Preanalytic Competency Assessment: A Q-Probes Study Involving 46 Health Care Institutions, 447 Blood Collectors/Phlebotomists, and 2212 Individual Assessments.

CONTEXT.­: Health care organizations face a challenge of assessing preanalytic competency of blood collectors/phlebotomists (BC/Ps). OBJECTIVE.­: To pilot a novel methodology for BC/P preanalytic competency assessment and identify potential areas for improvement. DESIGN.­: Study participants identified preanalytic errors present in 5 blood collection video vignettes. Submitted error descriptions were categorized and then consolidated into a list of standardized required errors for evaluation. RESULTS.­: The correct identification of required error rates across all videos viewed by 447 BC/Ps from 46 institutions ranged from 0.7% to 91.9%. The median phlebotomist score across all 5 videos was 55.9% for 440 eligible blood collectors and ranged between 38.2% (10th percentile) and 70.6% (90th percentile). The median institutional score from 42 eligible institutions was 55.9% (range, 43.3%-65.3% for the 10th to 90th percentiles). There were no significant associations between any laboratory practice characteristics and the institutional average overall phlebotomist scores. The following phlebotomist characteristics were significantly associated with overall phlebotomist scores: level of education (P = .01), having phlebotomy technician (American Society for Clinical Pathology) certification compared with no or other certifications (P = .002), years of experience in collecting blood specimens (P = .01), and higher average number of venipuncture specimens collected per shift (P = .001). CONCLUSIONS.­: Improvement of the awareness and knowledge of correct blood collection practices is needed, because the best performers (90th percentile) did not recognize approximately one-third of the errors. Using hypothetical blood collection scenarios that incorporate performance errors may be a way to assess preanalytic competency of BC/Ps and create opportunities for continuous improvement.

A Multicenter Evaluation of a Nongel Mechanical Separator Plasma Blood Collection Tube for Testing of Selected Therapeutic Drugs.

BACKGROUND: Some therapeutic drugs are unstable during sample storage in gel tubes. BD Vacutainer® Barricor™ Plasma Blood Collection Tube with nongel separator was compared with plasma gel tubes, BD Vacutainer PST™, PST II, and BD Vacutainer Serum Tube for acetaminophen, salicylate, digoxin, carbamazepine, phenytoin, valproic acid, and vancomycin during sample storage for up to 7 days. METHODS: Seven hospital sites enrolled 705 participants who were taking at least one selected drug. The study tubes were collected and tested at initial time (0 h), after 48 h of storage at room temperature and on day 7 (after additional 5 days of refrigerated storage). The performance of BD Barricor tube was evaluated for each drug by comparing BD Barricor samples with samples from the other tubes at 0 h from the same participant; stability was evaluated by comparing test results from the same tube at 0 h, 48 h, and 7 days. RESULTS: At 0 h, BD Barricor showed clinically equivalent results for selected therapeutic drugs compared with the other tubes, except phenytoin in BD PST. Phenytoin samples ≥20 µg/mL in BD PST had 10-12% lower values than samples in BD Barricor. During sample storage, all selected drugs remained stable for 7 days in BD Barricor and in serum aliquots. In BD PST, all drugs remained stable except phenytoin and carbamazepine and in BD PST II except for phenytoin. CONCLUSION: The BD Barricor Tube is effective for the collection and storage of plasma blood samples for therapeutic drug monitoring without sample aliquoting.

Evaluation of Pain and Specimen Quality by Use of a Novel 25-Gauge Blood Collection Set With Ultra-Thin Wall Cannula and 5-Bevel Tip Design.

