Viral load test reports: a description of content from a sample of US laboratories.

CONTEXT: Human immunodeficiency virus (HIV) RNA testing (viral load testing) is increasingly important in the care of patients infected with HIV-1 to determine when to initiate, monitor, and change antiretroviral therapy. Patient viral load testing information is communicated to the clinician through the laboratory test report. OBJECTIVES: To examine the format and information used in reporting viral load testing results and determine the clarity of the information provided in these reports. DESIGN: Patient test reports with all personal identifiers removed were requested of viral load testing laboratories participating in a telephone survey of laboratory practices. Hospital, independent, health department, and "other type" laboratories identified as university-associated laboratories participated in the telephone survey. RESULTS: Thirty-seven unique test reports were collected. All laboratories reported results in copies/mL, while 14% also reported results as "log(10) copies/mL." The test kit was identified by only 24% of the laboratories. Reportable ranges were specified by 70% of the laboratories, but there was considerable variation in terminology. One laboratory reported a viral load copy number below the manufacturer's test kit lower limit of sensitivity. The layout and format differed among reports. Some results were expressed in log(10), others contained nonsignificant integers, while others contained exponential numbers. Supplemental information in some reports included previous patient test results and significance of changes from baseline. The format of some reports made it difficult to read the report information and interpret the testing results. CONCLUSION: This study emphasizes the importance of standardizing the reporting of HIV-1 viral load test results to minimize result misinterpretation and incorrect treatment.

Correlates of vaccination for hepatitis B among adolescents: results from a parent survey.

OBJECTIVE: To identify correlates of hepatitis B vaccination status in sixth-grade students in the year prior to implementation of a requirement mandating immunization for seventh-grade entry. METHODS: A survey of parents of sixth-graders in 5 schools in San Diego County. Two logistic regression models were tested to predict the outcome variables: initiation and completion of the vaccination series. RESULTS: Factors associated with initiating the series included a recent nonacute medical visit, white race, hearing about the vaccination law from a health care provider, and the availability of a school-based vaccination clinic. Factors associated with completing the series included English as the primary language spoken at home, hearing about the law from a health care provider, a school-based vaccination clinic, and higher socioeconomic status. Health insurance was not significantly related to either outcome. CONCLUSIONS: There was a clear benefit for hepatitis B immunization status to have had a recent nonacute medical visit, to have heard about the law from a health care provider, and to have a school-based vaccination clinic. The factors associated with starting vs completing the vaccination series were not identical. However, both health care provider and school characteristics were related to starting and completing the vaccination series. Thus, a multifaceted strategy may be most appropriate for successful coverage of an adolescent population with a vaccination series such as hepatitis B.

The influence of perceived professional status on the career progression of CLS graduates.

OBJECTIVE: To determine if the perception of clinical laboratory science (CLS), as a profession, influences career progression. DESIGN: A questionnaire was designed to collect information on job history including salary and positions held, reasons for leaving the field, satisfaction with the field and the perception of the field as a profession or a technical occupation. SETTING: Research facilities at the Graduate School of Public Health, San Diego State University, San Diego, CA. PARTICIPANTS: Graduates from the CLS program of the University of Minnesota Division of Medical Technology, 1923-1996, were sent questionnaires; 1338 (70.2%) responded. MAIN OUTCOME MEASURES: The comparison of career progression for those who perceive CLS to be a profession to those who perceive it to be a technical field. RESULTS: Seventy-seven percent of the respondents perceived the field to be a profession. They were 1.7 times more likely to have progressed in their careers than those who perceived CLS to be a technical field. This was reflected in the percentage achieving higher positions both currently and over the respondents' entire job history. CONCLUSIONS: Those who perceive CLS to be a profession are more likely to progress in their career and remain in the field of CLS.

T-lymphocyte immunophenotyping blind proficiency testing: a model system for CD4+ T-cells.

