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Document expires June 2000

STANDING OPERATING PROCEDURE
Laboratory Computer Services Compliance with JCAHO
Accreditation Requirements


I. INTRODUCTION:

A. PURPOSE: To describe how the hospital and laboratory information systems are, and will continue to be, utilized by the Department of Pathology and Area Laboratory Services (DPALS), Landstuhl Regional Medical Center (LRMC), and subordinate medical treatment facilities (MTFs). To provide a vehicle which will be utilized to ensure that all information systems and methods employed by DPALS are properly evaluated to ensure full compliance with requirements and recommendations of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

B. SCOPE: This SOP applies to all personnel operating, maintaining, or otherwise using laboratory and hospital computer resources at LRMC and its subordinate MTF's to communicate and/or coordinate laboratory testing in support of patient care.

C. CLINICAL SIGNIFICANCE: The Composite Health Care System (CHCS) is a centralized and comprehensive 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 Joint Commission is essential to ensuring that CHCS remains a reliable information system for providing suitable communication related to patient care.


II. PRINCIPLE: A list of standards with intent commentary is reviewed to assess adherence to and compliance with accreditation requirements. While directives in this SOP provide explicit written instructions to all laboratory users, 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. INFORMATION MANAGEMENT PLANNING

STANDARD: IM.1 The laboratory plans and designs information management processes to meet internal and external information needs.

BACKGROUND: The Composite Health Care System (CHCS) is a comprehensive and integrated medical information system designed, developed, and deployed to support health care delivery within the Department of Defense (DoD) throughout the world. Great care was taken to ensure that CHCS was developed to provide fully for the different information needs of all the hospital functionalities. Integrated modules in CHCS cover Laboratory, Pharmacy, Radiology, Clinical Services, Patient Administration, and all others.

POLICY: The Laboratory module of CHCS will be utilized by DPALS to the fullest extent practicable as the primary information management system in order to improve production and management practices through automation.


STANDARD: IM.2 Confidentiality, security, and integrity of data and information are maintained.

BACKGROUND: Access to the programs and ancillary routines of CHCS is tightly defined and controlled through account privileges assigned by CHCS software specialists in accordance with established security policies. Software modules and data which pertain to patients, specimen testing, and other official proceedings will be used in such a manner as to safeguard confidentiality at all times as mandated in pertinent United States Code (USC), Department of the Army (DA) regulations and other published guidance. Protection of data from alteration, corruption, or destruction is accomplished by hardware and software configurations, system security plans, and off-site storage of backup materials.

POLICY: Subordinate laboratories will adjust work-place practices to ensure that appropriate controls and protection are maintained in accordance with applicable USC, DoD, DA, and other regulations.


STANDARD: IM.2.1 The laboratory determines appropriate levels of security and confidentiality for data and information.

BACKGROUND: 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. 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.

POLICY: Laboratory users will only be given access to the data and software options needed to perform their assigned duties. All Privacy Act data, including paper records and reports, will be protected against improper disclosure and any other misuse by all personnel. It is the responsibility of each user who generates an external copy of any Privacy Act data to ensure that the data is adequately protected during use, and properly secured or disposed of when no longer required.


STANDARD: IM2.2 Collection, storage, and retrieval systems are designed to allow timely and easy use of data and information without compromising their security and confidentiality.

BACKGROUND: All aspects of information and data management at LRMC are extensively automated through CHCS. The System currently has vast, reserve, on-line storage capacity and there is no need for archiving older data. All records and software options are immediately available, twenty-four hours a day, to registered CHCS users in accordance with their assigned account privileges.

POLICY: The advanced data communication capabilities of CHCS will be carefully employed to ensure that security and confidentiality are maintained for all data and information. Formalized user training and in-service training will be continually reviewed and revised to ensure the full compliance and involvement of all laboratory users, and, System User Security training will be revalidated and documented annually for all assigned.


STANDARD: IM.2.3 Records and information are protected against loss, destruction, tampering, and unauthorized access or use.

BACKGROUND: When employed as described in the preceding paragraphs, records and information stored on CHCS are safeguarded from any physical threat short of the most unthinkable holocaust. Hospital identification badges are issued to all employees, and all are cautioned against sharing security codes and leaving CHCS sessions unattended.

