Bone Density (DXA) - University of California, San Francisco
Contents
1. ee L D Was the hip scan repeated O Date scan performed LII 2 0 Month Day Year b Last 2 characters of Scan ID LI c Reason Mark only one O Original scan unacceptable e g corrupted O Scan lost O Other Please specify d Which hip was scanned O Right hip O Left hip 2 Was the whole body scan repeated i Yes O No a Date scan performed at L i2 0 Month Day Year b Last 2 characters of Scan ID Reason Mark only one O Original scan unacceptable e g corrupted O Scan lost Other Please specify MOST Repear DXA 18575 Version 3 0 3 28 11 5m Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 page 23 Whole Body and Hip DXA Bone Density Operations Manual MOST MOST 84 Month DXA Bone Density Scan Log Clinic Site Date of Upload to Gateway Week Beginning Week Ending MOST 84 Month DXA Bone Density Scan Log Whole body Whole body Whole body Whole body 1of4 Comments Reason for Flag Verson 1 2 5 26 11 6 1 13 Version 1 0 Whole Body and Hip DXA Bone Density Whole Body and Hip DXA Bone Density MOST Operations Manual page 24 DXA Batch Record Form Batch Number Date Batch Mailed l Ma iF D ay Year Circle City Birmingham lowa City MOST Staff ID Contents OC Plot Date Printed pas Day Year Participant2. eene tone ente te ette sete tte setae 3 3 2 Hip Analysis at Follow up e eere eren ee eene en nenne ette ette sete stes tna eoa 3 4 Scan Flagegirig Criteria 5 5 n erre erinnert roue opo ee ro ree VF oe uS Poe eo Poena ee Vo 3 5 Excessive Bone Loss Procedures 4 eee eee eee eene eee eee ete etes te ette sten stato 4 Scanner Quality Control eeneeee ineo eto 4 1 IUE DECIMI 4 2 Whole Body Air SCahs reor Ce PR Fee pee ena ae Vn see 4 3 Machine Software and Service Problems eee ee ee eere eene eese enne eene 4 4 Hardware Software Change Control e eee ee ecce cree eee eee 5 Data Manageme nts cccccccccsccsscccascsscscceceseccactsoeccccseseccccceasccteseseccacssseccceveseccsarssccccesess 5 1 Hard Copies of SCanssisecciscsssscssssscesecsasssensdsvac cesses soeesseccscecesssscensssessesesassedutessecocseses 5 2 Electronic Scan Archive scccscccssccssccsscscsssscsscccssccssccesccsssssscscseesscesseesseeseeeees 5 3 Transfer of Data to the MOST DXA Quality Assurance Center 5 4 Return materials sent by the MOST DXA Quality Assurance Center Appendix 1 Hologic Whole Body Phantom Protocol eee e
3. of unwanted movements Use a pillow for the head and a small pillow under the knee of the leg not being scanned Maintain the participant at a comfortable body temperature for the duration of the scan Instruct the participant to remain still until the end of the measurement Make sure that the leg is not moved during the scan Flag any scans in which the participant has moved and has not been rescanned Print out a hard copy of each scan and file in the participant s folder 3 3 2 Hip Analysis at Follow up Load the baseline scan onto the hard disk Display this baseline evaluation using the COMPARE feature along with the current scan to be analyzed It is important to realize that proper comparison of a follow up hip scan to its baseline depends upon maintaining the identical size and relative position of the region markers Vertical or horizontal shifts of these regions by one or more pixels can greatly alter the final values of the analysis 3 4 Scan Flagging Criteria General Scan has unusual appearance or is difficult to analyze Any of the following in scan field either in the bone or soft tissue Unusual anatomical variations Surgical hardware metal plates screws pins prostheses etc Participant motion during scan Superimposed buttons pins zippers pacemakers vitamin pills etc Bone edges have been altered in any way ROI used on follow up is different size than used at baseline Follow up scans cannot be
4. of flagged whole body scans and flagged hip scans Whenever scans are to be reviewed centrally 1 An original printout and electronic copy of the scan should be sent to the QA Center Write the reason for the flagged scan on the scan printout and on the Participant Scan Log 2 It is the responsibility of the operator to reanalyze the scan according to QA Center comments and return a printout of the reanalyzed scan with an electronic copy to the QA Center for verification Procedures for compiling and forwarding scans to the QA Center are outlined in Section 5 Data management 2 3 1 Flagged Scans Any scans that appear unusual or difficult to analyze should be flagged for review by the QA Center Guidelines for flagging scans are listed in Section 3 4 Scan Flagging Criteria Flagged scans should be sent to the QA Center monthly Note the reason s for flagging on the MOST Participant Scan Log and on the original printout for clarification of the problem Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 6 The printouts will be reviewed for standard positioning and analysis procedures and returned to the clinical centers with instructions for reanalysis if appropriate Often these problem scans have been analyzed correctly and will not require further action 2 3 2 Outlier Checks and Random Sample Reviews Monthly scans with outlying values will be review
5. that the beveled edge forms a V with the base Next place the medium size white plastic pieces on the phantom again forming a V with the two beveled edges of the middle pieces Then place the small white plastic pieces on top forming another V with the small pieces The final assembly will form a pyramid see Figure 1 side view This is the only valid configuration for the phantom measurement All other configurations including adding materials to the phantom removing pieces of the phantom scanning the phantom upside down etc violate the intended use of the phantom and may produce invalid results II Phantom Positioning Carefully position the whole body phantom in the center of the scanner table with the head of the phantom at the head of the table Allow 24 61cm of empty air space at the head of the table Carefully position the phantom parallel with the long axis of the table using the table pad markings as a guide When properly centered there will be a constant 3 5 8 9 cm gap between the side of the phantom and the front and back limits of the QDR 4500 scanner table see Figure 1 Head of Scanner Table Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 18 Figure 1 Layout of Whole Body Phantom positioned on the QDR 4500 scanner table Also shown the fully assembled phantom viewed from the side Note that the amount of e
