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KEMENTERIAN KESIHATAN MALAYSIA

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MANUAL PELAKSANAAN

PROGRAM JAMINAN MUTU (QAP)

DALAM PERKHIDMATAN

PERUBATAN NUKLEAR

Dikemaskini oleh,

Kumpulan Kerja Program Jaminan Mutu Dalam Perkhidmatan Perubatan Nuklear Di

Bawah Akta Perlesenan Tenaga Atom 1984 (Akta 304)

Kementerian Kesihatan Malaysia

Mac 2016 (Edisi 2)


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1. PENGENALAN

Program Jaminan Mutu (Quality Assurance Programme, QAP) di Kementerian

Kesihatan Malaysia telah dilancarkan pada tahun 1985. Objektif pelaksanaan QAP

adalah untuk memastikan pelanggan mendapat faedah daripada perkhidmatan yang

disediakan pada tahap yang optimum dengan sumber yang sedia ada. Indikator-

indikator diwujudkan untuk memantau kualiti pelbagai perkhidmatan dari aspek

penjagaan, pengurusan pelanggan, penggunaan sumber dan kepuasan pelanggan.

Dalam konteks pelaksanaan QAP yang menggunakan sinaran mengion bagi tujuan

diagnosis dan terapi, kepentingan pesakit perlu diutamakan. Ini dapat dicapai

dengan dedahan dos sinaran yang tepat dan optimum di samping dedahan sinaran

kepada pekerja dan orang awam adalah terkawal. Manakala penggunaan punca

sinaran mengion terlibat akan sentiasa dipantau dari aspek keselamatan termasuk

sekuriti. Melalui langkah-langkah sebegini, diharap dapat mencapai objektif

pelaksanaan QAP secara menyeluruh dan berkesan.

Keperluan pelaksanaan QAP selaras dengan Peraturan 41.(d) & 41.(e) dalam

Peraturan-Peraturan Perlesenan Tenaga Atom (Perlindungan Sinaran Keselamatan

Asas) 2010 iaitu:

“41. Tiap-tiap pemegang lesen atau majikan hendaklah memastikan bahawa:

d) bagi penggunaan sinaran secara diagnostik, program Penjaminan mutu yang

dinyatakan oleh pihak berkuasa yang berkenaan dijalankan oleh atau di

bawah penyeliaan seorang pakar yang berkelayakan dalam fizik perubatan;

e) bagi penggunaan sinaran secara terapeutik termasuk teleterapi atau

brakiterapi, penentukuran, dosimetri dan program Penjaminan mutu yang

dinyatakan oleh pihak berkuasa yang berkenaan dijalankan oleh atau di

bawah penyeliaan seorang pakar yang berkelayakan dalam fizik perubatan;”

Selain itu, Peraturan

“53. (1) juga menyatakan bahawa sebagai tambahan kepada pemakaian kehendak

yang berkaitan bagi jaminan mutu, pemegang lesen hendaklah mewujudkan suatu

program jaminan mutu yang komprehensif bagi dedahan perubatan dengan

penglibatan pakar berkelayakan yang sesuai dalam bidang yang berkaitan

sebagaimana yang dinyatakan oleh pihak berkuasa yang berkenaan.”

Mesyuarat Jawatankuasa Penasihat Radiologi (RAC) ke-37 yang diadakan pada

15hb Julai 2010 telah memutuskan supaya pelaksanaan QAP dalam perubatan


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nuklear ke atas pusat perubatan nuklear kerajaan dan swasta diwujudkan. Melalui

pelaksanaan QAP tersebut, diharapkan pusat-pusat perubatan nuklear akan dapat

menerap dan mengamalkan budaya kualiti dan selamat dalam penggunaan sinaran

mengion untuk tujuan perubatan kepada pesakit, pekerja dan orang awam.

Untuk memastikan QAP dilaksanakan dengan berkesan, jabatan berkaitan perlu

mewujudkan kumpulan staf yang sekurang-kurangnya terdiri daripada seorang

Pakar Perubatan Nuklear, Ahli Fizik Perubatan, Ahli Farmasi (Nuklear),

Juruteknologi Perubatan Nuklear dan lain-lain profesion yang terlibat.

2. OBJEKTIF

Objektif pelaksanaan QAP dalam perkhidmatan perubatan nuklear adalah:

2.1 Mempertingkatkan kualiti perkhidmatan dalam perubatan nuklear.

2.2 Memastikan penghasilan maklumat klinikal yang diperlukan dengan

penggunaan radioaktiviti yang optimum.

2.3 Memastikan penggunaan sumber yang sedia ada secara efektif.

2.4 Memenuhi dan mematuhi keperluan regulatori di bawah Akta Perlesenan

Tenaga Atom 1984.

