Lab Data Elements for Lab Microbiologist

Form Approved

OMB No. 0920-NEW

Expiration Date: ##/## #/####

SURRG Laboratory Data Elements

Public reporting burden of this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-new)

Strengthening United States Response to Resistant Gonorrhea (SURRG)

Attachment 3C-1

SURRG Laboratory Data Elements

Data managers at each public health laboratory will abstract laboratory results on patients included in the facility-based data collection and will transmit those data to the site data manager through secure file transfer mechanisms. This tool is used to represent the laboratory data elements that the Data Managers will abstract and transmit to the site data manager, who in turn will transmit data to CDC.

Selected data elements, such as date of birth, will be shared with the regional laboratory (Antibiotic Resistance Laboratory Network [ARLN]) that will conduct additional specialized testing but will not be shared with CDC.

Variable name	Data element	Description/Question	Response codes
SURRG_SPEC_ID	Specimen ID	Unique, site-created ID consisting of 3 character sentinel site code + locally assigned specimen ID (no hyphen or space); 18 character limit This specimen ID code will not contain elements of PII, such as parts of a name, social security number, date of birth, or medical record number. CDC will only receive the assigned unique identifier and will not have the ability to back-convert the specimen ID to a medical record number.	Character ID
SENT_SITE	Sentinel site	Sentinel site where specimen was collected: 3 character sentinel site code	ATL=Fulton County (GA); DEN=Denver (CO); GRB=Guilford County (NC); HON=Honolulu (HI); IND= Marion County (IN); MIL=Milwaukee (WI); NYC=New York City (NY); SEA=Seattle/King County (WA); SFO=San Francisco (CA)
GISP_SPEC_ID	GISP ID	If a GISP site, monthly submission specimen number consisting of sentinel site code + YRMO (YYYYMM of isolate submission date) + isolate number (01 through 50) generated at the clinic/lab	Character ID Ex: ABC-201701-02 ABC-201706-05 Note: Urethral specimens only; null for non-GISP sites and for extragenital specimens
PATIENTID	Patient ID	This ID must be unique per person, up to 18 characters in length, and allow for longitudinal tracking of patients within and across participating facilities in the 9 SURRG sites. The Patient_ID will be used to relate associated specimen(s) to each patient in transmission to the ARLN and later link a patient’s laboratory results to their epidemiologic data. CDC will only receive the unique identifier and will not have the ability to back-convert the ID to a medical record number, name, date of birth, or social security number (see SSA pages 7). Note: Not contained in LIMS and is assigned by the epi coordinator. Cannot include any personally identifiable information (PII).	Character ID
EVENTID	EventID	Event identifier distinguishes each GC diagnosis, or for GC-negative contacts, each clinic testing visit event. An EventID must be established for the following patient categories that are not mutually exclusive: 1) all NAAT+ patients from the STD clinic, 2) all patients for whom a culture was collected at STD or NSTD clinics, and 3) all sexual and social contacts identified through SURRG Epi investigation tested at participating clinics. This ID stays the same for the entire GC event, which could include testing, treatment, and TOC visits. This ID up to 18 characters in length. This event ID will be locally assigned and will not contain any elements of name, social security number, date of birth or medical record number. CDC will only receive the unique identifier and will not have the ability to back-convert the Patient ID to a medical record number. (see SSA page 7) Note: Not contained in LIMS and is assigned by the epi coordinator.	Character ID
LAB_GENDER	Gender		1=Male 2=Female 3=Female-to-male transgender (FTM) 4=Male-to-female transgender (MTF) 5= Other gender identity 8=Refused to Answer 9=Unknown
JURISDICTION_PHL	Local public health laboratory	Local public health laboratory where specimen was processed	DEL = Denver PHL (CO) GAL = GA PHL (Fulton County) GCL = Guilford County PHL (NC) MAL = Marion County PHL (IN) MCL = Milwaukee City PHL (WI) NYL = New York City PHL (NY) SFL = San Francisco PHL (CA) SLD = SLD PHL/Honolulu (HI) UWA = UWA Laboratory (King County/WA)