6. was performed 2 All scans that have been reanalyzed since the last archive Note that if a scan needs to be restored and reanalyzed for any reason it will need to be re archived Clinic disks will remain at the clinical center at all times The traveling disks will be sent back and forth between the clinical center and the QA Center The clinical centers are responsible for following the archive schedule and for keeping the disk archives safe until the end of the study 5 3 Transfer of Data to the MOST DXA Quality Assurance Center The following items are to be sent to QA Center on or around the first of the month 1 QC PRINTOUT Send a printout of the most recent plots of the QC database spine and hip BMD BMC and AREA The plots are reviewed at the QA Center and problems are reported back to the clinic Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 15 2 PARTICIPANT SCAN LOG Send a copy of the written participant scan log covering participants scanned since the last data transfer Use the log sheets to flag individual scans for review at the QA Center 3 SCANS FOR REVIEW Send original printouts of certification scans flagged scans random sample scans and any scans requested for review by the QA Center Please write directly on the printout the reason the scan was flagged requested or being sent These scans will be triaged visual
7. MOST Operations Manual page 1 WHOLE BODY AND HIP DXA BONE DENSITY TABLE OF CONTENTS 1 Ihm 2 Study Bruti e let 2 1 Division of Quality Assurance Responsibilities ecce eere ee enee 2 1 1 Clinical Center Responsibilities eren ee eene een eee eo sette sten aset taa 2 1 2 MOST DXA Quality Assurance Center responsibilities 2 2 Training and Certification of MOST DXA Operators eere 2 3 Review Of DXA SCAns mE 2 3 1 Flagged SCANS ient eer reor rhone aether oe un Vet eo eee PE Oe n ea eee PESE 2 3 2 Outlier Checks and Random Sample Reviews ecce ecce eee eerte ee enune 3 DXA Scan Acquisition and Analysis Procedures e eeeeeee ecce eerte ene 3 1 Participant Biography Follow up c ecce eee e eee eren etn ette ette stata sto 3 2 Whole Body Sans seccsccssescseccsccsscsssescosdcscessssessssovsescectcscsessosecsssuncvessssswsedcesacsvsedcessess 3 2 1 Whole Body Acquisition cessere eres ee eene eene enne etae en eese ette ette sete stes tna soa 3 2 2 Whole Body Analysis at Follow up e eee ee seta sese eaae 3 3 Tue c 3 3 1 Hip Acquisition at Follow up esee ener ener neenon
8. ST study must meet the following requirements l Read and understand both the Hologic user s guide and this manual Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 5 2 Successfully complete a Hologic training course 3 Satisfactory review of each operator s initial scans by the QA Center It is the clinical center s responsibility to ensure that all of the above certification criteria are met as new operators are brought into the study Since the Hologic central training sessions are held infrequently there may be several months delay between when a new operator is hired and when certification is complete Personnel not meeting these requirements may not scan participants without close supervision by a certified operator unless specifically authorized by the QA Center Recertification at Follow up In order for an individual operator to be certified to perform scans of a given skeletal site the first 10 follow up scans done on study participants at both skeletal sites hip and whole body for each operator must be sent to the QA Center for review Printouts of the corresponding baseline scans must accompany the follow up scans Printouts of the scans should be sent to the QA Center at the address listed above as soon as the first 10 follow up scans have been completed 2 3 Review of DXA Scans Scan analysis quality will be ensured by a central review
9. Scan Log Flagged Hip and Whole Y Number Body Scan Printouts Reanalyzed Scan Number Printouts Other Scans No Number Specii Traveling Optical a a Yes Repair Service Uporade a No Yes Log amp Hologic Report serve performed Certification Scans a No o Yes Please printout and mark certification We need 10 of each scan lype hip whole bodd from each staff member can be split between batches MOST Staff ID Number of Scans Scan Type MOST DXA Farms Version 1 1 OSAF Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 25 Hologic DXA Repair Service Upgrade Log MOST Instructions Please complete this log thoroughly and attach a copy of the Hologic service report Send copy with monthly DXA data transfer Keep one copy with your scanner in your own repair log Date problem s encountered System Serial 3 Describe problem Were there hardware software changes or upgrades Yes please describe Was the Hologic operational during the problem period Yes No Did problem affect scans How long was the Hologic out of service days a Yes No Please describe including time period Describe the action taken Was the problem resolved d Yes No gt Explain Date problem resolved Please describe how problem was resolved Was a recalibration of the Holog
