Preparing for your MQSA inspection A few questions.. What do I have? What do I need? r- How can you find your favorite shoes, if you can t find your closet?? What can I throw away? Hope Martinez, Sr. R.P.S., M.P.H., B.S.R.T (R,M) What do I have? Look for the following: 1. Certificates 2. Continuing education documents 3. Continuing experience documents 4. New modality training documents 5. Initial qualification documents (for new hires) 6. Quality Assurance information 7. Infection Control information 8. Consumer Complaint information 9. Communication of Results 10. Physicist Report 11. Medical Audit And of course.. The Quality Control binder -documentation that you have performed the appropriate tests, in the appropriate interval, under the appropriate conditions. Divide & Conquer Separate your documents into the previous categories listed. Certificates Interpreting Physicians State Medical License State perator/supervisor certificate Technologists State Mammography certificate Physicist State Approval letter Continuing Education Performed within the previous 36 months? Does each person have 15 units? Related to breast Imaging? -may not be applicable to State license renewal Continuing Experience Performed within the previous 24 months Interpreting Physician- 960 readings Technologist-200 mammograms performed Physicist - 6 units and/or 2 facilities 1
36 vs. 24 -count backward from the month of your inspection. example 2/14 2/13 2/12 2/11 12 months 24 months 36 months New Modality training 8 hours of education Initial Qualification everything else &: Interpreting Physicians -American Board of Radiology -Residency letter of training -Attestastion Technologists -Certificate of training/attestation -25 mammograms Quality Assurance Personnel List List of people important to the well-being of your mammography department. 1. Lead Interpreting Physician 2. Q.C. Technologist(s) 3. Physicist(s) 4. Mammography Unit Service Company 5. Printer Service Company 6. Monitor Service Company 7. Processer Service Company Should have name & contact information Infection Control 900.12(e)(I3)(i), (ii), (iii). Infection control. Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall: (i) Comply with all applicable Federal, State, and local regulations pertaining to infection control; and (ii) Comply with the manufacturer s recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or (iii) If adequate manufacturer s recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available. Consumer Complaint Policy 900.12(h)(1)(2)(3)(4): Consumer complaint mechanism. Each facility shall: (1) Establish a written and documented system for collecting and resolving consumer complaints. (2) Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received. (3) Provide the consumer with adequate directions for filing serious complaints with the facility s accreditation body if the facility is unable to resolve a serious complaint to the consumer s satisfaction. (4) Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body. & the State Communication of Results To the patient-30 days 900.12(c)(2)(i),(ii): Communication of mammography results to the patients. Each facility shall send each patient a summary of the mammography report written in lay terms within 30 days of the mammographic examination. To the medical doctor- 30 days Provide a written report of the mammography examination, including the items listed in paragraph (c)(1) of this section, to that health care provider as soon as possible, but no later than 30 days from the date of the mammography examination; Serious findings If assessments are "Suspicious" or "Highly suggestive of malignancy," the facility shall make reasonable attempts to ensure that the results are communicated to the patient and provider as soon as possible. - Attempt to communicate results to provider within 3 working days and the patient within 5 working days 2
Physicist Report Annually..Annually.Annually & After any major Repair, Replacement or Relocation. Medical Audit & utcome Analysis 1. Annually 2. For each Interpreting physician 3. For the all the doctors combined 4. All BX results included for the time period in question. This is really to look at how well your doctor reads. Document rganization Supplies Creation of the Mammo Trilogy Section one. Quality Assurance Personnel list Book ne: Personnel Lead Interpreting Physician Q.C. Technologist(s) Physicist(s) Mammography Unit Service Company Printer Service Company Monitor Service Company Processer Service Company Should have name & contact information 3
Section two. Interpreting Physician(s) FDA Inspection list A. Current Information 1. Certification a. Current Medical License b. Current p/sup X-ray certificate 2. Continuing Experience a. Number of readings performed in previous 24 months 3. Continuing Education a. Education units completed in previous 36 months Section two continued. Interpreting Physician(s) B. Qualifying Documents 1. New modality documents 2. Initial qualification documents a. ABR b. Self-Attestations c. Letters of attestation from college Section. 2 Section three. Technologists A. Current Information 1. Certification a. Current State Mammography Certificate 2. Continuing Experience a. Number of mammograms performed in previous 24 months 3. Continuing Education a. Education units completed in previous 36 months Section three continued. Technologists B. Qualifying Documents 1. New modality documents 2. Initial qualification documents a. Self-Attestations b. Certificate/letter of training c. 25 mammograms d. ARRT (m) 4
Section four. Physicist(s) Section 3 A. Current Information 1. Certification a. Current State Mammography Approval Letter 2. Continuing Experience a. Number of units/facilities in previous 24 months 3. Continuing Education a. Education units completed in previous 36 months Section four continued. Physicist(s). Qualifying Documents 1. New modality documents 2. Initial qualification documents a. FDA letter b. Certificate/letter of training c. Diploma d. Document of experience Section 4 Section five. Medical Audit & utcome Analysis 1. Auditing physician signature 2. Documentation of discussion 3. Proof of follow-up practices Book Two: Policy & Procedure /General Documents End of book ne 5
Section one. Consumer Complaint Policy TAB Section two. Infection Control Policy TAB Section three. Communication of Results TAB TAB Section four. Medical Reports Section five. General Documents End of book Two TAB Book Three: Quality Control Section one. FDA cert, ACR cert & Accreditation Certificate for each unit TAB Section two. 6 month review sign off sheet TAB Section three. Procedure Manual/ACR Manual TAB Section four. Physicist Report in front of each unit s Q.C. test records TAB End of book Three What Can I Throw Away? Per the FDA. Inspection films will be maintained for the following time: a) Films documenting a Level 1 noncompliance shall be maintained until the noncompliance is documented as being resolved by a subsequent inspection, plus 2 years. NTE: For phantom image test films, both films (the first phantom image and the backup phantom image) should be maintained. b) Films documenting Level 2 and Level 3 noncompliances should be maintained until all related noncompliances are documented as being resolved by a subsequent inspection, or 1 year; whichever is longer. c) All other films (for inspections with no adverse findings) should be maintained for a minimum of 1 year so that they are available for an audit by an MQSA Auditor. Q.C. Test records will be maintained for the following time: These records must be maintained until the next annual inspection that would verify compliance or until an individual test has been performed two additional times at the required frequency, whichever is longer. Verifying compliance implies that if QC records for a given test were found to be deficient and the facility was cited during an annual inspection, these records must be kept until the facility corrects the problem to FDA s satisfaction. This also means that records for semi-annual tests may have to be kept longer than the period between two successive annual inspections, and records for annual tests must include the most recent two California Code of Regulations, Title 17, Section 30319.20. Record Keeping Requirements 6
So what can I throw away?? Continuing education documents over 36 months old (excluding initial qualification documents) What Should Be Done With Documents That I Can No Longer Use? Continuing experience documents over 24 months old (excluding initial qualification documents) Q.C. test records over 3 years old Q.C. test films over 3 years old if involved in a violation & over 1 year old if no violation. A Beach Bonfire A Cozy Fire A Cute Piñata A Shredding ccasion Some Sources FDA http://www.fda.gov/radiation- EmittingProducts/MammographyQualityStandardsActand Program/Guidance/default.htm ACR http://www.acr.org/accreditation/mammography.aspx State of CA-Radiologic Health Branch http://www.cdph.ca.gov/programs/pages/radiol ogichealthbranch.aspx & don t forget. the coffee The End 7