Impact of new guidelines for blood exposure incidents in The Netherlands

Transcription

1 Occupational Medicine 2010;60: Advance Access publication on 6 May 2010 doi: /occmed/kqq035 Impact of new guidelines for blood exposure incidents in The Netherlands P. T. L. van Wijk 1,2, G. J. Boland 2,3, A. Voss 4,5 and P. M. Schneeberger 1,6 1 Department of Medical Microbiology and Infection Control, Jeroen Bosch Hospital, 5200 ME s-hertogenbosch, The Netherlands, 2 National Hepatitis Centre, Amersfoort, The Netherlands, 3 Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, The Netherlands, 4 Department of Medical Microbiology and Infectious Diseases, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands, 5 Nijmegen University Centre for Infectious Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands, 6 Centre for Infectious Disease Control/National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. Correspondence to: P. T. L. van Wijk, Department of Medical Microbiology and Infection Control, Jeroen Bosch Hospital, POB 90153, 5200 ME s-hertogenbosch, The Netherlands. Tel: ; fax: ; p.v.wijk@jbz.nl Background In 2007, a new set of guidelines for blood exposure incidents was introduced in The Netherlands to standardize management and reduce use of hepatitis B immunoglobulin (HBIg). Accidents now have to be assigned into risk categories with the corresponding medical intervention. Aims To study the consequences of the guidelines on overall risk assessment and costs of hepatitis B virus (HBV) prevention. Methods Incidents (n 5 461) from both hospital as well as non-hospital health care workers and others registered by a call centre from the year 2005 were reassessed and reclassified as no-risk, high-risk or low-risk according to the corresponding risk categories of the new guidelines. The differences in classification, use of HBV immunoglobulin, source testing and the costs of the HBV prevention strategy were evaluated. Results Of all incidents, 86% could be reassigned directly into the new risk categories. However, there was a significant shift from low- to high-risk incidents. Overall, administration of HBV vaccination increased and administration of HBIg decreased significantly, although within the group of high-risk incidents, administration of HBIg increased. There was no effect on the frequency of reference serum taken after an incident. While fewer incidents needed intervention, the total costs of HBV prevention still increased by 50%. Total costs increased by 13%, due to a shift in classification. Conclusions The use of the new protocol facilitated standardized risk assessment for blood exposure accidents. HBIg administration and source testing decreased. An increased proportion of high-risk classifications resulted in an increase in the associated costs. Key words Blood exposure incidents; costs; hepatitis B; risk assessment. Introduction Blood exposure incidents may lead to infection with hepatitis B virus (HBV), hepatitis C virus (HCV) and the human immunodeficiency virus (HIV) in the exposed [1 3]. In general, most incidents occur during work, especially in health care-related settings [3 6]. Adequate risk assessment and counselling of the injured party is a challenge because of the different nature of the incidents, the lack of standardized and universally used guidelines, the differences in medical background and attitude of counsellors and the anxiety of the injured person due to the possible consequences of becoming infected [3,7 9]. In May 2007, a new set of guidelines to handle blood exposure incidents were introduced in The Netherlands [10]. It was the result of cooperation among medical professionals from various disciplines. These guidelines were based on a review of existing national and international guidelines and the latest evidence with regard to the risk of transmission of blood-borne viruses and the prevalence of blood-borne viruses in The Netherlands. Three major differences distinguish the new version from previous guidelines. 1. The risk assessment is primarily based on the classification of the incident into a high-, low- or no-risk category. Risk categories are based on the kind of Ó The Author Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please journals.permissions@oxfordjournals.org

