Novis DA, Zarbo RJ, Saladino AJ. Inter-institutional comparison of surgical biopsy diagnosis turnaround time. A College of American Pathologists Q-Probes study of 5384 surgical biopsies in 157 small hospitals. Arch Pathol Lab Med. 1998;122:951-956. ( abstract JAMA 1999; 281:880. abstract Yearbook of Pathology and Laboratory Medicine 2000, 316-317. abstract JAMA 1997; 277:1179)

OBJECTIVES: To study the turnaround time (TAT) for rendering diagnoses on routine biopsy specimens, to examine pathology practice variables that influence TAT, and to assess the level of surgeons’ satisfaction with biopsy TAT.

DESIGN: Over a 3-month period, voluntary participants in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively collected TAT data on up to 20 biopsy specimens performed on elective surgical cases, completed questionnaires profiling their institution’s practice characteristics, and had surgeons complete questionnaires indicating their satisfaction with biopsy report TAT.

SETTING AND PARTICIPANTS: One hundred fifty-seven private and public small hospitals located in 43 American states (n = 153), Canada (n = 1), and Australia (n = 3).

MAIN OUTCOME MEASURES: The routine surgical biopsy report TATs for 2 testing intervals, each commencing when surgeons acquired the biopsy specimens. One interval concluded when pathologists signed off the biopsy diagnoses, and the other concluded when surgeons received the hard-copy reports.

RESULTS: Pathologists signed off 85.9% of 5384 biopsy diagnoses by the second working day, and surgeons received 88.3% of the hard-copy reports by the fourth working day. In 90% of hospitals participating in this study, pathologists signed off half their biopsy diagnoses between the second and third postcollection days, and 90% of surgeons received half their final hard-copy reports by the fourth postcollection day. Institutional practice variables associated with fewer sign-off and/or hard-copy receipt TATs exceeding the institutional 90th percentile performance benchmarks included yearly surgical caseloads greater than 2000 cases per full-time equivalent pathologist, provision of pathology support services on site, and accreditation of the hospital by the Joint Commission on Accreditation of Healthcare Organizations and of the laboratory by the College of American Pathologists. Most (96.4%) surgeons indicated that they were satisfied with hard-copy TATs and that they believed most (98.1%) of the hard-copy TATs had no effect on the lengths of their patients’ hospital stays.

CONCLUSIONS: Pathologists are capable of signing off most routine biopsy diagnoses within 2 working days and delivering the final hard-copy reports to surgeons within 4 working days (both intervals measured from the time that surgeons collect biopsy specimens). Most surgeons report they are satisfied with this level of performance.

Novis DA, Zarbo RJ, Valenstein P. Diagnostic uncertainty expressed in prostate needle biopsies. A College of American Pathologists Q-Probes study of 15,753 prostate needle biopsies performed in 332 institutions. Arch Pathol Lab Med. 1999;123:687-92. (abstract. Modern Pathology 12:102A, 1999 abstract #50. abstract JAMA, 1999;282:2106)

OBJECTIVE: To determine the rate of diagnostic uncertainty in rendering diagnoses on prostate needle biopsies and to examine pathology practice variables that influence that rate. DESIGN: Anatomic pathology departments participating in the College of American Pathologists Q-Probes laboratory quality improvement program retrospectively reviewed their last 50 consecutive prostate needle biopsy diagnoses. For each diagnosis, participants provided information concerning patients’ prostate-specific antigen levels; number, locations, and laterality of biopsy specimens; number of tissue levels examined; performance of high-molecular-weight cytokeratin immunoperoxidase staining; and acquisition of consultations from general pathologists or experts in prostate pathology. Characteristics of pathology practices included yearly surgical and prostate needle biopsy caseloads, number of pathologists rendering biopsy diagnoses, use of standard descriptive checklists, access to patients’ prostate-specific antigen and digital rectal examination results, percentages of prostate needle biopsies routinely submitted for internal consultations, and presence of departmental experts in prostate pathology.

SETTING AND PARTICIPANTS: Three hundred thirty-two public and private institutions located in the United States (n = 318), Canada (n = 6), Australia (n = 5), United Kingdom (n = 2), and Guam (n = 1).

MAIN OUTCOME MEASURE: The rate of diagnostic uncertainty in prostate needle biopsy diagnoses.

RESULTS: Participants submitted diagnoses on a total of 15 753 prostate needle biopsy cases, of which 33.4% were adenocarcinoma; 55.5% were benign; 3.9% were carcinoma in situ, prostatic intraepithelial neoplasia, or both; and 7.1% were diagnostically uncertain. The median rate of diagnostic uncertainty was 6%, ranging from 0 at the 10th percentile to 14% at the 90th percentile of all participating laboratories. Performing high-molecular-weight cytokeratin immunoperoxidase staining resolved diagnostic uncertainty in 68% of cases in which it was performed, and obtaining intradepartmental and extradepartmental consultations resolved diagnostic uncertainty in 70% to 87% of cases for which they were obtained. Knowledge of patients’ prostate-specific antigen results and examining multiple biopsy cores had marginal effects on the rate of uncertainty. Thoroughness of prostate gland sampling and examination of multiple tissue block levels were not associated with the aggregate rate of diagnostic uncertainty. We found no particular pathology departmental practices or institutional demographic characteristics associated with institutional rates of diagnostic uncertainty.

