Preanalytical errors and patient outcomes

Transcription

1 Preanalytical errors and patient outcomes ANA-MARIA SIMUNDIC C L I N I C A L I N S T U T E O F C H EMIS T RY U N I V ERS IT Y H O S PITA L C ENTER S ES T R E M I LO S RDNIC E Z A G R EB, C R O AT IA

2 It is estimated that 70% of all medical decisions are based on the results of laboratory tests.

3 70% claim 70% claim is not based on published evidence (data), evidence is not available Hallworth MJ. The '70% claim': what is the evidence base? Ann Clin Biochem. 2011;48(Pt 6):487-8.

4 The IFCC Task Force on the Impact of Laboratory Medicine on Clinical Management and Outcomes Aim: Evaluate the available evidence, Develop the study design for future studies established in 2012 Hallworth M, et al. Current Evidence and Future Perspectives on the Effective Practice of Patient-Centered Laboratory Medicine. Clinical Chemistry 2015:61;

5 IFCC TF: Contribution of the laboratory to the patient outcome? The available evidence is poor To obtain the evidence for the contribution of laboratory medicine to the healthcare, we need: better understanding of the mechanisms by which value is added or reduced original data, well designed clinical studies. Hallworth M, et al. Current Evidence and Future Perspectives on the Effective Practice of Patient-Centered Laboratory Medicine. Clinical Chemistry 2015:61;

6 Do we know the contribution of preanalytical errors to the value of laboratory medicine? The objective evidence is missing for the effect of many preanalytical errors on the: Patient outcome Sample quality Healthcare cost

7 Value? Clinical value (improvement of health-related outcomes) Economical value (cost-efficiency or effectiveness) Net value = benefit harm* *(undesirable effects of testing) Show the increase in benefit (difficult) Show a reduction of harm Hallworth M, et al. Current Evidence and Future Perspectives on the Effective Practice of Patient-Centered Laboratory Medicine. Clinical Chemistry 2015:61;

8 Instead of studying the process defects, we should focus more on studies that show a reduction of harm and cost. Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf. 2013;22 Suppl 2:ii6-ii10

9 We need better preanalytical studies! Most of the studies so far: have been descriptive have been reporting process defects without a connection to the patient harm/outcome: TAT sample haemolysis, Clotted samples, insufficient quantity of sample, etc Important sources of patient harm are overlooked. Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf. 2013;22 Suppl 2:ii6-ii10

10 Harms? most frequent Patient harm due to the laboratory testing Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf. 2013;22 Suppl 2:ii6-ii10

11 Lundberg GD. Adding outcome as the 10th step in the brain-to-brain laboratory test loop. Am J Clin Pathol. 2014;141(6): Appropriate test request helps the patient Appropriate test is ordered Test is conducted Test results are returned in time Test results are correctly interpreted Test results affect decision Direct improvement of patient outcome

12 Lundberg GD. Adding outcome as the 10th step in the brain-to-brain laboratory test loop. Am J Clin Pathol. 2014;141(6): Why are laboratory tests requested? diagnosis, monitoring, screening, prognosis education, to confirm a clinical opinion, to both establish and complete a database, insecurity, curiosity, patient or family pressure, peer pressure, pressure from the recent literature, concern for liability (legal requirement), documentation, question of accuracy of a prior result, unavailability of a prior result, hospital policy, personal or hospital profit, hunting or fishing expeditions, frustration at nothing better to do ( I don t know what is wrong with this patient better get some laboratory tests ), to buy time ( maybe by the time the laboratory results come back, I will have a better idea what is wrong with this patient or the patient may cure herself or himself ), simple availability, ease of doing, what I learned in residency pure habit.

13 Lundberg GD. Adding outcome as the 10th step in the brain-to-brain laboratory test loop. Am J Clin Pathol. 2014;141(6): Substantial proportion of the ordered tests was quite often not appropriate the results are normal (negative) the results show no change from prior test many test results have never been looked at were they necessary in the first place?

