N.J. Admin. Code § Tit. 8, ch. 57, subch. 1 app A

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Current through Register Vol. 56, No. 8, April 15, 2024

Appendix A

Communicable Disease Service New Jersey Department of Health and Senior Services

Electronic Laboratory Reporting Technical Manual

May 2007

Table of Contents

1. Introduction

2. Acceptable File Formats

2.1 HL 7 File format

2.1.1 HL 7 2.5

2.1.2 HL 7 2.3

2.2. XML Schema

2.2.1 File format

2.2.2 Sample Schema

3. LOINC/SNOMED

3.1 LOINC

3.2 SNOMED

4. Mode of Electronic Transmission

5. Test Plan

6. Contact Information

7. References

1. Introduction

In an effort towards improving disease surveillance and timely notification of reportable diseases for public health intervention, the New Jersey Departmnet of health and Senior Services (NJDHSS) Communicable Disease Service (CDS) is mandating electronic reporting of laboratory test results from all licensed state, commercial and hospital laboratories. Electronic laboratory reports (ELR) are critical for an effective public health response both for routinely reportable diseases as well as potential bioterrorism (BT) agents.

Currently the Communicable Disease Reporting and Surveillance System (CDRSS), is the data repository of all communicable diseases (with the exception of HIV, TB and STDs) and is designed to accept ELR in the CDC-recommended, PHIN-compliant format of Health Level 7 (HL 7). In addition, as per CDC-recommended industry standards, all HL 7 messages will include Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine (SNOMED) codes, where applicable, to describe the tests and organisms found. In order to standardize results, no text fields will be used to describe tests and results.

2. Acceptable File Formats

2.1 HL 7 File format

2.1.1 HL 7 2.5

The preferred format for electronic transmission of ELR data is HL 7 version 2.5.1, as supplemented and implemented, and as specified by the CDC standards at http://www.cdc.gov/phin/library/historical-archive.html.

2.1.2 HL 7 2.3

HL 7 Version 2.3.z will also be accommodated on a case-by-case basis. File specification of HL 7 version 2.3.z is available at - http://www.cdc.gov/nedss/ELR/HL7Spec.pdf.

File specifications can also be requested from NJDHSS, by writing to the Communicable Disease Service, PO Box 369, Trenton, NJ -08625-0369

2.2 XML Schema

2.2.1 File format

<?xml version="1.0" encoding="UTF-8"?>

<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" elementFormDefault="qualified" attributeFormDefault="unqualified">

<xs:element name="PHONE">

<xs:complexType>

<xs:all>

<xs:element name="COUNTRY_CODE" type="xs:string"/>

<xs:element name="AREA_CODE" type="xs:string"/>

<xs:element name="NUMBER" type="xs:string"/>

<xs:element name="EXTENSION" type="xs:string"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="PHONE_HOME" abstract="false" substitutionGroup="PHONE"/>

<xs:element name="PHONE_OFFICE" substitutionGroup="PHONE"/>

<xs:element name="PHONE_MOBILE" substitutionGroup="PHONE"/>

<xs:element name="FACILITY_PHONE" substitutionGroup="PHONE"/>

<xs:element name="PROVIDER_PHONE" substitutionGroup="PHONE"/>

<xs:element name="PERSON_DETAIL">

<xs:complexType>

<xs:all>

<xs:element name="FIRST_NAME" type="xs:string"/>

<xs:element name="LAST_NAME" type="xs:string"/>

<xs:element name="MIDDLE_NAME" type="xs:string" minOccurs="0"/>

<xs:element name="EMAIL" type="xs:string" minOccurs="0"/>

<xs:element ref="PHONE_HOME" minOccurs="0"/>

<xs:element ref="PHONE_OFFICE" minOccurs="0"/>

<xs:element ref="PHONE_MOBILE" minOccurs="0"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="PROVIDER_INFORMATION" substitutionGroup="PERSON_DETAIL"/>

<xs:element name="COLLECTOR_INFORMATION" substitutionGroup="PERSON_DETAIL"/>

<xs:element name="PATIENT_DETAIL" substitutionGroup="PERSON_DETAIL"/>

<xs:element name="ADDRESS">

<xs:complexType>

<xs:all>

<xs:element name="STREET" type="xs:string"/>

<xs:element name="CITY" type="xs:string"/>

<xs:element name="COUNTY" type="xs:string" minOccurs="0"/>

<xs:element name="MUNICIPALITY" type="xs:string" minOccurs="0"/>

<xs:element name="STATE" type="xs:string"/>

<xs:element name="ZIP" type="xs:string"/>

<xs:element name="COUNTRY" type="xs:string" minOccurs="0"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:simpleType name="TEST_TYPE">

