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Clinical Audits Pilot study Half way Marleen Vandecapelle 03/12/2010 10.00-12.00h.

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Presentation on theme: "Clinical Audits Pilot study Half way Marleen Vandecapelle 03/12/2010 10.00-12.00h."— Presentation transcript:

1 Clinical Audits Pilot study Half way Marleen Vandecapelle 03/12/ h

2 General remarks Yes/No to be replaced by percentages or 0/partial/almost complete/complete Many questions should be A instead of B or C because of proven legal basis Many questions are in fact multiple questions and should be subdivided Vague terminology e.g. regularly ? adequat ? Certain abbreviations should be explained e.g. BSS and SOP Composition of audit team ? Feasible for small departments ? Minimum professional requirements not clear. What is IAEA DAT certificate ? Guiding principles and procedures: only IAEA accepted ? E.g. NVNG document Feasibility within proposed time frame ?

3 Hospital coordinator quality management: –Did You find him/her ? –Did he/she cooperate ? How much time did You spent on filling out the checklists ? Did You experience it as being usefull ? General remarks

4 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 3.1.1Is the nuclear medicine service guided by specific objectives developed at the national level? B What is meant with « specific objectives ? Where to be found ? Quels objectifs et définis par qui ? Zijn we daar nu niet mee bezig ? 3.1.2Is the nuclear medicine service guided by specific objectives developed by the hospital management? B idem Is there adequate coordination with radiology, oncology, and cardiology? C c) 3.1.4Has the nuclear medicine department a written organizational chart? Is it up to date? B 3.1.5Does the organizational chart indicate channels of communication and lines of authority within the nuclear medicine department? B 3.1.6Is the range of specific nuclear medicine diagnostic imaging and therapeutic services appropriate to the size and scope of the hospital’s clinical service? B Hoe beoordelen ? 3.1.7Do the objectives of the nuclear medicine service include the provision of services for urgent requests? B 3.1.8Do the objectives of the nuclear medicine service include the provision and maintenance of high quality care through clinical audit and quality control? A zijn we daar nu niet mee bezig ? 51.4§ Does the department have a business plan?B masterplan = business plan ? Cela concerne seulement le matériel ou également le personnel ? Does the department have a strategy regarding new developments in diagnosis and treatment? B If the hospital itself does not provide a full range of nuclear medicine services, does the department have a strategy/policy to recommend access to diagnostic investigations, as required for adequate patient care, elsewhere? B Where satellite services are provided (e.g. technical and clinical support for other hospitals), is the responsibility for the operation of these services clearly defined? B Checklist 1: Strategies and policies

5 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 3.2.1Is there a regular review of the work procedures used in the reception areas? B Ndls: « Worden de werkprocedures in onthaalruimten regelmatig nagekeken ? » Procedures of secretariat? 3.2.2Is there a protocol for dealing with incomplete request forms?B And absent request forms ? Shouldn’t this be an A question ? 3.2.3What quality factors are in place to accommodate peak scheduling demands? B ? 3.2.4Are all requests reviewed, justified and approved by a nuclear medicine physician? A c) 51.3§ Does the department have written standard operating procedures (SOPs) for all tasks, including operational, administrative, technical and clinical? A Is het strikt noodzakelijk om bij de opstart voor elke taak een SOP te hebben ? Het lijkt me realistischer voor kleine diensten om te kunnen starten met de hirisk taken en verdere vervollediging in te plannen. Moet dit wel ? Do the SOPs identify level of competent operators/professionals?A Bekwaam: is dat in vergelijking met tabel p 10 ? 3.2.7Does the final responsibility for a nuclear medicine procedure lie with an appropriately qualified physician? A Is there a regular review of QM by an appointed medical physicist?A Is 4x/year by Controlatom enough ? Wat met kleine diensten in perifere ZH, hebben die wel deze mensen in dienst ??? 51.4§ Is there a regular review of QM by a registered pharmacist?A Enkel voor radiofarmacie of ook voor Hot Lab 2b ? Niet echt duidelijk in de omschrijving 51.4§ Is there a mechanism for dealing with short-comings or deficiencies? B ? Checklist 2: Administration and management

