Evaluation of the implementation of the rational use of laboratory tests in the clinical chemistry laboratory

Introduction

In today’s remarkably fast-developing era of laboratory applications with increased test diversity, communication between the clinician and the medical laboratory specialist has become more important. The test report formats, units, decision limits, and critical values varied among medical laboratories, causing many problems. For this reason, the rational laboratory project was born as a necessity. Rational laboratory use relies on evidence-based data, considers costs, and targets patient safety and the best treatment. It is the correct laboratory use by appropriate test selection, proper investigation, and, correspondingly, proper interpretation of the laboratory results. Given these reasons, many strategies have been developed to use laboratory studies rationally and effectively, to reduce inappropriate or unnecessary tests, to manage the increasing demands, and to optimize the clinical use of the tests.

This article will focus on a necessary provision, The Rational Laboratory Use Project (RLUP), implemented in 2018 by the Ministry of Health of the Republic of Turkey, General Directorate of Health Services, Department of Inspection and Diagnostic Services to ensure rational laboratory use. Medical Biochemistry, Medical Microbiology, Medical Pathology, Tissue Typing Laboratories, and Genetic Diseases Diagnosis Centers in all public/university/private sectors were held responsible by the legal authority for implementing this project.

The project aims to ensure the correct diagnosis of the patient, increase the clinical usefulness of the test results, standardize the test result reports, prevent unnecessary test requests, and provide communication, technical consultancy, and information exchange between the clinicians and the medical laboratory specialists. To reach these multiple goals, appropriate procedures were developed within the project: ‘Where this test is conducted?’ procedure, autoverification (AV) use procedure, consultation request procedure, reflex and reflective test applications, rational test request procedure, standardization of medical laboratory examination results report, and harmonization of decision limit-critical value and measurement units [1].

Although this project covers many laboratory branches, the content desired to be applied by each laboratory branch in the project may vary. For medical biochemistry laboratories, it is mandatory to apply all procedures, with the exception of AV, which is based on voluntary participation.

In this study, we aimed to investigate the implementation rate and effects of RLUP in medical biochemistry laboratories. Perceptions of laboratory specialists about the system, as well as their insights into its limitations and suggestions for improvement, were collected via an online survey to contribute to new regulations.

Materials and methods

This research was conducted via an online survey portal (SurveyMonkey^®, San Mateo, USA). The questionnaire included 30 questions; the first five were descriptive for laboratories. Descriptive questions were asked that could reveal the workload and capacity of the laboratory. The remaining 25 questions cover the titles within the scope of the project. These questions were related to the following topics. ‘Where is the test done?’; entering the tests studied into the core resource management system (CRMS). This system is organized to monitor where tests are carried out throughout Turkey. This system has been organized to monitor where tests were carried out throughout Turkey. The Ministry of Health requires these tests to be updated every six months. AV is a set of computer-based algorithms created by medical laboratory specialists in which test results are automatically confirmed by the AV. The question options were chosen from the tests with many annual tests.

Consultation; communication between the clinician and the relevant laboratory specialist, reflex and reflective tests; the process of automatically with specific algorithms adding new test(s) on the same patient sample according to the first sample results, the process of adding new test(s) with the knowledge of the clinician on the same patient sample, respectively. The test request warning system enables making test requests before the request period determined by the Ministry of Health. Patient outcome report standard: contains all information about the institution, laboratory, patient identity, and test results. Decision limit (threshold value) information is utilized in assessing the healthcare needs of patients. Critical values refer to measurements that must be reported immediately to the clinicians using SMS, phone calls, etc. Harmonization of units denotes the requirement for standardizing test units in result reports.

The survey was anonymous; thus, participants were not asked for information such as name, surname, title, and institution name.

The questions were initially shared with 20 medical biochemistry specialists, who are experts in their fields, to obtain their opinions and suggestions for the survey. Necessary adjustments were made in accordance with the comments and suggestions received.

The member list of the Turkish Biochemistry Society (TBS) was utilized to distribute the survey link to all medical biochemistry specialists across the country. After obtaining approval from the Board of Directors of the Society, the link was sent to the members’ email addresses twice, in May and June 2021, with an interval of twenty days between each sending. Only one specialist from each laboratory was asked to fill out the questionnaire reflecting the current situation in their laboratory regarding the project. The questionnaire was shared only with the laboratory administrative specialist for laboratories with more than one specialist. Only one expert from the same laboratory was allowed to fill out the questionnaire.

Later, Survey Monkey data was transferred to the Microsoft Excel program (Microsoft Corporation, 2010) for analysis. Statistics were reported as numbers and percentages.

