Review of the current state of whole slide imaging in pathology.

Whole slide imaging (WSI), or "virtual" microscopy, involves the scanning (digitization) of glass slides to produce "digital slides". WSI has been advocated for diagnostic, educational and research purposes. When used for remote frozen section diagnosis, WSI requires a thorough implementation period coupled with trained support personnel.

Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays.

Context: Estrogen receptor and progesterone receptor status is assessed on all newly diagnosed, invasive breast carcinomas and in recurrences to determine patient eligibility for hormonal therapy, but 10% to 20% of estrogen receptor and progesterone receptor test results are discordant when tested in multiple laboratories.

Objective: To define the analytic (technical) validation requirements for estrogen receptor and progesterone receptor immunohistochemistry assays used to select patients for hormonal therapy.

Data Sources: Literature review and expert consensus.

Responding to large-scale testing errors.

Extensive use of automation in the clinical laboratory creates the potential for systematic errors that affect a large number of patient results before the error is discovered. When a large-scale testing error is found, the approaches recommended for responding to individual medical mishaps are often inadequate. This report uses 2 case studies to illustrate some of the unique challenges facing laboratory managers confronted with a large-scale testing error.

Document control practices in 120 clinical laboratories.

Context: A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations.

Objective: To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance.

Design: Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived.

Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes study of 138 institutions.

Context: Monitoring customer satisfaction is a valuable component of a laboratory quality improvement program.

Objective: To survey the level of physician satisfaction with hospital clinical laboratory services.

Design: Participating institutions provided demographic and practice information and survey results of physician satisfaction with defined aspects of clinical laboratory services, rated on a scale of 1 (poor) to 5 (excellent).

Notification of critical results: a College of American Pathologists Q-Probes study of 121 institutions.

Context: Hospital accreditors are placing increased emphasis on the timeliness with which critical laboratory results are reported to caregivers.

Objective: To measure the speed of critical result notification at a group of laboratories, identify factors associated with faster reporting, and place findings in the context of the time required to transport and test specimens and to correct critical abnormalities.

Design: Contemporaneous review of 3545 inpatient and emergency department critical result notifications in 121 laboratories enrolled in the College of American Pathologists Q-Probes program.

Accuracy of send-out test ordering: a College of American Pathologists Q-Probes study of ordering accuracy in 97 clinical laboratories.

Context: Errors entering orders for send-out laboratory tests into computer systems waste health care resources and can delay patient evaluation and management.

Objectives: To determine (1) the accuracy of send-out test order entry under "real world" conditions and (2) whether any of several practices are associated with improved order accuracy.

Design: Representatives from 97 clinical laboratories provided information about the processes they use to send tests to reference facilities and their order entry and specimen routing error rates.

Formatting pathology reports: applying four design principles to improve communication and patient safety.

Context: Eighty-two million surgical pathology and cytology reports were issued in the United States during 2007; a subset of these reports will be misunderstood by readers. Recent attention has focused on standardizing the content of pathology reports, particularly for common malignancies, to facilitate transmission of required information. Comparatively little attention has been focused on the format of reports--the arrangement of headlines, text blocks, and other report elements to optimize communication.

The origin of reference intervals.

Context: Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting reference intervals.

Objectives: To determine (1) methods used by clinical laboratories to establish reference intervals for 7 common analytes, (2) variation in intervals, and (3) factors that contribute to establishment of "outlier" intervals.

Design: One hundred sixty-three clinical laboratories provided information about their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time.

Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions.

Context: Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown.

Objectives: To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors.

Design: One hundred twenty clinical laboratories provided information about identification errors during 5 weeks.

Trends in blood culture contamination: a College of American Pathologists Q-Tracks study of 356 institutions.

Context: Blood culture contamination extends hospital stays and increases the cost of care.

Objectives: To measure blood culture contamination rates in a large number of institutions over time and to elucidate practice patterns and demographic factors associated with sustained reduction in contamination rates.

Design: Longitudinal cohort study of 356 clinical laboratories that provided quarterly data about blood culture results, using a uniform definition of contamination.

A comparison of two hospitalist models with traditional care in a community teaching hospital.

Purpose: Many studies have documented significant length of stay reduction and cost savings when hospitalist care is compared with traditional care. However, less is known about the concurrent performance of more than one hospitalist model in a single site.

Subjects And Methods: This retrospective cohort study of 10595 patients was conducted between July 2001 and June 2002 in a tertiary care community-based teaching hospital.

Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-probes study of staffing at 151 institutions.

Context: Inadequate staffing of clinical laboratories may compromise quality and throughput, whereas excess staff unnecessarily increases the cost of testing.

Objectives: To measure productivity of technical staff and management span of control in a large number of laboratories and to determine factors associated with favorable staffing ratios.

Design: A total of 151 clinical laboratories provided information about technical and management staffing and output (workload) for 4 laboratory sections: anatomic pathology, chemistry/hematology/immunology, microbiology, and transfusion medicine.

Identification errors in pathology and laboratory medicine.

Identification errors involve misidentification of a patient or a specimen. Either has the potential to cause patients harm. Identification errors can occur during any part of the test cycle; however, most occur in the preanalytic phase.

Heparin monitoring and patient safety: a College of American Pathologists Q-Probes study of 3431 patients at 140 institutions.

Context: Appropriate laboratory monitoring of unfractionated heparin therapy promotes effective anticoagulation while minimizing hemorrhagic complications.

Objectives: To measure heparin therapy monitoring in a "real-world" setting and to assess the degree of anticoagulation achieved.

Design: One hundred forty institutions abstracted laboratory and pharmacy data from up to 30 inpatients receiving standard-dose unfractionated heparin therapy for 72 hours.

Productivity of Veterans Health Administration laboratories: a College of American Pathologists Laboratory Management Index Program (LMIP) study.

Context: The Veterans Health Administration (VA) operates the largest integrated laboratory network in the United States.

Objective: To assess whether the unique characteristics of VA laboratories impact efficiency of operations, we compared the productivity of VA and non-VA facilities.

Design: Financial and activity data were prospectively collected from 124 VA and 131 non-VA laboratories enrolled in the College of American Pathologists Laboratory Management Index Program (LMIP) during 2002.

Q-tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking.

Context: Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome.

Objective: To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine.

Design: Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms.