Quality improvement practices in clinical and anatomic pathology services. A College of American Pathologists Q-probes study of the program characteristics and performance in 580 institutions.

Participants of the College of American Pathologists Q-Probes program described their quality improvement practices for clinical and anatomic pathology. In 580 institutions, the median time required for a median of 12 indicators of quality was 40 hours/month, with the number of indicators and the time spent directly dependent on bed size (P = .0001). The overwhelming majority of participants reported benefit from their quality improvement programs in terms of patient outcomes, as a management tool, and for risk management. Six indicators in clinical pathology and four indicators in anatomic pathology were used in more than 75% of laboratories, whereas an additional seven indicators in clinical pathology and five in anatomic pathology were used in more than 50% of laboratories. The authors conclude that quality improvement practices are similar among laboratories, and irrespective of increasing regulatory requirements, pathologists and senior laboratory personnel spend large amounts of time for activities that they believe improve the quality of services rendered.

Quality assurance of the analytic process: pre- and postanalytic variation.

This article attempts to define and identify sources of variation in laboratory analysis that occur predominantly "away" from the analytic bench. Problems in the derivation and application of reference ranges are reviewed and sources of non-analytic error are "located" within the entire testing cycle. Reference sources are presented.

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part II.

This is the second of two articles summarizing federal regulation of clinical laboratories and reviewing specific aspects of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). This article includes a review of sanctions and enforcement, how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving implementation of CLIA 1988.

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part I.

In this first part of a two-part article, we have summarized some of the pertinent features of CLIA 1988 with review of the complexity model, waived testing, personnel standards, proficiency testing and quality control requirements, and patient test management. In addition to a survey of other Federal regulations applicable to clinical laboratories, we have briefly reviewed events subsequent to the publication of the Final Rule in February of 1992, specifically the recommendations of CLIAC and the Technical Corrections published on January 19, 1993. The second part of this paper will discuss sanctions and enforcement; how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving interaction between CLIAC, FDA, CDC, DHHS, and the regulated laboratory community.

The epidemiology of fear. Scientific, social, and political responses to the occupational risk of blood-borne infection.

Pathologists will have an important role in implementing safety precautions to prevent transmission of blood-borne diseases in the laboratory and elsewhere in the healthcare setting. This article reviews proposed professional and regulatory solutions in the context of widespread public and professional fear concerning occupational transmission of human immunodeficiency virus and hepatitis B virus. The proposed rule of the Occupational Safety and Health Administration of the Department of Labor, Washington, DC, is described in detail.

Alternate site testing. The old and new paradigm or the past is prologue.

This paper reviews broad themes emerging in the discussion concerning alternate site testing, including the emergence and continuing value of centralized testing, the reasons for alternate site testing, and the relative merits and negative aspects of traditional centralized testing and decentralized models. The paper attempts to identify the expectations of constituencies affected by alternate site testing (patients, physicians, nurses, administrators and managers, and pathologists and other laboratory professionals) and identifies criteria and implementation strategies for decentralized testing.

Patient outcomes and pathology practice: An introduction to the College of American Pathologists Conference XXXIV on Molecular Pathology: Role in Improving Patient Outcome.

This article provides an abbreviated conceptual framework for viewing general issues of outcomes research and management and consideration of the emerging interest in patient-referenced outcomes in medicine and pathology. Specific issues addressed are the reasons for increased interest in outcomes research within the past decade; a review of the current language of outcomes management and research; a critique of the advantages and weaknesses of contemporary outcomes analysis and research methods; a summary of the responses of government, regulatory and accreditation organizations, medical societies, and the College of American Pathologists to the outcomes movement; and, in conclusion, a discussion of opportunities provided through outcomes management for enhanced involvement by pathologists in the care of patients.

Bedside glucose monitoring. A College of American Pathologists Q-Probes study of the program characteristics and performance in 605 institutions.

