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Laboratory critical values policies and procedures: a college of American Pathologists Q-Probes Study in 623 institutions.

CONTEXT: Critical values lists have been used for many years to decide when to notify physicians and other caregivers of potentially life-threatening situations; however, these lists have not been studied widely. OBJECTIVES: To investigate critical values lists in institutions participating in the College of American Pathologists Q-Probes program and to provide suggestions for improvement. SETTING: A total of 623 institutions voluntarily participating in the Q-Probes program. DESIGN: A multipart study in which participants responded to information from preprinted lists, collected information about current practices, completed a questionnaire, monitored critical values calls, reviewed patients' medical records, and surveyed nursing supervisors and physicians about critical values. MAIN OUTCOME MEASURES: Defining critical values systems, including lists, personnel, costs, processes, usefulness, and related medical outcomes. RESULTS: Critical values lists were determined for routine chemistry and hematology analytes and were found to vary widely among participants. In contrast, more than 95% of participants reported positive blood cultures, cerebrospinal fluid cultures, and toxic therapeutic drug levels as critical values. Based on more than 13 000 critical values, participants' data showed that most critical values reports (92.8%) were made by the person who performed the test, and that 65% of reports for inpatients were received by nurses. For outpatients, physicians' office staff received the largest percentage (40%) of reports. The majority of participants (71.4%) had no policy on how repeat critical calls should be handled. On average, completion of notification required about 6 minutes for inpatients and 14 minutes for outpatients. Slightly greater than 5% of critical value telephone calls were abandoned, with the largest percentage abandoned for outpatients. More than 45% of critical values were unexpected, and 65% resulted in a change in therapy. Although only 20.8% of 2301 nursing supervisors thought critical values lists were helpful, 94.9% of 514 physicians found critical values lists valuable. CONCLUSIONS: Critical values systems were medically important, highly variable, but also costly practices for participants. We propose a number of recommendations for improvement, including that the critical values list should be approved by the medical staff, each laboratory should develop a written policy for handling initial and repeat critical values reports, a foolproof policy should be established to report results from calls abandoned, and efforts at automating the process should become widespread.

Clinical Chemistry Tests↗

Continuous wristband monitoring over 2 years decreases identification errors: a College of American Pathologists Q-Tracks Study.

CONTEXT: Identification of patients is one of the first steps in ensuring the accuracy of laboratory results. In the United States, hospitalized patients wear wristbands to aid in their identification, but wristbands errors are frequently found. OBJECTIVE: To investigate if continuous monitoring of wristband errors by participants of the College of American Pathologists (CAP) Q-Tracks program results in lower wristband error rates. SETTING: A total of 217 institutions voluntarily participating in the CAP Q-Tracks interlaboratory quality improvement program in 1999 and 2000. DESIGN: Participants completed a demographic form, answered a questionnaire, collected wristband data, and at the end of the year, best and most improved performers answered another questionnaire seeking suggestions for improvement. Each institution's phlebotomists inspected wristbands for errors before performing phlebotomy and recorded the number of patients with wristband errors. On a monthly basis, participants submitted data to the CAP for data processing, and at the end of each quarter, participants received summarized comparisons. At the end of each year, participants also received a critique of the results along with suggestions for improvement. MAIN OUTCOME MEASURES: The percentage of wristband errors by quarter, types of wristband errors, and suggestions for improvement. RESULTS: During 2 years, 1 757 730 wristbands were examined, and 45 197 wristband errors were found. The participants' mean wristband error rate for the first quarter in 1999 was 7.40%; by the eighth quarter, the mean wristband error rate had fallen to 3.05% (P <.001). Continuous improvement occurred in each quarter for participants in the 1999 and 2000 program and in 7 of 8 quarters for those who participated in both 1999 and 2000. Missing wristbands accounted for 71.6% of wristband errors, and best performers usually had wristband error rates under 1.0%. The suggestion for improvement provided by the largest number of best and most improved performers was that phlebotomists should refuse to perform phlebotomy on a patient when a wristband error is detected. CONCLUSIONS: The wristband error rate decreased markedly when this rate was monitored continuously using the CAP Q-Tracks program. The Q-Tracks program provides a useful tool for improving the quality of services in anatomic pathology and laboratory medicine.

