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Objectives.--To determine the rate with which blood collection is successful on the initial phlebotomy encounter, the rate with which laboratory personnel judge specimens unsuitable for analysis, and the practice characteristics associated with fewer unsuccessful collections and fewer rejected specimens. Design.--Clinical laboratories participating in the College of American Pathologists Q-Probes laboratory improvement program prospectively characterized the outcome of outpatient phlebotomies for 3 months or until 20 unsuccessful phlebotomy encounters occurred. By questionnaire, participants provided information about test ordering, patient preparation, and specimen collection. Setting and Participants.--Institutions in the United States (n = 202), Canada (n = 4), Australia (n = 3), and South Korea (n = 1). Main Outcome Measures.--Percentage of successful encounters and percentage of unsuitable specimens. Results.--Of 833 289 encounters, 829 723 were successful. Phlebotomies were unsuccessful because patients were not fasting as directed (32.2%), phlebotomy orders were missing information (22.5%), patients specimens were difficult to draw (13.0%), patients left the collection area before specimens were collected (11.8%), patients were improperly prepared for reasons other than fasting (6.3%), patients presented at the wrong time (3.1%), or for other reasons (11.8%). Only 2153 specimens (0.3%) were unsuitable; these samples were hemolyzed (18.1%), of insufficient quantity (16.0%), clotted (13.4%), lost or not received in the laboratory (11.5%), inadequately labeled (5.8%), at variance with previous or expected results (4.8%), or unacceptable for other reasons (31.1%). Facilities staffed by laboratory-administered phlebotomists reported higher success rates than facilities staffed by nonlaboratory-administered phlebotomists (P = .002). Conclusions.--Most outpatient phlebotomy encounters are successful and result in specimens suitable for laboratory analysis., The failure of phlebotomists to obtain blood samples from outpatients successfully may cause patients to return to the laboratory to have their blood redrawn, which may delay patient care, inconvenience [...]

Objectives.--To document the practice parameters and case characteristics associated with personal (expert) consultations. We also examine the value, level of participant (customer) satisfaction, turnaround time, and rate of personal consultations. Design.--We asked participants in the College of American Pathologists' Q-Probes program to document cases sent for consultation during 4 months or up to 20 cases. They documented patient and specimen characteristics, the turnaround times, and the participants' levels of satisfaction with the consultation experience. Participants.--One hundred eighty laboratories/surgical pathology practices. One hundred seventy-two (95.6%) were from the United States; the remainder were located in Canada and Australia. Main Outcome Measures.--Rate and turnaround time of consultations and participant level of satisfaction. Results.--A total of 2746 consultation cases were examined for an aggregate consultation rate of 0.5% (median, 0.7%). Institutions with a higher occupied bed size and a greater number of surgical pathology cases both had lower consultation rates (P [less than or equal to] .05). The median turnaround time (defined as the interval from the date on which the case was sent to the date on which the diagnosis was received) was 6 days. Twenty-nine percent and 68% of cases had a turnaround time within 3 and 7 days, respectively. Fifty-two percent of cases were sent to nationally known experts, and 32% were sent to local experts. Skin (18.0%), hematolymphoid (11.6%), and breast (9.6%) specimens were most commonly sent for consultation. In 70.5% of cases, the consultant confirmed the referring pathologist's original diagnosis, but in 15.9% of cases, the consultant also added significant information. Satisfaction rates were higher with faster turnaround times and verbal reporting. Satisfaction rates were lower for cases in which the patient or the clinician requested the consultation and in which the consultant's diagnosis was ambiguous. Conclusions.--This study establishes a multi-institutional consultation rate of 0.5%, defines the nature of surgical pathology consultations, and demonstrates that satisfaction with consultations is associated with a faster turnaround time and receipt of additional, clinically meaningful information., Surgical pathology cases are frequently sent for consultation to other institutions. Typically, extradepartmental consultations are sought to resolve diagnostic uncertainty or to obtain input on a case from an expert. [...]