POLICY: All personnel assigned to DPALS will be made aware of threats to physical and operational security through annual group training and periodic interim reminders. Supervisors will review individual training and qualification records quarterly to ensure compliance. Hospital identification badges will be worn by all at all times while on duty, and all workers will be reminded to note and approach strangers in the workplace to account for their presence. Supervisors will counsel uncautious workers and recommend rehabilitative action as necessary to ensure appropriate security.


STANDARD: IM.3 Uniform data definitions and data capture methods are used whenever possible.

BACKGROUND: The concept of data definitions pertains to declaring the type and size of data which will be required for a given field. Once the allowable values are thus defined, the software can handle the data more efficiently, in terms of storing, recalling, and performing operations. Uniformity in data definitions provides a data structure which enhances data input, management, and comparison, both within the local organization and between the local organization's database and other databases.

EXAMPLE: The SOCIAL SECURITY NUMBER field is a simple example of the importance of uniform data definitions. This entity could be defined as a 9-digit integer (counting numbers only) or as an 11-character, general text (mixed alphanumeric characters) field. A system requiring 9 digits would have to be modified to handle 11 alpha characters, and data exchange between the 9-digit system and the 11-character system would not be direct.

POLICY: CHCS and all ancillary systems use data files and tables which are standardized throughout the Department of Defense. All software routines will continue to be designed and modified in such a way as to constrain input and ensure data uniformity.


STANDARD: IM.3.1 Minimum data sets, data definitions, codes, classifications, and terminology are standardized whenever possible.

BACKGROUND: Minimum data sets is a term which describes all the data necessary to perform a function or to provide complete information to another routine.

EXAMPLE: Certain information must always be provided by CHCS users when ordering laboratories on patients. Such data as PATIENT NAME, TEST NAME, DATE, and REQUESTING HEALTH CARE PROVIDER are necessary to ensure that the requests are valid and that the necessary operations can be performed. These data constitute the minimum data set. On the other hand, certain data such as COMMENTS, although occasionally important for documentation, are not critical to filing and tracking, and are thus optional.

POLICY: CHCS and all ancillary systems use minimum data sets for all procedures, and these are standardized throughout the Department of Defense. All software routines will continue to be designed and modified in such a way as to require uniform input of minimum essential data.


STANDARD: IM.3.2 The laboratory collects data in a timely, economical, and efficient manner and with the degree of accuracy, completeness, and discrimination necessary for their intended use.

BACKGROUND: By purpose, the collection of data is extensively automated in CHCS. It begins with orders placed electronically by health care providers and also provides for: electronic receipt and acknowledgment of orders; passing of demographic data to lab instruments via bi-directional interfaces; passing of analytical results from instruments to CHCS via transmit function; and verification of results electronically by supervisory personnel.

POLICY: All laboratory divisions and production areas will ensure that policies and methods are established and monitored to exploit the automation and accuracy features of CHCS and related systems to the maximum benefit of patient care and cost containment.


STANDARD: IM.4 Leaders and other appropriate staff are educated and trained in the principles of information management.

BACKGROUND: All aspects of the CHCS deployment throughout the Department of Defense were preceded by the development of a master training strategy, preparation of training materials, and hiring and training of a work force to deliver the training. Additionally, the strategy, materials, and delivery techniques were alpha tested, beta tested, and modified as needed prior to deployment of the final version of the system.

POLICY: Every CHCS user is required to receive formal classroom training for all program options prior to receiving an account on the live system. All DPALS (and subordinate) personnel will be trained in accordance with the Standing Operating Procedure (SOP) titled, "Information System Training for LRMC Lab Personnel" (q.v.). Managers and supervisors will ensure that all employees complete the information system training appropriate to the duties they will be called on to perform, and will monitor all employees to ensure that conducts and behaviors are consistent with effective laboratory information management principles.


STANDARD: IM.5 Transmission of data and information is timely and accurate.

BACKGROUND: CHCS and its ancillary systems are homed at Landstuhl Regional Medical Center and employed at approximately forty medical treatment facilities (MTFs) throughout Central Europe. The distribution of CHCS is accomplished through a combination of Wide Area Network links and Local Area Network links in such a manner that user requests and procedural results are transmitted instantly upon entry. Hourly automatic monitoring of system status and sampling of accuracy of operations is accomplished by programs such as the Performance Monitoring Routine and others. Additionally, CHCS Operations and Maintenance personnel monitor system performance manually throughout the day and make adjustments and repairs as needed. Electronic mail, fax machines, photocopiers, and overland couriers are also important communication assets.

