Lean Production and Error Reduction
Quality Outcomes: College of American Pathologists Q-Probes Studies
Category Archives: Uncategorized
CAP Today
CAP Today is the trade news journal of the College of American Pathologists.
Low and inside: reducing laboratory staff turnover.
May 2019
On a regular basis, CAP Today includes Q & A and general education sections for CAP physician members. The following is a list of questions for which the answers reference published studies performed by Dr. Novis and his coworkers.
December 2005
Q. Is there a benchmark or community standard for the percentage of stat tests relative to total workload? Our overseas military hospital would probably be most comparable to a small community hospital.
A. Stats vary according to the institutional services and, as such, are a barometer of those services, rather than a target to be achieved. I am unaware of any published general benchmarks, although specific articles appear occasionally regarding turnaround time, which may have data regarding stats embedded in them, such as for troponin measurements (Novis DA, Jones BA, Dale JC, et al. Arch Pathol Lab Med. 2004;128: 158-164).
I believe staff should review the CAP Laboratory Accreditation Program standards regarding TAT and ensure that the needs of the medical staff are being met. If there is a perception that too many stats are being ordered (although that is not implied in the question), the medical director should perhaps review lab TAT in general or with respect to particular tests to ascertain if process improvement is needed. Alternatively, if there are individual abusers among the medical staff who regularly order stats inappropriately, then it is the medical director’s responsibility to attempt to change these ordering patterns and, thereby, assure appropriate laboratory use and resource consumption.
June 2005
Q. Our laboratory maintains cytology/histology correlation in a separate file and keeps track of any discrepancies noted. We send out a letter to clinicians for all abnormal cytology cases without correlation asking for documentation of followup. We have several questions about these correlations: Should a comment on correlation be included in our pathology reports? When should requests for followup be made, and what should be done with this information?
A. CLIA 88 mandates that there is laboratory comparison of clinical information, when available, with cytology reports and comparison of all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (either on-site or in storage), and determination of the causes of any discrepancies.1 These requirements are reflected in cytopathology checklist questions CYP.01900, CYP.07543, CYP.07556, and CYP.07569.2
The method for documenting the cytohistologic correlation results is not specified and is left to each individual laboratorys discretion. Communication of cytology and biopsy correlation results to clinicians is key and provides critical information for optimal patient management.6 Cytohistologic correlation for individual patients can be documented in biopsy reports, via phone calls, or in letters, and, in more general terms, correlation statistics can be discussed in interdepartmental committees or conferences.
Evaluation of cytohistologic correlations is also an important part of a laboratorys quality improvement program.10 The definition of what constitutes diagnostic discrepancy should be established, and it should be recognized that perfect correlation is not realistic. The 1996 CAP Q-Probes study5 of 22,429 paired cervicovaginal cytology and biopsy specimens reported a discrepancy rate of 16.5 percent with a Pap sensitivity of 89 percent and specificity of 65 percent. The majority of discrepancies in this study were due to sampling differences rather than screening or interpretive errors. Because both the Pap test and colposcopic biopsy are subject to sampling errors, reasons for discrepancies should be pursued when the biopsy is negative, as it may not always represent the gold standard. Negative cytology cases should also be reviewed, if available, when the biopsy is positive. Peer or multidisciplinary review or both of noncorrelating specimens may be helpful in achieving consensus. Regular summary and evaluation of results can identify trends and improvements.
There is no requirement for correlating biopsies with lesser abnormalities, for correlating subsequent cytology with previous biopsies, or for correlating concurrent biopsies. However, these cytohistologic correlations are recorded in many laboratories and may be a useful part of the quality improvement program. Laboratories are required to document the number of cases that do have histologic correlation in the annual laboratory cytology statistical report.
In a 1997 article by Andrew Renshaw, MD,7 the optimal time for correlation of cytology and subsequent biopsies was found to be between 60 to 100 days, during which time the correlation of the Pap test and the subsequent biopsies was the highest. Biopsies performed over 100 days were less likely to correlate with the initial Pap. The difference may be explained by regression of lesions over time.
