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submitted event description (DE156) (Q6) Q6 = a DE156 = A774 Q6 = b DE156 = A777 Q6 = c or d DE156 = A780 or UNK Type of defect or failure (DE159) (Q7) page 2 Reuse of single-use (D165) (Q9) Reuse of single-use (D165) (Q9) one Type of (DE141) (Q1) Q1 = b or c DE141 = A744 or A747 one Type of (DE141) (Q1) Q1 = a DE141 = A741 Q1= b or c DE141 = A744 or A747 Q1 = a DE141 = A741 Implantable placement (DE144) (Q2) Q2= b or c DE144 = A18 or UNK Implantable placement (DE144) (Q2) Q2 = b or c DE144 = A18 or UNK Q2 = a DE144 = A15 Implantable removal (DE147) (Q3) Q2 = a DE144 = A15 Implantable removal (DE147) (Q3) AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B 1

submitted Page 2 Type of operator error (D162) (Q8) Reuse of single-use (D165) (Q9) one Type of (DE141) (Q1) Q1 = b or c DE141 = A744 or A747 Q1 = a DE141 = A741 Implantable placement (DE144) (Q2) Q2 = b or c DE144 = A18 or UNK Q2 = a DE144 = A15 Implantable removal (DE147) (Q3) AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B 2

submitted Page 3 name (DE150) (Q4) manufacturer name (DE153) (Q5) Identifier(s) (DE168) (Q10) Q10 = a DE168 = A825 Q10 = b DE168 = A828 Q10 = c DE168 = A831 Q10 = d DE168 = A834 Q10 = e DE168 = A837 Q10 = f DE168 = A840 Q10 = g DE168 = A843 Model number (DE171) (Q11) Serial number (DE174) (Q12) Lot or batch number (DE177) (Q13) Type of other unique product identifier (DE180) (Q14) Expiration date of (DE186) (Q16) Unique identifier (DE189) (Q17) Other unique product identifier (DE183) (Q15) AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B 3

submitted Page 4 Number of s involved in event > 1 (DE142) No SIR Yes one AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B 4

or Medical/Surgical Supply Alternative Text Flow Chart Narrative 1. Start or Medical/Surgical Supply Flow. 2. Check event description (Data Element Identifier 156, also represented as Question 6). a. If Data Element Identifier 156 equals Answer Code A774, also represented as Question 6 equals a, proceed to Type of defect or failure. b. If Data Element Identifier 156 equals Answer Code A777, also represented as Question 6 equals b, proceed to Type of operator error. c. If Data Element Identifier 156 equals Answer Code A780 or UNK, also represented as Question 6 equals c or d, proceed to Reuse of single-use. 3. Check Type of defect or failure (Data Element Identifier 159, also represented as Question 7). a. All Answer Codes proceed to Reuse of single-use. 4. Check Type of operator error (Data Element Identifier 162, also represented as Question 8). a. All Answer Codes proceed to Reuse of single-use. 5. Check Reuse of single-use (Data Element Identifier 165, also represented as Question 9). a. All Answer Codes proceed to Type of. 6. Check Type of (Data Element Identifier 141, also represented as Question 1). a. If Data Element Identifier 141 equals Answer Code A741, also represented as Question 1 equals a, proceed to Implantable placement. b. If Data Element Identifier 141 equals Answer Code A744 or A747, also represented as Question 1 equals b or c, proceed to name. 7. Check Implantable placement (Data Element Identifier 144, also represented as Question 2). a. If Data Element Identifier 144 equals Answer Code A15, also represented as Question 2 equals a, proceed to Implantable removal. b. If Data Element Identifier 144 equals Answer Code A18 or UNK, also represented as Question 2 equals b or c, proceed to name. 8. Check Implantable removal (Data Element Identifier 147, also represented as Question 3). a. All Answer Codes proceed to name. 9. Complete name (Data Element Identifier 150, also represented as Question 4). a. All values proceed to manufacturer name. 10. Complete manufacturer name (Data Element Identifier 153, also represented as Question 5). a. All values proceed to identifier(s). AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B Page 1 of 3

11. Check identifier(s) (Data Element Identifier 168, also represented as Question 10). Note: Data Element Identifier 168 is check all that apply ; therefore proceed as directed for all applicable answer codes. a. If Data Element Identifier 168 equals Answer Code A825, also represented as Question 10 equals a, proceed to Model number. b. If Data Element Identifier 168 equals Answer Code A828, also represented as Question 10 equals b, proceed to Serial number. c. If Data Element Identifier 168 equals Answer Code A831, also represented as Question 10 equals c, proceed to Lot or batch number. d. If Data Element Identifier 168 equals Answer Code A834, also represented as Question 10 equals d, proceed to Type of other unique product identifier. e. If Data Element Identifier 168 equals Answer Code A837, also represented as Question 10 equals e, proceed to Expiration date of. f. If Data Element Identifier 168 equals Answer Code A840, also represented as Question 10 equals f, proceed to Unique identifier. g. If Data Element Identifier 168 equals Answer Code A843, also represented as Question 10 equals g, proceed to Number of s involved in event greater than one. 12. Complete Model number (Data Element Identifier 171, also represented as Question 11). 13. Complete Serial number (Data Element Identifier 174, also represented as Question 12). Note: This data element shall not be included in Clinical Document Architecture Extensible Markup Language (CDA XML) files submitted to the Privacy Protection Center (PPC) and Network of Patient Safety Databases (NPSD). 14. Complete Lot or batch number (Data Element Identifier 177, also represented as Question 13). 15. Complete Type of other unique product identifier (Data Element Identifier 180, also represented as Question 14). a. All values proceed to Other unique product identifier. 16. Complete Expiration date of (Data Element Identifier 186, also represented as Question 16). 17. Complete Unique identifier (Data Element Identifier 189, also represented as Question 17). Note: This data element shall not be to the PPC and NPSD. 18. Complete Other unique product identifier (Data Element Identifier 183, also represented as Question 15). Note: This data element shall not be to the PPC and NPSD. AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B Page 2 of 3

19. Check Number of s involved in event greater than one (Data Element Identifier 142). Note: This data element is for logic purposes CDA XML files submitted to the PPC and NPSD. a. If yes, proceed back to Type of (Data Element Identifier 141, also represented as Question 1). Note: Repeat and follow instructions for Data Element Identifier 141, also represented as Question 1, Data Element Identifier 144, also represented as Question 2, Data Element Identifier 147, also represented as Question 3, Data Element Identifier 150, also represented as Question 4, Data Element Identifier 153, also represented as Question 5, Data Element Identifier 168, also represented as Question 10, Data Element Identifier 171, also represented as Question 11, Data Element Identifier 174, also represented as Question 12, Data Element Identifier 177, also represented as Question 13, Data Element Identifier 180, also represented as Question 14, Data Element Identifier 183, also represented as Question 15, Data Element Identifier 186, also represented as Question 16 and Data Element Identifier 189, also represented as Question 17 for each involved. b. If no, proceed to the Summary of Initial Report flow chart. AHRQ Common Formats Technical Specifications Version 1.1 - March 2010 - Appendix B Page 3 of 3