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PubMed1999

Recommended policies for uses of human tissue in research, education, and quality control. Ad Hoc Committee on Stored Tissue, College of American Pathologists.

As recipients of tissue and medical specimens, pathologists and other medical specialists regard themselves as stewards of patient tissues and consider it their duty to protect the best interests of both the individual patient and the public. The stewardship of slides, blocks, and other materials includes providing, under appropriate circumstances, patient materials for research, education, and quality control. The decision to provide human tissue for such purposes should be based on the specific (ie, direct patient care) and general (ie, furthering medical knowledge) interests of the patient and of society. The same standards of responsibility should apply to all medical professionals who receive and use specimens. This document proposes specific recommendations whereby both interests can be fostered safely, ethically, and reasonably.

Biological Specimen Banks↗

PubMed1999

Requirements for accreditation by the College of American Pathologists Laboratory Accreditation Program.

The College of American Pathologists Laboratory Accreditation Program expects a participant laboratory or laboratory section to be able to demonstrate that it is in compliance with the Standards for Laboratory Accreditation. The program expects laboratories to demonstrate that they are continually taking steps to identify and correct deficient areas and improve performance, in compliance with the Clinical Laboratory Improvement Amendments of 1988 regulatory requirements, particularly those pertaining to proficiency testing performance, and participating as inspectors in the accreditation process.

Accreditation↗

PubMed1999

Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry accuracy in 660 institutions.

CONTEXT: Laboratory test order entry errors potentially delay diagnosis, consume resources, and cause patient inconvenience. OBJECTIVE: To evaluate the frequency and causes of computer order entry errors in outpatients. DESIGN: Cross-sectional survey and prospective sample of errors. Participants answered questions about their test order entry policies and practices. They then examined a sample of outpatient requisitions and compared information on the requisition with information entered into the laboratory computer system. Order entry errors were divided into 4 types: tests ordered on the requisition, but not in the computer; tests performed but not ordered on the requisition; physician name discrepancies; and test priority errors. PARTICIPANTS: Six hundred sixty laboratories enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURE: Overall order entry error rate. RESULTS: A total of 5514 (4.8%) of 114 934 outpatient requisitions were associated with at least 1 order entry error. The median participant reported 1 or more order errors on 6.0% of requisitions; 10% of institutions reported errors with at least 18% of requisitions. Of the 4 specific error types, physician name discrepancies had the highest error rate, and test priority errors the lowest error rate. Four institutional factors were significantly associated with higher overall error rates: orders verbally communicated to the laboratory; no policy requiring laboratory staff to compare a printout or display of ordered tests with the laboratory requisitions to confirm that orders had been entered correctly; failure to monitor the accuracy of outpatient order entry on a regular basis; and a higher percentage of occupied beds (ie, a busier hospital). CONCLUSIONS: Computer order entry errors are common, involving 5% of outpatient requisitions. Laboratories may be able to decrease error rates by regularly monitoring the accuracy of order entry, substituting written and facsimile orders for verbal orders, and instituting a policy in which orders entered into computer systems are routinely rechecked against orders on requisitions.

Ambulatory Care↗

PubMed2000

Employee competence and performance-based assessment: A college of American pathologists Q-probes study of larboratory personnel in 522 institutions.

