Clinical chemistry and laboratory medicine in Croatia: regulation of the profession

Heterogeneity exists across Europe in the definition of the profession of clinical chemistry and laboratory medicine and also in academic background of specialists in this discipline. This article provides an overview of the standards of education and training of laboratory professionals and quality regulations in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. Although term Medical biochemist often relates to medical doctors in other European countries, in Croatia medical biochemists are not medical doctors, but university degree professionals who are qualified scientifically. Practicing the medical biochemistry is regulated by The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. According to the law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree is earned after the 5 years of the studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists. Licensing is mandatory, valid for 6 years and regulated by the government (Law on the Health Care, 1993). Vocational training for medical biochemists lasts 44 months and is regulated by the national regulatory document issued by the Ministry of Health. Accreditation is not mandatory and is provided by an independent, non-commercial national accreditation body. The profession has interdisciplinary character and a level of required competence and skills comparable to other European countries.

Spe cial the med is sue: Edu ca tion in cli ni cal che mis try and la bo ra to ry me di ci ne in va rious Eu ro pean coun tries

In tro duc tion
The re is a great he te ro ge nei ty be tween Eu ro pean coun tries in de fi ni tion of the pro fes sion of cli ni cal che mis try and la bo ra to ry me di ci ne and the aca demic bac kgrou nd of spe cia lis ts in this dis cip li ne (1,2). La bo ra to ry pro fes sio na ls ac ro ss Eu ro pe may ha ve their ba sic edu ca tion in me di ci ne, phar ma cy or scien ce. A pos tgra dua te trai ni ng in the Eu ropean coun tries las ts from four to se ven yea rs, whereas the to tal num ber of yea rs of edu ca tion (acade mic edu ca tion and po st-gra dua te trai ni ng) ranges from ni ne to thir teen. Howe ver, des pi te su ch he te ro ge nei ty, the pro fes sion is prac ti ced at ful ly com pa rab le le vel in mo st coun tries in Eu ro pe.
Euro pean Com mu ni ties Con fe de ra tion of Cli ni cal Che mis try (EC4) has for ma ny yea rs been ve ry ac ti-ve ly de vo ted to im pro vi ng the le vel of the cli ni cal che mis try pro fes sion in Eu ro pean Union (3,4). Than ks to this ve ry ac ti ve group, the re has been qui te a lot of ac ti vi ty towar ds the har mo ni za tion and com mon re gu la tion of the un der gra dua te and pos tgra dua te edu ca tion as we ll as the vo ca tio nal trai ni ng prog ra ms in cli ni cal che mis try ac ro ss EU coun tries (5)(6)(7). Howe ver, a lit tle is known on the situa tion in so me ot her no n-EU coun tries.
The knowled ge on the si tua tion in in di vi dual countries gi ves in sig ht in to the le vel of edu ca tion and trai ni ng of pro fes sio na ls as we ll as about the le vel at whi ch the pro fes sion is prac ti ced. This infor mation be co mes es pe cial ly in te res ti ng when spe cialis ts in cli ni cal che mis try and la bo ra to ry me di ci ne Simundic AM.
Cli ni cal che mis try and laboratory medicine in Croa tia wa nt to mo ve from one coun try to anot her. Whi le me di cal pro fes sio na ls enjoy au to ma tic re cog ni tion in ma jo ri ty of the Eu ro pean coun tries, si tua tion is rat her diff e re nt for ot her la bo ra to ry pro fes sio na ls (8).
The pur po se of this pa per is to re view the cur re nt sta tus of the stan dar ds of edu ca tion and trai ni ng of la bo ra to ry pro fes sio na ls as we ll as la bo ra to ry qua li ty re gu la tio ns and ac cre di ta tion stan dar ds in Croa tia.
Croa tia is a re la ti ve ly sma ll no n-EU coun try in southea st Eu ro pe wi th 4.6 mil lion in ha bi tan ts co ve ri ng an area si mi lar to Slo va kia. . The re are 190 la bo ra to ries in Croa tia, out of whi ch the re are 102 in a pri ma ry heal th ca re section, 60 are hos pi tal la bo ra to ries and 28 are pri vate ly owned la bo ra to ries. Fur ther mo re, the re are 536 re gis te red me di cal bioc he mis ts, out of whi ch 51 ho ld a PhD deg ree, 8 of them bei ng As sis ta nt pro fes so rs and 8 Pro fes so rs. Cur ren tly, 175 (33%) of the re gis te red pro fes sio na ls are spe cia lis ts in medi cal bioc he mis try.