POLICY: All laboratory divisions and production areas will establish and monitor policies to ensure that workplace practices exploit and conserve the automation advantages made possible through CHCS and other resources.


STANDARD: IM.5.1 The format and methods for disseminating data and information are standardized, whenever possible. [ref. MCEUL-P: "CAP Checklist 01.4350"]

BACKGROUND: CHCS was designed to provide standard formats and methods for all aspects of operations, including patient care support, quality management and improvement, utilization management, etc. to all DoD Medical Treatment Facilities.

POLICY: Only standardized reports are used, and all report formats are reviewed annually by the medical director of lab. When necessary, revisions to reporting formats and methods of dissemination will be requested through formal channels by the CHCS Laboratory Automation Systems Office (LASO), which will initiate either a System Change Request (SCR - for efficiency enhancing modifications) or a System Incident Report (SIR - for problems which have an adverse impact on patient care). All requests for changes will be given a tracking number and priority level, and will be monitored until final disposition is reached.


STANDARD: IM.6 Adequate integration and interpretation capabilities are provided.

BACKGROUND: CHCS was designed as a fully integrated hospital information system that provides a file structure and relational database which is called and used by all authorized functionalities in support of all aspects of patient care and hospital administration. Software options and specially designed database queries called "ad hoc reports" provide the capability of drawing data from all files for the preparation of summaries and comparisons; and, input data from other systems and programs can be combined with CHCS output data to permit full comparisons and reporting. The storage capacity of CHCS is currently capable of keeping all files and records on line for use in such applications.

POLICY: All DPALS users of CHCS and other information systems are challenged to use every appropriate means available to improve their awareness of how patient care, work-flow, and data-flow are interrelated and integrated, not only in the laboratory, but also throughout the range of hospital functionalities. DPALS managers and supervisors will develop and publish written policies to require the retention of administrative, production and control records for appropriate length of time, in accordance with published standards.


B. LABORATORY-SPECIFIC DATA AND INFORMATION

STANDARD: IM.7 The laboratory develops tools for communication.

BACKGROUND: Good communication is the pathway to coordination, control, and command. In order to ensure good communication, the laboratory must methodically employ effective tools to assure good management of all information pertaining to input, process control, and output.
POLICY: All managers and supervisors will be actively involved in the development, use, and improvement of communication methods and the effectiveness of those methods will be tested and reflected in every aspect of managment and production. Communication surety will be reinforced by the methodical exploitation of meetings, seminars, written policies, procedures, and processes, in addition to automation systems and tools.


STANDARD: IM.7.1 Written procedures are developed for collecting specimens to ensure that they are satisfactory for the tests to be performed.

POLICY: Written guidance for specimen collection will be prepared and maintained by respective laboratory sections and will be communicated throughout the domain of hospitals, clinics, and other requesters using both CHCS menu options and printed paper information documents. All subordinate managers and supervisors will review methods and documentation yearly (minimum) to ensure that information sources (SOPs, CHCS files, send-out documents, etc.) are accurate and in consonance with each other. The CHCS option know as LTI (Laboratory Test Information) provides basic information pertaining the the proper collection of specimens.


STANDARD: IM.7.1.1 Such procedures are approved by the pathology and clinical laboratory services director or a qualified, specifically identified designee(s).

POLICY: Specimen collection policies and procedures will be developed and reviewed by the respective laboratory division chiefs and submitted for written approval by the appropriate division medical directors prior to being published for use. This requirement will be reflected in local SOPs and other documentation.


STANDARD: IM.7.2 All requests for laboratory tests are made in writing or through electronic means.

POLICY: All orders and requests for laboratory testing will normally be placed electronically through CHCS, except when the system is temporarily unavailable or when the order or request is from a provider or organization not linked to CHCS in Central Europe. The criteria for acceptable orders and specimens are described in the current LRMC Memo 40-55, which be followed. Additional information and assistance, as needed, will be provided on request.


STANDARD: IM.7.3 The laboratory performs tests and examines specimens upon the written or electronic request of authorized individuals.