6 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 3.3.1Are all staff members appropriately trained and qualified specialists for their job description? B § § Do all staff members within the department have a written job description which sets out duties and responsibilities clearly? B 3.3.3Is there continuous professional education and development for all staff categories? B 25§4 25§ §7 53.2§ Are there specialist training programmes for nuclear medicine technologists or radiographers to work in nuclear medicine? B Ndls: röntgenologen ? Fr: tecnologues en radiologie ? Are all ‘hot laboratory’ staff members suitably trained in safe handling of radiopharmaceuticals? B Are there adequate tools available for objective monitoring of any training? B Question à retirer Attestering of nog iets anders ? 3.3.7Is there a regular performance review to identify training needs?B Wat wordt verstaan onder een prestatiebeoordeling ? Een prestatiebeoordeling van de individuele medewerker ? Van een arts of van de dienst in het geheel ? Question à retirer 3.3.8Is there regular professional training in radiation safety and radiation protection? B Wettelijk jaarlijks of ??? Volgens Fanc en art 25 duidelijk bepaald. Technologendag kan hierin makkellijk bijspringen met jaarlijks opleiding RP in te calculeren in de dag, zo is iedere deelnemer onmiddelljk in orde 25§4 25§ §7 53.2§ Do staff members have access to web based learning, up to date books and journals? B Checklist 3: Human resources development

7 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis 4.1.1Is the department formally authorized by a recognized national authority? A 3.1.b)3.b) Do the radiation rules refer to national guidelines or cross-refer to international rules? A ? Moeten wij dat uitmaken ? 4.1.3Have all staff members signed to confirm that they have read and understood the local rules? A Leesbevestiging bij digitale versie voldoende ? Zit in arbeidsovereenkomst 4.1.4Are all radioactive sources identified and stored appropriately?A Moet een inventaris aanwezig zijn ! 27.4°g) c) 4.1.5Are sealed calibration sources checked periodically, cross- accounted and checked for any leakage? A Fuite n’est pas le mot correct Fr: « Les sources de calibration scellées font-elles l'objet de vérifications périodiques, et de contrôles de fuites éventuelles ? » 4.1.6Is there routine nuclear medicine personnel monitoring for radiation exposure including: - TLD badges; - Injection personnel hand/finger monitoring; - Dispensing staff hand/finger and occasional eye monitoring? A Hier wordt meer gevraagd dan in ARBIS wordt vermeldt Subdiviser la question en plusieurs Quelle est la différence entre personnel chargé des injections et personnel dispensateur ? Le contrôle des yeux correspond à une surveillance par détecteur ou la détection d’une éventuelle cataracte ? Oog monitoring noodzakelijk ? Are protective clothing, gloves, syringe shields, handling tongs, etc., available? A ° ° ° 4.1.8Are there adequate facilities for administration of radiopharmaceuticals, therapy and radioactive aerosols? B Checklist 4: Radiation regulation and safety compliance (1)

8 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis 4.1.9Have areas been classified as ‘supervised’ or ‘controlled’ according to the BSS (Basic Safety Standards) and/or local regulations? A ° Is there a procedure for dealing with a spillage or contamination incident? A Are there means to prevent unauthorized access to supervised and controlled areas? A ° 27.4°e) ° Are radiation signs (in local language(s)) displayed prominently on entry to supervised and controlled areas? A ° 31.2.a) + b) ° Do all departmental personnel receive instructions and training on local procedures, safety precautions for the protection of the patient and staff when they start working in nuclear medicine? A HR ? Are formal risk assessments and/or surveys of the department and equipment performed by designated staff? A Door wie moet dit gebeuren ? Haalbaar voor kleine diensten + wat wordt hiermee precies bedoeld ? Hoe vaak dienen deze analyses te gebeuren en moet hierbij een bepaalde methodiek gevolgd worden ? Are there suitably calibrated and functional radiation monitoring devices available? A ° a) Are there detailed procedures for handling patients’ specimens (blood, urine, etc.)? A Are there formal procedures for the disposal of liquid and solid radioactive waste? A Is the level of waste checked routinely against the authorized disposal limit? A Hoeveel bedraagt toegestane hoeveelheid ? Préciser la fréquence derrière le mot routinier ° Is there a policy on the transport of radioactive material?A Transport van en naar bunker ? Transport tussen diensten ? Terugsturen generator ? ° ° Checklist 4: Radiation regulation and safety compliance (2)