Me di cal bioc he mis try in Croa tia com pri ses cli ni cal bioc he mis try, he ma to lo gy and coa gu la tion, immuno lo gy, toxi co lo gy and the ra peu tic drug mo ni to ring and en doc ri no lo gy. Bloo d-ban ki ng, mic ro biolo gy and cyto ge ne ti cs are out of the sco pe of the cli ni cal che mis try in our coun try.

Pro fes sion of me di cal bioc he mi stexpli cit ly de fi ned by the law
Me di cal bioc he mis try as a pro fes sion is an in teg ral pa rt of the heal th ca re system. As in mo st of the Eu ro pean coun tries (1), prac ti ci ng the me di cal bioc he mis try in Croa tia is al so re gu la ted throu gh The Heal th Ca re Law, The Law of the Me di cal Bioche mis try Pro fes sion and The Law of the Sta te and Pri va te Heal th In su ran ce. Fur ther mo re, the re are so me ot her re gu la to ry do cu men ts is sued by the Croa tian Cham ber of Me di cal Bioc he mis ts, whi ch wi ll be men tio ned la ter in this text.
The com pe te nt aut ho ri ty for all heal th em ployees in our coun try is the Mi nis try of Heal th. As of The Heal th Ca re Law, the re are four es sen tial uni ver si ty le vel per son nel in heal th ca re: Mas ter of Me di cal Bioc he mis try, Mas ter of Phar ma cy, Me di cal Doc tor and Den tis try Doc tor.
The Law of the Me di cal Bioc he mis try Pro fes sion de fi nes the pro fes sion and its sco pe, com pe tencies and res pon si bi li ties. It fur ther mo re expli cit ly de fi nes res pon si bi li ty and sco pe of ac ti vi ties for the Croa tian Cham ber of Me di cal Bioc he mis ts. Accor di ng to that law, on ly me di cal bioc he mis ts can be em ployed in the me di cal bioc he mis try la bo rato ry. Li cen sed me di cal bioc he mis ts may wo rk in the me di cal la bo ra to ry, whe reas la bo ra to ries are hea ded by spe cia lis ts. This is ve ry mu ch con sis te nt wi th the si tua tion in Eu ro pe, whe re la bo ra to ries are al so mos tly hea ded by spe cia lis ts in cli ni cal che mis try and la bo ra to ry me di ci ne (1). To be head of the cli ni cal la bo ra to ry in uni ver si ty hos pi ta ls in Croa tia, one nee ds to ha ve a mi ni mum of PhD degree and a spe cia li za tion in me di cal bioc he mis try.
Spe cia lis ts in me di cal bioc he mis try are ac ti ve ly invol ved as con sul tan ts to the cli ni cia ns off e ri ng them gui dan ce and ad vi ce in se lec ti ng the rig ht te st for the rig ht pa tie nt. They are al so res pon sib le for ma na gi ng the to tal qua li ty of the la bo ra to ry per for man ce and are en ga ged in the con ti nuous pro fes sio nal de ve lop me nt and scien ti fi c re sear ch. They are edu ca to rs and men to rs in vol ved in con tinuous edu ca tion of me di cal bioc he mis ts, la bo rato ry tec hni cia ns and ot her heal th ca re pro fes siona ls. The le vel of com pe ten ce, knowled ge and skills requi red for the spe cia li st in me di cal bioc he mistry, see ms to be equal to ot her EU coun tries (5,9,10).