* Context.--Bioterrorism has existed since before the 14th century; however, the specter of such an attack is much greater today than ever before. Technical expertise in microbiology and molecular testing, combined with the rapidity of worldwide air travel, has ensured that no geographic area would be untouched in a widespread attack. Clinical microbiology laboratories will play a pivotal role in the detection of attacks involving weapons of mass destruction. Objective.--To identify and discuss the microorganisms most likely to be used as agents of bioterrorism. Data Sources.--Data were obtained from literature searches from 1997 through June 2001 using the subject headings of bioterrorism, biological weapons, biological warfare, anthrax, brucellosis, tularemia, smallpox, plague, and botulism. In addition, information was obtained from publications of the Center for Civilian Studies, Johns Hopkins University, the Centers for Disease Control and Prevention, American Society for Microbiology, and the United States Army Medical Research Institute of Infectious Diseases. Data Extraction and Synthesis.--Findings obtained from these studies and publications were analyzed for the most likely microorganisms that would be involved in a bioterrorist attack and the most efficient means by which they could be identified. In all instances, the guidelines from the Centers for Disease Control and Prevention for Level A laboratories were observed. Conclusions.--The most likely microorganisms to be utilized as biological weapons include Bacillus anthracis (anthrax), Brucella species (brucellosis), Clostridium botulinum (botulism), Francisella tularensis (tularemia), Yersinia pestis (plague), and variola major (smallpox). While knowledge of the potential of these microorganisms is critical, clinical microbiologists and medical technologists possess the basic tools to rule out the suspected pathogens or to refer these isolates to public health laboratories for identification and susceptibility testing., A bioterrorist attack may someday take place in the United States. While bioterrorism has been known for many centuries, (1) recent events have placed renewed emphasis on the subject. The [...]

* Context.--Patient safety is of prime concern in every laboratory. Double labeling of glass slides is performed in many cytology laboratories where handwritten patient information on the frosted portion of the glass is overlaid with paper labels (sometimes containing bar codes). The cytotechnologists match this information by turning slides over. We use SurePath liquid-based cytology for Papanicolaou tests in our laboratory and noticed patient misidentification because of slide labeling errors, a problem that has not been addressed in the literature. Objective.--To reduce slide labeling errors without increasing costs, using a systems-based approach. Design.--All errors from mislabeled slides during November 2006 were documented, and an informal rootcause analysis was performed. Slides were labeled on opposite ends and monitored for errors. Results.--Labeling on different ends of the glass slide reduced our error rate from 0.59% to 0%, made visual matching easy, and did not alter costs. Conclusions.--The practice of overlaying handwritten information with printed labels for liquid-based Papanicolaou tests should be strongly discouraged and replaced with placing patient information in separate portions of the glass slide so that crucial patient identification is not hidden and visual matching is easy. (Arch Pathol Lab Med. 2009;133:1297-1300), Accurate specimen identification is crucial to patient safety and care in every laboratory. (1-9) Wagar et al, (8) in a longitudinal analysis of specimen identification errors in the clinical laboratory, [...]

Context.--Anatomic pathology diagnosis is often based on morphologic features. In recent years, an appropriate increased attention to patient safety has led to an emphasis on improving maintenance of patient identity. Decreasing or eliminating cross-contamination from one specimen to another is an example of a patient identity issue for which process improvement can be initiated. Objective.--To quantify the presence of cross-contamination from histology water baths and the slide stainers. Design.--We assessed for the presence of contaminants in water baths at cutting stations and in linear stainer stain baths. We assessed the potential for tissue discohesion and carryover in tissue samples and we assessed the potential for carryover onto blank slides sent through the stainer. Results.--In the 13 water baths examined (totalling 195 L of water), only one fragment of tissue was identified. The stain baths, however, contained abundant tissue contaminants, ranging in size from 2 to 3 cells to hundreds of cells. The first sets of xylenes and alcohols were the most heavily contaminated. Cross-contamination to blank slides occurred at a rate of 8%, with the highest frequency in the late afternoon. Conclusions.--Cross-contamination can present a significant challenge in the histology laboratory. Although the histotechnologists' water baths are not heavily contaminated, the stainer baths do contain contaminating tissue fragments. Cross-contamination does occur onto blank slides in the experimental setting., The production of histologic sections for diagnosis is a fundamental process that is critical for all diagnostic work in anatomic pathology (AP). Most clinical AP laboratories function in a similar [...]