Hospitals↗

Operating room blood delivery turnaround time: a College of American Pathologists Q-Probe Study of 12647 units of blood components in 466 institutions.

OBJECTIVES: To determine the normative distribution of time elapsed for blood bank personnel to fill nonscheduled operating room (OR) blood component orders in hospital communities throughout the United States, and to examine hospital blood bank practices associated with faster blood component delivery times. DESIGN: Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the times elapsed for blood bank personnel to fill nonscheduled emergent orders from hospital ORs for red blood cell (RBC) products, fresh frozen plasma (FFP), and platelets (PLTs). Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices. SETTING AND PARTICIPANTS: Four hundred sixty-six public and private institutions located in 48 states in the United States (n = 444), Canada (n = 9), Australia (n = 8), the United Kingdom (n = 4), and Spain (n = 1). MAIN OUTCOME MEASURES: The median time elapsed between requests for blood components by OR personnel and the retrieval of those components by blood component transport personnel, and the median time elapsed between requests for blood components by OR personnel and the arrival of those components in ORs. RESULTS: Participants submitted data on 12 647 units of RBCs, FFP, and PLTs. The median aggregate request-to-retrieval turnaround times (TATs) for RBCs, FFP, and PLTs ranged from 30 to 35 minutes, and the median aggregate request-to-arrival TATs for RBCs, FFP, and PLTs ranged from 33 to 39 minutes. Most of the TAT was consumed by events occurring prior to, rather than after release of components from blood banks. Shorter prerelease TATs were associated with having surgical schedules that listed patients' names and procedures available to blood bank personnel prior to surgeries, and having adequate clotted specimens in the blood bank and completed type-and-screen procedures performed before requests for blood components were submitted to blood banks. Among the fastest-performing 10% of participants (90th percentile and above), request-to-retrieval TATs ranged from 12 to 24 minutes for the 3 blood components, whereas among the slowest-performing 10% of participants (10th percentile and below), request-to-retrieval TATs ranged from 63 to 115 minutes for the 3 components. Median TATs ranged from 33 to 37 minutes for the 3 components. Institutions with TATs in the fastest-performing 25th percentile more frequently stored cross-matched RBCs in the OR daily, stocked PLTs for unexpected surgical use, stored PLTs in or near the OR, and had laboratory rather than nonlaboratory personnel deliver components to the OR than did those institutions with TATs in the slowest-performing 25th percentile. CONCLUSIONS: Hospital blood bank personnel can deliver blood components to the OR in slightly longer than 30 minutes, measured from the time that those units are requested by OR personnel. Practices aimed at saving time before components are released from blood banks will be more efficient in reducing overall TAT than those practices aimed at saving time after components are released from blood banks. Specific practices associated with shorter blood delivery TATs included providing blood bank personnel with access to the names of surgical patients potentially requiring blood components, having pretransfusion testing completed on those patients prior to surgery, having ample blood products on hand, and having laboratory personnel control blood product delivery.

Blood Banks↗

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. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control. SETTING: Hospital-based laboratories in the United States (98%), Canada, and Australia. PARTICIPANTS: Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs. MAIN OUTCOME MEASURES: Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use. RESULTS: Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation. CONCLUSIONS: Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.

Accreditation↗

College of American Pathologists Consensus Conference XXXVI: Diagnostic Issues in Thrombophilia.

