Determinants of compliance with healthcare waste management regulations by European private healthcare facilities

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1 Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) ISSN: (prnt) IJCEES Vol 3(2):78-84, 2012 Determnants of complance wth healthcare waste management regulatons by European prvate healthcare facltes Anabela Botelho* Unversty of Mnho and NIMA Campus de Gualtar, Braga, Portugal ABSTRACT Healthcare unts generate substantal amounts of hazardous or potentally hazardous wastes as by-products of ther medcal servces. The napproprate management of these wastes poses sgnfcant rss to people and the envronment. Wthn the countres of the European Unon (EU), the management of HCW s strctly regulated by law. Measures pertanng to the collecton, storage, treatment and dsposal of hazardous waste are construed to ensure that the waste management process taes place n condtons that protect the envronment and human health. Despte the growng awareness by legslators that complance wth the applcable regulatons s essental to acheve the best envronmental protecton, lttle s nown about the complance of the ncreasngly large numbers of prvate EU outpatent healthcare facltes wth these measures. Usng a large survey of over 700 prvate outpatent healthcare facltes n the EU, ths study fnds that overall complance wth the law s far from deal, and dentfes mportant sources of varablty n complance behavor wth each of the measures comprsng the HCW legslaton. Key words: Healthcare waste, regulaton, management measures, complance 1.0 INTRODUCTION Healthcare unts generate substantal amounts of hazardous or potentally hazardous wastes as byproducts of ther medcal servces. The napproprate management of these wastes poses sgnfcant rss to people and the envronment. Envronment problems n terms of ar, water and land polluton arse from the mere generaton of healthcare waste (HCW) and from the process of handlng, treatment and dsposal. Extensve research conducted n the last decades has establshed that the approprate management of these wastes sgnfcantly reduces the rss to the envronment, as well as the costs assocated wth ts dsposal (e.g., Fay et al., 1990; Benco and Culova, 1993; Pruss et al., 1999;Tudor et al., 2005; Tsaona et al., 2007).Wthn the countres of the European Unon (EU), the management of HCW s strctly regulated by law n order to prevent the negatve mpacts of hazardous wastes on the envronment and human health (Drectve 91/689/EEC; Drectve 2008/98/CE). Although legal provsons pertanng to the collecton, storage, treatment and dsposal of hazardous waste date bac to the 1990s, lttle s nown about the complance *Correspondng author Emal: botelho.anabela@gmal.com 78

2 of the ncreasngly large numbers of prvate EU outpatent healthcare facltes (HCF) wth each of these legal provsons, or about sources of varablty n complance behavor. Ths study uses data collected by a large survey of over 700 small prvate HCFs dstrbuted all over Portugal, a full member of the EU snce 1986 where 50% of outpatent care s currently domnated by prvate operators, n order to assess complance behavor wth each of the exstng legal provsons amng at the safe management of HCW, and dentfy possble determnants of ther complance behavor. 2.0 MATERIAL AND METHODS 2.1 Regulatory Provsons In lne wth the EU legslaton, the legal provsons concernng the management of HCW n Portuguese law establsh that the responsblty for ts management belongs to the producers of such waste, whch s legally defned as the waste resultng from medcal actvtes tang place n healthcare facltes, preventon actvtes, dagnoss, treatment, rehabltaton and research, related to human bengs or anmals, n pharmaces, n forensc medcne, n teachng, and n any other nvolvng nvasve procedures such as acupuncture, percng and tattoos (Dec. Le 178/2006). The regulatory framewor also establshes that the treatment of HCW must be dfferentated accordng to the type of waste produced. A classfcaton system for HCW s establshed by law (Despacho 242/96, 13 August), separatng HCW n four categores or groups: Group I ths waste s consdered to be equvalent