When followup material is not available in the laboratory, documentation of followup correspondence or reports, telephone calls, or requests for information, whether as separate letters or in the histology report, must be maintained and kept for two years. In cases without biopsy followup, other studies such as human papillomavirus testing, repeat Pap tests, and colposcopic examination findings may provide useful information, especially in cases of HSIL, glandular abnormalities, and carcinoma.
References
5. Jones BA, Novis DA. Cervical biopsy-cytology correlation. A College of American Pathologists Q-Probes study of 22439 correlations in 348 laboratories. Arch Pathol Lab Med. 1996;120:523531.
May 2003
Is there a right time for cyto/histo correlation in gyn cytology?
Cytologic-histologic correlation is an important component of any quality improvement program in cytology. A documented effort must be made to obtain and review follow-up histologic reports or material that is available within the laboratory when high-grade squamous intraepithelial lesion or malignant findings are identified in gynecologic cytology.1 There is no specific requirement to obtain correlation for any gynecologic cytology specimen in the absence of HSIL, and there is no specific requirement that histologic findings be correlated with cytologic findings, though many laboratories do make these correlations and the results certainly can be a component of a quality improvement program.2-5
The time period over which these correlations should be made is not specified. Data do suggest, however, that the optimal period for examination may be 60 to 100 days. In a study involving 419 low-grade squamous intraepithelial lesion and 277 HSIL smears, Renshaw, et al.6 correlated the rate of subsequent biopsy and the rate of correlation with that biopsy over a period of one year. In this study, 811 biopsies were performed. While biopsies that correlated with the initial cytologic finding could be identified as late as one year after the initial cytology, the highest rate of confirmation was obtained in biopsies performed within 60 days, and fully 78 percent of all correlating biopsies were obtained within the first 100 days. The chance of finding a correlating smear decreased after that time. In other words, biopsies performed more than 100 days after the initial biopsy were less likely to correlate with the initial cytologic finding.
One explanation for the increased number of discrepancies was regression of the lesions. After 100 days, there is a greater likelihood of regression, which leads to an increase in the number of perceived false-positive cytology results when, in fact, a number of them are actually true positives. Limiting correlations to 100 days after the cytologic specimen was obtained is a reasonable way to limit the impact of false-positive correlations on the quality improvement program and the cytologic staff, while at the same time obtaining the majority of all biopsies for which correlation is available.
More controversial is whether cytologic specimens should be taken at the same time as the biopsy and correlated with it. Some literature suggests that cytologic specimens taken at that time have a higher likelihood of being false-negativesthat is, the cytologic specimen is more likely to not sample the lesion found in the biopsy.7 In the study by Renshaw, et al.,6 this was not found to be the case, and indeed cytologic specimens obtained at the time of biopsy were more likely to correlate with the results of biopsy than cytologic specimens taken at any subsequent time.
No requirement specifies that concurrent Pap tests need to be correlated with the biopsy since these cytology specimens were not the reason for obtaining the biopsy. Technically concurrent biopsies are not a followup to the cytology. In the interests of patient care, however, HSIL or malignancy identified on the cytology specimen with a concurrent negative or low-grade biopsy result should be reconciled. Furthermore, the subsequent histologic specimens must be correlated. It appears that the optimal biopsies to correlate are those obtained within 60 to 100 days after the Pap test.
Reference
• Jones BA, Novis DA. Cervical Biopsy-Cytology Correlation. Arch Pathol Lab Med. 1996;120:523-531.