OBJECTIVES: To review the state of the art relating to laboratory testing for thrombophilia, as reflected by the medical literature and the consensus opinion of recognized experts in the field, and to make recommendations regarding laboratory testing (whom to test, when to test, what tests to perform, rationale for testing, and other issues) in the assessment of thrombotic risk in individual patients and their family members. DATA SOURCES: Review of the medical literature (primarily from the last 10 years) and the experience and opinions of experts in the field were used as data sources. DATA EXTRACTION AND SYNTHESIS: Participating authors evaluated the medical literature and prepared manuscripts with specific proposed recommendations. Drafts of all of the manuscripts were prepared and circulated to every participant in the College of American Pathologists Conference XXXVI: Diagnostic Issues in Thrombophilia prior to the conference. Each of the conclusions and associated recommendations was then presented for discussion. Recommendations were accepted if a consensus of 70% or more of the 27 experts attending the conference was reached. The results of the discussion were then used to revise the manuscripts and recommendations into final form. CONCLUSIONS: Consensus was reached on 179 recommendations, all of which are presented in articles in this issue of the Archives. Detailed discussion of the rationale for each of these recommendations is found in the text of the respective articles, along with citations to justify the level of evidence for the recommendations. This is an evolving area of research, and it is certain that further clinical studies will change many of the recommendations, cause some to be deleted, and add others in the future.

Blood Coagulation Tests↗

Diagnosing allergic diseases in children. Practical recommendations for consulting pathologists.

In the environment of managed care, children with allergic diseases are increasingly likely to be evaluated by nonallergist physicians. While the presumptive diagnosis of an allergic disease can often be suspected on clinical grounds, signs and symptoms are not reliable for establishing a definitive diagnosis or for deciding on management options. This article discusses the use of immunoglobulin E antibody tests to classify children with allergic symptoms. The information is intended for pathologists who offer consultative laboratory services to nonallergist physicians. Emphasis is placed on defining the minimum number of tests necessary to identify allergic children at different ages.

Age Factors↗

Bethesda 2001 implementation and reporting rates: 2003 practices of participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology.

CONTEXT: The 2001 Bethesda System for the reporting of cervical cytology specimens and the use of new liquid-based and human papillomavirus testing technologies have led to changes in cervical cytology reporting practices. OBJECTIVES: To analyze current laboratory reporting practices using Bethesda 2001 terminology and to compare results with previous survey data from 1996. DESIGN: Questionnaire survey mailed to 1751 laboratories in mid-2003. PARTICIPANTS: Laboratories enrolled in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. RESULTS: Of the 759 responding laboratories, most (85.5%) had implemented Bethesda 2001 terminology, and the majority had adopted major changes, such as elimination of the benign cellular changes category and the satisfactory but limited category. The median reporting rate for low-grade squamous intraepithelial lesion was 2.1%, compared to a 1996 median rate of 1.6%, but the increase was confined to liquid-based preparations. Reporting rates for high-grade squamous intraepithelial lesion (median, 0.5%) and atypical squamous cells (ASC) had changed little. Most ASC cases were subclassified as "undetermined significance" (median, 3.9%) with ASC, cannot exclude high-grade SIL accounting for a minority (median, 0.2%). The median ratio of ASC to squamous intraepithelial lesions and carcinomas (SIL+) was 1.4 and was lower than the 1996 median ratio of 2.0. Median reporting rates for squamous abnormalities for 2002 were noted to be significantly higher for liquid-based preparations than for conventional smears, while median ASC/SIL+ ratios were lower. Most laboratories offer human papillomavirus testing, but almost half (47%) of laboratories do not know the percentage of positive testing results in patients with ASC. CONCLUSIONS: Most laboratories have implemented Bethesda 2001 terminology. New criteria and liquid-based methods have led to an increase in low-grade squamous intraepithelial lesion reporting rates and a decrease in ASC/ SIL+ ratios when compared with 1996 data. Liquid-based preparations have higher median squamous intraepithelial lesion rates and lower ASC/SIL+ ratios than conventional smears.

Cervix Uteri↗

Comparison of performance of conventional and ThinPrep gynecologic preparations in the College of American Pathologists Gynecologic Cytology Program.