<xs:annotation>

<xs:documentation>This is the test ordered coding type. The value must be one of the two following: LOINC andLOCAL</xs:documentation>

</xs:annotation>

<xs:restriction base="xs:string">

<xs:pattern value="LOINCLOCALTEXT"/>

</xs:restriction>

</xs:simpleType>

<xs:simpleType name="TEST_RESULT_TYPE">

<xs:annotation>

<xs:documentation>This is the test result coding type.</xs:documentation>

</xs:annotation>

<xs:restriction base="xs:string">

<xs:pattern value="SNOMEDNUMERICTEXT"/>

</xs:restriction>

</xs:simpleType>

<xs:simpleType name="TEST_STATUS_TYPE">

<xs:annotation>

<xs:documentation>This is the test result status. </xs:documentation>

</xs:annotation>

<xs:restriction base="xs:string">

<xs:enumeration value="FINAL"/>

<xs:enumeration value="INITIAL"/>

<xs:enumeration value="UPDATE"/>

</xs:restriction>

</xs:simpleType>

<xs:simpleType name="GENDER_TYPE">

<xs:restriction base="xs:string">

<xs:pattern value="malefemale"/>

</xs:restriction>

</xs:simpleType>

<xs:element name="NJ_LABTEST_DATA">

<xs:complexType>

<xs:all>

<xs:element name="LAB_INFORMATION">

<xs:complexType>

<xs:all>

<xs:element name="LAB_NAME" type="xs:string"/>

<xs:element name="CLIA" type="xs:string"/>

<xs:element name="NO_OF_TESTS"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="LABTEST_INFORMATION">

<xs:complexType>

<xs:sequence>

<xs:element name="TESTS" maxOccurs="unbounded">

<xs:complexType>

<xs:sequence>

<xs:element name="PATIENT_INFO">

<xs:complexType>

<xs:all>

<xs:element ref="PATIENT_DETAIL"/>

<xs:element ref="ADDRESS" minOccurs="0"/>

<xs:element name="GENDER" type="GENDER_TYPE" minOccurs="0"/>

<xs:element name="DOB" type="xs:date" minOccurs="0"/>

<xs:element name="AGE" type="xs:positiveInteger" minOccurs="0"/>

<xs:element name="RACE" type="xs:string" minOccurs="0"/>

<xs:element name="ETHNICITY" type="xs:string" minOccurs="0"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="LABTESTS" maxOccurs="unbounded">

<xs:complexType>

<xs:sequence>

<xs:element name="ORDERING_PROVIDER" minOccurs="0">

<xs:complexType>

<xs:all>

<xs:element ref="PROVIDER_INFORMATION" minOccurs="0"/>

<xs:element ref="ADDRESS" minOccurs="0"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="ORDERING_FACILITY" minOccurs="0">