BACKGROUND: Phlebotomy has significant impact on overall patient satisfaction. Smaller gauge needles, such as a 25 gauge, may lessen patient discomfort but increase hemolysis and tube-filling times. Our studies evaluated the effect of a 5-bevel, 25-gauge blood collection set (BCS) with ultra-thin wall cannula [BD Vacutainer® UltraTouch™ Push Button BCS (UltraTouch)] on patient pain and anxiety compared with two 3-bevel, thin-wall, 23-gauge BCSs [BD Vacutainer® Safety-Lok™ (Safety-Lok) and Greiner Bio-One Vacuette® (Vacuette)]. Our studies also evaluated the 25-gauge UltraTouch for sample quality and tube filling compared with the 3-bevel, thin-wall, 23-gauge BD Vacutainer Push Button BCS. METHODS: We conducted 2 studies with 214 subjects to compare pain and anxiety regarding future phlebotomy with the 3 aforementioned devices. Another study with 52 subjects assessed hemolysis in specimens collected with the UltraTouch and Push Button BCS; bench testing evaluated tube-filling times with these devices. A questionnaire captured pain upon needle insertion, overall pain, and anxiety regarding future phlebotomy. Hemolysis was evaluated visually, by Hemolysis Index and hemolysis-sensitive indicators potassium (K) and lactate dehydrogenase (LDH). RESULTS: A statistically significant decrease was noted for overall pain with UltraTouch compared with Vacuette and with insertion pain compared with Safety-Lok. There was no significant difference in anxiety regarding future phlebotomy. No increase was observed in Hemolysis Index, K or LDH. Tube-filling times were comparable for each device. CONCLUSIONS: The 25-gauge UltraTouch provided less overall pain compared with the 23-gauge Vacuette, less pain upon needle insertion than the 23-gauge Safety-Lok, and no compromise in specimen quality or flow rate.

Preanalytical quality improvement: from dream to reality.

Abstract Laboratory diagnostics (i.e., the total testing process) develops conventionally through a virtual loop, originally referred to as "the brain to brain cycle" by George Lundberg. Throughout this complex cycle, there is an inherent possibility that a mistake might occur. According to reliable data, preanalytical errors still account for nearly 60%-70% of all problems occurring in laboratory diagnostics, most of them attributable to mishandling procedures during collection, handling, preparing or storing the specimens. Although most of these would be "intercepted" before inappropriate reactions are taken, in nearly one fifth of the cases they can produce inappropriate investigations and unjustifiable increase in costs, while generating inappropriate clinical decisions and causing some unfortunate circumstances. Several steps have already been undertaken to increase awareness and establish a governance of this frequently overlooked aspect of the total testing process. Standardization and monitoring preanalytical variables is of foremost importance and is associated with the most efficient and well-organized laboratories, resulting in reduced operational costs and increased revenues. As such, this article is aimed at providing readers with significant updates on the total quality management of the preanalytical phase to endeavour further improvement for patient safety throughout this phase of the total testing process.

Quality improvements in the preanalytical phase: focus on urine specimen workflow.

In the past, laboratories have addressed issues of preanalytical variability in an opportunistic way, addressing discrete parts of the preanalytical process, such as patient identification, specimen rejection, and blood/urine culture contamination. To obtain needed quality improvements and error reduction, it is necessary to look at the preanalytical process as a whole - from test ordering to the moment the specimen is processed by the analyzer and apply process improvement methodologies, such as LEAN and Six Sigma. To achieve this, laboratories should map the preanalytical phase in its entirety, identify steps that are potential causes of unnecessary variability that lead can to laboratory errors, and find ways either to remove them or error proof them. At the same time, by using this approach it is possible to reduce unnecessary waste and obtain needed process efficiencies.

Document control practices in 120 clinical laboratories.

CONTEXT: A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. OBJECTIVE: To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. DESIGN: Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. RESULTS: Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. CONCLUSIONS: Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

Notification of critical results: a College of American Pathologists Q-Probes study of 121 institutions.

CONTEXT: Hospital accreditors are placing increased emphasis on the timeliness with which critical laboratory results are reported to caregivers. OBJECTIVE: To measure the speed of critical result notification at a group of laboratories, identify factors associated with faster reporting, and place findings in the context of the time required to transport and test specimens and to correct critical abnormalities. DESIGN: Contemporaneous review of 3545 inpatient and emergency department critical result notifications in 121 laboratories enrolled in the College of American Pathologists Q-Probes program. RESULTS: The median laboratory required a median of 5 minutes for staff to notify someone about a critical result once testing was complete. Laboratories affiliated with smaller institutions (P = .01), rural laboratories (P = .001), and sites that called results before releasing them from the laboratory computer (P = .02) were able to notify caregivers more quickly. There was variation among institutions in the time it took to notify caregivers (interquartile range, 1.5-8 minutes). At the median facility, notification took place 56.5 minutes after the specimen had been collected. CONCLUSIONS: The time required to notify caregivers of a critical laboratory result is a small proportion of the time taken to collect and test specimens or the time that has been reported for caregivers to correct abnormalities. Although failure to notify caregivers of critical results may represent an important patient safety vulnerability, the timeliness of laboratory notification is a minor contributor to total test turnaround time at most institutions.