In 1991, the College of American Pathologists' Q-Probes quality improvement program studied precision, accuracy, and program characteristics of bedside glucose monitoring (BGM) in 605 institutions. Precision measurements made in 569 institutions were based on 15,950 quality control results. Precision, expressed as a percentage coefficient of variation, was less than 10 in almost 90% of the institutions. For accuracy, 4517 BGM results from 181 institutions were compared with clinical laboratory glucose results. Approximately 58% of BGM results were within +/- 10% and 75% of BGM results were within +/- 15% of the corresponding clinical laboratory results. Program characteristics associated with better performance were (1) laboratorian program responsibility, laboratorian BGM test performance, and laboratorian involvement in training; (2) a policy requiring repeated scheduled operator training and/or performance review; (3) use of an internal comparison program; and (4) participation in an external proficiency testing program. We conclude that BGM frequently does not meet quality goals and provide recommendations on how BGM programs can be improved.

Quantification of errors in laboratory reports. A quality improvement study of the College of American Pathologists' Q-Probes program.

Over a 3-month period, 61,496 errors were detected in clinical laboratory reports by 631 participants in the College of American Pathologists' 1990 Q-Probes program. Each error detected was defined as an opportunity for improvement. Almost 4% of the detected errors were attributed to nonlaboratory personnel and approximately 4% (A errors) had a major impact on patient care. Rates of B (serious errors, but unlikely to affect patient care) and C errors (minor clerical errors) were approximately equal. When expressed in terms of measures of laboratory work loads, four of six measures of mean errors were lowest in blood banking, intermediate in chemistry and microbiology, and highest in hematology. Thirteen percent of participants did not have an error detection system in place. We conclude that many errors go undetected, and we recommend that an effective system for error detection in patient reports should be employed in all laboratories.

Preoperative autologous blood donation in 612 hospitals. A College of American Pathologists' Q-Probes study of quality issues in transfusion practice.

We compared predeposit autologous blood utilization practices in 612 hospitals (where 107,559 autologous and 2,504,522 homologous units were transfused in all of 1989). Participating blood bankers prospectively followed up donors who presented for initial donation during an 11-week period in early 1990. They recorded the number of autologous donors whose blood was drawn (n = 22,276); units that were donated (n = 40,163), transfused (n = 23,988), crossed over (n = 937), and discarded (n = 15,443); and donors transfused with autologous blood only (n = 11,923) or donors who received homologous blood (n = 2002). Most donors (89.7%) avoided homologous blood, including donors (39.5%) who did not require transfusion. Units that were donated for low-risk surgery represented 23.1% of all units that were collected, and the rate of donation for these procedures was directly proportional to the percentage of donors who did not require transfusion and to the discard rate. We concluded that a major focus of quality improvement in autologous transfusion practice should be the reduction of donations for surgical procedures for which blood replacement is rarely needed.

Interinstitutional comparison of performance in breast fine-needle aspiration cytology. A Q-probe quality indicator study.

In 1989, the College of American Pathologists, Northfield, Ill, instituted a voluntary quality assurance program, called "Q-Probes," that utilized nationwide interinstitutional peer comparison. One of the anatomic pathology modules retrospectively assessed performance in fine-needle aspiration cytology (FNAC) of the breast from cytohistologic correlations that were made in 294 institutions by 988 pathologists on their own cases that were accessioned during a 6-month period. Of the 13,066 cases of FNAC, 10,751 (82%) were satisfactory for evaluation. Of these satisfactory aspirates, 3471 cases (33%) had histologic correlation, which formed the basis for determining diagnostic accuracy. Of breast aspirates, 2254 (17%) were unsatisfactory for evaluation, with the mean frequency of unsatisfactory aspirates obtained by nonpathologists (18%), ie, more than twice that of unsatisfactory aspirates obtained by pathologists (7.2%). In the diagnosis of breast cancer by FNAC, the following performance results were derived with the use of the aggregate data: 82% sensitivity of the FNAC procedure, 97% sensitivity of diagnosis, 97% specificity, 95% positive predictive value, 86% negative predictive value, and 90% efficiency. No significant difference in performance was detected when institutions were stratified by six peer group characteristics. We made the following conclusions: (1) the aggregate and median breast FNAC performance values obtained from this interinstitutional comparison of data from routine procedures performed in diverse settings in North America compared very favorably with performance from single institutions published in studies of similar design in the literature, and (2) these data may provide a reference point for participant institutions to measure future quality improvement in fine-needle aspiration of breast.

