Novis, D. Being LEAN never hurt anyone. Medical Laboratory Observer. April 2011. Page 50.

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Novis DA, Steindel SJ. Emergency department test turnaround time: data analysis and critique. 93-12, Q- Probes. Northfield Ill: College of American Pathologists; 1993.

Novis DA, Zarbo RJ. Inter-institutional comparison of frozen section turnaround time. A College of American Pathologists Q-Probes study of 32868 frozen sections in 700 hospitals. Arch Pathol Lab Med. 1996;121:559-567

OBJECTIVES: To study the intraoperative turnaround time for performing a frozen section (FS) and to examine pathology practice variables that influence it.

DESIGN: Over a 4-month period in 1995, participants in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively collected data on up to 30 FS procedures performed on elective inpatient surgical cases and completed questionnaires profiling their FS practice characteristics.

SETTING: Surgical pathology laboratories serving private and public hospitals.

PARTICIPANTS: Seven hundred institutions located in North America (667), Australia (12), New Zealand (1), the United Kingdom (3), Hong Kong (1), Mexico (1), and Norway (1).

MAIN OUTCOME MEASURES: The 90% FS block completion time defined as the time interval, in minutes, within which the fastest 90% of all FS blocks were completed, measured from the time pathologists received FS specimens to the time they communicated FS results to the surgeon. RESULTS: Participants submitted data on 32868 FS blocks. Ninety percent of FS procedures were completed within 20 minutes. Frozen section turnaround times exceeding 20 minutes, termed outlier turnaround times, were more likely to occur when more than one pathologist participated in the FS diagnosis, pathology residents and medical students participated in the FS procedure, the pathologist had to retrieve and review previous case material during the FS procedure, the pathologist simultaneously received additional specimens from other FS cases, the pathologist was unable to reach a final FS diagnosis, and when technical problems occurred during the FS procedure. Seventy percent of all participating hospitals completed 90% of their frozen sections within 20 minutes. The institutional 90% completion times were shorter for hospitals containing 300 or fewer occupied beds than for those containing more than 300 occupied beds.

CONCLUSIONS: The data suggest that 90% of FS block turnaround times can be performed within 20 minutes, measured from the time that pathologists receive FS specimens to the time that pathologists return FS diagnoses to surgeons.

Jones BA, Novis DA. Cervical biopsy-cytology correlation. A College of American Pathologists Q- Probes study of 22,439 correlations in 348 laboratories. Arch Pathol Lab Med. 1996;120:523-531

OBJECTIVE–To study the diagnostic correlation between cervical cytology specimens and corresponding surgical biopsies.

DESIGN AND SETTING–College of American Pathologists Q-Probes laboratory quality improvement study in 348 laboratories.

MAIN OUTCOME MEASURES–Sensitivity, specificity, and positive predictive value of cervicovaginal cytology diagnosis.

RESULTS–Statistical analysis of 22 439 paired cervicovaginal cytology–cervical biopsy specimens reveals a sensitivity of 89.4%, specificity of 64.8%, and predictive value of a positive cytology of 88.9%. The majority of discrepancies were attributed to cytology or biopsy sampling errors. Routinely providing the patient’s recent cervical cytology report to the surgical pathologist at the time the biopsy was examined resulted in improved sensitivity. Correlations for cytology specimens obtained at the time of biopsy revealed lower sensitivity and higher specificity than for those obtained at a time prior to the biopsy.

CONCLUSIONS–We have defined current statistical expectations for cervical cytology-biopsy correlation, reasons for noncorrelation, and have provided recommendations for quality improvement.

Novis DA, Gebhardt GN, Zarbo RJ. Inter-institutional comparison of frozen section consultation in small hospitals. A College of American Pathologists Q-Probes study of 18532 frozen section consultation diagnoses in 233 small hospitals. Arch Pathol Lab Med. 1996;120:1087-1093 (abstract: Yearbook of Pathology and Laboratory Medicine 1998, 344-346. abstract JAMA 1997; 277:1179)

OBJECTIVES: To study the intraoperative turnaround time for performing a frozen section (FS) and to examine pathology practice variables that influence it.

DESIGN: Over a 4-month period in 1995, participants in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively collected data on up to 30 FS procedures performed on elective inpatient surgical cases and completed questionnaires profiling their FS practice characteristics. SETTING: Surgical pathology laboratories serving private and public hospitals.

PARTICIPANTS: Seven hundred institutions located in North America (667), Australia (12), New Zealand (1), the United Kingdom (3), Hong Kong (1), Mexico (1), and Norway (1). MAIN OUTCOME MEASURES: The 90% FS block completion time defined as the time interval, in minutes, within which the fastest 90% of all FS blocks were completed, measured from the time pathologists received FS specimens to the time they communicated FS results to the surgeon.

