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pdfGonococcal Isolate
Surveillance Project
(GISP)
Coding Guide
Updated December 2013
GONOCOCCAL ISOLATE SURVEILLANCE PROJECT
Instructions for completing
Form 1 - Demographic/Clinical Data
ITEMS:
1.
Sentinel Site (3 letter code): Enter the appropriate 3 letter
code.
Albuquerque
Atlanta
Birmingham
Boston
Buffalo
Chicago
Cleveland
Columbus
Dallas
Greensboro
Honolulu
Indianapolis
Kansas City
ALB
ATL
BHM
BOS
BUF
CHI
CLE
COL
DAL
GRB
HON
IND
KCY
Las Vegas
Los Angeles
Minneapolis
New Orleans
New York City
Orange County
Philadelphia
Phoenix
Pontiac
Portland
San Diego
San Francisco
Seattle
Tripler
LVG
LAX
MIN
NOR
NYC
ORA
PHI
PHX
PON
POR
SDG
SFO
SEA
TRP
2.
Specimens collected during (Year/Month): Enter all four
digits of the current calendar year followed by the two digit
code indicating the month (01 for January, 02 for February,
etc). Example: The Year/Month code for March, 2014 would be
201403.
3.
Patient
Number:
Patient
number
based
on
sequential
identification of the first 25 male patients with presumptive
or confirmed diagnosis of gonorrhea each month. The data
entry program requires an entry in this field. You must enter
the two digit number that is assigned to the patient’s
isolate at the local lab, including leading zeros (i.e. "01"
instead of "1").
4.
Clinic: For Sentinel Sites using more than one clinic to
collect the GISP sample, the clinic code should be entered
here.
Each clinic is assigned a single-digit code by the
Sentinel Site; codes and the corresponding clinic names
should be given to the GISP data manager.
Any changes in
participating clinics should be communicated to the GISP data
manager.
GISP Coding Guide, updated December 2013
1
5.
Sex: Although the GISP protocol restricts isolate procurement
to male patients only, errors do occur. If an isolate is
unintentionally submitted to the lab from a female patient,
identifying the sex of the patient on Form 1 will prevent
this patient from being coded as a "case" in the GISP
database at the coordinating center. Although the data entry
program will accept an entry of "2" for "female", you will be
asked to confirm your selection. If the patient has male
genitalia, please code as male.
1= male
2= female
9= unknown sex
Note: Specifying that patients with male genitalia should be
classified as “1” (even if transgendered) was made explicit
in 2014.
6.
Ethnicity: This question pertains to patients of Hispanic
origin and/or native Spanish speakers.
If this information
is
solicited
for
the
patient's
record,
please
code
accordingly.
Do not assume a patient's ethnicity based on
surname alone, as people can change their names, be adopted,
etc.
Use only self-reported ethnic status.
Furthermore,
note that race and ethnicity are not mutually exclusive
variables. Individuals who indicate their ethnicity as
"Hispanic" are not necessarily "white".
If the information
is unavailable, please code this item "9" to indicate
"unknown". If the patient is described as "Hispanic" with no
accompanying race data, please code "1" for ethnicity.
1= Hispanic
2= non-Hispanic
9= unknown ethnicity
7.
Race: It is important to be as precise as possible with
regard to demographic data as it may be used as an indicator
of, or proxy for, other variables affecting morbidity
outcomes such as socioeconomic status. We realize that data
on race may not be collected at each site; however, where the
information is available, please use the following guidelines
in coding these data.
Self-reported race status is considered to be the most valid.
If race is not self-reported in the clinic record, but is
noted by the clinician, this information may be used. If
there is a conflict between the two, e.g., the patient selfreports that racial status is "white", but the clinician
describes patient as "black", use the self-reported status.
GISP Coding Guide, updated December 2013
2
You should respond "yes" for all race categories that apply.
American Indian/ Alaskan Native
1= yes
2= no
9= unknown
Asian
1= yes
2= no
9= unknown
Black or African-American
1= yes
2= no
9= unknown
Native Hawaiian/ Pacific Islander
1= yes
2= no
9= unknown
White
1= yes
2= no
9= unknown
Other
1= yes
2= no
9= unknown
8.
Date of Clinic Visit (mm/dd/yyyy): Enter the month, day, and
year of the clinic visit at which the positive gonorrhea
culture was obtained. If the day is unknown, enter "01" for
day. The year and month should correspond to the year and
month entered for item 2 above.
9.
Age: Enter patient's
missing data as "99".
age
in
years.
Code
unknown
age
or
10. Sexual Orientation: Sex of the patient’s sexual partners
within the past 3 months. In clinics where sex of sex partner
is not directly ascertained from the patient, code "9" for
"unknown".
Do
not
code
data
on
sexual
orientation
"heterosexual" by default.
1=
2=
3=
9=
women only (heterosexual)
men only (homosexual)
women and men (bisexual)
unknown
Note: Prior to 2013, this variable was defined as “sexual
orientation” and responses were categorized as heterosexual
GISP Coding Guide, updated December 2013
3
(1), homosexual (2), and bisexual (3).
11. Symptoms: This question pertains to the symptoms of urethral
gonorrhea only (such as discharge and dysuria [pain with
urination]). If there is no data in the record regarding the
presence OR absence of urethral gonorrhea symptoms, code this
field "9" indicating "unknown symptomatology".
1= discharge and/or dysuria
2= no discharge and no dysuria
9= unknown symptomatology
12. Previous History of Gonorrhea (ever): Please note any
previous documented or self-reported history of gonorrhea in
patient's lifetime. If there is no information concerning
history in the record, code "9" to indicate "unknown".