OBJECTIVE: To survey employee competence assessment practices in departments of pathology and laboratory medicine and provide suggestions for improvement. DESIGN: A 3-part study consisting of a questionnaire about current competence assessment practices, an evaluation of compliance with stated competence assessment practices using personnel records of 30 employees, and a written appraisal of competence of 5 specimen-processing staff members per institution. SETTING: A total of 522 institutions participating in the College of American Pathologists 1996 Q-Probes program. MAIN OUTCOME MEASURES: Institutional competence assessment practices, compliance of each institution with their own practices, and determination of competence of specimen-processing personnel. RESULTS: Of the participating institutions, 89.8% had a written competence plan and 98.1% reported reviewing employee competence at least yearly. General competence was reviewed by direct observations (87.5%), review of test or quality control results (77.4%), review of instrument preventive maintenance (60.0%), written testing (52.2%), and/or other methods (20.8%). In 8.6% of institutions, employees who failed competence assessment were not allowed to continue their usual work. On review of records of 14 029 employees for adherence to the laboratory's general competence plan, adherence was 89.7% for direct observations, 85.8% for review of quality control and test results, 78.0% for review of instrument records, and 74.0% for written testing. Employee failure rate ranged from 0.9% to 6.4%, depending on the competence evaluated. Adherence to an institution's plan was 90.4% for new employees, 93.1% for computer skills, 95.8% for laboratory safety, and 92.1% for continuing education. When a written competence assessment was given to 2853 specimen-processing staff members, 90.0% responded satisfactorily. CONCLUSIONS: Opportunities for improvement in employee competence assessment are numerous, and we provide several specific suggestions.

Educational Measurement↗

PubMed2000

Atypical epithelial cells and specimen adequacy: current laboratory practices of participants in the college of American pathologists interlaboratory comparison program in cervicovaginal cytology.

CONTEXT: The Bethesda System for reporting cervical/vaginal cytologic diagnoses introduced terminology for atypical squamous and glandular cells and categories for specimen adequacy. OBJECTIVES: To analyze current laboratory reporting practices and compare trends to previous surveys. DESIGN: Questionnaire surveys were mailed to 2000 laboratories in 1996 and 1997. PARTICIPANTS: Laboratories enrolled in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. MAIN OUTCOME MEASURES: Laboratory policies, criteria, and reporting rates for Bethesda System categories. RESULTS: The 1996 specimen adequacy survey had 1166 respondents, and 768 laboratories returned the 1997 questionnaire focusing on atypical squamous cells of undetermined significance (ASCUS) and glandular cells of undetermined significance (AGUS). Nearly all laboratories (92%) routinely reported specimen adequacy, an increase from the 66% rate in 1991. The median rate for unsatisfactory specimens was 0.5% (mean 0.95%), and the median rate for the satisfactory but limited category was 5.8% (mean 9.3%). The Bethesda criteria for designating a specimen unsatisfactory were used by more than 90% of laboratories. Nearly all laboratories (97%) used the term ASCUS in 1997, and more than 80% of laboratories used the Bethesda criteria for this category. Median reporting rates for epithelial abnormalities were as follows: ASCUS, 4.5%; AGUS, 0.3%; low-grade squamous intraepithelial lesion (SIL), 1.6%; and high-grade SIL, 0.5%. The median ASCUS/SIL ratio was 2.0, with 80% of laboratories reporting ratios between 0.64 and 4.23. The median ASCUS rate and ASCUS/SIL ratio were higher than 1993 survey results. Nearly all laboratories attempted follow-up studies on patients with abnormal cytology results, and midsized laboratories achieved the highest rates of follow-up. Median rates of abnormalities following an ASCUS or AGUS diagnosis were 20% and 15%, respectively. Laboratory respondents commonly used written recommendations in ASCUS/AGUS reports. CONCLUSIONS: Most laboratories that responded to the surveys had adopted Bethesda terminology and criteria for specimen adequacy and ASCUS/AGUS. Reporting rates for SIL and adequacy categories have remained stable, but median ASCUS rates and ASCUS/SIL ratios are higher than in 1993. The AGUS category is reported infrequently, but can be associated with significant pathology.

Clinical Laboratory Techniques↗

PubMed2000

Morning rounds inpatient test availability: a College of American Pathologist Q-Probes study of 79860 morning complete blood cell count and electrolyte test results in 367 institutions.