CONTEXT: Results of clinical trials suggest that interpretation of liquid-based cytology preparations is more accurate and is associated with less screening error than interpretation of conventional preparations. OBJECTIVE: In this study, the performance of participants in interpreting ThinPrep (TP) preparations was compared with participants' performance on conventional Papanicolaou tests in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology (PAP). DESIGN: The results of the PAP from the year 2002 were reviewed, and the discordancies to series and exact-match error rates for the 2 cytologic methods were compared. RESULTS: For this study, a total of 89 815 interpretations from conventional smears and 20 886 interpretations from TP samples were analyzed. Overall, interpretations of TP preparations had both significantly fewer false-positive (1.6%) and false-negative (1.3%) rates than those of conventional smears (P =.001 and P =.02, respectively) for validated or validated-equivalent slides, as assessed by concordance with the correct diagnostic series. In this assessment of concordance to series, interpretations of educational TP and conventional preparations were similar, except for high-grade squamous intraepithelial lesion, in which the performance was significantly worse for educational TP preparations (false-negative rate of 8.1% vs 4.1% for conventional smears, P <.001). When interpretations were matched to the exact diagnosis, validated-equivalent TP preparations were generally more accurate for diagnoses in the 100 series and 200 series than were conventional smears. Notably, for the reference diagnosis of squamous cell carcinoma, the exact-match error rate on validated equivalent TP slides was significantly greater than that of conventional slides (44.5% vs 23.1%, P <.001). Interpretations of educational TP preparations also had a significantly higher error rate in matching to the exact reference diagnosis for squamous cell carcinoma (33.7% vs 22.8%, P =.007). CONCLUSIONS: Overall, TP preparations in this program were associated with significantly lower error rates than conventional smears for both validated and educational cases. However, unlike the negative for intraepithelial lesion and malignancy, not otherwise specified, low-grade squamous intraepithelial lesion, and adenocarcinoma cytodiagnostic challenges, participants' responses indicated some difficulty in recognizing high-grade squamous intraepithelial lesion and squamous cell carcinoma.

Female↗

Cytologic features of high-grade squamous intraepithelial lesion in ThinPrep Papanicolaou test slides: comparison of cases that performed poorly with those that performed well in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology.

CONTEXT: Conventional Papanicolaou (Pap) test slides of high-grade squamous intraepithelial lesions (HSILs) that are frequently misdiagnosed are known to have relatively few dysplastic cells. Whether this is true of cases of HSIL in ThinPrep Pap Test specimens is not known. OBJECTIVE: To determine if cases of HSIL in ThinPrep specimens that are frequently missed have relatively few dysplastic cells. DESIGN: The cytologic features of 16 ThinPrep cases of HSIL that performed poorly in the College of American Pathologists Interlaboratory Comparison Program were compared with 22 ThinPrep Pap Test cases that performed extremely well. RESULTS: Significantly more cases that performed poorly had fewer than 250 dysplastic cells (13/16) than cases that performed well (3/22) (P <.001). CONCLUSION: ThinPrep Pap Test cases with a diagnosis of HSIL that performed poorly in this program had significantly fewer dysplastic cells than those that performed well.

Carcinoma, Squamous Cell↗

Comparison of pooled fresh frozen serum to proficiency testing material in College of American Pathologists surveys: cortisol and immunoglobulin E.

