Gisborne Hospital Report - Health and Disability Commissioner

More documents

Recommendations

Info

Gisborne Hospital 1999 – 2000 PSA Testing Procedures 3.31 QC Reporter 2.0 was a software package created by Westgard Inc applying mathematical/statistical rules for quality control. This Westgard Rules programme was used to determine if the quality control rules were able to detect clinically significant errors, which had been introduced into the system. This programme required data to be entered before it could produce a CV% standard deviation graphically represented, so that it could be detected if results were going “out of control” (outside the tolerable limits of standard deviation). 3.32 The AxSYM and Beckman analysers had ‘on board’ quality control data management systems. However, according to Mr Rutledge, these quality control systems were not “easily managed in terms of data manipulation or data summary” and were more “labour intensive”. According to THL these ‘on board’ quality control systems were not in use at the time. 3.33 Mr Rutledge explained that it was his practice every month, using the QC Reporter 2.0 programme, to print out the quality control graphs (Levey- Jennings plots) for that month, as well as a weekly summary for the last 12 months. He could then see if over one week the results had shifted. If anything had happened he could make entries in the comments column of his spreadsheet to give an explanation for the observed variance. 3.34 The QC Reporter 2.0 programme required staff (usually Mr Rutledge) to take the quality control printouts off the analysers, and to sit down in the chemistry office and type in the data. The software would then assess the data against the Multirule tests and the programme would graphically represent the results as being within or outside the allowable range for that test. The programme produced a Levey-Jennings graph for each analyte. It showed what had happened over the month or weekly over a six-month period, averaging out results. Mr Rutledge thought this was superior to the analysis provided by the “on board” quality control data management systems. 3.35 Mr Rutledge believed “that the QC Reporter 2.0 programme allowed for easier calculations and produced good graph results to assist in analysis of the data”. He observed that “the QC Reporter programme was used over a number of years and [was] never commented on adversely in any of the IANZ reports, nor were any CARs [Corrective Action Requests] raised with regard to it”. PSA testing 3.36 Mr Rutledge stressed that he had not been asked for his perspective by THL during its investigation into the cause of the problem. He has attempted to determine a cause from media reports. Without access to the relevant data he was only able to surmise and speculate on what was found by the THL internal investigation. Nor was he able to say what may have happened since he left the laboratory in early March 2000. The PSA testing error was discovered in June 2000. 3.37 Mr Rutledge said that he followed the manufacturer’s standard operating procedures in running biochemistry tests. He noted, “the fact is that we were not informed by Abbott Diagnostics that the [Total PSA] calibrators would 147
Gisborne Hospital 1999 – 2000 PSA Testing Procedures successfully calibrate the PSA [reagents] and that the results would be lower [than they should be]. If we had not followed manufacturer[’s] instructions no calibration curve would have been produced hence … patient samples could not be analysed.” However, the manufacturer’s package inserts warned against the incompatibility of Total PSA and PSA assays. 3.38 Mr Rutledge advised that Abbott Diagnostics had not been able to explain to him why the combination of these two agents did not result in a rejection of the quality control process by the machine. As far as Mr Rutledge can surmise, the AxSYM accepted the calibration data from the Total PSA calibrators using the PSA controls and indicated that “everything was within limits. It produced a valid calibration curve which means the machine is ready to accept patient samples” for analysis. 3.39 Mr Rutledge recalled noticing that the control results were “say, 50% lower than expected” on the Levey-Jennings plots. He believed at that point he “would have thought that something was not quite right” and run the calibrators again. The machine accepted the process and gave a valid calibration curve. Mr Rutledge acknowledged that he “relied on the machine to inform him as to whether the calibration had failed and therefore to not use it”. He thought that at the time he would have “considered that the decrease in the control value was attributable to the laboratory using a third party control and new PSA – as opposed to old [Total] PSA reagents”. 3.40 Mr Rutledge assumed what would have happened is that whoever was running the test would have told him that the controls were out. He would have asked if the calibrators were “okay” and if he had been told they were new calibrators he would have advised the technician to run the calibrators again. When “that was done they would have said the controls were still out. Then I would have said as the calibration has been accepted [by the machine], it must be the controls causing these problems. The controls are third party controls [made by a manufacturer other than the manufacturer of the machine being used] – therefore I would have accepted those results.” Nobody drew to his attention that the calibrators, though PSA, did not match the PSA reagent-type. He did not discover it himself. 3.41 Abbott Diagnostics supplied the calibrators for the PSA testing and the reagents, Mr Rutledge said the controls were supplied by a third party manufacturer. Mr Rutledge therefore concluded that he would have attributed the controls being due to the use of the third party controls and a change in the test reagent (ie, from Total PSA to PSA). Mr Rutledge recalls that he did not go back to the manufacturer of the third party controls to query the “lower than expected” results “because he had rationalised the result”. He therefore did not feel he had to go back to the manufacturers. Mr Rutledge would have concluded that the results were lower based on the difference in the test itself, not due to the process used or the substances used in the biochemistry section of the laboratory. 3.42 As is clear from paras 3.38 to 3.40, Mr Rutledge assumed the laboratory was using third party controls, obtained from a source other than Abbott Diagnostics. THL advised that third party controls were not used. Apparently 148
Page 1 and 2:
GISBORNE HOSPITAL 1999 - 2000 A rep
Page 3 and 4:
Table of Contents Page Executive Su
Page 5 and 6:
1. BACKGROUND EXECUTIVE SUMMARY 1.1
Page 7 and 8:
3. THE ENVIRONMENT 3.1 My investiga
Page 9 and 10:
pathologist, staff shortages and pr
Page 11 and 12:
Gisborne Hospital 1999 - 2000 Intro
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Chapter 2 Quality Assurance Systems
Page 31 and 32:
Gisborne Hospital 1999 - 2000 Quali
Page 33 and 34:
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
Page 57 and 58:
Gisborne Hospital 1999 - 2000 Incid
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Gisborne Hospital 1999 - 2000 Opera
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106: Gisborne Hospital 1999 - 2000 Opera
Page 145 and 146: Gisborne Hospital 1999 - 2000 PSA T
Page 155: Gisborne Hospital 1999 - 2000 PSA T
Page 183 and 184: Gisborne Hospital 1999 - 2000 Patie
Page 189 and 190: RECOMMENDATIONS Quality Assurance S
Page 191 and 192: Gisborne Hospital 1999 - 2000 Recom
Page 193 and 194: Gisborne Hospital 1999 - 2000 Recom
Page 195 and 196: APPENDIX NZNO LETTER TO MINISTER OF
Page 197 and 198: 11. The anaesthetist had a practice
Page 199 and 200: THE ANONYMOUS LETTER The anonymous
Page 201: GLOSSARY ABBREVIATIONS A&E A,T&R AQ
show all

Gisborne Hospital Report - Health and Disability Commissioner

Create successful ePaper yourself

Delete template?

Save as template?