Effect of internal audit-guided intervention on quality indicators in the processing and reporting of complete hemogram

INTRODUCTION

Laboratories play an absolutely essential role in the overall quality of healthcare. All laboratories ensure that results are accurate and timely, allowing patients to get the best care as quickly as possible. The major decisions depend entirely on laboratory test results; therefore, the utmost priority is always a high-quality report from the laboratory.^[1] The quality of the laboratory indicates that the services are free from mistakes. This can be achieved by enrolling the laboratories in an accreditation program.^[2]

Accreditation is the process of an independent evaluation of conformity assessment against recognized standards to ensure impartiality and competence.^[2,3] Accreditation is often compulsory in the Western world, whereas in India, it remains voluntary. The apex body for accreditation in India is the National Accreditation Board for Testing and Calibration Laboratories (NABL) which is a Constituent Board of Quality Council of India.^[4] It usually assesses the technical competence of medical and calibration laboratories, proficiency testing (PT) providers, and reference material producers through third-party evaluations. These authorities inspect laboratories to check their compliance with the International Organization for Standardization (ISO) 15189 and the International Electrotechnical Commission (IEC) standard 17025.^[5,6]

The audit is defined as an “independent, systematic and recording process for acquiring evidence and estimating it impartially to determine the extent to which necessary criteria are satisfied.”^[6,7] Laboratory auditing has two components, namely, management and technical components and also comprises internal and external audits. An external audit is usually composed of assessments done by authorities from outside the laboratories, whereas an internal audit is usually conducted by the authorities working in one particular portion of the laboratory assessing another area within the same laboratory. These audits provide valuable details regarding the performance of the laboratory and the compliance requirements.^[7,8]

The aims and objectives of this study were to determine and verify the compliance of our laboratory with the requirements of the quality management system, including analytical methods, standard operating procedures (SOP), the quality manual, and internal laboratory policies. In addition, this study also aimed to assess the impact of the internal audit-guided intervention on the process and reporting of hemograms in accordance with ISO 15189 and NABL specific document 112.

MATERIALS AND METHODS

RESULTS

All samples received during the study period in the hematology laboratory for a complete hemogram were recruited in this study. A total of 38,129 samples were included in the study during the two phases of the study period (Phase I: January–April 2019 and Phase II: September–December 2019), handled according to our SOP, and analyzed using the Sysmex XT-2000i hematology analyzer.

We conducted an internal audit on the technical requirements in the processing and reporting of complete hemograms in accordance with ISO 15189:2012 and NABL-specific document 112. The following quality indicators were analyzed as parameters and compared between Phase I and Phase II.

Number of rejected samples and their reasons

During the Phase I period, we rejected samples according to our previous laboratory protocol, whereas minor amendments were made in Phase II, and samples were rejected in accordance with ISO 15189:2012 and NABL-specific document 112 guidelines.

During Phases I and II, we rejected 781 and 281 samples, respectively, based on various reasons. We compared the number of rejected samples in Phases I and II [Table 1] and their reasons and percentages are highlighted in Figure 1a. The major reason was that patients were not enrolled in the hospital information system (HIS) in both phases. This issue could not be reduced in our study, because most of the patients almost always outnumbered the bed availability. These patients were either waitlisted for the want of bed or under observation, and hence, the rejection rate did not decrease even in Phase II.

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Figure 1:

(a) Comparison of percentage of rejected samples and their reasons in Phases I and II; and (b) comparison of Phases I and II on the basis of turnaround time. TAT: Turn around time.

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Table 1: Comparison of number of rejected samples and their reasons in Phases I and II.

Reasons for rejection	Phase I (January-April 2019)	Phase II (September-December 2019)	Reduction in percentage between Phases I and II (%)
Wrong bar code	11	03	73
No bar code	15	03	80
Delay in receiving the samples	84	21	75
Incomplete form	116	21	82
Wrong tubes	19	02	90
Insufficient sample	14	05	65
Duplicate sample	56	22	61
Not assigned in HIS	367	281	23
Others (sample and form mismatch, clotted sample)	99	07	93
Total	781	365	54

HIS: Hospital information system

After giving adequate training to all the laboratory personnel according to NABL guidelines, we could able to significantly reduce the various rejection reasons by a total of 54%. These included sample and form mismatch (93%), wrong (90%)/no barcodes (80%) on the requisition form, incompletely filled forms (82%), delays in receiving samples (75%), samples received in wrong tubes (90%), insufficient (65%), duplicate (61%), or clotted samples (93%) [Table 1 and Figure 1a].

