NATIONAL JACIE MEETING EXPERIENCES OF QUALITY MANAGERS 24 JANUARI 2013
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1 NATIONAL JACIE MEETING EXPERIENCES OF QUALITY MANAGERS 24 JANUARI 2013
2 I. LOCATION DIENST HEMATOLOGIE II. APPLICATION FOR RE-ACCREDITATION III. PRE-AUDIT DOCUMENTS IV. ON-SITE INSPECTION V. INSPECTORS REPORT
3 I. LOCATION DIENST HEMATOLOGIE JESSA ZIEKENHUIS 1 januari 2010 Fusieziekenhuis Campus Salvator Campus Virga Jesse Campus St. Ursula
4 I. LOCATION DIENST HEMATOLOGIE Evolution fusion Three campuses stay as they are. Similar services will be concentrated on one specific campus registered beds & 3029 employees. New hospital within 15 to 20 years?
5 I. LOCATION DIENST HEMATOLOGIE Organisatiestructuur Jessa Ziekenhuis Algemene vergadering Raad van Bestuur Medische raad Directiecomité ZC 1 ZC 2 ZC 3 ZC 4 ZC 5 ZC 6 ZC 7 ZC 8 ZC 9 ZC 10 ZC 11 ZC 12
6 I. LOCATION DIENST HEMATOLOGIE
7 I. LOCATION DIENST HEMATOLOGIE Software package Mithras (Bitos nv.) has been chosen for the development and maintenance of our quality system and is used as document control tool. Same software as already used by the laboratory.(processing) Database from the clinical and collection part is linked with the database of the clinical lab. Softwarepackage complies with the strickt demands of ISO17025 and ISO
8 I. LOCATION DIENST HEMATOLOGIE Databases are linked, but clinical and collection can only have read-only access to the part of the processing lab and vice versa. For both databases reader tracking is installed.
9 I. LOCATION DIENST HEMATOLOGIE DIENST HEMATOLOGIE EBMT CIC 632 Clinical,part of ZC 2 Collection,part of ZC 2 Processing,part of ZC 11
10 DIENST HEMATOLOGIE Programma Directeur 1 JACIE stuurgroep 2 Kwaliteitsmanager 3 Subgroepen: -Kliniek/collectie -Verwerkingslabo -Apotheek -Psychosociale groep Beheerder EBMT 16 Datamanagement LOC 17 Kwaliteitsmedewerker Hematologie 4 Subgroepen: Technische Dienst 18 Voedingsdienst 19 Logistiek 20 Onderhoud 21 Ziekenhuishygiëne 22 Medisch Directeur Kliniek 5 Medisch Directeur Collectie 6 Directeur Verwerkingslabo 7 Artsen 8 Hoofdverpleegkundige 9a Adv Nurse 10 Verpleegkundigen 11 Verzorgenden 12 Artsen 8 Wetenschappelijk medewerker Hoofdverpleegkundige 9b 14 Adv Nurse 10 Verpleegkundigen 11 Vrijwilligers 13 MLT 15
11 Aantal I. LOCATION DIENST HEMATOLOGIE Aantal stamcelcollecties ( ) Jaartal
12 I. LOCATION DIENST HEMATOLOGIE Aantal transplantaties per jaar
13 II. APPLICATION FOR RE-ACCREDITATION A little bit of confusion : centre was waiting to be contacted, because JACIE contacted our centre for annual reports. INSTEAD : You have to contact the JACIE-office! JACIE remains a voluntary programme. JACIE does not penalise centres when there is a gap between accreditations.
14 II. APPLICATION FOR RE-ACCREDITATION Can inspire the same reactions as initial application
15 II. APPLICATION FOR RE-ACCREDITATION Renewal application : process to apply is identical to first-time application in almost all aspects Application included clinical, collection and processing facilities for adult patients. (auto only) -Submission of a request (application form), Inspection Checklist and your assessment -Submission of pre-inspection documentation Follow the checklist -On-site inspection and inspectors report -Reporting and corrective actions (where these are indicated) -Re-accreditation
16 III. PRE-AUDIT DOCUMENTS Next step in the process : submit pre-inspection documentation Please note that this remains a lot of work for everybody!!! Pre-formatted folder structure
17 III. PRE-AUDIT DOCUMENTS File is then returned to JACIE for checking and distribution Use of TEAMBOX (instructions on the JACIE-website) to facilitate the submission process.
18 III. PRE-AUDIT DOCUMENTS Experience of our centre Maintenance of the quality system : stay focussed. Everyone thinks they have plenty of time to get things done. If you don t watch out this will end in a mad rush prior to the inspection.
19 III. PRE-AUDIT DOCUMENTS Experience of our centre Review of SOP s on regular timepoints : Software triggers alerts, but the individual still has to do review. That applies to the approval flow as well.
20 III. PRE-AUDIT DOCUMENTS Experience of our centre Organisation of regular internal audits. Is not so obvious, considered that : -2 physicians : one physician is clinical director and one physician is collection and programme director - almost same nursing team since accreditation Adverse event follow up. Is manageable in your own zorgcluster. Is a lot more difficult when several zorgclusters are involved. The challenge is to keep people motivated, in stead of creating frustration. In some small projects success was booked. Example : dietician on site.
21 III. PRE-AUDIT DOCUMENTS Experience of our centre Stimulation of regular meetings. Getting staff to attend meetings is a continual challenge. When everything is done as originally planned in the QM-plan it is our experience that there are too many meetings. A way to keep the participants motivated is to schedule some larger meetings and decrease the frequency of smaller meetings. Note that for initial application these smaller meetings were necessary and usefull Now we rely more on ad hoc small committee meetings.
22 IV. On-site inspection With the re(inspection) the focus of the inspector lies more on the interactions and the maintenance of the quality system Verification of the applicant s self-check equally remains.
23 IV. On-site inspection CIC 632 was accredited with JACIE standard version 2. At the time of re-accreditation JACIE standard Version 4 was applicable. At this moment JACIE standard version 5 has to be implemented. Not only the centre has to evolve, the standards evolve as well, that way changing the rules of the game.
24 V. INSPECTORS REPORT After a visit of 1.5 days by three inspectors, we were informed of the inspectors findings.
25 VI. CORRECTIONS There were not a lot of remarks from the inspectors, but the corrections which had to executed were not so easy to implement. The remarks were detail-remarks, no framework remarks.
26 THANK YOU
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