Most of the questions asked for only one answer, while there were some in which participants were allowed to tick more than one option. Open-ended questions like “What is your suggestion about RLUP?” allowed writing down their views without limits.

Participants who answered “No” to the first question in interrelated questions were forwarded to the other section. Owing to the question-skipping feature, the number of responses to each question varied. The Survey Monkey program analyzed the average completion time for the survey to be approximately 8 min.

The approval for the study was obtained from the Ethics Committee of Health Sciences University Istanbul Training and Research Hospital (2 April 2021; No: 2,792) and the Ministry of Health (13 April 2021; No: 95,966,346). Informed consent was obtained at the beginning of the survey, and the participants started to answer the questions after they had approved this section.

Results

The survey was answered by 202 laboratories across Turkey.

Figure 1 shows the distribution of the institutions. Most participants were from state hospitals and Health Sciences University Training and Research Hospitals. 1.89 % of the respondents (who answered ‘other’ to this question) were from a diagnostic firm.

Figure 1:

Distribution of laboratories participating in the survey * all these institutions are affiliated by Ministry of Health, Republic of Turkey. ISLAB are large, central laboratories recently established in Istanbul.

44.64 % of the laboratories that participated in the survey, were from tertiary healthcare institutions, such as the University of Health Sciences Training and Research Hospitals, city hospitals, and public and private university hospitals. On the other hand, 49.68 % were from secondary healthcare institutions, including state hospitals, medical laboratories within private hospitals, and independent private medical laboratories. While 2.52 % of the public health laboratories within the primary healthcare institution participated in the survey, 1.26 % of the centralized laboratory (called ISLAB) from which samples were received from the primary, secondary, and tertiary healthcare institutions that participated in the survey.

More laboratories from the Marmara region (which includes Istanbul) and Central Anatolia region (which includes Ankara) participated in the survey.

The interconnected Core Resource Management System (CRMS) (Q6) performed by 62 %, of which only 66.36 % implemented the related 6-month updates. It was interesting to see that 6.36 % of the laboratories that performed CRMS, updated their data only when there was a new tender (Supplemental Table S2).

In Q9 30.08 % of the laboratories answered “others” which means they do not have many tests and want to evaluate the test results; they think requires additional cost; they request common algorithm for AV in the country and are against AV.

When the data were evaluated together, it was not surprising that laboratories that perform more than five million tests per year apply AV the most (Supplemental Table S1). 46.15 % of user have been authorized by the Ministry of Health for AV.

Reflex and reflective tests were performed in almost half of the laboratories (Q12, Supplemental Table S2).

Participants who did not apply listed their reasons as follows: problems originating from Laboratory Information Management System (LIMS)/Hospital Information Management System (HIMS); since it is a private hospital, there is a price shortage; they are already communicating with clinicians to ensure that new tests are added.

Q14 asked about the ‘Test Request Period Warning System’ of RLUP. 4.24 % of the laboratories reported that clinicians continued to request the test despite the warning “this test has been requested before”. The main explanation was that “it is not easy for the management to approve this in private institutions”.

In Q15 13.68 % of the laboratories applied it to only some tests (HbA1c, vitamin D, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), hepatitis markers). The test request intervals in the system recommended by the ministry were not applied in the emergency laboratory.

Some laboratories (4.26 %) also used critical decision limits in C-reactive protein (CRP), troponin, procalcitonin, D-dimer, and the oral glucose tolerance tests (Q19, Supplemental Table S2).

In Q24 other tests were: ferritin (microgram/L), folic acid (microgram/L), vitamin D (microgram/L), vitamin B12 (ng/L), insulin (mIU/L), follicle-stimulating hormone (FSH) (U/L), luteinizing hormone (LH) (U/L), estradiol (ng/L), CA 15.3, CA 19.9 and CA 125 (kU/L), carcinoembryonic antigen (CEA), free prostate specific antigen (fPSA) and total PSA (tPSA (microgram/L), progesterone (microgram/L), prolactin (mIU/L), FT3 (ng/L), testosterone (microgram/L), beta human chorionic gonadotropin (beta-HCG) (IU/L) (Supplemental Table S2).

The last five questions were on opinions and suggestions for the RLUP ( Table 1).

There were statements indicating that there were limitations in application due to the different tendering processes (different LIMS/HIMS companies took the tender for each laboratory), and the RLUP may function better if the Ministry of Health implements its own LIMS. In addition, it was stated that clinicians were essential stakeholders in these issues, but clinicians did not know the subject. One laboratory stated that RLUP was partially functional, but the enforcement power was insufficient for unnecessary testing. There were laboratories stating that its applicability was difficult in public university hospitals.

