ONC HIT Certification Program

Transcription

1 ONC HIT Certification Program Test Results Summary for 2014 Edition EHR Certification Part 1: Product and Developer Information 1.1 Certified Product Information Product Name: McKesson Patient Folder with McKesson Patient Folder Release of Information module Product Version: 16.1 Domain: Inpatient Test Type: Modular EHR 1.2 Developer/Vendor Information Developer/Vendor Name: McKesson Address: 5995 Windward Parkway Alpharetta GA Website: Phone: (404) Developer/Vendor Contact: Tim Shippy Page 1 of 12

2 Part 2: ONC-Authorized Certification Body Information 2.1 ONC-Authorized Certification Body Information ONC-ACB Name: Drummond Group Address: North Hwy 183, Ste B , Austin, TX Website: Phone: ONC-ACB Contact: Bill Smith This test results summary is approved for public release by the following ONC-Authorized Certification Body Representative: Bill Smith ONC-ACB Authorized Representative Certification Committee Chair Function/Title Signature and Date 2/18/ Gap Certification The following identifies criterion or criteria certified via gap certification (a)(1) (a)(17) (d)(5) (d)(9) (a)(6) (b)(5)* (d)(6) (f)(1) (a)(7) (d)(1) (d)(8) *Gap certification allowed for Inpatient setting only x No gap certification Page 2 of 12

3 2.3 Inherited Certification The following identifies criterion or criteria certified via inherited certification (a)(1) (a)(14) (c)(3) (f)(1) (a)(2) (a)(15) x (d)(1) (f)(2) (a)(3) (a)(16) Inpt. only x (d)(2) (f)(3) (a)(4) (a)(17) Inpt. only x (d)(3) (f)(4) Inpt. only (a)(5) (b)(1) x (d)(4) (f)(5) Optional & (a)(6) (b)(2) x (d)(5) Amb. only (a)(7) (b)(3) x (d)(6) (f)(6) Optional & (a)(8) (b)(4) x (d)(7) Amb. only x (a)(9) (b)(5) x (d)(8) x (g)(1) (a)(10) (b)(6) Inpt. only x (d)(9) Optional (g)(2) (a)(11) (b)(7) (e)(1) (g)(3) (a)(12) (c)(1) (e)(2) Amb. only x (g)(4) (a)(13) (c)(2) (e)(3) Amb. only No inherited certification Page 3 of 12

4 Part 3: NVLAP-Accredited Testing Laboratory Information Report Number: TEB _IN_ Test Date(s): N/A 3.1 NVLAP-Accredited Testing Laboratory Information ATL Name: Drummond Group EHR Test Lab Accreditation Number: NVLAP Lab Code Address: North Hwy 183, Ste B , Austin, TX Website: Phone: ATL Contact: Beth Morrow For more information on scope of accreditation, please reference NVLAP Lab Code Part 3 of this test results summary is approved for public release by the following Accredited Testing Laboratory Representative: Timothy Bennett Test Proctor ATL Authorized Representative Function/Title Signature and Date 2/18/14 Nashville, TN Location Where Test Conducted 3.2 Test Information Additional Software Relied Upon for Certification Additional Software Applicable Criteria Functionality provided by Additional Software SQL Server Client all underlying database Page 4 of 12

5 Additional Software Applicable Criteria Functionality provided by Additional Software No additional software required Test Tools Test Tool Version Cypress eprescribing Validation Tool HL7 CDA Cancer Registry Reporting Validation Tool HL7 v2 Electronic Laboratory Reporting (ELR) Validation Tool 1.6 HL7 v2 Immunization Information System (IIS) Reporting Validation Tool HL7 v2 Laboratory Results Interface (LRI) Validation Tool 1.7 HL7 v2 Syndromic Surveillance Reporting Validation Tool 1.6 Transport Testing Tool 174 Direct Certificate Discovery Tool x No test tools required Test Data Alteration (customization) to the test data was necessary and is described in Appendix [insert appendix letter] No alteration (customization) to the test data was necessary Standards Multiple Standards Permitted The following identifies the standard(s) that has been successfully tested where more than one standard is permitted Criterion # (a)(8)(ii)(a)(2) (b)(1) HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain Standard Successfully Tested (b)(2) HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide Page 5 of 12

