Bruce A. Jones

Quality management in gynecologic cytology using interlaboratory Comparison

OBJECTIVE To describe a comprehensive integrated laboratory quality management plan for gynecologic cytology. DESIGN AND SETTING Cytopathology laboratory performance monitors with interlaboratory comparison. RESULTS Utilizing College of American Pathologists Q-Probes studies, the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology, and other published data, a quality management program for gynecologic cytology involving diagnostic statistics, screening limits and competency assessment, retrospective rescreening, real-time rescreening, cytology-biopsy correlation, follow-up of patients with abnormal cytology results, turnaround time, examination of unknown slides (survey programs), and new technology is described. CONCLUSION Regular coordinated monitoring of performance, with longitudinal and interlaboratory comparison utilizing the methods described, provides an opportunity to optimize gynecologic cytology service.

Q-tracks: A College of American Pathologists program of continuous laboratory monitoring and longitudinal performance 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 decades 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.

Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 138 Institutions

CONTEXT Monitoring customer satisfaction is a valuable component of a laboratory quality improvement program. OBJECTIVE To survey the level of physician satisfaction with hospital clinical laboratory services. DESIGN Participating institutions provided demographic and practice information and survey results of physician satisfaction with defined aspects of clinical laboratory services, rated on a scale of 1 (poor) to 5 (excellent). RESULTS One hundred thirty-eight institutions participated in this study and submitted a total of 4329 physician surveys. The overall satisfaction score for all institutions ranged from 2.9 to 5.0. The median overall score for all participants was 4.1 (10th percentile, 3.6; 90th percentile, 4.5). Physicians were most satisfied with the quality/reliability of results and staff courtesy, with median values of excellent or good ratings of 89.9%. Of the 5 service categories that received the lowest percentage values of excellent/good ratings (combined scores of 4 and 5), 4 were related to turnaround time for inpatient stat, outpatient stat, routine, and esoteric tests. Surveys from half of the participating laboratories reported that 96% to 100% of physicians would recommend the laboratory to other physicians. The category most frequently selected as the most important category of laboratory services was quality/reliability of results (31.7%). CONCLUSIONS There continues to be a high level of physician satisfaction and loyalty with clinical laboratory services. Test turnaround times are persistent categories of dissatisfaction and present opportunities for improvement.

Urine culture contamination: a College of American Pathologists Q-Probes study of 127 laboratories.

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 patients 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.

Type and screen completion for scheduled surgical procedures. A College of American Pathologists Q-Probes study of 8941 type and screen tests in 108 institutions.

CONTEXT Market-driven changes in the timing of elective surgeries and admissions have introduced barriers to completing pretransfusion testing in a timely manner. Consequently, blood bank personnel may not have adequate time to identify appropriate blood products for scheduled surgeries. Incomplete pretransfusion testing can delay surgery and significantly compromise patient safety. OBJECTIVES To identify the incidence of avoidable problems associated with obtaining timely samples for adequate pretransfusion type and screen (T&S) testing, to identify the practices and characteristics associated with improved rates of pretransfusion testing completed prior to surgery, and to determine the likelihood of antibody identification problems that affect the availability of blood. DESIGN Participants in the College of American Pathologists (CAP) Q-Probes laboratory quality improvement program were asked to collect data on when a T&S was collected in anticipation of elective scheduled surgery, when the T&S was completed, when the surgery started, and the results of those T&S tests. Participants also completed questionnaires describing their facilities, procedures, and practices. SETTING AND PARTICIPANTS One hundred eight public and private institutions participated in this Q-Probes Study, 97% of which were located in the United States. MAIN OUTCOMES MEASURES Type and screen collection and completion relative to the start of surgery, and the results of those tests. RESULTS Of the 8941 T&Ss, 64.6% were collected prior to the day of surgery. The median laboratory completed approximately 69% of their T&S testing for scheduled surgeries at least 1 day prior to the surgery. Of those T&S tests that were collected on the day of surgery, the median laboratory completed almost 23% after the start of surgery. For 10% of participants, more than 75% of all T&Ss collected on the same day as surgery were not complete until after the start of surgery. When red blood cell-directed antibodies were identified, 78.7% were considered clinically significant, and 95.2% were alloantibodies. Positive antibody screens were significantly associated with delayed surgery and special efforts needed to obtain blood. Of those institutions with a specific protocol in place to collect T&S samples prior to hospital admission, the median laboratory completed the T&S at least 1 day prior to surgery 74% of the time. When the institution coupled the T&S collection protocol with T&S collection earlier than 3 days prior to surgery, the median laboratory completed the T&S at least 1 day prior to surgery almost 87% of the time. Type and screen collection less than 3 days prior to surgery resulted in special efforts needed to obtain blood more than 1% of the time. Type and screen collected on the same day as surgery directly resulted in a surgery delay 0.8% of the time. CONCLUSIONS Patients are unnecessarily being placed at risk by inadequate mechanisms to ensure available blood for surgery. All T&Ss were collected for scheduled surgeries with adequate opportunity for a T&S to be completed in advance of the surgery. Specific protocols helped improve the performance in terms of completing the T&S prior to surgery, as did mechanisms that permitted T&S collections in advance of the admission. Type and screen collection time relative to surgery was significantly associated with the incidence of surgery delay due to unavailable blood; the less time between collection and surgery, the less likely blood was available.