3. SKOP

Skop Jaminan Mutu bagi perkhidmatan perubatan nuklear merangkumi komponen-

komponen seperti berikut:

(a) Sejarah klinikal pesakit

Prosedur diperlukan bagi membolehkan maklumat sejarah pesakit dapat

diketahui sebelum perancangan rawatan dapat dikenalpasti.

Contohnya maklumat sejarah klinikal pesakit, soalan-soalan klinikal,

kesesuaian pemeriksaan dan kontraindikasi.

(b) Perancangan prosedur

Perancangan prosedur perlu dilaksanakan untuk memastikan pesakit

mendapat rawatan yang bertepatan dengan jenis penyakit bagi

mengelakkan kesilapan dalam pemberian dos kepada pesakit.

Ini merangkumi kebolehpercayaan prosedur pentadbiran (reliable

administrative procedures), maklumat pesakit serta prosedur persediaan

pesakit.


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(c) Prosedur klinikal

Prosedur klinikal perlu dilaksanakan untuk memastikan rawatan yang

diberikan adalah tepat dan mematuhi prinsip perlindungan sinaran serta

segala aktiviti yang berkaitan dengan pengurusan bahan radioaktif

dikendalikan secara selamat dan terkawal.

Prosedur klinikal perlu mengambilkira perkara-perkara seperti pembekal dan

bahan radioaktif yang diluluskan, penyimpanan bahan radioaktif, persediaan,

persekitaran klinikal, pengurusan dan persediaan pesakit, prestasi radas,

protokol pengendalian, pelupusan sisa radioaktif, pergerakan bahan

radioaktif.

(d) Latihan dan pengalaman

Semua personel yang terlibat seperti Pakar Perubatan Nuklear, Ahli Fizik

Perubatan, Ahli Farmasi (Nuklear), Juruteknologi Perubatan Nuklear dan

lain-lain yang terlibat perlu mempunyai latihan dan pengalaman yang sesuai.

(e) Penganalisaan data

Data-data yang diperolehi semasa prosedur pengimejan adalah sangat

penting untuk membekalkan maklumat diagnosis yang tepat. Ini dipengaruhi

oleh protokol pemprosesan data, prestasi peralatan, ketepatan dan integriti

data yang diperolehi.

(f) Laporan

Laporan diagnosis dan rawatan yang disediakan merangkumi data,

penyemakan semula imej, keputusan dan nasihat lanjutan oleh Pakar

Perubatan Nuklear bagi memastikan perkhidmatan perubatan nuklear yang

berkualiti.

(g) Hasil perkhidmatan (general outcomes)

Pelaksanaan QAP yang berkesan dapat ditentukan melalui keberhasilan

klinikal (clinical outcome), dos dedahan radiasi, kepuasan pesakit serta

kepuasan doktor/pakar yang merujuk.

(h) Audit

Proses audit adalah penting dalam pelaksanaan QAP bagi memastikan

kelemahan/ketidakpatuhan yang berlaku dapat diambil tindakan pencegahan

dan penambahbaikan bagi meningkatkan kualiti perkhidmatan yang

diberikan.


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4. PELAKSANAAN QAP DI BAWAH AKTA 304

Pelaksanaan QAP hendaklah merangkumi elemen-elemen yang diwajibkan seperti di

bawah:

4.1 INDIKATOR – KADAR KAJIAN BERULANG (RATE OF REPEAT STUDIES)

Pemonitoran dan analisa kajian kes berulang hendaklah diwujudkan di setiap

pusat perubatan nuklear. Laporan pemonitoran dan analisa termasuk tindakan

pembaikan yang telah diambil perlu dikaji setiap tahun. Kadar kajian kes berulang

hendaklah tidak melebihi 5%. Maklumat lanjut mengenai indikator adalah seperti

di Lampiran A1 dan Lampiran A2.

4.2 KAWALAN MUTU (QC) PERALATAN PENGIMEJAN DAN KEMUDAHAN

BERKAITAN

Semua peralatan pengimejan dan kemudahan berkaitan di pusat perubatan

nuklear hendaklah menjalani ujian kawalan mutu (QC) bagi memastikan

pematuhan terhadap piawaian dan prestasi yang ditetapkan. Pelaksanaan QC

bagi peralatan pengimejan dan kemudahan berkaitan perlu merangkumi ujian

penerimaan (acceptance tests) dan ujian kawalan mutu secara berkala. Ujian

penerimaan on site perlu dijalankan bersama pengilang/pembekal setelah

peralatan dipasang. Selain memastikan prestasi peralatan memenuhi spesifikasi

pengilang yang ditetapkan, ujian penerimaan perlu dilakukan bagi mendapatkan

data rujukan (baseline data).

Ujian QC bagi semua peralatan pengimejan dan kemudahan berkaitan hendaklah

dilaksanakan secara berkala mengikut tempoh yang ditetapkan bagi mematuhi

keperluan piawaian prestasi dan keselamatan seperti dalam Lampiran B.