10. am Thank you for your time and interest in the MOST study Please do not hesitate to call us if you have questions at and ask for Sincerely Cora Beth Lewis M D MOST Principal Investigator Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 29 Appendix 3 Apex Addendum Analysis Procedures with Apex 3 0 The purpose of this addendum is to describe supplemental analysis procedures to be used at the MOST Birmingham clinic due to an upgrade to Apex 3 0 Please do not reanalyze any baseline scans at this visit Please be sure to use the Compare feature when analyzing the 84 mo scans If you use the COMPARE feature for analysis the Apex software will analyze the scans using the analysis version of the BL scan If you do not the follow up will be analyzed in 3 0 and the BMD will be calculated in a DIFFERENT way BE CAREFUL TO ONLY USE COMPARE AND TO NOT REANALYZE ANY BASELINE SCANS Please flag any baseline scan that you believe must be reanalyzed the QA Center will review and reanalyze it at UCSF if necessary The scan will be sent back to the clinic for archival Whole Body and Hip DXA Bone Density Version 1 0 6 1 13
11. and any other requested scans are returned to the clinical center with instructions for reanalysis as necessary 2 Traveling disk Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 16 3 Any recommendations for service additional phantom scans etc as necessary based on the quality control data Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 17 Appendix 1 Hologic Whole Body Phantom Protocol I Phantom Assembly Before lifting or transporting the phantom break it down into its individual components Use care the impact force of a phantom component dropped from table height can cause severe injury particularly if the impact is delivered through one of the phantom s beveled edges Having another person help move the phantom components is strongly recommended A thin gray PVC sheet is attached to the large white plastic piece that contains the two plastic locating pins This HDPE PVC combination is the bottom layer base of the phantom Position it on the scanner table such that the PVC is on the bottom i e the gray PVC is in contact with the table pad and the two plastic locating pins project out of the plane of the table towards the ceiling Place the large white plastic piece on top of the phantom base using the locating pins as a guide The piece should be placed such
12. antom Restore the appropriate scan from the Hologic diskette labeled SAMPLE ANALYSES WB PHANTOM or Whole Body Phantom Analysis Template to the analysis workstation see Table 1 for the correct scan to restore for your QDR model Select the newly acquired WB Phantom scan Then use the Compare feature to register the ROI cutlines of the sample scan to the newly acquired scan of the WB Phantom Once the ROT s have been matched as nearly as possible complete the analysis and print the first and last pages of the report Archive the baseline measurement for safekeeping but do not delete it from the analysis workstation All future whole body phantom measurements will be compared to the initial baseline measurement After the initial measurement the sample scan restored from the sample diskette should be deleted Archive Whole Body Phantom scans to both the clinic and traveling opticals then delete the scans from the hard drive Table 1 Scans to restore for a given QDR model number WB PHANTOM SCAN RESTORE MOREE NUMBER FROM SAMPLE DISK 1000W 1500 2000 Pencil beam 1000 1500 2000 Pencil WB Phantom 2000 Fan Beam 2000 Fan WB Phantom 4500W 4500W WB Phantom 4500A 4500A WB Phantom V Interpretation of measured values The phantom measurements should be printed out placed in a logbook file and kept at the clinic center The QA Center will plot selected variables periodically from the scans sent on the traveling optical and no
13. antom scan the phantom four 4 times a day for the first week 20 scans This will allow the setting of a consistent mean for monitoring performance and comparison purposes Note that the whole body phantom scans can NOT be added to the QC database The QA Center will plot and check the data and notify the clinical centers of any problems 7 After the first 20 scans are performed scan the phantom three times a week IV Analysis A General Comments The goal of the analysis is to carefully delineate the various body regions in a standard and reproducible fashion so that measured results will reflect instrument performance not variations in analysis techniques Of particular importance are the placement of the head ROI cutline and the cutlines that delineate the ribs since these two regions affect global body composition and BMD It is essential that the baseline measurement is technically adequate and that the analysis is performed by direct comparison to the sample analysis on the Hologic diskette labeled SAMPLE ANALYSES WB PHANTOM or Whole Body Phantom Analysis Template Use the sample scan for your model of scanner see Table 1 B Specific Instructions Hologic QDR systems Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 19 Follow the instructions in Sections II and III of Appendix A to acquire a technically adequate scan of the Whole Body ph
14. by the whole body scan analysis e g left breast implant is in left ribs left hip replacement is in pelvis and left leg Sub regions Hardware Other Artifacts i Head i Left arm iii Right arm Left ribs v Rightribs vi Thoracic spine vii Lumbar spine viii Pelvis ix Left Leg x Rightleg Page 65a Month 3 Have you had any of the following in the past ten days Yes x a Barium enema b Upper GI X ray series Lower GI X ray series o d Nuclear medicine scan e Other tests using contrast dye or radioactive materials Examiner Note If Yes to any responses above reschedule bone density measurement so that at least 10 days will have passed since the tests were performed 4 Wasa bone density measurement obtained a Whole body Reason No Last 2 characters of scan ID LE Date of e BE EN ILELT Reason O Metal in hip O Severe degenerative disease O Other Please specify Last 2 characters of scan ID Date EN 11 Which hip was scanned Right O Left MOST Ghnic Visit Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 22 m p Repeat DXA Bone Density Form BE 18576 MOST ID Acrostic Form Completed
