A secondary analysis of laboratory testing results from the KwaZulu-Natal reference laboratory (2001 to 2004) and from the National Health Laboratory Services reference laboratory (2006). Thank you for sharing the data from the proficiency test, without which this study would not have been possible.
INTRODUCTION 122 6.2 RECOMMENDATIONS 122
CONCLUSIONS 128 6.4 RECOMMENDATION FOR FURTHER STUDY 130
INTERVIEW GUIDE 136 ANNEXURE 03: ETHICS APPROVAL FORM 138
CONSENT DOCUMENT 140 ANNEXURE 05: INFORMATION DOCUMENT FOR STUDY PARTICIPANTS. 141
PROCESSING OF SPECIMENS FOR MICROSCOPY 145
MAKING OF SMEARS FOR MICROSCOPY 146 ANNEXURE 08: STAINING OF SLIDES - ZIEHL-NEELSEN STAIN 147
Sensitivity, specificity, positive predictive value, negative. predictive value 62 Table 9: Summary of results of proficiency testing conducted in KwaZulu Natal. Laboratories in KwaZulu-Natal pool data from 2001 to 2004 and 2006 83 Figure 4: Comparison of proficiency testing results obtained with the KZN reference.
1 CHAPTER I: INTRODUCTION AND BACKGROUND TO THE STUDY
- INTRODUCTION
- BACKGROUND .1 What is the Problem?
- What is known so far?
- What needs to be known?
- Why is proficiency testing important?
- How will the study assess the problem?
- STA TEMENT OF THE PROBLEM .1 Research Hypothesis
- Research Questions
- PURPOSE OF THE RESEARCH
- ASSUMPTION UNDERLYING THE STUDY
- OPERA TIONAL DEFINITIONS USED IN THE STUDY
- SCOPE OF THE STUDY
- SUMMAR Y OUTLINE PER CHAPTER
A quantitative analysis of these existing proficiency testing data will provide a retrospective situational analysis of tuberculosis smear microscopy services in KwaZulu-Natal from 2001 to 2006. Therefore, the purpose of the study also included an assessment of laboratory staff's knowledge, attitudes and practices towards proficiency testing.
2 CHAPTER II: LITERATURE REVIEW
INTRODUCTION
PURPOSE OF THE LITERA TURE REVIEW
SCOPE OF LITERA TURE REVIEW .1 Theoretical Application
- Concepts and theories
- Conceptual framework
The research was also used to pilot the logistics involved in testing the capacity of TB microscopy services for Southern African Development Community countries (including South Africa) on behalf of the Tuberculosis Control Initiative Laboratory Team of South Africa (in consultation with the National Tuberculosis Control Programme). Corrective actions were implemented in laboratories that performed poorly in proficiency testing after the first round.
LITERATURE REVIEWED .1 Background to study
- Laboratory network
- Health systems research in Limpopo Province and abroad
- Quality Assurance
The study provided an indicator of technical quality and allowed to analyze the impact of errors in different technical steps on the quality of the results. The number of positive AFB saliva tests was related to the quality of the saliva sample.
ROLES OF LABORATORIES INEFFECTIVE TUBERCULOSIS CONTROL PROGRAMMES
AN EFFECTIVE TB LABORATORY SERVICE INVOLVES
- Microscopy
- Culture methods and drug susceptibility testing
- Human resources
- Laboratory network structure
- Laboratory safety
- Quality assurance systems
- Turnaround Time
The South African National TB Control Program defines processing time as "the duration of time from collection of a sample from the patient to receipt of the result at the health facility". Transportation of samples from health facilities to laboratories and delivery of AFB results from the laboratory to the health center pose another major challenge, especially in remote areas of the country.
SUMMARY
3 CHAPTER III: METHODS
- INTRODUCTION
- TYPE OF RESEARCH The study is health systems research
- STUDYDESIGN
- TARGET POPULATION
- STUDY POPULATION Proficiency testing
- Inclusion / Exclusion Inclusion criteria
- Sampling
- DATA SOURCES
- KwaZuIu-Natal reference laboratory
- Telephonic interviews
- VARIABLES
- Measurement instruments
- Measures to ensure reliability and validity
- LIST OF VARIABLES Proficiency testing
- PILOTSTUDY
- Proficiency testing data
- Key informant interviews
- DATA COLLECTION .1 Proficiency testing
- Key informant interviews
- DATA HANDLING
- The Measures taken to ensure safe storage of data
- STATISTICAL PROCESSING AND ANALYSIS .1 Proficiency testing
- Classification of errors
- Scoring system
- Criteria for assessment for performance
- Assessment of overall performance of the province
- Assessment of overall performance of individual laboratories
- Calculation of sensitivity, specificity, positive predictive value and negative predictive value
- Key informant interviews
- ETHICS
- Institutional Review Board
- Permissions
- REFERENCE SLIDE PREPARATION PROCEDURE
- Distribution of reference slides
- SUMMARY
Comparison of proficiency test results obtained by the KwaZulu-Natal reference laboratory and the National Health Laboratory Service reference laboratory. The study population for the proficiency testing program was all public health laboratories that performed TB smear microscopy in KwaZulu-Natal from 2001 to 2006. Therefore, proficiency testing assesses the quality of results produced by the laboratory and not by each individual.