Q30 focused on suggestions for RLUP (Table 1). In general, it was found to be beneficial however; some limitations were listed as well: it is not yet fully realized in practice that the infrastructure of LIMS/HIMS should be good, that there are laboratories of different sizes and qualities in different regions of Turkey, that the project steps cannot be applied everywhere, that standardization will be required, that it increased the quality of the laboratory, that consultation should be encouraged for more applicability, that infrastructure problems and staff deficiencies should be eliminated, that the covid pandemic has revealed the importance of this project more, that the creation of sample algorithms for AV will facilitate the work and that the project should continue with soft controls.

Some laboratories evaluated RLUP negatively: that it was not applicable and realistic, that it was not suitable for all laboratories, that it was unnecessary, that the pricing situation in applying the reflex test complicated the work, that the experts working in the periphery of Turkey should be consulted while these projects are being prepared, that the unnecessary requests should be deducted from the clinicians’ performance scores and that the consultation cannot be activated unless they are paid.

In addition, there were opinions that if it was fully implemented, it would strengthen the role of medical biochemistry specialists, and that the ministry could encourage laboratory specialists with remuneration. It was also stated that the active participation of clinicians in this project will increase the success of the project.

Discussion

We aimed to evaluate the field situation of the RLUP application in Turkey, which was initiated to standardize all the steps in the total testing process and to reflect this successfully on the diagnosis, follow-up, and treatment of the patient, and to contribute to its feasibility in the future. Good laboratory practices necessitate rational, critical steps from test ordering to result accuracy. This includes requesting the right test, taking the sample, and delivering it to the laboratory promptly and under suitable conditions. Accurate results entail presenting the analysis and reporting in appropriate standards and standardized units. Additionally, consultation and follow-up with the clinician are required when necessary [2], [3], [4].

The web-based system called CRMS in the “Where this test is done procedure” was developed to see where the tests that require advanced analysis techniques and are rarely performed throughout Turkey are made. Before this system, neither laboratory specialists nor clinicians were aware of where such tests were performed in our country. Laboratory specialists and clinicians need to know where the test is performed to guide the patient. The web-based ‘where this test is done’ system created by the Ministry of Health paved the way for domestic tests regarding time, patient safety, and cost. It is seen that 62 % of the laboratory specialists participating in the survey implemented this system in their laboratories, and only 66 % of those who applied it carried out the test updates (Supplemental Table S2). It is necessary to ensure full participation throughout the country.

Participating laboratories stated that AV, consultation, reflex, and reflective testing are not applicable. AV can significantly contribute to increasing the Turnaround Time (TAT) of laboratory result quality by using meticulously created post-analytic algorithms [5], [6], [7], [8]. This is becoming increasingly important for very high-capacity laboratories. AV has become an essential part of the post-analytic process [9]. It was seen that only 26 % of laboratories with an annual number of tests of 10 million or more use AV.

Numerous laboratories contend that their infrastructure is inadequate for utilizing AV (Table 1, Supplemental Table S2) [10].

With the Consultation Request Procedure, the medical laboratory specialist has been included in the existing consultation system between various branches [11]. This survey showed that laboratories consider consultation practices inefficient. It was stated that the consultation practice may also be more encouraging with pricing. Except for the university and some large laboratories, clinical biochemistry consultation is mostly done by talking to the relevant specialist via telephone. Since clinicians can easily reach laboratory specialists, they get the answers they want over the phone. This survey reveals that there should be new initiatives in consultation and that these can be realized by training for laboratory specialists and clinicians.