POLICY: Analytical testing and reporting are the primary functions of DPALS, and will be performed promptly on collected and submitted specimens in accordance with the precedence under which the testing is ordered. No testing will be performed in support of patient care unless electronic, handwritten, or verbal orders are first received from properly credentialed and recognized health care providers. All DPALS personnel are charged to ensure that authorized specimens and requests are carefully and expeditiously conveyed through all testing and reporting processes, in accordance with relevant written procedures and policies.


STANDARD: IM.7.4 The laboratory report includes the date and time of reporting and the condition of any unsatisfactory specimens. [cross reference CAP 01:4350]

POLICY: All laboratory report formats are reviewed no less than once annually by the Chief, DPALS, to ensure that test performance/certification dates and times and all other pertinent information is properly displayed on finished reports, and a portfolio of sample reports is maintained by the Laboratory Automation Services Office located on Ward 9D. All section managers and supervisors will ensure that results documentation is appropriately addressed in local testing and resulting SOPs.


STANDARD: IM.7.5 A system exists to identify the individual responsible for performing or completing laboratory procedures. [cross reference CAP 01:4145]

POLICY: Each production area in the laboratory will maintain documentation which assigns and delineates the responsibilities of all personnel involved in all aspects of the analytical testing, administration, and quality improvement processes. This documentation will include a registry of signatures and initials which may be used to help resolve the identity of persons making entries on various written documents employed in support of laboratory operations. The activities of all laboratory computer system users is auditable through a variety of program options in CHCS, CoPath, and DBSS. Options such as IFE (Inquire to File Entries) can be used to examine the Lab Result File and the Accession File and pinpoint the identity of all hospital workers who make electronic entries in the computerized records. Additional options which provide information to regular CHCS users include PLI (Patient Laboratory Inquiry) and review of the Specimen Master Log. Resources such as these will be employed as necessary to detect and resolve discrepancies.


STANDARD: IM.7.6 Required records and reports are maintained and, as appropriate, filed in the clinical record of the patient and in the pathology and clinical laboratory services. [cross reference CAP 01:4148]

POLICY: Policies for the filing of records and reports in patient records are prescribed by official regulations and implementing procedures, the proponent agency for which is the Medical Records Branch of the Patient Administration Division. However, laboratory written and computerized records of patient results, instrument printouts, accession records, quality control records, proficiency testing records, and quality improvement records must be retained for a minimum of two years. Instrument maintenance records will be retained for the life of the instrument. All managers and supervisors will ensure that these policies are appropriately communicated in local implementation SOPs.


STANDARD: IM.7.6.1 Authenticated, dated reports of all examinations performed by the pathology and clinical laboratory services are made part of the clinical record of the patient.

POLICY: All certified results and reports from analytical testing are stored indefinitely and on line in CHCS, and they are electronically available for review by authorized CHCS users at all times. The current policy of the Medical Records branch of LRMC Patient Administration Division is to insert paper copies of results from laboratory and other service providers into the patient record folder at the time the patient and record are moved out of the LRMC catchment region.


STANDARD: IM.7.6.2 The name of the laboratory performing the test is included in the report contained in the clinical record of the patient. [cross reference CAP 01:4350]

POLICY: All final reports generated by CHCS and ancillary programs are automatically labeled with the name of the laboratory which performed the testing. Examples of reference intervals displayed on testing reports are maintained for review by the LASO.


STANDARD: IM.7.7 Current reference intervals approved by the clinical laboratory director are provided in the clinical record when test results are reported. [cross reference CAP 01:4350]

POLICY: Age- and gender-specific reference intervals and alert ("panic") values will be developed and reviewed by the respective laboratory division chiefs and submitted for written approval by the appropriate division medical director prior to being published for use. This requirement will be reflected in local SOPs and other documentation. Examples of reference intervals displayed on testing reports are maintained for review by the LASO. [reference MCEUL-P "Development and Review of Reference Intervals and Alert Values"]


STANDARD: IM.7.8 The pathology and clinical laboratory services maintain a record of daily specimen accession and an appropriate system for identifying each specimen.

POLICY: All specimens accessioned for testing in the LRMC and subordinate laboratories will be recorded electronically in CHCS. The CHCS-Lab functionality is designed to require input of accessioning data prior to making a specimen electronically available for subsequent handling and testing within the laboratory. Supplementary paper records, such as sign-in sheets and logbooks will be used as required to enhance specimen security and coordination.