15. can s following our instructions and send the scans to the QA Center for further review For those with confirmed excessive bone loss TOTAL HIP BMD Follow up scan BL Visit Actual Change After scan review we cannot confirm excessive bone loss Comment Signature of QA Center Reviewer MOST Excessive Bone Loss Tracking Form 3 2BH 1 Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 28 Excessive bone loss alert letter April 30 2011 Jane Doe 1234 Market Street Birmingham AL 35201 Dear Ms Doe During your last clinic visit for the MOST study we repeated measurements of your hip bone density Analysis of the results indicated that you have lost bone in the hip at a rate greater than 2 per year since your baseline measurement was made This loss is greater than average for a person your age and may indicate an increased risk of fracture This bone loss may also be related to other health conditions or could result from use of certain medications We have enclosed both copies of your hip scan your baseline measurement and your last measurement We suggest that you consult with your personal doctor to find out why this is occurring and we would be happy to forward these results to your doctor If you do not have a source of medical care we can provide you with the name of a doctor who specializes in treating osteoporosis in Birmingh
16. ecce eere ee eren ene Appendix 2 Study ono reat eno eoo een reae un pae ea e et rua aun Pa Ee ee ee EUR Va PER REESE EUR Appendix 3 Apex Addendum ce eere leer ee eese es stesse seen sette stesse eaae s sean essa aee Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 2 1 Introduction The purpose of this manual is to describe the DXA body composition and bone mineral density BMD quality assurance programs for the clinical centers participating in the MOST study It provides information specific to the Hologic 4500A and 4500W scanner operating with Windows based software and is intended as a supplement to the appropriate Hologic Users Guide To use this manual effectively it is essential to have read and understood the appropriate Hologic User s Manual The study densitometry operators are required to have participated in a Hologic training session and should be familiar with all instrument features and procedures discussed in the Hologic User s Manual During the study any questions regarding procedures that arise should be directed to Caroline Navy MOST DXA Quality Assurance Center University of California San Francisco 185 Berry Street Lobby 5 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Fax 415 514 8150 cnavy psg ucsf edu IMPORTANT Unauthorized changes in scan
17. ed Additionally a random sample will be conducted to verify site performance These checks may result in requests for reanalysis by the QA Center 3 DXA Scan Acquisition and Analysis Procedures Standard scanning and analysis procedures for the hip and whole body bone density measurements are described in detail in the Hologic User s Guide Some of the information from the Hologic manual is repeated in this manual for emphasis Please note however that some of the scanning evaluation protocols for this study differ from those detailed by Hologic NOTE Please be careful to use the SAME scan mode that was used on the baseline scans For hip scans this was most likely FAST ARRAY for whole body scans the ARRAY default mode is the only mode available Be sure to completely fill out the appropriate MOST forms before and after scanning the participant see Appendix B This includes the Participant Scan Log and any forms provided by the Study Coordinator 3 1 Participant Biography Follow up The Patient Biography was created in the Hologic database for the MOST baseline scan Do not create a new biography for the follow up visit The participant s current weight and height must be updated at follow up Last Name JSMI First Name Middle Initial Sex M Ethnicity White DOB Month October Patient ID MB01010 Day 20 Identifier2 Year 1930 Referring Physician MOST Menopause Age Weight 130 Ib Height 64 in Patient Comm
18. ent 84 Figure 1 MOST Follow up Visit Patient Biography Screen Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 7 3 2 Whole Body Scans The Hologic user s guide should be consulted for the proper whole body scanning and analysis procedures Clarifications for the MOST Study are noted below 3 2 1 Whole Body Acquisition Before scanning the participant have a printout of the baseline scan available to ensure consistent scanning of the same area Careful positioning and visual comparison of the current scan with baseline are essential for producing precise measurements Use the DXA Bone Density Follow up Visit TELEForm follow up see Appendix B to determine and document artifacts File this TELEForm in the participant s clinic binder do not send to the QA center The following points should be followed 1 Have the participant remove all clothing including shoes and dress them in a hospital gown Check that no metal or plastic objects remain in the scanning area This includes hair clips and pins snaps zippers and buttons Have participant remove any jewelry earrings bracelets watches or rings 2 Position the participant in the center of the scanning table with their head just below the head of the table It is extremely important that the participant is correctly positioned on the exact center of the table The arms should be separated fr
