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.

CONTEXT: Hemolytic transfusion reactions are often the result of failure to follow established identification and monitoring procedures.

OBJECTIVE: To measure the frequencies with which health care workers completed specific transfusion procedures required for laboratory and blood bank accreditation.

DESIGN: In 2 separate studies, participants in the College of American Pathologists Q-Probes laboratory quality improvement program audited nonemergent red blood cell transfusions prospectively and completed questionnaires profiling their institutions’ transfusion policies.

SETTING AND PARTICIPANTS: A total of 660 institutions, predominantly in the United States, at which transfusion medicine services are provided.

MAIN OUTCOMES MEASURES: The percentages of transfusions for which participants completed 4 specific components of patient and blood unit identifications, and for which participants monitored vital signs at 3 specific intervals during transfusions.

RESULTS: In the first study, all components of patient identification procedures were performed in 62.3%, and all required patient vital sign monitoring was performed in 81.6% of 12 448 transfusions audited. The median frequencies with which institutions participating in the first study performed all patient identification and monitoring procedures were 69.0% and 90.2%, respectively. In the second study, all components of patient identification were performed in 25.4% and all patient vital sign monitoring was performed in 88.3% of 4046 transfusions audited. The median frequencies with which institutions participating in the second study performed all patient identification and monitoring procedures were 10.0% and 95.0%, respectively. Individual practices and/or institutional policies associated with greater frequencies of patient identification and/or vital sign monitoring included transporting units of blood directly to patient bedsides, having no more than 1 individual handle blood units in route, checking unit labels against physicians’ orders, having patients wear identification tags (wristbands), reading identification information aloud when 2 or more transfusionists participated, using written checklists to guide the administration of blood, instructing health care personnel in transfusion practices, and routinely auditing the administration of transfusions.

CONCLUSIONS: In many hospitals, the functions of identification and vital sign monitoring of patients receiving blood transfusions do not meet laboratory and blood bank accreditation standards. Differences in hospital transfusion policies influence how well health care workers comply with standard practices. We would expect that efforts designed to perfect transfusion policies might also improve performance in those hospitals in which practice compliance is substandard.

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.

CONTEXT: The laboratory test turnaround times (TATs) that exceed the expectations of clinicians who order those tests, the so-called outlier test reporting rates, may be responsible for perceptions of inadequate laboratory service.

OBJECTIVE: To monitor outlier test reporting rates for emergency department stat potassium results and routine inpatient morning blood tests.

DESIGN: In 2 different monitors, each conducted for 2 years, laboratory personnel in institutions enrolled in the College of American Pathologists (CAP) Q-Tracks program tracked the percentages of emergency department stat potassium results and/or the percentages of morning rounds routine test results that were reported later than self-imposed reporting deadlines.

SETTING: A total of 291 hospitals participating in 2 CAP Q-Tracks monitors.

RESULTS: Participants monitored 225,140 stat emergency department potassium TATs, of which 33,402 (14.8%) were outliers, and 1,055040 routine morning test reporting times, of which 123,554 (11.7%) were outliers. For both monitors, there was a significant (P <.05) downward trend in the outlier rates as the number of quarters in which participants submitted data increased.

CONCLUSION: Outlier reporting rates for emergency department stat potassium and routine morning test results decreased during the 2-year period of continuous monitoring. The CAP Q-Tracks program provides an effective vehicle by which providers of laboratory services may improve the timeliness with which they deliver the results of laboratory tests.

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.

Data relating to the occurrence of medical errors from over 125 bench marking and outcome studies in quality medical performance conducted by members of the College of American Pathologist Quality Practice Committee were analyzed. Key strategies for reducing medical errors was developed from this analysis published in the Clinics of Laboratory Medicine.

This review extracts from the College of American Pathologists Q-PROBES and Q-TRACKS programs, those studies that have benchmarked and monitored the occurrence of errors in the practices of laboratory medicine and anatomic pathology. The outcomes of these studies represent in aggregate the analysis of millions of data points collected in thousands of hospitals throughout the United States. Also presented in this review are hospital and laboratory practices associated with improved performance (ie, fewer errors). Only those associations that were shown to be statistically significant are presented. From the results of these studies, there emerge two complementary strategies that appear to be associated with reduction of errors. Obviously, the first strategy involves doing what is necessary to prevent the occurrence of errors in the first place. Several tactics may accomplish this goal. Healthcare workers responsible for specific tasks must be properly educated and motivated to perform those tasks with as few errors as possible. There must be written policies and protocols detailing responsibilities and providing contingencies when those responsibilities are not met. The successful completion of required tasks must be documented, especially those tasks that are performed as requisite to others. In other words, it should be impossible to move on to subsequent operations in testing processes before documenting the successful completion of previous requisite operations. Finally, the opportunities for making errors must be reduced. Specifically, the number of steps in which specimens are delivered to laboratories, tests are performed, and results are disseminated to those who use them must be reduced as much as possible. The second strategy involves the assumption that despite our best efforts to prevent them, errors will occur. No matter how smart we are, no matter how careful we try to be, we will make mistakes. It is essential that systems designed to eliminate errors include elements of redundancy to catch those mistakes. Work must be checked and verified before therapeutic decisions are finalized. This is especially true when those decisions are irrevocable and the potential damage caused by errors cannot be undone. Ideally, systems that use redundancy should include provisions to shut down the testing process altogether when the successful execution of previous steps cannot be verified. Once error detection systems are established, service providers can gauge their performance by employing tools of continuous monitoring to assess the degree to which health care workers comply with required procedures, and with which services achieve their intended outcomes.