November 2002
Fresh frozen plasma and platelet utilization
The authors of this study reported normative rates of expiration and wastage for units of fresh frozen plasma and platelets. Participants in the CAP Q-Probes laboratory quality improvement program collected data retrospectively on the number of units of FFP and PLTs that expired or were wasted due to mishandling. The participants also completed questionnaires describing their hospitals’ and blood banks’ laboratory and transfusion practices. The studies covered 1,639 public and private institutions and included data submitted on 8,981,796 units of FFP and PLTs. The aggregate combined FFP and PLT expiration rates ranged from 5.8 to 6.4 percent, and aggregate combined FFP and PLT wastage rates ranged from 2.0 to 2.5 percent. Among the top-performing participants (at the 90th percentile and above), FFP and PLT expiration rates were 0.6 percent or lower and FFP and PLT wastage rates were 0.5 percent or lower. Among the worst-performing participants (at the 10th percentile and below), expiration rates were 13.8 percent or higher and wastage rates were 6.8 percent or higher. The authors were unable to associate selected hospital characteristics or blood bank practices with lower rates of FFP and PLT utilization. They concluded that it is possible for hospital blood bank personnel to achieve FFP and PLT expiration and wastage rates of less than one percent.
Novis DA, Renner S, Friedberg RC, et al. Quality indicators of fresh frozen plasma and platelet utilization. Arch Pathol Lab Med. 2002;126:527-532.
Reprints: Dr. David A. Novis, For reprints, contact Dr. Novis at davidnovis.com .
August 2002
Q. New requirement for nongyn TAT
A. The 2002 CAP Laboratory Accreditation Program checklist contains a new question related to turnaround time of nongynecologic cytology, or NGC, cases:
0YP.06532 Phase I: Are 90 percent of reports on routine nongynecologic cytology cases completed within two working days of receipt by the laboratory performing the evaluation?
This question was added to the checklist to underscore the importance of turnaround time as a measure of laboratory service quality. In a 2000 Q-Probe authored by Bruce A. Jones, MD, and David A. Novis, MD (QP08), the factors influencing TAT for 16,925 NGC specimens from 180 laboratories were analyzed. The authors found that 50 percent of participating laboratories had a mean TAT of 2.1 days or less from specimen collection to final report sign-off. The factors that delayed TAT included the use of reference laboratories for screening, lack of timely transcription, difficulty obtaining adequate specimen information from the submitting physician, and pulling old slides/tissue blocks for review or performing special stains, or both.
The CAP believes that a goal of two working days TAT for routine NGC specimens is reasonable. Documentation can consist of continuous monitoring of data or periodic auditing of reports. Longer times may be allowed for specimens requiring special processing or staining (for example, immunohistochemistry), provided these special classes of specimens are documented so that the inspector can evaluate their appropriateness.
For laboratories that are finding it difficult to meet the CAP TAT guidelines, the 2000 Q-Probe study makes recommendations for improving overall TAT. They are as follows: minimize the use of reference laboratories; educate the submitting physician’s office staff or change requisitions to expedite the gathering of important information, or both; reevaluate general laboratory workflow and transcription services; and continuously monitor TAT.
Nongynecologic cytology plays an important role in diagnosing and managing patients, many of whom may be acutely ill. The new CAP guideline emphasizes the importance of NGC turnaround time for patient care and clinical decision-making in today’s competitive, customer-service-oriented health care systems. Of course, the quality of diagno-sis should never be compromised for the sake of TAT.
June 2001
Q. I have a question about correlation between Pap testsboth regular and ThinPrepand biopsy. What percentage is the benchmark? Some physicians are not satisfied with our service, and they seem to expect 100 percent correlation.
A. The percentage of cytology-biopsy discrepancies depends on the definition of discrepancy and the methods used to track discrepancies. One discrepancy definition offered in the CAP Quality Improvement Manual in Anatomic Pathology is a difference in interpretation that would have an impact on patient management decisions.1 Another definition is a two-step interpretive difference, for example low-grade squamous intraepithelial lesion on biopsy versus squamous cancer on the Pap. Excluding certain specimen types, for example endocervical curettings, will also have an impact on the discrepancy rates. Finally, the time interval and number of specimens considered per patient (single versus multiple cytology-histology combinations) will also affect the calculation.