19. ent monthly to the DXA QA Center COPY them to the traveling disk and archive to the clinic disk The traveling disk will be sent to the DXA QA Center once a month IMPORTANT o In the event that the Hi or LoAir values exceed 3 0 immediately fax the worksheet to Caroline Navy at UCSF 415 514 8150 and call Hologic o If the SD for any of the individual lines 10 through 19 exceeds 2 0 units immediately fax the worksheet to Caroline Navy at UCSF 415 514 8150 The DXA QA Center will review the data and decide if further action is needed 4 3 Machine Software and Service Problems If your machine needs to be repaired or if any adjustment has to be made that possibly might affect your data 1 Perform a System Backup before any work is done on your scanner 2 If possible contact the QA Center before the repairs or adjustments are made to find out whether additional measures are required 3 Perform 10 scans of the Hologic daily QC spine AND hip phantoms before if possible and after the repairs or adjustments are made Send the Hologic service report along with the Repair Service Upgrade Log to the QA Center with the monthly shipment 4 4 Hardware Software Change Control Unauthorized hardware software changes must be avoided If for any reason you think you have to change the hardware software or your Hologic service representative recommends a hardware software change contact the QA Center before any changes are made if pos
20. ic necessary aYes No Were phantom scans performed after the repair orthe recalibration o Yes a No Did you notice a change in the phantom values MOST DXA Forms Version 1 0 03 22 11 Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 26 Clinical Center Serial Number LINE SEGMENT SD HiBone ___10 11 12 HiBone 13 14 15 13 HiBoe X4 14 HiBone x Hi Air Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 27 Excessive Bone Loss Tracking Form MOST ID Date of Form Completed a LEVEL Examiner note Be sure to follow all procedures for participants with suspected excessive bone loss Suspected Excessive Bone Loss Please make sure that this form is accompanied by all the items listed below for the spine and or hip with suspected excessive bone loss O Printouts of the baseline and follow up hip exams O Printouts of the rate of change report O Copies of the baseline and follow up hip scans on disk CD Comments To be filled out by the QA Center Yes we can confirm excessive bone loss The scans are technically correct and the analyses are accurate O Yes we can confirm excessive bone loss However the scans were not analyzed properly Please reanalyze the s
21. ing Data to QC Database Note the Whole Body phantom and Whole Body Air scan data can not be added to the QC database Be sure to scan the hip phantom in Array mode not the default Fast Array mode Fast Array hip scans cannot be added to the QC database See the Hologic manual Quality Control Chapter section Setting Up a New QC Plot Graphs Follow the directions to set up the mean and limit lines for the hip QC plot After the set up is done scan the hip phantom two times a week Use the plot feature to verify that the spine and hip phantom BMD BMC and AREA values of your scanner are within normal limits It is best to plot at least one year of data If the most recent scan falls outside the limits reposition the phantom and repeat the scan If the scan also falls outside the limits and or the CV of the BMD exceeds 0 60 contact both Hologic and the QA Center After the spine and hip phantom scans have been analyzed and added to the QC database delete the scans from the hard drive Note the Whole Body phantom scans should be archived to the clinic optical and copied to the traveling optical disks before being deleted from the hard drive Generate a printout of the daily phantom plots BMD BMC and AREA for hip and spine once a week on your designated QC day This will facilitate detection of long term drifts as well as short term inconsistencies Store these plots in a QC log book QC plots BMD BMC and AREA for h
22. ip and spine are to be sent to the QA Center with each batch The date range for the plots should cover the entirety of the study The whole body phantom scans should be copied to the traveling disk Perform a System Backup at least once a week and store at the clinical site Disks may be rotated monthly 4 2 Whole Body Air Scans A Whole Body scan of air should be performed at least once a week This scan is performed automatically on scanners with later versions of software It is called the radiographic uniformity scan The air scan will assess the proper functionality of the scanner and indicate any potential problems with the x ray beam or tabletop To prepare for the air scan clear the entire tabletop of any objects and clean the pad of any debris Only the table pad should remain on the table This is critical since the test can detect items as thin as a single piece of Scotch tape Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 13 Once the air scan has been performed you will need to fill out the WB Air Scan Worksheet see Appendix B You will find the SD values for HiBone in the upper right hand corner Record these values for lines 10 through 19 10 values in all on the worksheet Also record the Global Hi and Lo Air values on the worksheet The global values are displayed right after the air scan is completed Air scans should be s
