Send letter to journal:
Re: Response to comments by Leman and colleagues

Dear Editor

We were interested to read the recent rapid response to our short report by Leman and colleagues,[1] but were surprised that they seem to have taken issue with the findings, particularly as the purpose of audit is to evaluate practice and, with the application of the iterative audit cycle, improve the quality, effectiveness, and efficiency of care provided.

While we accept that the paper has several limitations, and that Dr Leman and his emergency department (ED) colleagues make some useful points, we still feel there are important lessons to be learnt for both occupational health (OH) and the emergency departments, and would like to respond in detail to the comments made by the ED physicians.

We agree that the title could have been different and, while we accept that there may be factors which may influence out-of-hours performance, we disagree with their assertion that there is a significant difference between the groups of staff seen in the ED and the OH department; there is no information to suggest that the two groups of staff (that is those seen in-hours and those seen out-of-hours) are so different that the results were significantly biased.

We agree that the major limitation in this study is that non-recording of data was used as a surrogate for omission in procedures and this was naturally discussed in the paper. However, we would like to point out that adequacy of records is an important part of clinical practice, and many audits and research are based on this. Furthermore, incompleteness of proforma or records cannot be excused both from a clinical governance or from a medicolegal perspective, and the fact that ED proforma are not being completed in itself warrants some further evaluation.

In addition, it seems that Dr Leman and colleagues feel that our conclusions are based purely on non-recording of data. This is not the case; our conclusions were also based on incorrect or inappropriately recorded data. Furthermore, data such as whether appropriate recipient and source blood testing had been arranged, or whether hepatitis B post-exposure prophylaxis or HIV post-exposure prophylaxis had been prescribed were corroborated by checking objective information such as blood test results, and batch numbers or completed drugs charts documenting administration of drugs or vaccines.

There also seems to be an intimation by the ED physicians that the paper was biased because of non-blinding and because the authors used their own criteria for assessing adequacy of risk assessments and management. The issue of non-blinding was discussed in our paper, and we do not accept that non-blinding would have seriously affected the results. The criteria used for assessing adequacy of assessment and management were based on both trust policy and national standards – not made up on the whims of the authors.

As stated in our paper, there are shortcomings in the management of occupational body fluid exposures both in and out-of-hours. The deficiencies in the OH Department are being addressed and extra staff training has been instituted. We are confident that our management of body fluid exposures has improved as a result of this.

We disagree that it is ‘difficult to draw many conclusions about the HIV PEP data.’ The data extracted from the notes is shown in table 2, and the validity of our concerns is selfevident in this table, and shows that even with incomplete risk assessments HIV PEP should not have been prescribed in a number of ED cases. ,

We were aware that some of the individuals presenting to the ED with body fluid exposures were not staff, and as this was clearly recorded in the ED records we were able to specifically exclude non-employees from the data analysis. Therefore, there was no patient misclassification, and the poor attendance rate at the OH department was an accurate, and non-biased finding.

We agree that ED staff are experienced in clinical risk assessment; however, in our paper we were referring to risk assessment in the context of occupational health. While this was not stated explicitly in our paper, it is something that would have been clear to the readers of Occupational and Environmental Medicine - who will appreciate that clinical risk assessment for managing disease in ‘patients’ is very different to risk assessment in healthy staff in the context of disease prevention.

Our paper mentions several solutions to the shortcomings in present procedures in our trust – one being the provision of out-of-hours OH telephone advice for management of body fluid exposures, another being the development of management algorithms. We provided examples of two similar trusts where this system seems to work efficiently. Our suggestion that using management algorithms may help is based on the fact that they seem to have been useful in many aspects of medicine. Of course, an intervention study would be the best way of ascertaining this, and would be an ideal way of completing the audit cycle.

The final point in the response from Dr Leman and colleagues is astonishing: the authors seem to think that audit should be subject to the same consent and ethics committee review processes as research. The General Medical Council guidelines on confidentiality and research state quite clearly that guidance relating to research does not apply ‘to clinical audit which involves no experimental study...’ Moreover, in the case of audit the guidance states that disclosure of anonymised data does not require patient consent.

In addition, the assertion that this work was performed without the consent of the ED is similarly surprising: one of the signatories gave their permission and support for this analysis to be done. Furthermore, at least three of the signatories saw an early draft of this paper which was sent to one of the ED physicians for comment. The less than constructive criticism from three of the signatories actually made us question whether this paper was worth submitting for publication. Accordingly, we asked three senior consultants (in other relevant specialties) within the same trust to provide an objective overview of the paper. All three (one a professional epidemiologist) felt that, despite the acknowledged limitations, our findings were worth reporting. The peer review process instituted by OEM confirmed this, including as it did a helpful critique from the US where they are in no doubt of the importance of this issue. As a consequence of our original experience with the ED, we did not feel that asking for their consent for publication would serve any useful purpose.