CONTEXT: The College of American Pathologists (CAP) provides proficiency testing (PT) surveys to laboratories around the world. OBJECTIVES: To compare diagnostic assay methods for serum/plasma cortisol and immunoglobulin (Ig) E in terms of their bias and precision, to determine how well CAP PT specimens simulate human serum, and to reassess proficiency test grading criteria in light of these findings. DESIGN: A participant-blinded, prospective trial. One vial of pooled fresh frozen serum (FFS) and 4 different admixtures of PT material (PTM) were sent to laboratories participating in PT surveys. PARTICIPANTS: Laboratories providing cortisol (>1000) or IgE (>230) results among the subscribers to the CAP surveys, Ligand (General) 2003, set K/KN-A and Chemistry 2003, set C-C. MAIN OUTCOME MEASURES: The main outcome measures were (1) bias among laboratories using the same method (peer groups), defined relative to the median of method means (MedMM); (2) imprecision as measured by the SD and coefficient of variation (CV) about each method mean; and (3) total error across laboratories for the FFS cortisol results, defined as |Bias Relative to Reference Method| + 2 SD. RESULTS: Cortisol method biases, relative to MedMM, ranged from -22% to 9% for the FFS challenge and from -24% to 36% for comparable PTM challenges. The method biases, relative to the reference method, ranged from -3% to 19% for the FFS challenge. The cortisol method CVs ranged from 4.2% to 13.6% for the FFS challenge and from 4.7% to 12.7% for comparable PTM challenges. Total error across laboratories ranged from 1.4 to 6.9 microg/dL (39 to 190 nmol/L) for the FFS challenge. Immunoglobulin E method biases, relative to MedMM, ranged from -8% to 9% for the FFS challenge and from -7% to 5% for comparable PTM challenges. The IgE method CVs ranged from 3.6% to 6.7% for the FFS challenge and from 3.4% to 9.8% for comparable PTM challenges. CONCLUSIONS: The bias for cortisol results was less with FFS than with PTM, but imprecision was comparable. The FFS MedMM was 8.5% higher than the reference value. Fresh frozen serum and PTM bias and imprecision for IgE methods were each less than 10%. Because some of the methods demonstrated greater bias when analyzing PTM than FFS, peer group grading of both these analytes is appropriate.

Clinical Laboratory Techniques↗

Comparison of fresh frozen serum to traditional proficiency testing material in a College of American Pathologists survey for ferritin, folate, and vitamin B12.

CONTEXT: Comparison of different analytical methods in proficiency surveys may be affected by the artificial nature of the survey material. OBJECTIVE: To compare intermethod differences in proficiency survey results between 2 types of survey material, conventional proficiency testing material (PTM) and fresh frozen human serum (FFS), for 3 markers of anemia: ferritin, folate, and vitamin B12. DESIGN: Data were gathered from a 2003 survey event in the College of American Pathologists Ligand ("K") Series, in which the specimens to be tested by each participating laboratory included 1 vial of FFS and 2 vials of PTM with different analyte concentrations. The more than 1600 laboratories subscribing to the survey were not advised as to the nature of the specimens. MAIN OUTCOME MEASURES: The bias of each method relative to the median of method means for each analyte and each type of survey material, and the interlaboratory coefficient of variation for each method. RESULTS: For each of the 3 analytes, moderate to large method biases were observed. For ferritin, method biases correlated strongly between comparable PTM and FFS specimens (Spearman r = 0.863, P < .001), whereas virtually no correlation was found for folate (r = -0.224, P = .48), and a marginally significant correlation existed for B12 (r = 0.55, P = .049). CONCLUSIONS: With ferritin, proficiency survey performance of PTM is similar to that of FFS, implying that method biases relate mainly to calibration. With folate and to a lesser extent with B12, PTM and FFS exhibit different method biases, implying that the biases reflect analyte heterogeneity and/or matrix effects.

Clinical Laboratory Techniques↗

A comparison of human chorionic gonadotropin- related components in fresh frozen serum with the proficiency testing material used by the College of American Pathologists.

