Type II Inspection Worksheet Use Type: 872 - therapeutic nuclear medicine

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Work Doc: 1 TII Records
# Description Regulatory Requirements Compliance Expectations Risk*
1

Change notified

GN 15 (c)

Changes of personnel responsible for management and control of licensed activity (RSO, Applicant Authority and Signing Authority) have been reported to the CNSC within 15 days.

M
Rating: Comments:
2

Laboratory lists

LC 2569-1

A list of rooms where more than 1 Exemption Quantity (EQ) of nuclear substance is used or stored is available.

L
Rating: Comments:
3

Inventory

NSRD 36 (1) (a)

A complete nuclear substance and radiation device inventory is available.

M
Rating: Comments:
4

Records retained

NSRD 36 (1) (c), (e), (3), (4)

  • (1)(c) Records of transfer, receipt, disposal and abandonment are available.
  • (1)(e) Records of inspection, measurement, test and servicing are available.
  • (3), (4) Records of inspection, measurement, test and servicing are kept on file for three years.
L
Rating: Comments:
5

License details

NSCA 26

Licence activities are conducted in accordance with the licence.

H
Rating: Comments:
6

Annual Compliance Report

LC 2916

The licensee submits the annual compliance report in the form specified in the appendix of the licence for each year the licence is valid.

M
Rating: Comments:
7

Records retained

GN 28

(2) The CNSC was notified 90 days prior to the disposal of any prescribed records.

L
Rating: Comments:
8

Reportable events

GN 29

Incidents and unplanned events have been immediately reported to the CNSC and a detailed written report was submitted within 21 days (refer to NSRD 38).

H
Rating: Comments:
9

Reporting requirements

PTNS 37-38-40

The consignor, the carrier and the consignee must provide an immediate report to the CNSC (PTNS 37 (1)) and a 21 day
report (PTNS 38) when becoming aware of any of the following situations:

  • failure to comply with the requirements of section 26;
  • a conveyance carrying radioactive material is involved in an accident;
  • package damage or tampering or leaking;
  • radioactive material lost, stolen or loss of control;
  • radioactive material has escaped from a containment system, a package or a conveyance during transport;
  • failure to comply with the Act and Regulations can lead to a situation in which the environment, the health and safety of
    persons or national security is adversely affected;
  • the level of non-fixed contamination as defined in the IAEA Regulations, during transport exceeds limits;
  • licensee has provided reports of damage or tampering discovered while opening packages as per PTNS 40(4), (5), (6).
H
Rating: Comments:
10

Training and sufficient workers

GN 12 (1) (a), (b)

There are (a) a sufficient number of trained and (b) qualified workers to carry on licensed activity.

H
Rating: Comments:
11

Worker records retained

NSRD 36 (1) (b), (d), (2)

  • (1)(b) The name of each worker who handles nuclear substances and/or radiation devices is recorded.
  • (1)(d) Training records for all workers who handle nuclear substances and/or radiation devices are available.
  • (2) Worker training records are kept on file for three years after termination.
M
Rating: Comments:
12

TDG training certificate on file

TDG 6.6, 6.7

A copy of the TDG training certificate is kept on file for two years and is available to the inspector.

M
Rating: Comments:
13

List of NEWs

RP 24

A record including names and job category of each NEW is available.

L
Rating: Comments:
14

Nuclear Energy Workers informed

RP 07

  1. Each NEW has been informed in writing of their NEW designation, of the risks associated with their work, of the regulatory dose limits and of their individual dose.
  2. Female NEW has been informed in writing of their rights (RP 07) and obligations (RP 11).
  3. A signed acknowledgment form is available for each NEW.
M
Rating: Comments:
15

Ascertainment and recording of doses

RP 05

  1. Personnel doses are ascertained and recorded.
  2. Doses are determined by (a) direct measurement or (b) estimation.
H
Rating: Comments:
16

Dose limits

RP 13(1),14

Dose limits not exceeded.

H
Rating: Comments:
17

Licenced dosimetry

RP 08

A licensed dosimetry service is used where the effective dose of a NEW will likely exceed 5 mSv in a one-year period.

H
Rating: Comments:
18

Thyroid Monitoring

LC 2046-11

Thyroid screening has been performed within a period of more than 24 hours and less than five days after handling radioiodine in amounts set out in the licence condition.

H
Rating: Comments:
19

Thyroid Screening

LC 2600-3

The thyroid screening method is capable of detecting 1 kBq of radioiodine. If the screening is performed using bioassay, the assay procedure must be approved by the CNSC.