2 P. T. L. VAN WIJK ET AL.: IMPACT OF NEW GUIDELINES FOR BLOOD EXPOSURE 271 injury and the assumed amount of blood transmitted. High-risk incidents pose a risk for transmission of HBV, HCV and HIV low-risk incidents only for HBV. In all cases classified as no risk, no risk of transmission of any blood-borne viruses is assumed. In order to support an adequate and reproducible classification of incidents, a list of the most commonly observed blood exposure incidents were compiled (Table 1). 2. The management of incidents involving the risk of HBV transmission has changed significantly, aimed at reducing the use of HBV immunoglobulin (HBIg). Non-immunized persons at risk of HBV infection now preferably receive HBV vaccination instead of HBIg, with the exception of those who might not respond to vaccination or are known non-responders. This was based on the assumption that with a relatively small amount of transmitted HBV and a long incubation period, actively immunized individuals still have enough time to develop protection [11]. Long-term protection against HBV by active vaccination is also important for injured persons who may be at risk of future accidental blood exposure incidents. Last but not least, there is some concern about transmitting pathogens by using human blood products, such as HBIg [12]. However, if the source is HBV positive or likely to be positive, HBIg as well as HBV vaccines are administered. 3. For prevention of HIV in high-risk incidents when the source patient is unavailable for testing, one has to refer to the potential risk within known risk groups, if known at all, before administering post-exposure prophylaxis [10]. To assess the consequences of the new guidelines on the risk assessment and handling of incidents, we reassessed the data from 1 year of blood exposure incident registration in our region (2005). We specifically studied the differences in risk assessment between the new and old guidelines and whether it was possible to assign blood exposure incidents into an appropriate category. We also calculated whether the use of HBV immunoglobulin and source testing decreased. Finally, we calculated the differences in the costs of the HBV prevention strategy prior to and after the change in the guidelines. Table 1. Summary of the National Guidelines on Needlestick Injuries, risk assessment based on the nature of the injury Risk accident Overall estimate Risk according to virus HBV HCV HIV Blood spots on intact skin None Blood spots on non-intact skin (e.g. active eczema or fresh scrapes) Low Extensive contact with blood in combination with open wounds (e.g. stab wounds, cuts) Blood or blood-contaminated fluid on mucous membrane Other potentially infectious fluid on mucous membrane Low Bite wounds, risk for the person bitten (saliva of perpetrator in Low the wound of the person bitten) Bite wounds occurring during a fight, risk for the person bitten (saliva mixed with blood) Bite wounds, risk for perpetrator (blood of the person bitten on mucous membrane of the mouth of the perpetrator) Superficial skin injury of the victim with no visible blood (scratch) None Injury involving a needle used for subcutaneous injection Low (insulin/heparin) Injury involving a needle used for intramuscular injection (blood Low from the source not visible) Injury involving a needle used for intramuscular injection (blood from the source visible) Injury involving a suture needle used for an intracutaneous/subcutaneous Low procedure (blood from the source not visible) Injury involving a suture needle used for a procedure other than those specified above or involving a suture needle when blood from the source is visible Injury involving needle or lancet used for a finger prick test (glucose test) Percutaneous injury other than those specified above (e.g. infusion needle, operating room equipment) 2 indicates negligible risk of transmission of the virus in question; 1 indicates low risk of transmission of the virus in question; 11 indicates high risk of transmission of the virus in question.

3 272 OCCUPATIONAL MEDICINE Methods In the Dutch region of North East Brabant, a call centre for blood exposure incidents handles all incidents occurring both inside and outside hospital settings by telephone on a 24/7 basis [6]. The centre serves a region of inhabitants and two major hospitals (1800 beds) and registers all incidents systematically. On an annual basis, 450 incidents are registered [13]. All incidents registered by the call centre in the year 2005 were analysed with regard to risk classification and measures. All incidents were then reassessed (authors P.T.L.W. and P.S.) and reclassified as no-risk, low-risk or high-risk, according to the corresponding risk category of the new guidelines. Three groups of injured were identified: hospital employees, non-hospital health care workers (HCW) and other persons. The last category includes, for example, law enforcement and prison workers, cleaning staff and