It cannot be determined whether the skill test slides were read by the same people who read the patient slides. Hard copies of proficiency test results were obtained from the reference laboratory and transcribed in EXCEL format for analysis (Appendix 01: Data Collection Tool). The analytical study was used to conduct repeated cross-sectional analysis of the TB skills test results.
4 CHAPTER IV: RESULTS
INTRODUCTION
- Removal of round two from the study
- Presentation of data
Data from the KwaZulu-Natal skills testing program was used to assess laboratory performance from 2001 to 2004 (KZN panel). Results from the National Health Laboratory Service proficiency testing program were used to assess laboratory performance for the year 2006 (NHLS panel). No proficiency testing data is available for the year 2005, as proficiency testing was not conducted for this period.
Out of 61 preparations submitted to participating laboratories, results from 8 laboratories were not submitted to the reference laboratory. One slide was read as 'negative', 2 were read as 'scarce' and one as 1+.
Quantitative analysis
- Correct
- Quantification errors
- Low false negative results
- Low false positives
- High false negative results
- High false positive results
- Sensitivity (Positive consistency)
- Specificity (Negative consistency)
- Positive predictive value
- Negative predictive value
- Summary of results by level of health care facility
- Summary of results by urban and rural facilities
- Summary of results by region
- Summary of TB microscopy proficiency testing results by year: 2001 to 2006
- Specific objective 2: Identification of laboratories that have unacceptable levels of performance
- Specific objective 3: Comparison of proficiency testing results obtained by the KZN reference laboratory and the NHLS reference laboratory
Laboratories were observed to report at least 1 high false negative result for the period. A total of 6% (95) of proficiency test slides were read as false negatives for the KZN panel while 2% (26) were read as false negatives for the NHLS panel. The primary healthcare level and the district level achieved similar results for the KZN panel (92% and 93% respectively) and for the NHLS panel (98% for both).
The tertiary level had a much higher proportion of quantification errors (27%) than the primary health level (8%) and the district level (8%) for the KZN panel. The tertiary level was responsible for 7(19%) for the KZN panel and 3(8%) for the NHLS panel. However, the low false positive rates for the KZN panel and the NHLS panel were the same (0.4%) in 2006.
Qualitative analysis
- Specific objective 4: Determination of the role laboratory workers and managers think proficiency testing plays as a quality assessment technique
- Knowledge Attitudes and practices of laboratory staff towards proficiency testing
- Perception of laboratory staff towards proficiency testing
- Identification of possible solutions to problems highlighted
The disadvantage is that the proficiency test results sent to the reference laboratory would be biased. All but one of the respondents felt that the aptitude test was a worthwhile exercise and not a waste of time. Six (60%) of respondents felt that proficiency testing was effective enough to detect errors in microscopy technique.
Two respondents believed that proficiency testing was not effective enough to detect errors in microscopy technique. Some lab managers get the best people to process proficiency slides or even process it themselves. Improve reference laboratory feedback through regular and timely return of proficiency test results.
Specific objective 5: To make recommendations to decision makers on the key gaps identified from the information obtained in this study
SUMMARY
All respondents agreed that skills testing was a valuable exercise as it enabled the detection of 'errors' and also tested the technical competence of technologists/technicians. Therefore, acceptance of the proficiency testing program by laboratory personnel is imperative to the success of the program.
5 CHAPTER 5: DISCUSSION
INTRODUCTION
Quantitative analysis
- Specific objective 1: Analysis of proficiency testing results (2001-2006)
- Specific objective 2: Identification of laboratories that sustained an unacceptable level of performance
- Specific objective 3: Comparison of proficiency testing results obtained by the KwaZulu-Natal reference laboratory and the National Health Laboratory
So, provided the skill test slides are well prepared, any high false negative results are unacceptable and should trigger an evaluation and corrective action. In 2006, as only one tertiary level laboratory participated in the proficiency testing exercise, the results should be interpreted with caution. Both tertiary level laboratories are encouraged to participate in all future rounds of proficiency testing.
Improving the technical skills of microscopists as a result of the skills testing program. Operating conditions could have improved since the KwaZulu-Natal reference laboratory conducted the last proficiency test. The quality of the proficiency test slides produced by the KwaZulu-Natal reference laboratory was not as good as the NHLS reference laboratory.