H
Rating: Comments:
20

Thyroid Bioassay

LC 2601-6

Thyroid uptake above 10 kBq of radioiodine has been reported to the CNSC.

H
Rating: Comments:
21

Shipping doc kept 2 years

TDG 3.11

Shipping documents used are kept on file for two years.

M
Rating: Comments:
22

Meter calibrated

NSRD 20

Survey meter that is used has been calibrated within the previous twelve months of its use.

H
Rating: Comments:
23

Type A package certification

PTNS 42

Type A package design, test results and packaging instructions kept on file for two years after last shipment.

H
Rating: Comments:
24

Decomissioning

LC 2571-5

Prior to decommission an area, room or enclosure the following items have been confirmed:

  1. loose contamination levels meet the licence criteria;
  2. release of any room that contains fixed contamination has been approved in writing by the CNSC;
  3. all nuclear substances and radiation devices have been removed; and
  4. all radiation warning signs have been removed.
H
Rating: Comments:
25

Act/Regs avaliable

GN 12 (1) (k)

A copy of the Act and Regulations (paper or electronic copy) are readily available to all workers.

L
Rating: Comments:
26

Import Export Restrictions

LC 2480

The licensee is not authorized to import or export all items described in the schedule, Parts A and B, of the Nuclear Non-proliferation Import and Export Control Regulations, and specifically listed in the licence condition.

H
Rating: Comments:
27

Device use restrictions

LC 2000-8

Prior to the date of the transfer, the licensee was given permission by the CNSC to transfer a device listed in the licence to another licensee. The device listed in the appendix was disposed of at a licenced nuclear waste facility

H
Rating: Comments:

* Risk level:

  • H - High
  • M - Medium
  • L - Low
Doc. Trav.: 2 TII Operation/Storage
# Description Regulatory Requirements Compliance Expectations Risk
28

Posting of Signs

RP 21

A radiation warning symbol is posted:

  • (a) at the boundary of and at every point of access where there is more than 100 times the Exemption Quantity (EQ) of nuclear substances; or
  • (b) where the radiation dose rate could exceed 0.025 m μSv/h.
H
Rating: Comments:
29

Contact details posted

NSRD 23

The name or job title and a 24 hr. telephone number are posted in a readily visible location where the nuclear substance is
stored or used (refer to RP 21).

H
Rating: Comments:
30

Radiation Warning Sign

RP 22

When a radiation warning symbol is used, it is posted in accordance with regulations.

L
Rating: Comments:
31

Frivolous posting of signs

RP 23

Radiation warning symbols are not posted where there is no radiation, nuclear substance or prescribed equipment.

L
Rating: Comments:
32

Storage

LC 2575-2

  1. (a) Access to storage areas containing nuclear substances or radiation devices is restricted to authorized personnel
  2. (b) Dose rates at occupied areas outside storage areas do not exceed 2.5 μSv/hr.
  3. (c) Dose limits are not exceeded as a result of nuclear substances or radiation devices in storage.
H
Rating: Comments:
33

Security indicators

GN 12 (1) (c), (g), (h), (i), (j)

Provisions are in place to ensure the security of nuclear substances and radiation devices and the health and safety of
persons. This may be achieved through restricted access (for example use of locks, alarms, and security systems) and
reporting of incidents including loss, theft and sabotage.

H
Rating: Comments:
34

Sealed Source Security

LC 2490-1

Licensees have in place security measures including:

  • Inventory accounting
  • Access control measures
  • Up-to-date security plan
  • Information security measures
  • Intrusion detection with monitoring and testing
  • Response protocol
  • Secure storage of substances and devices
  • Security awareness program
  • Vehicle security measures
H
Rating: Comments:
35

Post licence

GN 14

  1. (1) A copy of the licence or an appropriate notice is posted in a conspicuous place at the site of the licensed activity.
  2. (2) The complete licence is available at field locations.
L
Rating: Comments:
36

Therapy patient instructions

RP 03

The licensee provides therapy patient with instructions for reducing exposure to others before leaving the treatment centre.

H
Rating: Comments:
37

Patient Room Assignment

LC 2580-1

A private room with a washroom is assigned to each thyroid therapy inpatient.

H
Rating: Comments:
38

Patient Room Reassignement

LC 2583-3

Prior to a therapy patient's room being released for a new patient or for non-radioactive use, the room has been surveyed for
contamination. Decontamination is done to ensure levels of non-fixed contamination and fixed contamination meet the
licence criteria.

H
Rating: Comments:
39

Patient room area control

LC 2581-0

Dose rates in occupied areas outside of the treated patient's room do not exceed 2.5 μSv/hr. No other patient will receive a
dose greater than 500 μSv per hospital stay.

