MUDr. Peter Bandura, PhD. Systém rýchlej výstrahy nežiaducich udalostí pri poskytovaní zdravotnej starostlivosti | Medicínske právo
              

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MUDr. Peter Bandura, PhD. Systém rýchlej výstrahy nežiaducich udalostí pri poskytovaní zdravotnej starostlivosti


 | 7.4.2014 | komentárov: 289

Jedná sa o dobrovoľný webový systém pre zdieľanie a výmenu informácií o otázkach týkajúcich sa bezpečnosti pacientov a výmeny osvedčených postupov v oblasti bezpečnosti pacientov medzi členskými štátmi EÚ. Cieľom tohto mechanizmu je efektívne a rýchlo šíriť informácie medzi členskými štátmi o otázkach bezpečnosti pacientov a osvedčených postupov, aby sa zabránilo vzniku nežiaducich udalostí a zároveň umožnila skorá reakciu v závislosti od ich závažnosti.

Obrazok

Podľa stupňa závažnosti a nutnosti reakcie na hlásené udalosti sú možné  3 stupne rýchlej výstrahy:

1.stupeň: nežiaduce udalosti, ktoré si vyžadujú okamžité opatrenia na  zabránenie vzniku poškodenia pacientov


2.stupeň: nežiaduce udalosti, ktoré predstavujú potenciálne riziko a potrebu určiť, či aj na lokálnej úrovni existuje možnosť vzniku nežiaducej udalosti.


3.stupeň: Osvedčené klinické a organizačné postupy, výsledky výskumu a inovácie, ktoré viedli k zlepšeniu  bezpečnosti pacientov. Tieto informácie nekladú požiadavky na okamžitú reakciu, ale sú vhodné na implementáciu na národnej alebo miestnej úrovni.

Informácie, ktoré sa hlásia do medzinárodného systému vychádzajú z národných systémov hlásení nežiaducich udalostí.   Vo väčšine členských štátov EÚ  zdravotnícki pracovníci hlásia nežiaduce udalosti v samotnom zariadení, kde dôjde k poškodeniu pacienta pri liečbe alebo diagnostike a zároveň inštitúcii, ktorá sa zaoberá analýzou a vyvodením poučenia pre ostatné zdravotnícke zariadenia. Udalosti, ktoré by mohli mať za následok poškodenia pacienta aj v iných zdravotníckych zariadenia a osvedčené klinické alebo organizačne postupy, ktoré im dokážu predísť  budú predmetom dobrovoľného medzinárodného výmenného systému informácií SEAL, ktorý sa pripravuje pod vedením Slovenskej republiky v rámci projektu Európskej siete bezpečnosti pacientov a kvality zdravotnej starostlivosti PaSQ (Patient Safety and Quality of Care).


V každej členskej krajine zapojenej do systému rýchleho varovania bude určený jeden národný kontaktný bod, ktorý bude prijímať hlásenia v rámci svojej členskej krajiny a v prípade, že zodpovedajú kritériam vhodným pre nahlásenie do medzinárodného systému, zatriedia ich podľa stupňa závažnosti a  odošlú  do medzinárodného systému SEAL. Na druhej strane národné kontaktné miesta v ostatných členských krajinách po obdŕžaní výstrahy sú zodpovedné za rozšírenie výstrahy v rámci členskej krajiny a upozornenie príslušných zdravotníckych zariadení na potrebu prijatia nevyhnutných opatrení na zabránenie výskytu podobných nežiaducich udalostí.

Vzhľadom na to, že európsky systém výstrahy je prevádzkovaný v anglickom jazyku, kontaktný bod zabezpečí preklad hlásenia v rámci členskej krajiny do anglického jazyku a naopak po obdŕžaní hlásenia z medzinárodného systému, zabezpečí jeho preklad do národného jazyka a ďalšie rozšírenie v rámci členskej krajiny. Výmena informácií prebieha v elektronickej podobe na štandardizovanom elektronickom formulári. V záujme zabezpečenia ochrany osobných údajov sú informácie o zdravotníckom zariadení, pacientovi a hlásiteľovi anonymizované.