9 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 4.2.1Are there standard operating procedures (SOPs) to identify patients correctly prior to administration of radiopharmaceuticals? A Are there SOPs for enquiring whether females of child bearing age are pregnant or breast feeding? A 51.4§ Are written and verbal instructions given to patients before and following administration of radiopharmaceuticals? B Moet de uitleg door de arts gebeuren ? Mondeling = A ; Schriftelijk =B ; wat ivm de taalvereisten voor vreemdelingen ? c) 4.2.4Is the activity in each patient dose measured prior to administration and entered into the patient’s record? A patiëntendossier = aanvraagformulier ? Mesurée mais pas consignée § Is there an SOP for checking that radioactivity doses do not exceed the reference values given in the Basic Safety Standards (BSS), national or international regulations or guidelines? A Referentiewaarden in de BSS zeer moeilijk te vinden ??? Is an adequately trained person available in the institute who can estimate the effective radiation dose to patients following administration of radiopharmaceuticals? C Are written instructions for staff available to decide when to release patients after therapy administration? B Beslissing van de geneesheer ? 4.2.8Are there adequate SOPs to minimize the risk of misadministration of radiopharmaceuticals? B § Are there adequate SOPs to minimize the risk of multiple exposures? B C’est-à-dire pour éviter une 2° injection par inadvertance ou des examens radiologiques ? c) §3 Checklist 5: Radiation protection of the patient

10 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 4.3.1Are standards set for the nuclear medicine service, preferably in the form of a quality manual (includes operational flow charts, standard operating procedures (SOPs), etc.)? B welke onderdelen verwacht men in het kwaliteitshandboek of kan de instelling dit zelf invullen ? Zijn er bepaalde vormvoorschriften of men hierin ook vrij ?? Quelles normes ? 51.4§ Are there systems for monitoring compliance with standards, with defined criteria of acceptability? B VAAG § Does the department regularly perform self-assessments/audits?B Impossible de revoir l’ensemble de l’audit chaque année en interne 4.3.4Is there a system for assessing customer satisfaction and for assessing the satisfaction level of the referring physicians? B worden er vereisten gesteld aan dit systeem inzake frequentie ? 4.3.5Is there is an SOP for handling non-compliance, including recording and correction/prevention? B Non-conformité= ? 4.3.6Is there a mechanism for monitoring data to ensure quality improvement? B vraag klinkt nogal abstract. Wordt hier bedoeld dat er kwaliteitsindicatoren worden opgevolgd om de kwaliteit op klinisch en operationeel vlak op te volgen en dat er vandaaruit een verbetercyclus wordt opgezet ? 4.3.7Are all staff members involved in formal reviewing and monitoring of quality? B Noodzakelijk dat ALLE personeelsleden betrokken zijn bij de formele beoordeling van kwaliteit ? Waarom ??? 4.3.8Are all items of equipment purchased against technical specifications prepared by a competent person in conjunction with the users? B ? Are these specifications used for the acceptance testing of equipment?B ? Checklist 6: Evaluation and assurance of quality system (1)

11 4.3.10Is there a quality assurance programme, with regular calibration and inspection of all equipment (e.g. calibrator, beta and gamma counters, radiation survey monitors, planar and tomographic gamma cameras, PET and PET/CT scanners, thyroid counters, gamma probes, aerosol delivery systems, etc.) in accordance with the BSS, international and local standards and regulations? A Wat met sentinelprobes die uitgegeven worden aan het OP ? Vallen die nog onder de nucleaire of wordt dit bij het OP nagezien. subdiviser la question § Are the results of all of the above QM programmes recorded, evaluated and regularly reviewed? B Is there a procedure to ensure that any equipment or material which fails a quality test is not used unless specifically authorized by a designated member of staff? A § Are action levels and responsibilities defined to determine when equipment should be repaired, replaced, or taken out of service? A § Are plans for maintenance, repair and replacement established for all major equipment (either in-house or external)? B Does the department participate in external QM programmes?B Externe à l’hôpital ou au service ? No.ComponentClassY/NComments/planned action Date achieved Regulatory basis Checklist 6: Evaluation and assurance of quality system (2)