Un der gra dua te and pos tgra dua te edu ca tion
Me di cal Bioc he mis try has been stu died for al mo st 50 yea rs at the Fa cul ty of Phar ma cy and Bioc hemis try (11), who se cur ri cu lum was re cen tly re de sig-Simundic AM. Cli ni cal che mis try and laboratory medicine in Croa tia ned ac cor di ng to the requi re men ts of the Bo log na dec la ra tion (12). Uni ver si ty deg ree (Mas ter of Science) is ear ned af ter the 5 yea rs of the stu dies. Ob liga to ry and elec ti ve un der gra dua te cour ses in Medi cal Bioc he mis try at the Fa cul ty of Phar ma cy and Bioc he mis try are lis ted in Tab le 1. Eu ro pean Cre dit Tran sfer and Ac cu mu la tion System (ECTS) cre di ts are as sig ned to all sub jec ts and are ful ly tran smittab le amo ng ot her uni ver si ties in Croa tia as we ll as ac ro ss Eu ro pe (13). Stu den ts are off e red the op portu ni ty to expe rien ce the la bo ra to ry prac ti ces from the fi r st year of the cur ri cu lum. Prac ti cal pa rt of the teac hi ng is per for med in se ve ral teac hi ng hos pi tal la bo ra to ries and in cli ni cal de par tmen ts. Em pha sis is gi ven to the prob lem ba sed lear ni ng, cli ni cal cases wi th dis cus sio ns and se lf-o rien ted lear ni ng. Me di cal bioc he mis ts wi th a Mas ter of Scien ce degree can eit her pro ceed wi th one year trai ni ng and spe cia li za tion in me di cal bioc he mis try or (a nd) con ti nue their edu ca tion to get the PhD deg ree.
The Fa cul ty of Phar ma cy and Bioc he mis try pro vides the pos tgra dua te edu ca tion wit hin the three yea rs of Doc to ral stu dies for a) Phar ma cy scien ces and b) Bio me di cal scien ces. PhD deg ree is requi reme nt for a head of the cli ni cal la bo ra to ry at the uni ver si ty hos pi tal. Al so, on ly spe cia lis ts wi th a PhD and As sis ta nt pro fes sor deg ree are en tit led to be mem be rs of the exa mi na tion boa rd for the exam at the end of the vo ca tio nal trai ni ng (mentio ned be low). Howe ver, PhD deg ree is not a require me nt for me di cal bioc he mis try spe cia lis ts to prac ti ce the pro fes sion in a la bo ra to ry.

Re gis ter of me di cal bioc he mis ts
Re gis ter of me di cal bioc he mis ts is ke pt by the Croa tian Cham ber of Me di cal Bioc he mis ts (CCMB), es tab lis hed in 1995. The Croa tian Cham ber of Medi cal Bioc he mis ts is an in de pen de nt pro fes sio nal or ga ni za tion res pon sib le for pro fes sio nal re gu lation, li cen si ng and con ti nuous edu ca tion of its mem be rs. Sin ce it was es tab lis hed, CCMB has issued nu me rous re gu la to ry do cu men ts. The se regu la to ry do cu men ts are com pre hen si ve la bo ra tory stan dar ds and/or re gu la tio ns to pro vi de la bo rato ries a gui de in main tai ni ng a mi ni mum man dato ry qua li ty. The mo st re le va nt re gu la to ry do cumen ts are: Qua li ty as su ran ce and good la bo ra to ry prac ti ce • (1995); Con ti nuous edu ca tion and exa mi na tion: con te-• nt, dead li nes and pro to col (1995); Re gis ter of CCMB mem be rs (1995); • Co de of et hi cs (1996); • Type of la bo ra to ry ana lyses (2003); • Ru les on au di ti ng me di cal bioc he mis try la bo ra-• to ries and me di cal bioc he mis ts (2004); Har mo ni za tion of la bo ra to ry re sul ts in ge ne ral • me di cal bioc he mis try (2004) (14); Prac ti ci ng me di cal bioc he mis try in physi cia ns' • offi ce (2005); Prac ti ci ng poi nt-o f-ca re ana lysis (2005); • Upon gra dua tion, me di cal bioc he mis ts en ter the one year prog ram of su per vi sed prac ti cal trai ni ng in la bo ra to ry. This one year pos tgra dua te trai ni ng is in con tra st to the four yea rs in mo st ot her Eu ropean coun tries. Howe ver, the con te nt of the under gra dua te deg ree is mu ch mo re vo ca tio nal in Croa tia, in con tra st to ot her coun tries, whe re the pri ma ry qua li fi ca tion may be mo no va le nt, li ke biolo gy, phar ma cy etc. This one year prog ram of super vi sed prac ti cal trai ni ng can be do ne in any medi cal bioc he mis try la bo ra to ry hea ded by the medi cal bioc he mis try spe cia li st. Af ter com ple tion of that trai ni ng, a Sta te exam has to be ta ken. This exam is or ga ni zed by the Croa tian Mi nis try of Health and is man da to ry. Af ter com ple ti ng trai ni ng and exam, me di cal bioc he mi st be co mes re gis te red as a mem ber of CCMB and ge ts the li cen se for in depen de nt wo rk. Me di cal bioc he mis ts wi th a li cen se may prac ti ce the pro fes sion, but may not be in volved and res pon sib le for so me spe cia li zed la bo rato ry tes ts (im mu no lo gy, mo le cu lar diag nos ti cs, toxi co lo gy etc.). The sco pe of as says and pro ce dures for whi ch a spe cia li st deg ree is requi red, is de fined by CCMB.