6 Criterion # (a)(13) (a)(15)(i) (a)(16)(ii) (b)(2)(i)(a) (b)(7)(i) (e)(1)(i) (a)(3) IHTSDO SNOMED CT International Release July 2012 and US Extension to SNOMED CT March 2012 Release (b)(1) HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain (g) Network Time Protocol Version 3 (RFC 1305) (i) The code set specified at 45 CFR (c)(2) (ICD-10- CM) for the indicated conditions (i) The code set specified at 45 CFR (c)(2) (ICD-10- CM) for the indicated conditions Standard Successfully Tested Annex A of the FIPS Publication [list encryption and hashing algorithms] (j) HL7 Version 3 Standard: Clinical Genomics; Pedigree (b)(2) HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide (g) Network Time Protocol Version 4 (RFC 5905) (a)(3) IHTSDO SNOMED CT International Release July 2012 and US Extension to SNOMED CT March 2012 Release (a)(3) IHTSDO SNOMED CT International Release July 2012 and US Extension to SNOMED CT March 2012 Release (e)(1)(ii)(a)(2) (e)(3)(ii) (g) Network Time Protocol Version 3 (RFC 1305) Annex A of the FIPS Publication [list encryption and hashing algorithms] (g) Network Time Protocol Version 4 (RFC 5905) Common MU Data Set (15) (a)(3) IHTSDO SNOMED CT International Release July 2012 and US Extension to SNOMED CT March 2012 Release (b)(2) The code set specified at 45 CFR (a)(5) (HCPCS and CPT-4) Page 6 of 12

7 Criterion # Standard Successfully Tested x None of the criteria and corresponding standards listed above are applicable Newer Versions of Standards The following identifies the newer version of a minimum standard(s) that has been successfully tested Newer Version Applicable Criteria No newer version of a minimum standard was tested Optional Functionality Criterion # (a)(4)(iii) (b)(1)(i)(b) (b)(1)(i)(c) (b)(2)(ii)(b) (b)(2)(ii)(c) (f)(3) Common MU Data Set (15) Common MU Data Set (15) Optional Functionality Successfully Tested Plot and display growth charts Receive summary care record using the standards specified at (a) and (b) (Direct and XDM Validation) Receive summary care record using the standards specified at (b) and (c) (SOAP Protocols) Transmit health information to a Third Party using the standards specified at (a) and (b) (Direct and XDM Validation) Transmit health information to a Third Party using the standards specified at (b) and (c) (SOAP Protocols) Ambulatory setting only Create syndrome-based public health surveillance information for transmission using the standard specified at (d)(3) (urgent care visit scenario) Express Procedures according to the standard specified at (b)(3) (45 CFR (a)(4): Code on Dental Procedures and Nomenclature) Express Procedures according to the standard specified at (b)(4) (45 CFR (c)(3): ICD-10-PCS) x No optional functionality tested Page 7 of 12

8 Edition Certification Criteria* Successfully Tested Criteria # Version Version Criteria # TP** TD*** TP TD (a)(1) (c)(3) (a)(2) 1.2 (d)(1) 1.2 (a)(3) (d)(2) 1.4 (a)(4) (d)(3) 1.3 (a)(5) (d)(4) 1.2 (a)(6) (d)(5) 1.2 (a)(7) (d)(6) 1.2 (a)(8) 1.2 (d)(7) 1.2 (a)(9) (d)(8) 1.2 (a)(10) (d)(9) Optional 1.2 (a)(11) 1.3 (e)(1) (a)(12) 1.3 (e)(2) Amb. only (a)(13) 1.2 (e)(3) Amb. only 1.3 (a)(14) 1.2 (f)(1) (a)(15) 1.5 (f)(2) (a)(16) Inpt. only (f)(3) (a)(17) Inpt. only 1.2 (f)(4) Inpt. only (b)(1) (f)(5) Optional & (b)(2) Amb. only (b)(3) (f)(6) Optional & (b)(4) Amb. only (b)(5) (g)(1) (b)(6) Inpt. only (g)(2) (b)(7) (g)(3) 1.3 (c)(1) (g)(4) 1.2 (c)(2) x No criteria tested *For a list of the 2014 Edition Certification Criteria, please reference (navigation: 2014 Edition Test Method) **Indicates the version number for the Test Procedure (TP) ***Indicates the version number for the Test Data (TD) Page 8 of 12

