test results?
YES. Access to all data and program options is controlled through the assignment of appropriate User Keys to different Provider Classes as outlined in the procedural guidance of the CHCS Project Office.
[01:4333] 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?
YES. For the most part, Privacy Act data is transmitted only over the Government-owned Local Area Network and Wide Are Network. Any use of the Internet to transmit Privacy Act data requires that the data first be encrypted by a method acceptable to the Department of Defense.
G. Data Entry and Reports
[01:4335] Is there a written 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)?
YES. All analytical sections will ensure that periodic verifications are accomplished in accordance with section 3.1.7. of SOP "Laboratory CHCS General Operating Instructions and Computer Policies".
[01:4336] If the laboratory employs autoverification procedures for tests performed on any instrumentation, is there a signed policy by the laboratory director approving this action?
NOTE: Autoverification is the process by which the computer performs the initial verification of test results. Any data that fall outside of set parameters should be reviewed by the human operator. N/A.
[01:4337] Is there documentation that the laboratory has validated the autoverification process against the rules prescribed by the laboratory director before implementation? N/A.
[01:4338] Is there documentation that the autoverification process has been tested at least quarterly? N/A.
[01:4340] Has the laboratory documented the accuracy and consistency of laboratory results (reference ranges and appropriate comments) across all computer interfaces with external systems (LISs, HISs, and others)?
YES. All analytical sections will conduct periodic reviews and verifications to ensure that reference ranges and reporting comments employed in CHCS laboratory matters are consistent with local procedural guidance and values set in all automatic analyzers.
[01:4345] Is there documentation that calculations performed on patient data by the computer are periodically reviewed?
YES. All analytical sections will ensure that periodic verifications are accomplished in accordance with section 3.5. of SOP "Verifying Accuracy of Laboratory Computer Reports".
[01:4350] Does the medical director review and approve the content and format of all computer-printed reports at least annually?
YES. Ref. memorandum, "Annual Review of the Content and Format of All Computer-printed Reports Generated by DPALS, LRMC".
[01:4355] Are manual and automated result entries verified before final acceptance and reporting by the computer?
NOTE: This does not imply the need for an individual to verify all result entries.
YES. Ref. SOP, "Laboratory CHCS Gerneral Operating Instructions and Computer Policies", sections 3.1.4 through 3.1.7.
[01:4356] When individual tests of 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?
YES. Ref. SOP, "Laboratory CHCS Gerneral Operating Instructions and Computer Policies", section 3.1.6. (REM: LLM > LRA > Acc# REM: [History] IFE > LAB RESULT > PATIENT)
[01:4358] If point-of-care testing result 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? N/A.
[01:4360] Are result entries checked against a defined range of expected results to detect absurd values before reporting?
YES. Ref. SOP, "Laboratory CHCS Gerneral Operating Instructions and Computer Policies", sections 3.1.7.
[01:4365] Are corrected results clearly specified as such on all patient reports (paper and video displays)?
YES. Software automated process. Ref. copy of corrected report.
[01:4370] Is there a written system to ensure that all revised reports for previously reported incorrect (erroneous) patient results are identified as revised, corrected, or amended?
NOTE: "Revisions" includes any changes to accompanying reference intervals and interpretations, but not minor typographical errors of no possible clinical consequence.
YES. Software automated process. Ref. copy of corrected report.
[01:4372] Are both original and revised patient reports retained for at least 2 years?
YES. Software automated process. Ref. copy of corrected report.
[01:4373] When there are sequential corrections of a single test result, are all corrections listed in sequential order, including dates and results of corrections made on subsequent reports?
YES. Software automated process. Ref. copy of corrected report.
[01:4375] Does the system provide for comments on specimen quality that might compromise the accuracy of analytic results (e.g., hemolyzed, lipemic)?
YES. Software automated process. Ref. copy of report.
[01:4380] Is there an adequate system to identify all individuals who have entered or modified patient data, control files, or computer programs.