CONCLUSIONS: Use of high-molecular-weight cytokeratin immunoperoxidase staining and obtaining intradepartmental and extradepartmental consultations may be effective in reducing diagnostic uncertainty in prostate biopsies

Steindel SJ, Novis DA. Using outlier events to monitor test turnaround time: A College of American Pathologists Q-Probes study in 495 laboratories. Arch Pathol Lab Med. 1999;123:607-14. (Reprint: abstract JAMA, 1999;282 1408m)

OBJECTIVES: To determine the causes of excessive test turnaround time (TAT) and to identify methods of improvement by studying reasons for those tests reported in excess of 70 minutes from the time the test was ordered (ie, outliers).

DESIGN: Self-directed data-gathering of stat outlier TAT events from intensive care units and emergency departments, with descriptive parameters associated with each event and additional descriptive parameters associated with the participant.

PARTICIPANTS: Laboratories enrolled in the 1996 College of American Pathologists Q-Probes program.

MAIN OUTCOME MEASURES: Components associated with outlier TAT events and outlier TAT rates. RESULTS: Four hundred ninety-six hospital laboratories returned data on 218 551 stat tests, of which 10.6% had TATs in excess of 70 minutes. Ten percent of stat emergency department tests and 14.7% of stat intensive care unit tests were outliers. Major areas in which delays occurred were test ordering, 29.9%; within-laboratory (analytic) phase, 28.2%; collection of the specimen, 27.4%; postanalytic phase, 1.9%; and undetermined, 12.5%. The type of test performed was a significant factor and was independent of location: Chemistry-Multiple Test appeared most frequently ( approximately 40%), followed closely by Hematology-Complete Blood Count (approximately 20%) and Chemistry-Single Test ( approximately 18%). Factors of outlier TAT components for intensive care unit specimens were identified using statistical modeling and included hour of day, type of health care personnel collecting specimen, performing the test in a stat laboratory, and reason for delay. Outlier rates were not associated with any identified factors. The practice parameters of laboratories with outlier rates in the lowest 10th percentile significantly differed from those with rates in the top 10th percentile in test request computerization, report methods, and ordering methods.

CONCLUSIONS: We observed that outlier analysis yields new information, such as type of test and reason for delay, concerning test delays when compared with TAT determination alone. Laboratories experiencing stat test TAT problems should use this tool as an adjunct to routine TAT monitoring for identifying unique causes of delay.

Jones BA, Novis DA. Follow-up of abnormal gynecologic cytology: a College of American Pathologists Q-Probes study of 16,132 cases from 306 laboratories. Arch Pathol Lab Med. 2000; 124:665-71. See Editorial: Austin RM. Arch Pathol Lab Med. 2000; 124:1113-4.

OBJECTIVES: To measure the percentage of women with abnormal gynecologic cytology who have follow-up within 1 year and to identify patient and laboratory characteristics associated with higher percentages of follow-up.

DESIGN AND SETTING: Retrospective identification of patients with abnormal cervicovaginal cytology and identification of the initial clinical follow-up activity during the 12 months following the cytologic diagnosis.

MAIN OUTCOME MEASURE: Percentage of women receiving follow-up.

RESULTS: Three hundred six laboratories reported follow-up information on 16 132 patients with gynecologic cytology diagnoses of carcinoma, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion, or glandular intraepithelial lesion. The following percentages of women received follow-up within 1 year: 85.6% of patients with cytologic diagnoses of carcinoma, 87.2% with diagnoses of high-grade squamous intraepithelial lesion, 82.7% with diagnoses of low-grade squamous intraepithelial lesion, and 84.9% with diagnoses of glandular intraepithelial lesion. Within 6 months, 82.2% of patients with cytologic diagnoses of carcinoma, 82.4% with diagnoses of high-grade squamous intraepithelial lesion, 71.9% with diagnoses of low-grade squamous intraepithelial lesion, and 74.7% with diagnoses of glandular intra-epithelial lesion received follow-up. Overall, 90. 8% of patients who received follow-up within the 1-year time frame of this study had their follow-up completed within 6 months. Specific follow-up activities and their frequencies are listed for each diagnostic category. Patients 30 years old or younger and pregnant patients had lower follow-up percentages.

CONCLUSIONS: With less than 83% of patients with high-grade squamous intraepithelial lesion or carcinoma cytology findings having available documentation of follow-up within 6 months, and less than 88% within 1 year, there is room for improvement in this area of health care. Monitoring and critical analysis of the follow-up process is a starting point for improvement.

Novis DA, Dale JC. Morning rounds inpatient test availability: A College of American Pathologists Q- Probes study of 79 860 morning CBC and electrolyte test results in 367 institutions. Arch Pathol Lab Med.2000; 124:499-503. (abstract: Yearbook of Pathology and Laboratory Medicine 2002, 374-375)

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.