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10 Clinical Quality Measures* Type of Clinical Quality Measures Successfully Tested: x Ambulatory Inpatient No CQMs tested *For a list of the 2014 Clinical Quality Measures, please reference (navigation: 2014 Clinical Quality Measures) Ambulatory CQMs CMS ID Version CMS ID Version CMS ID Version CMS ID Version Inpatient CQMs CMS ID Version CMS ID Version CMS ID Version CMS ID Version Page 10 of 12

11 3.2.8 Automated Numerator Recording and Measure Calculation Automated Numerator Recording Automated Numerator Recording Successfully Tested (a)(1) x (a)(9) (a)(16) (b)(6) (a)(3) (a)(11) (a)(17) (e)(1) (a)(4) (a)(12) (b)(2) (e)(2) (a)(5) (a)(13) (b)(3) (e)(3) (a)(6) (a)(14) (b)(4) (a)(7) (a)(15) (b)(5) Automated Numerator Recording was not tested Automated Measure Calculation Automated Measure Calculation Successfully Tested (a)(1) (a)(9) (a)(16) (b)(6) (a)(3) (a)(11) (a)(17) (e)(1) (a)(4) (a)(12) (b)(2) (e)(2) (a)(5) (a)(13) (b)(3) (e)(3) (a)(6) (a)(14) (b)(4) (a)(7) (a)(15) (b)(5) x Automated Measure Calculation was not tested Attestation Attestation Forms (as applicable) Safety-Enhanced Design* x Quality Management System** Appendix A B 3.3 Appendices Attached below. x Privacy and Security *Required if any of the following were tested: (a)(1), (a)(2), (a)(6), (a)(7), (a)(8), (a)(16), (b)(3), (b)(4) **Required for every EHR product C Page 11 of 12

12 Test Results Summary Document History Version Description of Change Date 07-Feb-2014 Modified layout 07-Feb Nov-2013 Updated test tool sections 20-Nov Oct-2013 Corrected numbering of section 25-Oct Oct-2013 Modified layout slightly 15-Oct Oct-2013 Initial Version 01-Oct Edition Test Report Summary Page 12 of 12

13 MCKESSON McKesson QMS Process Documentation QMS Process Documentation for ^.4 Quality Management System McKesson Patient Folder with McKesson Patient Folder Release ofinformation module Release 16 Testing Results: A single Quality Management System (QMS) was used for all applicahle capabilities for which certification is sought. The Quality Management System (QMS) used in the development, testing, implementation and maintenance is ISO 13485:12003 Standard. ISO Certificate *: US02/58088 Date JQ Jew* - /3 McKesson Corporation One Post Street San Francisco, CA

14 MCKESSON June Drummond Group Inc North Hwy 183, Ste B Austin, TX Attn: Bill Smith DTR d.2-2: Permit Audit Log Disabling The purpose of this letter is to inform you of our compliance with DTR d.2. In the McKesson Patient Folder 16.0 release, two changes were made to ensure that our customers will audit any and al events. The first change was to remove the ability for the customer to disable logging on any actions. Please see Appendix 1 for supporting collateral. The second change was to automatically force all auditing to be enabled for both upgrades and for new facilities, even ifthe customers had previously told the system to not log certain actions. Please see Appendix 2 for supporting collateral. Since the auditing functionality is an integrated part of the application functionality, these two changes ensure that the Patient Folder 16.0 release does NOT permit audit log disabling. Regan Patrick Gardner Vice President, Solution Line Manager Document Management & Intelligent Coding McKesson

15 Appendix 1: End-User Client Changes The following screen captures demonstrate that the functionality to permit disabling of audit logs has been removed from the application. Copyright, Proprietary or Confidential Removed at McKesson s Request.