to urban waste, presentng no specal requrements n ts treatment; Group II ths s non-hazardous medcal waste, not subject to specfc treatments, and may be treated as urban waste; Group III ths s consdered as bohazard medcal waste, requrng ncneraton or other effectve pre-treatment wth a vew to subsequent dsposal as urban waste; Group IV ths group comprses varous types of hazardous waste subject to mandatory ncneraton. Thus, the frst two groups of waste are deemed non-hazardous waste, whle the last two are deemed hazardous waste. Ths waste classfcaton can be lned to the 18 th chapter (on HCW) of the European waste catalogue establshed by Commsson Decson 2000/532/EC, whch s a mandatory classfcaton for all EU members. In addton to ths classfcaton system, the same legal text establshes fve specfc requrements to handle HCW n order to mnmze ts negatve mpacts on the envronment. These requrements are detaled n Table 1, and nclude waste segregaton at the source, use of approprate colored contaners, avalablty of dfferent storage places for hazardous and non-hazardous waste, mnmum storage capacty, and the exstence of a waste management plan (WMP) at the faclty level. In order to better acheve complance wth these requrements, the regulatory framewor also contemplates a number of polcy measures to be mplemented at the faclty level, namely that the HCFs shall provde educaton and tranng (E&T) opportuntes on waste handlng ssues to ther staff; appont an ndvdual responsble for the management of the waste wthn the faclty; and, mplement regular nternal audts Data Collecton A survey was desgned and sent out to the HCFs based n contnental Portugal, and regstered at the offce of the Portuguese Health Regulatory Entty (HRE). Answers to the survey were collected durng March May 2010 usng an electronc survey platform developed by HRE. Rough estmates based on the HRE data ndcate a response rate of about 20% from the prvate outpatent HCFs, a fgure that s common n studes assessng complance wth envronmental regulatons (e.g., Botelho et al., 2005, Marnovc et al., 2008). In lne wth the fgures for hgh-ncome countres, the estmated producton of HCW by the largest producers (hosptals) n Portugal s about 7.0 Kg/ (occuped bed-day), and the prvate outpatent HCFs account for at least 20% of the HCW produced at the natonal level (APA, 2010; Almeda (2010)). Table 1: Legal requrements 0. Waste must be segregated at the pont of generaton. 1. Waste must be stored at a temporary storage place n specfc colored contaners (blac contaners for Group I and II waste; whte contaners mared wth a bohazard sgn for Group III waste; red contaners for Group IV waste). 2. Group III and Group IV waste must be stored at a dfferent place from the waste belongng to Groups I and II. 3. The storage place must have a mnmum storage capacty correspondng to 3 days of producton, and, n case the collecton perod exceeds those 3 days, the storage place must be equpped wth a refrgeraton system. In any case, the perod between collectons cannot exceed 7 days. 4. Each healthcare faclty must have a waste management plan. Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 79

3 The facltes n the sample ndcate an average annual producton of 444 Kg and 39 Kg of Group III and Group IV waste, respectvely. Ths corresponds to an average weely producton of 9.3 Kg of Group III and Group IV waste, a fgure that sts well wth the producton estmate for all small producers n Portugal (LPN, 2010). In addton, the average sample producton of Group IV waste corresponds to 8% of the total producton of Group III and Group IV waste as predcted by the Portuguese Envronmental Agency (APA, 2010). Thus, the nformaton provded by the sampled facltes conforms to the predctons made by the relevant natonal enttes concernng the populaton of HCFs. The survey was composed of two broad parts. One part conssted on questons elctng the HCFs complance wth each of the legal requrements detaled n Table 1. It also ncluded questons elctng ther use of the polcy varables contemplated n the regulatory framewor. In partcular, polcy varables elcted n the survey were whether the HCF has apponted a person