* Context.--There are multiple elements that can be measured to assess the quality of a surgical pathology laboratory. Overall customer satisfaction is an excellent "global" measure, because it highlights the unique insight of laboratory performance from the users' perspective. Objective.--To measure customer satisfaction with surgical pathology reports. Design.--This study was based on a subscription Q-Tracks study. Voluntary participants were asked to distribute and collect a minimum of 25 surveys per quarter from their clients. Four parameters were graded, which included overall satisfaction, report turnaround time (TAT), completeness, and style on a scale of 1 (poor) to 5 (excellent). Each laboratory submitted quarterly data to the College of American Pathologists, where the data were tabulated and analyzed. Each laboratory could compare their performance in all 4 measures against the entire cohort or a selected subgroup of laboratories. Overall customer satisfaction with surgical pathology reports and 3 subcategories of report TAT, completeness, and style were the main outcome measures. Results.--This study ran during 2004 and 2005, with 41 and 33 participant laboratories, respectively. The median score for overall satisfaction, TAT, completeness, and style were 4.57, 4.31, 4.62, and 4.64 in 2004, and 4.64, 4.56, 4.65, and 4.68 in 2005, respectively. Most laboratories reported results for 4 quarters or fewer. There was no statistically significant change in overall satisfaction over time. Conclusions.--Overall satisfaction scores for surgical pathology reports as well as satisfaction with report TAT, completeness, and style were high. ReportTAT received the lowest scores of all parameters. (Arch Pathol Lab Med. 2008;132:1719-1722), The surgical pathology report (either printed or via electronic distribution) is the final product of surgical pathology laboratories. Elements necessary for quality in surgical pathology reports include accuracy, timeliness, and [...]

* Context. -- While urine culture contamination may not be completely avoidable, some laboratories have lower contamination rates than others. A College of American Pathologists (CAP) 1998 Q-Probes study showed that many interventions commonly assumed to reduce contamination were not demonstrably effective. This article revisits the issue. Objective. -- To examine the frequency of urine culture contamination, review current laboratory practices in the collection of urine culture specimens, and determine practice characteristics that may be associated with the contamination rate. Design. -- Laboratories participating in a CAP Q-Probes study were required to prospectively collect data on 120 consecutive urine culture specimens and provide information on the patient's demographics (age and sex), the location where the specimen was collected, how the specimen was handled, the number of isolates in quantities greater than or equal to 10 000 colony-forming units (CFU)/mL, and whether the laboratory considered the specimen to be contaminated. Specific inclusion and exclusion criteria were provided to the participants. Each laboratory completed a supplemental questionnaire that probed for specific laboratory urine culture collection practices. Results. -- One hundred twenty-seven laboratories participated in the study. Results from a total of 14 739 urine specimens were received. For the purpose of this study, a urine specimen was determined to be contaminated if the culture yielded more than 2 isolates in quantities greater than or equal to 10 000 CFU/mL. Using these criteria the median institution had a contamination rate of 15.0%. Laboratories in the 10th percentile (low performance) had an average contamination rate of 41.7%, while laboratories in the 90th percentile had an average rate of 0.8%. The collection site had no influence on the contamination rate, but postcollection processing, especially refrigeration of the specimen, had a substantial effect. Providing instruction to patients produced a statistically significant lowering of contamination rates for specimens from male patients (P = .006) but not for female patients, except when written instructions were provided in the emergency room, in which case specimen contamination rates for both male and female patients dropped (P = .01). Conclusions. -- The median contamination rates remain at a level comparable to the results seen in a previous Q-Probes study, and some laboratories have very high contamination rates. Specimen refrigeration is associated with lower overall urine culture specimen contamination rate. Providing patient instruction is also associated with lower contamination rates under specific circumstances. (Arch Pathol Lab Med. 2008;132:913-917), Some contamination of urine specimens may be unavoidable. A College of American Pathologists (CAP) Q-Probes study (1) published in 1998 found that the contamination rate was as high as 36.8% [...]

* Context.--Harmonization and standardization of results among different clinical laboratories is necessary for clinical practice guidelines to be established. Objective.--To evaluate the state of the art in measuring 10 routine chemistry analytes. Design.--A specimen prepared as off-the-clot pooled sera and 4 conventionally prepared specimens were sent to participants in the College of American Pathologists Chemistry Survey. Analyte concentrations were assigned by reference measurement procedures. Participants.--Approximately 6000 clinical laboratories. Results.--For glucose, iron, potassium, and uric acid, more than 87.5% of peer groups meet the desirable bias goals based on biologic variability criteria. The remaining 6 analytes had less than 52% of peer groups that met the desirable bias criteria. Conclusions.--Routine measurement procedures for some analytes had acceptable traceability to reference systems. Conventionally prepared proficiency testing specimens were not adequately commutable with a fresh frozen specimen to be used to evaluate trueness of methods compared with a reference measurement procedure. (Arch Pathol Lab Med. 2008;132:838-846), Along-standing objective of clinical laboratory medicine has been to produce harmonized test results among laboratories and methods. (1) Harmonized results are those that agree within clinically acceptable limits among different [...]

* Context.--Management of laboratories and pathology practices is increasingly complex. Residents and fellows in laboratory medicine and pathology need more structured curricula in leadership and management (L&M) training to function [...]