ABSTRACT

Corresponding Author:
Dr. D. Sudha Madhuri,
Assistant Professor,
Department of Microbiology,
Gandhi Medical College,
Secunderabad.
E-mail: sudha_devara@yahoo.com

ABSTRACT

BACKGROUND

Monitoring of quality indicators covering the critical areas of total testing process in pre-analytical, analytical and post-analytical phases have a significant impact on performance of laboratory as 80–90% of clinical diagnosis and treatment is made on the basis of laboratory test results in healthcare.

Aim of the study is to evaluate the performance of serology laboratory with the implementation of set of quality indicators.

Study Design - This is a prospective observational study conducted in serology section of clinical microbiology laboratory, Gandhi Hospital, Hyderabad, from July 2013 to June 2014.

MaterialS and methods

All the blood/serum samples received for routine serology were included in the study. A total of 32,026 samples were received and analysed using rapid methods and ELISA. Quality indicators selected were Sample Rejection Rate (SRR), incomplete Test Request Form (TRF), repeat testing, Proficiency Testing Performance (PTP) failures evaluation by EQAS and ILC, Turnaround Time (TAT) and Critical alert reporting. Selected indicators were monitored progressively over time.

Result

A significant change in performance of serology laboratory observed after implementation of Quality indicators. Major impact was observed in incomplete TRF, which reduced from 16.34% to 4.5% followed by reduced sample rejection rate from 9.82% to 1.50%. Most significant improvement was observed in pre-analytical phase and post-analytical phase, but not much impact on analytical phase in Total Testing Process (TTP).

Conclusion

Quality indicators have huge impact on the performance of diagnostic laboratory services in patient care.

Keywords

Test request form (TRF), Quality indicator (QI), TAT (Turn around Time).

Background

Laboratory services play a key role in health outcomes. Quality indicators have been advocated for use as internal quality assessment tools to evaluate all phases of total testing process to identify, correct and monitor the errors in improvement of the performance of laboratory services. Quality assurance plays a major role in the patient care, as 80% of clinical diagnosis and treatment is based on laboratory reports.¹ No other field of medicine is better positioned than laboratory medicine in control and prevention of disease and disease surveillance by providing timely information.²Quality indicators are measured information qualitative or quantitative which indicates the performance of a process, determines quality of services, identifies areas that

DISCUSSION

Monitoring of correct performance of the Total Testing Process of the laboratory is very important, as it helps to identify errors but also to formulate quality improvement strategies to prevent an error from sample collection, transportation, analysis of sample to the reporting of test results invalidates the quality of the test results.^6,7

During the pre-analytical phase, incomplete TRF received in the lab was the poorest quality indicator observed (4.5%), which was followed by sample rejection rate (1.5%) close to the rate reported by Chawla et al (1.54%).⁸ The most common cause of sample rejection was inadequate quantity of sample received (2.75%) followed by haemolysis (0.74%) and wrong identification (0.05%). Reasons for inadequate quantity and haemolysis may be due to repeated sampling in already sick patients, which leads to collapse of veins which makes it difficult to take appropriate amount of sample. Regular training of lab technicians and clinical staff on sample collection techniques was done, which led to reduction in sample rejection due to inadequate quantity of sample from 5.13% to 1.19%. Meticulous screening of prefixed checklist initiated. The staff was trained in proper labelling of samples, correct filling of TRF which has led to significant improvement in pre-analytical errors due to incomplete TRF reduced from 16.34% to 4.50%. Introduction of colour coded vacutainers and central lab collection facilities to avoid repeat sampling for different tests has been done. For any add-on additional tests, samples were stored for 72 hours at 2-4⁰ C. There was a remarkable decrease in errors in pre-analytical phase.

In analytical phase, 4.37% tests were retested. Repeat tests were done on the same samples to reconfirm the results in case of doubt at laboratory level and on request by physicians. All the results were under predefined coefficient of variable (CV %) of the lab; 18 (0.05%) instances of random errors observed which may be due to Pipetting Error, Calibration Failure and Instability of reagents or Calibration drift. These errors were detected on regular monitoring of Levy Jennings (LJ) chart for each test parameter. Participation in EQAS/ILC was done. Non-conformity to PT was observed only one time (0.20%). It may be due to inappropriate storage of reconstituted QC material in the lab. Standard Operation Procedures (SOPs) were written and implemented to regulate Random Errors in our laboratory. A checklist was developed to ensure proper storage and maintenance of reagents/kits, pipettes and instruments were checked regularly and more stringently. Sensitisation of staff for the same was done as part of intervention.

A questionnaire with multiple choice questions covering various aspects of quality system and procedures in Total Testing Process was prepared and approved by Quality Manager. Questionnaire was given to test the knowledge and awareness of the laboratory personnel before and after sensitisation and training of the laboratory staff and total gain was calculated in terms of marks. Mean score improved from 4.2-8.9. The lab personnel showed a marked improvement in knowledge, but also their readiness to implement the policies and procedures laid down in the laboratory to ensure patient safety and good laboratory practices after sensitisation.

In the post-analytical phase, critical value reporting and TATs were monitored. Critical value reporting is defined as values that represent situations that could be life-threatening without treatment.^9,10 The literature shows failure of critical value reporting 0.1% to 1.4%. In our laboratory, 0.04% critical values could not be communicated to the concerned physician. Our lab has defined TAT as 24 hrs. for Rapid Tests and 72 hrs. for ELISA. In 24 (0.07%) instances, the test results could not be dispatched in stipulated time as we do not have LIS system and only manual reporting is done.

Conclusion

Quality indicators have huge impact on the performance of diagnostic laboratory services in patient care, as every step in the Total Testing Process is prone to errors. To improve the quality of the reported results, a systematic monitoring and evaluation of laboratory performance by different quality indicators covering critical areas of Total Testing Process is extremely a valuable tool.