STANDARD: IM.7.9 The laboratory retains a copy of all reports of anatomic and clinical laboratory results and examinations, which are readily retrievable.

POLICY: Records of all laboratory transactions are maintained in perpetuity on CHCS and its ancillary programs, and the system is in continuous operation and available to authorized users 24 hours a day.


STANDARD: IM.7.10 The laboratory has current descriptions of and instructions for all analytical methods and procedures. [cross reference CAP 02:2100]

POLICY: Clearly written, up-to-date procedural descriptions are essential to ensuring that proper techniques and methods can be performed accurately and reliably with maximum precision. The complete procedure manual must be written in substantial compliance with, and meet the intent of, NCCLS GP2-A2, and must be available to, and used by, personnel at the workbench. All managers and supervisors will ensure that satisfactory Standing Operating Procedures (SOPs) are written to cover all aspects of testing and administration prior to approving any testing procedure for production mode.


C. AGGREGATE DATA AND INFORMATION

STANDARD: IM.8 The laboratory collects and analyzes data to support managerial decisions and operations, performance-improvement activities, and patient care.

BACKGROUND: Storage, assembly, and analysis of data enables continuous review and improvement of all aspects of hospital and laboratory operations. Utilization and performance reports and other output from such analyses provide the wherewithal for making changes which can improve patient care and resource utilization. Systems, policies, and activities are all critical factors in the equations for success.

POLICY: All managers and supervisors affiliated with DPALS, LRMC, will develop methods and explicit written policies to ensure the timely review of aggregate data to support good management and planning in all phases of laboratory operation. Hospital and clinic laboratories subordinate to LRMC have a host of tools and methods available for collecting and analyzing data. As an example, CHCS, CoPath, and DBSS (Defense Blood Standard System) all have built-in software routines for tracking nosocomial infections; antibiotic resistant organisms; lab orders and results which were deleted, amended, or changed; and for preparing correlation studies. Additionally, ad hoc programs provide the capability of performing customized database queries to report on such characteristics as resource utilization, property maintenance and movement, and testing turnaround times.

D. KNOWLEDGE-BASED INFORMATION

STANDARD: IM.9 Knowledge-based information systems, resources, and services meet the laboratory's needs.

BACKGROUND: Conversancy with medical, technical, and administrative literature is fundamental to the careful practice and delivery of reliable laboratory medicine and technology. Current, authoritative reference materials are provided at LRMC through a variety of services and systems, including the LRMC Medical Library, laboratory-owned texts and periodicals, and the World Wide Web.


STANDARD: IM.9.1 Knowledge-based information resources are available, current, and authoritative.

POLICY: It is the responsibility of pathologists, laboratory managers, and supervisors at all levels of organization to be aware of standard and current reference materials such as books, periodicals, newsletters, and others which provide up-to-date information and guidance on the practice of laboratory medicine and the delivery of laboratory services. All are directed to make full use of information facilities and resources available at LRMC to enhance and improve professional and technical performance.


E. COMPARATIVE DATA AND INFORMATION

STANDARD: IM.10 Comparative performance data and information are defined, collected, analyzed, transmitted, reported, and used in accordance with national and state guidelines for data-set parity and connectivity.

BACKGROUND: Participation in laboratory survey programs permits one laboratory to compare its analytical performance with a group of laboratories performing identical procedures on identical specimens. Such comparisons provide a mechanism for detecting and correcting otherwise undetectable failures in analytical and production methods.


STANDARD: IM.10.1 The laboratory uses external reference databases for comparative purposes.

POLICY: Managers at all organizational levels in DPALS will ensure that CAP or other acceptable survey material is analyzed periodically for each analytical procedure performed. Where CAP survey materials are not available, other sources will be found. Subscription to the CAP Survey program will be monitored and coordinated by the Laboratory Manager and Laboratory Quality Assurance Specialist.


STANDARD: IM.10.2 The laboratory contributes to external reference databases when required by law or regulation or when appropriate to the laboratory.

POLICY: Analytical results from all survey materials will be reported to the CAP Survey Program in time to meet published suspense dates and thereby qualify for comparison with results received from other laboratories. Survey performance results and discrepancies will be reported in writing to and reviewed by the DPALS Quality Assurance Committee.


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