Pengujian ini juga perlu dijalankan selepas kerja-kerja pembaikan atau

pertukaran sebarang komponen peralatan yang boleh menjejaskan fungsi dan

prestasi peralatan atau kemudahan berkaitan. Di samping itu, peralatan

pengukuran sinaran hendaklah dipastikan ditentukur secara berkala.

Kerja-kerja pembaikan perlu dijalankan sekiranya prestasi peralatan pengimejan

dan kemudahan berkaitan tidak mematuhi spesifikasi atau/dan piawaian yang

ditetapkan. Pengujian penerimaan dan QC hendaklah dijalankan dan disahkan

oleh personel yang diiktiraf oleh pihak berkuasa KKM.


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4.3 PENDIDIKAN PERUBATAN SECARA BERTERUSAN (CME)

Semua personel hendaklah menghadiri program pendidikan perubatan secara

berterusan yang diiktiraf oleh pihak berkuasa di bawah Akta 304 untuk

meningkatkan pengetahuan dan kompetensi mereka. Tempoh latihan hendaklah

sekurang-kurangnya 6 jam terkumpul setahun dengan merangkumi sekurang-

kurangnya 3 bidang seperti berikut:

Radiation Safety Awareness in Nuclear Medicine

Accident and Emergency Preparedness

Update in Nuclear Medicine Technologies

Update in Radiopharmaceutical

Clinical Procedures/Protocol Update

Image/Fusion Image Reporting

Management of Quality Assurance Program

Legislation and Regulatory Requirement

Bukti kehadiran kursus seperti sijil/senarai kehadiran yang disahkan oleh

penganjur/ketua jabatan hendaklah direkod dan dikemukakan kepada pihak

berkuasa KKM.

5. PENGURUSAN REKOD

Rekod-rekod berkaitan dengan kawalan mutu (QC), indikator, CME dan lain-lain

yang berkaitan hendaklah diurus dan disimpan mengikut tempoh yang ditetapkan

oleh pihak berkuasa KKM.


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6. DEFINISI

Dalam manual ini, melainkan jika konteksnya menghendaki makna yang lain:

Ahli Farmasi (Nuklear)

Seseorang ahli farmasi berdaftar yang telah menjalani program latihan dalam bidang farmasi nuklear yang diluluskan oleh pihak berkuasa berkaitan. Juga digelar sebagai Pegawai Farmasi (Nuklear).

Ahli Fizik

Perubatan

Seseorang yang mempunyai pengetahuan, latihan dan pengalaman untuk mengaplikasikan prinsip-prinsip fizik untuk tujuan diagnosis dan rawatan dalam bidang perubatan yang berkenaan. Juga digelar sebagai Pegawai Sains (Fizik).

Data rujukan Nilai atau keputusan yang diperolehi semasa ujian

penerimaan.

Fizik perubatan Bidang pengkhususan yang melibatkan penggunaan dan

pemakaian fizik dalam perubatan.

Indikator Sesuatu perkara yang telah dirancang, dipersetujui dan

dilaksanakan untuk mengenalpasti tahap kualiti bagi

perkhidmatan yang diberi. Juga dikenali sebagai quality

indicator.

Juruteknologi

Perubatan Nuklear

Seseorang personel kesihatan bersekutu berdaftar yang telah

menerima latihan khas dalam bidang perubatan nuklear yang

diluluskan oleh pihak berkuasa berkenaan. Personel ini

bertanggungjawab dalam menjalankan tugas pengimejan

perubatan nuklear dan ujian in-vitro yang melibatkan

pengukuran sinaran serta memberi (administer)

radiofarmaseutikal kepada pesakit untuk tujuan diagnosis di

bawah pemantauan Pakar Perubatan Nuklear.

Pakar Perubatan

Nuklear

Seseorang pengamal perubatan berdaftar yang telah

menerima latihan khas dalam perubatan nuklear yang

diluluskan oleh pihak berkuasa berkenaan dan mempunyai

pengetahuan khas mengenai penggunaan radiofarmaseutikal

atau radionuklid untuk prosedur diagnosis dan rawatan.


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Perubatan nuklear Bidang pengkhususan perubatan yang melibatkan semua

pemakaian bahan radioaktif dalam diagnosis atau rawatan

atau dalam penyelidikan perubatan kecuali penggunaan

punca terkedap dalam radioterapi.

Program Jaminan

Mutu

Pengurusan dan prosedur keseluruhan yang merangkumi

tindakan penjaminan mutu untuk pelaksanaan perkhidmatan

perubatan nuklear. Ia merupakan suatu aktiviti terancang

untuk memberi penjaminan mutu dalam perkhidmatan yang

melibatkan teknik kawalan mutu dan prosedur pentadbiran

berkualiti. Komponen dan tahap pelaksanaan aktiviti ini

adalah bergantung kepada jenis dan saiz kemudahan, jenis

prosedur yang dilakukan dan faktor lain-lain yang berkaitan.