23. ly based on the original printouts and analyzed on the Hologic workstation if necessary 4 TRAVELING DISK Send electronic copies of all scans acquired and reanalyzed since the last data transfer 5 REANALYZED SCANS Send original printouts of all scans that have been reanalyzed according to the QA Center instructions since the last data transfer Attach the annotated printouts sent by the QA Center that indicated the problems requiring reanalysis Be sure to copy reanalyzed scans to the traveling disk 6 Copy of the Hologic Repair Service Upgrade Log with a copy of the Hologic service report if service has been done Pack the materials carefully The disk should be placed in a protective envelope Batches containing DXA data should be sent via FedEx UPS or a trackable courier Assign a number to each batch of DXA data shipped to the QA Center The first 84 month batch should be assigned the next sequential number e g if the last batch number was 057 the first 84 month batch number will be 058 The DXA data should be shipped monthly to the following address UCSF SFCC MOST DXA Quality Assurance Center ATTN Caroline Navy 185 Berry Street Lobby 4 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 5 4 Return materials sent by the MOST DXA Quality Assurance Center The QA Center will return the following items to the clinical center after review 1 Annotated printouts of flagged scans random sample scans
24. mpty space between the side of the phantom and the sides of the table will vary depending upon scanner model III Data acquisition Scanning the whole body phantom 1 Make sure that the phantom is centered is parallel to the long axis of the table and is correctly oriented with respect to the head of the table 2 Enter Whole Body Phantom in the Name field of the Patient Biography where XXXX is the phantom serial number including any letters found on the phantom label Enter XXXX in the Pat ID field of the Patient Biography where XX XX 15 the phantom serial number including any letters found on the phantom label 3 Remove all artifacts from the table surface Extraneous objects in the scan field will interfere with the measured results in an unpredictable fashion 4 Select the standard Adult Whole Body scan mode commonly employed at your facility Accept the default scan length and scan width Perform a complete scan of the entire table surface including the phantom Do not interrupt the scanner during the measurement 5 Carefully inspect the scan image to ensure that the phantom was 1 centered 1 parallel to the long axis of the scanner table and 11 the phantom s head appears at the top of the image If the scan image appears satisfactory proceed to the analysis section If not carefully reposition the phantom according to the instructions in Section II and repeat the scan 6 After receipt of the whole body ph
25. n 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 8 7 Instruct the participant not to move until the end of the measurement 8 Print out a hard copy of each scan and file in the participant s folder 3 2 2 Whole Body Analysis at Follow up Display the baseline evaluation using the COMPARE feature and compare it to the current image on the screen Match the location of the region markers as closely as possible to the baseline measurement Optimally matched in this context means that the markers should be at the same position between the body regions as on the baseline image 3 3 Hip Scans The Hologic user s guide should be consulted for the proper hip scanning and analysis procedures Clarifications for the MOST Study are noted below 3 3 1 Hip Acquisition at Follow up Before scanning the participant have a printout of the baseline scan available to ensure consistent scanning of the same area Careful positioning and visual comparison of the current scan with baseline are essential for producing precise measurements 1 Refer to the baseline hip scan printout Use the DXA Bone Density Follow up Visit TELEForm see Appendix B to determine and document which side to scan File this TELEForm in the participant s clinic binder do not send to the QA center If the opposite hip from baseline must be scanned perform the acquisition and analysis according to the baseline MOST DXA operations manual instructio
26. nd back up procedures for participant scans are performed and that archives are stored securely on appropriate archiving media until the end of the study 5 Once per month on or about the Ist of the month send the following materials to the QA Center Printouts of plots of the daily QC data BMD BMC Area Hologic service reports if appropriate Original printouts of flagged scans Original printouts of other requested scans Traveling disk with all newly acquired scan files obtained since the last data transfer PRFP Reanalyze centrally reviewed scans as requested by the QA Center Assure proper functioning of hardware software and request service from Hologic a Notify Hologic and the QA Center of any machine or software problems or if the QDR machine is being relocated b Record machine software problems and service on the Hologic DXA Repair Service Upgrade Log c Perform 10 QC spine phantom scans before if possible and after service d Perform 10 QC spine phantom scans before and after machine relocation Contact the QA Center with any questions or problems that cannot be dealt with in the batch mailings Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 MOST Whole Body and Hip DXA Bone Density Operations Manual page 4 2 1 2 MOST DXA Quality Assurance Center responsibilities The following are the responsibilities of the QA Center 1 2 Write and maintain the quality assurance operations ma
27. ner software or personnel can have a large impact on the integrity of study data If for any reason changes in any of these areas are anticipated please contact the MOST DXA Quality Assurance Center in San Francisco in advance for further instructions 2 Study Logistics Table 1 summarizes the body composition and bone density scan acquisition schedule A whole body and hip scan will be obtained at the baseline and 84 month follow up visit Follow up visit scans will be compared to the MOST baseline visit scans for positioning analysis and excessive bone loss at the hip Table 1 Scan Acquisition DXA Scans Baseline 84 Month Whole Body and Hip X X Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 MOST Whole Body and Hip DXA Bone Density Operations Manual page 3 2 1 Division of Quality Assurance Responsibilities 2 1 1 Clinical Center Responsibilities The clinical centers must ensure the overall quality and completeness of the DXA data and that all protocols and procedures are strictly followed Specific responsibilities include the following 1 4 Require that operators are properly trained and certified If there are state requirements for DXA operators these must be met Identify a chief densitometry operator to train and supervise other operators Perform and review daily QC scans and schedule cross calibration scans of traveling phantoms Assure that proper archiving a
