Overall, 65 Laboratories responded to the survey in Germany (42), Austria (17), and Switzerland (6). About two thirds (42) of the responding laboratories were hospital laboratories and one third (23) were commercial laboratories. About one third of hospital laboratories (14) and two thirds of commercial laboratories (15) processed more than 1000 patients per day. Hospital laboratories served on average about 1000 patients per day, while commercial laboratories served more than twice this number (about 2300 patients per day) and processed sometimes more than 6000 primary tubes in clinical chemistry alone. Detailed results beyond those presented in the body of this manuscript can be found in the online supplement. Formal quality management systems were established in little more than half of the laboratories (35; 54%), with certifications/accreditations other than ISO 9000 or ISO 15189 playing almost no role whatsoever. Only one laboratory was certified according to ISO 14000, no laboratory at all used JCIA (Joint Commission International Accreditation), CAP (College of American Pathologists) or MLE (Medical Laboratory Evaluation). Informal quality improvement programs, on the other hand, were widely used. Most dominant were survey-based approaches (employee satisfaction survey, clinician satisfaction survey, patient satisfaction survey, in that order) and continuous development programs for employees. Again, there was a lower, in this case even much lower, use of formalized approaches, like LEAN Six Sigma or Activity Based Costing (ABC).
Besides turn-around time, which was represented by several items, 10 KPIs were assessed in the survey. These were “Employee productivity (e.g. samples per full time equivalent)”, “Workspace utilization (e.g. tests per square meter)”, “Amount of implemented auto-validation rules”, “Reduction of consumable waste”, “Reduction of expired reagent stock”, “Return on investment (e.g. total cost of ownership, total value of ownership)”, “Instrument noise levels”, “Systems uptime/downtime”, “Rerun rates”, and “Blood smear review rates”. For detailed results see Online Supplement, only the five more commonly used KPIs are discussed here.
Metrics used to monitor operational performance varied widely. Besides turn-around time, systems uptime/downtime was used as a KPI most commonly, with instrument noise levels and expired reagent stock following as close second and third, respectively. Rerun rates and blood smear reviews were used by about a third of the laboratories. The use of all other KPIs listed in the survey was positively indicated by 25% or less of the laboratories. Turn-around time was identified as a KPI by about two thirds of hospital laboratories and slightly more than half of commercial laboratories. The various types of TAT examined in this survey can be identified in Fig. 1, with “Lab TAT” dominating and “Pre-Lab TAT” trailing. Only 14% of laboratories measured “Brain-to-Brain TAT” or “Clinician Expectation Time”, defined as the time between physician order and physician access to laboratory results [20, 21].
While TAT was defined as a KPI by the majority of laboratories answering this survey, continuous monitoring or frequent review did not appear to be the main concern. Only about a third of laboratories monitored TAT real-time, about 20% each daily and/or weekly. This may partly be due to the software used to monitor TAT: about 80% of hospital laboratories monitoring TAT only use spreadsheet software like Excel, this proportion still being 50% for commercial laboratories. Comprehensive middleware IT solutions or dedicated TAT monitoring software is thus used for only 20% of hospital laboratories and 50% of commercial laboratories monitoring TAT.
Consistent with the relatively low use of KPIs in general and various versions of TAT in particular, less than a third of laboratories overall have a fully electronic order process, this number being lower than 10% for commercial laboratories. Apart from the functionalities commonly implemented in the laboratory information system (LIS), like result reporting, age/gender-related rules, and basic statistical reporting, advanced use of IT functionality is not widely practiced. This extends to features like autovalidation, which are used by less than 20% of hospital laboratories and less than 40% of commercial laboratories.
Digitalization and mechanical automation appeared to go hand in hand up to a certain degree. While all laboratories processing more than 2000 samples per day used at least preanalytical automation, less than half of the laboratories processing 1000 samples or less per day used preanalytical automation. On the other hand, roughly 75% of laboratories used integrated instruments for clinical chemistry and immunoassays, irrespective of whether they were hospital or commercial laboratories. Track connection was established for the most frequently performed types of analyses (clinical chemistry, immunoassays, and hematology) for only about a quarter of laboratories.
Integrated clinical care
More than 90% of laboratories provide services above and beyond measurements to physicians. Among these are (in descending order) alerts, interpretations and proactive consultations, reflexive test suggestions, as well as diagnostic pathway guidance. From the six services possible, only real time decision support appeared to be applied by less than two thirds of laboratories.
Interestingly, only two thirds of laboratories regularly review guidance given for diagnostic pathways, half of which annually, the other half more frequently. Correspondingly, only about 75% of laboratories participate in various diagnostic committees. A similar proportion of hospital laboratories performed physician satisfaction surveys, while only half of commercial laboratories were active in this direction.
In contrast to the relatively high level of activity regarding classical laboratory/physician-interaction, levels of activity were much lower for more recent areas of laboratory professional activity. Among the latter are test utilization management, with less than 20% of laboratories actively engaged, direct measurement of patient outcomes, and combining data digitally with diagnostic statements from other disciplines. Interestingly, activity was highest in the last of the three areas specified, with commercial laboratories leading the way (26%) and hospital laboratories aiming to follow (18% currently, 8% planning relevant activity in the next 12 months).
About one third to two thirds of laboratories in the survey faced staff shortages, the latter being more pronounced for higher skilled staff compared to lower skilled staff. Also, the shortage was more pronounced in the commercial than in the hospital sector, the former reporting a major staff shortage in 39% of cases while the latter only in 11% of cases. For lower skilled staff, there was almost no major shortage reported in hospital laboratories, while 13% of commercial laboratories reported a major shortage.
Staff productivity, on the other hand, was higher in the commercial sector compared to the hospital sector. In commercial laboratories about 2700 tests were performed per FTE, where this number was less than half in hospital laboratories. The number of tests performed per sample was in both cases around six, the number being slightly higher in commercial laboratories (6.5) as compared to hospital laboratories (5.9).
Automation was associated with higher efficiency in both staff productivity as well as workspace utilization. Laboratories with a high degree of automation executed about 200 tests per m2, with laboratories with a low degree of automation achieved only about half that number. For staff productivity, the association was even stronger with 2600 tests being achieved per FTE in a high-automation environment and only slightly more than 1000 tests per FTE in a low-automation environment.
Subscales and correlations
A significant correlation (Pearson’s r = 0.37, p = 0.002) between the operational performance and integrated clinical care performance subscales was identified. Individual observations can be found in Fig. 2, where hospital laboratories are shown in black, and commercial laboratories are shown in grey. No significant interaction effect between this relation and type of laboratory could be identified (Supplement Fig. 4).
Only 34 out of 65 of laboratories (52%) were able to provide sufficient data to estimate the financial sustainability subscale. Due to this lower de facto sample size, correlation between the operational excellence and financial sustainability subscales, even though of similar magnitude as the correlation between the operational performance and integrated clinical care performance subscales, was significant but would not withstand multiple comparison correction (Person’s r = 0.36, p = 0.037; Fig. 3).
In contrast to financial sustainability subscale and similar to the operational performance subscale, all laboratories surveyed were able to provide sufficient data to estimate the integrated clinical care performance subscale score. No significant correlation could be identified between the integrated clinical care performance and financial sustainability subscales (Supplement Fig. 5). No significant difference (t-test) could be identified between hospital laboratories and commercial laboratories in any of the scales.