Extraneous tissue in surgical pathology: a College of American Pathologists Q-Probes study of 275 laboratories

OBJECTIVE: To develop a multi-institutional reference database of extraneous tissue (contaminants) in surgical pathology. DESIGN: In 1994, participants in the College of American Pathologists Q-Probes quality improvement program performed prospective and retrospective evaluations of extraneous tissue found in surgical pathology microscopic sections for a period of 4 weeks or until 1000 slides were reviewed in each participating laboratory. PARTICIPANTS: Two hundred seventy-five surgical pathology laboratories institutions, predominantly from North America. MAIN OUTCOME MEASURES: Extraneous tissue contamination rate for slides in prospective and retrospective reviews; staffing and practice procedures; location of extraneous tissue on slides; type of extraneous tissue (normal, abnormal, nonneoplastic, neoplasm, microorganisms, etc); class of extraneous tissue (slide or block contaminants); source of extraneous tissue (different or same case); origin of extraneous tissue (pathology laboratory, physician's office or operating room); and degree of diagnostic difficulty caused by extraneous tissue. RESULTS: Three hundred twenty-one thousand seven hundred fifty-seven slides were reviewed in the prospective study and 57083 slides in the retrospective study. There was an overall extraneous tissue rate of 0.6% of slides (2074/321757) in the prospective study and 2.9% of slides (1653/57083) in the retrospective study. Of those slides with extraneous tissue, the extraneous tissue was located near diagnostic tissue sections in 59.5% of the slides reviewed prospectively and in 25.3% of slides reviewed retrospectively; deeper sections were performed to evaluate extraneous tissue in 12.2% of prospective cases and in 3.1% of retrospective cases. Of the laboratories, 98% had written guidelines for changing solution in tissue processors, and 64.9% had guidelines for maintaining water baths free of extraneous tissue. A total of 98.9% used lens paper, filter bags, or sponges for processing fragmented and small specimens. Written protocols for documentation of extraneous tissue in surgical pathology reports were established in 6.1% of laboratories, for removal of extraneous tissue from blocks in 5.7%, and for removal of extraneous tissue from microscopic slides in 4.7%. In 24% of laboratories no comment or record was kept to document extraneous tissue. Extraneous tissue consisted of neoplasm in 12.7% of the prospectively reviewed slides and in 6.0% of the retrospectively reviewed slides. For the prospective study, 59.4% of extraneous tissue was classified as slide contaminants, and 28.4% was found to be contaminants within the paraffin block; for the retrospective study, 72.9% was classified as slide contaminants and 15.9% as block contaminants. For the prospective study, 63.2% of extraneous tissue was presumed to be from a different case, and in the retrospective study, 48.5% was presumed to be from a different case. Over 90% of extraneous tissue was thought to originate from the pathology laboratory. The degree of diagnostic difficulty caused by extraneous tissue was judged to be severe in 0.4% of slides in the prospective study and 0.1% of slides in the retrospective study. In the prospective study, it could not be determined whether the tissue in the diagnostic sections was extraneous in 0.6% of slides, and in the retrospective study, it could not be determined whether tissue in the diagnostic sections was extraneous in 0.1%. CONCLUSIONS: This study has documented the frequency, type, origin, source, and diagnostic difficulty of extraneous tissue and presents benchmarks of extraneous tissue experienced in the general practice of surgical pathology.     

Gynecologic cytology turnaround time. A College of American Pathologists Q-Probes Study of 371 laboratories.

OBJECTIVES: To determine the turnaround time for gynecologic cytology in a large sample of laboratories and to identify laboratory and specimen characteristics associated with better and worse performance. DESIGN AND SETTING: Prospective evaluation of gynecologic cytology turnaround times in 371 laboratories. MAIN OUTCOME MEASURE: Gynecologic cytology case turnaround time. RESULTS: Three hundred seventy-one laboratories submitted information regarding laboratory characteristics and processes, and turnaround times of 66 042 gynecologic cytology cases. Half of the participating laboratories had mean turnaround times of 6 calendar days or less and were able to complete 90% of their cases within 8 calendar days. Ten percent of participants had mean turnaround times greater than 13 days and required 19 or more days to report 90% of their cases. Longer turnaround times were associated with the use of reference laboratories for all or part of the evaluation; contacting the physician's office for additional information; using cytotechnology students, residents, or fellows in the evaluation; and providing service on the weekend. CONCLUSION: Practice patterns contribute to the long turnaround times for gynecologic cytology found in some laboratories and may be improved by local site-specific process analysis.     

