Laboratory management of haemolysed samples results of an RCPAQAP survey. Penny Petinos

Transcription

1 Laboratory management of haemolysed samples results of an RCPAQAP survey Penny Petinos

2 Agenda Background to KIMMS survey on haemolysis Results of the 2010 and 2014 surveys Outcomes/decisions 2

3 Background to KIMMS survey KIMMS data consistently showed that haemolysis was one of the top 3 reasons why laboratories reject a sample/test There is little published data on how laboratories manage haemolysed samples To determine current practice in Australian laboratories for haemolysed samples 3

4 Summary data

5 Summary data

6 Survey data 6

7 What information should be captured? What policies exist to manage haemolysed samples (report/results) Where does the problem originate? How is haemolysis determined (manually/electronically)? What does the laboratory do to minimise/reduce haemolysed samples? Is there a need for guidelines from the industry (RCPA/AACB or other professional bodies) on how to manage haemolysis? 7

8 Definition of Haemolysis Haemolysis: the breakdown of erythrocytes in blood, which frees the haemoglobin and intracellular contents from the cells. NOTE: Serum or plasma prepared from hemolysed blood has visible red color when released haemoglobin exceeds 200mg/L (20 mg/dl). The serum or plasma concentrations of other abundant red cell components such as potassium, phosphate and lactate dehydrogenase also may be increased. CLSI Haemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of interference in Clinical Laboratory Analysis: Approved Guideline CLSI document C56- A Wayne, PA. Clinical and Laboratory Standards Institute;

9 Haemolysis Studies have shown that pre-analytical errors are quite significant and haemolysis is the most predominant interference, in pathology laboratories. Carraro P, Plebani M. Errors in a stat laboratory; types and frequencies 10 years later. Clinical Chemistry 2007; 53(7): Haemolysis can interfere with accurate measurement of some analytes in serum or plasma. In particular, lactate dehydrogenase (LD) concentration may be 160 times greater, potassium may be 22 times greater and magnesium up to 3 times greater in a haemolysed sample. CLSI Haemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of interference in Clinical Laboratory Analysis: Approved Guideline CLSI document C56- A Wayne, PA. Clinical and Laboratory Standards Institute; 2012 Moderate haemolysis can influence the reliability of haemostasis results Lippi G, Montagnana M, Salvagno GL, Guidi GC. Interference of blood lysis on routine coagulation testing. Arch Pathol Lab Med 2006; 130(2):

10 Agenda Background to KIMMS survey on haemolysis Results of the 2010 and 2014 surveys Outcomes/decisions 10

11 Results from 2010 and 2014 The 2010 survey was quite comprehensive All Australian participants were invited to complete the survey (Chemical Pathology/Haematology/Transfusion/Microbiology etc.) Huge amount of data collected, report issued over a year later Survey conducted again in 2014 to compare results and identify any significant changes to policies/management of haemolysis 2014 survey not as extensive as the previous survey 11

12 2010 Survey Data Data submitted by 332 laboratories, shown here by discipline Genetics General Pathology (multidisciplinary) Microbiology/Serology Transfusion Immunology Haematology Anatomical Pathology/Cytopathology Clinical Chemistry 0.0% 10.0% 20.0% 30.0% 40.0% 12

13 Demographics 13

14 Causes of Haemolysis Table Major causes of haemolytic specimens in clinical laboratories (European Preanalytical Scientific Committee, EPSC. Available at: 14

15 In vivo haemolysis It is important to note that in vivo haemolysis is a cause of haemolysed samples and it is vital to identify this as the cause of the haemolysis, as soon as possible. In vivo haemolysis can be caused by several disease states including haemolytic anaemia. Where in vivo haemolysis is suspected, it is advisable to differentiate the cause of the haemolysis as rejecting these samples may delay treatment to for the patient and monitoring of the disease. Haemolysis as influence and interference factor, Thomas L, ejfcc vol 13 no 4: 15

16 Causes of haemolysis Studies conducted in the US indicate that haemolysis was higher in samples collected by an iv catheter and the number of haemolysed samples may be reduced by collecting blood samples via venepuncture Kennedy C, Angermuller S, King R, Noviello S, Walker J, Warden J, Vang S. A comparison of haemolysis rates using intravenous catheters versus venepuncture tubes for obtaining blood samples. J Emerg Nurs. 1996; 22(6): Lowe G, Stike R, Pollack M, Bosley J, O'Brien P, Hake A, Landis G, Billings N, Gordon P, Manzella S, Stover T. Nursing blood specimen collection techniques and hemolysis rates in an emergency department: analysis of venipuncture versus intravenous catheter collection techniques. J Emerg Nurs Feb;34(1): Epub 2007 Sep

