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and the number of RBC-containing units that were transfused into patients, the number of units that expired (outdated) prior to being utilized, and the number that were wasted due to mishandling.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.

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.

OBJECTIVE: To determine the normative rates of expiration and wastage for units of fresh frozen plasma (FFP) and platelets (PLTs) 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 numbers of units of FFP and PLTs that expired (outdated) prior to being used and 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, more than 80% of which were known to be located in the United States.

MAIN OUTCOME MEASURES: Quality indicators of FFP and PLT utilization: the rates of expiration and wastage of units of FFP and PLTs.

RESULTS: Participants submitted data on 8 981 796 units of FFP and PLTs. In all 3 studies, aggregate combined FFP and PLT expiration rates ranged from 5.8% to 6.4% and aggregate combined FFP and PLT wastage rates ranged from 2.0% to 2.5%. Among the top-performing 10% of participants (90th percentile and above), FFP and PLT expiration rates were 0.6% or lower and FFP and PLT wastage rates were 0.5% or lower. Among the bottom-performing 10% of participants (10th percentile and below), expiration rates were 13.8% or higher and wastage rates were 6.8% or higher. We were unable to associate selected hospital characteristics or blood bank practices with lower rates of FFP and PLT utilization.

CONCLUSIONS: The rates of FFP and PLT expiration and wastage vary greatly among hospitals in the United States. Hospital blood bank personnel are capable of achieving FFP and PLT expiration and wastage rates below 1%.

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.

OBJECTIVES: To determine the normative distribution of time elapsed for blood bank personnel to fill nonscheduled operating room (OR) blood component orders in hospital communities throughout the United States, and to examine hospital blood bank practices associated with faster blood component delivery times.

DESIGN: Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the times elapsed for blood bank personnel to fill nonscheduled emergent orders from hospital ORs for red blood cell (RBC) products, fresh frozen plasma (FFP), and platelets (PLTs). Participants also completed questionnaires describing their hospitals’ and blood banks’ laboratory and transfusion practices.

SETTING AND PARTICIPANTS: Four hundred sixty-six public and private institutions located in 48 states in the United States (n = 444), Canada (n = 9), Australia (n = 8), the United Kingdom (n = 4), and Spain (n = 1).

MAIN OUTCOME MEASURES: The median time elapsed between requests for blood components by OR personnel and the retrieval of those components by blood component transport personnel, and the median time elapsed between requests for blood components by OR personnel and the arrival of those components in ORs.

RESULTS: Participants submitted data on 12 647 units of RBCs, FFP, and PLTs. The median aggregate request-to-retrieval turnaround times (TATs) for RBCs, FFP, and PLTs ranged from 30 to 35 minutes, and the median aggregate request-to-arrival TATs for RBCs, FFP, and PLTs ranged from 33 to 39 minutes. Most of the TAT was consumed by events occurring prior to, rather than after release of components from blood banks. Shorter prerelease TATs were associated with having surgical schedules that listed patients’ names and procedures available to blood bank personnel prior to surgeries, and having adequate clotted specimens in the blood bank and completed type-and-screen procedures performed before requests for blood components were submitted to blood banks. Among the fastest-performing 10% of participants (90th percentile and above), request-to-retrieval TATs ranged from 12 to 24 minutes for the 3 blood components, whereas among the slowest-performing 10% of participants (10th percentile and below), request-to-retrieval TATs ranged from 63 to 115 minutes for the 3 components. Median TATs ranged from 33 to 37 minutes for the 3 components. Institutions with TATs in the fastest-performing 25th percentile more frequently stored cross-matched RBCs in the OR daily, stocked PLTs for unexpected surgical use, stored PLTs in or near the OR, and had laboratory rather than nonlaboratory personnel deliver components to the OR than did those institutions with TATs in the slowest-performing 25th percentile.

CONCLUSIONS: Hospital blood bank personnel can deliver blood components to the OR in slightly longer than 30 minutes, measured from the time that those units are requested by OR personnel. Practices aimed at saving time before components are released from blood banks will be more efficient in reducing overall TAT than those practices aimed at saving time after components are released from blood banks. Specific practices associated with shorter blood delivery TATs included providing blood bank personnel with access to the names of surgical patients potentially requiring blood components, having pretransfusion testing completed on those patients prior to surgery, having ample blood products on hand, and having laboratory personnel control blood product delivery.

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.

Abstract not available

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.