28. ns 2 Position the hip in exactly the same position as In particular the hip rotation must be the same The best way to check hip rotation is to be sure that the lesser trochanter has the same size shape and location on the follow up scan as at baseline 3 If it is impossible to reproduce the positioning from baseline e g pain worsening arthritis produce the best possible scan Flag the follow up scan write the problem on the scan printout and send copies of both the baseline and follow up scan to the QA center 4 Use the same scan mode e g fast array or array that was used on the baseline scan 5 No metal or plastic object should remain in the scanning area Check for jewelry coins or other objects in the hip pockets zippers buttons rivets belts or any other clothing fasteners as well as hip and back braces 6 Keep the participant s hands out of the scanning area by placing them well away from the hips Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 MOST Whole Body and Hip DXA Bone Density Operations Manual page 9 10 11 Ensure rotation of the hip by holding the knee and the ankle when positioning the leg Optimum positioning of the leg is most important to achieve a consistent projection of the femur After proper rotation attach the leg to be scanned to the angled foot block supplied by the manufacturer The participant should be made as comfortable as possible to reduce the chance
29. nual Promptly review the QC phantom scan data received from each clinical center in order to identify surges or drifts in machine performance Incorporate new participant data into the study wide database Review certification and flagged scans and return results to each clinical center Review random samples of scans from each clinical center Arrange for cross calibration of all DXA instruments using traveling phantoms Prepare quality control summary reports for MOST Steering Committee review Identify possible sources of error and suggest possible solutions However the QA Center will not be responsible for the solution of a hardware or software problem that will rest with the clinical center and Hologic Any questions or correspondence regarding this manual or the technical aspects of the DXA measurements should be directed to Caroline Navy MOST DXA Quality Assurance Center SF Coordinating Center 185 Berry Street Lobby 5 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Fax 415 514 8150 cnavy psg ucsf edu 2 2 Training and Certification of MOST DXA Operators To obtain consistent results the densitometry operators must be aware of possible sources of error that may affect data collection and analysis Only those operators who have been certified through Hologic training and the QA Center review are allowed to perform the scanning and analysis for this study Anyone performing scans for the MO
30. om the sides of the body with the hands placed palm down within a few centimeters of the table edge If the hands do not fit in the scan field tuck the hands under the thighs 3 Place a loop of tape around the top of the feet so that the feet are slightly inverted this will help to prevent motion during the scan and create a separation between the tibia and fibula If the feet do not fit in the scan field keep the legs straight and cut the feet from the scan field 4 Verify that the participant is aligned with the scanner axis solid line on the table If during scanning it is apparent that part of the participant s body lies outside the scan field restart the scan 5 The participant should be positioned as comfortably as possible since this reduces the chances of unwanted movements In general try to avoid the use of any pillows or blankets If the participant feels uncomfortable in that position you may use pillows for the head only after the upper half of the scan is done You may then carefully place a pillow under the head of the participant without causing motion artifacts This procedure should be practiced with the participant before scanning If the participant cannot lie flat at all without the aid of a pillow due to kyphosis use a radio lucent pillow 6 If the participant is very tall try to include their feet in the scan by placing their head near the very top of the table Whole Body and Hip DXA Bone Density Versio
31. oth 84 month scans at the affected site The QA Center will review the scans and confirm EBL The completed EBL form will be returned to the clinic The study site investigator should be notified about confirmed cases of EBL to provide the participant and their physician with the appropriate MOST Sample Excessive Bone Loss letter see Appendix B These letters can be altered by the Principal Investigator as desired Do not discuss the presence or implication of EBL with a participant until the DXA QA center has confirmed the bone loss The investigator should be notified and inform the onsite staff how to proceed Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 11 4 Scanner Quality Control Monitoring of machine performance throughout the study is the joint responsibility of the clinical centers and the QA Center Table 2 lists the quality control procedures and schedule Table 2 Quality Control Scanning Schedule Local Hologic Spine Phantom 3 times week and always on a day that participants are scanned 4 1 Phantom scans Perform the spine and hip QC phantom scans as outlined in the Hologic manual Quality Control Chapter The results of these scans should be reviewed locally for abrupt changes in machine performance and sent to the QA Center once a month Whole body quality control consists of Hologic whole body phantom scans whole body air scan