17 Causes of Haemolysis 17

18 Reporting haemolysis data outside pathology It was interesting to note that 60-64% of laboratories do not report haemolysis rates to those outside the laboratory, despite widespread knowledge that the causes of haemolysis occurs during collection, transport and processing/storage of samples. The data shows most haemolysis originating from areas outside the control of the laboratory, with the exception of collection centres (the 2010 data may reflect changes to the deregulation of collection centres around that time). 18

19 Investigating haemolysis Any failures in the total testing process should be investigated by laboratories conducting root cause analysis of problems. Where the root cause analysis identifies a particular area of concern, then it makes sense to communicate the problems to those areas and work with that area to reduce haemolysis rates, where possible. By reducing haemolysis, laboratories can prevent negative impact to patient care regardless of whether the error was caused by the laboratory or outside the laboratory. Plebani M, The detection and prevention of errors in laboratory medicine. Annals of Clinical Chemistry. 2010; 47: Some KIMMS participants do report the data to specific wards and relevant quality meetings within their organisation and they have reported reductions in haemolysis rates. It is important to stress that this is a continuous improvement process. 19

20 Determining in vitro Haemolysis Visual detection of haemolysis is quite a subjective and unreliable method. In recent times, manufacturers have introduced Haemolysis Index (HI) reporting for analysers. The main advantage to Haemolysis Index reporting is that it overcomes the subjectiveness of visual haemolysis reporting and provides a level of standardisation in the reporting of haemolysis. Haemolysis as influence and interference factor, Thomas L, ejfcc vol 13 no 4: 20

21 Recording haemolysis 21

22 Recording haemolysis 22

23 Cut off values It was impossible to determine the most commonly used cut off for haemolysis as the results were reported in various units, other than those requested. Referring to the 2010 data, values vary from

24 HI as indicator of pre-analytical quality The haemolysis index (HI) is a (semi)quantitative estimate of free haemoglobin and provides a marker or alert to haemolysis interference. In some systems the HI closely approximates the range of haemoglobin concentrations within the haemolysis index. These systems usually monitor absorbance of serum or plasma at various wavelengths. Automated haemolysis index can be used to provide a numerical value that can be used to assess the integrity and quality of the sample. The numerical value can then be utilised to set cut-off values for rejecting a sample. CLSI Haemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of interference in Clinical Laboratory Analysis: Approved Guideline CLSI document C56- A Wayne, PA. Clinical and Laboratory Standards Institute; 2012 Plebani and Lippi suggest consideration should be given to routine reporting of serum indices along with the results of individual analytes and that objective measures of sample integrity such as the serum indices would offer considerable benefits for quality management. Plebani M, Lippi G. Hemolysis index: quality indicator or criterion for sample rejection? Clinical Chemistry & Laboratory Medicine 2009; 47(8):

25 HI as indicator of pre-analytical quality Söderberg et al considered the use of the haemolysis index as a measure of preanalytical quality. Their study measured haemolysis in a number of primary healthcare settings and reports that Emergency Departments stood out as significant contributors to haemolysed samples. Although they used a low cut off of 0.15mg/L of free haemoglobin, they were able to show haemolysis rates were 6 times higher in some primary health settings than others. The haemolysis rate in primary healthcare settings was 10.4% compared to 31.1% in Emergency Departments. The authors were able to show that haemolysis index can be a useful measure of pre-analytical quality. Söderberg J, Jonsson P.A, Wallin A, Grankzist K, Hultdin J. Haemolysis index an estimate of preanalytical quality in primary health care. Clinical Chemistry & Laboratory Medicine 2009; 47(8): KIMMS inlcudes rejection rates for haemolysed samples as one of the key quality indictors in the pre-analytical phase. 25

26 Comments from 2010 survey Any haemolysed coagulation samples are rejected. Biochemistry samples rejected if Haemolysis index >200. Run and reported with affected tests deleted if haemolysis index >100. If haemolysis index between 40 and 100, automatic comment added to report. Haematology samples rejected if biochemistry haemolysis index >200 Haemolysis commenting and specimen rejection is based on multivariant criteria. This is subjective based on such criteria as the urgency, difficulty or likelihood of recollection or clinical worth of a value If a precious sample is haemolysed results are reported with an appropriate comment depending on the assay requested but only if the interference is less than +/- 10%, e.g. Report Potassium as less than the analysed result For difficult to recollect samples such as paediatric or off site collections a result may be reported with a qualifying statement A corrected result is issued only for our Emergency department up to a certain H index, once exceeded results are rejected When recollect is easy, for example on hospital ward, recollect will be organised. When haemolysed sample is a pathology staff collect, at any location, a recollect is organised. When haemolysed sample is a GP collect, sample is run and haemolysis index is used 26