V súčasnej dobe existuje v rámci európskej únie niekoľko systémov vzájomnej výstrahy v oblasti nežiaducich účinkov výrobkov, liekov, potravín a krmív, falošných liekov, ľudských tkanív a buniek:


•    RAPEX: Rapid Exchange of information about products that constitute a serious and immediate risk – rýchly systém informácií o výrobkoch, ktoré predstavujú vážne a okamžité riziko


•    RAS – Rapid Alert System in pharmacovigilance – systém rýchlej výstrahy v oblasti liekov


•    RASFF – Rapid Alert System for Food and Feed – systém rýchlej výstrahy v oblasti potravín a kŕmiv

•    WHO rapid alert system for counterfeit drug incidents and to disseminate of first response information – systém rýchlej výstrahy Svetovej zdravotníckej organizácie pre nežiaduce udalosti spôsobené falošnými liekmi

•    RATC – Rapid Alert mechanism for human Tissues and Cels – mechanizmus rýchlej výstrahy pre ľudské tkanivá a bunky.

SEAL - Medzinárodný systém výmeny nežiaducich udalostí v oblasti poskytovania zdravotnej starostlivosti ešte nie je vytvorený. Úspešne fungujú národné systémy  rýchlej výstrahy v rámci niektorých členských štátov. Ako inšpirácia pre návrh medzinárodného systému poslúžili príklady z fungovania systémov rýchleho hlásenia v Dánsku a Holandsku. Vo Veľkej Británii od 1.apríla tohto roku spustili CAS- Central Alerting System.

Pre pochopenie, aké sú možnosti a význam mechanizmu rýchlej výstrahy, môžeme uviesť výstrahu, ktorá bola nahlásená 4.marca 2014 do CAS vo Veľkej Británii.

Výstraha bezpečnosti pacientov 1.stupňa- varovanie. Nebezpečenstvo pripojenia záznamu EKG vyšetrenia nesprávnemu pacientovi.

Popis udalosti

EKG sa bežne vykonáva diagnostika srdcových problémov a neexistujú žiadne riziká spojené so samotným vyšetrením, ale je tu riziko pripojenia EKG záznamov nesprávnemu pacientovi, ktoré môžu viesť k chybnej diagnóze a nesprávnej liečbe.Bola nahlásená udalosť, kedy namiesto tlačidla auto/ štart stlačil personál tlačidlo tlačiť a prístroj vytlačil EKG záznam predchádzajúceho pacienta. Personál si neuvedomil svoju chybu a EKG záznam označil nesprávne údajmi nového pacienta. Pacient podstúpil zbytočný invazívny zdravotný výkon, v dôsledku ktorého mal ďalšie komplikácie. Bolo nahlásených aj ďalších sedemnásť prípadov vytlačenia nesprávneho EKG záznamu, ale našťastie bez zdravotnej ujmy u pacientov.

Pri analýze prípadov sa zistili nasledujúce príčiny:


1.    predvolené nastavenie prístroja nevyžadovalo zadanie identifikačných údajov pacienta
2.    Zlý dizajn prístroja- tlačidlo Tlačiť sa nachádzalo vedľa tlačidla štart
3.    Nesprávny postup zdravotníckeho personálu

Potrebné opatrenia:


Kto: všetky oddelenia, kde sa nachádzajú EKG prístroje
Kedy: okamžite, najneskôr do 4.4.2014
Čo:


1.Zistiť, či existuje riziko, zámeny EKG záznamy nesprávnemu pacientovi a či k takémuto prípadu už došlo.
2. Prijať okamžité opatrenia na miestnej úrovni a vypracovať akčný plán, aby sa znížilo riziko podobnej mimoriadnej udalosti.
3. Oboznámiť s touto informáciou všetkých zdravotníckych pracovníkov, ktorí pracujú s EKG prístrojmi.

To je jeden z príkladov, ktorý názorne ukazuje, ako  sa dá vzájomnou výmenou informácii  a následnými organizačnými opatreniami zabrániť vzniku nežiaducich udalostí bez nutnosti  veľkých finančných investícií.

Slovenský tím projektu Európskej komisie PaSQ v spolupráci s partnermi z Francúzska, Dánska, Talianska, Chorvátska a Veľkej Británie pripravuje spustenie európskeho systému rýchleho varovania SEAL, ktorý bude predstavený na medzinárodnej konferencii projektu PaSQ v októbri t.r. v Bratislave.

Vytvorenie Európskej siete  rýchlej výmeny informácií  o nežiaducich udalostiach pri poskytovaní zdravotnej starostlivosti prispeje k zjednoteniu úsilia členských štátov EÚ v oblasti bezpečnosti  pacientov s cieľom zabezpečiť využívanie bezpečných a kvalitných diagnostických a liečebných postupov.

 

AUTOR: MUDr.Peter Bandura, PhD., vedúci WP7 projektu PaSQ Európskej komisie

Národný kontaktný bod - Ministerstvo zdravotníctva SR
slovakia@pasq.eu
www.pasq.eu










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