OBJECTIVES: To determine the success with which laboratories were able to report morning test results on time, the laboratory practice characteristics associated with improved success, and the degree of satisfaction among clinicians with the timeliness of laboratory service. DESIGN: Hospital laboratories participating in the College of American Pathologist Q-Probes laboratory quality improvement program prospectively calculated the percentages of morning-run complete blood cell count (CBC) and electrolyte results that were reported on or before predetermined reporting deadlines, completed questionnaires concerning their departments' practice characteristics as they related to performing morning blood work, and distributed to physician utilizers of morning laboratory services questionnaires evaluating physician satisfaction with laboratory services. SETTING AND PARTICIPANTS: A total of 367 public and private institutions located in the United States (355), Canada (5), Australia (2), and 1 each in the United Kingdom, Spain, Brazil, Korea, and Guam. MAIN OUTCOME MEASURE: The percentages of morning-run CBC and electrolyte results reported on or before predetermined reporting deadlines. RESULTS: Participants submitted data on 40 256 CBC and 39 604 electrolyte specimens. In aggregate, a total of 88.9% of these tests (90.2% of CBCs and 87.6% of electrolytes) were reported on or before the reporting deadlines that the participating laboratories set for themselves. Half of the participants reported 94.6% of their CBC results and 95.5% of their electrolyte results on or before their self-imposed reporting deadlines. No specific demographic features or departmental practice characteristics were associated with higher or lower rates of institutional reporting compliance. Most physician utilizers of early-morning laboratory test results believed that the laboratory is sensitive to and meets the needs of clinicians for timely reporting of early-morning test results. CONCLUSIONS: Most laboratories are capable of reporting 95% of their routine morning laboratory tests on time, and most physicians are satisfied with their laboratories' morning testing service.

Australia↗

PubMed2000

Postanalytical quality improvement: a College of American Pathologists Q-Probes study of elevated calcium results in 525 institutions.

OBJECTIVE: To evaluate elevated patient calcium results as a postanalytic quality indicator of physician practices. DESIGN: Participants prospectively identified hypercalcemic patient results for 4 months or until they found 320 hypercalcemic results, and then, after at least 3 days, reviewed the medical records of these patients. Hypercalcemia was defined as a calcium value that exceeded the upper limit of each laboratory's reference range by 0.12 mmol/L or more. Participants, as well a subset of their physicians who did not acknowledge or respond to elevated results in the medical record, answered a questionnaire about their practices. PARTICIPANTS: Five hundred twenty-five laboratories enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURES: The presence of hyercalcemic results in patients' medical records and physicians' acknowledgement and response to those elevated results. RESULTS: More than 5500 hypercalcemic results were identified, of which 53.2% represented a new finding. About 3.5% of results were not charted in the patients' records, and 23.1% of patient records did not contain clinician documentation of the abnormal result. Follow-up laboratory tests were not ordered for 13.8% of the elevated values. For 570 of the 808 results for which there was neither clinician documentation nor designated follow-up laboratory tests ordered, patients' physicians received written notification of the elevated calcium results along with a questionnaire. Responses were received from 386 physicians (68%). One hundred physicians indicated they did not order the specific calcium measurement, and of these 100, 85 responded it was part of a panel. The 286 physicians who ordered the test stated the results ultimately led to further testing (69%), a change of management (56%), or a new diagnosis (25%). CONCLUSIONS: We found that a high percentage of abnormal results (3.5%) were not documented in the patients' medical records, the diagnosis of hypercalcemia frequently was new (53.2%), and a high percentage of physicians did not respond to elevated calcium results by writing a note (23.1%) or ordering another test (13.8%). Opportunities for quality improvement at these postanalytical steps are far greater than at the analytical step. Laboratorians must help physicians identify and respond to clinically important laboratory results.

Calcium↗

PubMed2000

College of American Pathologists Conference XXXV: solid tumor prognostic factors-which, how and so what? Summary document and recommendations for implementation. Cancer Committee and Conference Participants.

