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Inspection procedure

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  • MQSA INSPECTION PROCEDURES 6.05 (9/1/09)

    1. INTRODUCTION................................................................................................... 10 - 1.1 Further Details ...................................................................................................... 11

    1.1.1 Inspection Kit...............................................................................................................11 1.1.2 Laptop Failure during an Inspection ............................................................................ 11 1.1.3 Preventing Theft (ref. MQSA Document # 107) ......................................................... 11 1.1.4 Internet Access from the Laptop.................................................................................. 12 1.1.5 Noting Change within a Facility .................................................................................. 13

    2. GENERAL GUIDANCE ........................................................................................ 14 - 2.1 Advance Notice for Inspections............................................................................ 14

    2.1.1 Inspection Elements Common to Multiple Facilities................................................... 14 2.1.2 Routine Annual Facility Inspections - When should a facility be inspected?.............. 15 2.1.3 Equipment Testing During an MQSA Inspection........................................................ 15

    - 2.2 Getting Started ...................................................................................................... 16

    2.2.1 Identification Cards...................................................................................................... 16

    - 2.3 What to Do in Unusual Situations ........................................................................ 16

    - 2.3.A Operating without a Valid Certificate................................................................... 16

    - 2.3.B Conducting Mammography with an Unaccredited Machine ................................ 17

    2.3.1 Expired Certificates Found During Inspections........................................................... 18 2.3.2 Facilities that Changed Status, Moved, Ceased Operations, or Closed ....................... 18

    - 2.4 When Certain Documents are Claimed but Unavailable for Review ................... 23

    2.4.1 Claimed Items Use During Inspections........................................................................ 23

    - 2.5 Using the Remarks Sections.............................................................................. 24

    2.5.1 Remarks Section - What to Include ............................................................................. 24 2.5.2 Additional Information for Level 1 and Level 2 Noncompliances .............................. 25

    - 2.6 Facility Grouping for Inspection Fee Consolidation ............................................ 25

    2.6.1 Inspection Fees............................................................................................................. 26 2.6.2 Inspection Fee Consolidation....................................................................................... 26 2.6.3 Billing Changes............................................................................................................ 26

    - 2.7 Repeat Observations ............................................................................................. 26

    - 2.8 Discussion of Inspection Observations with Facility Personnel (exit interview). 27

    2.8.1 Inspection Citation Levels ........................................................................................... 28 2.8.2 Inspector Actions at the Facility after Completing the Inspection............................... 28 2.8.3 Facility Personnel Responsibility Re Inspection Observations Follow-Up................. 29 2.8.4 Documentation and other Issues Related to Inspection Observations ......................... 30 2.8.5 Inspection Findings Disputed by Facilities..................................................................30 2.8.6 Inspection Errors Discovered by FDA or the State...................................................... 31 2.8.7 Recording State vs. MQSA Requirements................................................................... 31 2.8.8 Advice to a Facility Following a Serious Citation....................................................... 31 2.8.9 Advice to Facilities Regarding Corrective Actions ..................................................... 32 2.8.10 Responding to FDA after Inspections (Letters with Inspection Report and Facility

    Comments) ................................................................................................................... 32 2.8.11 Copying Records during Inspections and Using Remarks........................................... 33 2.8.12 Veteran Health Administration (VHA) Inspections.....................................................38 2.8.13 Corrected Before Inspection (CBI) Policy................................................................... 38 2.8.14 Facilities Comments Concerning Their Inspections .................................................... 38

    1

    MQSA Inspection Procedures - V 6.05 9/1/09

  • 3. PRELIMINARY INFORMATION and DATA RECORDING......................... 40 - 3.1 General.................................................................................................................. 40

    - 3.2 Data Recording ..................................................................................................... 40

    - 3.2.1 Inspection Outline................................................................................................. 40

    - 3.2.2 Equipment Registration ........................................................................................ 43

    - 3.2.3 Preliminary Facility and Inspection Information.................................................. 44

    - 3.2.4 Facility Contacts ................................................................................................... 46

    - 3.2.5 X-ray System(s) Information ................................................................................ 46

    - 3.2.6 Updating Pre-filled Data (Important) ................................................................... 50

    - 3.3 Further Details ...................................................................................................... 52

    3.3.1 Facility Inspection Download (FISS Screen. 2.0 on your laptop) ...............................52 3.3.2 Individuals Accompanying on Inspections ..................................................................52 3.3.3 Calibration Criteria for Densitometers and Sensitometers - Replacements ................. 52 3.3.4 EIN and CFN (FEI)...................................................................................................... 53 3.3.5 Additional Sites............................................................................................................54 3.3.6 Post-Exposure Indication of Pre-selected Focal Spot and Target Material - Alternative

    Standard # 4 ................................................................................................................. 54 3.3.7 Dedicated Buckys and Spot Compression Paddles...................................................... 55 3.3.8 Unit Accreditation........................................................................................................ 55 3.3.9 Subsequent Use of X-Ray Units that Failed during the Inspection ............................. 55

    4. SYSTEM PERFORMANCE TESTS .................................................................... 56 - 4.1 General.................................................................................................................. 56

    4.1.1 Equipment Measurements which Result in Borderline Values.................................... 56 4.1.2 Retention of MQSA Inspection Test Films.................................................................. 56 4.1.3 Unusual Errors ............................................................................................................. 57 4.1.4 Situations without Corresponding Questions in the Software ..................................... 57

    - 4.2 Phantom Image Quality Evaluation ...................................................................... 58

    4.2.1 Phantom Image Scoring - General Procedure.............................................................. 61 4.2.2 Phantom Scoring Video ............................................................................................... 62 4.2.3 Phantom Images Exposed in a Fully Automatic Mode - Assigning a kVp.................. 62

    - 4.3 The Sensitometric Technique for Evaluation of Processing (STEP) Test............ 62

    4.3.1 The STEP Test General Guidance ............................................................................ 65 4.3.2 Step Reference Number for the Control Film.............................................................. 65 4.3.3 Control Film Used for the STEP Test .......................................................................... 66 4.3.4 Update on Film Processor Testing ............................................................................... 66 4.3.5 STEP (Test) Field Calibration Protocol .......................................................................67 4.3.6 Processing Cycle and the STEP Test ........................................................................... 68

    - 4.4 The Darkroom Fog Test........................................................................................ 69

    4.4.1 Darkroom Fog - Daylight System Inspection Issues....................................

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