State of California--Health and Human Services Agency California Department of Public Health Radiologic Health Branch Application for Mammography Facility/Machine Certification PLEASE PRINT OR TYPE ALL INFORMATION SECTION 1--FACILITY STATUS a. Application is for: (check one category box below and circle appropriate selection within category checked) Biopsy-only facility: New facility New machine Renewal ACR MQSA facility: New facility New machine State certificate renewal Change of address Transferring machine to different address * Submit a Radiation Machine Registration Form RH 2261with all above actions* Change of facility name or owner ­ Submit with legal documentation and RH 2261 Changes to facility personnel: Technologists Radiologists Physicist b. Current FDA facility identification number FDA certificate expiration date c. State registration number State certificate expiration date SECTION 2--FACILITY ADDRESS INFORMATION a. Facility name b. D.B.A. (if applicable) c. Contact name Contact title d. Phone number Fax number e. Employer Identification number (Federal Tax ID number) ­ f. Facility location address (line 1) g. Facility mailing address (line 1) (address line 2) (address line 2) City State ZIP code City State ZIP code SECTION 3--FACILITY MAMMOGRAPHY ACCREDITATION HISTORY a. For this physical location address, have you previously applied for FDA MQSA certification? b. Has the accreditation status of this facility ever been denied (including failure to pass provisional, reinstatement, or renewal periods), revoked or suspended? Yes Yes No No · If yes, provide a detailed written explanation and attach to this application. The following information must be included: (1) indicate the identity of specific machines that failed, (2) the dates of failure, (3) details of how you corrected CIR deficiencies (including any physician or technologist training and machine/processor repair) and, (4) if the machine subsequently passed CIR after corrective actions were taken. · If the failed CIR was performed under the direction of an Accrediting Body other than the State of California (for example ACR) and occurred within the last three years, submit full copies of failure reports with this application. · For suspensions or revocations, describe the circumstances that led to suspension or revocation. SECTION 4--FACILITY PROCEDURE INFORMATION a. Do you currently accept self-referrals? b. Number of screening procedures performed per year: c. Number of diagnostic procedures performed per year: Yes No d. Total number of procedures performed per year in 4b and 4c above: e. Number of stereotactic procedures performed per year: f. Number of needle localizations performed per year: American LegalNet, Inc. www.FormsWorkflow.com CDPH 8623 (11/07) SECTION 5--ASSOCIATED PROGRAM INFORMATION a. Do you now participate or intend to participate in the Every Woman Counts Program (formerly known as BCEDP/BCCCP)? b. Supply the nine-digit Medi-Cal number used to bill for mammographic examinations performed at this facility location address: Yes No SECTION 6--PERSONNEL QUALIFICATIONS a. Physician's qualifications (list all physicians who interpret mammography exams for this facility): NAME (CHECK BOX OF THE INTERPRETING PHYSICIAN) CALIFORNIA MEDICAL BOARD LICENSE NUMBER SUPERVISOR/ OPERATOR CERTIFICATE (RHL) NUMBER SUPERVISOR/ OPERATOR EXPIRATION DATE ABR, AOBR, OR RCPSC CERTIFIED IN DIAGNOSTIC RADIOLOGY? 1. 2. 3. 4. 5. 6. 7. Yes Yes Yes Yes Yes Yes Yes No* No* No* No* No* No* No* (Use additional sheets if necessary.) * If a physician is non-ABR, -AOBR or -RCPSC certified, supply attachments documenting their qualification as an interpreting physician under Section 900.12 (a)(1) of 21 Code of Federal Regulations, Part 900. These must include the following initial qualifications: (1) attending three months full-time training in the interpretation of mammograms (provide a signed statement by the physician-preceptor who administered this training); (2) copies of certificates demonstrating 60 hours of continuing medical education in mammography (time spent in a radiology residency program will be accepted if documented in writing); and (3) documentation that they have read and interpreted 240 mammograms in the six months preceding this application. b. Technologist's qualifications (list all technologists performing mammography at this facility): NAME (CHECK BOX OF THE LEAD QA/QC TECHNOLOGIST) STATE MAMMOGRAPHY CERTIFICATE NUMBER CERTIFICATE EXPIRATION DATE 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. (Use additional sheets if necessary.) c. Physicist's qualifications (identify the physicist that performs required annual mammography physicist surveys): Mammography Medical Physicist State Physicist registration number CDPH 8623 (11/07) American LegalNet, Inc. www.FormsWorkflow.com SECTION 7--MAMMOGRAPHY EQUIPMENT INFORMATION a. Mammography Machine Listing (Complete one line for each machine at your facility.) THIS MACHINE IS USED FOR THE UNIT IF MANUFACTURER FOLLOWING PROCEDURES: MAP ID STEREOTACTIC, AND TYPE OF (Check all that apply) NUMBER CHECK: FILM/SCREEN IS THIS ON ACR SYSTEM USED FOR MACHINE CERT D = DEDICATED THIS UNIT MOBILE? AND/OR INCLUDING UNIT OR FACILITY ENTER "D" IF NUMBER (see A = ADD-ON ROOM THIS MACHINE IS AFTER Section 7c SCREENING/ NEEDLE UNIT below) DIGITAL ONLY NUMBER HYPHEN STEREO DIAGNOSTIC LOC FOR OFFICE USE ONLY MAKE MODEL CONTROL SERIAL NUMBER OR THE FACILITY'S RADIATION MACHINE IDENTIFICATION NUMBER XM NUMBER 1. 2. 3. 4. 5. b. Film Processor Listing Yes No Yes No Yes No Yes No Yes No D A D A D A D A D A MAKE MODEL EXTENDED THIS PROCESSOR IS USED PROCESSING? FOR THE ABOVE MACHINE NUMBERS: (Y/N) 1. 2. c. Additional Requirements for mobile machines: Yes No Yes No Attach a separate sheet providing the following information. For each mobile machine, specify: (1) the address of each location where mammography will be performed; (2) the name and telephone number of the responsible person who is allowing the service to be provided at the location; (3) whether mammograms will be processed on-board or, if processed at different locations, the address of each location; (4) whether the machine is used exclusively in a mobile vehicle or, if transported to the use location and moved to the area examinations are to be performed, the designated room number within the building at each use location; and (5) a description of the quality control tests that will be performed each time the radiation machine is reloc