responsble for waste management (Responsble for WM); whether nternal waste audts have been regularly conducted (Regular Audts); and, whether tranng opportuntes on waste handlng ssues have been provded to the HCF s staff (Educaton and Tranng). All these varables are expected to mpact postvely the HCFs complance wth the legal requrements n Table 1. The other part of the survey conssted on questons concernng the amount of the varous types of medcal waste generated wthn the HCF, along wth questons regardng a general characterzaton of the HCFs. Because prevous studes have found the sze of frms and ther regon of locaton to be sgnfcant determnants of envronmental complance (eg., Botelho et al., 2005, Rahman et al., 2010, Rousseau, 2009), the latter set of questons ncluded the number of worers n the HCF, ther regon of locaton, and the type of servces provded (Type of Healthcare Faclty --each HCF could ndcate several types of servces).the varables pertanng to the general characterzaton of the HCF are, therefore, ncluded as control varables n the statstcal analyss below Statstcal Methods In order to dentfy mportant sources of varablty n complance behavor wth each of the specfc requrements comprsng the HCW legslaton, the data s analyzed usng the bnary response of the HCFs concernng complance wth each of the legal requrements as the dependent varables n multvarate logt models. The logt model allows for estmatng the probablty that complance occurs or not by predctng the bnary dependent outcome from a set of explanatory varables, and entals a lelhood functon that s constructed to be approprate for bnary dependent varables. In ths context, let the dependent varable y be 1 f HCF comples wth requrement j, and 0 otherwse. The smplest formulaton would be to specfy the probablty of complance π as a lnear functon of the explanatory varables: π =x β, for vector of explanatory varables x, and parameter vectorβ. Ths formulaton s nown as the lnear probablty model, and s often estmated from ndvdual data usng ordnary least squares (OLS).One problem wth the lnear probablty model s that the probablty π on the left-hand-sde has to be between zero and one, but the lnear predctor x βon the rghthand-sde can tae any real value, so there s no guarantee that the predcted values wll be bounded between zero and one unless complex restrctons are mposed on the coeffcents. A smple soluton to ths problem s to transform the probablty to remove the range restrctons, and model the transformaton as a lnear functon of the explanatory varables: π =G(x β). Usng ths estmaton approach n the present analyss, the log-lelhood of observaton s specfed as [ G( x β )] + (1 y )log[ G( x β )] l ( β) = y log 1 for some nown functon G (.) satsfyng ( ) 1 0 < G z < for all z R The logstc functon G(.) s one of the most commonly used transform (Greene, 2003), devsng the logt model adopted n the present analyss. Fnally, because the condtonal expectaton functon s nonlnear, the parameter value β does not drectly measure the effect of a change n explanatory varable x on the mean of the dependent varable. In the present applcaton, the margnal effect of condtonal expectaton functon s gven by g xβ) β (, where ( 1 exp( )) 2 g ( z) dg( z) / dz = exp( z) / + z =. x on the Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 80

4 3.0 RESULTS AND DISCUSSION 3.1 Complance wth regulatory provsons After dscardng observatons wth mssng values for the relevant questons ased n the survey, the worng sample conssts of 741 prvate outpatent HCFs. A characterzaton of ther complance wth the legal requrements prevously dentfed s presented n Table 2. All of these HCFs ndcate that the waste produced s segregated at the source as requred by law. In addton, about 91% ndcate that the waste s stored at a temporary storage place n the colored contaners specfed n the legslaton. However, only 30% of the HCFs comply wth the requrement of storng the hazardous waste n a dfferent place from that used to store the non-hazardous waste. Complance wth the requrement that the perod between collectons s not to exceed 7 days s observed by only 23% of the HCFs. Fnally, only 34% of