Licen se is va lid for a pe riod of six yea rs. Du ri ng that pe riod cre di ts are ear ned wit hin the prog ram of con ti nuous edu ca tion pro vi ded by CCMB. Cre di ts can al so be ear ned for the edu ca tion pro vi ded by ot her pro fes sio nal bo dies, by at ten di ng and/or givi ng lec tu res at se mi na rs, con fe ren ces, cour ses and wor ksho ps. Al so, cre di ts may be ear ned for pub lis hed pa pe rs and boo ks/chapters, as we ll as for ear ni ng a deg ree (PhD) and for spe cia li za tion in me di cal bioc he mis try. Spe cia lis ts who are men to rs to you ng PhD stu den ts and re si den ts al so get credi ts for that. Cre di ts are de sig na ted by CCMB to various edu ca tio nal ac ti vi ties ac cor di ng to the we ll de fi ned cri te ria. Mem be rs shou ld pro vi de evi dence for their cre di ts ear ned at the end of the li cen sing pe riod, in or der to be re-li cen sed. Li cen si ng is man da to ry and re gu la ted by the Go ver nme nt (Law on the Heal th Ca re, 1993).
The li cen si ng po li cy and pro ce du re in Croa tia appea rs to be in so me res pe ct qui te unique re la ti ve to ot her Eu ro pean coun tries. Na me ly, whi le li cen sing oc cu rs in Croa tia af ter one year of po st-gra duate prac ti cal trai ni ng and an exam, in all Eu ro pean Union mem ber sta tes the mi ni mum of trai ni ng befo re re gis tra tion is four yea rs.
In ma jo ri ty of Eu ro pean coun tries pro fes sio nal regis tra tion is now requi red for prac ti ci ng cli ni cal che mis try pro fes sion (9) and re gis te rs are go verned by va rious go ver nmen tal bo dies (Mi nis try of Heal th, Mi nis try of Edu ca tion, Cham be rs etc.) and even pro fes sio nal so cie ties (8). Al so, a fi nal exa mina tion is in clu ded in mo st coun tries. Spe cia lis ts in cli ni cal che mis try and la bo ra to ry me di ci ne are in so me coun tries ob li ged to con ti nuous pro fes sio nal de ve lop me nt whe reas in ot he rs are not. In tho se coun tries whe re con ti nuous pro fes sio nal de ve lopme nt is ob li ga to ry, it may and may not be requi red for re-li cen si ng, de pen di ng on the coun try.
What has al so been re gu la ted by the go ver nme nt is the res pon si bi li ty of the CCMB to pro vi de the qua li ty con trol as su ran ce system for me di cal bioche mis ts and me di cal bioc he mis try la bo ra to ries. CCMB has or ga ni zed the qua li ty con trol as su ran ce system in to two se pa ra te mo du les: 1) au dit for medi cal bioc he mis ts and me di cal bioc he mis try la bora to ries, and 2) na tio nal exter nal qua li ty con trol prog ram. Bo th prog ra ms are man da to ry.