32. reasonably matched to baseline analysis Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 10 Hips e Femoral midline is not aligned and cannot be corrected by following proper analysis techniques e Neck box width reduced from default e Ischium bone deleted bone added to femoral head neck e Analysis program repeatedly fails to place regions appropriately major operator interaction required for analysis Whole Body e Internal or external artifacts that cannot be removed prostheses implants medical bracelets etc e Participant motion without rescanning e Unable to fit both arms in scan field e Significant changes in positioning between baseline and follow up scan 3 5 Excessive Bone Loss Procedures Excessive Bone Loss EBL is defined as a loss of greater than or to 15 from baseline to 84 month visit Use the Hologic rate of change to determine the actual percent loss between the baseline and follow up visit If EBL is found rescan by having the participant get off and on the table repeat the positioning and scanning analysis and check again for EBL This will necessitate analyzing the follow up scans while the participant is still on the scan table Whether or not the scan confirms EBL fill out the Excessive Bone Loss Form see Appendix B and forward to the MOST DXA QA Center along with electronic copies of the baseline and b
33. s and tissue bar scans Hologic whole body phantom comes with instructions from Hologic and there are supplemental instructions in Appendix A The instructions for the whole body air scans are in Section 4 2 of this manual The tissue bar comes with instructions from Hologic Points of procedure to note 1 Create only one patient biography per phantom There should be a biography for the Spine Hip and Whole Body phantoms Avoid duplication of phantom biographies by using the patient menu to select the appropriate biography prior to scanning the phantom 2 Use the following instructions to create the phantom biographies The phantom serial number is on the phantom label It may have letters in front of the numbers If this is a new biography put in both letters and numbers The NAME field contains the type of phantom and the phantom serial number indicated by XX XX Spine Phantom XXXX Hip Phantom XXXX Whole Body Phantom XXXX 3 The PAT ID field contains the phantom serial number indicated by XXXX XXXX 4 Scan each phantom on top of the pad Ensure alignment with the scanner axis by using Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 MOST Whole Body and Hip DXA Bone Density Operations Manual page 12 10 11 the laser cross hairs Add the spine and hip phantom scan data to the QC database immediately after completing scanning and analysis See the Hologic manual Quality Control Chapter section Add
34. sible Future hardware software upgrades will be checked by the QA Center in conjunction with Hologic technical support personnel to assure that the upgrade will not adversely affect the study Authorized upgrades must be cleared by the QA Center before installation at the clinical centers Record hardware software upgrades on the Hologic DXA Repair Service Upgrade Log Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 14 5 Data Management 5 1 Hard Copies of Scans 1 The clinical center is responsible for maintaining original hard copies of all scans performed during the study Keep the original printouts in the participant s scan printout folder The following printed reports are needed for each scan Hip Print the standard report Whole body Print the BMD and body composition reports 2 pages 5 2 Electronic Scan Archive Each clinical center works on a four disk system two clinic disks and two traveling disks Both clinic disks and one traveling disk are updated at the end of each day The other traveling disk may be in transit between the QA Center and clinical center Please be sure to re archive any scans that are reanalyzed One clinic disk should be a dedicated MOST disk used only for archiving scans acquired for MOST Scans to be archived each day to the clinic and traveling disks include 1 All new participant scans acquired since the last archive
35. tify the clinic center of any problems Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 20 Appendix 2 Study Forms Copies of DXA forms are included in this manual Always keep a copy of any form you send to the QA Center MOST DXA Bone Density data collection form as provided by the MOST Coordinating Center Do NOT photocopy DXA Participant Scan Log DXA Batch Record Form Hologic DXA Repair Service Upgrade Log Whole Body Air QC Scan Worksheet Excessive Bone Loss Form Excessive bone loss alert letter Whole Body and Hip DXA Bone Density Version 1 0 6 1 13 Whole Body and Hip DXA Bone Density MOST Operations Manual page 21 MOST DXA Form DXA Bone Density First Repeat DXA Acrostic MOST ID 3t Date Form Completed Staff IDF P 1 Have you ever had a hip surgery for joint replacement or fracture repair O Yes O No Scan right hip On which side did you have hip surgery O Right O Left o Both O Refused Scan left hip Scan right hip Do NOT scan either hip 2 Do you have any metal objects or implants in your body such as a pacemaker staples screws plates breast implants etc doe ONo ODon t Know O Refused a Flag scan for review by DXA Reading Center b Indicate the location of the artifacts Sub regions are those defined
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