FACILITY_LOCATION	Submitter facility ID	Clinic where specimen was collected	Unique facility/clinic identifier This ID generated specifically for the SURRG activity and identifies the health center. A 3 character sentinel site code, hyphen, 2 digits (keep preceding 0 for single digits). ATL-01 Fulton County HD Aldredge Clinic (GA) ATL-02 Positive Impact (GA) ATL-03 AID Atlanta DEN-01 Denver Metro Health Clinic (CO) DEN-02 Denver Health Eastside Clinic (CO) DEN-03 Denver Health HIV/ID Clinic (CO) DEN-04 Not yet assigned DEN-05 Not yet assigned DEN-06 Not yet assigned DEN-07 Not yet assigned DEN-08 Not yet assigned GRB-01 Greensboro Clinic (NC) GRB-02 High Point Clinic (NC) GRB-03 Cone Health System Emergency Department GRB-04 Women’s Health (NC) GRB-05 Wesley Long Emergency Department (NC) GRB-06 Med Center High Point (NC) GRB-07 High Point Regional Emergency Department (NC) GRB-08 Not yet assigned GRB-09 Not yet assigned GRB-10 Not yet assigned HON-01 STD/HIV Clinic Diamond Head Health Clinic (HI) HON-02 Not yet assigned HON-03 Not yet assigned HON-04 Not yet assigned HON-05 Not yet assigned HON-06 Not yet assigned IND-01 Bell Flower Clinic (IN) IND-02 Community Hospital East Emergency Department (IN) IND-03 Community Hospital East Infectious Disease Clinic (IN) IND-04 Damien Center (IN) IND-05 Eskenazi Hospital (IN) IND-06 Not yet assigned IND-07 Not yet assigned IND-08 Not yet assigned IND-09 Not yet assigned MIL-01 Keenan Health Center STD Clinic (WI) MIL-02 Brady East STD Clinic/BEST (WI) MIL-03 WI Ave Planned Parenthood Clinic (WI) MIL-04 Northwest Planned Parenthood Clinic (WI) MIL-05 Not yet assigned MIL-06 Not yet assigned MIL-07 Not yet assigned NYC-01 Fort Greene STD Clinic (NYC) NYC-02 Riverside STD Clinic (NYC) NYC-03 Callen-Lorde Community Health Center (NYC) NYC-04 APICHA Community Health Center (NYC) NYC-05 Gotham Medical Group (NYC) NYC-06 Not yet assigned NYC-07 Not yet assigned NYC-08 Not yet assigned NYC-09 Not yet assigned NYC-10 Not yet assigned NYC-11 Not yet assigned NYC-12 Not yet assigned NYC-13 Not yet assigned NYC-14 Not yet assigned NYC-15 Not yet assigned SEA-01 Public Health - Seattle & King County (PHSKC) STD Clinic (WA) SEA-02 Madison Clinic at Harborview Medical Center HIV (WA) SEA-03 Peter Shalit MD and Associates (WA) SEA-04 Seattle Infectious Disease Clinic (WA) SEA-05 Capitol Hill Medical (WA) SEA-06 Planned Parenthood-Kent (WA) SEA-07 Planned Parenthood-Federal Way (WA) SEA-08 Not yet assigned SEA-09 Not yet assigned SEA-10 Not yet assigned SFO-01 San Francisco City Clinic (SF/CA) SFO-02 3rd Street Youth Center (SF/CA) SFO-03 Not yet assigned SFO-04 Not yet assigned SFO-05 Not yet assigned OPR-00 Other Non-SURRG) Provider Grantees should notify CDC SURRG Program when new facilities are assigned.
SPEC_COLLECT_DATE	Specimen collection date	Date of specimen collection	Character; YYYY/MM/DD
SPEC_SOURCE	Specimen source	Source of specimen collection	B=Blood C=Conjunctival E=Endocervical P=Pharyngeal R=Rectal U=Urethral UR=Urine V=Vaginal O=Other NC=Not captured
DOB_LAB	Patient DOB	Date of birth Used for submission to ARLN, but DOB will not be sent to CDC	Character; YYYY/MM/DD
AGE_LAB	Patient age	Age in years at time of specimen collection	Numeric; 999=Unknown
DATETESTLAB	Specimen arrival date	Date specimen arrived at laboratory performing Etest	Character; YYYY/MM/DD
TESTTYPE	Test type	Type of specimen test	1=culture 2=nucleic acid amplification test (NAAT) 3=Etest 4=molecular probe 8=other 9=unknown
RESULT	Test result	Qualitative test result [Note: use response=8 for all Etests; use response=0 for non-viable cultures	0=Negative 1=Positive 2=Not tested 3=Indeterminate 8=Not Applicable (e.g. Etest) 9=Unknown
DATEDONE	Result date	Date of completion of whichever test performed (final result)	Character; YYYY/MM/DD
CFX_MIC_DD	Cefixime MIC	Etest Cefixime MIC reported in doubling dilutions 999=insufficient growth Leave blank if Etest not performed	0.016, 0.032, 0.064, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16, 32, 64, 128, 256, 999
CRO_MIC_DD	Ceftriaxone MIC	Etest Ceftriaxone MIC reported in doubling dilutions 999=insufficient growth Leave blank if Etest not performed	0.002, 0.004, 0.008, 0.016, 0.032, 0.064, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16, 32, 999
AZI_MIC_DD	Azithromycin MIC	Etest Azithromycin MIC reported in doubling dilutions 999=insufficient growth Leave blank if Etest not performed	0.016, 0.032, 0.064, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16, 32, 64, 128, 256, 999
OTH_TEST	Other test	(Can be left blank)	Text field
OTH_RSLT	Other test result	(Can be left blank)	Text field
DATESENTEC	Date Alert Etest result sent to SURRG Epi Coordinator	Date Alert Etest result sent/accessible to SURRG Epi Coordinator	Character; YYYY/MM/DD
DATESENTGT	Date Alert Etest result sent to SURRG Grantee	Date Alert Etest result sent/accessible to SURRG Grantee DateSentGT=DateSentEC (if Epi Coordinator is based at grantee agency, eg. State HD,)	Character; YYYY/MM/DD
DATESENTCLIN	Date Alert Etest result sent to clinician	Date Alert Etest result sent to clinician	Character; YYYY/MM/DD
DATEALTCDCPGM	Date Alert Etest MIC alert result to send to CDC SURRG Program	Date Alert Etest MIC result to send to CDC SURRG Program (by Epi or Lab Coordinator)	Character; YYYY/MM/DD
DATEALTCDCLAB	Date Alert Etest MIC alert result to send to CDC Laboratory	Date Alert Etest MIC result to send to CDC Laboratory (by Epi or Lab Coordinator)	Character; YYYY/MM/DD
DATESENTARLN	Date isolate sent to ARLN laboratory	Date isolate sent to ARLN laboratory	Character; YYYY/MM/DD
DATESENTCDC	Date isolate sent to CDC laboratory	Date isolate sent to CDC laboratory (only “Quick Send Alert Cases)	Character; YYYY/MM/DD

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