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28 Haemolysis Rejection Policy Participants were surveyed to determine if they had a policy on reporting results on haemolysed samples. In % of respondent indicated they had a Haemolysis Rejection policy compared to 90% in There is still approximately 10% of respondents to the survey indicating they have no formal policy on reporting results on Haemolysed samples 28

29 Survey data on haemolysis policies Response Response % 2010 Response % 2014 Rejects all haemolysed SAMPLES, i.e. all tests on a haemolysed sample Rejects all haemolysed SAMPLES (as above), except precious or irreplaceable samples REJECT TEST results depending on Instrument Haemolysis Index or other assessment of haemolysis interference Perform the test and report TEST RESULTS, WITH QUALIFYING statement that the sample was haemolysed Perform the test and report TEST RESULTS, WITHOUT QUALIFYING statement Haemolysed comment and single ESTIMATE of analytical result reported Haemolysed comment and ESTIMATED RANGE of analytical result reported

30 Haemolysis rejection policy The CLSI guidelines while stating it is the responsibility of the laboratory to reject and/or report results of a haemolysed sample, does not provide guidance on how to report or annotate a result from a haemolysed sample. A survey of Italian laboratories on pre-analytical variables showed that; 54% of laboratories perform testing and report results with a Haemolytic comment in the report 27% do not process the samples (and request a repeat sample) 16% do not test the sample and include a Haemolytic comment and 3% process the sample and correct the result for the haemolysis. This survey demonstrated the variation in reporting of results on haemolysed samples and the apparent lack of policies on haemolysed samples. Lippi G, Montagnana M, Giavarina D, National survey on the pre-analytical variability in a representative cohort of Italian laboratories. Clinical Chemistry & Laboratory Medicine 2006; 44(12):

31 Conclusions The survey data indicates significant variability in the way laboratories reject and report results on heamolysed samples It was difficult to draw any conclusions from this data, other than to highlight the variability in practices, which appears to have improved from 2010 to

32 Agenda Background to KIMMS survey on haemolysis Results of the 2010 and 2014 surveys Outcomes/decisions 32

33 Outcomes RCPAQAP has approached AACB to consider forming a Working Party to develop guidelines for Recommendations for reducing haemolysis of samples It would be useful if the AACB working party can define the exact level that analytical interference starts to be seen and then laboratories can report a rate of haemolysis that is comparable. KIMMS data can be used to raise awareness of unsafe work practices so targeted solutions can be implemented to improve patient safety. A recent example of KIMMS data utilisation is the need for best practice standards for collection of pathology samples. This has been addressed by the Best Practice Pathology Collection Project. Pilbeam, V., Badrick, T. and Ridoutt, L. (2013) Best practice pathology collection for Department of Health, Canberra, Australia. 33

34 Best Practice Pathology Collection To establish best practice pathology collection both the service (customer focus) and technical (laboratory focus) processes are considered and is established by three components: 1. A consensus on the technical aspects or procedure that is undertaken by pathology collectors when collecting blood from a vein. 2. Structured quality assurance systems linked to accredited management standards such ISO 15189, in conjunction with laboratory systems to detect errors in samples; and 3. Assessing and maintaining competence of pathology collectors (including customer service competencies) through training programs that develop the correct skills and techniques required and can provide a structure from which to assess individual competence and benchmark practice 34

35 Outcomes evidence based decisions The Centre for Health Systems and Safety Research, Australian Institute of Health Innovation, UNSW, in collaboration with RCPAQAP KIMMS has undertaken a study with the aim of; Comparing the reported frequency and prevalence, risk and detection variability for haemolysed specimens Measure the levels of haemolytic specimens involving Troponin from Emergency Departments (ED) and the number of tests not reported, and Investigate the measures employed by a group of pathology laboratories to identify variation and their impact on the quality and effectiveness of laboratory processes The study will provide real data on the impact these incidents have on patients and the risk associated with these incidents, from a quality health care perspective. 35

36 Outcomes Findings; Haemolysis rate was 3 times higher from the Emergency Department than other hospital departments The Emergency Department length of stay was increased when the sample was haemolysed 5.3% of specimens collected for a Troponin test were haemolysed and there were 11, 983 repeat Troponin tests Risk factors associated with haemolysis in hospitals; there was a higher rate of haemolysis in the very young and elderly patients, in females compared to males, specimens collected by non-phlebotomy staff and specimens collected on weekends 36

37 Acknowledgements RCPAQAP KIMMS Advisory Committee Stephanie Gay KIMMS Project Officer Department of Health, Quality Use of Pathology Program (QUPP) for funding of the KIMMS Program 37