12 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 4.4.1Are there documented policies and protocols on the operation, quality control and assurance for all imaging equipment in clinical use? B § Do these policies conform to the manufacturers’ instruction manuals?A 4.4.3Are there documents detailing actual results of quality control and measurements from gamma camera performance? B § Is there a written policy for specifying, procuring and testing new imaging equipment? B 4.4.5Is there a regular physical inspection of the hardware including the detector head(s), shielding, etc.? A Oui partiel Question pas claire § Is there regular checking, review of results and trend analysis of: - Uniformity - Intrinsic uniformity; - Intrinsic uniformity versus energy windows; - Intrinsic uniformity for various energies; - System uniformity? A §4 Checklist 7: Quality control for imaging equipment (1)

13 4.4.7Is there regular checking, review of results and trend analysis of: - Spatial resolution - Intrinsic spatial resolution (qualitative); - Intrinsic spatial resolution (quantitative); - System spatial resolution (qualitative); - System spatial resolution (quantitative)? A § Is there regular checking, review of results and trend analysis of: - Spatial linearity (distortion); - Intrinsic spatial linearity; - System spatial linearity? A § Is there regular checking, review of results and trend analysis of: - Count rate performance; - Intrinsic count rate performance; - Maximum count rate performance; - System count rate performance? A Obsoleet ? § Is there regular checking, review of results and trend analysis of: - System sensitivity; - Point source sensitivity; - Plane sensitivity? A § Is there regular checking and review of: - Multiple window spatial registration; - Angular variation of spatial position; - Whole body imaging spatial resolution? A No.ComponentClassY/NComments/planned action Date achieved Regulatory basis Checklist 7: Quality control for imaging equipment (2)

14 No.ComponentClassY/NComments/planned action Date achieved Regulatory basis 4.5.1Is there a policy for computer procurement, installation, and acceptance of hardware and software? B Niet duidelijk of het hier gaat om administratieve software of om beeldverwerkingssoftware. Administratieve SW = onderdeel van de ZH bepalingen, beeldverwerkings SW = dienst nucleaire geneeskunde Is there a written policy on computer hardware and software upgrades? B idem Is there a written procedure for assessing integrity of data following a major software revision for: - Count rate losses; - Data framing; - Imaging quantification; - Image arithmetic; - Activity-time curve arithmetic? B Verantwoordelijkheid leverancier 4.5.4Is there a policy on QM of ‘in-house’ software?B Checklist 8: Computer systems and data handling

15 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis 4.6.1Is there a policy for acquiring equipment certified with ‘CE’ mark or that has undergone review by a national authority (similar to FDA)? A Aankoopbeleid apparatuur ? Do the above policies conform to IAEA/IEC/NEMA publications AND the manufacturer’s instruction manual? A Conform IAEA ? 4.6.3Is there documentation that compares the tender with the actual delivery? B 4.6.4How do the manufacturers’ test results compare with independent acceptance tests? B 4.6.5Are intrinsic NEMA procedures undertaken for:A All acceptance tests are excecuted by the firm before first use: sufficient ? Energy resolution; - Flood field uniformity; - Spatial resolution; - Spatial linearity; - Count rate performance and maximum count rate; - Multiple window spatial registration? 4.6.6Are extrinsic (system) NEMA procedures undertaken for:A idem Flood field uniformity; - Spatial resolution with and without scatter; - Sensitivity for each collimator; - Detector head shielding leakage? Checklist 9: Acceptance tests (1)

