Bloodstream Infection(BSI)

CONFORMANCE STATEMENTS

For CDC

Healthcare Associated Infections Pilot

v1.0

May 2007

Contacts

Liora Alschuler

Kate Hamilton

Dan Pollock

Introduction to the document

Version History

Generic Guide

2.16.840.1.113883.3.117.1.1.1 Generic Header and Body

Generic HAI header model

Generic body model

Generic section model

APPENDIX: form-specific requirements

2.16.840.1.113883.3.117.1.1.3.1 BSI Numerator Form

BSI-specific header details

BSI-specific body details

2.16.840.1.113883.3.117.1.1.3.2 SSI Numerator Form

2.16.840.1.113883.3.117.1.1.3.3 ICU Denominator Form

2.16.840.1.113883.3.117.1.1.3.4Procedure DenominatorForm

appendix: SECTION-library

2.16.840.1.113883.3.117.1.1.2.1 Risks Section

2.16.840.1.113883.3.117.1.1.2.1.1 Risks Entry

2.16.840.1.113883.3.117.1.1.2.3 Custom Fields Section

2.16.840.1.113883.3.117.1.1.2.4 Comments Section

2.16.840.1.113883.3.117.1.1.2.3.1 Free-text entry

2.16.840.1.113883.3.117.1.1.2.3.2 Custom-date entry

2.16.840.1.113883.3.117.1.1.2.2 Details Section

Details in a BSI report

2.16.840.1.113883.3.117.1.1.2.2.1 Event-date entry

2.16.840.1.113883.3.117.1.1.2.2.3 BSI Event-type entry

Table: BSI Event-type Code System

Table: LCBI Pathways Code System

2.16.840.1.113883.3.117.1.1.2.2.4 Death entry

2.16.840.1.113883.3.117.1.1.2.2.5 Pathogens-identified entry

2.16.840.1.113883.3.117.1.1.2.5 Findings Section

2.16.840.1.113883.3.117.1.1.2.5.1 Findings entry

2.16.840.1.113883.3.117.1.1.2.5.2 Gram-sensitivity observation

Table: Gram Sensitivity Code System

2.16.840.1.113883.3.117.1.1.2.5.5 Pathogen-ranking observation

2.16.840.1.113883.3.117.1.1.2.5.3 Anti-microbial Susceptibilities Organizer

2.16.840.1.113883.3.117.1.1.2.5.4 Anti-microbial Susceptibility Observation

Table: Anti-microbial Susceptibility Code System

2.16.840.1.113883.3.117.1.1.2.6 Aggregate-summary Section

APPENDIX – PILOT CONSTRAINTS AND DATA CONSTRAINTS

2.16.840.1.113883.3.117.1.1.2 Pilot Constraints and Data Constraints

Pilot Constraints for the BSI Form

Data Constraints

APPENDIX – Long Tables

Table: NHSN Location-Type Codes

Table: NHSN Anti-microbial Drugs Code System

Introduction to the document

This document is provided to support developers participating in the CDA Challenge, May 30, 2007. It contains the conformance statements for BSI numerator reports and corresponds to the sample (strawman) BSI XML instance file: BSI-num.May1107.xml and to the accompanying Schematron validating rule set. The Implementation Guide will contain additional normative and explanatory material.

The organization of this document reflects the structure of the Implementation Guide:

Requirements for any HAI report
Report-specific requirements
Section Library
Code-system Tables

This document also includes a section of constraints specific to the pilot project; notably, only BSI reports for ICU/Other are in scope.

We welcome comment on the document organization and content.

Version History

Version / Change history / Date
1.0 / Initial draft / May 11 2007

Conformance Statements for Pilot1/9/2019 p1

Generic Guide

2.16.840.1.113883.3.117.1.1.1GenericHeader and Body

Generic HAIheader model

CONF-1: A ClinicalDocument/templateId element shall be present representing conformance to form-specific requirements of this Guide. See the appropriate form-specific section for the required detail.

CONF-2: A ClinicalDocument/templateId element shall be present representing conformance to the Pilot Constraints and Data Constraints. (templateId 2.16.840.1.113883.3.117.1.1.2).

CONF-3: A ClinicalDocument/templateId element shall be present representing conformance to CDA General Header Constraints. (templateId 2.16.840.1.113883.10.20.3).

CONF-4: A code element shall be present where @codeSystem has the value 2.16.840.1.113883.6.1 and @code has the value x-HAI.

Generic body model

CONF-5: A ClinicalDocument/component element shall be present and shall contain a single structuredBody element.