Nongynecologic cytology turnaround time: a College of American Pathologists Q-Probes study of 180 laboratories

OBJECTIVES: To determine the turnaround time for nongynecologic cytology and to identify laboratory and specimen characteristics associated with variations in turnaround time. DESIGN AND SETTING: Prospective evaluation of nongynecologic cytology turnaround times in 180 laboratories. MAIN OUTCOME MEASURE: Nongynecologic cytology case turnaround time. RESULTS: Participants from 180 laboratories submitted turnaround times for 16 950 nongynecologic cytology cases and submitted information describing their laboratories' practice characteristics relating to the processing of nongynecologic cytology specimens. Half of the participating laboratories had mean receipt to report turnaround times of 1.6 calendar days or less and were able to complete 90% of their cases within 3.0 calendar days. Ten percent of participants had mean turnaround times greater than 3.2 days and required 6.0 or more days to report 90% of their cases. Longer turnaround times were associated with processing fluid and fine-needle aspiration specimens, issuing atypical/suspicious for malignancy and nondiagnostic diagnoses, having cytotechnologist students screen slides, having to contact the physician offices for additional information, having to retrieve prior case material for review, and having to perform cell blocks and/or special stains. CONCLUSION: There is an opportunity for laboratories to shorten nongynecologic turnaround time by altering certain laboratory practices.     

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.     

Reasons for proficiency testing failures in clinical chemistry and blood gas analysis: a College of American Pathologists Q-Probes study in 665 laboratories

OBJECTIVE: To determine the reasons for proficiency testing (PT) failures from 41 chemistry and blood gas analytes using data collected to benchmark performance. DESIGN: Self-administered survey requesting number of challenges by analyte encompassing nine PT events. When the challenge resulted in a self-defined failure, further information was requested concerning the magnitude of the failure (as a standard deviation index) and categorization of the type of failure into six major groups (Methodologic, Technical, Clerical, Survey, Unexplained, or Other) and then into subgroups. PARTICIPANTS: Laboratories enrolled in the 1992 College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURES: Rate of PT failures and reasons for failure. RESULTS: Proficiency testing data from 670,489 challenges performed in 665 laboratories revealed 9268 (1.4%) unacceptable results. Failure types were distributed as follows: Methodologic, 33.5%; Technical, 17.4%; Clerical, 11.1%; Survey, 7.8%; Unexplained, 25.7%; and Other, 7.4%. CONCLUSIONS: Individual analyte PT failure is a common event in the participating laboratories, but failures in successive or alternate events are rare. Analysis of the reasons for failed events indicates that most identified reasons occurred in either the Methodologic or Technical categories (50.9%). Analysis of the failure types suggested investigation pathways based on the magnitude of the failure that could reduce the 25.7% rate of unexplained failures.     

Surgical pathology specimens for gross examination only and exempt from submission: a College of American Pathologists Q-Probes study of current policies in 413 institutions

OBJECTIVE: To survey the scope of current written institutional policies for types of surgical pathology specimens exempt from submission to the laboratory and those that may be examined by gross inspection only. DESIGN AND SETTING: In the first quarter of 1997, a total of 413 voluntary participant institutions enrolled in the College of American Pathologists Q-Probes quality improvement program completed a checklist of 115 proffered specimens. Also included was a questionnaire defining demographic, practice, and reimbursement variables. MAIN OUTCOME MEASURES: The number and types of specimens exempt from submission and submitted for gross examination only based on written institutional policy rather than on unapproved actual practices. RESULTS: Most institutions had a written policy for types of specimens deemed exempt from submission to pathology (87.1 %) and for types of specimens subject to gross examination only (76.6%). There was a wide range of numbers of specimen types with a median number of 17 (range, 2-40) in the exempt category and 29 (range, 6-57) in the category of gross examination only. Significantly higher absolute counts of specimens exempt from submission to pathology were reported by institutions with a greater surgical pathology volume in 1996 and by nonteaching institutions. No aspect of practice was associated with numbers of specimens for gross examination only. CONCLUSIONS: This Q-Probes study creates a multi-institutional reference database of current practices to assist pathologists and clinical staff in the development of written guidelines pertaining to surgical pathology specimen submission exceptions and gross-only examinations.     

Duplicate laboratory orders: a College of American Pathologists Q-Probes study of thyrotropin requests in 502 institutions

OBJECTIVE: To examine the frequency and cause of duplicate thyrotropin (TSH) testing. METHODS: Five hundred two institutions, ranging in size from fewer than 100 to more than 600 beds, examined consecutively processed TSH assays to identify duplicate orders. Duplicates were defined as two or more TSH tests performed within 7 days. All together, participants submitted data on 221,476 TSH orders. RESULTS: The median institution reported that 1.5% of TSH tests duplicated a TSH order that had been received from the same patient within the previous 7 days. Ten percent of institutions reported that 4.5% or more of their TSH tests were duplicates. Institutions with higher duplicate rates tended to be larger (ie, they had a greater number of occupied beds) and to have duplicate tests that were more likely to be ordered by a physician other than the one who ordered the initial test. Participants reported that for 19% of duplicate orders, physicians were unaware that the first test had been ordered. Physicians also indicated that duplicate assays were ordered to see if a previous result had changed (15%) or to check on the accuracy of a previous result (13%). Participants reported that 11% of duplicate TSH assays that their laboratory performed had apparently never been ordered. CONCLUSIONS: A large number of institutions are performing duplicate TSH tests that, in most cases, appear to be medically unnecessary. Institutions aiming to reduce the frequency of duplicate testing should consider policies that decrease the opportunity for different physicians to order tests on a single patient and should increase the accuracy with which physician orders are transmitted to the laboratory.     