<xs:complexType>

<xs:all>

<xs:element name="ORDERING_FACILITY_NAME"/>

<xs:element ref="ADDRESS"/>

<xs:element ref="FACILITY_PHONE"/>

</xs:all>

</xs:complexType>

</xs:element>

<xs:element name="TEST_DETAIL" maxOccurs="unbounded">

<xs:complexType>

<xs:all>

<xs:element name="TEST_ID"/>

<xs:element name="PLACER_ORDER_NUMBER"/>

<xs:element name="TEST_ORDERED">

<xs:complexType>

<xs:sequence>

<xs:element name="TEST_CODE_TYPE" type="TEST_TYPE"/>

<xs:element name="TEST_CODE"/>

<xs:element name="TEST_DESCRIPTION" minOccurs="0"/>

</xs:sequence>

</xs:complexType>

</xs:element>

<xs:element name="TEST_RESULT">

<xs:complexType>

<xs:sequence>

<xs:element name="TEST_RESULT_TYPE"/>

<xs:element name="TEST_RESULT_VALUE"/>

<xs:element name="TEST_RESULT_DESCRIPTION"/>

<xs:element name="TEST_RESULT_STATUS" type="TEST_STATUS_TYPE"/>

<xs:element name="TEST_RESULT_REF_RANGE" minOccurs="0"/>

<xs:element name="TEST_RESULT_UNITS" minOccurs="0"/>

</xs:sequence>

</xs:complexType>

</xs:element>

<xs:element name="TEST_REQUESTED_DATETIME" minOccurs="0"/>

<xs:element name="SPECIMEN_COLLECTED_DATETIME"/>

<xs:element name="OBSERVATION_DATETIME" minOccurs="0"/>

<xs:element name="SPECIMEN_SOURCE" minOccurs="0"/>

<xs:element name="TEST_COMMENT"/>

<xs:element name="PARENT_TEST_ID" type="xs:positiveInteger" minOccurs="0"/>

</xs:all>

</xs:complexType>

</xs:element>

</xs:sequence>

</xs:complexType>

</xs:element>

<xs:element name="PATIENT_COMMENT"/>

</xs:sequence>

</xs:complexType>

</xs:element>

</xs:sequence>

</xs:complexType>

</xs:element>

</xs:all>

</xs:complexType>

</xs:element>

</xs:schema>

2.2.2 Sample Schema

<LAB_INFORMATION>

<LAB_NAME>String</LAB_NAME>

<CLIA>String</CLIA>

<NO_OF_TESTS/>

</LAB_INFORMATION>

<LABTEST_INFORMATION>

<TESTS>

<PATIENT_INFO>

<PATIENT_DETAIL>

<FIRST_NAME>String</FIRST_NAME>

<LAST_NAME>String</LAST_NAME>

<MIDDLE_NAME>String</MIDDLE_NAME>

<EMAIL>String</EMAIL>

<PHONE_HOME>

<COUNTRY_CODE>String</COUNTRY_CODE>

<AREA_CODE>String</AREA_CODE>

<NUMBER>String</NUMBER>

<EXTENSION>String</EXTENSION>

</PHONE_HOME>

</PATIENT_DETAIL>

<STREET>String</STREET>

<CITY>String</CITY>

<COUNTY>String</COUNTY>

<MUNICIPALITY>String</MUNICIPALITY>

<STATE>String</STATE>

<ZIP>String</ZIP>

<COUNTRY>String</COUNTRY>

</ADDRESS>

<RACE>String</RACE>

<ETHNICITY>String</ETHNICITY>

</PATIENT_INFO>

<ORDERING_PROVIDER>

<PROVIDER_INFORMATION>

<FIRST_NAME>String</FIRST_NAME>

<LAST_NAME>String</LAST_NAME>

<MIDDLE_NAME>String</MIDDLE_NAME>

<EMAIL>String</EMAIL>

<PHONE_HOME>

<COUNTRY_CODE>String</COUNTRY_CODE>

<AREA_CODE>String</AREA_CODE>

<NUMBER>String</NUMBER>

<EXTENSION>String</EXTENSION>

</PHONE_HOME>

</PROVIDER_INFORMATION>

<STREET>String</STREET>

<CITY>String</CITY>

<COUNTY>String</COUNTY>

<MUNICIPALITY>String</MUNICIPALITY>

<STATE>String</STATE>

<ZIP>String</ZIP>

<COUNTRY>String</COUNTRY>

</ADDRESS>

</ORDERING_PROVIDER>

<ORDERING_FACILITY>

<ORDERING_FACILITY_NAME/>

<STREET>String</STREET>

<CITY>String</CITY>

<COUNTY>String</COUNTY>

<MUNICIPALITY>String</MUNICIPALITY>

<STATE>String</STATE>

<ZIP>String</ZIP>

<COUNTRY>String</COUNTRY>

</ADDRESS>

<FACILITY_PHONE>

<COUNTRY_CODE>String</COUNTRY_CODE>

<AREA_CODE>String</AREA_CODE>

<NUMBER>String</NUMBER>

<EXTENSION>String</EXTENSION>

</FACILITY_PHONE>

</ORDERING_FACILITY>

<TEST_DETAIL>

<TEST_ID/>

<PLACER_ORDER_NUMBER/>

<TEST_ORDERED>

<TEST_CODE_TYPE>LOINC</TEST_CODE_TYPE>

<TEST_CODE/>

<TEST_DESCRIPTION/>

</TEST_ORDERED>

<TEST_RESULT>

<TEST_RESULT_TYPE/>

<TEST_RESULT_VALUE/>

<TEST_RESULT_DESCRIPTION/>

<TEST_RESULT_STATUS>FINAL</TEST_RESULT_STATUS>

<TEST_RESULT_REF_RANGE/>

<TEST_RESULT_UNITS/>

</TEST_RESULT>

<TEST_REQUESTED_TIME/>

<SPECIMEN_COLLECTED_TIME/>

<OBSERVATION_TIME/>

<SPECIMEN_SOURCE/>

<TEST_COMMENT/>

<PARENT_TEST_ID>2</PARENT_TEST_ID>

</TEST_DETAIL>

</LABTESTS>

<PATIENT_COMMENT/>

</TESTS>

</LABTEST_INFORMATION>

</NJ_LABTEST_DATA>

3. LOINC/SNOMED

3.1 LOINC

