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Journal of Clinical Microbiology, May 2001, p. 1969-1971, Vol. 39, No. 5
Tuberculosis Control
Branch1 and Division of Mycology and
Mycobacteriology,2 California Department of
Health and Human Services, and University of California at
Berkeley School of Public Health,3 Berkeley,
California 94704-1011
Received 27 November 2000/Returned for modification 22 January
2001/Accepted 26 February 2001
This study assessed the extent to which laboratory methods
recommended by the Centers for Disease Control and Prevention were used
in tuberculosis testing of patients in California in 1998. While
recommended methods were used for most patients, there was room for
improvement by hospital and independent non-health maintenance organization laboratories.
The resurgence of drug-susceptible
and multidrug-resistant tuberculosis (MDR-TB) in the United States
between 1985 and 1992 led to new recommendations that urged
laboratories to use more rapid and accurate testing methods for
diagnosing TB (2, 4). Studies assessing the use of
recommended testing methods for TB have consistently shown increases in
the proportion of laboratories adopting rapid methods (1, 3, 5,
6). However, the extent to which laboratory-level improvements
correlate with improvements at the patient level is unknown. TB testing
services are gradually being consolidated in a smaller number of
laboratories; consequently, a few laboratories using less rapid testing
procedures now have the potential to disproportionately affect the
quality of testing for a large proportion of TB patients.
In 1998, TB cases in California represented approximately 20% of all
the TB cases in the United States (Centers for Disease Control and
Prevention [CDC], www.cdc.gov/nchstp/tb/surv/surv.htm). That
year, we conducted a study to assess the use of recommended testing
methods for California patients with culture-confirmed TB and to
evaluate the testing procedures of the mycobacteriology laboratories
that performed the tests for those patients.
Study population.
The study population comprised 300 culture-confirmed cases of TB reported to the TB control programs in
Los Angeles, Riverside, San Francisco, and Santa Clara counties between
1 January and 31 December 1998. In 1998, 48% of California's TB cases
were reported in these counties. We selected the first 75 culture-confirmed cases reported in each county during the study
period. Because only 68 cases were reported in Riverside County during
1998, 7 additional cases were selected from Los Angeles County. These two counties are adjacent to each other and have similar populations.
TB testing laboratories.
Fifty-five separate laboratories were
identified through patient records as having performed primary TB
testing for one or more of the study patients. If a patient had many
specimens tested for TB, the specimen with the earliest test result was
selected for this evaluation. The laboratories that served the patient sample included 7 (13%) public health laboratories, 2 (4%) health maintenance organization (HMO) laboratories, 11 (20%) independent non-HMO laboratories, and 35 (64%) hospital laboratories.
Laboratory-specific calculations are based on 54 laboratories
because one hospital laboratory declined to participate in
the study. In addition to patient-specific data, each laboratory was
asked to complete a questionnaire concerning laboratory practices,
including the range of testing services performed and monthly volume of
specimens processed in that laboratory.
Completeness of data.
Information on the testing method used
was available for 268 (89%) of the 300 patients for smear microscopy,
265 (88%) of the 300 patients for mycobacterial culture, 272 (91%) of the 300 patients for identification of M. tuberculosis, and 266 (89%) of the 300 patients for drug
susceptibility testing. Unless otherwise noted, patient-specific
analyses are based on these denominators. Analyses were performed using
SAS 6.12 (SAS Institute, Cary, N.C.). If information on a specific
variable was missing for a laboratory or a patient, the laboratory or
patient was excluded from analyses relating to that variable; for this
reason, denominators for different analyses may vary.
Comparison of laboratories performing TB testing and patient
specimens tested by those laboratories.
In some cases, a small
proportion of the laboratories was responsible for testing a relatively
large proportion of patient specimens for TB (Table
1). Public health and HMO laboratories accounted for <15% of the laboratories performing smear microscopy and mycobacterial culture, but they tested more than one-third of the
patient specimens in our study population. Although most (60 to 90%)
laboratories performing TB testing were either hospital or independent
non-HMO laboratories, they performed a relatively smaller proportion of
testing. Even so, these laboratories performed more than half of all TB
testing.