Au di ts for me di cal bioc he mis ts and me di cal bioche mis try la bo ra to ries are con ti nuous ly sup por ted by the go ver nmen tal fi nan cial re sour ces. CCMB has a com mit tee for pro fes sio nal au dit whi ch aim is to con ti nuous ly con trol and su per vi se the qua lity of me di cal bioc he mis ts and me di cal bioc he mistry la bo ra to ries. Au di to rs are trai ned by the Com-mit tee mem be rs, ac cor di ng to re gu la to ry do cumen ts is sued by the CCMB, ba sed on the ISO 15189 stan da rd for me di cal la bo ra to ries. Au di ts co ver orga ni za tio nal, tec hni cal and pro fes sio nal as pec ts of the la bo ra to ry.
Na tio nal exter nal qua li ty con trol prog ram ma nage me nt is de le ga ted to the Croa tian So cie ty of Me di cal Bioc he mis ts (CSMB). CSMB is an in de pende nt, pro fes sio nal as so cia tion of all uni ver si ty degree la bo ra to ry pro fes sio na ls, who se mem ber ship is vo lun ta ry. CSMB pro vi des the exter nal ana lyti cal qua li ty as ses sme nt sche me for the ma jo ri ty of gene ral cli ni cal che mis try, he ma to lo gy and coa gu lation ana lyses (15). Par ti ci pa tion for the exter nal ana lyti cal qua li ty as ses sme nt sche me for all la bora to ries in Croa tia is man da to ry. Al thou gh CSMB has re cen tly laun ched a pi lot extra-a na lyti cal survey, the re is sti ll not a for mal and syste ma tic program of qua li ty as su ran ce for the extra-a na lyti cal pha se in our coun try. One re ce nt sur vey stu dy on extra-a na lyti cal pha se in Croa tia has in di ca ted that the re is a need for im pro vi ng the extra-a na lyti cal prac ti ces, es pe cial ly blood sam pli ng pro ce du res (16,17). The re fo re, the for mal EQA prog ram co ve ring the extra-a na lyti cal pha se is hig hly re com mended and shou ld be im ple men ted.

Vo ca tio nal trai ni ng
Voca tio nal trai ni ng for me di cal bioc he mis ts is regu la ted by the na tio nal re gu la to ry do cu me nt issued by the Mi nis try of Heal th. Ac cor di ng to that do cu me nt, on ly me di cal bioc he mis ts gra dua ted from the Fa cul ty of Phar ma cy and Bioc he mis try are eli gib le for spe cia li za tion in me di cal bioc hemis try. The du ra tion of the en ti re pe riod of vo catio nal trai ni ng is 48 mon ths. Trai ni ng prog ram mat ches the Eu ro pean Sylla bus (18) and it con sis ts of pos tgra dua te spe cia li st stu dy and four yea rs of ob li ga to ry vo ca tio nal trai ni ng in de sig na ted hos pita ls. The con te nt of the me di cal bioc he mis try postgra dua te stu dy com pri ses fol lowi ng cour ses: regu la tion of me ta bo li sm, cli ni cal en zymo lo gy, mole cu lar diag nos ti cs, mo le cu lar pat ho bioc he mis try, ac cre di ta tion, or ga ni za tion and ma na ge me nt of the me di ca l bioc he mistry la bo ra to ry, ana lyti cal tec hniques in me di ca l bioc he mistry la bo ra to ry, Simundic AM. Cli ni cal che mis try and laboratory medicine in Croa tia neu ro bioc he mis try, au toim mu ne di sea ses, mo lecu la r-bio lo gi cal met ho ds in me di ca l-bioc he mi cal la bo ra to ry, toxi co lo gy and TDM, la bo ra to ry he mato lo gy, im mu no he ma to lo gy and coa gu la tion, endoc ri no lo gy, tran sfu sion me di ci ne, tu mour mar kers, bios ta tis ti cs and met hod va li da tion. The vo catio nal trai ni ng prog ram for me di cal bioc he mis try com pri ses 15 mon ths of me di cal bioc he mis try, 11 mon ths of he ma to lo gy and coa gu la tion, 5 mon ths of im mu no lo gy, 2 mon ths of mic ro bio lo gy and 11 mon ths of poi nt-o f-ca re tes ti ng. The se lec tion of the hos pi tal that can ho st vo ca tio nal trai nees is do ne by the Mi nis try of Heal th.