The College of American Pathologists convened a prognostic factor conference in June 1999 to consider prognostic and predictive factors in breast, colon, and prostate cancer, and to stratify these factors into categories reflecting the strength of published evidence. Because so little progress in prognostic factor clinical utility has been made in the last 5 years, the conference participants focused their attention on decreasing variation in methods, interpretation, and reporting of these factors so that greater clarity of value could be achieved. The conference was organized to promote discussion, broad input, and future planning. An initial plenary session provided an overview of the status of tumor marker research, the impact of variation in medicine and pathology, and statistical issues related to prognostic factor research. In working group sessions for each cancer type, participants interactively evaluated and refined the documents created by the expert panels. A second plenary session dealt with issues common to all 3 groups, including the problem of micrometastases in lymph nodes in these sites; statistical issues that arose during the breakout discussions; and issues of variation in methods, interpretation, and reporting of immunohistochemical assays. A faculty session brainstormed strategies that could be used to implement the changes recommended. This session included invited representatives of the Food and Drug Administration, Health Care Financing Administration, Centers for Disease Control and Prevention, National Cancer Institute, American Joint Committee on Cancer, and International Union Against Cancer. Cancer site and general recommendations were presented and discussed during a final session to achieve consensus of the conference participants and to address feasibility of implementation of these recommendations. A final discussion focused on future initiatives that might lead to implementation of the changes proposed in the conference by the various organizations represented. This report summarizes the general conference recommendations, cancer working group recommendations, and plans for implementation of the recommendations.

Biometry↗

PubMed2000

Prognostic factors in colorectal cancer. College of American Pathologists Consensus Statement 1999.

BACKGROUND: Under the auspices of the College of American Pathologists, the current state of knowledge regarding pathologic prognostic factors (factors linked to outcome) and predictive factors (factors predicting response to therapy) in colorectal carcinoma was evaluated. A multidisciplinary group of clinical (including the disciplines of medical oncology, surgical oncology, and radiation oncology), pathologic, and statistical experts in colorectal cancer reviewed all relevant medical literature and stratified the reported prognostic factors into categories that reflected the strength of the published evidence demonstrating their prognostic value. Accordingly, the following categories of prognostic factors were defined. Category I includes factors definitively proven to be of prognostic import based on evidence from multiple statistically robust published trials and generally used in patient management. Category IIA includes factors extensively studied biologically and/or clinically and repeatedly shown to have prognostic value for outcome and/or predictive value for therapy that is of sufficient import to be included in the pathology report but that remains to be validated in statistically robust studies. Category IIB includes factors shown to be promising in multiple studies but lacking sufficient data for inclusion in category I or IIA. Category III includes factors not yet sufficiently studied to determine their prognostic value. Category IV includes factors well studied and shown to have no prognostic significance. MATERIALS AND METHODS: The medical literature was critically reviewed, and the analysis revealed specific points of variability in approach that prevented direct comparisons among published studies and compromised the quality of the collective data. Categories of variability recognized included the following: (1) methods of analysis, (2) interpretation of findings, (3) reporting of data, and (4) statistical evaluation. Additional points of variability within these categories were defined from the collective experience of the group. Reasons for the assignment of an individual prognostic factor to category I, II, III, or IV (categories defined by the level of scientific validation) were outlined with reference to the specific types of variability associated with the supportive data. For each factor and category of variability related to that factor, detailed recommendations for improvement were made. The recommendations were based on the following aims: (1) to increase the uniformity and completeness of pathologic evaluation of tumor specimens, (2) to enhance the quality of the data needed for definitive evaluation of the prognostic value of individual prognostic factors, and (3) ultimately, to improve patient care. RESULTS AND CONCLUSIONS: Factors that were determined to merit inclusion in category I were as follows: the local extent of tumor assessed pathologically (the pT category of the TNM staging system of the American Joint Committee on Cancer and the Union Internationale Contre le Cancer [AJCC/UICC]); regional lymph node metastasis (the pN category of the TNM staging system); blood or lymphatic vessel invasion; residual tumor following surgery with curative intent (the R classification of the AJCC/UICC staging system), especially as it relates to positive surgical margins; and preoperative elevation of carcinoembryonic antigen elevation (a factor established by laboratory medicine methods rather than anatomic pathology). Factors in category IIA included the following: tumor grade, radial margin status (for resection specimens with nonperitonealized surfaces), and residual tumor in the resection specimen following neoadjuvant therapy (the ypTNM category of the TNM staging system of the AJCC/UICC). (ABSTRACT TRUNCATED)

Biomarkers, Tumor↗

PubMed2000

Policies and procedures related to weak D phenotype testing and Rh immune globulin administration. Results from supplementary questions to the Comprehensive Transfusion Medicine Survey of the College of American Pathologists.