Laboratory phlebotomy. College of American Pathologists Q-Probe study of patient satisfaction and complications in 23,783 patients.

Outpatients from 630 institutions participated in a phlebotomy module of Q-Probes, a quality assurance program of the College of American Pathologists, Northfield, Ill. This module assessed patient outcome measurements of complications, discomfort, and satisfaction with the phlebotomy procedure. Of the 29,700 ostensibly healthy individuals registered, 80.1% returned postcards containing measurements and assessments they made about the procedure and information recorded by the phlebotomist. The median time required for phlebotomy was 6 minutes, with 25% of patients requiring less than 5 minutes and 10% more than 21 minutes for completion of the procedure. The average number of phlebotomy attempts per patient was 1.03, with 95 patients (0.4%) experiencing three to 11 attempts. Ecchymoses occurred in 4048 (16.6%) attempts, with the median size of ecchymosis being 15.1 mm. On the average, an outstanding employee was identified by patients 46.6% of the time. The discomfort caused by the needle puncture was more than expected by 35.3% of patients. Although 98.6% of the patients were satisfied, 336 patients were dissatisfied with the procedure. We conclude that the technical skills of phlebotomists and patient satisfaction with phlebotomy are outstanding, but that patient discomfort from the procedure needs to be minimized.

Blood culture quality improvement: a College of American Pathologists Q-Probes study involving 909 institutions and 289 572 blood culture sets.

OBJECTIVE: To evaluate solitary blood culture (SBC) collections as a preanalytic quality indicator of blood culture practice. DESIGN AND SETTING: Two College of American Pathologists Q-Probes laboratory quality improvement studies involving prospective evaluation of the proportion of and reasons for SBC collections in 909 institutions. OUTCOME: Reduction in the proportion of SBCs. RESULTS: Of 289572 blood culture sets studied, the median proportion of SBCs per institution was 10.1% and 12.1% among adult inpatients, 25.4% and 33.3% among adult outpatients, and 89.0% and 100% among pediatric/infant patients in the first and second (follow-up) studies, respectively. The two most common reasons for not performing a second culture in adults were (1) test not indicated and (2) physician believed one was sufficient. When compared with inpatient cultures, a significantly higher proportion of outpatient SBCs were classified as not indicated (P < .0001). Among 198 institutions participating in both studies, a significant decline in SBC rates was observed in the subgroup (n = 50) that continued to monitor SBCs (P = .004). CONCLUSIONS: Interinstitutional evaluation of solitary blood cultures provides a benchmark for quality assessment and an opportunity for performance improvement in blood culture specimen collections.

Wristband identification error reporting in 712 hospitals. A College of American Pathologists' Q-Probes study of quality issues in transfusion practice.

The correct wristband identification of patients is essential to prevent acute, hemolytic transfusion reactions from incompatible transfusion. We compared wristband identification errors for 712 hospitals. Phlebotomists checked patient wristbands on 2,463,727 occasions, finding 67,289 errors; in 33,308 instances, patient wristbands were missing entirely. The median total error rate was 2.2%; 10% of participants had error rates of 10.9% or greater. Absent wristbands represented 49.5% of errors; multiple wristbands with different information, 8.3%; wristbands with incomplete data, 7.5%; erroneous data, 8.6%; illegible data, 5.7%; and patients wearing wristbands with another patient's identifying information, 0.5%. The monitoring for errors by phlebotomy staff was the most important policy associated with lower error rates. Initial placement of wristbands by nursing staff was the only policy associated with increased error rates. We conclude that wristband identification error rates depend on differences in hospital policy and procedure and should be responsive to quality improvement efforts.