Radiofarmaseutikal Bahan radioaktif atau produk termasuk sebatian tidak organik

dan organik, peptide, protein, monoklonal antibodi, fragment

dan oligonucleotide yang dilabel dengan radionuklid yang

mempunyai separuh hayat dari beberapa saat hingga

beberapa hari untuk tujuan diagnostik dan kegunaan

terapeutik.

Ujian penerimaan Ujian bagi mengenalpasti sesuatu radas yang diterima adalah

mengikut spesifikasi teknikal yang dipersetujui dan nilai

keputusan ujian-ujian ini akan menjadi nilai rujukan kepada

ujian berkala yang dijalankan pada masa hadapan.

7. SINGKATAN

CFOV Central Field of View

COR Center of Rotation

CME Continuous Medical Education

cps counts per second

CT Computed Tomography

FWHM

IAEA

Full Width at Half Maximum

International Atomic Energy Agency

kBq kiloBecquerel

KKM Kementerian Kesihatan Malaysia

PET Positron Emission Tomography

PHA Pulse Height Analyzer


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QAP Quality Assurance Programme

QC Quality Control

RAC Radiological Advisory Committee

SPECT Single Photon Emission Computed Tomography

TR Tomography Resolution

UFOV Useful Field of View

8. RUJUKAN

i) Akta Perlesenan Tenaga Atom 1984 (Akta 304).

ii) Peraturan-Peraturan Perlesenan Tenaga Atom (Perlindungan Sinaran

Keselamatan Asas) 2010.

iii) Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bil. 26/2010: Keperluan

Pakar Perubatan Nuklear Bagi Perkhidmatan Perubatan Nuklear Di Bawah Akta

Perlesenan Tenaga Atom 1984 (Akta 304) Bagi Maksud Perubatan.

iv) IAEA Human Health Series No. 1: Quality Assurance for PET and PET/CT

Systems. Vienna: IAEA.

v) IAEA Human Health Series No. 6: Quality Assurance for SPECT Systems.

Vienna: IAEA.

vi) IAEA Safety Reports Series No. 4: Applying Radiation Safety Standards in

Nuclear Medicine. Vienna: IAEA.

vii) World Health Organization. Quality Assurance in Nuclear Medicine. Geneva:

WHO.

viii) Ministry of Health Malaysia. Quality Assurance-A Problem Solving Approach.

Kuala Lumpur: MOH.

ix) Family Health Development Division, Ministry of Health Malaysia. 2008. Quality

Assurance Programme Manual. Putrajaya: MOH.

x) H. Wengenmair, J. Kopp. Gamma Probes for Sentinel Lymph Node

Localization: Quality Criteria, Minimal Requirements and Quality of

Commercially Available Systems. Germany: Central Clinic, Augsburg.

xi) Operational Guidance on Hospital Radiopharmacy: A Safe and Effective

Approach, Vienna IAEA, 2008.

xii) Guides to the Development of Radiopharmaceutical Preparation Facilities for

Healthcare Establishments, 1st Edition, Pharmaceutical Services Division: MOH,

2010.

xiii) G.B. Saha. Fundamentals of Nuclear Pharmacy, 6th Edition, SpringerVerlag,

New York.

LAMPIRAN A1

STRUCTURE OF A PERFORMANCE INDICATOR 1

NUCLEAR MEDICINE PROGRAMME : Nuclear Medicine Services AREA OF CONCERN : Performance Quality and Radiation Safety of Nuclear

Medicine Services INDICATOR : Rate of Repeat Study for the administration of

Radiopharmaceuticals in Nuclear Medicine Services DEFINITION OF TERM Repeat study is defined as those cases that require re-administration of the intended/same radiopharmaceutical when and where the first administered radiopharmaceutical has not achieved its intended purposes as a result of any technical or non technical causes. Postponement of study not involving re-administration of radiopharmaceutical is not considered a repeat study. RATIONALE 1. To avoid delaying patient management and to reduce waiting time for

treatment. 2. To keep the radiation dose to patient as low as reasonably achievable. 3. To avoid incurring unnecessary cost due to extra man-power and time. 4. To avoid unwarranted repercussions due to longer appointment times. TYPE OF INDICATOR : This is a rate-based indicator.

It is a measure of clinical, radiopharmacy, physics and maintenance services.

NUMERATOR : Total number of repeat studies per year.

DENOMINATOR : Total number of cases done per year. STANDARD : Should not exceed 5 %. CALCULATION OF RATE (Numerator/Denominator) x 100 %

LAMPIRAN A1

EXPLANATION Rate of Repeat Studies

– This is a clinical audit to look into the quality of performance after an imaging study.