civilians. Two types of incidents with suture needles and needles used for the administration of local anaesthetics were analysed separately. The new guidelines assign incidents with these devices to different risk categories (low- and high-risk, respectively) depending on whether there is visible blood on the device at the moment of injury. Because this was not recorded in 2005, the proportion of devices with visible blood in 2008 was used. Next to assessing the differences with regard to risk group assignment, we evaluated the impact of the changes with regard to HBV, HCV and HIV prevention. Comparing the old and new guidelines, differences in the outcome of risk estimation were calculated (odds ratios (OR), confidence intervals (CI) and chi-square tests were used to calculate P-values), as well as the difference in costs involved in taking the appropriate measures. Price levels of 2005 were used for HBIg (e145), hepatitis B vaccination (e150) and testing hepatitis B surface antigen (HBsAg) (e25) in source patients. For calculating the costs of HBV measures per incident taken in 2005 and those which should have been taken according to the new guidelines, the Mann Whitney test was used. All calculations were performed using SPSS for Windows 15.0 (SPSS Inc.; Chicago, IL) software. Results Overall, 458 of 461 registered incidents were analysed. Of these incidents, 225 involved hospital employees, 181 non-hospital HCWs and 52 involved other persons. Three records were excluded because of inadequate registration. Regarding hospital employees, 197/225 (86%) of the incidents could be reassigned directly into the new risk category according to the new guidelines (Table 2, available as Supplementary data at Occupational Medicine online). In 2005, 66 of these incidents were high risk while this was 100 according to the new guidelines (OR 2.05, 95% CI , P, 0.01) and 127 (65%) were low risk while this was 92 (47%) according the new guidelines (OR 0.48, 95% CI , P, 0.01) (Table 3). While in 2005, needles used for local anaesthetic and suture needles were all reassigned as low risk (31/31), according to the new guidelines more of these incidents (19/31) should have been reassigned into high risk because of visible blood on the needle. The proportion between high and low risk for these incidents of the registration data of 2008 was 60% high risk and 40% low risk for anaesthetic needles (n 5 9) and 67% high risk and 33% low risk for suture needles (n 5 18). Twelve per cent of all the injuries in the hospital (31/ 225) could not be reassigned into a new category. These included superficial scratches with used intravenous (IV) used needles, needles of unknown origin, incidents with endoscopes and cuts with used scalpels or tweezers where no visible blood was involved. Regarding HCWs outside the hospital, 163/181 (90%) of the incidents could be reassigned into the categories of the new guidelines (Table 2). In 2005, 10 (6%) of these incidents were high risk while this was 34 (21%) according to the new guidelines (OR 4.03, 95% CI , P, 0.01) and 147 (90%) were low risk while this was 122 (75%) according to the new guidelines (OR 0.32, 95% CI , P, 0.01) (Table 3). The reassignment of incidents involving blood collection lancets from low risk to high risk was entirely responsible for this shift in risk. Ten per cent of the injuries such as dental sharp devices with no visible blood and superficial scratches with IV used needles could not be reassigned into new categories. Regarding non-hcws outside the hospital, 35/52 (67%) of the incidents could be reassigned into the categories of the new guidelines (Table 2). In 2005, 2 (5%) of these incidents were high risk while this was 9 (24%) according to the new guidelines (OR 5.71, 95% CI , P ) and 26 (68%) were low risk while this was 19 (50%) according to the new guidelines (OR 0.46, 95% CI , P ). Twenty-seven per cent of the injuries, such as needles of unknown origin and razor blades, could not be reassigned into new categories. In all low-risk incidents, significantly fewer HBIg, 18/ 290 (6%) versus 55/357 (15%), and consequently more HBV vaccinations, 95/290 (33%) versus 77/357 (22%), were administered (P, 0.01, 95% CI and P, 0.01, 95% CI , respectively). In high-risk incidents, significantly more HBIg (15% versus 3%) and more HBV vaccinations (22% versus 4%) had to be administered (P, 0.01, 95% CI and P, 0.02, 95% CI , respectively). The new protocol had no effect on the reference serum taken after an incident, this was 10% in both high-risk groups, respectively; however, the total administration of HBIg decreased significantly (Table 4).