Many clinical branches do not refer to the reflective test protocol initiated by medical laboratories while referring to the test order algorithms and steps to reach the diagnosis in international guidelines [12]. In the application of reflex or reflective testing in any clinical scenario, the choice of reflex test has been reported to be more effective if the number of tests required to diagnose is low (NND: number needed to diagnose; low), or when more complex factors (NND: high) need to be considered (e.g., diagnosis of hemochromatosis) [13, 14]. It has been seen that reflex tests are applied more than reflective tests in medical biochemistry laboratories, that reflex test choices of the participants reflect the automated protocol created by the laboratory specialist, and that the reflective test choices reflect the test preferences of the clinicians in the institution they work. In cases such as laboratory workload, analyzer failure, and maintenance, it could be helpful to add reflex and reflective test working procedures in detail to the laboratory test guide for how the operation will be if the samples are kept at room temperature in a way that affects their stability [15]. 33.87 % of the participants thought that reflex and reflective test applications were not applicable in public and private institutions due to the addition of tests to HIMS and the pricing problems. Tests that participants used reflexively were albumin, AST, Ca, creatinine, direct LDL, GGT, glucose, indirect bilirubin, Mg, sodium, urea, TSH, fT₃, fT₄, fPSA, TPSA, Beta-HCG, urinalyses, peripheral blood smear, coagulation tests, flow cytometry. Tests that participants used reflectively were albumin, CK, CK-MB, direct LDL, HDL, cholesterol, triglyceride, TSH, FT₃, folic acid, vitamin B₁₂, vitamin D, macroprolactin, ferritin, PSA, hemoglobin variant, peripheral blood smear, flow cytometry. The fact that the reflex and reflective test responses were the same tests suggested that the participants were likely to confuse these two definitions. In semi-automatic systems such as flow cytometry, especially in leukemia-lymphoma typing, reflective testing can be performed by a medical biochemistry specialist who is well-trained in flow cytometry and hematology. After the first study of the sample that comes with the preliminary diagnosis of this test, the expert decides which test panel will be studied in the second stage, and the test can be requested from HIMS by a medical biochemistry specialist. There is a wide variety of these and similar tests in clinical biochemistry laboratories, and there are many publications about the rational demands of these tests [14, 16], [17], [18]. It would be appropriate to support these algorithms with guidelines [9].

The rational Test Request Procedure has been created with the aim of correct diagnosis, a cost-effective approach, and increasing clinical usefulness. Through the Information Management System (IMS), it is ensured that clinicians can access the patient’s previous results. Test request periods are determined, and unnecessary test requests are prevented by a warning system alerting the clinician [16], [17], [18], [19]. In Q15, Q16, and Q17 questions, 86.32 % of the laboratories stated that the “you have requested this test before” warning system to the clinician to make the test requests correctly, effectively, and on time. Some laboratories were not very effective. It can be thought that although clinicians see the warning, they still make their requests in the system, which is why clinicians’ awareness should be raised. Perhaps in the LIMS/HIMS system, it would be more efficient to make it ‘you cannot make a request’ instead of a warning. We believe that this cost-effectiveness aligns with patient safety and helps to avoid unnecessary testing.

Standardization of the Medical Laboratory Examination Result Report is a requirement of the ISO 15189 standards. These standards require that each test result should be reported accurately and clearly, in accordance with the special instructions in the examination procedures. Additionally, the report should contain all the information necessary for interpreting the examination results [20]. While the standardization of the report format throughout Turkey provides convenience to laboratory specialists, the fact that many laboratories do not use this format (Supplemental Table S2) makes one think about the need to raise awareness and monitor the field again on this issue.

The laboratories stated that the critical value was reported to the clinicians via SMS, telephone, or LIMS. This research demonstrated that our laboratories were aware of the importance of critical value reporting. Guidelines show to whom, when, and for how long, and many organizations state that following these guidelines is obligatory [21]. In our view, the Ministry of Health has achieved critical value standardization through this project.

The fact that 59.54 % of the unit change (Q22–Q25, Supplemental Table S2) in the Troponin parameter of the unit change reported by the ministry for unit harmonization was made by the laboratory made us think that more progress should be made for harmonization. Concordance was much better in parameters such as protein, albumin, and CRP (Supplemental Table S2).

Laboratory specialists reported that they were unable to implement rational laboratory practices in both their own and their subordinate service laboratories. This failure was attributed to unresolved issues with hospital administration, LIMS, HIMS, and hardware.

The interest in the survey by medical laboratory specialists is low (Number of laboratories actively participating in the survey/Number of licensed medical biochemistry laboratories in Turkey=202/518). However, answering the questionnaire from every geographical region of our country is sufficient to show compliance with the realization of the project.

Symposiums held throughout the country (RLUP Symposium Presentation – 20 June 2018, Turkish Biochemistry Society) increased awareness, but it may not have been enough. It is of great importance for the project’s success that this study is repeated every year and that the numerical data are followed through the indicators.

Although the data is local, it is hoped that it will be useful in other countries that wish to implement a similar process.

On the international platform, the Model of Quality İndicators (MIQ) [22] developed by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and Clinic and Laboratory Standards Institute (CLSI) named “Development and Use of Quality Indicators for Laboratory Improvement Guide” [23] similar projects could be done by IFCC post-analytic working group which can standardize the steps of rational laboratory use.