All electronic test results should include LOINC values to identify the laboratory observation. LOINC applies universal code names and identifiers to medical terminology related to the electronic health record. The purpose is to assist in the electronic exchange and gathering of clinical results (e.g. laboratory tests, clinical observations, outcomes management, research). The LOINC database is developed and maintained by the Regenstrief Institute. The most current database can be downloaded from the Regenstrief Institute website available at http://www.regenstrief.org/medinformatics/loinc/or by written request to Regenstrief Institute, Inc., Health Informational and Translational Sciences Building, 410 West 10th Street, Suite 2000, Indianpolis, IN, 46202.

3.2 SNOMED

SNOMED is a system of standardized medical terminology developed by the College of American Pathologists. It can be described as comprehensive clinical terminology covering diseases, clinical findings, and procedures, that allows for a consistent way of indexing, storing, retrieving and aggregating [page=1438] clinical data across specialties and sites of care. SNOMED helps provide structure and computerize the medical record, reducing the variability in the way data is captured, encoded and used for clinical care of patients and research. For additional explanational please refer to the following document available at http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=snomed_page.

A complete list of SNOMED codes is available at http://www.snomed.org/or by written request to SNOMED Customer Service, SNOMED International, 325 Waukegan Road, Northfield, IL, 60093.

In addition a subset for the notifiable diseases is available at the CDC website, available at http://www.cdc.gov/phin/library/documents/xls/SNOMED_Organism_Lists.xls.

CDC is also working to distribute the SNOMED codes through their PHIN Vocabulary Authoring and Distribution System (VADS) in the near future.

4. Mode of Electronic Transmission

NJDHSS will work with individual laboratories to set up Secure File Transfer Protocol (SFTP) connections to transmit data. Additional technologies like Virtual Private Networks (VPN), if available, may be considered.

SFTP is a program that uses the secure shell (SSH) program to transfer files. Unlike standard FTP, it encrypts both commands and data, preventing passwords and sensitive information from being transmitted in the clear over the network.

VPN is a network that is constructed by using the Internet to connect nodes (NJDHSS and lab server). This will allow the data to be encrypted and provide other security mechanisms to ensure that only authorized users can access the network and that the data cannot be intercepted.

5. Test Plan

All electronic interfaces will be tested by NJDHSS and the appropriate laboratory staff before being sent to the production system. The test phase will only be initiated once laboratories provide evidence that they have a complete list of diseases that they would be reporting and the accompanying LOINC and SNOMED tables required to map these diseases and conditions.

In the first phase of testing, the laboratories can provide test data files to OITS staff to process into our test environment. Once approved, the second phase of testing can be initialized, where the laboratories will provide their production data, which will be processed into NJDHSS test environment. Laboratories will also provide hard copies of all test results (as they appear at the physicians' office) to CDS staff. During this phase intense quality testing and assurance will be conducted to verify that all information on the hard copy result is captured accurately in the electronic transmission. Upon completion of phase II testing, data will be processed into production, but hard copies might still be requested by CDS staff, for another few months. Hard copy of results can be discontinued upon agreement by both CDS and the specific laboratory.

6. Contact Information

Mail: Communicable Disease Service, PO Box 369, Trenton, NJ, 08625-0369

Phone: (609) 588 7500

7. References

http://www.hl7.org/

http://www.cdc.gov/phin/library/historical-archive.html

N.J. Admin. Code Tit. 8, ch. 57, subch. 1 app A

The adopted version of this appendix 56 N.J.R. 213(a), effective 1/3/2024 is not yet available