– It is based on the basis that if the required clinical information can be obtained

from a study, there is no need to repeat it. Definition of repeat study 1. Any failed study after administration of radiopharmaceutical where there is no

information available or any study that needs to be repeated due to inadequate information that require administration of the intended/same radiopharmaceutical whether on the same day (e.g. Technetium thyroid scan) or on a different day (e.g. Renal DTPA study).

2. The following would not be considered as a repeat study:

a. Quantitative reanalysis of studies

As the study data is still available on computer

b. Reprinting of Scan ordered by doctor

c. Studies not performed because of equipment or radiopharmaceutical problems

3. Reasons for a repeat study:

a. Human factors (i) Staff – administration problems

failed administration or extravasation of radiopharmaceutical

incorrect radiopharmaceuticals administration – image acquisition problems

incorrect field, inadequate counts obtained, inadequate views obtained

– computer problems

accidental deletion of patient studies (ii) Patient – motion artefacts due to:

inadequate instructions to patient

inadequate sedation, especially in children

uncooperative child – case cancellations due to unstable patient

b. Machine factors

– Intrinsic problems in gamma camera or power interruptions – Computer problems (crashes) – Contamination on the machine

LAMPIRAN A1

c. Radiopharmaceutical factors – Faulty radiopharmaceutical (undetected by QC) – Incorrect QC procedure – Inadequate dose of radiopharmaceutical which lead to poor quality

image – Drug Interactions

(b) and (c) should normally be addressed through proper QC measures. Methodology 1. Data Collection Any repeat study must be recorded immediately in a record book reserved for this purpose and signed by the relevant staff. The responsible person/licensee or the delegated staff should ensure the Form A1 is completed before the end of the day. 2. Data Analysis Data should be transferred from Form A1 to Form B1. Data analysis should be carried out by the responsible person/licensee or the delegated staff at least 3 monthly. An example of the final presentation format is in Appendix 1. Parameters may vary from time to time. Periodic trend analysis is recommended. 3. Action plan The root cause of each repeat study should be identified. Corrective and preventive measures should then be taken. 4. Annual Report Analysis of root cause identification and remedial action must be stated in the annual report. This annual report should be submitted to the appropriate authority yearly.

LAMPIRAN A1 FORM A1

NUCLEAR MEDICINE DEPARTMENT HOSPITAL ______________________

Date (dd/mm/yyyy): / /

REPEAT STUDY FORM Patient Particulars Name : _________________________________________________________ Gender : Male / Female New I/C : _______________________Passport no.: _______________________ RN : ____________ DOB: _________________ Age: __________________ Address : _________________________________________________________ Tel. (Office) : ____________ Tel. (Home): ____________ Tel. (H/P): _____________ Type of Study : _________________________________________________________ Technologist’s Level Human factors

Staff a. Administration problems

failed administration or extravasation of radiopharmaceutical incorrect radiopharmaceuticals administration

b. Image Acquisition problems incorrect field, inadequate counts obtained, inadequate views obtained

c. Computer accidental deletion of patient studies

Patient a. Motion artefacts mainly movement due to

inadequate instructions to patient inadequate sedation, especially in children unable to image uncooperative child

b. Case cancellations due to unstable patient Machine factors

a. Intrinsic problems in gamma camera or power interruptions b. Computer problems (crashes) c. Contamination on the machine

Radiopharmaceutical factors

a. Faulty radiopharmaceutical (undetected by QC) b. Incorrect QC procedure c. Inadequate dose of radiopharmaceutical which lead to poor quality image d. Drug Interactions

Doctor’s Level Reasons for repeat

a. Inadequate information b. Poor image quality c. Others (please specify)

Appointment date for repeat study: _________________ Operator : Supervisor : Name : Name : Date : Date : Note: Form A1 is to be completed before the end of day of the incident.

LAMPIRAN A1

FORM B1 Nuclear Medicine Department

Hospital _______________

REPEAT STUDY ANALYSIS FORM

No. RN Type of Study

Date

Technologist’s Level Doctor’s Level

Repeat Study date

(Comments)

Human Factors Machine Factors Radiopharmaceutical Factors

Staff Patient Movement Gamma Camera/ Power

Comp prob

Contamination

Faulty RP

Incorrect QC

Inadeq dose

Drug interactions

Inadeq info

Poor image quality

Others (please specify)

Administration

Acquisition

Comp Inadeq inst

Inadeq sed

Uncoop child

Unstable patient

Numerator : Total number of repeat studies per year Denominator : Total number of cases done per year Rate of Repeat study : (Numerator/Denominator) x 100 % Prepared by : Head of Department Name : Date :

Verified by : Responsible person/ Licensee Name : Date :

LAMPIRAN A1

APPENDIX 1

LAMPIRAN A2

STRUCTURE OF PERFORMANCE INDICATOR 2

NUCLEAR MEDICINE PROGRAMME : Nuclear Medicine Services AREA OF CONCERN : Performance Quality and Radiation Safety of Nuclear

