Radiation Safety Laboratory Inspection Program

A. Radiation Safety Laboratory Inspection Program

Items of Compliance

  1. Performance-Based Assessment of Non-radioactive Material Worker

    1. Completion of the on-line Radiation Safety course.

    2. Aware of the OSU policy that requires radioactive material to be secured from unauthorized access or removal.

    3. Aware of laboratory specific procedures for the receipt and storage of packages containing radioactive material.

    4. Aware of the prohibition of eating, drinking, smoking, mouth pipetting, or applying cosmetics in laboratories posted for the use or storage of radioactive material.

    5. Aware of where radioactive material is used and stored in the laboratory.

    6. Aware of where the spill/personnel contamination emergency response procedure is posted.

  2. Performance-Based Assessment of Radioactive Material User

    1. Demonstrate appropriate survey meter use.

    2. Demonstrate appropriate techniques for smear wipe surveys.

    3. Implementation of ALARA.

    4. Explain the lab-specific procedures for ordering radioactive material.

    5. Explain lab-specific procedures for receipt, storage, and security of radioactive material packages.

    6. Articulate and/or demonstrate proper procedures to follow if there is a spill of radioactive material or a personnel contamination incident.

    7. Explain the lab-specific procedures for handling low-level radioactive waste.

    8. Explain lab-specific personnel monitoring requirements.

    9. Aware of proper postings and labeling requirements.

    10. Proper use of EHS Assist

    11. Explain the URSC-approved procedures for handling animals used with radioactive material

  3. Radiation Safety Inspection

    1. All area surveys have been completed during periods of use and documentation is complete.

      1. Frequency of laboratory surveys is based on the total activity used and must be performed at the frequency as specified by the committee-approved permit. If use is < 100 μCi/month, surveys are required at least monthly. If use is > 100 μCi/month surveys are required at least weekly. Changes from weekly to monthly surveys must be by an approved RS-7 Form. Surveys do not need to be performed if there has been no use since the previous survey.

      2. Results of smear wipe surveys and direct contamination surveys (survey meter surveys) must be maintained in units of disintegrations per minute (dpm). Areas with loose contamination is excess of 200 dpm/100 cm2 must be decontaminated and re-wipe results documented.

      3. Radiation dose rate surveys shall be documented in units of mrem/hr. Dose rate surveys are normally performed with an ion chamber. Most laboratories using only beta emitting nuclides are not required to perform dose rate surveys.

      4. Laboratory surveys must be documented on the RS-15 Form, Laboratory Survey Results (or equivalent).

    2. All radioactive material is secured from unauthorized access or removal.

      1. All laboratories or areas in which radioactive material is used or stored must be either under constant surveillance by laboratory works in the lab, or be locked when constant surveillance is not possible. Radioactive material must be secured from unauthorized access or removal.

    3. Physical inventory accounted for all material on the inventory list.

      1. Inventory records are required to be maintained by active and storage only laboratories. Inventory records are maintained on a web-based inventory system, EHS Assist. Radiation Safety will perform a physical inventory of all stock vials during an inspection.

    4. Waste containers are labeled correctly and disposals are made in the appropriate manner.

      1. Waste issues reviewed during a laboratory inspection include hot sink disposals, sharps in the solid waste, appropriate postings, storage of waste, and proper record keeping. Information on low-level radioactive waste can be found on our website. Radiation Safety will perform a physical inventory of all waste containers during an inspection.

    5. Radiation survey instruments are within current calibration frequency and are appropriate for the radionuclides used.

      1. Survey instruments are required to be calibrated at least annually and after any repair or other service performed by either the manufacturer or OSU. The Approved Supervisor is responsible for obtaining/borrowing an equivalent survey instrument when repair or calibration is being performed on the laboratory survey meter.

    6. All personnel monitoring guidelines are followed as required.

      1. Compliance of individuals required to wear dosimeters or participate in the OSU bioassay programs will be reviewed.

    7. All laboratory radiation safety training is current.

      1. Documentation of the in-laboratory training program on the RS-6 Form must be submitted with the one-year renewal of the permit and initially for new users to the laboratory. Documentation must also be maintained in the laboratory for review during an inspection. A 70% is needed to pass the written and performance-based evaluation.

      2. All users and Approved Supervisors of radioactive material must successfully complete the on-line Radiation Safety course prior to using radioactive materials. In addition, all personnel who work within the posted laboratory must also take the on-line course.