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.

The Effect of Continuous Monitoring of Cytologic-Histologic Correlation Data on Cervical Cancer Screening Performance

CONTEXT The use of Papanicolaou (Pap) test cytologic-histologic correlation in quality improvement activities is not well studied. OBJECTIVE To determine if continuous monitoring of correlation data improves performance. DESIGN Participants in the College of American Pathologists Q-Tracks program (213 laboratories) self-reported the number of Pap test-histologic biopsy correlation discrepancies every quarter for up to 8 years. A mixed linear model determined if the length of participation in the Q-Tracks program was associated with improved performance. Main outcome measures were predictive value of a positive Pap test, Pap test sensitivity, sampling sensitivity, and proportion of positive histologic diagnoses following a Pap test diagnosis of atypical squamous cells or atypical glandular cells. RESULTS Institutions evaluated 287,570 paired Pap test-histologic correlation specimens and found 98,424 (34.2%) true-positive Pap test correlations, 19,006 (6.6%) false-positive Pap test correlations, and 6575 (2.3%) false-negative Pap test correlations. The mean predictive value of a positive Pap test, sensitivity, screening and interpretive sensitivity, sampling sensitivity, and proportion of positive histologic diagnoses following a Pap test diagnosis of atypical squamous or glandular cells were 83.6%, 93.7%, 99.2%, 94.2%, 60.3%, and 38.8%, respectively. Longer participation was significantly associated with a higher predictive value of a positive Pap test (P = .01), higher Pap test sensitivity (P = .002), higher Pap test sampling sensitivity (P = .03), and higher proportion of positive histologic diagnoses for a Pap test diagnosis of atypical squamous cells (P < .001). CONCLUSIONS Long-term monitoring of cytologic-histologic correlation is associated with improvement in cytologic-histologic correlation performance.

Quality improvement opportunities in gynecologic cytologic-histologic correlations: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 4.

CONTEXT Cytopathology experts, interested stakeholders, and representatives from the College of American Pathologists, the Centers for Disease Control and Prevention, the American Society of Cytopathology, the Papanicolaou Society of Cytopathology, the American Society for Clinical Pathology, and the American Society of Cytotechnology convened the Gynecologic Cytopathology Quality Consensus Conference to present preliminary consensus statements developed by working groups, including the Cytologic-Histologic Correlations Working Group 4, using results from surveys and literature review. Conference participants voted on statements, suggested changes where consensus was not achieved, and voted on proposed changes. OBJECTIVES To document existing practices in gynecologic cytologic-histologic correlation, to develop consensus statements on appropriate practices, to explore standardization, and to suggest improvement in these practices. DATA SOURCES The material is based on survey results from 546 US laboratories, review of the literature from 1988 to 2011, and the College of American Pathologists Web site for consensus comments and additional survey questions. CONCLUSIONS Cytologic-histologic correlations can be performed retrospectively, during initial case review, or both. At minimum, all available slides should be reviewed for a high-grade squamous intraepithelial lesion Papanicolaou test with negative biopsies. The preferred monitor for correlations is the positive predictive value of a Papanicolaou test. Laboratories should design cytologic-histologic correlation programs to explore existing or perceived quality deficiencies.

Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.

CONTEXT One of the major attributes of laboratory testing is cost. Although fully automated central laboratory glucose testing and semiautomated bedside glucose testing (BGT) are performed at most institutions, rigorous determinations of interinstitutional comparative costs have not been performed. OBJECTIVES To compare interinstitutional analytical costs of central laboratory glucose testing and BGT and to provide suggestions for improvement. DESIGN Participants completed a demographic form about their institutional glucose monitoring practices. They also collected information about the costs of central laboratory glucose testing, BGT at a high-volume testing site, and BGT at a low-volume testing site, including specified cost variables for labor, reagents, and instruments. PARTICIPANTS A total of 445 institutions enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURE Median cost per glucose test at 3 testing sites. RESULTS The median (10th-90th percentile range) costs per glucose test were 1.18 dollars (5.59 dollars-0.36 dollars), 1.96 dollars (9.51 dollars-0.77 dollars), and 4.66 dollars (27.54 dollars-1.02 dollars) for central laboratory, high-volume BGT sites, and low-volume BGT sites, respectively. The largest percentages of the cost per test were for labor (59.3%, 72.7%, and 85.8%), followed by supplies (27.2%, 27.3%, and 13.4%) and equipment (2.1%, 0.0%, and 0.0%) for the 3 sites, respectively. The median number of patient specimens per month at the high-volume BGT sites was 625 compared to 30 at the low-volume BGT sites. Most participants did not include labor, instrument maintenance, competency assessment, or oversight in their BGT estimated costs until required to do so for the study. CONCLUSIONS Analytical costs per glucose test were lower for central laboratory glucose testing than for BGT, which, in turn, was highly variable and dependent on volume. Data that would be used for financial justification for BGT were widely aberrant and in need of improvement.

The value of monitoring human papillomavirus DNA results for papanicolaou tests diagnosed as atypical squamous cells of undetermined significance : A college of american pathologists q-probes study of 68 institutions

CONTEXT Papanicolaou (Pap) tests are often diagnosed as atypical squamous cells of undetermined significance (ASC-US). Human papillomavirus (HPV) DNA testing has been proposed as a quality metric for this diagnosis. OBJECTIVE To measure the frequency of HPV positivity in Pap tests diagnosed as ASC-US and to examine laboratory variables that are associated with institutional deviation from the mean percent of HPV positivity. DESIGN As part of a College of American Pathologist Q-Probes program, 68 participating laboratories retrospectively identified approximately 50 consecutive ASC-US Pap tests that had HPV testing results. RESULTS The mean percentage of HPV positivity for ASC-US was 43.74% among institutions surveyed, but it had a broad distribution, with an SD of 17.77%. Associations were found for lower difference of the institutional mean from the surveyed interinstitutional mean percentage of positive HPV with (1) higher numbers of Pap tests in the past year that had HPV testing, (2) in-house HPV testing, and (3) teaching hospitals. All 3 factors correlated with a larger volume of Pap tests per institution. An association was found between patient age and the probability of a positive HPV result, indicating a dependence upon prevalence of HPV. CONCLUSIONS Larger volumes of Pap tests may offer an opportunity to gain greater comfort in interpreting Pap tests. While there is significant variability in interinstitutional HPV-positive rates in ASC-US Pap tests, monitoring the HPV-positive rate in ASC-US Pap tests is a valuable broad measure of quality. Performance beyond 2 SDs of the mean should prompt reassessment of diagnostic criteria used in the evaluation of Pap tests and/or investigation of the prevalence of HPV positivity in the population from which the Pap tests are obtained.