Medicine Services INDICATOR : Rate of Repeat CT exposure for hybrid imaging in

Nuclear Medicine Services DEFINITION OF TERM Any repeat CT scan, be it partial or a full repeat study over the same region which has just been scanned, as the first CT acquisition has failed to achieve the initial intended purpose(s). The main purpose(s) for acquiring CT data in nuclear medicine hybrid imaging are for attenuation correction and/or anatomical correlation. RATIONALE Analysis of repeat CT exposure rate is a method effective in monitoring and reducing unnecessary radiation exposure to a patient. TYPE OF INDICATOR : This is a rate-based indicator. NUMERATOR : Total number of repeat CT exposure per year. DENOMINATOR : Total number of hybrid imaging cases (patients) done

per year. STANDARD : Should not exceed 5%. CALCULATION OF RATE (Numerator/Denominator) x 100 % EXPLANATION Rate of Repeat CT Exposure

1. This is a clinical audit to look into the rate of undesired, possibly avoidable CT radiation dose to the patients when hybrid imaging is used in nuclear medicine services.

2. Such situation arises when the initial acquired CT data has failed to provide satisfactory or adequate information for attenuation correction and/or anatomical correlation. As a result, a repeat scan (with or without the radionuclide imaging component) at the same site or part of the previously scanned site needs to be carried out in order to complete the study.

LAMPIRAN A2

3. The notion is based on the basis that should at all a proper planning and preparation have been carried out before the procedure, adequate CT data for that identified purpose(s) could have been attained in the first CT scan itself.

4. A sequential CT exposure carried out as part of the study protocol so as to be used for reporting will not be considered as a repeat CT exposure (example: (1) dual-time imaging protocol to ascertain benign inflammatory and malignant disease; (2) forced diuresis dual-phase bladder protocol for urinary bladder cancer or tumour at its close proximity).

5. The table below lists out some of the reasons for a repeat CT exposure:

Reasons for a repeat CT exposure

Human factors

a. Artefact (e.g. streaks, ring, jewellery or anything that could have been temporarily removed during imaging.)

b. Incorrect technical parameter (e.g. need higher mAs or some other technical adjustment etc.)

c. Incorrect positioning

d. Incorrect examination

e. Misregistration due to motion (including respiratory motion artefact)

f. Residual contrast (including oral contrast) left from previous radiological procedure

g. Failure or incorrect radiotracer injection resulting in a total repeat study

Machine factors

a. Scanner malfunction / down

b. Electrical power outage

Methodology

1. Data Collection

Any repeat CT exposure must be recorded immediately in a record book reserved for this purpose and signed by the relevant staff. The responsible person/licensee or the delegated staff should ensure the Form A2 is completed before the end of the day.

2. Data Analysis

Data should be transferred from Form A2 to Form B2. Data analysis should be carried out by the responsible person/licensee or the delegated staff to determine the reason for the repeat CT exposure, at least 3 monthly. Parameters may vary from time to time. Periodic trend analysis is recommended.

3. Action Plan

The root cause of each repeat CT exposure should be identified. Corrective and preventive measures should then be taken.

4. Annual Report

Analysis of root cause identification and remedial action must be stated in the annual report. This annual report should be submitted to the appropriate authority yearly.

LAMPIRAN A2 FORM A2

NUCLEAR MEDICINE DEPARTMENT HOSPITAL ______________________

Date (dd/mm/yyyy): / /

REPEAT CT EXPOSURE FORM

Patient Particulars Name : _________________________________________________________ Gender : Male / Female New I/C : _______________________Passport no.: _______________________ RN : ____________ DOB: __________________ Age: _________________ Address : _________________________________________________________ Tel. (Office) : ____________ Tel. (Home): ____________ Tel. (H/P): _____________ Type of Study : _________________________________________________________

Reasons for repeat CT exposure Human factors

a. Artefact

b. Incorrect technical parameter

c. Incorrect positioning

d. Incorrect examination

e. Misregistration due to motion (including respiratory motion artefact)

f. Residual contrast left from previous radiological procedure

g. Failure or incorrect radiotracer injection Machine factors

a. Scanner malfunction / down

b. Electrical power outage

Others, please specify: __________________________________________ Site(s) of the repeat CT exposure

Please specify: ____________________________________________________ Notes / Comments

Operator:

Supervisor:

Appointment date for repeat CT: _________________ Operator : Supervisor : Name : Name : Date : Date : Note: Form A2 is to be completed before the end of day of the incident.

LAMPIRAN A2

FORM B2 Nuclear Medicine Department

Hospital _______________

REPEAT CT EXPOSURE FORM

No. RN Type of Study Date Reason(s) for repeat CT exposure Site(s) of the

repeat CT exposure

Date of repeat CT, if this is not done in the same day

Numerator : Total number of repeat studies per year.