OBJECTIVE: To determine and evaluate policies and procedures related to weak D phenotype testing and terminology and the administration of Rh immune globulin in selected clinical situations. Design, Setting, and Participants.-Institutions participating in the College of American Pathologists 1999 J-A Comprehensive Transfusion Medicine Survey program were asked to respond to a series of supplementary questions related to weak D phenotype testing and Rh immune globulin administration. More than 3500 institutions and transfusion services participated. RESULTS: Most supplementary questions elicited more than 3000 responses. Despite no clinical or regulatory mandate, 58. 2% of transfusion services routinely perform an antiglobulin test for the weak D phenotype in patients who test negative with anti-D reagents. Significant differences were found concerning the transfusion of blood components to patients with the weak D phenotype and the administration of Rh immune globulin to these individuals. At least one patient with the weak D phenotype with anti-D alloantibody formation was observed during a 12-month period by 31.8% of transfusion services. CONCLUSIONS: Significant variability concerning policies and procedures related to weak D typing and terminology was found in this survey. Transfusion of blood components to patients with the weak D phenotype and the administration of Rh immune globulin also demonstrated variations. Anti-D alloantibody formation by patients with the weak D phenotype may not be as rare as previously thought. Additional study related to the clinical significance of these results is warranted.

Blood Banks↗

PubMed2000

Neonatal bilirubin testing practices: reports from 312 laboratories enrolled in the Colege of American Pathologists Excel Proficiency Testing Program.

OBJECTIVE: To characterize laboratory practices for neonatal bilirubin testing and to identify opportunities for improvement. DESIGN: A voluntary self-assessment questionnaire was used to assess the laboratory practices of 312 laboratories subscribing to the College of American Pathologists (CAP) Excel Chemistry Proficiency Testing Program. RESULTS: A range of preanalytic and analytic practices were reported. The most notable problems identified were the use of overly long capillary puncture devices (17.8%), failure to protect the specimen from light prior to analysis (3.4%), failure to use a control containing >171 micromol/L bilirubin (26.1%), use of single-level control (4.2%), and lack of established linearity limits (7.0%). CONCLUSION: Opportunities exist to improve specimen collection, processing, and analysis for some physician-office and small-hospital laboratories.

Bilirubin↗

PubMed2000

Perceptions of the ethical acceptability of using medical examiner autopsies for research and education: a survey of forensic pathologists.

BACKGROUND: Forensic pathologists face difficult moral questions in their practices each day. Consistent ethical and legal guidelines for autopsy tissue use extending beyond usual clinical and legal imperatives have not been developed in this country. OBJECTIVE: To obtain the perceptions of medical examiners regarding the ethical acceptability of autopsy tissue use for research and education. METHOD: A written, self-report questionnaire was developed and piloted by a multidisciplinary team at the University of New Mexico, Albuquerque. All individuals who attended a platform presentation at the National Association of Medical Examiners Annual Meeting in September 1997 were invited to participate. RESULTS: Ninety-one individuals completed the survey (40% of all conference registrants and approximately 75% of presentation attendees). Sixty-three percent of respondents had encountered an ethical dilemma surrounding autopsy tissue use, and one third reported some professional ethics experience. Perspectives varied greatly concerning the ethical acceptability of using autopsy tissues to demonstrate or practice techniques (eg, intubation, brachial plexus dissection) and of fulfilling requests to supply varying kinds and quantities of tissues for research and education. Most respondents indicated that consent by family members was important in tissue use decisions. Respondents agreed on the importance of basic values in education and research, such as integrity, scientific or educational merit, and formal institutional approval of a project. Characteristics of the decedent did not influence decisions to release tissues, except when the individual had died from a mysterious or very rare illness. Attributes of medical examiners, with the exception of sex, also did not consistently predict responses. CONCLUSION: Significant diversity exists in beliefs among medical examiners regarding perceptions of the appropriate use of autopsy tissues for education and research. There is need for further inquiry and dialogue so that enduring policy solutions regarding human tissue use for education and research may be developed.

