Attachment_2D.pdf

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Attached to
2017 Mammography Quality Standards Act (MQSA) State Inspection Contracts
Solicitation number
FDA-17-MQSA
Issued by

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Attachment 2D

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Attachment_1.docx DOCX document
Attachment_6.docx DOCX document
Attachment_11.pdf PDF
Attachment_3.ppt PPT presentation
Attachment_12.docx DOCX document
Attachment_2A_MQSA_Nomination_Form.pdf PDF
SF33-14a.pdf PDF
Attachment_2.docx DOCX document
Attachment_2B_MQSA_COURSE_II_Observation_FORM.doc DOC document
MQSA_RFP_2017.docx DOCX document
Attachment_7.docx DOCX document
Attachment_4.docx DOCX document
Attachment_8.docx DOCX document
Attachment_13.pdf PDF
Attachment_9.docx DOCX document
Attachment_2C_MQSA_COURSE_III_MENTORSHIP_REQUIREMENT_5_1_14.doc DOC document
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Attachment_10.docx DOCX document
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Text version

Facility MQSA ID:

YES NO

Student observed MQSA insepctor schedule the inspection

MQSA inspector reviewed MPRISweb and its contents to student

MQSA inspector demonstrated how to find search for and download inspection from FISSweb

MQSA inspector demonstrated how to download inspection in to FISS Client

MQSA inspector provided information on the purpose of and how to access the Policy Guidance

Help System (PGHS)

MQSA inspector demonstrated the following: YES NO

How to enter information in to FISS

How to view information from the previous inspection

How and when to use printed and internal remarks

YES NO

Student was provided with the Interpreting Physician Qualification (IP) Worksheet (may obtain from PGHS)

MQSA inspector explained the initial qualification requirements for the IP and reviewed at least one IP's initial qualifications with the student

MQSA inspector explained the continuing experience requirements for the IP and reviewed at least one IP's continuing experience documents with the student

MQSA inspector explained the continuing education requirements for the IP and reviewed at least one IP's continuing education documents with the student

MQSA inspector explained the new modality training requirements for the IP and reviewed at least one IP's new modality training documents with the student

YES NO

Student provided with the Radiologic Technologist (RT) Qualification Worksheet (may obtain from

PGHS)

MQSA inspector explained the initial qualification requirements for the RT and reviewed at least one RT's initial qualifications with the student

MQSA inspector explained the continuing experience requirements for the RT and reviewed at least one RT's continuing experience documents with the student

PRE INSPECTION

INTERPRETING PHYSICIAN

RADIOLOGIC TECHNOLOGIST

INSPECTION

PERSONNEL

MQSA INSPECTION OBSERVATION CHECKLIST

MQSA Student Name:

MQSA Inspector Name and ID:

Facility Name:

Date:

MQSA inspector explained the continuing education requirements for the RT and reviewed at least one RT's continuing education documents with the student

MQSA inspector explained the new modality training requirements for the RT and reviewed at least one RT's new modality training documents with the student

YES NO

Student was provided with the Medical Physicist (MP) Qualification Worksheet (may obtain from

PGHS)

MQSA inspector explained the initial qualification requirements for the MP and reviewed at least one MP's initial qualifications with the student

MQSA inspector explained the continuing experience requirements for the MP and reviewed at least one MP's continuing experience documents with the student

MQSA inspector explained the continuing education requirements for the MP and reviewed at least one MP's continuing education documents with the student

MQSA inspector explained the new modality training requirements for the MP and reviewed at least one MP's new modality training documents with the student

YES NO

MQSA inspector explained which QC tests were required to be completed by the facility based on the FFDM QC manual

MQSA inspector reviewed QC manual with student while reviewing QC

MQSA inspector reviewed how to find action limits for each QC test in the FFDM QC manual

YES NO

MQSA inspector explained which annual physicist tests were required to be completed by the facility based on the FFDM QC manual

MQSA inspector reviewied QC manual with student while reviewing the survey report

MQSA inspector reviewed how to find action limits for each physicist test in the FFDM QC manual

YES NO

MQSA inspector provided information on the acceptable assessment categories (i.e., from the

PGHS) to the student

MQSA inspector reviewed five medical reports from the facility with the student

YES NO

MQSA inspector explained requirements for the Medical Audit and Outcome Analysis to the student MQSA inspector reviewed the facility's medical audit and outcome analysis with the student

YES NO

MQSA inspector demonstrated how to score a phantom

Student scored a phantom

PHANTOM IMAGE REVIEW

MEDICAL PHYSICIST

QUALITY CONTROL

PHYSICIST SURVEY

MEDICAL RECORDS

MEDICAL AUDIT AND OUTCOME ANALYSIS

YES NO

Infection Control SOP

Consumer Complaint SOP

Quality Assurance Personnel

Written SOP's for QC Tests

YES NO

MQSA inspector explained the levels of noncompliances and facility's expected response for each level of noncompliance to student

MQSA inspector reviewed the document "MQSA Important Inspection Close‐Out Discussion

Information" with the student and explained when to provide it to the facility

MQSA inspector reviewed the document "Important Information about Your MQSA Inspection" with the student and explained when to provide it to the facility

MQSA Inspector demonstrated a proper close out discussion with the facility to include a review of the inspection debrief report and the close out discussion letter.

MQSA inspector demonstrated how to upload the inspection from FISS Client to MPRISweb

MQSA inspector demonstrated how to upload the inspection from FISSweb to MPRISweb

MQSA inspector demonstrated how to locate the Post Inspection Report and the Inspection Detail

Report in MPRISweb

MQSA Inspector demonstrated how to print the Post Inspection Report, and discussed office procedures and deadlines for mailing/faxing/e‐mailing final MQSA reports to the facility

Please provide an explanation for any box checked "No":

MQSA inspector explained the requirements and reviewed the facility's document(s) with the student for the following:

QUALITY ASSURANCE

POST INSPECTION

Student Signature:

Mentor Signature:

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