Denominator : Total number of cases done per year. Rate of Repeat CT Exposure : (Numerator/Denominator) x 100 % Prepared by : Head of Department Name : Date :

Verifid by : Responsible person/ Licensee Name : Date :

LAMPIRAN B

QUALITY CONTROL TESTS AND PERFORMANCE STANDARDS FOR EQUIPMENT USED IN NUCLEAR MEDICINE

(A) QC Tests for Scintillation Camera No. Test Parameter Tolerance Frequency

1. Physical Inspection Functional and according to manufacturer’s specifications

Acceptance Daily (except for

emergency button)

Annually

2. Background Count Rate ≤ 20% of the reference value Acceptance Daily

3. Centring Pulse Height Analyser

(PHA) Window Settings

Photopeaks must be properly centered

Acceptance Daily

4. Energy Resolution Manufacturer’s specifications Acceptance Under Condition (1)

5. Intrinsic Flood Field Uniformity For 99mTc a) Qualitative Method

(Comparable With Reference Image)

or b) Quantitative Method For

CFOV And UFOV (Each Comprises Of Integral Uniformity & Differential Uniformity)

No cold/ hot spot Manufacturer’s specifications

Acceptance Weekly

Note: This test should be done

daily if QC Test 7 is done weekly.

6. Intrinsic Spatial Resolution a) Qualitative (Visual Image)

Method b) Quantitative Method

≤ 20% of manufacturer’s specifications ≤ 10% of reference value

Acceptance Semi-annually

Acceptance

7. System Flood Field Uniformity (On Common Clinically Used Collimator) a) Qualitative Method b) Quantitative Method

No cold/ hot spot Manufacturer’s specifications

Acceptance Daily

Note: This test should be done

weekly if QC Test 5 is done daily.

8. System Spatial Resolution a) Qualitative (Visual Image) Method

≤ 20% of manufacturer’s specifications


LAMPIRAN B

No. Test Parameter Tolerance Frequency

or b) Quantitative Method

≤ 10% of reference value

9.

System Planar Sensitivity Manufacturer’s specifications (Acceptance) ≤ 10% of acceptance value (Semi-annually)


10. Count Rate Performance 10.1 Intrinsic Count-Rate

Performance 10.2 Maximum Count Rate

The R-20% is within ± 10% of the manufacturer’s specifications The maximum count rate is within ± 10% of the manufacturer’s specifications


Acceptance

Semi-annually

11. Multiple-Window Spatial Registration (With Gallium 67 Application)

≤ 10% of displacement Acceptance Annually

(Applicable only to the system using

radionuclide Gallium 67 for

imaging purposes)

12. Detector Head Shielding Leakage

Negligible (No leakage) Acceptance

13. Image Display 13.1 Visual Display 13.2 Hardcopy Display

Manufacturer’s specifications Manufacturer’s specifications

Acceptance Weekly

Acceptance

Annually

Note:

(1) Whenever detector system performance is suspected to have changed significantly. All above tests shall be carried out during commissioning and after replacement of major components.

LAMPIRAN B

(B) Additional QC Tests for SPECT No. Test Parameter Tolerance Frequency

1. Absolute Pixel Size

Difference between the values in X and Y ≤ 5% manufacturer specification


2. Tomographic Uniformity (If Applicable)

≤ 10% of difference between maximum and minimum counts/pixel


3. Tomographic Resolution (TR) In Air (SPECT Reconstructed Spatial Resolution Without Scatter)

Manufacturer’s specifications or difference between planar and tomographic resolution should not be more than 2 mm or 10% of the planar resolution


4. Center Of Rotation (COR) / Multi Head Registration (MHR) Test / Image Registration Correction (IRC) Analysis

2 mm or Manufacturer’s specifications

Acceptance Weekly (for

dedicated cardiac system only)

Monthly

Note:

All above tests shall be carried out during commissioning and after replacement of major components.

LAMPIRAN B

(C) QC Tests for PET/CT

No. Test Parameter Tolerance Frequency

1. Physical And Mechanical Inspection

No component of the system is malfunction or not proper installed

Acceptance

Daily (except for

emergency button)

Semi-annually

2. PET Normalization A visual inspection should be acceptable


Under Condition (1) Under Condition (2)

3. Spatial Resolution FWHMobserved < 1.05FWHMexpected

Acceptance

4. Scatter Fraction, Count Losses And Randoms Measurement

SFobserved < 1.05SFexpected NECobserved ≥ NECrecommended

Acceptance

5. Sensitivity

Stot,observed > 0.95Stot,expected Acceptance

Annually

6. Energy Resolution REobserved < 1.05REexpected

Acceptance

7. Image Quality & Accuracy Of Attenuation And Scatter Correction

Acceptable visual assessment Acceptance

Annually

8. Daily PET QC Procedure Manufacturer’s specifications

Acceptance

Daily

9. Well Counter Correction Manufacturer’s specifications

Acceptance

Quarterly

10. 2D Or 3D Activity Concentration Calibration

10% from expected results Acceptance

Annually

11. Test Of PET/CT In Clinical Mode Reconstructed PET and CT images should appear uniform Ensure that PET and CT data appear to be correctly co-registered