CONTEXT: As part of a College of American Pathologists (CAP) proficiency testing survey, a comparison is made between human chorionic gonadotropin (hCG) results from an actual patient pool and a similarly targeted artificial sample. The goal is to gain insight into the possible source(s) of bias attributable to the proficiency testing material (PTM) with a view toward creating more appropriate survey materials. OBJECTIVE: To compare hCG and related variants in a pool of fresh frozen sera (FFS) with that found in PTM. DESIGN: The 2003 CAP K/KN-A Survey included a FFS specimen along with admixtures of PTM. The FFS (K-02) and 1 PTM admixture (K-01) had similar mean hCG values. Five hCG-related analytes were measured on these 2 samples by a reference laboratory. PARTICIPANTS: Approximately 1800 clinical laboratories and diagnostic test kit manufacturers participated in the K/ KN-A Survey. MAIN OUTCOME MEASURES: Method imprecision (coefficient of variation) and method bias (relative difference between peer group mean and all-method median) were computed for the 2 samples. Differences were evaluated with respect to hCG-related analytes levels. RESULTS: All-method hCG results were 12.9 mIU/mL (12.9 IU/L) for the PTM material and 21.6 mIU/mL (21.6 IU/L) for the FFS material. Method biases for 14 manufacturers were greater for PTM than for FFS (-40% to +35% and -16% to +23%). Twelve of 14 methods had higher coefficients of variation on PTM. Total hCG and free beta hCG measurements by the reference laboratory were 14.1 mIU/ mL (14.1 IU/L) for the PTM material and 18.5 mIU/mL (18.5 U/L) for the FFS material (FFS), and 2.4 (PTM) and 0.7 (FFS) mIU/mL (2.4 and 0.7 IU/L), respectively. On a molar basis, free beta represented 17% and 4% of the total hCG, respectively. Levels of hyperglycosylated hCG, nicked hCG, and beta core fragment were not measurable in either sample. CONCLUSIONS: It is unlikely that the hCG added to the PTM is the source of the increased bias and variability. The main difference is a 3-fold increase in free beta found in the PTM, but methods previously found to strongly react with free beta were not systematically elevated. The biases between manufacturers found for the FFS specimen are likely attributable to calibration differences.

Chorionic Gonadotropin↗

Comparison of fresh frozen serum to proficiency testing material in College of American Pathologists surveys: alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin, and prostate-specific antigen.

CONTEXT: Most proficiency testing materials (PTM) contain an artificial matrix that may cause immunoassays to perform differently with this material than with clinical samples. We hypothesized that matrix effects would be reduced by using fresh frozen serum (FFS). OBJECTIVE: To compare the performance of an FFS pool to standard PTM for measurement of alpha-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin (hCG), and prostate-specific antigen (PSA). DESIGN: One FFS specimen and 4 different admixtures of PTM were distributed in the 2003 College of American Pathologists K/KN-A (for alpha-fetoprotein, carcinoembryonic antigen, hCG, and total and free PSA) and C-C (hCG only) Surveys. PARTICIPANTS: The number of laboratories that participated in the surveys varied from a low of 288 (free PSA, K/KN-A Survey) to a high of 2659 (hCG, C-C Survey). MAIN OUTCOME MEASURES: Method imprecision and method bias were compared between the FFS specimen and the standard PTM specimen with the closest value. Method imprecision was determined by calculating the coefficients of variation for each method and for all methods combined. Bias was defined as the proportional difference between peer-group mean and the median of all method means. RESULTS: The FFS specimen gave significantly higher imprecision than PTM for the analytes alpha-fetoprotein, carcinoembryonic antigen, total PSA, and free PSA. For hCG, no substantial imprecision differences were observed in both surveys. Bias was significantly greater for the alpha-fetoprotein, carcinoembryonic antigen, and total PSA assays and significantly lower for the hCG and free PSA assays when comparing the FFS with the PTM. CONCLUSIONS: Fresh frozen serum did not provide consistently lower imprecision or bias than standard PTM in a survey of commonly ordered tumor markers.

Carcinoembryonic Antigen↗

North American pretransfusion testing practices, 2001-2004: results from the College of American Pathologists Interlaboratory Comparison Program survey data, 2001-2004.

