Lab Data Elements for Lab Data Manager

Form Approved

OMB No. 0920-NEW

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

SURRG Laboratory Testing Data Elements

Public reporting burden of this collection of information is estimated to average 10 minutes 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-2

SURRG Laboratory Testing Data Elements

Microbiologists at participating local public health laboratories will conduct STD testing and antibiotic susceptibility testing on N. gonorrhoeae isolates collected as part of routine clinical care at the participating clinical sites (from patients included in the facility-based data). This tool is used to represent the laboratory testing data elements used by the microbiologists to conduct the required testing.

This is a subset of the data elements displayed in Attachment 3C-1 and is limited to those data elements that the microbiologist will complete as part of laboratory testing.

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
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
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=E-test 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

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