PWS_Attachment_5-_QASP_Worksheet.pdf

Required Service (Performance Requirement) Standard (Performance Standard) Method of Surveillance (MS) Acceptable Quality

Levels (AQL)

Points for

Reduction of Bonus

Number of non-compliant* surveys

0 0

1 1

2 2

3 3

4 4

5 5

6-10 10

11+ 20

0-2 0

3 1

4 2

5 3

6 4

7-8 5

9-10 10

11+ 20

0-5 0

6-10 2

11-15 4

15+ 10

0 0

1-2 5

3+ 10

Number of non-compliant* surveys

0-2 0

3 1

4 2

5 3

6 4

7-8 5

9-10 10

11+ 20

0-2 0

3-5 1

6-8 2

9-10 3

B. Monthly Surveys:

Cotractor shall utilize DRS database*** to track and report data input times. DRS may spot-check entered data for timeliness and accuracy.

3. All reports and supporting documentation shall be submitted in accordance with the time frames outlined in the Statement of Work.

1. Monthly surveys were completed within the month they are due.

2. The correct type of monthly survey (use/no use) was performed for each lab, and surveys were done correctly.

DRS shall spot check surveys to ensure all requirements have been satisfied. DRS may also establish a customer feedback and analysis program for use by

Authorized Users.

DRS oversight will apply, as DRS may spot-check the tracking & report completion and accuracy.

Comparison of completed surveys to a list generated by the database indicating the labs required to have a survey performed for that month.

1. Comprehensive surveys shall be completed during the month in which they are due.

Comparison of completed surveys to a list generated by the database indicating the labs required to have a survey performed for that month.

2. Comprehensive survey reports shall be submitted in an acceptable format, with accurate content. Surveys shall be conducted in accordance with the Statement of Work.

The contractor shall utilize DRS database*** to track and report unacceptable survey statistics. DRS oversight will apply, as DRS may spot-check the tracking and reporting data.

A. Comprehensive Surveys:

4. Data requiring database entry shall be entered completely and accurately. Utilize methods to track and report accuracy.

11-12 4

12-15 5

15+ 10

0-5 0

6-10 2

11-15 4

15+ 10

0 0

1-2 5

3+ 10

Number of non-compliant security checks

0 0

1 1

2 2

3-4 5

5 10

6+ 20

0-1 0

2-3 1

4 2

5 3

6 5

7+ 10

100% 0

<100% 20

0-10 0

11-20 2

21-30 4

31+ 10

Percent of non-compliant elements

0 0

1 10

2 20

3+ 30

0-3 0

4-5 5

6-10 10

11-15 15

C. Security Checks:

Spot checks by DRS

2. Contamination meters calibrated within required time frame.

Spot checks by DRS

DRS oversight will apply, as DRS may spot-check the tracking and report completion and accuracy.

B. Monthly Surveys:

2. Results shall be completely and accurately documented. Data requiring database entry shall be entered completely and accurately.

Utilize methods to track and report accuracy.

Review of lab surveillance forms. DRS oversight will apply, as DRS may spot-check the tracking and report completion and accuracy.

Review security check results for each cycle; random inspections by a member of the Division of Radiation Safety (DRS).

1. Exposure meters calibrated within required time frame.

3. All reports and supporting documentation shall be submitted in accordance with the time frames outlined in the Statement of Work.

The contractor shall utilize DRS database*** to track and report data input times. DRS may spot-check entered data for timeliness and accuracy.

4. All reports and supporting documentation shall be submitted in accordance with the time frames outlined in the Statement of Work.

The contractor shall utilize DRS database*** to track and report data input times. DRS may spot-check entered data for timeliness and accuracy.

2. The correct type of monthly survey (use/no use) was performed for each lab, and surveys were done correctly.

DRS shall spot check surveys to ensure all requirements have been satisfied. DRS may also establish a customer feedback and analysis program for use by

Authorized Users.