Specimen labeling errors: a Q-probes analysis of 147 clinical laboratories.

CONTEXT: Accurate specimen identification is critical for quality patient care. Improperly identified specimens can result in delayed diagnosis, additional laboratory testing, treatment of the wrong patient for the wrong disease, and severe transfusion reactions. Specimen identification errors have been reported to occur at rates of 0.1% to 5%. OBJECTIVE: To determine the frequency of labeling errors in a multi-institutional survey. DESIGN: Labeling errors were categorized as: (1) mislabeled, (2) unlabeled, (3) partially labeled, (4) incompletely labeled, and (5) illegible label. Blood specimens for routine or stat chemistry, hematology, and coagulation testing were included. Labeling error rates were calculated for each participant and tested for associations with institutional demographic and practice variable information. RESULTS: More than 3.3 million specimen labels were reviewed by 147 laboratories. Labeling errors were identified at a rate of 0.92 per 1000 labels. Two variables were statistically associated with lower labeling error rates: (1) laboratories with current, ongoing quality monitors for specimen identification (P = .008) and (2) institutions with 24/7 phlebotomy services for inpatients (P = .02). Most institutions had written policies for specimen labeling at the bedside or in outpatient phlebotomy areas (96% and 98%, respectively). Allowance of relabeling of blood specimens by primary collecting personnel was reported by 42% of institutions. CONCLUSIONS: Laboratories actively engaged in ongoing specimen labeling quality monitors had fewer specimen labeling errors. Also, 24/7 phlebotomy services were associated with lower specimen error rates. Establishing quality metrics for specimen labeling and deploying 24/7 phlebotomy operations may contribute to improving the accuracy of specimen labeling for the clinical laboratory.

Quality improvements in the preanalytical phase: focus on urine specimen workflow.

Despite advances in the performance of analytic systems, there still remains a high level of variability in the total testing process. Most laboratory errors currently occur in the preanalytical phase, which is complex because it consists of numerous steps. To reduce the number of errors in the preanalytical phase and achieve targeted quality improvements, particular attention should focus on process improvement and reduction of unnecessary steps. Using the example of urine specimen collection and processing, major causes of preanalytical variability are identified, as are potential areas of process improvement that significantly impact quality of urine testing. Means of achieving them through application of various Lean techniques are also discussed.

Accuracy of send-out test ordering: a College of American Pathologists Q-Probes study of ordering accuracy in 97 clinical laboratories.

CONTEXT: Errors entering orders for send-out laboratory tests into computer systems waste health care resources and can delay patient evaluation and management. OBJECTIVES: To determine (1) the accuracy of send-out test order entry under "real world" conditions and (2) whether any of several practices are associated with improved order accuracy. DESIGN: Representatives from 97 clinical laboratories provided information about the processes they use to send tests to reference facilities and their order entry and specimen routing error rates. RESULTS: In aggregate, 98% of send-out tests were correctly ordered and 99.4% of send-out tests were routed to the proper reference laboratory. There was wide variation among laboratories in the rate of send-out test order entry errors. In the bottom fourth of laboratories, more than 5% of send-out tests were ordered incorrectly, while in the top fourth of laboratories fewer than 0.3% of tests were ordered incorrectly. Order entry errors were less frequent when a miscellaneous test code was used than when a specific test code was used (3.9% vs 5.6%; P = .003). CONCLUSIONS: Computer order entry errors for send-out tests occur approximately twice as frequently as order entry errors for other types of tests. Filing more specific test codes in a referring institution's information system is unlikely to reduce order entry errors and may make error rates worse.

Evaluation of lancets for pain perception and capillary blood volume for glucose monitoring.

