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).