Transfusion medicine monitoring practices. A study of the College of American Pathologists/Centers for Disease Control and Prevention Outcomes Working Group.

OBJECTIVE: To survey transfusion medicine practices in 1990, to determine the distribution of defects in the transfusion process, to examine the relationship between defects and complications, and to recommend improvements in the transfusion process. DESIGN: A mail survey that divided the transfusion process into 24 risk-prone steps and gathered defect rates on each step, along with incidence data for eight known complications of transfusions and other demographic information. SETTINGS: Hospitals, independent laboratories, and blood centers that provide transfusion medicine services. OTHER PARTICIPANTS: Respondents were 1365 participants in the College of American Pathologists 1991 Blood Bank Quality Assurance Survey. RESULTS: While processing 6.2 million units of blood and blood products, respondents reported detecting over 88,000 defects: 41% in the preanalytic phase of testing, 55% in the postanalytic phase, and only 4% in the analytic phase, the phase to which most monitoring efforts were devoted. A median of eight steps were actively monitored by survey participants overall, whereas 96 facilities sought defects in all 24 steps. CONCLUSIONS: Analysis of the data showed several monitoring steps provide similar information. Although monitoring of the transfusion process could not be linked with prevention of the complications studied, active surveillance does focus attention on defect-prone steps and allows testing of strategies to improve the transfusion process. We describe how defect detection systems may be improved.

Indications and immediate patient outcomes of pathology intraoperative consultations. College of American Pathologists/Centers for Disease Control and Prevention Outcomes Working Group Study.

OBJECTIVE: To evaluate the reasons (indications) for and immediate intraoperative surgical results (outcomes) associated with pathology intraoperative consultation. DESIGN: In 1992 and 1993, surgeons collaborated with pathologists in 472 voluntarily participating institutions from the United States (462), Canada (7), Australia (2), and New Zealand (1) in a study jointly sponsored by the College of American Pathologists and the Centers for Disease Control and Prevention. Pathologists selected 20 consecutive intraoperative consultations and assembled a cover letter, a checklist questionnaire, and a copy of the corresponding surgical pathology report, all of which were sent to the surgeon(s) for retrospective evaluation. PARTICIPANTS: The study was distributed to participants in the College of American Pathologists voluntary Q-Probes quality improvement and Surgical Pathology Performance Improvement programs and to Canadian and Australian hospitals with more than 200 beds. RESULTS: Evaluation of 9164 cases established the five most common indications for intraoperative consultation: (1) establish or confirm diagnosis to determine type or extent of operation (51%), (2) confirm adequacy of margins (16%), (3) confirm nature of tissue to direct sampling for immediate culture or other laboratory study (10%), (4) expedite obtaining diagnosis to inform family or patient (8%), and (5) confirm sufficient tissue submitted to secure diagnosis in permanent section (8%). The information provided by the intraoperative consultation resulted in changed surgical procedures that were either modified, terminated, or newly initiated in 47%, 30%, 6%, 9%, and 28% of cases, corresponding respectively to each of the above five common indications. Rarely cited reasons for intraoperative consultation were to expedite obtaining diagnosis for surgeon's knowledge (3%), to facilitate patient management, other professional communication or discharge planning prior to permanent section availability (3%), academic protocol (< 1%), and consultation not needed or no reason for request (< 1%). CONCLUSIONS: This multi-institutional, interdisciplinary database confirms that pathology intraoperative consultations, regardless of the initial indications, influence immediate patient care decisions, resulting in changed surgical procedures in an average of 39% of all operative cases.

Quality control in the new environment. Part III: Automated hematology.

Modern hematology instruments and commercial control material have simplified precision control. Further QC savings are possible through such means as retained patient specimens and weighted moving averages.