4 P. T. L. VAN WIJK ET AL.: IMPACT OF NEW GUIDELINES FOR BLOOD EXPOSURE 273 Table 3. Comparison of risk assessment of old versus new guidelines in reassigned incidents Data 2005 OR 95% CI P (x 2 test) Old guidelines New guidelines n (%) n (%) Hospitals (n 5 194) No risk 1 (1) 2 (1) Low risk 127 (65) 92 (47) ,0.01 High risk 66 (34) 100 (52) ,0.01 Non-hospital HCW (n 5 163) No risk 6 (4) 7 (4) Low risk 147 (90) 122 (75) ,0.01 High risk 10 (6) 34 (21) ,0.01 Others (n 5 38) No risk 10 (26) 10 (26) Low risk 26 (68) 19 (50) High risk 2 (5) 9 (24) Table 4. Measures taken in 2005 and according to the new guidelines Measures in risk groups (n 5 458) 2005 New guidelines OR 95% CI P (x2 test) n (%) n (%) No risk 21 (5) 24 (5) Not HBV immunized 14 (67) 15 (63) Low risk 357 (78) 290 (63) ,0.01 Not HBV immunized 116 (32) 95 (33) Injured age. 50, not immunized 18 (6) HBsAg tested in source 46 (13) Source HBsAg positive 3 (1) HBIg administered 55 (15) 18 (6) ,0.01 HBV vaccination administered 77 (22) 95 (33) ,0.01 Anti-HBs tested 29 (8) Reference serum 1 (0) High-risk regarding HBV 80 (17) 145 (32) ,0.01 Not HBV immunized 7 (9) 22 (15) HBsAg tested in source 4 (5) HBIg administered 3 (4) 22 (15) ,0.01 HBV vaccination administered 4 (5) 22 (15) Anti-HBs tested regarding HCV/HIV 5 (6) Source known 76 (95) 130 (90) HCV tested in source 68 (85) HCV positive 0 (0) HIV tested in source 68 (85) HIV positive 1 (1) Post exposure prophylaxis 1 (1) Reference serum 8 (10) 15 (10) Measures in total Not HBV immunized 137 (30) 132 (29) Injured age. 50, not immunized 18 (4) HBsAg tested in source 50 (11) HBIg administered 58 (13) 40 (9) HBV vaccination administered 81 (18) 117 (26) ,0.01 Anti-HBs tested 34 (7) Reference serum 9 (2) 15 (3)

5 274 OCCUPATIONAL MEDICINE Applying the new guidelines to hospital incidents, fewer incidents needed intervention but the total costs of HBV prevention increased by 50% from e1690 to e2535. The mean costs per intervention increased significantly from e94 to e149 for hospital HCWs. In non-hospital HCWs, the need for intervention increased slightly (74 instead of 72 interventions) when applying the new guidelines. Total costs increased by 13% and the mean costs increased from e109 to e149 per intervention. For non-hcw, more interventions were needed (31 instead of 20). The total costs decreased by 16%, while the mean cost per intervention increased from e134 to e149 (Table 5). Discussion Overall, applying the new protocol, 83% of all incidents registered in 2005 could be appropriately assigned into categories, whereas 17% did not fit into any of the suggested categories. Of all incidents, in the hospital 14% and in non-hospital health care settings 10% could not be reassigned into risk categories. In the reassigned incidents, a significant shift occurred from low- to highrisk in all three groups. While overall less HBIg had to be administrated, the mean costs of HBV prevention per accident increased in hospital (50%) and non-hospital HCW (13%), while it decreased in others (16%). Using the registered data of 1 year (2005) from our needle-stick counselling centre, the new protocol was analysed on feasibility and usability and its effect on the management of blood exposure accidents. Using registered data from both inside and outside, the hospital gave us the opportunity to assess the impact of the new guidelines in different occupational, as well as non-occupational, settings. However, not all data of 2005 were sufficiently complete for the assessment of HCVand HIV in case they were categorized into a high-risk instead of a low-risk category. Also only the direct costs of administering HBIg, HBV vaccination and HBsAg testing could be calculated in this study. The costs of counselling and logistics were not taken into account. The new set of guidelines were developed to standardize the management of accidental exposures to blood. These guidelines are based on the assumption that minor incidents only pose a risk of HBV transmission and on the assumption that there is a significant risk of HBV, HCV and HIV transmission if a significant or visible amount of blood is involved [10]. The aim of the guidelines is to Table 5. Costs of HBV prevention for high- and low-risk incidents in 2005 compared with prevention effectiveness under the new guidelines Price (e) Interventions 2005 Costs 2005 (e) Interventions new Costs new (e) Percentage Hospital (n 5 225) Cases with intervention HBIg HBV vaccination Test HBsAg Total interventions and costs Mean costs per case with intervention Mean costs per accident ,0.01 Non-hospital HCW (n 5 181) Cases with intervention HBIg HBV vaccination Test HBsAg Total interventions and costs Mean costs per case with intervention Mean costs per accident ,0.01 Others (n 5 52) Cases with intervention HBIg HBV vaccination Test HBsAg Total interventions and costs Mean costs per case with % intervention Mean costs per accident ,0.01 P a Cost prices of Not calculated: in high-risk accidents HBsAg in source could be tested to check if administering HBIg to the injured is required. a Mann Whitney test.