CONF-6: The structuredBody element shall contain acomponent element that contains the section elements appropriate to the particular report being made. See the appropriate report-specific Appendix for the necessary conformance details.

Generic section model

Each section element will contain a templateId element, a code element, a title element, a text element, and at least one entry element. The remaining details depend on the particular report being made. See the appropriate report-specific Appendix for the necessary conformance statements.

CONF-7: Asection element shall contain a templateId element, where the value of @root is as specified in the appropriate report-specific Appendix.

CONF-8: Asection element shall contain a code element where the value of @codeSystem is 2.16.840.1.113883.6.1, and the value of @code is a LOINC code corresponding to the section type as specified in the appropriate report-specific Appendix.

CONF-9: Asection elementSHALL contain a title element that provides a title for the section.

CONF-10: Asection elementshall contain a narrative block followed by at least one entry element.

Conformance Statements for Pilot1/9/2019 p1

APPENDIX: form-specific requirements

2.16.840.1.113883.3.117.1.1.3.1 BSI Numerator Form

BSI-specific header details

The BSI form is a single-patient form.

CONF-11: A templateId element shallbe present where @root has the value 2.16.840.1.113883.3.117.1.1.3.1.

CONF-12: A recordTarget element shall be present and shall contain a patientRole element. The patientRole element shall contain an id element that represents the patient ID assigned by the local facility, may contain an id element that representsa secondary ID for the patient, and should contain an id element where the value of @root is 2.16.840.1.113883.4.1 that represents the patient’s SSN. The patientRole element shall contain a patient element. The patient element shall contain a name element, an administrativeGenderCode element where the value of @codeSystem is 2.16.840.1.113883.5.1 (HL7 gender codes), and a birthTime element.

The author may be software or may be someone in the role of "infection control professional".

CONF-13: An author element shallbe present. The author element shallcontain a time element that represents the time of authoring of the information, and an assignedAuthor element that represents the author of the information. The assignedAuthor element shall contain an id element.

The document custodian is CDC.

CONF-14: A custodian/assignedCustodian/representedCustodianOrganization/id element shall be present where the value of @root is 2.16.840.1.113883.3.117.1.2and the value of @extension is CDC.

CONF-15: A legalAuthenticator element shall be present. The legalAuthenticator element shall contain a time element that represents the time of authentication of the document, a signatureCode element where the value of @code is S, indicating that ..., and an assignedEntity element that represents the authenticator of the document. The assignedEntity element shall contain an id element.

The NHSN event number is not available when the CDA document is created. The event number recorded by componentOf/encompassingEncoutner/id is the facility event number.

CONF-16: A componentOf element shall be present and shall contain an encompassingEncounter element. The encompassingEncounter element shall contain an id element that represents the event number as assigned by the facility, an effectiveTime element, and a location element. The effectiveTime element shall contain a low element that represents the date admitted to the facility, and a high element that represents the date of discharge. The location element shall contain a healthCareFacility element. The healthCareFacility element shall contain an id element that represents the facility OID assigned by NHSN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.5 (NHSN (pilot) location-type codes) and the value of @code isdrawn from Table: NHSN Location-Type Codes, and a location element that contains an addr element that contains a unitID element that represents the facility’s identifier for the location, such as “9W”.

BSI-specific body details

Many HAI forms use the same sections in the CDA Body. Details for each type of body section are set out in Appendix: Section Library.

CONF-17: The structuredBody of a Bloodstream Infection numerator report shall contain a Risks section (templateId 2.16.840.1.113883.3.117.1.1.2.1), a Details section (templateId 2.16.840.1.113883.3.117.1.1.2.2), a Custom Fields section (templateId 2.16.840.1.113883.3.117.1.1.2.3), a Comments section (templateId 2.16.840.1.113883.3.117.1.1.2.4), and a Findings section (templateId 2.16.840.1.113883.3.117.1.1.2.5).

The following CDA Body requirements for the SSI, ICU, and Procedure forms are provided for illustration only and are notparf of the pilot project.

2.16.840.1.113883.3.117.1.1.3.2 SSI Numerator Form

CONF-18: The structuredBody of a Surgical Site Infection numerator report shall contain a Details section (templateId 2.16.840.1.113883.3.117.1.1.2.2), a Custom Fields section (templateId 2.16.840.1.113883.3.117.1.1.2.3), and a Comments section (templateId 2.16.840.1.113883.3.117.1.1.2.4).

2.16.840.1.113883.3.117.1.1.3.3 ICU Denominator Form

CONF-19: The structuredBody of a ICU Denominator report shall contain a Details section (templateId 2.16.840.1.113883.3.117.1.1.2.2), a Custom Fields section (templateId 2.16.840.1.113883.3.117.1.1.2.3), and a Comments section (templateId 2.16.840.1.113883.3.117.1.1.2.4).

