PCD User Handbook
User Handbooks for the Patient Care Devices (PCD) domain are an important tool to help implementors understand specific topics in the PCD domain. The first effort is targeted for administrators to show how to specify IHE PCD Profiles in an RFP or RFI. The book will discuss the various profiles and the benefits of specifying and implementing them.
- Note: Documents are available on the PCD Handbook ftp folder.
- 2011 Edition rev 2.0 (June 2011)
- 2011 Edition rev 1.0 (Mar 2011)
- IHE Handbooks page (Jan 2010 public comment version)
- 2010 Edition rev 1.2 (Dec 2009)
- 2010 Edition rev 1.1 (Dec 2009)
- 2010 Edition rev 1.0 (Nov 2009)
- 2009 Edition rev 0.5 (Oct 2009)
- 2009 Edition rev 0.4 (June 2009)
- 2009 Edition rev 0.1 (March 2009)
Editorial Plan & Schedule
- Changes from 2010 to 2011
- 2010 Public comments
- Addition of Appendix H Mapping Clinical Requirements to Purchasing Requirements
- Consolidation of the 2 major sections into 1 section
- Changes from rev 1.0 to rev 1.2
- See committee comments table above for list of changes from 1.0 to 1.2
- Changes from rev 0.5 to rev 1.0
- Change to 2010 edition
- Ensure proper usage of validate versus verify - delete incorrect references to validate
- Clafify use of NIST test tools at PCD Connectathon
- Add URL to NIST test tools
- Clarify that end point devices of ACM AC actor are mobile phones, pagers, etc
- Add note in RTM section to comment how RTM makes testing/implementations more efficient
- Changes from rev 0.4 to rev 0.5
- Added section B.3 "Rosetta Terminology Mapping"
- Moved section 1.1.2 to 1.1.1 and 2.1.2 to 2.1.1 - this allows profiles to be described before mapping the benefits of implemting the profiles
- Added section B.4 "PCD Content Profiles"
- Modified Appendix D
- Moved Appendix E to D.3
- Modified Appendix D.3 "Reading Integration Statements"
- Added section D.4 "Verifying Integration Statements"
- Added note in section D.1 regarding Connectathon results and profile options
- Modified sections X.2.1 Considering changes to your workflow to include CSA, FSA, gap
- Modified sections 126.96.36.199 to include validating data sent/recieved
- Section 188.8.131.52 include particular attention to units of measure and nomenclature
- Thursday, November 12, 2009 at 1PM EDT [webex]
- Thursday, December 17, 2009 at 12PM EST [webex]
(add newest items to the top of the list)
No. Action Item Owner Participants Due Open/Closed Description/Update 10 Add section around certification and clarify stance on commercially available ... ... 2013.03 Open Add section around certification and clarify stance on commercially available. 9 Page 31 - Reword ... ... 2012.11 Open Consider rewording the statements about IHE nomenclature and terminologies to include PCD requiring RTM conformance. 8 MDFire reference ... ... 2012.11 Open The next revision of the Handbook should include references to the MDFire document and relevant discussion 7 Appendix H Comments ... ... 2011.04 Comments accepted and incorporated into 2011 v2.0 KF - For Use Case 1, pumps should also comply with PCD-01 for results reporting, but this is not covered in the table.
KF - For both Use Case 1 and 2, there is no requirement for a Server between a device and the EMR, EHR, CIS, etc. A device can have a native IHE-PCD output.
KF - For Use Case 2 or the general appendix - what do I do if I am specifying an anesthesia system, ventilator, bed, or some other device that is not covered by the Use Cases. I still need RFP assistance for that. You may want to make Use Case 2 more general covering a more general device than a VSM, which is a special case of patient monitor. Also make sure to not require a server, the device could talk directly
6 Glossary Definitions for BPOC and BCMA ... ... 2011.04.20 Comments accepted and incorporated into 2011 v2.0 There was a definition added for BPOC (barcode point of care) but not for BCMA (barcode computer-assisted medication administration or bar code medication administration, depending on who you ask). We use the term BCMA (and not BPOC) in the PIV profile.
I'd suggest that definitions for both BPOC and BCMA be included, and it should be noted that these terms are often used interchangeably. Note: Technically, BCMA is a subset of BPOC. For example, BPOC might include the administration of transfusions or specimen collection as well as medication administration, while BCMA is restricted to medication administration. I
5 Device Life Expectancy ... ... 2009.12.1 Comments accepted and incorporated into 2011 v2.0 Comment about life range of medical devices. even if you are not considering device connectivity right now, the devices you are buying now will likely still be around when you do consider device connectivity. ensuring the product is extensible is needed. 4 Section ordering ... ... 2009.06.16 Closed Accepted. Should section X.1.2 come before section X.1.1 since the profiles are described in X.1.2? 3 PIV implementation safety ... ... 2009.03.01 Closed Accepted. Address the comments from the PIV working group related to incompatibilities between BCMA systems and discuss assumptions that must be assessed when implementing BCMA systems with PIV 2 Glossary ... ... 2009.03.18 Comments accepted and incorporated into 2011 v2.0 It is important to have a glossary for implementors to navigate the terminology used in the IHE PCD domain as well as the interoperability of regulated medical devices. Assess glossary work that is already underway in the PCD such as in the Technical Framework and DPI white paper to determine if this effort should be harmonized. 1 Discussion notes from Spring 2009 F2F Steve Merritt Everyone at F2F 2009.05.05 Closed
- There was a general direction given to the TC that options within profiles should be avoided when possible
- Action: Go into more depth in handbook about options and how to handle them from a user perspective
- An addtional Appendix was suggested which would be an checklist for purchasers of things they are looking for
- Specify that this first revision is more for specifying purchasing requirements not for implementation
- Make sure to stress the importance of testing (this is a first step in the purchasing process, but not the end-answer)
3 Lessons from connecting legacy equipment ... ... 2014.07.16 Open Draft a section on common lessons learned from connecting legacy equipment 3 RTM appendix ... ... 2014.07.16 Open Draft a new appendix for RTM - what/why/how is it incorporated with IHE PCD profiles? 3 Support roles and definitions ... ... 2014.07.16 Open Appendix on support. Importance of defining roles, examples of support models and scenarious typically encountered to consider 3 Diagram on Page 1 ... ... 2014.07.15 Open Remove consolidator, add arrow from devices to gateway, add dotted arrow bypassing gateway. define gateway and other actors in the text. 3 Define POC Med block on page 26 ... ... 2014.07.15 Open Define the systems in text, clarify bedside poc med system 3 Use case page 29 ... ... 2014.07.15 Open Add alarming into Use case or remove ACM from the diagrams and tables 3 Define middleware/gateway ... ... 2014.07.15 Open Clarify somewhere that majority of implementations leverage middleware to integrate device data, why, trend of devices with direct outputs 3 Integration strategy roadmap/phasing ... ... 2014.07.15 Open Determining phasing of integrating device data, which devices, which locations, mention best practices and things to consider (costs, efficiency, clinical care priority, etc) 3 Define interdisciplinary team during implementation and strategy development ... ... 2014.07.15 Open Appendix C this would be useful to suggest roles, 3 Verifying capabilities ... ... 2014.07.15 Open The process to vet IHE-PCD capabilities, connectathon results, integration statements, certification, commercially available list
Working Group Decisions
NOTE: These decisions are in addition to the action items listed above.
No. Decision Date Description 1 ... <wiki page for discussion session + date 2009.xx.yy> ...