A discordant Pap-biopsy combination, as defined by Joste et al, is one “in which one of the specimens is reported as a significant squamous or glandular lesion and the other specimen is reported as within normal limits.”2 This definition excluded atypical squamous cells of undetermined significance and biopsies lacking the transformation zone. In their 14-month study of 56,497 cervical smears, 2.8 percent (1,582) were followed by cervical biopsy. Of 1,582 paired samples, 175 cases (11 percent) were identified as discrepant. (This group represents 0.3 percent of all smears reviewed.) In a vast majority (93.2 percent) both cytologic and histologic diagnoses were confirmed and the discrepancies were classified as sampling errors. Only 3.4 percent of cases were found to have correctable (interpretive or screening) errors. Tritz et al also found an 11 percent discrepancy rate, with the majority representing sampling issues, although the definition of discrepancy involved a two-step difference in interpretation.3
Jones and Novis reported results of 12 months’ followup of 16,132 cervical smears from 306 laboratories as part of a CAP Q-Probes evaluation.4 They found that 18 percent of patients with low-grade squamous intraepithelial lesion on cytology had high-grade squamous intraepithelial lesion, or HSIL, on followup biopsy. Only 67 percent of patients with LSIL on cytology had LSIL on biopsy, and 86.5 percent had any abnormal biopsy. Of those patients with HSIL on smear, 15.5 percent had LSIL on corresponding biopsy, 75.5 percent had HSIL on biopsy, and 93.5 percent had an abnormal biopsy.4 Similar to the American experience, the United Kingdom’s screening program ranges between 65 and 85 percent concordance for biopsy-proven HSIL after HSIL on cervical smear.5
Brown et al evaluated 48 discrepant cases of HSIL on cervical smears with corresponding biopsies revealing LSIL.6 Biopsy specimens were tested and typed for HPV with molecular techniques. Thirty-seven cases were positive for HPV DNA: two for low-risk HPV types, 17 for high-risk types, and 18 for types of unknown oncogenicity. The prevalence of high-risk HPV was significantly higher in LSIL biopsies with a history of HSIL smears.6
Some cytology-histology discrepancy data have also been reported using liquid-based cytology. For example, Diaz-Rosario and Kabawat reported that 20.9 percent of HSIL ThinPreps and 26.8 percent of LSIL ThinPreps were followed by negative biopsies.7
It is unrealistic to expect 100 percent correlation between cervical cytology and cervical biopsies, and an open discussion with concerned clinicians is recommended. Cervical cytology is appropriately used as a screening test, which means that some specificity will be sacrificed for increased sensitivity, while the colposcopically guided cervical biopsy is recommended as a confirmatory test. Both tests are subject to sampling error. Although the cervical biopsy is often considered the gold standard, not all lesions will be fully characterized on an initial colposcopy, and a lesion that is small or deep in the glands may not be sampled. Some lesions will regress in the interval between the Pap test and the colposcopy. In some cases, the cervical smear may better represent the pathology of the cervix than the biopsy.2-6 Appropriate treatment and followup should then be dictated by a combination of clinical, cytology, and biopsy data. In addition, the pathologist’s advice or report comments may be extremely helpful.
References.
4. 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;124:665-671.
May 2001
Sidestepping common deficiencies
A top deficiency from the anatomic pathology checklist comes from this recently revised question, 08:1182, on frozen section turnaround time: “Are at least 90 percent of frozen section interpretations rendered within 20 minutes of specimen arrival in the frozen section area?”
The new guideline is based on a Q-Probe study of frozen section turnaround time published in the Archives of Pathology & Laboratory Medicine (Novis DA, et al. 1997;121: 559-567). It requires specimens to be prepared, analyzed, interpreted, and reported within 20 minutes. Previously, frozen section slides had to be ready for a pathologist to analyze within 15 minutes.
“A lot of labs just didn’t realize that it changed or they’re not tracking their turnaround time, so they can’t say whether they’re hitting that [target] or not,” Dr. Ruhlen says.
Complicated cases that require multiple frozen sections, however, aren’t expected to meet this new standard. One example is a skin lesion with multiple margins that requires several frozen specimens for a complete interpretation. “Clearly it would be ridiculous to say you have to do them all in 20 minutes when that’s often just impossible,” Dr. Ruhlen says.
