Continuous quality improvement - quo vadis?

Transcription

1 Continuous quality improvement - quo vadis? Solveig Linko, PhD, EurClinChem solveig.linko@hus.fi

2 HUSLAB Clinical chemistry and hematology section

3 Hospital districts 2004 Sairaanhoitopiirit 2004 HUS Varsinais-Suomi Pirkanmaa Pohjois-Pohjanmaa Keski-Suomi Pohjois-Savo Satakunta Päijät-Häme Etelä-Pohjanmaa Kymenlaakso Pohjois-Karjala Kanta-Häme Vaasa Etelä-Karjala Lappi Etelä-Savo Kainuu Keski-Pohjanmaa Länsi-Pohja Itä-Savo Ahvenanmaa

4 HUS hospital areas (7) Hanko Pohja Nummi- Pusula Vihti Sammatti Karjalohja LohjaSiuntio Karjaa Tammisaari Inkoo Karkkila Hyvinkää Kauniainen Espoo Kirkkonummi Järvenpää Mäntsälä Askola Liljendal Nurmijärvi Pornainen Perna Tuusula Porvooja Sipoo Vantaa Kerava Myrskylä Lapinjärvi Helsinki

5 Active research unit HUSLAB HUSLAB started Joint laboratory of Helsinki hospital and Helsinki city hospital laboratories Jorvi (Espoo) Hospital Laboratory Peijas (Vantaa) Hospital Laboratory Vantaa health care centre laboratories 8 sections ca employees, 100 M, 10 million laboratory tests per year

6 HUSLAB vision 2006 Automated routine analytics Fit-for-purpose acute- ja POCT analytics A harmonised POCT concept in 24 h hospitals and health care centers Sample taking on the laboratory's responsibility

7 HUSLAB - sections (8) Clinical chemistry and hematology Clinical microbiology Pathology Molecular genetics Poisoning info center Clincal physiology Clinical neurophysiology Research and education

8 HUSLAB organisation Board + Managing director Financing Admininstration Quality system Data management Customer care Purchasing Clin.chem. and Pathology Mol. genetics Clin. neurophysiology Poisoning info hematology center Clin. microbiology Clin. physíology Research and education

9 Clinical chemistry and hematology 40 units 15 hospital laboratories 8 hospital laboratories 24 h 25 health care center laborat-ories

10 Clinical chemistry and hematology ca. 800 employees (of 1500 in HUSLAB) > 600 lab technicians, clinicians and clinical chemists, and chief nurses 1:1

11 Laboratory Investigations - Finland ~ 45 million laboratory tests yearly in HUS ~25% of the total in Finland Million tests per yr Finland HUS HUSLAB Clinical chemistry and haematology

12 Accredited laboratory T055 (SFS-EN ISO/IEC 17025) Scope of accreditation: Clinical chemistry Hematology Coagulation tests Blood banking ca. 100 different tests

13 QA + IQC + EQA + TQM CQI Knowledge + Skills + Will

14 Quality systems and international standards EN 45001:1989 ISO Guide 25:1990 ISO/IEC 17025:1999 ISO 15189:2002

15 BSC-model and four parts of the quality system PROCESSES ORGANISATION AND MANAGEMENT CONTINUOUS TRAINING CUSTOMER CARE F i n a n c i n g R e s o p u r c e s Requests Sampling Analysing QA Raporting Data management

16 Instrumentation/T chemistry analysers 17 blood gas/electrolyte analysers 2 immuno analyzers 3 cardiac marker analysers 14 hematology analysers 12 coagulation test analysers 3 blood grouping analysers

17 Re-organising and centralising the analytics harmonised instrumentation and methodology improved analytical quality less documentation and SOP s more effective and less training

18 Methods/T055 ISO/IEC Para Reference materials shall, where possible, be traceable to SI units of measurements, or to certified reference materials. Internal reference materials shall be checked as far as is technically and econimically practicable.

19 IVDD-requirement on traceability "The metrological traceability of value assigned to calibrators and controls must be assured through available reference materials and reference measurement procedures." IVDD 98/79 EC on

20 different glucose meters - results between 1.5 and 5.0 mmol/l AccuTrend Sensor One Touch Basic II Profile GlucoTouch EuroFlash Medisense Card PrecisionQ.I.D Medisense Precision Xtra Glucocard II/Super Glucometer Elite Ascensia Elite XL Muu laite

21 Cholesterol Talouselämä : 111 M reimbursements in 2002 for 300,000 Finnish people >50% Finnish people exceed >5.0 mmol/l NORIP: y: mmol/l y: mmol/l 50 y: mmol/l

22 Cholesterol - ST 12/2003

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