      3. All Approved Supervisors must participate in the initial Supervisor Evaluation Conference.

    8. All laboratory postings and equipment labels are appropriate.

      1. All laboratories are to be posted with appropriate caution signs, labels, and Notice To Employees as provided by RSS. All equipment used with radioactive material must be labeled with the trilobe symbol and/or “Caution, Radioactive Material” sign. All containers of radioactive material (e.g. stock vials, labeled proteins, or probes) must be labeled or marked with the radionuclide present, activity, date, and radiation level (if appropriate).

      2. Radiation symbols or the wording “Caution, Radioactive Material” must be removed from shipping containers (after a smear wipe survey demonstrates no contamination) prior to disposal in the normal waste stream.

    9. Personnel protective equipment is available and used as required. All users must wear lab coats, gloves, and protective eyewear when manipulating radioactive material.

      1. Appropriate shielding must be used.

      2. Absorbent pads, trays, or bench covers must be used.

    10. Evidence of eating, drinking, smoking, use of cosmetics, and mouth pipetting.

      1. Eating, drinking, smoking, use of cosmetics, and mouth pipetting or evidence of these activities is prohibited in all posted areas, including storage only laboratories. Food preparation is also prohibited in posted laboratories as is the presence of food in refrigerators or freezers in active or storage only facilities.

    11. Packaging of Radioactive Materials for Transportation (on-campus)

      1. Radioactive material must be transported in closed containers. Containers with liquids must be surrounded with enough absorbent material to contain twice the volume of free liquid.

    12. Contamination discovered during a Radiation Safety audit in excess of 2,200 dpm/100 cm2 may result in points assessed. Areas with contamination in excess of 200 dpm/100 cm2 must be decontaminated and re-wipe results documented.

    13. Administrativeitemsareincompliance.

      1. Administrative items include following URSC-approved procedures; reporting spills; permit renewals; performance of maintenance surveys; documentation of corrective actions to deficiencies through EHS Assist; and completion of written corrective action plans. Deficiencies are closed once EHS personnel or the URSC have accepted the corrective actions.

    14. Points Assessed

Items of Non-compliance

Points Assessed

Radiation worker is unable to articulate and/or demonstrate proper procedures to follow if there is a spill of radioactive material or a personnel contamination incident.

5

A laboratory under suspension used radioactive material.

5

Radiation worker is unable to demonstrate appropriate survey meter use. All radiation workers must be able to demonstrate which meter and detector is appropriate for the radionuclides in use; perform a battery check; and survey the work area.

4

Radiation worker is unable to demonstrate appropriate techniques for smear wipe surveys including locations to survey; avoiding cross-contamination of smear wipes; preparation of smear wipes for counting; interpretation of results; and documentation.

4

Removable contamination >22,000 dpm/100 cm2.

4

All surveys were not performed during periods of use.

4

Radioactive material found unsecured (quantities > Appendix A of OAC 3701:1-38-18)

4

Transfers of radioactive material were not performed according to approved procedures (on or off campus).

4

Laboratory made an unauthorized acquisition of radioactive material.

4

Sharps were not segregated from other solid radioactive waste.

4

Radioactive waste was placed into the biohazard, chemical, or normal waste stream.

4

Personnel did not have the required dosimetry or did not wear it as required.

4

Bioassays were not performed as required.

4

Personnel did not perform or receive radiation safety training prior to using radioactive material (web- based Radiation Safety course and/or initial in-lab training).

4

Evidence of eating, drinking, smoking, application of cosmetics, or mouth pipetting.

4  

Items of Non-CompliancePoints Assessed

Personnel did not wear lab coat, eye protection, or gloves as a minimum to handle radioactive material.

4

Appropriate shielding was not used.

4

A major spill or personnel contamination incident was not immediately reported to Radiation Safety.

4

Failure to submit a completed and signed written corrective action plan.

4

Non-radioactive material worker is unaware of the OSU policy that requires radioactive material to be secured from unauthorized access or removal.

3

Non-radioactive material worker is unaware of the regulation regarding the prohibition of eating, drinking, smoking, applying cosmetics, or mouth pipetting in laboratories posted for the use or storage of radioactive material.

3

Radiation worker is unable to explain the concept and site-specific implementation of an ALARA (As Low As Reasonably Achievable) program including time, distance, shielding, and containment.

3

Radiation worker is unable to explain lab specific procedures for receipt, storage, and security of radioactive material packages. Shipping materials must be smear wiped, free of contamination, and radiation symbols or the word “radioactive” removed or defaced prior to disposal.

3

Radiation worker is unaware of the lab specific procedures for handling low-level radioactive waste including appropriate waste segregation, decay-in-storage, long-lived waste, de minimus waste, mixed waste, and hot sink disposals.