Novis DA. Routine review of surgical pathology cases as a method by which to reduce diagnostic errors in a community hospital. Pathology Case Reviews 2005; 10:63-67.

ABSTRACT

When surgical pathology reports are discovered to contain errors after those reports have been released to clinicians, it is common practice for pathologists to correct and reissue them as amended reports. Measuring the rates with which surgical pathology reports are amended is a convenient quality assurance tool by which to gauge the frequencies of errors occurring in surgical pathology reporting. The purpose of this study was to determine whether or not routine review of surgical pathology case material prior to the release of surgical pathology reports would lower the rate with which surgical pathology reports were amended to correct misdiagnoses. In the year-long periods before and after institution of this intervention, the annual rates of amended reports issued for the purpose of correcting misdiagnoses were 1.3 per 1000 cases and 0.6 per 1000 cases respectively.

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.

 Context. Automated laboratory hematology analyzers are capable of performing differential counts on peripheral blood smears with greater precision and more accurate detection of distributional and morphologic abnormalities than those performed by manual examinations of blood smears. Manual determinations of blood morphology and leukocyte differential counts are time-consuming, expensive, and may not always be necessary. The frequency with which hematology laboratory workers perform manual screens despite the availability of labor-saving features of automated analyzers is unknown.

Objective. To determine the normative rates with which manual peripheral blood smears were performed in clinical laboratories, to examine laboratory practices associated with higher or lower manual review rates, and to measure the effects of manual smear review on the efficiency of generating complete blood count (CBC) determinations.

Design. From each of 3 traditional shifts per day, participants were asked to select serially, 10 automated CBC specimens, and to indicate whether manual scans and/or reviews with complete differential counts were performed on blood smears prepared from those specimens. Sampling continued until a total of 60 peripheral smears were reviewed manually. For each specimen on which a manual review was performed, participants indicated the patient’s age, hemoglobin value, white blood cell count, platelet count, and the primary reason why the manual review was performed. Participants also submitted data concerning their institutions’ demographic profiles and their laboratories’ staffing, work volume, and practices regarding CBC determinations. The rates of manual reviews and estimations of efficiency in performing CBC determinations were obtained from the data.

Setting. A total of 263 hospitals and independent laboratories, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program.

Results. There were 95141 CBC determinations examined in this study; participants reviewed 15423 (16.2%) peripheral blood smears manually. In the median institution (50th percentile), manual reviews of peripheral smears were performed on 26.7% of specimens. Manual differential count review rates were inversely associated with the magnitude of platelet counts that were required by laboratory policy to trigger smear reviews and with the efficiency of generating CBC reports. Lower manual differential count review rates were associated with laboratory policies that allowed manual reviews solely on the basis of abnormal automated red cell parameters and that precluded performing repeat manual reviews within designated time intervals. The manual scan rate elevated with increased number of hospital beds. In more than one third (35.7%) of the peripheral smears reviewed manually, participants claimed to have learned additional information beyond what was available on automated hematology analyzer printouts alone.

Conclusion. By adopting certain laboratory practices, it may be possible to reduce the rates of manual reviews of peripheral blood smears and increase the efficiency of generating CBC results.

Novis DA. The Quality of Customer Service in Anatomic Pathology. Diagnostic Histopathology 2008; 14: 308-315.

The Quality of Customer Service in Anatomic Pathology

Abstract. Customer service, namely ensuring that the quality of goods and services meet the expectations of those who use them is a fundamental element by which customers gauge the value of a company. The subject of customer service in the practice of Anatomic Pathology (AP) receives little time in pathologists’ training programs and little print in medical literature. In this paper, the author will discuss the importance of customer service to customer retention in the practice of AP. The author will also compare the use of two metrics–one of process: test turnaround time and the other of outcome: customer satisfaction–by which the success of customer service is evaluated.

Key words

Anatomic pathology

Customer service

Customer satisfaction

Turnaround time

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.

CLIA Compliance Handbook: The Essential Guide for the Clinical Laboratory, 2nd Edition

To operate legally and be eligible for reimbursement under Medicare and Medicaid within U.S. jurisdictions, an entity performing clinical laboratory testing for diagnosis, prevention, treatment, and monitoring, or for the assessment of patient health or impairment, must satisfy federal requirements that implement the Clinical Laboratory Improvement Act of 1988 (CLIA).

Prepared with the help of five leading laboratory professionals, legal experts C. Anne Pontius; Kathleen A. Murphy, PhD; David. A. Novis, MD; Alyn J. Hansen, MT; and Robert E. Mazer, JD and Washington G-2 Reports editors this exclusive Research Report gives you detailed coverage of key issues, such as:

• Lab regulations under CLIA
• CLIA certification programs and fees
• CLIA standards for test performance
• How to meet CLIA quality system requirements
• Lab inspections and surveys under CLIA
• New approaches to surveys
• CLIA sanctions and other legal issues

To order, access Washington G2 Reports at www.G2Reports.com.

Novis DA, Ellzey I, Cojita, D. Complete Histology Slide Lab Set-up Manual. IEPG. Casselberry, FL. 2009.

Novis, DA. The Lean Way. Chapter 2. How to Lean Your Laboratory Outreach Program. In Business Strategies for Lab Outreach Programs, edited by Kim Scott and Mark Terry. Newark, NJ. Washington G2 Reports 2009: 104-117