OBJECTIVE: The purpose of this study was to assess patient pain perception and capillary blood volume of four currently marketed lancets [BD Microtainer Contact-Activated Lancet, Low Flow (Contact-Activated Lancet); LifeScan OneTouch SureSoft Gentle (OneTouch SureSoft Gentle); BD Genie Blue; SurgiLance Safety] in a diabetic population following routine finger-puncture procedures and glucose monitoring. METHODS: Data were collected from adult subjects diagnosed with type I or type II diabetes mellitus at a 300-bed US hospital following finger-puncture procedures for glucose monitoring. Based on quantitative and qualitative measurements, each blood collection device was evaluated for pain perception and calculated total capillary blood volume. RESULTS: A total of 80 subjects received four skin punctures in an alternating finger and hand sequence using each lancet. The ten clinicians (nurses and phlebotomists) conducted the study, collected and then calculated total capillary blood volume. It was determined that the Contact-Activated Lancet produced less perceived pain and bleeding, while obtaining an adequate capillary blood volume for glucose monitoring. CONCLUSION: This study demonstrated that the Contact-Activated Lancet provided an adequate sample volume required for blood glucose monitoring. In addition, less perceived pain was elicited with this lancet when compared with the other lancets evaluated in the study.

Critical values comparison: a College of American Pathologists Q-Probes survey of 163 clinical laboratories.

CONTEXT: Critical laboratory values are values that may be indicative of life-threatening conditions requiring rapid clinical intervention. Designation of critical values by clinical laboratories is required by the Clinical Laboratory Improvement Amendments and regulatory agencies. The development of critical values often involves consultation with clinical services. Also, questions are frequently asked about how critical values compare between institutions. OBJECTIVE: To examine and compare critical value ranges for selected common critical value analytes. Additional specific questions addressed the source of these values, the inclusion of specific items on a critical values list, and the procedures for establishing such lists. DESIGN: A total of 163 clinical laboratories provided critical values for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time. Collected data were subjected to analysis for statistical variation. A questionnaire regarding demographic characteristics, institutional practices, and critical values management was also completed by participants. RESULTS: There was slight variation in pediatric and adult critical values used by the central 80% of study laboratories. Three areas of interest were noted: (1) 27% of laboratories allowed nonpractitioners to accept inpatient critical value reports, (2) there was nonconsensus regarding the handling of outpatient critical values during weekday versus evening/weekend hours, and (3) only 56% of respondents had a written critical values policy or procedure. CONCLUSIONS: Pediatric and adult critical values for the selected analytes were consistent in a comparison between the 163 clinical laboratories. Several weaknesses in current critical values management were identified. A consensus critical values list that may be of value to other institutions was assembled.

The role of in vitro diagnostic companies in reducing laboratory error.

Laboratory errors have a significant impact on patient safety. The manufacturers of in vitro diagnostic (IVD) products play an important role in the reduction of laboratory errors by ensuring the highest possible safety and efficacy of their products. In order to achieve this, the IVD industry has implemented rigorous product development and manufacturing processes. Many IVD companies apply Six Sigma principles in order to minimize variability within the whole product life cycle, starting with customer requirements, through product design and manufacture, as well as management of the potential issues that occur after the products have been released for use. A closer look into this process is presented here, using an evacuated blood collection tube as a model device.

The origin of reference intervals.

CONTEXT: Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting reference intervals. OBJECTIVES: To determine (1) methods used by clinical laboratories to establish reference intervals for 7 common analytes, (2) variation in intervals, and (3) factors that contribute to establishment of "outlier" intervals. DESIGN: One hundred sixty-three clinical laboratories provided information about their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time. RESULTS: Approximately half the laboratories reported conducting an internal study of healthy individuals to validate reference intervals for adults. Most laboratories relied on external sources to establish reference intervals for pediatric patients. There was slight variation in intervals used by the central 80% of study laboratories, but some laboratories outside the central 80% had surprisingly low and high limits for their reference intervals. In some cases the intervals used by 2 laboratories had no overlap. For example, one laboratory considered a hemoglobin of 13.8 g/dL in a woman to be "low" while another considered the same value to be "high." Three percent of reference intervals contained a limit that qualified as an "outlier" using standard statistical tests; we could not identify any practice associated with adoption of outlier intervals. CONCLUSIONS: Many laboratories adopt reference intervals from manufacturers without on-site testing of healthy individuals. Reference intervals used by facilities that forgo on-site testing are not statistically different from intervals validated with on-site studies.

Assessment monitoring of laboratory critical values: a College of American Pathologists Q-Tracks study of 180 institutions.