2.16.840.1.113883.3.117.1.1.3.4Procedure DenominatorForm

CONF-20: The structuredBody of a Procedure denominator report shall contain an Aggregate-summary section (templateId 2.16.840.1.113883.3.117.1.1.2.6).

appendix: SECTION-library

2.16.840.1.113883.3.117.1.1.2.1 Risks Section

CONF-21: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.1.

CONF-22: A code element shallbe present wherethe value of @codeSystem is 2.16.840.1.113883.6.1, andthe value of @codeis x-RISKS.

CONF-23: A single entryelement shall be present representing risk factors (templateId 2.16.840.1.113883.3.117.1.1.2.1.1).

2.16.840.1.113883.3.117.1.1.2.1.1Risks Entry

CONF-24: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.1.1.

CONF-25: An organizer element shall be present where the value of @classCode is CLUSTER and the value of @moodCode is EVN.

CONF-26: AstatusCodeelement shall be present where the value of @code is completed.

The observations required in the risks entry depend on the location type, which is specified byClinicalDocument/componentOf/encompassingEncounter/location/healthcareFacility/code.

CONF-27: If the location typerepresents an ICU, the risks entryelement shallcontain a singlecomponentelement that represents the use of a central line.

CONF-28: If the location typerepresents an SCA, the risks entry element shall contain a componentelementthat represents the use of a permanent central lineand a component element that represents the use of a temporary central line.

CONF-29: If the location type represents an NICU, the risks entry element shall contain a componentelement that represents the use of a central line, a component element that represents the use of an umbilical catheter, and a component element that represents birth weight.

CONF-30: A componentelement representing use of a central line shallcontain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.7 and the value of @code is centralLine, and a value element where the value of @xsi:type is BL and@valueis present.

CONF-31: A componentelement representing use of a permanent central line shall contain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.7 and the value of @code is permCentralLine, and a value element where the value of @xsi:type is BL and @value is present.

CONF-32: A componentelement representing use of a temporary central line shallcontain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.7 and the value of @code is tempCentralLine, and a value element where the value of @xsi:type is BL and @valueis present.

CONF-33: A componentelement representing use of an umbilical catheter shall contain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.7 and the value of @code is umbCatheter, and a value element where the value of @xsi:type is BL and @valueis present.

CONF-34: A componentelement representing birthweight shall contain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.7 and the value of @code is birthwt, and a value element where the value of @xsi:type is PQ and the value of @unit is lbs and @value is present.

2.16.840.1.113883.3.117.1.1.2.3 Custom Fields Section

CONF-35: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.3.

CONF-36: A code element shall be present where the value of @codeSystem is 2.16.840.1.113883.6.1, and the value of @codeis x-CUSTOM.

CONF-37: Each custom field shall be represented by a pair of entries consisting of a free-text entry (templateId 2.16.840.1.113883.3.117.1.1.2.3.1) and a custom-date entry (templateId 2.16.840.1.113883.3.117.1.1.2.3.2).

2.16.840.1.113883.3.117.1.1.2.4 Comments Section

CONF-38: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.4.

CONF-39: A code element shall be present where the value of @codeSystem is 2.16.840.1.113883.6.1, and the value of @codeis x-COMMENTS.

CONF-40: A single entry element shall be present representing the free-text comment (templateId 2.16.840.1.113883.3.117.1.1.2.3.1).

2.16.840.1.113883.3.117.1.1.2.3.1 Free-text entry

CONF-41: A templateId element shallbe present where the value of @rootis 2.16.840.1.113883.3.117.1.1.2.3.1.

CONF-42: Anobservation element shallbe present where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shall contain a code element where the value of @nullFlavor is UNK, and a value element where the value of @xsi:type is ST and element content is present representing the free text.

2.16.840.1.113883.3.117.1.1.2.3.2Custom-date entry

CONF-43: A templateId element shall be present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.3.2.

CONF-44: A observation element shallbe present where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shall contain a code element where the value of @nullFlavor is UNK, and a value element where the value of @xsi:type is TS and @value is present representing the date.

2.16.840.1.113883.3.117.1.1.2.2Details Section

CONF-45: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.2.

CONF-46: A code element shall be present where the value of @codeSystem is 2.16.840.1.113883.6.1, and the value of @codeis x-DETAILS.

The specific details recorded in the Details section vary according to report type. The report type can be inferred from ClinicalDocument/templateId. The outline of each report is shown first, followed by the requirements for each type of entry.