H
Rating: Comments:
40

Patient room access control

LC 2582-1

Access to the therapy patient's room is limited to authorized persons and a clearly visible and legible radiation warning sign
and the emergency contact number are posted at the entrance.

H
Rating: Comments:
41

Linen release criteria

LC 2584-2

Linens are released once the contact dose rate has reached 2.5 μSv/h.

H
Rating: Comments:
42

Container/Device labelled

RP 20

Each container or device containing greater than one Exemption Quantity of nuclear substance(s) is labelled with the
radiation warning symbol and the required wording.

H
Rating: Comments:
42

Use of equipment & procedures

GN 12 (1) (e)

Licensee ensures equipment, clothing and procedures are used appropriately at the site of the licensed activity.

H
Rating: Comments:
44

Area classification

LC 2110-2

Each area of use is classified in accordance with the licence condition.

H
Rating: Comments:
45

Laboratory Procedures

LC 2570-3

An approved radioisotope safety poster is displayed where nuclear substances are handled.

L
Rating: Comments:
46

Contamination Criteria

LC 2642-5

The licensee can demonstrate that sampling and counting methods can meet licence criteria. No loose contamination is
detected in amounts exceeding the limits specified in the licence.

H
Rating: Comments:
47

Disposal (Nuclear Medicine)

LC 2162-9

Records indicate that all disposals of unsealed nuclear substances are in accordance with the licence condition.
Non-radioactive waste containers do not contain radioactive waste (refer to GN 12 (1) (f)).

H
Rating: Comments:
48

Inaccuracies Notification

LC 2920-6

Changes to documents listed in the licence appendix have been reported to the CNSC.

B
Rating: Comments:
49

Operation Limitations - General

LC 2917-7

Activities and procedures, as listed in the licence appendix, are followed.

B
Rating: Comments:
50

Contamination meter requirements

LC 2572-1

A functional portable contamination meter is available.

H
Rating: Comments:
51

Survey Meter Requirements

LC 2058-1

A properly functioning survey meter is available at all times.

M
Rating: Comments:
52

Extremity Dosimeters-Beta

LC 2578-1

Ring dosimeters provided by a licensed dosimetry service are worn by all workers handling a container which contains more
than 50 MBq of the specified nuclear substances (P-32, Sr-89, Y-90 and Sm-153) in the condition.

M
Rating: Comments:
53

Worker's obligations

RG 17

Every worker:

  • (a) uses equipment, devices, facilities and clothing in a responsible and reasonable manner in accordance with the Act,
    Regulations and Licence Conditions;
  • (b) complies with procedures and measures established by the licensee;
  • (c) informs the licensee or supervisor of any situation where there may be:
    • (i) an increase in the risk to the environment or the health and safety of persons;
    • (ii) a threat to security;
    • (iii) a failure to comply with regulatory requirements;
    • (iv) sabotage, theft, loss or illegal use or possession of prescribed equipment, or
    • (v) a release into the environment not authorized by the licence;
  • (d) observes and obeys all notices and warning signs; and
  • (e) takes all reasonable precautions to ensure the safety and security of individuals, the environment and the nuclear
    substances or facilities.
H
Rating: Comments:
54

ALARA/RP program

RP 04 (a)

The licensee has implemented a radiation protection program that keeps doses ALARA and includes:

  • (i) management control over work practices;
  • (ii) personnel qualification and training;
  • (iii) control of occupational and public exposure to radiation; and
  • (iv) planning for unusual situations.
H
Rating: Comments:
55

Radiation safety

NSRD 17

Referenced emergency procedures are available to workers at the site of licensed activity.

M
Rating: Comments:
56

Device provided & maintained

GN 12 (1) (d)

Required devices have been provided and have been maintained according to manufacturer's instruction.

M
Rating: Comments:

* Risk level:

  • H - High
  • M - Medium
  • L - Low
Work Doc: 4 TII - Packaging and Transport
# Description Regulatory Requirements Compliance Expectations Risk*
56

Type A package requirements

PTNS 28 (1)

A Type A package must be prepared and labelled in accordance of PTNS 28(1) and associated requirements from SSR-6.
Package requirements are as follows:

  • contact dose rate below 2 mSv/h (non-exclusive use) - SSR-6 527;
  • name of consignor or consignee package - SSR-6 531;
  • shipping name - SSR-6 532 and TDG 4.11;
  • activity within limits - PTNS 26(2) and SSR-6 428;
  • UN number - SSR-6 532 and TDG 4.12;
  • "Type A" marking - SSR-6 534(b);
  • VRI code - SSR-6 534(c);
  • two (I-white, II-Yellow or III-Yellow) labels - SSR-6 538, 539, and TDG 4.6, 4.7;
  • identify the radionuclide on labels -SSR-6 540 (a);
  • maximum activity on labels - SSR-6 540 (b)(c) and TDG 4.14;
  • transport index on labels (II-Yellow and III-Yellow) - SSR-6 540(d) as determined by SSR-6 523-524;
  • package integrity must not be compromised - PTNS 24(a) and SSR-6 306(b).
H
Rating: Comments:
57

Excepted packages content/activity

PTNS 26 (1) (a)

Excepted

Excepted packages meet the following criteria:

  • dose rate below 0.005 mSv/h – PTNS 25(4)(a) and SSR-6 516;
  • activity within limits of PTNS 26(2) and SSR-6 422;
  • consignor or consignee I.D. - PTNS 28(1)(i) and SSR-6 531;
  • UN number on package - PTNS 28(1)(i) and SSR-6 532;
  • package must be accompanied by a shipping document (a log kept by driver is acceptable for UN 2909, 2910, 2911) that
    identifies the shipping name and UN number - PTNS 29(2)(a) and TDG 1.43;
  • "RADIOACTIVE" visible inside package(UN2910) upon opening - PTNS 26(1)(a)(i) and SSR-6 424(b)(i).

For UN 2908 (Empty Packages):

  • contamination inside an empty package does not exceed 100 times the levels specified in SSR-6 427(c) and PTNS
    26(1)(a)(i);
  • Labels removed PTNS 26(1)(a)(i) and SSR-6 427(d);
  • package integrity must not be compromised – PTNS 26(1)(a) and SSR-6 306(b).
H
Rating: Comments:
58

Surface contamination

PTNS 28(1)(c)/SSR-6
508

The package has been tested to confirm surface contamination is below 4 Bq/cm2 for beta and gamma emitters and low
toxicity alpha emitters, and 0.4 Bq/cm2 for all other alpha emitters - PTNS 28(1)(c) and SSR-6 508.

H
Rating: Comments:
59

Transport document requirement

PTNS 29(1)

The consignor of radioactive material provides a shipping document that includes the following (refer to TDG 3.5 and SSR-6
546):

  • consignor and consignee names and addresses;
  • 24 hour contact number;
  • number of packages;
  • UN number*;
  • shipping name*;
  • Class # 7*;
  • radionuclide identification*;
  • form*;
  • maximum activity*;
  • category of package*;
  • transport index*;
  • competent authority certificate number(s)*.

For consignments of more than one package, the required information (*) must be given for each package.

  • Consignor's certification with printed name of the consignor - PTNS 25(1), TDG 3.6.1.
M
Rating: Comments:
60

Showing proof of TDG training

PTNS 25 (1)

A person handling dangerous goods must provide their training certificate or copy of it to an inspector immediately upon request.

M
Rating: Comments:
61

TDG training certificate

TDG 6.1, 6.3, 6.5

The employer is responsible for:
6.1(2)(a) ensuring that only an adequately trained worker who holds a valid TDG certificate handle Class 7 dangerous goods
; or
6.1 (2)(b) performs those activities in the presence and under the direct supervision of a person who is adequately trained
and who holds a training certificate in accordance with this Part.
6.3 issuing training certificate that includes:

  • the employer's business address;
  • the employee's name;
  • aspects of handling and transporting;
  • employee and employer signatures; and
  • the expiry date of the certificate (TDG 6.5).
M
Rating: Comments:
62

Package secured in vehicle

PTNS 25 (4)

Consignments are segregated and securely stowed (refer to SSR-6 562, 564, 574 - PTNS 25(1) and TDG 5.4). Category
II-Yellow and III-Yellow packages are not carried in compartments occupied by passengers - SSR-6 563.

H
Rating: Comments:

* Risk level:

  • H - High
  • M - Medium
  • L - Low

Disclaimer: CNSC licensees may use this worksheet voluntarily to ascertain the CNSC`s general expectations regarding regulatory requirements. Such requirements would generally be assessed during a Type I and Type II Inspection of licences issued pursuant to the Nuclear Substances and Radiation Devices Regulations. The expectations listed for each regulatory requirement are only provided as a guide. Similar worksheets will be used by CNSC staff for on-site inspections. Inspections, will, however, be carried out on a case-by-case basis in the context of the licensed activities and the circumstances of individual situations. This worksheet is not intended to limit the scope of CNSC inspections or the powers of CNSC inspectors. Licensees should contact the CNSC to obtain information regarding their specific licence requirements.