CONTEXT: Critical laboratory value reporting is a highly visible and essential key activity for clinical laboratories. OBJECTIVE: To measure critical laboratory value reporting in multiple institutions over time and to examine the practice patterns and demographic factors associated with sustained improvement in critical value reporting. DESIGN: A longitudinal cohort study of 180 clinical laboratories that provided quarterly critical values reporting data for 2 to 16 quarters was conducted using a uniform definition of successful caregiver notification. Mixed linear model analysis of the 2001 through 2004 dataset was performed. RESULTS: A decrease in total and inpatient rates of undocumented critical values per 1000 results was associated with (1) the American Association of Blood Banks inspection within the past 2 years (P = .01, for both total and inpatient rates); (2) unit secretary/clerical staff not authorized to accept inpatient critical value notification (P = .004 [total] and .001 [inpatient]); and (3) the mandatory practice of requiring notification of health care providers when handling inpatients known to have results repeatedly in the critical range (P = .01, for both total and inpatient rates). Continued participation in the Q-Tracks monitoring program was associated with significant and progressive improvement in total, inpatient, and outpatient critical value reporting (P = .02, .01, and .003, respectively). CONCLUSIONS: Critical value reporting improved as the duration of participation in the Q-Tracks monitoring program increased. Improved total and inpatient critical value reporting was associated with factors that may be markers for institutions with priorities of quality management and enhanced communication with responsible caregivers.

Genetically characterized positive control cell lines derived from residual clinical blood samples.

BACKGROUND: Positive control materials for clinical diagnostic molecular genetic testing are in critically short supply. High-quality DNA that closely resembles DNA isolated from patient specimens can be obtained from Epstein-Barr virus (EBV)-transformed peripheral blood lymphocyte cell lines. Here we report the development of a process to (a) recover residual blood samples with clinically important mutations detected during routine medical care, (b) select samples likely to provide viable lymphocytes for EBV transformation, (c) establish stable cell lines and confirm the reported mutation(s), and (d) validate the cell lines for use as positive controls in clinical molecular genetic testing applications. METHODS: A network of 32 genetic testing laboratories was established to obtain anonymous, residual clinical samples for transformation and to validate resulting cell lines for use as positive controls. Three panel meetings with experts in molecular genetic testing were held to evaluate results and formulate a process that could function in the context of current common practices in molecular diagnostic testing. RESULTS: Thirteen laboratories submitted a total of 113 residual clinical blood samples with mutations for 14 genetic disorders. Forty-one EBV-transformed cell lines were established. Thirty-five individual point and deletion mutations were shown to be stable after 20 population doublings in culture. Thirty-three cell lines were characterized for specific mutations and validated for use as positive controls in clinical diagnostic applications. CONCLUSIONS: A process for producing and validating positive control cell lines from residual clinical blood samples has been developed. Sustainable implementation of the process could help alleviate the current shortage of positive control materials.

A simplified nutrition screen for hospitalized patients using readily available laboratory and patient information.

OBJECTIVE: We assessed admission screening information that best identifies patients who are at risk for malnutrition-related complications (MRCs). METHODS: We evaluated 13 patient characteristics associated with MRC for adults screened over a 3-mo period (n = 448) to determine which factors correlated best with the risk level assigned. The existing screen stratified patients into four levels defined as no risk, mild risk, moderate, and high risk for MRC. The analyzed variables were weight for height, wound, surgery/cancer therapy, fever, vomiting/diarrhea, poor oral intake, no oral intake, unplanned weight loss, malnutrition-related admission diagnosis, serum albumin, white blood cell count, hemoglobin, and total lymphocyte count. We modeled the relation between assigned MRC and the predictors by using state-of-the-art methods. RESULTS: The characteristics that correlated best with MRC risk level assignment were occurrence of a wound, poor oral intake, malnutrition-related admission diagnosis, serum albumin value, hemoglobin value, and total lymphocyte count. A model using four variables (malnutrition-related admission diagnosis, serum albumin value, hemoglobin value, and total lymphocyte count) was almost as good as that using six predictors. CONCLUSIONS: The ability of admission information to accurately reflect MRC risk is crucial to early initiation of restorative medical nutritional therapy. There is currently no uniform or proved standard for identifying MRC risk within 24 h of acute care admission. The ideal nutritional screen correlates well with the occurrence of MRC and also uses data routinely obtained at admission. The models described can be uniformly used by hospitals to screen patients for MRC risk.