Wall Street Journal
Laura Landro The InformedPatient : Hospitals Move to Cut Dangerous Lab Errors. Wall Street Journal. June 14, 2006. Pages D1 and D11
Good Housekeeping
Leslie Pepper Can You Trust Your Lab Results Good Housekeeping. July 2007. Pages 45-50
AMA News
Lean Production and Error Reduction
Mistake Proofing the Laboratory: An Industrial View. Clinical Laboratory Management Association. Webinar, December 2, 2009; American Society for Clinical Pathology. Annual Meeting. Chicago. October 29, 2009; Clinical Laboratory Managment Association. ThinkLab ’09 Conference & Exhibition, Tampa, Florida, Tuesday, May 5, 2009;
Reducing Errors in the Laboratory: A Lean System Approach. Clinical Laboratory Managment Association AudioLab Webinar. December 2, 2008.
Reducing Errors in the Clinical Laboratory A Lean Production System Approach. American Society of Clinical Pathologists Annual Meeting, Baltimore, Maryland, October 19, 2008 – Details
Practice Management Institute: Reducing Error and Patient Risk in the Practice of Pathology College of American Pathologists Annual Meeting, San Diego, California, September 26, 2008 – Details
Reducing Errors in Pathology and Laboratory Medicine: A Lean Production System Approach. Washington G2 Reports Laboratory Outreach 2008. June 18, Las Vegas, Nevada; College of American Pathologists Annual Meeting September 26, 2008, San Diego, California; American Society of Clinical Pathologists Annual Meeting, October 19, 2008 Baltimore Maryland; American Society of Clinical Pathologists Annual Meeting, October 20, 2007 the Hilton New Orleans Riverside Hotel.
Improving Value and Reducing Errors: What does making automobiles have to do with your practice? Wentworth Douglass Hospital May 1, 2007 8:00 AM.
Strategies to reduce errors in the delivery of health care services: Lessons from the College of American Pathologists Q-Probes Program. Presented at the Conference on “Improving Hospital & Laboratory Safety” University of Pittsburgh School of Medicine, Pittsburgh, PA. May 10, 11, 2006.
Reducing Errors in Surgical Pathology: an Industrial View. Lessons from the College of American Pathologists Q-PROBES Program and Summary of notes Pittsburgh Regional Healthcare Initiative: Perfecting Patient Care November 11-18, 2005 Baystate Medical Center, Springfield MA April 26, 2006.
Adapting industrial techniques to health care delivery. 49th Annual Meeting of the Northeast Medical Association, Zermatt, Switzerland, March 30, 2006.
Medical Practice
Laboratory Medical Directorship, A Pragmatic Approach. Annual Meeting of the Ohio Society of Pathologists, April 21, 2018
Coping with the Quota: Ethnic profiling in American medical school admissions, 1930’s Annual Meeting of the Northeast Medical Association, Park City, UT March 9, 2017; and President’s Lecture, 51st Annual Meeting of the Northeast Medical Association, Steamboat Springs, CO March 7, 2000.
Small community-based pathology practice–The current issues. CBLPath, Rye Brook, New York. April 21, 2010.
Strategic Planning in Youth Sports: Physical Fitness Beyond Childhood. Presented at the 50th Annual Meeting of the Northeast Medical Association, Mont St. Anne Quebec, Canada February 11, 2007
Managing Conflict: Bridging the Generational Gap,” Medical Group Management Association (MGMA) 2006 Annual Conference. Las Vegas Convention Center, Las Vegas, Nevada. October 20, 2006.
Reducing Errors in Pathology 49th Annual Meeting of the Northeast Medical Association, Zermatt, Switzerland, March 28, 2006.
Medical Legal Issues in Gynecologic Cytology. American Society of Clinical Pathologists, Spring Meeting, Los Angeles California, April 5, 1998.
Utilization of Pathologic Findings in the Treatment of Breast Cancer, Project HOPE Breast Cancer Project, Poland, Hungary and the, Czech Republic, Fall, 1998.