16 4.6.7Are the following acceptance tests for SPECT (non-NEMA) undertaken for: A idem SPECT centre of rotation; - Angular linearity errors; - Uniformity; Tomographic slice uniformity; Rotational uniformity; - System volume sensitivity (NEMA); - Tomographic resolution: Tomographic resolution in air (NEMA); Tomographic resolution in a scatter medium (NEMA); - Test of slice thickness (IAEA); - Total performance check (data spectrum phantom) (American Association of Physicists in Medicine (AAPM)): Tomographic uniformity; Tomographic resolution (spheres and rods); Contrast? 4.6.8Are specific tests for multiple detector systems undertaken for:A idem Multiple detector registration; - Matched sensitivity; - Matched pixel calibration; - Matched centre of rotation? No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Checklist 9: Acceptance tests (2)

17 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis 5.1.1Are the BSS principles applied in clinical nuclear medicine services? A Quels sont-ils ? § Is a regular review of timelines undertaken from booking to performance of the scan, to reporting? B 5.1.3Are doctors available to answer patient’s questions?B 5.1.4Is there a system of patient surveillance during the time the patient is in the nuclear medicine department? B A ? Toch primair voor kwaliteitsvolle werking ??? Zowel voor kleine als grote diensten Is there a specific policy for paediatric nuclear medicine patients including dose adjustment, sedation, etc.? A § Is there an appropriate medical supervision during nuclear medicine interventions such as diuretics, ACE inhibitors, etc.? A 5.1.7Is medical advice given before obtaining patient informed consent — specifically for therapy? B Geïnformeerde toestemming van de patiënt met getuige ???? A ne faire que pour les traitements c) Checklist 10: General aspects - clinical services

18 Type of investigation Type of study Clinical problem Patient preparation Radio-pharmaceutical and activity Acquisition parameters Processing parameters Images Final report Recommendations PlanarThyroid Planar Whole bodyBone Mettre type d’examens avant type d’étude DynamicRenography SPECT For example, bone Cardiac SPECTMPS Checklist 11: Summary of imaging diagnostic procedures Kies je voor een externe audit ook zelf je onderzoeken of is het gewoon de bedoeling dat je kan aantonen dat dit regelmatig gecontroleerd wordt.

19 Type of study Clinical problem Patient preparation Radio-pharmaceutical and activity Study protocol Calculation methods Final reportRecommendations GFR Schilling test Blood volumes Red cell survival Sentinel node A mettre dans les procédures d’imagerie diagnostiques Iron kinetics Checklist 12: Summary of non-imaging diagnostic procedures valt schildwachtklier onder niet beeldvormingsdiagnoseprocedures ?

20 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis 5.3.1Are the BSS principles applied in the radionuclide therapy service from nuclear medicine? A Quels sont-ils ? § Is there a written standard operating procedure (SOP) for radionuclide therapy service? B Is the appropriateness of the clinical indications for the requested therapy reviewed and approved by the nuclear medicine department or equivalent specialist? A c) 51.3§ Is the radioactive dose to be administered to the patient in concurrence with a medical physicist (calculation of the effective dose absorbed), nuclear medicine physician or equivalent specialist? A Is the administrated activity individually measured and checked in a standardized calibrator which has been quality checked with the radionuclide concerned? A verantwoordelijkheid leverancier radiofarmaca § Are appropriate facilities (dedicated room) for out and in-patients available? B 29 33§ d) 5.3.7Is there a multidisciplinary clinical follow-up of these patients?B ? 5.3.8Are written rules available for discharging patients?B Idem als ? 5.3.9Is patient’s activity/emitted dose measured and recorded in the patient’s file before discharge from the department? B ambulatant versus hospitaal Are written instructions available for the patient on discharge?B Idem als ? Ndls: « Zijn er schriftelijke instructies voor het ontslag van de patiënt ? » c) Checklist 13: General aspects - radionuclide therapy service

21 Type of therapy Clinical problem Patient preparation Radio- pharmaceutical Activity Treatment protocol Calculation methods Discharge report Post therapy follow-up Recommendations Thyroid Pain palliation Tumour therapy Radiosynovectomy Checklist 14: Summary of therapeutic procedures Haalbaar voor kleine diensten ??? Prioritair ???