RESULTS: Participants submitted data on 32868 FS blocks. Ninety percent of FS procedures were completed within 20 minutes. Frozen section turnaround times exceeding 20 minutes, termed outlier turnaround times, were more likely to occur when more than one pathologist participated in the FS diagnosis, pathology residents and medical students participated in the FS procedure, the pathologist had to retrieve and review previous case material during the FS procedure, the pathologist simultaneously received additional specimens from other FS cases, the pathologist was unable to reach a final FS diagnosis, and when technical problems occurred during the FS procedure. Seventy percent of all participating hospitals completed 90% of their frozen sections within 20 minutes. The institutional 90% completion times were shorter for hospitals containing 300 or fewer occupied beds than for those containing more than 300 occupied beds.

CONCLUSIONS: The data suggest that 90% of FS block turnaround times can be performed within 20 minutes, measured from the time that pathologists receive FS specimens to the time that pathologists return FS diagnoses to surgeons.

Novis DA, Jones BA. Inter-institutional comparison of blood glucose monitoring program characteristics, accuracy, and quality control documentation. A College of American Pathologists Q- Probes study of bedside blood glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502.

OBJECTIVES: To assess the accuracy of bedside blood glucose monitoring (BGM) in small hospitals, to assess the compliance with which hospital workers performing bedside BGM adhere to quality control (QC) procedures, and to identify those practice characteristics in small hospitals that are associated with better BGM accuracy and with better performance of BGM QC.

DESIGN: Over a 1-month period in 1996, voluntary participants in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively compared glucose results of 30 split samples run on BGM instruments with those performed on laboratory glucose analyzers, collected quality control data on up to five inpatient BGM instruments, and completed questionnaires profiling BGM practice characteristics in their institutions.

SETTING AND PARTICIPANTS: Two hundred twenty-six hospitals with 200 or fewer occupied beds.

MAIN OUTCOME MEASURES: The percentages of glucose determinations performed on BGM instruments differing by more than 10%, 15%, and 20% from those split-sample results performed on laboratory glucose analyzers; the percent of BGM QC determinations required by institutions’ BGM QC programs that BGM operators actually performed; and the percent of patient values reported when BGM QC was documented to be out of range and uncorrected, or reported when BGM QC was not performed at all. RESULTS: Of 6095 split-specimen glucose results that participants simultaneously performed on BGM instruments and on laboratory glucose analyzers, 45.6% differed from each other by more than 10%, approximately 25% differed from each other by more than 15%, and almost 14% differed from each other by more than 20%. Of 216 laboratories that performed at least 30 QC events during the study period, slightly over a third completed 100% of their required QC determinations, and 10% completed, at most, 77% of their required BGM QC determinations. Of 115,973 BGM determinations that participants reported on hospitalized patients, 3.3% were reported when QC was either out of range or when there was no documentation that QC had been performed at all. Better accuracy and/or better QC performance was associated with laboratory personnel rather than nursing personnel both supervising institutions’ BGM QC programs and running institutions’ daily routine BGM QC; with BGM operators both routinely running three, rather than two, levels of QC analytes; with BGM operators regularly comparing BGM results with laboratory analyzer glucose results; and with institutions participating in external proficiency programs. Institutions that completed all required BGM QC tasks tended to perform better on the BGM accuracy study than did those institutions that completed, at most, 77% of their required QC.

CONCLUSIONS: We found the rates of BGM accuracy and of QC performance adequacy achieved in small hospitals to be similar to those determined in previous Q-Probes studies conducted in large institutions. A significant amount of institutional bedside testing does not meet current standards for accuracy or for quality control. Some institutions may improve their accuracy and/or QC performances by having laboratory personnel intimately involved in their institution’s BGM QC program, by routinely comparing BGM results with those performed using glucose analyzers in the clinical laboratory, by routinely running three rather than two glucose QC control levels, by participating in external proficiency programs, and by strictly adhering to institutional QC protocols

Novis, DA. Current state of malpractice litigation. Acta Cytol. 1998; 42:1302-4.

April 28, 1998

George L. Wied, M.D., F.I.A.C., or Marluce Bibbo, M.D., Sc.D., F.I.A.C. Editors-in-Chief Acta Cytologica P.O. Box 12425 8342 Olive Boulevard St. Louis, MO 63132-2814

To the Editors:

I enjoyed reading the definitive and comprehensive review by Frable et al concerning the current state of malpractice litigation, as well as the thoughtful and provocative commentaries that followed it [Frable WJ et al: Medicolegal affairs. IAC Task Force summary. Acta Cytol 1998:42:76-132]. My interest alighted on several endorsements, both explicit and implied, concerning the notion of establishing centralized panels to review Pap smears in litigation. Until recently, I was convinced that the creation of review panels would improve our system of malpractice litigation. I also believed that the American Society of Cytopathology (ASC) should be the institution that establishes these panels because I thought that might be a way for the ASC to resolve several major problems facing it. I now believe that these review panels are unworkable, and that the ASC is already well on its way to resolving its problems without needing to establish review panels.