Quality
Benchmarking turnaround time in Pathology and Laboratory Medicine, Program Director; College of American Pathologists, Spring Meeting, Boston, MA April 10, 2000 and Fall Meeting, Philadelphia, PA, October 21 2001
Benchmarking in Anatomic Pathology; College of American Pathologists, Spring Meeting, Chicago, Illinois, April 1997
Q-Probes; 37th Annual Meeting Northeast Medical Association, Grindelwald, Switzerland, March 6,1994
Laboratory Practice
Contributing author, Quality Management in Clinical Laboratories. 2nd Ed. College of American Pathologists, Northfield Ill. 2024
THE POINT OF CARE TESTING TOOLKIT The Point of Care Testing Committee College of American Pathologists Northfield, IL 2010.
Novis DA, Bowman C. Gastrointestinal Bleeding. Continuing Education. College of American Pathologists, Northfield IL. 2010 .
Novis DA, Ellzey I, Cojita, D. Complete Histology Slide Lab Set-up Manual. IEPG. Casselberry, FL. 2009.
Murphy K, Novis DA, Hansen AJ. Chapter VI.A New Approach To Surveys: Building Quality From the Inside. CLIA Compliance Handbook. The Essential Guide for the Clinical Laboratory. 2nd Edition. Institute of Management & Administration Inc. New York. 2009.
Howanitz PJ, Miller KA, Dale JC, Novis DA. 02-QP17. Physician satisfaction with clinical laboratory services: A College of American Pathologists Q-PROBES STUDY. Data Analysis and Critique. College of American Pathologists. Northfield, Ill. 2002.
Novis DA, Walsh M, St. Louis MA, Ben-Ezra J, Wilkinson DS. Laboratory Productivity and the Rate of Manual Peripheral Blood Smear Review: A College of American Pathologists Q-PROBES Study of 95,141 Complete Blood Count Determinations Performed in 263 Institutions. Arch Pathol Lab Med. 2006;130:633-637.
Novis DA. Detecting and preventing the occurrence of errors in the practices of Laboratory Medicine and Anatomic Pathology: Fifteen years experience with the College of American Pathologists Q- PROBES and Q-TRACKS programs. Clin Lab Med. 2004; 24:965-978.
Novis DA, Jones BA, Dale, JC, Walsh, MK. Biochemical markers of myocardial injury test turnaround time: A College of American Pathologists Q-PROBES study of 7 020 troponin and 4 368 CK-MB determinations in 159 institutions. Arch Pathol Lab Med. 2004;128: 158-164.
Novis DA, Walsh MK., Dale JC., Howanitz PJ. Continuous monitoring of stat and routine outlier turnaround times: two College of American Pathologists Q-TRACKS monitors in 291 hospitals. Arch Pathol Lab Med. 2004;128:621-626.
Novis DA, Miller KA, Howanitz PJ, Renner MD, Walsh MK. Audit of transfusion procedures in 660 hospitals: a College of American Pathologists Q-Probes study of patient identification and vital sign monitoring frequencies in 16 494 transfusions. Arch Pathol Lab Med. 2003; 127:541-548.
Howanitz P, Novis D. Accuracy and Adequacy of point of care glucose testing: A College Of American Pathologists Q-Probes study. Clin Chem Clin Lab Med 2002; 40 (Suppl) S244.
Novis DA, Friedberg RC, Renner SW, Meier FA, Walsh MK. Operating room blood delivery turnaround time. A College of American Pathologists Q-Probes study of 12 647 units of blood components in 466 institutions. Arch Pathol Lab Med. 2002; 126:909-914.
Novis DA, Renner S, Friedberg R, Walsh MK, Saladino AJ. Quality indicators of fresh frozen plasma And platelet utilization: three College of American Pathologists Q-Probes studies of 8 981 796 units of fresh frozen plasma and platelets in 1 639 hospitals. Arch Pathol Lab Med. 2002; 126:527-532.