CONTEXT: Pretransfusion testing of whole blood and red blood cell recipients is regulated by the federal government under the authority of the Clinical Laboratory Improvement Amendments of 1988. Regulated tests include determination of ABO group, Rh D type, antibody detection, antibody identification, and crossmatching. A wide variety of methods and reagents are available for these regulated tests. During 2001-2004, the College of American Pathologists (CAP) Interlaboratory Comparison Program (Proficiency Testing) J-Survey collected data from more than 4000 laboratories regarding their pretransfusion testing practices. Those data are presented in this report. OBJECTIVE: To assess current testing practices for ABO grouping, Rh D typing, antibody detection, and crossmatching in North America. DESIGN: Data collected for the CAP Interlaboratory Comparison Program (Proficiency Testing) J-Survey were analyzed for trends in laboratory testing practice during 2001- 2004. The data were grouped for analysis by peer group (testing method used) for ABO grouping, Rh D typing, antibody detection, and crossmatching and then analyzed. SETTING, PATIENTS, OR OTHER PARTICIPANTS: Subscribers to the CAP Interlaboratory Comparison Program Transfusion Medicine J-Series. RESULTS: The most common testing schemes used in North America during 2001-2004 are as follows: ABO grouping (most laboratories perform tube testing: 97.6% in 2000 and 91.1% in 2004); Rh D typing (most laboratories perform tube testing: 97.7% in 2001 and 91.1% in 2004); antibody detection (most laboratories perform tube testing: 69.7% in 2001 and 55% in 2004, most frequently with the low ionic strength solution anti-human globulin [AHG] method, 48.3% in 2001 and 39.9% in 2004; as of 2004 slightly more laboratories use the gel AHG method [42%] than the low ionic strength solution AHG tube method); crossmatching for alloimmunized patients (most laboratories perform tube testing using a low ionic strength solution AHG method; 55.8% in 2001 and 47.6% in 2004); and crossmatching for nonalloimmunized patients (tube testing using an immediate spin method; 42% in 2001 and 40.4% in 2004). CONCLUSIONS: Most North American laboratories currently favor tube methods when performing ABO grouping, Rh typing, antibody screening, and crossmatching. However, there has been a significant increase in the use of gel-based methods in recent years, especially for antibody detection and crossmatching. Data collection and data analysis of CAP Interlaboratory Comparison Program Survey results allow for assessment of laboratory proficiency and provide insights into current North American practice trends in pretransfusion compatibility testing.

Blood Banks↗

Diagnostic molecular pathology: an increasingly indispensable tool for the practicing pathologist.

CONTEXT: Diagnostic molecular pathology is rapidly becoming an indispensable tool for anatomic pathologists. Familiarity with some of the technologic principles and current, as well as upcoming, molecular diagnostic applications is greatly advantageous for today's practice of pathology. OBJECTIVES: To provide a discussion of the most common techniques currently used in molecular pathology laboratories and review their essential applications to diagnosis and management of neoplastic diseases. DATA SOURCES: A literature review and illustrative cases from the authors' molecular diagnostic practices. CONCLUSIONS: Applications such as clonality assays, molecular cytogenetics, and chimerism analysis are providing us with accurate tools to resolve difficult diagnostic and management decisions in hemato-oncology. This should serve as a future model to expand molecular applications into the wider field of solid tumors.

Chromosome Painting↗

Effect of fondaparinux on coagulation assays: results of College of American Pathologists proficiency testing.

CONTEXT: Fondaparinux, a factor Xa inhibitor, is approved for thromboprophylaxis after orthopedic surgery and for treatment of venous thromboembolism. It may also be efficacious, safe, and cost-effective for other patients; thus, more widespread use of fondaparinux is likely. The effect of fondaparinux on coagulation testing needs to be thoroughly examined. OBJECTIVE: To report the effects of fondaparinux on coagulation tests (prothrombin time, activated partial thromboplastin time, fibrinogen, antithrombin, factor VIII, thrombin time, anti-factor Xa) across diverse methodologies. DESIGN: Samples with different concentrations of fondaparinux (0, 0.4, 0.8, and 2.0 microg/mL) were sent to laboratories participating in the College of American Pathologists Comprehensive Coagulation proficiency survey (N = 898). Laboratory-specific methods were used to assay coagulation parameters. RESULTS: Prophylactic or therapeutic fondaparinux prolonged the prothrombin time by approximately 1 second and the activated partial thromboplastin time by 4 to 5 seconds, and reduced factor VIII from 119% to 107% and 102%, respectively. Supratherapeutic fondaparinux reduced factor VIII to 85%. The activated partial thromboplastin time was prolonged in 19%, 29%, and 52% of laboratories with prophylactic, therapeutic, and supratherapeutic fondaparinux levels, respectively. Fibrinogen, antithrombin, and thrombin time assays did not show clinically significant changes. When measuring fondaparinux concentration using an anti-factor Xa assay, the most accurate results were obtained when fondaparinux was used as the calibrator. CONCLUSIONS: Fondaparinux, even in prophylactic doses, slightly prolongs the prothrombin time and activated partial thromboplastin time and can interfere with factor VIII assays, but it has no clinically relevant effect on fibrinogen, antithrombin, or thrombin time. A fondaparinux standard curve should be used for reporting fondaparinux levels using an anti-factor Xa assay.