Acceptance

Annually

12. PET/CT Offset Calibration Manufacturer’s specifications

Acceptance

Semi-annually

LAMPIRAN B

No. Procedure Tolerance Frequency

13. PET/CT Image Registration Accuracy

Within ± 1 pixel (or ± 1 mm, whichever is smaller) when using a 512 × 512 matrix

Acceptance

Under condition (1)

14. Image Display 14.1 Visual Display 14.2 Hardcopy Display

Manufacturer’s specifications

Manufacturer’s specifications

Acceptance Weekly

Acceptance

Annually

15. Computed Tomography Number Calibration

Within ± 5 HU of the values specified by the manufacturer

Acceptance

Daily

Note:

(1) Whenever detector system performance is suspected to have changed significantly. (2) This test should be performed whenever servicing is suspected to have affected the test

results. All above tests shall be carried out during commissioning and after replacement of major components.

LAMPIRAN B

(D) QC Tests for Dose Calibrator No. Test Parameter Tolerance Frequency

1. Physical Inspection No component of the system is

malfunction or not properly installed

Acceptance

Daily (Each day of use)

Annually

2. Accuracy And Precision The accuracy is within ± 10%

The precision of individual measured

activities is within ± 5%

Acceptance

Annually

3. Linearity Of Activity

Response

3.1 Decaying Source

Method

3.2 Graded Sources

Method (Optional)

The linearity is within ± 10% of the

values corresponding to the straight

line fitted to the data points

Acceptance

Annually

4. Background Response While specific limits of acceptability

cannot be laid down for the results of

the test, an increase in background

response of 20% or greater would call

for further investigation

Acceptance


5. Operational Checks Of

Reproducibility

(Constancy)

The reproducibility of performance

should be such that all individual

measured activities are within ± 5% of

the mean measured activity, provided

that radioactive decay has a negligible

effect over the measurement period

IAEA recommended for repair or

replacement if the error exceed 10%

Acceptance


Annually

6. Geometric Variation Of

Sources Activity Within

Active Measurement

Volume

6.1 Syringe Test

6.2 Vial Test

If the difference of various readings of

the same activity exceeds ± 10%

because of different geometric

configurations, a correction should be

carried out

Acceptance

Whenever dose

calibrator system

performance is

suspected to have

changed significantly.

LAMPIRAN B

(E) QC Tests for Gamma Counter / Well Counter / Thyroid Uptake System No. Test Parameter Tolerance Frequency

1. Physical Inspection No damage Acceptance


2. Auto Calibration Or Daily Test (If Applicable)

Manufacturer’s specifications Acceptance Daily (Each day of use)

3. Constancy Manufacturer’s specifications Acceptance


4. Isotope Efficiency

(Sensitivity) Manufacturer’s specifications Acceptance

Quarterly or Semi-annually

5. Chi-square Manufacturer’s specifications Acceptance

Manufacturer’s recommendations

LAMPIRAN B

(F) QC Tests for Gamma Probe No. Test Parameter Tolerance Frequency

1. Physical Inspection Functional and according to

manufacturer’s specifications

Acceptance

Before clinical use

2. Display And Sound: Sound Acoustic Digital Display or Analogue

Good correlation between measurement signal and tone Continuous display with adjustable measurement time interval Suitable measurement interval with adjustable time constant

Acceptance

Before clinical use

3. Spatial Selectivity & Spatial Resolution 3.1 Spatial Selectivity: Radial Sensitivity Distribution (Far- Field) 3.2 Spatial Resolution: Lateral Sensitivity Distribution

FWHM ≤ 40° or Manufacturer’s specifications FWHM ≤ 15 mm or Manufacturer’s specifications

Acceptance Annually

4. Sensitivity Within ± 10% of acceptance value or ≥ 5 cps/kBq

Acceptance Annually

5. Shielding ≤ 0.1% of maximum system sensitivity

Acceptance Annually

6. Energy Selection

(Where Applicable) Manufacturer’s specifications Acceptance

Before clinical use

Annually

General Note:

1. The procedures of the QC tests and its tolerance limit as well as frequency of test

subject to reviewed when necessary.

2. QC tests of Computed Tomography (CT) Scanner in a hybrid imaging modality

(SPECT/CT or PET/CT) should be referred to the diagnostic CT requirements as

stipulated by the appropriate authority. Additional tests may be requested by the

appropriate authority whenever necessary.

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