22 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Staffing 6.2.1Is the radiopharmacy unit operated under the direction of a person with appropriate training as defined by local or national regulations? A ? Pas de radiopharmacie mais bien un labo chaud équipé selon les normes Hoofd: voorschriften 6.2.2Are there written staff training manuals for all grades of staff?B Facilities 6.2.3Does the unit have appropriately finished rooms (including adequate lighting, appropriate finishes to walls, floors, ceilings and ventilation) and a shielded dispensing station? A Question pas claire. s’agit il de la radiopharmacie ou du labo chaud 27.4°h) For operational level 1b: Is there a well ventilated area or a shielded dispensing station for radioiodine capsules? A 27.4°h) Is there a validated (annual check on air flow, safety and challenge testing) fume hood with suitable filters for handling radioiodine solutions? A Est-il indispensable d’avoir une hotte alors que cette obligation n’est pas inscrite nommement dans la loi ? Purchase of materials 6.2.6Are there suitable protocols and trained staff for the purchase of approved or marketing authorized radiopharmaceuticals? A 6.2.7Are all goods received checked and recorded against the order for correctness of delivery? B Checklist 15: Hospital radiopharmacy - operational level 1 (1)

23 Dispensing protocols 6.2.8Under operational level 1a: Are there written procedures for the aseptic dispensing and labelling of unit doses of ready to use radiopharmaceuticals? B ? 6.2.9For operational level 1b: Is a shielded dispensing station and/or a fume hood available? (Is there a fume cupboard with suitable filters for volatile radioactive materials such as 131I solutions?) (If only radioiodine capsules are handled, is the package opened in a well-ventilated area?) A Est-il indispensable d’avoir une hotte alors que cette obligation n’est pas inscrite nommement dans la loi ? 27.4°h) For operational level 1b: Do the written procedures contain clear safety and monitoring instruction for dispensing radioiodine solutions or capsules? A ? Can the audit and documentation for each radiopharmaceutical batch be traced from the prescription to the actual administration of individual patient doses? A ? Lot tracering = software QA/QC Are periodic quality checks on radiopharmaceuticals performed?B Is there a written procedure for dealing with products that do not meet the required standards and/or for which a complaint has been received? B Waste Are there written procedures for the disposal of radioactive and non-active waste specific to the radiopharmacy? A No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Checklist 15: Hospital radiopharmacy - operational level 1 (2)

24 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Staffing 6.3.1Is there specific staff training and assessment of competency at operational level 2, including aseptic practice? A 6.3.2Is there training provided for staff required to perform final checks on all products prepared before release for patient use? A 6.3.3Before release of radiolabelled RBC (red blood cells) and WBC (white blood cells) labelling is there confirmation of training? A bevestiging van opleiding: niet meer te achterhalen Facilities 6.3.4For operational level 2: Are there regular checks on validated Class II type B microbiological safety cabinets located in a dedicated room? A 6.3.5For negative pressure isolators: Before preparation takes place, are gloves or gauntlets visually inspected and integrity tests carried out and recorded? B mug en olifant ? Preparation protocols 6.3.6In practice, have all systems of work and documentation related to radiopharmaceutical preparation and processing formally approved? B Approbation par qui ? 6.3.7Do all products, kits and generators have product approval, marketing authorization, or bear a product licence number? A 51.4§ Is the preparation of 99m Tc radiopharmaceuticals from kits and generators carried out in a laminar air flow (LAF) cabinet? A haalbaar voor kleine diensten ??? Echt wettelijk verplicht om elke dienst een LAF-kast te hebben ??? Lokalen moeten voor de bereiding goed zijn ingericht maar ARBIS spreekt niet van een wettelijke LAFkast Est-il indispensable d’avoir une hott alors que cette obligation n’est pas inscrite nommement dans la loi ? 27.4°h) 6.3.9Can each individual patient dose be traced to a specific generator and kit batch number? A Under operational level 2b: Do the written procedures for any autologous preparation, e.g. RBCs and WBCs, include clear instructions on safety, cleaning and decontamination? A Reiniging ontsmetting = disposable Are there written procedures for the preparation and dispensing of radio-labelled biologicals, e.g. monoclonal antibodies, peptides from approved kit formulations? A Checklist 16: Hospital radiopharmacy - operational level 2 (1)