3

Radiation worker is unaware of the lab specific personnel monitoring requirements which may include dosimeter types (whole body, ring) placement and storage, bioassay types (thyroid and urine), and that thyroid bioassays should occur 24-72 hours post use.

3

Radiation worker is unaware of proper posting and labeling requirements in a laboratory using radioactive material including door signs, hot sinks, spill response, and ODH “Notice To Employees” identifying their rights and responsibilities.

3

Radiation workers are not following the proper URSC-approved procedures for handling animals used with radioactive material.

3

Removable contamination >2,200 dpm/100 cm2 but <22,000 dpm/100 cm2.

3

Radioactive material found unsecured (quantities < Appendix A values of OAC 3701:1-38-18 or radioactive material considered low specific activity i.e. radioactive waste).

3

Radioactive waste was not stored in an appropriate container.

3

Radioactive waste containers were not labeled with radionuclide and/or container number.

3

Long-lived radioactive waste was in a lab for a period of greater than 1 year after the container was sealed.

3

Items of Non-CompliancePoints Assessed

Survey meter was not operable or was not within the calibration frequency.

3

Survey meter or detector was not appropriate for the radionuclides used.

3

Annual in-lab training has not been provided and/or is not documented.

3

Equipment used with radioactive material was not labeled “radioactive”.

3

Absorbent pads, bench covers, or trays were not used.

3

University Radiation Safety Committee-approved procedures were not followed.

3

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies.

2

Non-radioactive material worker has not completed the on-line Radiation Safety course*

2

Non-radioactive material worker is unaware of laboratory specific procedures for the receipt and storage of packages containing radioactive material.

2

Non-radioactive material worker is unaware of where radioactive materials are used and stored in the laboratory.

2

Radiation worker is not entering data into EHS Assist at the appropriate frequency or is inaccurately entering disposal information. Radiation workers must be able to navigate EHS Assist or communicate disposal information to the data entry person.

2

Surveys are not documented correctly.

2

Inventory was not maintained on the web-based inventory system or was not entered in a timely manner.

2

Radioactive waste was not segregated according to approved procedures.

2

Decay-storage waste was stored in a lab for greater than 3 years after the container was sealed.

2

Survey meter was not used in the appropriate manner.

2

Dosimetry was not returned after the wear period.

2

Door postings were missing or incomplete.

2

All stock solutions > Appendix A quantities (OAC 3701:1-38-18) were not labeled with radionuclide, activity, and radiation level (as appropriate).

2

Radiation symbols or the wording “Caution, Radioactive Material” was not removed from shipping containers prior to disposal.

2

A minor spill was not reported to Radiation Safety within 24 hours.

2

Items of Non-CompliancePoints Assessed

One-year renewal of a radioactive material permit was not completed.

2

Failure to have a proper maintenance survey performed on labeled equipment prior to relocation or repair.

2

Non-radioactive material worker is unaware of where the spill/personnel contamination emergency response procedure is posted.

1

Radiation worker is unable to explain the laboratory’s site-specific procedures for ordering radioactive materials and that all orders must be approved by Radiation Safety prior to OSURF or Purchasing placing the order with the vendor.

1

Web-based transactions were not entered correctly

1

Failure to label stock vials with EHS Assist inventory number

1

*If points are assessed for this item, additional deficiencies for non-radioactive material worker will not be issued points.

B. Enforcement Actions

Approved Supervisors are evaluated under the following Point System:

  1. Accumulation of points is within a six-month rolling calendar. Failure to submit a written corrective action plan will result in the suspension of the rolling calendar. The points that are accumulated will remain until the written correction action plan is submitted and approved by the University Radiation Safety Committee.

  2. Repeat items of non-compliance are double the original value assessed in the point system. Items of non- compliance are considered a repeat if it reoccurs within the 6 month rolling calendar.

  3. Re-inspections will occur within 30 days if an Approved Supervisor has accumulated >8 points. If an Approved Supervisor is assessed >3 points during any single re-inspection, the lab will be inspected again within another 30 days.

  4. When a written corrective action plan is required, it must address the following for each item of non- compliance:

    1. Acknowledge and state the cause of the deficiency,

    2. A statement of corrective actions implemented and actions taken to prevent future occurrences,

    3. Date of full compliance,

    4. Documentation that all users have signed a statement that describes the nature of the deficiency and corrective actions implemented.

  5. For the four highest point total action levels, irrespective of the number of points accumulated, each attempt at reconciliation and punitive action must have already taken place before the next more severe punitive action is taken.