Qualitative analysis
- Specific objective 4: Perception of laboratory workers and managers towards proficiency testing as a quality assurance technique
If more than one technician performs AFB microscopy in the laboratory, the proficiency test slides should be examined by the microscopist performing the day stain microscopy. This would ensure that the results of the proficiency test slides truly reflect the quality of the results produced for routine patient slides. Some staff may spend extra time reading the aptitude test slides for fear of submission.
They must ensure that the appropriate person processes the skill test slides in the same way they would process routine patient slides. They should also use the proficiency test results to implement the necessary changes for quality improvement. The number of slides in a proficiency test panel should be sufficient to validate the exercise as a quality assessment indicator and yet not add an unnecessary burden to the workload of the technician in the laboratory being evaluated.
LIMITATIONS Proficiency testing
EFFECT MODIFICATIONS .1 Low positive slides
The quality of TB microscopy services in the primary health care level and the district health care level is similar, but tertiary level health care facilities perform below the acceptable level of performance. As of 2006, both urban and rural laboratories produce similar results, which are within acceptable levels of performance. The quality of smear microscopy as determined by the NHLS dataset was much better than the quality as determined by the KZN dataset.
Laboratory staff expressed that proficiency testing is an essential exercise to ensure good quality results. Some of the major problems experienced by the laboratory staff were the inherent problems of proficiency testing (for example, it cannot be determined whether the right person is reading the proficiency test slides), high workload, poor feedback and communication from the reference laboratories, and need for knowledge. service training.
6 CHAPTER VI: RECOMMENDATIONS AND CONCLUSIONS
- INTRODUCTION
- RECOMMENDATIONS
- Quantitative analysis
- Qualitative analysis
- CONCLUSIONS
- RECOMMENDATION FOR FURTHER STUDY
Similar to the study conducted in Limpopo Province, the use of proficiency test results in this study achieved the objective of identifying laboratories performing below the acceptable level of performance. The reference laboratory should clear any misunderstanding regarding proficiency testing during training sessions and through newsletters. The key informants had a good understanding of the basic theoretical aspects of proficiency testing as a quality assurance technique.
Before a new proficiency testing program is implemented, the reference laboratory must adopt clear interpretation guidelines. It identified laboratories that performed below the acceptable level of performance and also highlighted some of the shortcomings of proficiency testing as a quality assurance technique. This study was a rapid quality assessment of TB microscopy services in KwaZulu-Natal.
7 REFERENCES
Van Rie, A., et al., Sputum smear microscopy: evaluation of the impact of training, and the use of External Quality Assessment Guidelines for resource poor settings. Martinez, A., et al., Evaluation of new external quality assessment guidelines involving randomized blinded rechecking of acid-fast bacillus smears in a pilot project setting in Mexico. Endo, S., Trono, M., et al, Operational conditions affecting the proficiency of AFB microscopy services in the Philippines.
Huong, N.T., et al., Evaluation of sputum smear microscopy in the National Tuberculosis Control Program of northern Vietnam. Selvakumar, N., et al., Lot quality assurance of sputum acid-fast bacillus smear sampling for assessing sputum smear microscopy centers. Selvakumar, N., et al., Application of batch sampling of sputum AFB smears for the assessment of microscopy centers.
8 ANNEXURES
- DATA COLLECTION TOOL Data collection tool
- INTERVIEW GUIDE Broad objectives
- ETHICS APPROVAL FORM
- CONSENT DOCUMENT
Who processes slides for proficiency testing (taking into account that corrective action reports must be written if results are unsatisfactory). It has been said that some lab managers get the best person to process proficiency test slides or even process it themselves. In your opinion, the proficiency testing program is effective enough to detect errors in microscopy technique.
Following our letter to you dated 04 June 2008, this letter serves to inform you that the Committee during a full session of the Biomedical Research Ethics Committee meeting held on 08 July 2008 the subcommittee's decision to approve the Recertification of the above , ASKED. protocol received by us on 26 May 2008.
CONSENT DOCUMENT
- INFORMATION DOCUMENT FOR STUDY PARTICIPANTS
- PROCESSING OF SPECIMENS FOR MICROSCOPY
- MAKING OF SMEARS FOR MICROSCOPY MAKING OF S M E A R S F O R M I C R O S C O P Y ONLY
- STAINING OF SLIDES - ZIEHL-NEELSEN STAIN
The aim of the study is to determine the quality of tuberculosis microscopy in KwaZulu-Natal as determined by proficiency testing. To describe and analyze the results of proficiency tests conducted between 2001 and 2006 at 72 salivary smear microscopy facilities by the KZN PHL in the province to determine quality and trends by year and district. The study will be carried out in partial fulfillment of the requirements for the Master's Degree in Public Health.
However, participation in the research is voluntary, you will not be penalized if you refuse to participate and you can stop participating at any time. Heat decontaminate the numbered sample by placing it in the hot air oven at 85°C for 20 minutes. Check and recheck laboratory numbers cm own lubricants and in the i < i - that the cones,;.