25 QA/QC Are there set QC criteria before release for preparation before patient use? A Verband ? Redundant ? Is a record of approval/release made by an authorized person before a product is administered to a patient? A Haalbaar bij elke labeling of oplossing voor kleine diensten ??? Que doit comprendre exactement le rapport de libération d’un produit en dehors de la dose ? Mug en olifant ? For operational level 2: Is 99 Mo molybdenum breakthrough measurement performed on the first eluate of each 99m Tc technetium generator and repeated when the generator is moved? A prioritair ? Haalbaar voor kleine diensten ? Is aluminium ion breakthrough checked on the first eluate from a 99m Tc technetium generator? A idem Before patient use, are radiochemical purity tests performed on all new batches or newly delivered radiopharmaceutical kits? B Ces contrôles doivent-ils être fait obligatoirement par un radiopharmacien ? Verband ? Redundant ? Is there routine microbiological monitoring of preparation and aseptic dispensing area in the radiopharmacy? A Are changes in the use of kits, diluents or vehicles, needles, syringes, swabs and sterile containers recorded? B te veel noteren Are pH tests carried out regularly?B Are rapid alternative methods employed for swift prospective QC, e.g. for the determination of the radiochemical purity of 99m TcHMPAO? A ? QC verband met 12 en 16 ? No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Checklist 16: Hospital radiopharmacy - operational level 2 (2)

26 No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Good laboratory practices 7.1.1Does the radioimmunoassay service have formal authorization from a recognized national authority? A 3.1.c Is there a clear written protocol for using all radioimmunoassay, IRMA, ELISA analytes used in your laboratory? A 7.1.3Is there is a clear protocol stating the action required in a follow- up of suspected result errors in the laboratory? A 7.1.4Is there a mechanism to check why its recent results are 20% lower, while all previous results have all been within 10% of the target? B 7.1.5Is there a mechanism to follow-up random errors, e.g. wrong sample on analyser, wrong specimen assayed, wrong result reported by accident? B 7.1.6Is there a mechanism to double-check records of reported ‘undetectables’ when the expected result was clinically significant? B Pre-analytical phase 7.1.7Is there a procedure to follow when the clinical user does not provide the necessary information or the correct specimen? B 7.1.8Is there a periodic review to prevent pre-analytical errors, e.g. use of inappropriate specimen collection tubes, specimen mix- ups, incorrectly labelled or mixed-up requests from the requesting unit or lab? B 7.1.9Is there a periodic review of the appropriateness and integrity of the sample transport system? A Is there a periodic review to ensure that the confidentiality of patients’ results is guaranteed? A Is there a periodic review to ensure biological safety?A Checklist 17: Tumour marker radioimmunoassay service (1) In vele ziekenhuizen in RIA geïntegreerd in klinisch labo en is dit hoofdstuk niet van toepassing in nucleaire geneeskunde Le RIA se fait au labo et pas en médecine nucléaire

27 Analytical phase Are there records of regression line analyses with a known amount of the international standard in serum? B Are there records of recovery experiments to validate a new method? B For each type of assay and/or each type of data set, is there a record of calculated mean, standard deviations and a coefficient of variation? B Is there a Levey-Jennings plot, including controls and standards for each assay? A Is there a clear written protocol when points are outside the 2 standard deviation limits? A Is there a system in place to guarantee safe disposal of samples and are samples treated as infectious waste? A Post-analytical phase Is there a standard format for reporting laboratory results which includes laboratory’s name, patient details, requesting person, test description, sample type (serum, urine, etc.), results (+ reference values), interpretative comments (if any), signature of authorized professional? A Is there a list of authorized staff members who are designated to amend patient notes or reports and for communicating results? A Are reference values based on national or regional findings available for each assay type? B Is feedback from clinical interpretative services documented?B No.ComponentClassY/NComments/planned actionDate achieved Regulatory basis Checklist 17: Tumour marker radioimmunoassay service (2) In vele ziekenhuizen in RIA geïntegreerd in klinisch labo en is dit hoofdstuk niet van toepassing in nucleaire geneeskunde Le RIA se fait au labo et pas en médecine nucléaire


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