6 P. T. L. VAN WIJK ET AL.: IMPACT OF NEW GUIDELINES FOR BLOOD EXPOSURE 275 simplify assessment and handling by assigning accidents into risk categories with corresponding measures in a standardized manner as well as reducing the use of HBIg. The new guidelines are based on a review of existing national and international guidelines, the knowledge of the risk of transmission of blood-borne viruses and the prevalence of blood-borne viruses in The Netherlands [14,15]. It was endorsed by different medical professionals involved in handling blood exposure accidents. Using the new guidelines, difficulty in categorization arose most commonly with devices used infrequently in a health care setting such as biopsy needles or diathermy needles. Solid devices that did not carry visible blood were also difficult to categorize. In previous guidelines, these were categorized as low risk, whereas the new guidelines categorizes them as high risk. In places like dentists practices and general practitioners surgeries, less well-defined devices are used. Of incidents occurring in non-hcws, 27% could not be assigned into any of the categories. The majority of these incidents, (21%), were caused by stray needles of unknown origin. According to the new guidelines, these should be assessed according to the circumstances in which the accident took place and whether someone from a high-risk group might have recently used the needle. These risk categories are described in the guidelines [10]. A large number of sharp devices are available for medical use that are not specifically mentioned in the guidelines (Table 1). This makes it more difficult to assign all these devices into the three categories. Using the presence of visible blood on the instrument would appear a logical step to help in assigning the incidents. Currently, this procedure is only recommended for intramuscular injection needles and suture needles. The shift in risk from low to high risk means that more measures have to be taken after assessing the risk of an accident. If an accident is assigned as low risk and the injured person appears to be HBV immunized, no follow-up measures are necessary and the case can be closed. In high-risk accidents, the risks of HCV and HIV infection also have to be assessed. Eventually, this will lead to more laboratory testing, more time investment both for the injured as well as the counsellor and therefore to more costs. Experience in the assessment of blood exposure accidents, even with detailed guidelines, remains essential to prevent unnecessary measures and costs [16]. The new protocol makes the assessment and handling of HBV risk easier. When an accident is assigned into a low-risk category, the victim can be vaccinated on the following working day, provided no reduced immune response is expected, such as in those aged.50 years or in immunocompromised victims [11]. This means there is more time available and measures can be taken during office hours. In that case, testing the source for HBsAg is not needed. This will lead to a reduction of the administration of HBIg. If the injured do have a reduced immune response, in order to avoid HBIg administration, it is recommended to test for HBsAg in the source. In our study, overall less HBIg had to be administered. While in 2005, 55 victims of low-risk accidents were entitled to HBIg administration, this decreased to 18 according to the new guidelines. All these cases were attributed to the presumed reduced immune response. In high-risk accidents, three injured persons received HBIg in 2005, while according to the new guidelines, 22 should have received protection by HBIg. However, if the source patient nevertheless has to be tested for HCV and HIV, testing for HBsAg as well could prevent unnecessary HBIg administration. In 2005, in 85% of all cases, the source patients were known and therefore potentially available for testing [13]. This can prevent unnecessary administration of post-exposure prophylaxis in difficult to assess cases and in cases with a victim that might not respond to vaccination or is a known non-responder. Testing the source, if possible, could also reduce anxiety in the injured [8]. The increase in costs of HBV prevention was mainly caused by the increased costs of administration of HBV vaccination compared with the administration of HBIg only and the increased number of high-risk accidents. In hospitals, the costs per accident are lower, due to the high HBV vaccination levels of hospital employees. Due to more high-risk assessments in all three groups, relatively more costs are generated for the administration of HBIg. Source testing for HBsAg must be performed if possible to prevent unnecessary HBIg administration and save costs. The higher mean cost per accident for non-hospital HCW is caused by lower vaccination levels in these HCWs. A HCW having undergone a blood exposure accident has proven to be at risk and should therefore be vaccinated. Employees working in medical professions in The Netherlands are entitled to HBV vaccination [17]. Because The Netherlands has no universal HBV vaccination programme, employers have to provide vaccination for their employees. For handling blood exposure incidents, high levels of HBV vaccination coverage in risk groups are ultimately more cost effective. Using the new guidelines for blood exposure accidents, accidents can be more easily assigned into a risk category and therefore, the new protocol facilitates a proper standardized risk assessment. Standardization could also make it possible for different hospitals or regions to compare data and assess quality of treatment. Risk categories may be further specified and more specifications could be given for accidents that cannot presently be assigned directly.