Details in a BSI report

CONF-47: An entry element shallbe present representing the event date (templateId 2.16.840.1.113883.3.117.1.1.2.2.1).

(The facility location and date of admission to the facility, which appear next on the BSI PDF form, are recorded in the CDA header.)

CONF-48: An entry element SHALLbe present representing the BSI event type (templateId 2.16.840.1.113883.3.117.1.1.2.2.3).

CONF-49: An entry element SHALLbe present representing whether the patient died. (templateId 2.16.840.1.113883.3.117.1.1.2.2.4).

(The discharge date, which appears next on the BSI form, is recorded in the CDA header, in Discharge date is in encompassingEncounter/effectiveTime/high.)

CONF-50: An entry element SHALLbe present representing whether pathogens were identified (templateId 2.16.840.1.113883.3.117.1.1.2.2.5).

2.16.840.1.113883.3.117.1.1.2.2.1 Event-date entry

CONF-51: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.2.1.

CONF-52: An act element shall be present where the value of @classCode is ACT and the value of @moodCode is EVN. The act element shall contain a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.2 and the value of @code is eventDate, and an effectiveTime element,representing the date of the BSI event, where @value is present.

2.16.840.1.113883.3.117.1.1.2.2.3 BSI Event-type entry

CONF-53: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.2.3.

CONF-54: An observation element shall be present where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shall contain a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.3.1andthe value of @code is drawn from Table: BSI Event-type Code System.

Table: BSI Event-type Code System
2.16.840.1.113883.3.117.1.1.4.3.1
Code / Meaning
CSEP / Clinical sepsis= 1 clinical symptom + blood culture not done or negative + no infection at another site + antimicrobial therapy
LCBI / Laboratory confirmed: No infection at another site

CONF-55: If the event type is laboratory-confirmed (LCBI), the observation element shall contain anentryRelationship element to represent information about the LCBI pathways, where the value of @typeCode is SUBJ. The entryRelationship element shallcontain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shallcontain a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.3.2 and the value of @code is lcbipath, a statusCode element where the value of @code is completed, and a value element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.3.2 and the value of @code is drawn from Table: LCBI Pathways Code System.

Table: LCBI Pathways Code System
2.16.840.1.113883.3.117.1.1.4.3.2
Code / Meaning
A / Recognized pathogens =1 blood culture positive
B / Other organisms: >= 2 blood cultures from separate sites positive w/same organism + clinical sx
C / Other organisms: >= 1 blood culture positive in pt with IV + clinical sx + antimicrobial therapy

2.16.840.1.113883.3.117.1.1.2.2.4 Death entry

This entry records whether the patient died and, if so, whether the event being reported contributed to that death.

CONF-56: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.2.4.

CONF-57: An observation element shall be present where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shall contain a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.2and the value of @code is died, and a value element where the value of xsi:type is BL and @value is present.

CONF-58: If the patient died, the observation element shallcontain an entryRelationship element to represent whether the event contributed to the death, where the value of @typeCode is SUBJ. The entryRelationship element shallcontain an observation element where the value of @classCode is OBS and the value of @moodCode is EVN, a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.2and the value of @code is contribDeath, and a value element where the value of @xsi:type is BL and @value is present.

2.16.840.1.113883.3.117.1.1.2.2.5Pathogens-identified entry

CONF-59: A templateId element shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.2.5.

CONF-60: An observation element shall be present where the value of @classCode is OBS and the value of @moodCode is EVN. The observation element shall contain a code element where the value of @codeSystem is 2.16.840.1.113883.3.117.1.1.4.2and the value of @code is pathIdentified, and a value element where the value of @xsi:type is BL and @value is present.

2.16.840.1.113883.3.117.1.1.2.5 Findings Section

CONF-61: A templateId element shall be present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.5.

CONF-62: A code element shall be present where the value of @codeSystem is 2.16.840.1.113883.6.1 and the value of @code is x-FINDINGS.

CONF-63: The Findings section shallcontain at least one and no more than three findings entries (templateId 2.16.840.1.113883.3.117.1.1.2.5.1).

2.16.840.1.113883.3.117.1.1.2.5.1 Findings entry

CONF-64: A templateIdelement shallbe present where the value of @root is 2.16.840.1.113883.3.117.1.1.2.5.1.

CONF-65: An organizer element shall be present where the value of @classCode is BATTERY and the value of @moodCode is EVN. The organizer element shallcontain a code element where the value of @codeSystem is 2.16.840.1.113883.6.1 and the value of @code is x-SC; a statusCode element where the value of @code is completed; and an effectiveTime element representing the time of final reporting on an isolate.