Routine outpatient laboratory test turnaround times and practice patterns: a College of American Pathologists Q-Probes study.

OBJECTIVES: To determine baseline parameters for routine outpatient test turnaround time (TAT), to identify influential factors, and to study the impact of managed care on this testing. METHOD: Using forms supplied by the College of American Pathologists Q-Probes program, laboratories conducted a self-directed study of routine outpatient TATs over a 4-week period. Data requested included various times of day associated with the collection, laboratory receipt, and result verification of specimens, as well as details on the drawing location and ordering and delivery methods for up to 3 tests, namely, a complete blood cell count (CBC), biochemical profile, or thyrotropin test. For the CBC, an indication was requested if a manual differential was performed. Additionally, practice-related questions were asked, including several about whether the laboratory was associated with a managed care organization (MCO). The main outcome measures included the components of the TAT process and related factors.Participants.-Six hundred nineteen laboratories from those enrolled in the 1997 College of American Pathologists Q-Probes program. RESULTS: Data were submitted by 614 participants, most US hospitals, and represented 30 240 CBCs, 25 683 biochemical profiles, and 14 801 thyrotropins. Collection to verification TATs increased for specimens received later in the day for all analytes, but the magnitude of the increase was greatest for thyrotropin. Collection to laboratory receipt TAT was similar for all analytes, but the time and distribution increased with time of day. Testing time (receipt to verification) was similar for the CBC and biochemical profile, but was greatly increased for thyrotropin. Most participants tested the CBC and the biochemical profile as they arrived, but many delayed testing for thyrotropin. Most (70%) outpatient specimens were collected within the institution; only about 10% came from local physicians' offices. A median 46.7% of hospital testing involved outpatients. Only 10% of laboratories operated under an MCO; these laboratories reported a median of 45% of specimens coming from their MCO. Being associated with an MCO increased TAT for the CBC and biochemical profile. CONCLUSIONS: Outpatient testing comprises about half of all hospital testing, yet systems are not optimized. Preanalytic TAT increases during the day, which indicates increasing delays in the collection and transport stages. Imposition of a test schedule on thyrotropin results in a delay pattern that is very different from the CBC and biochemical profile, which are tested on arrival. A laboratory's association with an MCO had a weak impact on TAT.     

Autopsy result utilization: a College of American Pathologists Q-probes study of 256 laboratories.

OBJECTIVES: To document the level of involvement and communication with nonpathology clinical personnel regarding autopsies and to document the destination of autopsy reports. DESIGN: The College of American Pathologists Q-Probes format was used to collect information on 15 consecutively performed autopsies per institution or for 6 months, whichever occurred first. The following information was recorded for each autopsy: decedent's age, hospital service, length of hospital stay, whether organs were donated, who was present at autopsy, methods of communicating preliminary and final autopsy results, special techniques used to arrive at a preliminary diagnosis, activities for which the autopsy was used, and destination of final report. PARTICIPANTS: Two hundred fifty-six laboratories collected information on 2755 autopsies. RESULTS: The aggregate autopsy rate was 12.4% (median 8.5%). Nonpathology clinical personnel attended 35.8% of all autopsies. A clinical physician was more likely to attend an autopsy if the patient was from a surgical service. Three primary methods were used to communicate preliminary autopsy results, namely, written reports (82.5%), telephone calls (50.6%), and meetings (11.5%). The primary care physician was sent the autopsy report in 91.1% of cases. Approximately half of the autopsy cases were used in both pathology departmental and extradepartmental activities. Aggregate autopsy data were distributed in the majority of cases to various departmental chairpersons and institutional quality assurance committees. CONCLUSIONS: This study provides a comparative multiinstitutional database for the utilization of autopsy results by clinicians and clinical departments. Although autopsy rates are low, autopsy results are routinely being used for hospital quality assurance activities and for educational purposes.     

Intralaboratory performance and laboratorians' expectations for stat turnaround times. A College of American Pathologists Q-Probes study of four cerebrospinal fluid determinations

More than 400 laboratories participated in the module of the College of American Pathologists' quality assurance program, Q-Probes, which measured intralaboratory turnaround time (TAT) of stat cerebrospinal fluid tests. Four determinations encompassing more than 14,000 specimens were monitored and intralaboratory TATs were compared with participants' TAT goals. The median TATs were as follows: cell count, 32 minutes; glucose, 34 minutes; protein, 37 minutes; and Gram's stain, 45 minutes. Between 14% and 21% of participants (test dependent) met their goals 100% of the time, with 72% of the determinations completed within the time laboratorians required. Standard statistical stepwise regression analysis was used to model influence of up to eight factors on TAT. Correlations were test and bed-size dependent, but ranged from a high of .23 to a low of .02. Only computerized reporting and instrumentation measuring protein and glucose had a consistent effect, delaying TAT, whereas use of a stat laboratory, one workstation, automation, computerized order entry, and centralized processing gave variable results. We conclude that laboratorian goals for cerebrospinal fluid test TAT are met most of the time, and that a stepwise regression analysis poorly explains factors that statistically influence TAT.