Data Management and Laboratory Information Systems


Cervical Cytology Practice Guideline

Approved by the ASC Executive Board November 10, 2000



VIII. Data Management and Laboratory Information Systems

Manual methods as well as computerized systems exist for management of laboratory data.  Manual methods may include logs and card files organized by date, patient name, specimen number or interpretation.  Computerized systems, most often referred to as laboratory information systems (LIS) may stand alone, be part of an integrated anatomic pathology system, part of a multispecialty laboratory system, or integrated with a larger hospital or corporate information system.  This section of the Guideline describes data management components needed to generate the information used by the laboratory, clinicians and other healthcare organizations.

VIII.A.  Record Storage and Retrieval

The laboratory must have the ability to record and retrieve specimen information and patient reports for the periods specified by regulatory agencies.61114  The system, whether manual or automated, should allow access to all cytology reports and all available and related surgical pathology reports to facilitate cytologic/histologic correlation. Older data may be electronically archived or records may be stored offsite as long as retrieval does not hinder patient care or delay regulatory inspections. The ability of a system to correlate or merge records when there is an alteration in patient identifiers (such as name, hospital record number or other identifiers) without altering the data in the original records is also desirable.  The use of unique identifiers, such as the patient’s hospital record number, allows for more accurate matching.

VIII.B.  Accessioning and Work Flow

The laboratory must assign a unique accession number for each individual case.  All patient demographic data required by regulatory agencies should be entered at accessioning.  The unique accession number facilitates the tracking of a case through all stages of handling in the cytology laboratory from pre-analytic (accessioning and specimen preparation,) and analytic (screening and interpretation,) through post-analytic processing (reporting, and quality assurance follow up.)115  Labels for paperwork and slides may be handwritten, purchased, printed with a stand-alone printer or generated by the LIS as part of accessioning.  Bar coded labels can increase the efficiency and accuracy of this process.

VIII.C.  Security

All laboratory records are confidential.  Access should be limited to authorized individuals.  Locked cabinets for paper records and security codes for electronic systems are recommended. Limiting access may deter corruption of computer software or inadvertent change or release of results by unauthorized individuals.  Electronic signatures are preferable for reports that are stored in electronic format.  A procedure should be in place to assure that the electronic signature identifies the person who is responsible for the case and indicates that they approve of the content of the report.   This procedure should prohibit interpretations that require pathologist review from being released by any other individual prior to the pathologist’s authorization. 

VIII.D.  Terminology

Standardized terminology (The Bethesda System or other comparable system) used in the LIS should be stored in the computer database and accessed by use of mnemonics or assigned codes.  Free-text capabilities are necessary for rare or unusual interpretations or for comments and/or recommendations that are not routine.  Manual reporting should be standardized to allow retrieval of data based upon interpretation.

VIII.E.  Data Transfer

Transfer of clinical information and interpretive data to the report must be precise.  This may occur via a manual written report, by manual entry into the LIS, or by use of optical mark readers that are interfaced with the LIS.  The accuracy of this information must be monitored through the laboratory’s Quality Assurance Program.116  In addition to storing patient information and reports, laboratory information systems (LIS) may be used to generate billing statements or to transfer data to billing systems, clinician offices, hospital computer systems, Medicare, and other third party payers. Linkage of reports to interpretation and procedure codes [International Classification of Disease (ICD-9)], hospital procedure and billing codes [HCFA Common Procedure Coding System (HCPCS)] and Current Procedural Terminology (CPT) codes may be required for billing purposes.  Linkage of reports to SNOMED (Systematized Nomenclature of Medicine) is desirable for statistical reporting.

VIII.F.  Quality Assurance

Laboratory data must be retrievable for quality assurance purposes and to generate statistical reports required by regulatory agencies and accrediting organizations within the retention period prescribed by CLIA ’88 (2 years) or applicable state regulations.  The system should provide the breakdown of the interpretive categories reported by each individual.  This individual statistical data must be available for comparison with the laboratory average.117

It is desirable for the LIS to facilitate the selection of cases initially screened as negative for random and directed rescreening. The laboratory must not allow release of results until the rescreen examination is complete.  Results of rescreening should be available for calculation of false negative proportions or other measures of performance within the retention period prescribed by CLIA ’88 (2 years) or applicable state regulations. Cytologic/histologic correlation information needs to be available for review (again within the retention period prescribed by applicable regulations.)  The data management system must allow the laboratory to follow-up premalignant and malignant lesions and monitor unsatisfactory rates by clinician.

VIII.G.  Variability of Practice

Differences between manual and electronic data management systems are discussed throughout this section and encompass most practice settings.

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61  College of American Pathologists. Commission on Laboratory Accreditation Inspection Checklist 2000 edition, Cytopathology, Section 8A, Northfield, Illinois.

114  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 493.1257(g).

115  Buffone GJ, Moreau D, Beck JR. Workflow computing.  Improving management and efficiency of pathology diagnostic services. Am J Clin Pathol 1996; 105:S17-24.

116  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 493.1703(f).

117  Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal Register. Feb. 28, 1992; 57: 493.1257(d)(5).