Dale JC, Novis DA, Meier. Reference laboratory telephone service quality. Arch Pathol Lab Med. 2001 May;125(5):608-12.

OBJECTIVES: To establish the rates with which reference laboratories resolve inquiries telephoned to them from primary laboratories and to identify reference laboratory practices associated with higher rates of inquiry resolution.

DESIGN AND PARTICIPANTS: For 2 months, or until 50 contacts had occurred, 545 primary laboratories participating in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively documented and characterized telephone inquiries they made to a reference laboratory of their choice. Participants also cataloged their own laboratory’s demographic and practice characteristics and their reference laboratory’s customer service characteristics.

MAIN OUTCOME MEASURE: Rates with which reference laboratories resolved telephone inquiries.

RESULTS: Participants characterized 11 031 (78.7%) of 14 017 telephone inquiries as resolved by the reference laboratories. Ranked according to inquiry resolution rates, primary laboratories in the 90th percentile characterized reference laboratories as resolving 100% of their inquiries; those in the 10th percentile characterized reference laboratories as resolving only 54.2% of their inquiries. The rate of resolved inquiries was significantly higher (P =.0047) for participants using reference laboratories with 24-hour customer service than it was for participants using reference laboratories with less than 24-hour service. Most primary laboratories (80.9%) chose to monitor 1 of 11 national reference laboratories; in this subset, median rates of inquiry resolution ranged from 90.2% to 55.0% (P <.0001), despite no significant variation in other measured customer service characteristics.

CONCLUSIONS: Primary laboratories experience significant differences in the rates with which reference laboratories resolve telephone inquiries. The performance benchmark for reference laboratories is resolution of at least 90% of telephone inquiries from primary laboratory customers.

Jones BA, Novis DA. Non-Gynecologic Cytology Turnaround Time: A College of America Pathologists Q-Probes Study of 180 Laboratories. Arch Pathol Lab Med: 2001;125:1279-1284.

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.

Novis, DA, Dale JC, Schifman RB, Ruby SG, Walsh MK Solitary blood cultures: A College of American Pathologists Q-Probes Study of 132 778 Blood Culture Sets in 333 Small Hospitals. Arch Pathol Lab Med: 2001;125:1285-1289.

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.

Novis DA, Renner S, Friedberg R, Walsh MK, Saladino AJ. Quality indicators of blood utilization: three College of American Pathologists Q-Probes studies of 12 288 404 red blood cell units in 1 639 hospitals. Arch Pathol Lab Med. 2002; 126:150-156.

A multi hospital study in which measurable indicators were devised to evaluate the efficiency with which healthcare workers utilized transfusable blood units, and to determine whether or not certain transfusion practices were associated with more efficient utilization of transfusable blood. The study was performed in over 1600 hospitals, and the results were reported in the Archives of Pathology. The findings of the study were incorporated into the College of American Pathologists Laboratory Accreditation Program.

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.

Dale JC, Novis DA. Outpatient phlebotomy success and reasons for specimen rejection. A Q-Probes Study. Arch Pathol Lab Med. 2002; 126:416-419.

OBJECTIVES: To determine the rate with which blood collection is successful on the initial phlebotomy encounter, the rate with which laboratory personnel judge specimens unsuitable for analysis, and the practice characteristics associated with fewer unsuccessful collections and fewer rejected specimens.

DESIGN: Clinical laboratories participating in the College of American Pathologists Q-Probes laboratory improvement program prospectively characterized the outcome of outpatient phlebotomies for 3 months or until 20 unsuccessful phlebotomy encounters occurred. By questionnaire, participants provided information about test ordering, patient preparation, and specimen collection.

SETTING AND PARTICIPANTS: Institutions in the United States (n = 202), Canada (n = 4), Australia (n = 3), and South Korea (n = 1).

MAIN OUTCOME MEASURES: Percentage of successful encounters and percentage of unsuitable specimens.

RESULTS: Of 833289 encounters, 829723 were successful. Phlebotomies were unsuccessful because patients were not fasting as directed (32.2%), phlebotomy orders were missing information (22.5%), patients specimens were difficult to draw (13.0%), patients left the collection area before specimens were collected (11.8%), patients were improperly prepared for reasons other than fasting (6.3%), patients presented at the wrong time (3.1%), or for other reasons (11.8%). Only 2153 specimens (0.3%) were unsuitable; these samples were hemolyzed (18.1%), of insufficient quantity (16.0%), clotted (13.4%), lost or not received in the laboratory (11.5%), inadequately labeled (5.8%), at variance with previous or expected results (4.8%), or unacceptable for other reasons (31.1%). Facilities staffed by laboratory-administered phlebotomists reported higher success rates than facilities staffed by nonlaboratory-administered phlebotomists (P =.002).

CONCLUSIONS: Most outpatient phlebotomy encounters are successful and result in specimens suitable for laboratory analysis.