OBJECTIVE: To develop and evaluate methods and results for blind proficiency testing for CD4+ T-cells by T-lymphocyte immunophenotyping. DESIGN: A model system was developed to submit duplicate specimens for T-lymphocyte immunophenotyping as if they were routine patient specimens rather than proficiency specimens. Testing results were compared both interlaboratory and intralaboratory. The model system was designed to gather information on not just the analysis, but other segments of the total testing process. SETTING: Research facilities at the Graduate School of Public Health, San Diego State University, San Diego CA. PARTICIPANTS: 1) A healthy adult volunteer donating one pint of blood. 2) Laboratories offering T-lymphocyte immunophenotyping. MAIN OUTCOME MEASURES: 1) Feasibility of blind proficiency so that PT specimens are received, analyzed, and reported by laboratories without being identified as 'proficiency specimens.' 2) The ease and cost of such a system. 3) The comparability of results and report content among laboratories. RESULTS: A total of twenty-two laboratories received blind proficiency specimens. The model developed to submit specimens and receive results proved feasible. The interlaboratory coefficient of variation for CD4+ count for the four survey years ranged from 10% to 66% and for the CD4+ percent ranged from 4% to 15%. The per specimen cost in this blind proficiency testing was $437.65, approximately seven and a half times the cost for nonblinded proficiency testing or performance evaluations. CONCLUSIONS: Blind proficiency as a tool to compare laboratory test results for T-lymphocyte immunophenotyping is feasible but adds costs. The model system is useful to examine more of the laboratory total testing process than the analysis segment.

Competency assessment--an exploratory study.

CLIA '88 regulations require that laboratories evaluate and assure the competency of all personnel who perform laboratory tests. The study objective was to determine the interpretation of, compliance with, and implementation of these regulations by laboratories. Interviews were conducted with a stratified nonrandom sample of 20 laboratories including hospital, blood bank, commercial reference, physician office, group practice, and independent laboratories from 12 selected states. Information was collected about the history and development of their competency assessment programs and activities, their definition of competent staff, the interrelationship of competency assessment with performance appraisals, cost, benefits, and the assessment methods and tools used. Competence of laboratory personnel is a complex issue reflecting the dynamics and environment of each unique laboratory setting. This research found no consistent method of competency assessment implementation. This report provides a summary of methods and approaches. Learning what other laboratories are doing will assist managers in developing meaningful and cost-effective competency assessment programs. Documenting all competency assessment activities is important; it serves as a personnel performance management tool and satisfies inspectors. Used in the spirit of continuous quality improvement, the competency assessment program may point to ways of improving processes, personnel, and performance.

A critical review of personnel standards.

Qualified personnel are necessary to ensure quality results, but there is no evidence on what minimal educational requirements are necessary. In the future, cost-effectiveness analysis may be useful for policy questions such as the utility of personnel regulations. CLIA '88 regulations require explicit assessment of personnel competency. Survey evidence suggests that previously regulated laboratories tend to have highly formalized competency assessment programs, while physician office laboratory programs are minimal. Responding laboratory supervisors had no uniform definition of competency, but technical abilities, productivity, and professionalism were regarded as essential. Suggestions for contemporary strategies by laboratory professionals and their organizations in the current increasingly competitive managed care environment are described. Faced with limited empirical evidence on personnel, laboratory directors and supervisors should focus on the total testing process, the needs of clinicians, and the uses of testing information to guide personnel assignments.

Infectious disease physicians rate microbiology services and practices.

Recent years have seen increasing emphasis on cost containment and quality improvement in clinical laboratory activities. Modifying those activities to enhance clinical relevance is one strategy that should be satisfying to both laboratory scientists and administrators. This guest commentary describes one approach to quality improvement--the use of user surveys to identify areas for improvement. As an initial attempt to define such areas in clinical diagnostic microbiology, infectious disease specialists, targeted for their particular interest and expertise in microbiology laboratory results, were polled and their responses were analyzed. Some of these data have been presented previously (E. J. Baron, D. P. Francis, and K. M. Peddecord, abstr. C-170, p. 520, in Abstracts of the 94th General Meeting of the American Society for Microbiology, 1994; K. M. Peddecord, E. J. Baron, D. P. Francis, and A. S. Benenson, abstr. C-172, p. 520, in Abstracts of the 94th General Meeting of the American Society for Microbiology, 1994; K. M. Peddecord, E. J. Baron, D. P. Francis, and J. A. Drew, Am. J. Clin. Pathol. 105:58-64, 1996). The discussion includes our recommendations for the use of these survey responses, and their limitations, as stimuli to initiate reexamination of certain microbiology laboratory practices in the interest of developing more cost-effective and clinically relevant protocols.