Attitude of Health Personnel↗

PubMed2000

Redesigned proficiency testing materials improve survey outcomes for prostate-specific antigen. A College of American Pathologists Ligand Assay Survey tool.

CONTEXT: Large disparities in prostate-specific antigen (PSA) results from different assays have been observed in the College of American Pathologists (CAP) Ligand Assay Survey, with interassay results varying severalfold. Survey specimens are predominately composed of free PSA and do not reflect the composition of typical patient specimens. OBJECTIVES: To characterize a pilot material developed for CAP in which pooled sera samples were spiked with purified PSA and alpha(1)-antichymotrypsin-bound PSA at targeted concentrations and to compare it to CAP survey and reference materials. DESIGN: CAP survey, reference, and pilot materials were analyzed using 10 total PSA and 7 free PSA assays. These assays included Food and Drug Administration-approved assays and assays for research use only. RESULTS: Variability among the 10 total PSA methods was greatest for the 1997 ligand survey material (CV range, 56%-65%) followed by the pilot material (CV range, 10%-29%) and the reference material (CV range, 6%-13%). In contrast, interassay variability for the 7 free PSA methods was similar for the 3 preparations, with the exception of one specimen close to the limit of detection of the assays. As determined with the Hybritech Tandem-R method, the ligand survey specimens were essentially composed of all free PSA, whereas the reference and pilot materials were composed of approximately 10% and 35% free PSA, respectively. CONCLUSIONS: The newly formulated pilot material prepared using a human base that contained defined concentrations of free PSA and alpha(1)-antichymotrypsin-bound PSA more closely resembled patient specimens and minimized differences among methods compared with the semen-supplemented original survey material.

Humans↗

PubMed2001

Sources of variability: a College of American Pathologists Therapeutic Drug Monitoring study.

OBJECTIVE: To determine the magnitudes and sources of analytic variation in testing for therapeutic drugs. Specifically, among laboratories using the same analytic method, to compare the within-laboratory variation (including both short- and long-term variation) with the between-laboratory variation. DESIGN: Four identical challenges were prepared from a lyophilized pool of spiked sera and were sent in pairs 4 months apart to laboratories participating in a nationwide proficiency-testing program. For each of 25 drugs, the variability in reported results from laboratories using the same method was investigated using nested analysis of variance. SETTING: The first 2 mailings of the College of American Pathologists Therapeutic Drug Monitoring Survey, 1996, sets Z and ZM. MAIN OUTCOME MEASURES: For each drug, total variance was partitioned into within- and between-laboratory components for common methods. The within-laboratory component was further partitioned into short- and long-term components. PARTICIPANTS: The approximately 5000 laboratories enrolled in the survey. RESULTS: For the 25 drugs, the average percentages of the total variance due to short-term, within-laboratory variance; long-term, within-laboratory variance; between-laboratory variance; and total laboratory variance were 25.0% (range, 8.8--50.6%), 57.8% (35.3--73.7%), 17.3% (5.0--35.4%), and 82.7% (64.6--95.0%), respectively. CONCLUSION: For all drugs tested, the within-laboratory component of variance was greater than the between-laboratory component of variance. Within laboratories, the magnitude of the long-term component was generally greater than the magnitude of the short-term component. This information will be helpful in determining the clinical utility of various drug assays and in evaluating the appropriateness of regulations involving therapeutic drug testing.

Analysis of Variance↗

PubMed2001

An evaluation of analytic goals for assays of drugs: a College of American Pathologists Therapeutic Drug Monitoring Survey Study.