16 Appendix 2: Database Objects New Install The following SQL code is run on the database server for every new install of the McKesson Patient Folder 16.0 system: Copyright, Proprietary or Confidential Information Removed at McKesson s Request. Upgrade Install The following SQL code is run on the database server for an upgrade install of the McKesson Patient Folder 16.0 system: Copyright, Proprietary or Confidential Removed at McKesson s Request.

17 MCKESSON June 20,2013 Drummond Group Inc North Hwy 183, Ste B Austin, TX Attn: Bill Smith DTR d.2-4: Protect Audit Log DTR d.2-5: Detection of Audit Log Alteration The purpose of this letter is to inform you of our compliance with the two directives listed above. For DTR d.2-4: Protect Audit Log, in the McKesson Patient Folder 16.0 release, two changes were made to ensure that our customers will not modify or delete the data found within our audit log entries. The first change was to ensure that application access to the audit log data passes through a database object in front of the audit log data. This database object is called a "view". Please see Appendix 1 for the definition of the database view object. The second change was to add two database objects called "triggers" to this new view that would get called by the database when a modification to the audit log occurs. These triggers will raise an error and prevent the modifications to the audit log. Please see Appendix 1 for the definition of the database trigger objects. For DTR d.2-5: Detection of Audit Log Alteration, in the McKesson Patient Folder 16.0 release, the change described above also serves to notify the database system administrator that an unauthorized modification has been attempted. The database trigger option "with log" ensures that the error message is placed in the error log and the application log for the instance of the Microsoft SQL Server Database Engine. This allows the database system administrator to detect and take action on an unauthorized modification to the audit log. Regar, Patrick Gardner Vice President, Solution Line Manager Document Management & Intelligent Coding McKesson

18 Appendix 1: Database Objects View Definition The following is the definition of the database view that is used to protect against direct access to the audit log tables. Copyright, Proprietary or Confidential Removed at McKesson s Request. Update View Trigger The following trigger on the view defined above will prevent the modification of any of the records within the audit log and raise an error within the database. Copyright, Proprietary or Confidential Removed at McKesson s Request. Delete View Trigger The following trigger on the view defined above will prevent the deletion of any of the records within the audit log and raise an error within the database. Copyright, Proprietary or Confidential Removed at McKesson s Request.

19 MCKESSON June 20,2013 Drummond Group Inc North Hwy 183, Ste B Austin, TX Attn: Bill Smith DTR d.2-3: Record Actions: Copy The purpose of this letter is to inform you of our compliance with DTR d.2-3. For DTR d.2-3: Record Actions: Copy, in the McKesson Patient Folder 16.0 release, the copy function does not exist. Records can be modified or deleted, but they cannot be copied. Patrick Gardner Vice President, Solution Line Manager Document Management & Intelligent Coding McKesson

20 MCKESSON June 20, 2013 Drummond Group Inc North Hwy 183, Ste B Austin, TX Attn: Bill Smith Subject: DTR d.7-3: Encrypt Data on End-User Device After Use is Stopped DTR d.7-4: Prevent Local Storage on End-User Device After Use is Stopped The purpose of this letter is to inform you of our compliance with DTR d.7.3 and DTR d.7-4. For DTR d.7-3: Encrypt Data on End-User Device After User is Stopped, in the McKesson Patient Folder 16.0 release, data accessed by an end user is referenced from the server and there is no time where data is stored on the end user device. Because there is no data stored on the end user device during use, there is no functionality needed to encrypt the data once use is stopped. For DTR d.7-4: Prevent Local Storage on End-User Device After Use is Stopped, the same concept applies from the previous item. Because there is no data stored on the end user device during use, there is no functionality needed to remove data once use is stopped. Patrick Gardner Vice President, Solution Line Manager Document Management & Intelligent Coding McKesson