  6. Offenses, situations, or circumstances endangering the immediate health and safety of employees, students, or visitors will be reported directly to the University Radiation Safety Officer who will implement whatever actions are appropriate to the circumstances.

7. Radiation Safety Enforcement Actions

Total Points

Enforcement Action

1-3

The Approved Supervisor of a laboratory that has accumulated 1-3 points shall receive documentation of the deficiencies through EHS Assist. The Approved Supervisor shall correct the deficiencies and document the corrective actions via EHS Assist within 14 calendar days from the date of notification.

If a written record (e.g. RS-6) is required to correct the deficiencies, the Approved Supervisor has 14 calendar days from the date of notification to submit the required information.

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies will result in an additional 2 point violation.

4-7

The Approved Supervisor of a laboratory that has accumulated 4-7 points shall receive documentation of the deficiencies through EHS Assist. The Approved Supervisor shall correct the deficiencies and document the corrective actions via EHS Assist within 14 calendar days from the date of notification. In addition, a written corrective action plan must be submitted within 14 calendar days for review and approval by the University Radiation Safety Committee. If a corrective action plan is disapproved, the Approved Supervisor has 14 calendar days to resubmit a revised corrective action plan. The URSC may designate Radiation Safety to review and approve/disapprove the revised corrective action plan.

If a written record (e.g. RS-6) is required to correct the deficiencies, the Approved Supervisor has 14 calendar days from the date of notification to submit the required information.

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies will result in an additional 2 point violation.

Failure to provide a written corrective action plan for URSC review will result in suspension of the use of radioactive materials until the written corrective action plan has been submitted and approved.

8-11

The Approved Supervisor of a laboratory that has accumulated 8-11 points shall receive documentation of the deficiencies through EHS Assist. In addition, written notification from the URSO will be issued with copies of the letter sent to the appropriate Dean and Department Chair.

The URSO may impose a 2 week suspension of ordering privileges.

The Approved Supervisor shall correct the deficiencies and document the corrective actions via EHS Assist within 14 calendar days from the date of notification. In addition, a written corrective action plan must be submitted within 14 calendar days for review and approval by the University Radiation Safety Committee. If a corrective action plan is disapproved, the Approved Supervisor has 14 calendar days to resubmit a revised corrective action plan. The URSC may designate Radiation Safety to review and approve/disapprove the revised corrective action plan.

If a written record (e.g. RS-6) is required to correct the deficiencies, the Approved Supervisor has 14 calendar days from the date of notification to submit the required information.

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies will result in an additional 2 point violation.

Failure to provide a written corrective action plan for URSC review will result in suspension of the use of radioactive materials until the written corrective action plan has been submitted and approved.

Total PointsEnforcement Action

12-15

The Approved Supervisor of a laboratory that has accumulated 12-15 points shall receive documentation of the deficiencies through EHS Assist. In addition, written notification from the URSC Chair, Senior Director for Environmental Health and Safety, and the URSO will be issued with copies of the letter sent to the appropriate Dean and Department Chair.

The URSC Chair will impose a 2 week suspension of the use of radioactive materials.

The Approved Supervisor shall correct the deficiencies and document the corrective actions via EHS Assist within 14 calendar days from the date of notification. In addition, a written corrective action plan must be submitted within 14 calendar days for review and approval by the University Radiation Safety Committee. If a corrective action plan is disapproved, the Approved Supervisor has 14 calendar days to resubmit a revised corrective action plan. The URSC may designate Radiation Safety to review and approve/disapprove the revised corrective action plan.

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies will result in an additional 2 point violation.

Failure to provide a written corrective action plan for URSC review will result in suspension of the use of radioactive materials until the written corrective action plan has been submitted and approved.

16-19

The Approved Supervisor of a laboratory that has accumulated 16-19 points shall receive documentation of the deficiencies through EHS Assist. In addition, written notification from the URSC Chair, Senior Director for Environmental Health and Safety, and the URSO will be issued with copies of the letter sent to the appropriate Dean and Department Chairperson. The Purchasing Agent will also be copied on the written notification.

The URSO will impose suspension of the use of radioactive materials until the URSC rescinds the suspension.

The Approved Supervisor shall correct the deficiencies and document the corrective actions via EHS Assist within 14 calendar days from the date of notification. In addition, a written corrective action plan must be submitted within 14 calendar days for review and approval by the University Radiation Safety Committee. The Approved Supervisor is required to attend the URSC meeting to show cause as to why the URSC should reinstate privileges to use radioactive materials. If a corrective action plan is disapproved, the Approved Supervisor has 14 calendar days to resubmit a revised corrective action plan. The URSC may designate Radiation Safety to review and approve/disapprove the revised corrective action plan.