DISCUSSION

A major portion of medical conclusions relies on results from laboratory medicine; therefore, quality holds the highest priority in the laboratory.^[1-3] Quality controls in the laboratory were to identify, cut down, and fix the errors in the analytical process before releasing results, thereby improving the quality of laboratory results.^[3-10] An internal audit is the process in which the staff working in one area of the laboratory assesses another area within the same laboratory.^[9,10]

Quality indicators are required to systematically monitor and evaluate the laboratory’s contribution to patient care.^[1-3,9,11] In our study, we mainly focused on technical quality indicators, including the number of rejected samples and their reasons, IQC results, critical value entries, TAT and reasons for delay in dispatching the reports, and finally, EQAS. The first indicator was directly related to pre-analytical variables.^[1-3] The IQC and critical value indicators were directly related to analytical phase, while TAT spans around all the three phases of laboratory work-up.^[1-3,9-16] Finally, EQAS was directly related to overall performance by the laboratory in comparison with other participating laboratories in the country.^[9-12,17]

In Phase I, we processed and reported complete hemogram samples according to our usual laboratory protocol. We analyzed the result of Phase I, documented the deviation, and then implemented the amended protocol in accordance with NABL and ISO guidelines.^[1,4-6] After Phase II, we compared the results of both phases to identify the impact of our internal audit.

After providing adequate training to all laboratory personnel pertaining to various pre-analytical variables, we were able to significantly reduce the sample rejection rate by 54% overall. The various reasons for rejection that showed improvement included sample and form mismatches (93%), wrong (90%) or no bar code (80%) in the requisition forms, incompletely filled forms (82%), delay in receiving the samples (75%), samples received in wrong tubes (90%), insufficient (65%), duplicate (61%), and clotted samples (93%).

Our study results closely matched those of Makubi et al.,^[15] who conducted an audit on hematology and blood transfusion. They screened 195 laboratory request forms and found out that 100% of those forms did not have complete information such as unique ID number, time of collection, and clinical history. In addition, 82% of specimens were improperly labeled, and 65% of samples did not contain the proper amount of blood.

In this study, the only major reason that could not be reduced in either phase was patients not being enrolled in the HIS. This was because most of the patients almost always outnumbered the bed availability. Many of these patients were either waitlisted for the want of bed or under observation and hence could not bring down this issue even in Phase II.

Regarding the IQC results, we encountered a systematic error in most reportable parameters during Phase I. After doing minor adjustments but not performing a full calibration,^[9-11] we demonstrated that all parameters showed significant improvement in Levels I, II, and III, except RBC count (P = 0.651), HCT (P = 0.074), and MCV (P = 0.144), respectively. However, during the study period, there was no major break down in the hemogram counter in our hematology laboratory.

There was a significant increase in the critical value entries^[1-3] during Phase II by almost 3 times. However, there was no change in the malarial parasite reporting across both phases. The reason which we presume is that the prevalence of malarial parasite remains the same throughout the year. Notably, there was a 50% decrease in Hb critical value entries in the Phase II, while all other parameters were significantly increased. We could not figure out the exact reason for drop in the Hb critical value entries.

The average TAT during Phase I and II study period were 130 and 170 min, respectively. This delay was expected and primarily due to stringent adherence rejection criteria, strict IQC measures, and the subsequent reporting process in the HIS. Although, TAT increased in Phase II, the quality of results becomes much greater in Phase II. Joshi et al.^[16] strongly recommend using an abnormal flagging system in hematology analyzers to be correlated with manual blood smears to avoid false-negatives to improve the performance in a hematology laboratory. This might affect the average TAT. From the above analysis, it is evident that Phase II was more successful than Phase I in terms of EQAS, with improvements in both accuracy and precision testing. The Clinical Laboratory Improvement Amendments (CLIA) guideline^[17] helped us in amendments and implementing minor changes, which resulted in better z-score and enhanced overall quality management in our laboratory.

We analyzed changes in laboratory practices to determine whether they are improving in accordance with NABL and ISO guidelines. Our study results were very similar to those of Anjarani et al.^[18] conducted in Tehran, Iran. They analyzed the degree of agreement in the terms of quality with national standard guidelines between government and private hospital laboratories. They included 164 questions in the checklist and concluded that standard guidelines were prominently implemented in private hospital laboratories than in government hospital laboratories. They pointed out that lack of encouragement; sincerity and management pressure were the main factors for the poor performance of public health laboratories in their study.^[18]

Similarly, the major limitation of this study was the lack of motivation among staff members, which was the primary reason for improper entries in the registers. Continuous monitoring by higher officials became necessary to maintain standards. In addition, this internal audit was performed in 2019 using ISO 15189:2012, while further amendments were released in 2022. Therefore, future studies are warranted using ISO 15189:2022.^[6]

We found that this internal audit significantly improved the quality of processing and reporting complete hemograms. It also provided opportunities for improving our own standards and enhanced patient management and care. We strongly recommend that these audits continue, not only in the hemogram laboratory but across all laboratory departments, to ensure continual improvements in our standards.

CONCLUSIONS

This study improved our existing laboratory techniques, including quality control, better documentation, and ensures high-quality reporting. It concludes that the outcomes of internal audits are very important for essential amendments needed to improve the quality management system.