Anticoagulants↗

Hospital nursing satisfaction with clinical laboratory services: a College of American Pathologists Q-Probes study of 162 institutions.

CONTEXT: Monitoring customer satisfaction is an important and useful quality improvement tool and is required of most clinical laboratories in the United States. OBJECTIVE: To survey the level of nursing satisfaction with hospital clinical laboratory services. DESIGN: Participating laboratories provided information regarding laboratory demographics and practices. These laboratories then surveyed hospital nursing personnel regarding their level of satisfaction with defined aspects of laboratory service. SETTING: College of American Pathologists Q-Probes laboratory quality improvement study in 162 hospital laboratories. MAIN OUTCOME MEASURES: Nursing overall satisfaction score (ranging from 1, not satisfied, to 5, very satisfied) and satisfaction scores for 13 specific aspects of clinical laboratory services. RESULTS: One hundred sixty-two institutions submitted data from a total of 7033 nursing surveys. The overall satisfaction score for all institutions ranged from 2.5 to 4.6. The median overall score for all participants was 3.9 (10th percentile, 3.2; 90th percentile, 4.2). Nursing personnel were most satisfied with the accuracy of test results, phlebotomy courtesy toward patients and nursing staff, and notification of abnormal results. They were least satisfied with stat test turnaround time, laboratory management responsiveness and accessibility, phlebotomy responsiveness to service requests, and routine test turnaround time. The most important aspect of laboratory service reported by nursing personnel was stat test turnaround time. CONCLUSIONS: Most nursing personnel are satisfied with the clinical laboratory services that are provided to the patients in their care. Although test result accuracy is very highly regarded, there is room for improvement in several aspects of service, particularly in test turnaround time and laboratory management accessibility and responsiveness.

Clinical Laboratory Techniques↗

Fine-needle aspiration biopsy of lymphoproliferative disorders--interpretations based on morphologic criteria alone: results from the College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytopathology.

CONTEXT: Diagnosis of lymphoproliferative disorders is one of the most challenging tasks faced by the cytologist. The initial cytomorphologic evaluation of lymphoproliferative lesions directs the choice of ancillary studies that ultimately lead to a diagnosis based on the World Health Organization classification system using a composite of clinical, morphologic, immunophenotypic, and molecular features. OBJECTIVE: To evaluate the ability of participating laboratories in the College of American Pathologists Interlaboratory Comparison Program in Non-Gynecologic Cytopathology to appropriately categorize lymphoproliferative lesions based solely on cytomorphologic criteria. DESIGN: Laboratory responses for lymph node aspirates were examined. All responses were based on review of glass slides without ancillary immunologic or molecular data available. The benchmarking data provided for each specific diagnosis were analyzed, with a focus on the performance for evaluation of lymphoproliferative lesions. RESULTS: Based on morphology alone, responses for lymph node aspirates in the Non-Gynecologic Cytopathology program were correct to the exact reference diagnosis for 87.1% of Hodgkin lymphoma. Non-Hodgkin lymphoma was identified in 69.5% of the large cell non-Hodgkin lymphoma cases, of which 66.8% were correctly classified as large cell type. Non-Hodgkin lymphoma was identified in 68.1% of non-Hodgkin lymphoma, other than large cell cases, and of these, 94.7% were identified as other than large cell type. CONCLUSIONS: The spectrum of specific responses was consistent for lymphoproliferative lesions, with a reasonable differential diagnosis based on cytomorphology alone, which, in practice, facilitates the appropriate choice of immunophenotypic markers and other ancillary studies.

Biopsy, Fine-Needle↗