Attachment_2D.pdf
PDF 83 KB Posted
- Solicitation number
- FDA-17-MQSA
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Attachment 2D
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment_1.docx | DOCX document | |
| Attachment_6.docx | DOCX document | |
| Attachment_11.pdf | ||
| Attachment_3.ppt | PPT presentation | |
| Attachment_12.docx | DOCX document | |
| Attachment_2A_MQSA_Nomination_Form.pdf | ||
| SF33-14a.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 | ||
| Attachment_9.docx | DOCX document | |
| Attachment_2C_MQSA_COURSE_III_MENTORSHIP_REQUIREMENT_5_1_14.doc | DOC document | |
| Attachment_5.pdf | ||
| 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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