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for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
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MQSA INSPECTION PROCEDURES 6.03 – (8/1/07)(Note: The sections in blue, which also begin with the ^+ symbol and end with the ^ - symbol, indicate notes, further details, clarifications, and guidance issues.)
1.1.2 Laptop Failure during an Inspection
1.1.3 Preventing Theft (ref. MQSA Document # 107)
1.1.4 Internet Access from the Laptop
1.1.5 Noting Change within a Facility
2.1 Advance Notice for Inspections
2.1.1 .......................................... ^+Inspection Elements Common to Multiple Facilities
2.1.2 ........ Routine Annual Facility Inspections - When should a facility be inspected?
2.3 What to Do in Unusual Situations
2.3.A Operating without a Valid Certificate
2.3.B Conducting Mammography with an Unaccredited Machine
2.3.1 ^+Expired Certificates Found During Inspections
2.3.2 Facilities that Changed Status, Moved, Ceased Operations, or Closed
2.4 When Certain Documents are Claimed but Unavailable for Review
2.5 Using the “Remarks” Sections
2.5.1 ^+Remarks Section - What to Include
2.5.2 Additional Information for Level 1 and Level 2 Noncompliances
2.6 Facility Grouping for Inspection Fee Consolidation
2.6.2 Inspection Fee Consolidation
2.8 Discussion of Inspection Observations with Facility Personnel (exit interview)
2.8.1 ^+Inspection Citation Levels
2.8.2 Inspector Actions at the Facility after Completing the Inspection
2.8.3 Facility Personnel Responsibility Re Inspection Observations Follow-Up
2.8.4 Documentation and other Issues Related to Inspection Observations
2.8.5 Inspection Findings Disputed by Facilities
2.8.6 Inspection Errors Discovered by FDA or the State
2.8.7 Recording State vs. MQSA Requirements
2.8.8 Advice to a Facility Following a Serious Citation
2.8.9 Advice to Facilities Regarding Corrective Actions
2.8.10 Responding to FDA after Inspections (Letters with Inspection Report and Facility Comments)
2.8.11 Copying Records during Inspections and Using Remarks
2.8.12 Veteran Health Administration (VHA) Inspections
2.8.13 Corrected Before Inspection (CBI) Policy
2.8.14 Facilities Comments Concerning Their Inspections
3. PRELIMINARY INFORMATION and DATA RECORDING
3.2.3 Preliminary Facility and Inspection Information
3.2.5 X-ray System(s) Information
3.2.6 Updating Pre-filled Data (Important)
3.3.1 Facility Inspection Download (FISS Screen. 2.0 on your laptop)
3.3.2 Individuals Accompanying on Inspections
3.3.3 Calibration Criteria for Densitometers and Sensitometers - Replacements
3.3.6 Post-Exposure Indication of Pre-selected Focal Spot and Target Material - Alternative Standard
3.3.7 Dedicated Buckys and Spot Compression Paddles
3.3.9 Subsequent Use of X-Ray Units that Failed during the Inspection
4.1.1 ^+Equipment Measurements which Result in Borderline Values
4.1.2 Retention of MQSA Inspection Test Films
4.1.3 Unusual or Unexplainable Errors
4.1.4 Situations without Corresponding Questions in the Software
4.2 Phantom Image Quality Evaluation
4.2.1 ^+Phantom Image Scoring - General Procedure
4.2.3 Phantom Images Exposed in a Fully Automatic Mode - Assigning a kVp
4.3 The Sensitometric Technique for Evaluation of Processing (STEP) Test
4.3.1 ^+The STEP Test – General Guidance
4.3.2 Step Reference Number for the Control Film
4.3.3 Control Film Used for the STEP Test
4.3.4 Update on Film Processor Testing
4.3.5 STEP (Test) Field Calibration Protocol
4.3.6 Processing Cycle and the STEP Test
4.4.1 ^+Darkroom Fog - Daylight System Inspection Issues
5. QUALITY ASSURANCE (QA) PROGRAM
5.3.2 Specific Personnel Responsibilities
5.3.3 Consumer Complaint Mechanism – Compliance Criteria
5.3.4 Procedures for Infection Control - Compliance Criteria
5.3.5 Dealing with Breast Implant Patients - Compliance Criteria
5.3.6 Consumer Complaint Mechanism – Handling Complaints about a Facility
5.3.7 Facility Complaints Regarding MQSA Inspectors - Resolution Process
6. QUALITY CONTROL (QC) RECORDS
6.0.1 ^+QC Records Retention Requirement for Replaced Equipment
6.0.2 Documentation of the Required Screen-Film QC Tests
6.0.3 Reviewing QA/QC Records for Retired Equipment
6.1 Processor Performance QC (Daily)
6.1.1 ^+Charting of Quality Control (QC) Test Results
6.1.3 Performing the Daily Processor QC when the Densitometer is not Available
6.1.4 Situations Warranting Re-establishment of Processor Operating Levels