Dale JC, Novis DA. Outpatient phlebotomy success and reasons for specimen rejection. A Q-Probes Study. Arch Pathol Lab Med. 2002; 126:416-419.
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.
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.
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.
Dale JC, Novis DA, Meier. Reference laboratory telephone service quality. Arch Pathol Lab Med. 2001 May;125(5):608-12.
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).
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.
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).
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).
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).
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.
Novis DA, Steindel SJ. Emergency department test turnaround time: data analysis and critique. 93-12, Q- Probes. Northfield Ill: College of American Pathologists; 1993.
Pathology Practice
Less is More. Solutions to the shortage of pathologists in America
Pathologists—Why Your Strategic Plan May Not Be Working
Pathology Outlines: Strategic Planning for Pathology Practices and Laboratory Directors
Pathology Outlines: Creating a Business Plan
Pathology Reports, a Second Look. Reducing errors in anatomic pathology. Novis, D.Pathol Lab Med, April 2016, Vol 150, No. 4, Page 300.
The Pathologist Workforce in the United States. II. An Interactive Modeling Tool for Analyzing Future Qualitative and Quantitative Staffing Demands for Services. Robboy J…Novis DA. et alPathol Lab Med. 2015; 139(11):1413-1430.
Pathology Practice Management. Novis Networks. Outsourcing to reduce the need for manpower. D.Novis MLO October 1, 2015.
Requisites to Strategic Planning. Archives of Pathology & Laboratory Medicine., D. Mudge-Riley M, Raich M. March 2015, Vol. 139, No. 3, pp. 305-6.
Corporate Culture in Decision Making. Archives of Pathology & Laboratory Medicine: Novis, D. 2014, Vol. 138, No. 8, p. 999.
Providing value: the key to job security. Novis, D. Laboratory Observer, Volume 42 November 2010 Page 20.
The Quality of Customer Service in Anatomic Pathology. D. Novis. Diagnostic Histopathology 2008; 14: 308-315.
Best Practices: Passing the Test. D Novis Health Executive. 4; April 20,2008; 14-17.
Novis, David. LAB WORK Advice to hospital administrators: Maximizing the Value of Your Laboratory Medical Director. Health Executive. August 2006.
Routine review of surgical pathology cases as a method by which to reduce diagnostic errors in a community hospital. D Novis. Pathology Case Reviews 2005; 10:63-67.
Current state of malpractice litigation. Novis, DA. Cytol. 1998; 42:1302-4.
College of American Pathologists CAP connect blog
Turnaround Time–The Wrong Metric?
Is It Time for a Change in CAP Governance?
A Shortage of Pathologists. The right solution?
Workforce Strategy: Aiming for the Wrong Target?
Now is the Time to Re-arm Ourselves: Requisites to Strategic Planning
Suggestions for Sharpening Your Competitive Razor
CAP Cancer Protocols and Checklists Upper Aerodigestive Tract (Including Salivary Glands) Pilch, Gillies, Houck, Kyung-Whan Min, Novis, Shah, Zarbo, Wenig. November 16, 2006
. Follow-up of abnormal gynecologic cytology: a College of American Pathologists Q-Probes study of 16,132 cases from 306 laboratories. Jones BA, Novis DA Pathol Lab Med. 2000; 124:665-71. See Editorial: Austin RM. Arch Pathol Lab Med. 2000; 124:1113-4.
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. Novis DA, Gebhardt GN, Zarbo RJ. Pathol Lab Med. 1996;120:1087-1093 (abstract: Yearbook of Pathology and Laboratory Medicine 1998, 344-346. abstract JAMA 1997; 277:1179).
Cervical biopsy-cytology correlation. A College of American Pathologists Q- Probes study of 22,439 correlations in 348 laboratories. Jones BA, Novis DA. Pathol Lab Med. 1996;120:523-53.
Inter-institutional comparison of frozen section turnaround time. A College of American Pathologists Q-Probes study of 32868 frozen sections in 700 hospitals. Novis DA, Zarbo RJ. Pathol Lab Med. 1996;121:559-567.