Failure to provide an on-line corrective action response to deficiencies through EHS Assist and/or failure to provide a written record to correct deficiencies will result in an additional 2 point violation.

>20

The Approved Supervisor of a laboratory that has accumulated 20 or more points shall receive written notification from the Sr. Vice President of Administration and Planning informing the Approved Supervisor that their Approved Supervisor status at The Ohio State University has been suspended for three years. The appropriate Dean, Department Chair, and Purchasing Agent are copied

The Approved Supervisor must cease operations involving radioactive materials immediately and close out all areas posted for the use or storage of radioactive materials. No sanctions are imposed against the users. Users may seek user status under another Approved Supervisor.

During the first year of the suspension, the individual may not use radioactive materials. During the second and third year of the suspension, the individual may use radioactive materials under the supervision of another Approved Supervisor. After three years, the individual may apply to the URSC for Approved Supervisor status.

C. Radionuclide Risk Categories, Security and Required Training

Radionuclide Risk Categories

Level 1: No Significant Risk

  • Areas where only generally licensed materials or naturally occurring radioactive materials (NORM) are used including small button check sources, Ni-63 electron capture detectors and compounds of uranium and thorium.

Level 2: Low Risk

  • Collections of unit dosages of nuclear medicine diagnostic radiopharmaceuticals.

  • Unit dosages of most therapeutic radiopharmaceuticals used in nuclear medicine, including those

    containing P-32, Sr-90, Sm-153, and activities of I-131 not exceeding 100 mCi.

  • Vials or groups of vials of typical tracers used in biomedical research labeled with radionuclides such as H-3, C-14, S-35, P-32, P-33 and I-125.

  • Sealed Sources in activities less than 50 mCi

  • Total activity not exceeding 100 ALIs per laboratory.

Level 3: Intermediate Risk

  • Individual sealed sources or groups of sealed sources in a single location of Cs-137, Co-60, Sr-90, Ir- 192, Pu-239 and Am-241 of total activity from 50 mCi up to a maximum of 1 Ci.
  • Activity in a single location of I-131 exceeding 100 mCi.

  • Mo-99/Tc-99m generators

Level 4: Higher Risk

  • Individual sources or groups of sources in a single location of Cs-137, Co-60, Sr-90, Ir-192, Pu-239 and Am-241 of total activity greater than 1 Ci.

 

Levels of Security and Training (Corresponding to Radionuclide Risk Categories)

 

Level 1: No Significant Risk

  • Security
    • An active police and security presence on campus

    • Laboratory entrances are locked during off-hours

  • Training

    • Laboratory personnel should be trained with basic knowledge of chemical, biological and radiological hazards and procedures – Lab Safety Training

  • Level 2: Low Risk

    • Security

      • An active police and security presence on campus

      • Laboratory entrances are locked during off-hours

      • Radioactive material must be secured or under constant surveillance

    • Training

      • Laboratory personnel should be trained with basic knowledge of chemical, biological and radiological hazards and procedures – Lab Safety Training

      • Personnel who work within the laboratory must take the On-Line Radiation Safety Course

      • Personnel who use radioactive material are required to take the Initial In-Lab training and Annual In-Lab training

  • Level 3: Intermediate Risk

    • Security

      • An active police and security presence on campus

      • Laboratory entrances are locked during off-hours

      • Radioactive material must be secured or under constant surveillance

      • Key access must be limited to authorized users

      • Ancillary personnel shall not be left unattended

    • Training

      • Laboratory personnel should be trained with basic knowledge of chemical, biological and radiological hazards and procedures – Lab Safety Training

      • All personnel who work within the laboratory must take the on-line Course (or equivalent for Nuclear Medicine and Radiation Medicine)

      • All personnel who use radioactive material are required to take the Initial In-Lab training and Annual In-Lab training

  • Level 4: Higher Risk

    • Security

      •  An active police and security presence on campus

      • Laboratory entrances are locked during off-hours

      • Radioactive material must be secured or under constant surveillance

      • Key access must be limited to authorized users

      • Ancillary personnel must not be left unattended

      • Licensed materials must be separately locked

      • Access to secondary keys must be by authorized users only

    • Training

      • Laboratory personnel should be trained with basic knowledge of chemical, biological and radiological hazards and procedures – Lab Safety Training

      • All personnel who work within the laboratory must take the on-line Course (or equivalent for Nuclear Medicine and Radiation Medicine)

      • All personnel who use radioactive material are required to take the Initial In-Lab training and Annual In-Lab training.