Policy & Procedure Templates

Policy 1.01: Interpreting Physician Initial Qualifications

Credentialing requirements for physicians before their first independent mammogram interpretation under 21 CFR §900.12(a)(1).

Policy 1.02: Interpreting Physician Continuing Experience & Education

Ongoing qualification tracking: 960 exams per 24-month period and 15 CME hours per 36-month period under 21 CFR §900.12(a)(2).

Policy 1.03: Mammography Technologist Continuing Experience & Education

Continuing qualification requirements for mammography technologists: 200 exams per 24-month period and required continuing education units under 21 CFR §900.12(a)(4).

Policy 1.04: Medical Physicist Qualification & Credentialing

Credentialing requirements for medical physicists conducting mammography equipment evaluations: two qualification pathways, continuing experience, and no-exceptions written authorization under 21 CFR §900.12(a)(3).

Policy 1.05: Equipment Inventory & Modality Listing with Tracking

Inventory documentation for all mammography units: unit identification, modality type, accreditation status, and operational tracking supporting facility-wide MQSA compliance visibility.

Policy 1.06: Mammography Unit Acceptance Testing (New & Relocated)

Requirements for medical physicist acceptance testing before clinical use of any new or relocated mammography unit under 21 CFR §900.12(e)(6).

Policy 1.07: Annual Medical Physicist Survey

Annual mammography equipment evaluation by a qualified medical physicist: image quality, radiation output, compression force, and facility performance standards under 21 CFR §900.12(e)(5).

Policy 1.08: MQSA QC Log Sheets & Corrective Action Forms

Documentation requirements for quality control activities, equipment performance monitoring, and corrective action tracking under 21 CFR §900.12(e).

Policy 1.09: Daily QC Detector & Imaging System Check

Technologist-performed daily detector and imaging system quality checks verifying performance meets standards before patient imaging under 21 CFR §900.12(e).

Policy 1.10: Phantom Image Quality Testing

Periodic phantom image quality evaluation verifying spatial resolution, contrast, and artifact levels meet MQSA performance standards under 21 CFR §900.12(e).

Policy 1.11: Workstation Monitor QC

Quality control requirements for mammography interpretation display devices: luminance thresholds, DICOM calibration, and stop-use criteria under 21 CFR §900.12(e)(5).

Policy 1.12: Preventive Maintenance Scheduling

Structured preventive maintenance scheduling for all mammography equipment: frequency requirements, vendor coordination, and documentation standards to prevent unplanned failures.

Policy 1.13: Service Call Documentation & Closeout

Documentation and closeout requirements for all mammography equipment service calls: tracking repairs, verifying performance restoration, and maintaining the service history record.

Policy 1.14: Clinical Documentation Standards

Standards for clinical documentation completeness and accuracy across the mammography workflow, from patient intake through report delivery and record retention.

Policy 1.15: Image Identification & Labeling Standards

Required image identification and labeling elements for every mammographic acquisition: patient, facility, laterality, and technical parameter labeling under 21 CFR §900.12(c)(1).

Policy 1.16: Record Retention & Retrieval

Retention schedules and retrieval requirements for all mammography records: federal minimums, state-specific requirements, and the procedures for honoring patient transfer requests.

Policy 1.17: Prior Images, Reports, Request & Comparison

Procedures for requesting, receiving, and using prior mammography images and reports for comparison, including patient request workflows and interpreting physician responsibilities.

Policy 1.18: Interpretation Workflow & Peer Review

Standards for mammography interpretation workflow and peer review: double-reading protocols, audit requirements, and radiologist accountability under 21 CFR §900.12(d).

Policy 1.19: Mammography Report Content Standards

Required content elements for every mammography report: assessment categories, recommendation language, and BI-RADS compliance under 21 CFR §900.12(c)(1)(i).

Policy 1.20: Patient Results Lay Letter: Content & Timeliness

Patient notification requirements for mammography results: 30-day normal and 7-day abnormal timeliness standards, plain-language content requirements, and mandatory dense breast notification under 21 CFR §900.12(c)(1)(ii).