0095-1137/01/$04.00+0 DOI: 10.1128/JCM.39.5.1969-1971.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.
Use of Recommended Laboratory Testing Methods among
Patients with Tuberculosis in California

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ABSTRACT
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TEXT
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TABLE 1.
Proportion of laboratories performing TB testing,
compared with the proportion of TB patients tested by these
laboratories, by laboratory type
Use of recommended testing methods.
Most of the study patients
were tested using CDC recommended methods (Table
2). In general, the proportion of
laboratories that performed TB testing using recommended methods
correlated closely with the proportion of patients tested using those
methods (Table 3). However,
differences in these proportions were noted for smear microscopy,
mycobacterial culture, and drug susceptibility testing. With regard to
smear microscopy and culture testing, hospital laboratories largely
accounted for these discrepancies. For drug susceptibility testing in
independent non-HMO laboratories, the proportion of patients tested
using BACTEC was lower than the proportion of laboratories that used
this method. These differences suggest that laboratory-level surveys
may yield inaccurate estimates of the proportion of patients tested
using recommended methods.
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Areas for improvement. Our results suggest that efforts to further expand the use of recommended methods for smear microscopy and mycobacterial culture should focus on hospital laboratories. Whereas other laboratories adhered to the use of recommended methods for these tests, a large proportion of hospital laboratories did not use a fluorochrome method for the initial smear and/or liquid medium for mycobacterial culture.
Efforts to further expand the use of recommended methods for drug susceptibility testing could focus on independent non-HMO laboratories. In our study, a lower proportion of patients in independent non-HMO laboratories was tested using BACTEC compared with patients tested in other laboratories. In California, the task of improving or monitoring the adherence to recommended drug susceptibility testing methods is facilitated by the relatively small number of laboratories involved with this type of testing.Study limitations. First, although the sample included 300 patients, testing for these patients was performed in a small number of public health, HMO, and independent non-HMO laboratories. Therefore, our results may not provide an accurate portrayal of laboratory testing procedures. For example, assessment of the role of specimen volume in the use of recommended testing methods for smear microscopy and culture in hospital labs was limited by the small number of hospital laboratories used in the analysis. However, our results do agree with the results from previous studies showing that hospital laboratories processing fewer specimens were less likely to use recommended testing methods for smear microscopy and culture (6).
Second, data obtained from laboratories that tested a small number of patients may not accurately describe the testing practices in these laboratories. Some laboratories did not always use the same testing method for all specimens tested in those laboratories. Therefore, it may not be appropriate to assume a laboratory did or did not comply with recommended testing practices based on data from a few patients.Summary. Our findings suggest that most patients undergoing evaluation for TB in California are tested using CDC-recommended laboratory methods. These analyses also indicate that results based on surveys at the laboratory level may not accurately reflect results at the patient level. Future efforts to expand the use of recommended methods for smear microscopy and mycobacterial culture should focus on low-volume hospital laboratories, and for drug susceptibility testing the focus should be on independent non-HMO laboratories.
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ACKNOWLEDGMENTS |
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This work was supported by a cooperative agreement, M2854, from the Association of Public Health Laboratories.
We thank the members of the Advisory Committee convened by the Association of Public Health Laboratories during the design of this study and for their assistance with piloting the study questionnaire. We also thank Peter Oh for assistance with data collection and management, Sarah Royce for critical reading of the manuscript, the four county TB control programs that participated in the study, and all of the laboratory personnel who facilitated our access to patient laboratory records and who completed and returned the questionnaires.
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FOOTNOTES |
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* Corresponding author. Mailing address: California Department of Health Services, Tuberculosis Control Branch, 2151 Berkeley Way, Rm. 608, Berkeley, CA 94704-1011. Phone: (510) 540-3585. Fax: (510) 849-5269. E-mail: Lpascope{at}dhs.ca.gov.
Present address: 155 Primrose La., Fredericksburg, TX 78624.
Present address: World Health Organization, 100600 Beijing, China.
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