the HCFs ndcate havng the WMP as requred. Thus, apart from segregaton, complance wth waste management regulatons s n general qute unsatsfactory, and the most problematc requrement appears to be the requred perodcty between collectons, wth more than 75% of the unts falng to comply wth t. Table 2: Complance wth legal requrements Specfc Legal Requrements Percentage of complant facltes 0. Segregaton at the pont of generaton 1. Approprate colored contaners 2. Avalablty of requred waste storage place 3. Perod between collectons 7 days 4. Waste management plan 3.2 Statstcal determnants of complance behavor Along wth the average sample values ( X ) for the varables consdered n the condtonal statstcal analyss, Table 3 provdes maxmum lelhood estmates of the margnal effects of each explanatory varable on the probablty of complance wth requrements 1-4. The descrptve statstc shows that about 59% of the HCFs have a staff member desgnated for the management of the waste generated wthn the faclty. However, only about 19% report conductng nternal waste audts regularly. In addton, t s found that just 5% of the HCFs provde regular (.e., at least once a year and lastng for more than 2 hours) E&T opportuntes on waste handlng ssues to ther staff. The descrptve statstc also shows that waste classfed as hazardous accounts on average for 69% of the total waste produced, a fgure that substantally exceeds the 10%-25% predcted n the World Health Organzaton (WHO, 2005b) gudelnes. Such hgh hazardous waste fractons, however, are not unheard of for the type of HCFs n ths sample. For example, Da Slva et al., 2005, found hazardous waste accountng for 74.7% of the total waste produced n dental offces n the State of Ro Grande do Sul- Brazl. Concernng the ncluded control varables, the results show no statstcally sgnfcant regonal mpacts on the probablty of complance wth each of the ndvdual regulatory requrements. Larger HCFs (e, those havng a number of collaborators equal to or hgher than the medan number (4) of collaborators n the sampled facltes) are more lely to comply wth requrements 2-4 than smaller HCFs, but no statstcally sgnfcant effect s found concernng the sze of the HCF on the probablty of complance wth requrement 1. Lewse, medcal and nursng offces do not dfferentate themselves from Other types of facltes (the omtted category) n complance behavor. However, the results show that the dental clncs n the sample are more lely to comply wth each of the requrements than all the other types of the HCFs. Importantly, the results show that the fracton of hazardous HCW generated by the HCFs s a sgnfcant predctor of the probablty of complance wth of the consdered requrements. The sgn of ts effects on the probablty of complance, however, s not consstent across all of the requrements. Whle ncreases n the fracton of hazardous HCW generated lead to ncreases n the probablty of complance wth requrements 1, 2 and 4 n the 7 to 11 percentages ponts range, those same ncreases lead to a decrease n the probablty of complance wth requrement 3 by about 16 percentage ponts. Apart from the effects found for dental clncs, ths s actually the strongest factor affectng the probablty of complance wth the requred perodcty between collectons ( 3). Together, these fndngs suggest that the requred perodcty mght be too costly and unfeasble for small waste producers generatng hgh fractons of hazardous HCW, and a revew of the legslaton better talored to the perodcty of these HCFs hazardous waste generaton s recommended. Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 81