14 Many results are never looked at Kilpatrick ES, Holding S. Use of computer terminals on wards to access emergency test results: a retrospective audit. BMJ 2001;322:

15 11-month period, outpatients 464/22,445 (2.1%) patient reports were never collected 1.4 report/day Most expensive tests most likely to not be collected (mollecular, immuno, tox, etc.) The total cost for those tests was 30% of the average 1-month laboratory budget. Simundic AM, et al. Efficiency of test report delivery to the requesting physician in an outpatient setting: an observational study. Clin Chem Lab Med. 2009;47(9):

16 Tools to manage test requests many options are available some tools are better and other are not, tools are most effective when many are used simultaneously utilization management interventions improve patient health and reduce waste Baird G. The laboratory test utilization management toolbox. Biochem Med. 2014;24(2):

17 Baird G. The laboratory test utilization management toolbox. Biochem Med. 2014;24(2):

18 Baird G. The laboratory test utilization management toolbox. Biochem Med. 2014;24(2):

19 Baird G. The laboratory test utilization management toolbox. Biochem Med. 2014;24(2):

20 Baird G. The laboratory test utilization management toolbox. Biochem Med. 2014;24(2):

21 only 9% ctn are positive Example 1: Cardiac troponins Test is useful only when applied to patients with a high pretest probability of ACS. Study done in 2014, at the Royal Gwent Hospital in Newport, Wales: it was noted that in most cases a troponin request was just a routine "tick box" practice troponins were requested even before patient was assessed by a clinician. the aim: reduce the unnecessary ctn requests 3 x one week audit (before and after the intervention) Gardezi SA. Troponin: think before you request one. BMJ Quality Improvement Reports 2015; u w3221

22 Improvement strategy Results were presented in a clinical gathering. Strategy for improvement: Requesting troponin only when ACS was suspected Discouraging the random tick box practice Poster display of results in all clinical areas and specifically in accident and emergency (A&E) department and the medical assessment unit (MAU). AND/OR chest pain palpitations shortness of breath collapse/syncope await clinical assessment Gardezi SA. Troponin: think before you request one. BMJ Quality Improvement Reports 2015; u w3221

23 Intervention improves ctn requesting pattern TOTAL REQUESTS POSSIBLY CARDIAC NON-CARDIAC PDSA (72%) 60 PDSA (84%) 24 PDSA3 159 (25% reduction) 144 (90%) 15 number of requests decreased test used better saving of 100 per week still room for improvement Gardezi SA. Troponin: think before you request one. BMJ Quality Improvement Reports 2015; u w3221

24 Example 2: vitamin D request management 25 hydroxyvitamin D level (25(OH)D) is recommended to evaluate vitamin D status 1,25 hydroxyvitamin D (1,25(OH)2 D) is only recommended to monitor several particular conditions (chronic kidney disease, hereditary phosphatelosing disorders, and some other) Comment added to the test report: Serum 1,25(OH)2D does not reflect vitamin D reserves, and its measurement is not useful for monitoring vitamin D status. The use of vit D is defined by the Endocrine Society clinical guidelines. Salinas M, et al. Education and communication is the key for the successful management of vitamin D test requesting. Biochemia Medica 2015;25(2):

25 number of requests decreased test used better saving of 1200 per annum still room for improvement Salinas M, et al. Education and communication is the key for the successful management of vitamin D test requesting. Biochemia Medica 2015;25(2):

26 Meta analysis Focusing on ordering the right test during initial evaluation, may have even greater impact on improving care. Zhi M, et al. The landscape of inappropriate laboratory testing: a 15-year meta-analysis PLoS One. 2013;8(11):e78962

27 Harm is also caused by delays in reporting the test results...

28 Specimen rejection related harm? Repeated sampling: 86.8% of rejected blood specimens led to repeated phlebotomy. 13.8% of rejected urine specimens required recatheterization of the patient to collect a new urine sample. inconvenience and discomfort for the patient, potential for patient complications. Delay in reporting of the results: the median specimen processing delay was 65 minutes potential for the failure to provide adequate care in a timely manner Karcher DS, et al. Clinical Consequences of Specimen Rejection: A College of American Pathologists Q-Probes Analysis of 78 Clinical Laboratories. Arch Pathol Lab Med. 2014;138:

29 Minimizing delays 1/2 Hemolysis was frequent in sera collected in distant primary care locations ( K) False hyperkalemia may lead to inappropriate admission to the hospital and delays due to the need to repeat the test. Study lasted six months prior to and after the intervention Intervention: on-site centrifugation. Turner HE, et al. The impact of centrifugation in primary care on pseudohypokalaemia: a retrospective evaluation. Ann Clin Biochem 2013;50:

30 Minimizing delays 2/2 Result a significant decrease in the number of: hyperkalemic samples following the implementation (2244 vs. 524; P < ). inappropriate hospital admissions (22 vs. 6 cases). Conclusions: The centrifugation of serum samples in primary care improves the sample quality and the integrity of the potassium results Also, improvement in patient management and quality of care was demonstrated. Turner HE, et al. The impact of centrifugation in primary care on pseudohypokalaemia: a retrospective evaluation. Ann Clin Biochem 2013;50:

31 Harm is caused by reporting the inaccurate test results...

32 Example 1: manual management of serum indices

33 Manual management of serum indices Aim: To asses the patient risk caused by visual assessment and manual handling of hemolyzed samples in our emergency laboratory, in December /3 (N=260) 2/3 (N=520) inaccurate results reported unnecessary rejection In the period of one week there were 495 (15.5%) hemolyzed samples with 2518 requested tests. Even 780 results (31%) were incorrectly managed (4.8% of the total test volume). Miler M, Nikolac N, Luksic AH, Bakliza A, Dukic L, Simundic AM. Risk assessment for manual handling of hemolyzed samples on patient safety. 2015;Suppl1:I10

34 Critical tests with the highest combination of risk and occurrence* are ctnt and K O5 S1 S2 S3 S4 S5 O4 AST, LDH Bil (dir) Total Bilirubin K TnT O3 Amil O2 ALT Ca, Cl O1 ALP, GGT P, Mg, PROT CRP, Urea, Na, Creat Lakt, LIP, ALB, Ethanol, CK Glucose *ISO14971:2012 Medical devices: application of risk management to medical devices. ISO: Geneva, Manual handling of hemolyzed samples increases the risk of reporting inaccurate results for ctnt, K and total bilirubin, possibly affecting the clinical decision and patient outcome. Miler M, Nikolac N, Luksic AH, Bakliza A, Dukic L, Simundic AM. Risk assessment for manual handling of hemolyzed samples on patient safety. 2015;Suppl1:I10

35 Example 2: liquid citrate tube leads to missclassification of DM patients Juricic G, Milevoj Kopcinovic L, Saracevic A, Bakliza A, Simundic AM. Liquid citrate acidification introduces significant glucose bias and leadsto missclassificatioon of patients with diabetes. CCLM, 2015, in press

36 Juricic G, Milevoj Kopcinovic L, Saracevic A, Bakliza A, Simundic AM. Liquid citrate acidification introduces significant glucose bias and leadsto missclassificatioon of patients with diabetes. CCLM, 2015, in press

37 Juricic G, Milevoj Kopcinovic L, Saracevic A, Bakliza A, Simundic AM. Liquid citrate acidification introduces significant glucose bias and leadsto missclassificatioon of patients with diabetes. CCLM, 2015, in press

38 The future (outcome based) preanalytical studies must aim to. obtain the evidence showing that... Reducing the number of unnecessary tests Increasing of the number of necessary tests Minimizing delays Ensuring that accurate results are reported...leads to the improved patient outcome or reduced cost.

39 A good preanalytical outcome study... Assess the risk of preanalytical errors Focus on the errors that have the highest risk of patient harm Define a good study question (PICO): is the reduction of some preanalytical error associated with improved patient outcome and cost reduction? good outcome studies are difficult to do because: the association of the intervention and the outcome is not always so obvious. the outcome is affected by many other intermediate variables data collection and reporting methods are not standardized but not impossible...

40 Outcome studies can teach us how to sail safely, how to avoid Titanic errors and possibly reach the land of a beautiful paradise island. The Pathologist. Simundic AM. Avoiding Titanic errors. Texere Publishing. May 2015

41 Thank you! Stiniva, Island Vis, Croatia