Fi nal exa mi na tion af ter vo ca tio nal trai ni ng is ob liga to ry and is un der the res pon si bi li ty of the Mi nistry of Heal th. The two-day exa mi na tion com pri ses the prac ti cal pa rt in the la bo ra to ry (day one) and a com pre hen si ve oral exam (day two) in fro nt of the three mem be rs of the exa mi na tion boa rd. Exa mina tion boa rd mem be rs are me di cal bioc he mis ts wi th PhD deg ree, spe cia lis ts in me di cal bioc he mistry, hol di ng the mi ni mum deg ree of As sis ta nt profes sor, de le ga ted by the Mi nis try of Heal th.

Ac cre di ta tion stan dar ds
As in mo st of the Eu ro pean coun tries (19), la bo rato ry ac cre di ta tion is not man da to ry in Croa tia. So far the re are on ly few me di cal bioc he mis try la bora to ries ac cre di ted ac cor di ng to ISO 15189 (20). Accre di ta tion is re cog ni zed by the pro fes sio nal bodies as an ine vi tab le step in fu tu re im pro ve me nt of the qua li ty of la bo ra to ry prac ti ces on the na tional le vel and CCMB is the re fo re con ti nuous ly provi di ng its mem ber ship wi th edu ca tio nal wor kshops and trai ni ng cour ses on ac cre di ta tion and la bora to ry ma na ge me nt. Croa tian Ac cre di ta tion Agency (HAA) is an in de pen de nt, no n-com mer cial natio nal ac cre di ta tion bo dy, en tit led for ac cre di ta tion of me di cal la bo ra to ries, whi ch com plies wi th all in-ter na tio nal and Eu ro pean stan dar ds for ac cre di tation bo dies re cog ni zed in the Re pub lic of Croa tia as the Croa tian Stan da rd HRN EN ISO/IEC 17011:2005. Tec hni cal as ses so rs are spe cia lis ts in me di cal bioc he mis try and are se lec ted and trai ned by the na tio nal ac cre di ta tion bo dy (HAA). Whe reas ac cre di ta tion is playi ng an im por ta nt ro le for contrac ti ng wi th heal th ca re in su ran ce com pa nies and reim bur se me nt of expen ses for heal th ca re in some Eu ro pean coun tries (18), ac cre di ta tion sta tus is not of re le van ce to heal th in su ran ce agen cies in Croa tia.

Con clu sion
The re is a he te ro ge nei ty in de fi ni tion of our profes sion as we ll as in the aca de mic bac kgrou nd of spe cia lis ts in cli ni cal che mis try and la bo ra to ry medi ci ne ac ro ss Eu ro pean coun tries as we ll as worldwi de (21,22). Croa tia is one good exam ple of a hig hly re gu la ted pro fes sion of me di cal bioc he mistry prac ti tio ne rs. Des pi te so me ob vious diff e rences from ot her Eu ro pean coun tries, the pro fes sion has a si mi lar in ter dis cip li na ry cha rac ter and a compa rab le le vel of requi red com pe ten ce and skil ls. The edu ca tion las ts for 10 yea rs (5 yea rs of un dergra dua te study + 1 year of ob li ga to ry trai ni ng + 4 yea rs of vo ca tio nal trai ni ng) and is ful ly in ac cordan ce wi th the Eu ro pean stan dar ds. The offi cial regu la tion of pro fes sion is es tab lis hed by law. The re is a we ll es tab lis hed prog ram for li cen si ng and con ti nuous edu ca tion for me di cal bioc he mis ts, based on the cre dit poin ts and stric tly de fi ned cri teria.
One of the main goa ls on the na tio nal le vel is to pro mo te hi gh pro fes sio nal and scien ti fi c stan dards of the me di cal bioc he mis try pro fes sion to be ful ly pre pa red for the com mon plat fo rm for profes sio na ls in cli ni cal che mis try and la bo ra to ry medi ci ne at the Eu ro pean le vel.
Re fe ren ces