7 276 OCCUPATIONAL MEDICINE The use of HBIg and source testing and therefore the associated costs decrease when using the new guidelines. Key points The new guidelines facilitate standardized risk assessment of blood exposure accidents. Costs of administering medication decrease when using the new guidelines. More specifications should be given how to handle accidents that cannot be assigned directly into a risk category. Conflicts of interest None declared. References 1. Puro V, De Carli G, Cicalini S et al. European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus. Euro Surveill 2005;10: Puro V, Scognamiglio P, Ippolito G. [HIV, HBV, or HDV transmission from infected health care workers to patients]. Med Lav 2003;94: Trim JC, Elliott TS. A review of sharps injuries and preventative strategies. J Hosp Infect 2003;53: Pruss-Ustun A, Rapiti E, Hutin Y. Estimation of the global burden of disease attributable to contaminated sharps injuries among health-care workers. Am J Ind Med 2005; 48: Tarantola A, Golliot F, Astagneau P, Fleury L, Brucker G, Bouvet E. Occupational blood and body fluids exposures in health care workers: four-year surveillance from thenorthern France network. Am J Infect Control 2003;31: van Wijk PT, Pelk-Jongen M, de Boer E, Voss A, Wijkmans C, Schneeberger PM. Differences between hospital- and community-acquired blood exposure incidents revealed by a regional expert counseling center. Infection 2006;34: van Wijk PT, Pelk-Jongen M, Wijkmans C, Voss A, Timen A, Schneeberger PM. Variation in interpretation and counselling of blood exposure incidents by different medical practitioners. Am J Infect Control 2008;36: Fisman DN, Mittleman MA, Sorock GS, Harris AD. Willingness to pay to avoid sharps-related injuries: a study in injured health care workers. Am J Infect Control 2002; 30: Worthington MG, Ross JJ, Bergeron EK. Posttraumatic stress disorder after occupational HIV exposure: two cases and a literature review. Infect Control Hosp Epidemiol 2006;27: Landelijke Richtlijn Prikaccidenten. cib/binaries/landelijke%20richtlijn%20prikaccidenten% 20nieuw_tcm pdf (29 March 2010, date last accessed). 11. Palmovic D, Crnjakovic-Palmovic J. Prevention of hepatitis B virus (HBV) infection in health-care workers after accidental exposure: a comparison of two prophylactic schedules. Infection 1993;21: Houston F, McCutcheon S, Goldmann W et al. Prion diseases are efficiently transmitted by blood transfusion in sheep. Blood 2008;112: van Wijk PT, Pelk-Jongen M, Wijkmans C, Voss A, Schneeberger PM. Three-year prospective study to improve the management of blood-exposure incidents. Infect Control Hosp Epidemiol 2008;29: Op de Coul EL, Beuker RJ, Prins M et al. [HIV-infection and AIDS in the Netherlands: prevalence and incidence, ]. Ned Tijdschr Geneeskd 2003;147: Hahné SJ, Veldhuijzen IK, Smits LJ, Nagelkerke N, van de Laar MJ. Hepatitis B virus transmission in The Netherlands: a population-based, hierarchical case-control study in a very low-incidence country. Epidemiol Infect 2008;136: van Wijk PT, Pelk-Jongen M, Wijkmans C, Voss A, Schneeberger PM. Quality control for handling of accidental blood exposures. J Hosp Infect 2006;63: Dutch Ministry of Social Affairs and Employment. Arbobeleidsregel 4.87: Preventive Measures from Infections of Blood Exposure Accidents with Human Blood; grondslag arbobesluit artikel 4.87, derde lid Staatscourant, 2002;236:12.