YES. [History] IFE > LAB RESULTS > PATIENT NAME
H. Data Retrieval and Storage
[01:4385] Can archived patient result data be retrieved rapidly (less than 4 hours) when necessary? N/A.
[01:4390] Can a complete copy of archived patient test results be reprinted, including original reference ranges and interpretive comments? N/A.
[01:4392] 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?
YES. Indicated on section-level work documents and log books, and absolutely through LA^GLOBAL options available to programmers (Ref. sample of LA^GLOBAL search and key to instrumentation).
[01:4395] Is the data storage capacity of the computer system sufficient to meet the patient care needs of the organization? YES.
[01:4400] Are storage data media (e.g., tape reels, disk cartridges) properly labeled, stored and protected from damage or unauthorized use? YES: OM SOP #30.
[01:4405] Is there an acceptable system to prevent loss of patient result data in case of hardware or software failure?
YES: Platform, basic hardware and software, plus OM Backup SOP (#30).
[01:4410] Are automatic alarms that alert computer operators of imminent problems monitored and tested periodically? YES. Ref. SAIC
[01:4412] As possible and practical, does the laboratory have a system to positively identify all patient specimens, specimen types, and aliquots at all times?
YES. Ref. CHCS-LAB and section-level SOPs.
I. Hardware and Software
[01:4415] Is there a written schedule and procedure for regular maintenance of hardware (cleaning, lubrication, etc.)? YES. Ref. SAIC
[01:4420] Is there evidence of active review of system maintenance records? YES. Ref. SAIC
[01:4425] Is there a written system to verify the integrity of the system after restoration of data files? YES. Ref. SAIC
[01:430] Is there a written system to document and respond to any error message during the system backup? YES. Ref. SAIC
[01:4435] Is there a written record of all hardware and software modifications? YES. Ref. SAIC
[01:4437] 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?
YES. Responsibility delegated in memorandum, "Renewal of Laboratory Automation System Office Assignments". Review and approval memo (signed by delgates) attached to appropriate SOPs.
[01:4440] Is there documentation that programs are adequately tested for proper functioning when first installed and after any changes or modifications have been made? YES. Ref. SAIC
[01:4445] Are computer programs appropriately documented? YES. Ref. SAIC
[01:4450] Is there documentation that all appropriate users of the computer system receive adequate training whenever the computer system is modified or a new system is installed?
YES. Ref. SOP: "CHCS Training and Security Keys"
[01:4455] Is there a responsible person (e.g., Computer System Manager) in the laboratory who is notified of significant computer malfunctions?
YES. Responsibility delegated in memorandum, "Renewal of Laboratory Automation System Office Assignments
J. System Maintenance
[01:4460] Is downtime for maintenance scheduled to minimize interruption of service?
YES. Ref. SAIC and CHCS Project Manager
[01:4465] Are there documented procedures to ensure data integrity, uniterrupted delivery of laboratory services, and workflow during partial or complete downtime and recovery of the system? YES. Ref. SOP: LAB COOP
[01:4470] Are there written procedures for the changes in laboratory functions necessary during the partial or complete shutdown and recovery of systems that interface with the laboratory system? YES. Ref. SOP: LAB COOP
[01:4475] Is there a written record of unscheduled downtime, system degradation (response time), or other computer problems which includes reasons for failure and corrective actions taken? YES. Ref. SAIC
[01:4480] Is there a written definition of backup procedures in the event of a computer system failure such that patient results are reported in a prompt and useful fashion? YES. Ref. SOP: LAB COOP
[01:4485] Is emergency service for both computer hardware and software available at all necessary times? YES. Ref. SAIC
[01:4490] Are service and repair records available for all hardware and software? YES. Ref. SAIC
[01:4495] Is the computer system reliability (hardware and software) satisfactory to the laboratory medical director? YES.
[01:4500] Does the system meet needs for patient care in the judgment of the laboratory medical director? YES.