6.1.5 Facility Actions while Establishing/Re-establishing Processor Operating Levels
6.1.7 Performing Daily QC on the Back-up Processor (General Purpose or Dedicated for Mammography)
6.1.9 Performing the Daily QC Tests on a Processor Used Only for Duplication of Mammograms
6.1.11 Performing Processor QC Using Phantom Image Measurements
6.1.12 Preset Scanning Densitometers
6.1.13 Automatic Densitometers and Saving Data
6.1.14 Sensitometer Calibration
6.2 Fixer Retention QC (Quarterly)
6.2.1 ^+Fixer Retention QC Records
6.3.1 ^+Phantom Image QC Records - Operating Levels
6.3.3 Reviewing Phantom Image QC Records
6.3.4 Test Conditions for the Weekly Phantom Image
6.3.8 Facility Use of a Cracked Breast Phantom
6.3.10 Using the Phantom Image QC Test as a Substitute for Sensitometry
6.3.11 Performance Verification Test for Mobile Mammography Units
6.4 Compression QC (Semi-annually)
6.4.1 ^+Maintaining Compression
6.5 Repeat Analysis QC (Quarterly)
6.5.1 ^+Repeat Analysis in a JCAHO Facility
6.6 Screen-Film Contact QC (Semi-annually)
6.6.1 ^+Screen-Film Contact QC - Procedures Manual
6.6.2 S/F Contact - Test Conditions and Pass/Fail Criteria
6.7 Darkroom Fog QC (Semi-annually)
6.7.1 ^+Darkroom Fog QC – Daylight System Issues
6.8.1 ^+Evaluation Procedures for FFDM Systems (APPENDIX 2)
6.8.2 Facility’s Use of Printers and Monitors not Specifically Approved as Part of its FFDM Unit
7. Annual PHYSICS SURVEY REPORT
7.2 Facility Response to Medical Physicist’s Observations
7.3.A Survey Report - Information Screen
7.3.B Survey Questions (Screens 3.10.1 & 3.10.2)
7.4.1 Data Entry - Information Tab (Screen 3.10)
7.4.2 Survey Report Availability for FFDM Systems.
7.4.3 Direct Supervision & Signature on the Survey or Mammography Equipment Evaluation (MEE) Report
7.4.4 Extension of the 14 Month Limit for the Medical Physicist Survey
7.4.5 Multiple Dates for the Medical Physicist Survey
7.4.6 If the Survey Shows Mistakes or Contradictions
7.4.7 Citation Levels Associated with Report Status and Date(s)
7.4.8 Using BR12 Rather than the RMI 156 Phantom for Dose Calculations
7.4.10 Focal Spot Condition (System Resolution) Test
7.4.11 AEC Performance – Clarification of Terms
7.4.12 AEC Performance – Meeting the Annual Survey Test Requirements
7.4.13 AEC Performance – Testing Units with Multiple Detectors
7.4.14 AEC Performance – Testing with Different Image Receptor Sizes
7.4.15 AEC Performance – Testing outside the 2-6 cm Range
7.4.16 Testing of AEC Modes not Used Clinically
7.4.17 AEC Reproducibility –Units with Multiple Detectors and AEC Modes
7.4.20 Artifact Test for Daylight Processing Systems
7.4.21 KVp Values Used during Testing
7.4.22 Screen Speed Uniformity – Cassettes with Different Speeds
7.4.23 Decompression Test – Alternative Standard
7.4.24 Scope of the Survey Tests
7.4.26 Facility Actions when the AEC Fails the Medical Physicist Testing
8. MAMMOGRAPHY EQUIPMENT EVALUATIONS (MEE)
8.1.A Newly Installed or Reassembled X-ray Unit
8.1.B Newly Installed or Reassembled Processor
8.4.2 AEC Performance Testing for the MEE – Scope and Action Limits
8.4.3 AEC Performance Testing during the MEE outside the 2-6 cm Range
8.4.4 Validity of the kVp(s) Used in MEE Testing
8.4.5 Motion of the Tube-Image Receptor Assembly
8.4.6 Manufacturer’s Software Modification of the AEC – Alternative Standard
8.4.8 ^+Moving a Unit within a Facility
9.1.1 Maintenance of Personnel Records
9.1.2 Letters from Approved Certifying Boards
9.1.3 Direct Supervision Issues
9.1.4 Past or Part Time Employees
9.1.5 Credits for Mammography Personnel Teaching a Course/Reading or Writing Articles
9.1.6 Criteria for Accepting Training/CME/CEU Certificates
9.1.7 Examples of New Mammographic Modalities
9.2 Interpreting Physician (Screen 3.11.1)
9.2.1 ^+Qualification Requirements - Interpreting Physicians
9.2.2 Direct Supervision for Interpreting Physicians
9.2.3 Applicability of the Requirement for 8 Hours of Training in Each Mammographic Modality
9.2.4 Requirements for the Content of the FFDM Training
9.3 Radiologic Technologist (Screen 3.11.2)
9.3.1 ^+Qualification Requirements - Radiologic Technologists
9.3.2 Direct Supervision for Radiologic Technologists
9.3.3 The ARRT (M) Certificate
9.3.4 Applicability of the Requirement for 8 Hours of Training in Each Mammographic Modality
9.3.5 Requirements for the Content of the FFDM Training
9.3.7 CME/CEU Credit for MQSA Teleconference (Live or Tape Viewing)