It had seemed to me that an institutionalized mechanism of slide review may have undermined what I consider to be betrayal of our membership by officers who use their ASC status to profit from malpractice litigation brought against the very Society members who elected them to those offices in the first place. I’m not saying that our colleagues shouldn’t be allowed to sell their expertise to plaintiffs’ attorneys. However, when expert witnesses bolster their credentials in court by conjuring up their positions of leadership in our esteemed Society, lawyers have a way of making it sound as if they speak for all of us. If that be the case, I think we should be a part of the process that determines what the standards of performance are going to be, and who, in the name of our Society, will articulate them. As it turns out, the Society is already attempting to deal with this issue. Candidates for ASC office must now declare their malpractice activity to the membership. If we choose, we can take these activities into account when we cast our votes.

Secondly, I believed that an ASC-based national arbitration board would show that, contrary to the characterization that it sometimes inadvertently projects, the Society’s leadership is truly sensitive to the anxieties of its members. In a recent poll conducted by the ASC, members indicated that the number one issue that they wanted the Society to confront was that of practice standards, particularly regarding malpractice litigation. There, too, the Society may be on the way to resolving this, if it indeed embraces the so-called South Carolina Guidelines.

Finally, and this really provided me the main impetus for the concept, I believed that the creation of an impartial arbitration board reviewing litigation material, never knowing if they were rendering opinions for the plaintiff or the defense, struck me as a fair way to decide whether or not a defendant achieved, and the plaintiff received, a reasonable standard of care. Subsequently, I came to find out that the Committee on Cytopathology Practice considered, and then rejected the notion of a review board quite some time ago. To understand why, I retraced their research. I talked to lawyers and malpractice risk managers representing the Doctor’s Company, the College of American Pathologists, the American College of Radiology, and the American Medical Association, as well as to private practitioners of malpractice law. Their opinions, with only a few exceptions, were much the same: the system is not about what is or what is not fair to cytopathologists angered at having their competence publicly impugned. It’s about winning cases in malpractice court.

The people with whom I spoke all agreed that a central review board is, in concept, a great idea. In fact, many states have arbitration boards for civil litigation. Nobody uses them. In many states, the court itself can call its own unbiased expert witnesses. They don’t. This does not represent some sort of legal irony; it’s how our legal justice system operates. Malpractice attorneys don’t start out with missed cells on a Pap smear. They start out with a client who claims injury and an obligation to that client to convince a jury that the client should be compensated for that injury. If the plaintiff’s attorney needs to show that Pap smear results contributed to the injury, he/she will try to find someone to say so. Indeed, in most states, a plaintiff’s attorney can not initiate legal action without the endorsement of an expert witness. The defense cannot coerce the plaintiff into submitting a smear to some central arbitration panel.

Defendants’ insurance companies do not necessarily endorse these arbitration panels, either. Once a case has been filed, insurance companies prefer to have their arguments articulated by experienced experts who are adept at defense testimony rather than by impartial panels who may render an opinion that might be less than favorable to their own position. In fact, the last thing that the defense wants to do is to give the plaintiff’s expert the soap box upon which to perch in front of a jury and crow about how cumbersome and unnecessary the review panel is to conclude what is obvious to the most casual observer, namely, that the defendant’s error was gross and that the laboratory’s practice did not meet the most minimal standard of care. Until we see tort reform in America, I think we’re stuck with this system.

Rather than trying to change the entire legal system, maybe all the ASC can do is try to change the behavior of those who choose to belong to it. The Society can establish standards of practice for its members. It can devise mechanisms of case review for members who would like to measure how their practice compares to that of their peers. It can ratify uniform standards of slide review, such as those embodied in the South Carolina Guidelines. I suspect that not many members would choose to deviate from Society standards, at least not if they desired maintaining the esteem of their fellow Society members, let alone their very membership in the Society. Perhaps, too, Society members might perceive these types of activities as adding value to their ASC membership.

As I understand it, the Committee on Cytopathology Practice is engaged in setting standards of practice and standards of behavior for members involved in malpractice litigation. I patiently await their report later this year.

David A Novis, M.D. Wentworth Douglass Hospital Dover, New Hampshire 03820

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.