OBJECTIVE: To determine if the levels of imprecision of the commonly used analytic methods for drug measurements are suitable for long-term therapeutic drug monitoring. DESIGN: In 1996, 4 identical lyophilized samples (2 in the first mailing and 2 in the second mailing 4 months later) were sent to laboratories participating in a nationwide proficiency testing program. Similarly, in 1999, replicates from a liquid pool of spiked sera were mailed 3 times, 4 months apart, to participating laboratories. For each of 11 drugs regulated under the Clinical Laboratory Improvement Amendments of 1988 and 1 metabolite, the total variance for each method was partitioned into within- and between-laboratory components. The total within-laboratory and the total survey coefficients of variation (CVs) for each method were then compared with the "acceptable" precision criteria of Glick, Burnett, and Fraser for each drug. SETTING: The first 2 mailings of the College of American Pathologists Therapeutic Drug Monitoring surveys for 1996, sets Z and ZM, and the 3 mailings of 1999, sets ZM, Z, and Z2. MAIN OUTCOME MEASURES: For each drug studied, the CV of each method was compared with the various imprecision criteria, and if greater than any of the criteria, the method was then tabulated as not meeting that specific criterion.Participants.-The approximately 5000 participants of the survey. RESULTS: The number of methods deemed as not having acceptable total long-term within-laboratory precision by the various criteria ranged from 35% to 88% in 1996 and from 22% to 77% in 1999. CONCLUSION: The number of failures possibly indicates that many of the reagent assays being utilized are not precise enough for long-term therapeutic drug monitoring of chronically administered drugs or that the published criteria used to evaluate the data in this study are too stringent.

Data Collection↗

PubMed2001

Six-year trends in productivity and utilization of 73 clinical laboratories: a College of American Pathologists Laboratory Management Index Program study.

OBJECTIVES: To describe longitudinal trends in the efficiency, labor productivity, and utilization of clinical laboratories in the United States. METHODS: Financial and activity data were prospectively collected from 73 clinical laboratories continuously enrolled in the College of American Pathologists Laboratory Management Index Program from 1994 through 1999. Each laboratory reported quarterly on its costs, labor inputs, and test activity using uniform data definitions. RESULTS: During the 6-year study period, there was a significant increase in laboratory labor productivity (2.1% more tests/full-time equivalent/y; P <.001). Productivity increases were offset by increasing labor expense (1.5%/full-time equivalent/y; P <.001), consumable expense (1.7%/on-site test/y; P =.005), and blood expense, which comprised more than 10% of laboratory expenses by 1999 (4.4% increase/y; P <.001). As a result, overall expense per test showed no significant change in non-inflation-adjusted dollars. Reference laboratory expense per test did not change significantly during the study period; the proportion of tests sent to reference laboratories grew slightly (0.06% increase/y; P <.001). Test volume of the median laboratory grew by 5442 tests per year (2.3% annual increase; P <.001), while the proportion of testing from inpatients declined by 1.7% per year (P <.001). Inpatient test utilization declined on a discharge basis (annual decline of 1.2 tests/inpatient discharge; P <.001) and on a per diem basis (annual decline of 0.08 tests/inpatient day; P =.002). Inpatient laboratory expense declined on a discharge basis (annual decline of $2.40 or 1.3% per discharge; P <.001), but did not change significantly per inpatient day. Most of the reduction in the expense per discharge occurred during 1994-1996. CONCLUSIONS: Between 1994 and 1999, clinical laboratories in the United States experienced significant changes in the cost of operations, utilization, and labor productivity. Laboratory administrators who compare local institutional performance with that of peers are advised to use current or forward-trended peer data. Quarter-to-quarter improvement in many measures of laboratory financial activity may not signal a superior operation, as performance of the whole industry appears to be improving.

Blood↗

PubMed2001

Solitary blood cultures: a College of American Pathologists Q-probes study of 132,778 blood culture sets in 333 small hospitals.