Physician satisfaction with human immunodeficiency virus type 1 and hepatitis B virus testing in San Diego County.

Physician satisfaction with the laboratory testing process is one indicator of the physician's perception of the quality of laboratory testing and the effectiveness of the communication of the laboratory results. This study compares the level of satisfaction of physicians reporting their experience with human immunodeficiency virus type 1 (HIV-1) testing with the satisfaction levels of those physicians reporting their experience with hepatitis B virus (HBV) testing. By mail, 6,570 licensed San Diego County physicians were surveyed. Among those who tested for HIV-1 or HBV, their satisfaction with four different HIV-1 or HBV testing parameters was assessed: 1) specimen submission process, 2) test accuracy, 3) clarity of test report, and 4) turnaround time. Overall, physician satisfaction with both HIV-1 and HBV testing was high, particularly for test accuracy (means of 2.79 and 2.84, respectively on a 3-point scale), although slightly lower for turnaround time (means of 2.40 and 2.43, respectively). Mean satisfaction with the specimen submission process and test accuracy were higher for physicians who ordered HBV tests than for those who ordered HIV-1 tests. Satisfaction with the four HIV-1 testing process parameters varied significantly by physician specialty, practice type, and type of laboratory used. For HBV testing, significant differences were observed only for turnaround time. For both HIV-1 and HBV testing, those who received a final interpretation of laboratory results were more satisfied with test report clarity than those who did not. Although physician satisfaction with HIV-1 and HBV testing is high, this study identifies the least satisfied groups and specific areas in the testing process than may need improvement.

Quality perceptions of microbiology services. A survey of infectious diseases specialists.

Opinions about the quality of their primary microbiology laboratory were received from more than 500 practicing infectious diseases specialists by a nationally distributed questionnaire. Approximately 92% of the respondents' primary laboratories were hospital-based. These sophisticated users rated the quality of their microbiology laboratories to be generally high, with bacteriology receiving highest scores and parasitology the lowest scores. Fortunately, the serious problems, such as failing to call a critical result and culture mishandled in the laboratory, were experienced rarely. Laboratories directed by pathologists with specialty microbiology training, PHD microbiologists, and infectious diseases specialists were judged to be of highest quality. American Board of Medical Microbiology certification of the laboratory director was related to higher overall quality perceptions. Whereas physician-customer opinions may not directly measure a laboratory's analytic quality, they are an important performance measure on which laboratories can base quality improvement activities in both service and analytical aspects of performance.

Variability of reporting and lack of adherence to consensus guidelines in human T-lymphocyte immunophenotyping reports: results of a case series.

Percentages and absolute counts of CD4+ lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagnostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneumonia prophylaxis and antiretroviral therapy. In December 1990, we requested that a nonrandom sample of 17 laboratories provide us with typical reports of their TLI results from an immunodeficient patient and from a patient whose TLI results were within the laboratory's normal reference ranges. We also searched published literature and documents proposed by professional organizations for recommendations regarding T-lymphocyte testing and reporting. This article compares guidelines for reporting TLI results, as proposed by the National Committee for Clinical Laboratory Standards in Document H42-P, with samples of reports obtained in our case series. Most reports follow some, but not all, of the proposed guidelines. A majority of the laboratories provided interpretations of the results in their reports. We found considerable variation in normal reference ranges. We describe this variation in detail for the CD4+ T-lymphocyte counts and CD4+ T-lymphocyte percentages. This article describes some of the TLI result report forms currently being used and identifies important quality issues in this rapidly expanding area of clinical laboratory testing.

Use of a modified nominal group process for improving laboratory performance in human immunodeficiency virus type 1 antibody testing. Reaching consensus on three questions concerning HIV-1 testing.

Using expert panels of medical technologists and public health microbiologists, a modified nominal group process was used to reach a consensus on three questions concerning current human immunodeficiency virus type 1 (HIV-1) testing methods. The questions related to important sources of error, improving the testing process, and improving proficiency testing. The modified nominal group process proved to be effective in developing lists of errors in laboratory testing; it provided a fast, economic means of identifying possible areas for improving laboratory quality assurance and training programs. For the HIV testing model, the focus group panelists indicated laboratory pipetting errors, labeling, and specimen identification as the most important sources of error. To improve the quality of this testing, the panel recommended standardizing test interpretation and restricting testing to laboratories licensed to perform HIV-1 testing. To improve proficiency testing, the use of blind specimens and establishing minimum standards of performance were suggested.

Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing.

In a pilot study involving proficiency testing for human immunodeficiency virus, markedly diverse and potentially confusing test report forms were encountered among participating laboratories. Therefore, a comprehensive study of human immunodeficiency virus type 1 report forms was conducted from state-licensed testing laboratories in California. Participants analyzed three serum samples of known human immunodeficiency virus type 1 antibody reactivity and reported their results on forms that they would normally submit to clinicians. Report forms from 84 laboratories were evaluated for content, design, and clarity. Differences were found among commercial, hospital, and public health laboratories. The significance of these findings is discussed. This technique also may be applied to evaluate laboratory report form design and content for other diagnostic test results.

Analytic results of HIV-1 testing using blind proficiency testing.

The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California. A total of 26 laboratories were located throughout California, with six laboratories located in six other states. Results from 306 enzyme immunoassay screening tests and 192 supplemental tests for HIV-1 were reported. Although one positive specimen was reported as indeterminate in almost 30% of results, screening and supplemental testing performances were excellent, with accuracy levels comparable to performance reported on open PT and performance evaluation surveys in the United States. The indeterminate results were attributed to the interpretive criteria used rather than to laboratory errors. Blind PT can be an important tool in improving the quality of total laboratory testing, the usefulness of laboratory results in patient care, and ultimately the health of the public.

Methods for a model blind proficiency testing system.

The method developed for establishing a blind proficiency testing (PT) system is presented. The Laboratory Assurance Program of the Graduate School of Public Health at San Diego State University is developing and pilot testing innovative strategies that will evaluate and improve the performance of clinical laboratories. To date, a total of 32 laboratories have been incorporated into this program along with 12 counseling and testing sites. From June 1988 to December 1989, five blind PT surveys for human immunodeficiency virus type 1 antibody testing were conducted, representing 306 proficiency specimens entered into the testing system as simulated patient specimens. Despite the difficulties and expense involved, we found the system to be acceptable and to have certain advantages over conventional methods of external testing.

Identification of nonanalytic issues in HIV-1 antibody testing using blind proficiency testing.

Blind proficiency testing was used to examine nonanalytic performance indicators for human immunodeficiency virus type 1 (HIV-1) antibody testing. Physician offices, clinics, and hospitals located throughout Southern California submitted simulated patient specimens to laboratories as routine test requests. A total of 32 laboratories were involved during five blind proficiency testing surveys. Turnaround time for a reactive specimen ranged from three to 17 days. Laboratory charges for evaluating a reactive specimen varied depending on the volume of testing, prevalence of reactive specimens, and whether screening and confirmatory tests were billed separately or as a package price. Charges for an enzyme immunoassay screening test plus supplemental tests ranged from $11.75 to $114.50, with a median of $31.00 for 24 laboratories that participated in one of the five surveys. Evaluation of laboratory report content revealed that 37% of the 16 screening reports and 71% of the 14 supplemental reports contained information that was unrelated to the patient results. Evaluation of the testing system documents the need to monitor multiple outcomes of the total laboratory testing process, not just the analytic testing phase.

The laboratory diagnosis of HIV infection.

Testing for HIV is a procedure with possible dire consequences; hence, reports should not be rendered to the patient without appropriate counseling. And this must be based on firm information whether the individual is truly infected if the report is positive. The reactive results of the EIA screening test should always be confirmed by supplemental testing. However, it must be remembered that a nonreactive serum does not exclude the possibility of the individual being infected; only by additional research studies, such as the polymerase chain reaction, can one be sure that the patient is not in the phase in which antibodies have not yet developed but the virus is present and the patient can transmit the infection. Our studies have found that the accuracy of testing HIV serum specimens is excellent. The biggest problem may be the potential confusion caused by the laboratory reports. All clinicians (nurses, educators, and physicians) who counsel or test potential HIV patients must be sure that they understand their laboratory's report. If there is any doubt about the report content, it must be clarified by contacting the laboratory director. The results of HIV antibody testing are so important to the patient that the significance of the report must be crystal clear to the counselor and any possible ambiguity clarified.