The response by Leman and colleagues shows quite clearly that they have not appreciated the main message of our paper - namely, that present procedures do not serve the best interests of staff, and there are implications for both the OH department and ED. Moreover, the suggestion that an occupational health department could run as a telephone advisory service indicates their lack of understanding of occupational health practice. We agree that audit should be collaborative in order to develop and support best practice.

Dr Dipti Patel (Occupational Physician)
Dr Ira Madan (Occupational Physician)
Dr David Snashall (Occupational Physician)

Reference

(1) Leman P, O'Connor N, Terris J, Goudie A and Lacy C. Occupational Health Department role in bodily fluid exposures [electronic response to Patel D et al., Out of hours management of occupational exposures to blood and body fluids in healthcare staff] occenvmed.com 2002 http://oem.bmjjournals.com/cgi/eletters/59/6/415#39

Send letter to journal:
Re: Occupational Health Department role in bodily fluid exposures

Editor

We read with interest Patel et al.'s paper [1] on healthcare workers exposures to blood/bodily fluids. The title of the paper is a misnomer, as none of the patients seen in the Occupational Health Department (OHD) were managed out of hours, and this significant difference in the populations studied is one of the majors biases affecting the results of this study.

The authors have attempted in the first instance to draw conclusions about clinical effectiveness from the completeness of data collection forms, this surrogate marker has not been shown to be a good quality predictor of overall clinical effectiveness. The absence of a written (or readable) record does not imply that the information was not obtained by the clinicians, only that it was not recorded by the investigator. The authors freely admit that non blinding of the data analysis may have led to bias in ascertaining completeness of the forms. The pejorative use of the words 'inadequate', 'inexperience', and 'alien' by the authors serves to illustrate one of the hazards of this lack of blinding,

The authors are keen to draw conclusions about the completeness of forms, and we are concerned that up to one quarter of the patients seen in the OHD had an inadequate risk assessment performed (see table 1 [1]) according to the authors criteria. This is despite the non emergent working environment of the OHD, and that occupational health exposure and screening is the main purpose of the staff employed there. We would hesitate to accept training when the potential OHD trainers failed to meet their own criteria of effectiveness.

It is difficult to draw many conclusions about the HIV PEP data. Clearly access to information about patients and access to blood tests is vastly different between the opening hours of the OHD and the time when staff members present to the Emergency Department (ED), which invalidates the authors conclusions. The majority of patients with blood borne virus exposure that are treated in the department are not staff but members of the public and public services (Police, Council employees, etc). Expert advice upon management is available on a 24-hour basis from a consultant virologist. Many of these patients are followed up outside the OHD and it seems that the reason for the poor attendance rate at the OHD is misclassification by the authors of these patients.

The authors state that one their main findings was the inappropriate prescribing of HIV PEP, yet without adequate data extraction by the investigators, it is hard to see how this has been proved by the investigators.

I am surprised that the authors feel that the emergency department staff are unable to provide risk assessments (..may be alien...), perhaps the authors lack of exposure to modern ED clinical practice has led them to this specious conclusion. We would certainly welcome member of any OHD team into the department to see the constant risk assessments that occur on a minute by minute basis across the whole spectrum of medical illness.

The authors conclude that a 24-hour OHD on-call service would solve the problem of inadequate data collection, yet fail to provide any evidence to support this statement.. Neither do they provide any evidence in the paper to support their assertions that further training or involvement in algorithm development is a means of improving data collection.

We do agree that OHD staff are best placed to assess occupational blood or bodily fluid exposure and would be very happy to support hospital staff attending a 24-hour OHD clinic for formal assessment, examination and blood testing., if they were willing to provide this. If the authors fell that a telephone call is all that is required, then perhaps this could also be sufficient for the daytime practice of OH medicine as well.

On a final point we are concerned that this retrospective audit has been performed upon patients and published without either the consent of the consultants responsible for the ED patients, the ethics committee of the trust involved or indeed the consent of the patients themselves.

Retrospective audit should be collaborative in order to develop and support best practice. The seamless integrated care pathway that is needed to improve care for health care workers (and others) affected by exposure to blood/bodily fluids, requires the co-operation and team working of all parties, not the unsubstantiated and biased conclusions provided by the authors of this paper

Dr Peter Leman
Emergency Physician

Mr Niall O'Connor
Emergency Physician

Dr Jane Terris
Emergency Physician

Dr Adrian Goudie
Emergency Physician

Dr Chris Lacy
Emergency Physician (Head of Service)

Emergency Department
St Thomas' Hospital

References

[1] Patel D, Gawthrop M, Snashall D, Madan I. Out of hours management of occupational exposures to blood and bodily fluids in healthcare staff. Occup Environ Med 2002;59:415-8.