1. Security checks shall be completed within the time frame outlined in the statement of work.

3. Unsecured radioactive materials were secured by contractor or notified DRS.

Review of lab surveillance forms.

4. Data requiring database entry shall be entered completely and accurately. Utilize methods to track and report accuracy.

D. Calibrations:

16+ 20

0 0

1 10

2 20

3+ 30

0-3 0

4-5 5

6-10 10

11-15 15

16+ 20

>0-4% 0

>4-6% 1

>6-10% 5

>10% 10

Number of non-compliant* elements

0 late 0

1 1

2 5

3 10

4+ 20

0 missed 0

1 1

2 5

3 10

4+ 20

0-2 errors 0

3 1

4 5

5+ 10

0-1 0

2-3 1

4+ 10

Instances of non-compliance with the statement of work

0 0

1 10

2+ 20

3. Reports submitted for review are complete, accurate, and in compliance with guidelines and regulations listed in the Statement of Work.

DRS review of submitted reports.

2. Contamination meters calibrated within required time frame.

Spot checks by DRS

4. Contamination meteres were calibrated in accordance with SOW.

Spot checks by DRS

F. Preparation and decontamination of I-131 therapy room:

Spot checks by DRS

5. Documentation is complete and accurate in accordance with the SOW.

Compare stickers to calibration sheets

1. The contractor shall prepare the I-131

Therapy rooms for occupancy as needed, within the time frame outlined in the statement of work

DRS will verify the room is prepared prior to occupancy and notify the contractor if modifications are required.

D. Calibrations:

3. Exposure meters were calibrated in accordance with the SOW.

DRS review of submitted reports.4. Reports must be submitted within 5 days of the survey completion.

E. Surveys of Radiation-Producing Machines

& Protective Garments:

1. Radiation-producing machines for which the contractor is responsible were surveyed within

12 months of the previous survey, unless a machine was inoperable or inaccessible.

Review of master listing of radiation-producing machines.

2. Protective garments were surveyed within 12 months of the previous survey.

Review of master listing of protective garments.

1 5

2+ 10 Number of non-compliance

0 0

1 10

2+ 20

0 0

1 10

2+ 20

0 0

1 10

2 15

3+ 20

1 10

2 15

3+ 20

Number of days non-compiance

0-1 0

2 10

3+ 30

Number of missed inventories

0 0

1 1

2 5

3 10

4 15

1. All required supplies on hand and in working order. The contractor shall maintain at least

150lb of dry ice at the end of each work day. All vehicles shall be in working order.

Inspection by DRS.H. Contractor Provided Supplies

F. Preparation and decontamination of I-131 therapy room:

3. LSC must be verified daily to be in working order before processing package swipes.

Inspection by DRS.

I. Annual Inventory: The contractor shall complete inventory by

December 1st of each year.

Inspection by DRS.

1. The contractor shall receive, inspect, package and delivery radioactive materials in accordance with the NIH NRC license and federal regulations.

Random inspections will be performed by

DRS. Customer complaints will also be used in assesment.

G. Radioactive materials inspected, packaged and delivered:

4. Lab surveys must be completed and documented accurately daily after use.

Inspection by DRS.

2. All patient deliveries must be completed within an hour of arrival.

Random inspections will be performed

DRS. Customer complaints will also be used in assesment.

2. The contractor shall decontaminate, for free release all surfaces to less than 200 dpm/100cm , as needed, within two or three days of receiving the swipe results unless instructed to do so within one day by the COR.

The contractor shall decontaminate, for reset, all surfaces to less than 2000 dpm/100cm2, as needed, within one day of receiving the swipe results.

The contractor shall provide a survey report with swipe and meter results attached to demonstrate compliance. DRS staff may spot check with swipes and meters.

5+ 20

I. Annual Inventory: The contractor shall complete inventory by

December 1st of each year.

Inspection by DRS.