5 Table 3: Estmates of the margnal effects of regressors on complance wth each regulatory provson Varable X Educaton and Tranng (0.026) [0.886] Responsble for WM (0.013) [0.035] Regular Audts (0.009) [0.560] Fracton of hazardous HCW (0.020) Medan number of Worers (0.007) [0.588] Type of Healthcare Faclty Dental Clnc (0.012) [0.008] Medcal Offce (0.006) [0.146] Nursng Offce (0.009) [0.082] Regon of locaton North (0.006) [0.802] Alentejo (0.013) [0.952] Algarve (0.024) [0.441] (0.087) [0.002] (0.035) [0.004] (0.046) [0.227] (0.046) [0.028] (0.036) (0.038) [0.001] (0.042) [0.301] (0.060) [0.283] (0.039) [0.913] (0.069) [0.752] (0.090) [0.210] (0.066) [0.841] (0.032) [0.004] (0.040) [0.866] (0.038) (0.032) [0.011] (0.036) (0.034) [0.080] (0.060) [0.560] (0.035) [0.487] (0.046) [0.142] (0.072) [0.686] (0.095) [0.019] (0.034) (0.051) (0.048) [0.027] (0.041) (0.041) [0.003] (0.043) [0.101] (0.064) [0.841] (0.041) [0.813] (0.078) [0.111] (0.103) [0.317] Log-pseudolelhood χ 2 statstcswth 11 df Note: N=741; Margnal effects are n talcs; Standard errors are n parentheses; p-values are n square bracets. Wald tests for the null hypothess that all coeffcents n each model are zero have χ 2 values mplyng p-values less than Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 82

6 Turnng to the analyss of the effects of the polcy varables, the results show that conductng nternal waste audts affects postvely the probablty of havng a waste management plan as requred ( 4), but has no effects on complance wth any of the remanng requrements. As expected, the nomnaton of an ndvdual responsble for the management of the HCW sgnfcantly contrbutes to the probablty of complance wth each of the requrements. The results show that, ceters parbus, HCFs that desgnate a staff member to manage or coordnate waste management have on average a 27 percentage ponts hgher probablty of havng a waste management plan than HCFs that do not do so. Lewse, the probablty of storng waste classfed as hazardous n a dfferent place from that used to store non-hazardous waste ( 2), the probablty that the perod between collectons does not exceed 7 days ( 3), and the probablty of storng the waste n the approprate colored contaners are, respectvely, 10, 9, and 3 percentage ponts hgher for HCFs that desgnate an ndvdual responsble for the management of the HCW than for those HCFs that do not do so. Fnally, whle the provson of E&T opportuntes on waste handlng ssues to staff members does not affect complance wth requrements 1 and 3, t s one of the strongest factors affectng complance wth requrements 2 and 4. Ceters parbus, provson of E&T opportuntes ncreases the probablty of havng a waste management plan at the faclty level by 22 percentage ponts. Smlarly, all else the same, provson of E&T opportuntes ncreases the probablty of storng waste classfed as hazardous n a dfferent place from that used to store non-hazardous waste by 26 percentage ponts. Ths requrement has a drect mpact on the envronment and potental crtcal health rss at the HCFs. Ths result, therefore, adds weght to the argument (eg. Botelho, 2012) that the delvery of educaton and tranng programs at the facltes level s an essental condton to ensure a system that protects the envronment and human health. 4.0 CONCLUSIONS Healthcare unts generate substantal amounts of hazardous or potentally hazardous wastes as byproducts of ther medcal servces. The napproprate management of these wastes poses sgnfcant rss to people and the envronment. Wthn the countres of the European Unon (EU), the management of HCW s strctly regulated by law. Measures pertanng to the collecton, storage, treatment and dsposal of hazardous waste are construed to ensure that the waste management process taes place n condtons that protect the envronment and human health. Despte the growng awareness by legslators that complance wth the applcable regulatons s essental to acheve the best envronmental protecton, lttle s nown to date about the complance of the ncreasngly large numbers of prvate EU outpatent healthcare facltes wth these measures. Usng a large survey of over 700 prvate outpatent healthcare facltes n the EU, ths study fnds that overall complance wth the law s far from deal, and dentfes mportant sources of varablty n complance behavor wth each of the measures comprsng the HCW legslaton. In partcular, t s found that the magntude and statstcal sgnfcance of polcy varables that can be manpulated at the HCFs level are not constant across these dfferent measures. The same fndng apples wth respect to general characterstcs of the HCFs under scrutny. Importantly, t s found that the most problematc regulatory measure s the requred perodcty between collectons, wth more than 75% of