OBJECTIVE: To determine the frequency with which solitary blood culture samples were submitted to laboratories serving small hospitals and to ascertain whether certain hospital practices relating to the performance of blood cultures were associated with lower solitary blood culture rates (SBCRs). DESIGN: Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the numbers of solitary blood culture sets from adult patients submitted to their laboratories and answered questions about their institutions' practice characteristics relating to the collection of blood culture specimens. SETTING AND PARTICIPANTS: Three hundred thirty-three public and private institutions with a median occupied bed size of 57. Participants were located in the United States (n = 329), Canada (n = 3), and Australia (n = 1). MAIN OUTCOME MEASURE: The solitary blood culture rate was defined as the number of instances in which only 1 blood culture venipuncture was performed on an individual patient during a 24-hour period divided by the total number of blood culture venipunctures that were performed during the study period. RESULTS: Participants submitted data on 132 778 adult patient blood culture sets. The SBCRs were 3.4% or less in the top-performing 10% of participating institutions (90th percentile and above), 12.7% in the midrange of participating institutions (50th percentile), and 42.5% or more in the bottom-performing 10% of participating institutions (10th percentile and below). In half the participating institutions, the SBCRs for inpatients were 8.3% or less and for outpatients, 22% or less. Solitary blood culture rates were lower for institutions in which phlebotomists rather than nonphlebotomists routinely collected blood culture specimens, in which internal policies required drawing at least 2 blood culture sets, in which hospital personnel contacted clinicians when their laboratories received requests for solitary blood culture sets, and in which quality control programs monitored SBCRs routinely. CONCLUSIONS: Hospitals can achieve SBCRs under 5%. Those hospitals with particularly high SBCRs may lower their rates by altering certain institutional practices.

Adult↗

PubMed2002

Quality indicators of blood utilization: three College of American Pathologists Q-Probes studies of 12,288,404 red blood cell units in 1639 hospitals.

OBJECTIVES: To determine the normative rates of blood unit crossmatched to transfused (C:T) ratios, red blood cell (RBC) unit wastage, and RBC unit expiration that exist in hospital communities throughout the United States, and to examine hospital blood bank practices associated with more desirable (lower) rates. DESIGN: In 3 separate studies, participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data retrospectively on the number of transfusion crossmatches performed in their institutions and the number of RBC-containing units that were transfused into patients, the number of units that expired (outdated) prior to being utilized, and the number that were wasted due to mishandling. Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices. SETTING AND PARTICIPANTS: One thousand six hundred thirty-nine public and private institutions, well more than 80% of which were known to be located in the United States. MAIN OUTCOME MEASURES: Quality indicators of blood utilization (namely, the C:T ratio, the rate of RBC unit expiration, and the rate of RBC unit wastage). RESULTS: Participants submitted data on 12,288,404 RBC unit transfusions. The C:T ratios were 1.5 or less in the top-performing 10% of participating institutions (90th percentile and above), 1.8 to 1.9 in the midrange of participating institutions (50th percentile), and 2.4 or greater in the bottom-performing 10% of participating institutions (10th percentile and below). Red blood cell unit expiration rates were 0.1% or less at the 90th percentile and above, 0.3% to 0.9% at the 50th percentile, and 3.5% or greater at the 10th percentile and below. Red blood cell unit wastage rates were 0.1% or less at the 90th percentile and above, 0.1% to 0.4% at the 50th percentile, and 0.7% or greater at the 10th percentile and below. Depending on which quality indicator was examined, lower values (ie, better performances) were found in institutions that had fewer than 200 hospital beds, no teaching programs, no on-site full-time medical directors of transfusion services, did not utilize maximum surgical blood order schedules, set C:T threshold goals of 2.0 or less, monitored categories of health care workers responsible for RBC wastage, monitored requests for RBC components by transfusion indication, did not accept short-dated units from blood distribution centers, and if they did accept short-dated units, were allowed to return those units to the distribution centers. CONCLUSIONS: Hospital blood bank personnel can achieve C:T ratios below 2.0, RBC unit expiration rates below 1.0%, and RBC unit wastage rates below 0.5%. Lower C:T ratios and/or RBC unit expiration rates were associated with blood bank personnel setting C:T thresholds of 2.0 or less, monitoring requests for blood components by transfusion indication criteria, monitoring categories of health care workers responsible for blood wastage, not accepting short-dated units from blood distribution centers, and if short-dated units were accepted, being allowed to return those units to the blood distribution center. These practices were not associated with lower blood wastage rates.

Blood Banks↗