1

QA Violations

A Look at the First

3 Years...

2

QA-Preparing the FacilitiesRemembering the Beginnings-

Subchapter 22 Quality Assurance Regs

Workshops provided QA education

Over 1500 registrants in attendance

Compliance Guidance Documents

3

QA Findings Year 1

Inspectors--inspection review to ensure QA program started.

--Medical Physicist QC Survey completed

--QA Manual completed

--Initial QC tests completed

--Processor QC started

4

QA Findings Year 2

AHA! . . . QA Program and QC testing . . . here to stay!

Some registrants stored, disposed of units Inspectors checking QC reports thoroughly

Annual Medical Physicist QC Survey - - - actually meant ANNUAL!

5

QA Findings Year 3

Continue to perform thorough reviews during inspection

Registrants still not performing all QC tests at specified time intervals

Repeat Violations result in monetary penalty assessments

6

TRENDS

What types of violations

are we seeing?

How do they impact the work of the QA Medical Physicist?

7

QC VIOLATIONS

What 5 violations do you think

are the MOST POPULAR?

8

1st Most Popular QC Violation

Missing QC Test Items - Rad 46%

Year 1 2 3 Total

# Violations 741 819 512 2072

9

2nd Most Popular QC Violation

No annual Medical Phys. QC Survey - Rad 18%

Year 1 2 3 Total

# Violations 346 239 240 825

10

3rd Most Popular QC Violation

No or Incomplete QA Manual 11%

Year 1 2 3 Total

# Violations 323 104 82 509

11

4th Most Popular QC Violation

No QA Program 8%

Year 1 2 3Total

# Violations 345 11 20 376

12

5th Most Popular QC Violation

Processing Film when QC Test Failed 7%

Year 1 2 3 Total

# Violations 123 90 102 315

13

Total QA Violations by Year

2001

1581

1272

0

300

600

900

1200

1500

1800

2100

Year 1 Year 2 Year 3

Num

ber Q

A Vi

olatio

ns

14

Violation Documents Annually

636 619488

376

182104 110 132

1231

0200400600800100012001400

Year 1 Year 2 Year 3

Num

ber V

iola

tion

docu

men

ts

(NOV)(AO)(NOP)

15

Penalties Issued Annually

$109,900

$128,300$133,400

$0

$20,000

$40,000

$60,000

$80,000

$100,000

$120,000

$140,000

$160,000

Year 1 Year 2 Year 3

Pe

na

ltie

s Is

sue

d

16

Medical Physicists’ Role

How do these violations

impact the work

of the QA Medical Physicist?

17

QA Violations & Medical Physicists

Medical Physicist’s Annual QC Survey

MP review all the periodic QC tests - done and reported properly

If test items are missing - must be noted on the annual QC Survey

If items are missing, the facility FAILS in these items

18

QA Violations & Medical PhysicistsMedical Physicist’s Annual QA

Program Review

MP review with the Registrant: QA program & QA Manual

Registrant must: document the periodic tests Table 1 throughout the year

See the FAQs for more information

19

QA Violations & Medical PhysicistsDocumentation is very important!

When inspectors find QC test violations, sometimes the MP QC survey indicates the facility passed, some items not done.

Confusion for registrant.

The MP annual QA Review - facility missed some QC tests.

NOTE: ALL test result records MUST BE made available for review by the certified medical physicist and the state inspector.

20

QA Goals

• Increase Registrant Compliance • BRH Inspector & Physicist

– communication– collaboration

• Educate Registrants – how to lower ESE– how to improve IQ

21

Quality Assurance

THANK YOU!

GRACIAS!

MERCI BEAUCOUP!