the unts falng to comply wth t. Ths requrement, however, has a drect mpact on the envronment. Along wth the fndng that HCFs generatng hgher fractons of hazardous HCW are also the least lely to comply wth ths requrement, the reported results suggests that a revew of the legslaton better talored to the perodcty of these HCFs hazardous waste generaton may be needed, but also add weght to the argument that more publc nvestments n montorng healthcare facltes complance wth the law n EU countres s warranted. In addton, the results show that the lac of educaton and tranng opportuntes on HCW management ssues mpars complance wth essental requrements regardng the storage of hazardous waste thereby endangerng the envronment and human health. Together, these fndngs suggest that along wth the development of better bottom-up solutons to the HCW problem, more research and attenton to the management practces of the growng number of prvate healthcare provders n Europe s needed to ensure a system that s economcally sustanable, and protects human health and the envronment. ACKNOWLEDGMENTS The author acnowledges the pvotal nput of Professor Líga Pnto and the Portuguese Health Regulatory Entty (PHRE) n the collecton of data. The author alone s responsble for the analyss and vews expressed n ths paper, and they do not represent the polces or vews of the PHRE. Ths research was Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 83

7 partally funded by FCT through the Appled Mcroeconomcs Research Unt (NIMA), and completed whle the author was on sabbatcal leave at the Water Scence and Polcy Center, Unversty of Calforna, Rversde, and Unversty of Arzona, Tucson. REFERENCES [1] Almeda, J.C.N. (2010). A Cost Optmzaton Model for Hazardous Medcal Waste Management n Portugal.Insttuto Superor Técnco, Unversdade Técnca de Lsboa, Portugal. [2] APA (2010). Plano Estratégco dos Resíduos Hosptalares Agênca Portuguesa do Ambente Drecção Geral Saúde, Lsboa, Portugal. [3] Benco, V., Culova, H., (1993). Hosptal waste management practce n the Czech Republc Insttute of Hygene. Cent. Eur. J. Publc Health, 1(1), [4] Botelho, A. (2012). The mpact of educaton and tranng on complance behavor and waste generaton n European prvate healthcare facltes. Journal of Envronmental Management, 98, [5] Botelho, A., Pnto, L. M. C., Rodrgues, I. (2005). How to Comply wth Envronmental Regulatons? The Role of Informaton. Contemporary Economc Polcy, 23(4), [6] Da Slva, C.E., Hoppe, A.E., Ravanello, M.M., Mello, N. (2005). Medcal wastes management n the south of Brazl. Waste Management, 25(6), [7] Fay, M.F., Bec, W.C., Fay, J.M., Kessnger, M.K. (1990). Medcal waste: The growng ssues of management and dsposal. AORN Journal, 51(6), , [8] Greene, W.H. (2003). Econometrc Analyss.5 th Ed., Prentce-Hall. [9] LPN (2010). Parecer- Plano Estratégco de Resíduos Hosptalares Lga para a Protecção da Natureza. Portugal. ( ). [10] Marnovc, N., Vtale, K., Holcer, N. J., Dzaula, A., Pavc, T. (2008). Management of hazardous medcal waste n Croata. Waste Management, 28, [11] Pruss, A., Groult, E., Rushbroo, P. (1999). Safe Management of Wastes from Health Care Actvtes. World Health Organzaton, Geneva. [12] Rahman, T.; Kohl, M.;Megdal, S.; Aradhyula, S.; Moxley, J. (2010). Determnants of Envronmental Noncomplance by Publc Water Systems. Contemporary Economc Polcy, 28(2), [13] Rousseau, S. (2009). Emprcal Analyss of Sanctons for Envronmental Offenses. Internatonal Revew of Envronmental and Resource Economcs, 3, [14] Tsaona, M., Anagnostopoulou, E., Gdaraos, E. (2007). Hosptal waste management and toxcty evaluaton: a case study. Waste Management, 27 (7), [15] Tudor, T.; Noonan, C.; Jenn, L. (2005), Healthcare waste management: a case study from the Natonal Health Servce n Cornwall, Unted Kngdom, Waste Management, 25, [16] WHO (2005a).Healthcare Waste Management. Geneva: World Health Organzaton. [17] WHO (2005b).Management of sold healthcare waste at prmary healthcare centres: a decson-mang gude. Geneva: World Health Organzaton. Internatonal Journal of Chemcal and Envronmental Engneerng Systems (IJCEES) 84

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