1= yes
2= no
9= unknown
13. Number of Previous Episodes in Past Year: Enter the number of
previous episodes of gonorrhea documented in the patient's
record within the past 12 months.
Please code:
0= no documented previous episodes in the past 12 months
(includes patients for whom this is the initial clinic
visit)
99= unknown (patient record not available or clinic staff
unable to collect this information due to record-keeping
system)
GISP Coding Guide, updated December 2013
4
14. HIV Status: Enter patient’s HIV status as known at the time
of the clinic visit for gonorrhea. Code "1" for "positive" if
the patient’s medical record documents a positive HIV test or
if the patient self-reports as HIV-positive. This can include
rapid tests for which results are available on the day of the
clinic visit. Code "2" for "negative" if the patient’s
medical record documents a negative HIV test within the
previous 3 months.
If the available information does not
allow you to code "1" or "2," then code "9" for "unknown."
1=
2=
3=
9=
positive
negative
indeterminate
unknown
15. Travel History (previous 60 days): Code "1" for "yes" if the
patient traveled outside of the United States (50 U.S.
states) during the previous 60 days. Code "2" for "no" if
the patient did not travel internationally during the
previous 60 days.
If travel information is not available,
code "9" for "unknown."
1= yes
2= no
9= unknown
Note: From November 2005-December 2013, this variable was
defined as travel outside of the state where the sentinel
site is located, in the previous 60 days. Prior to November
2005, this variable was defined as travel to Hawaii or
outside of the United States in the previous 60 days.
16. Sex Work Exposure (previous 12 months): If the patient
exchanged drugs or money for sex (or exchanged sex for drugs
or money) during the previous 12 months, code "1" for "yes."
If the patient did not exchange drugs or money for sex (or
sex for drugs or money), code "2" for "no." If it is unknown
whether the patient had sex work exposure, code "9" for
"unknown." Do not code "2" for "no" by default.
1= yes
2= no
9= unknown
Note: Prior to 2014, the time period for this variable was
the previous 60 days. In 2014, the time period was changed
to 12 months to align with other surveillance data systems.
GISP Coding Guide, updated December 2013
5
17. Previous Antibiotic Use (previous 60 days): Code "1" for
"yes" if the patient took antibiotics for any reason during
the previous 60 days. This should only include systemic oral
or injectable antibiotics, and should not include antibiotic
ointments or eye drops. Code "2" for "no" if the patient did
not take antibiotics for any reason during the previous 60
days.
If it is unknown whether or not the patient took
antibiotics, code "9" for "unknown."
Do not code "2" for
"no" by default.
1= yes
2= no
9= unknown
Note: Starting in 2014, language stating that “This should only
include systemic antibiotics, taken orally or by injection, and
should not include antibiotic ointments or eye drops,” was added.
18. Injection Drug Use (previous 12 months): Code "1" for "yes"
if the patient reported using recreational injection drugs
during the previous 12 months.
Code "2" for "no" if the
patient reported not doing recreational injection drugs
during the previous 60 days. If it is unknown whether or not
the patient used recreational injection drugs, code "9" for
"unknown." Do not code "2" for "no" by default.
1= yes
2= no
9= unknown
Note: Prior to 2014, the time period for this variable was
the previous 60 days. In 2014, the time period was changed
to 12 months to harmonize with other surveillance data
systems.
19. Noninjection Drug Use (previous 12 months): Code "1" for yes
if the patient reported using recreational non-injection
drugs during the previous 12 months. Examples: ecstasy,
crack, cocaine, marijuana, methamphetamines, poppers. (But
excluding alcohol, medications for erectile dysfunction, and
steroids.) Code "2" for "no" if the patient reported not
doing recreational non-injection drugs during the previous 60
days.
If it is unknown whether or not the patient used
recreational non-injection drugs, code "9" for "unknown." Do
not code "2" for "no" by default.
1= yes
2= no
9= unknown
GISP Coding Guide, updated December 2013
6
Note: Prior to 2014, the time period for this variable was
the previous 60 days. In 2014, the time period was changed
to 12 months to align with other surveillance data systems.
In 2014, the statement that this variable “excludes alcohol,
medications for erectile dysfunction, and steroids,” was
added.
20. Treatment One (Primary treatment of gonorrhea): Indicate the
primary antimicrobial prescribed to treat the case of
gonorrhea. Please use the two-digit treatment codes below.
If entering the code "88" for "other", include the name of
the drug in the space provided. If no treatment for gonorrhea
was given, code "00". You must enter both digits of the
treatment code, including leading zeros. Please note that
"01" and "02" are not valid codes.
00=
03=
04=
05=
06=
07=
12=
15=
17=
18=
21=
22=
23=
24=
25=
26=
27=
28=
88=
no treatment given
spectinomycin (Trobicin) 2 g
ceftriaxone (Rocephin) 250 mg
ceftriaxone (Rocephin) 125 mg
ciprofloxacin (Cipro) 500 mg
cefoxitin (Mefoxin) 2 g
cefixime (Suprax) 400 mg
ofloxacin (Floxin) 400 mg
ceftizoxime (Cefizox) 500 mg
cefotaxime (Claforan) 500 mg
azithromycin (Zithromax) 2 g
levofloxacin (Levaquin) 250 mg
cefpodoxime proxetil (Vantin) 400 mg
ceftibuten (Cedax) 400 mg
cefdinir (Omnicef) 300 mg
cefdinir (Omnicef) 600 mg
gemifloxacin 320 mg
gentamicin 240 mg (or weight-based dosage)
other primary treatment and dosage for gonorrhea (please
indicate name and dosage below)
99= therapy data unknown/ missing
Note: gemifloxacin and gentamicin were added in 2014.
25. Other Treatment One: If code "88" ("other") was entered for
Treatment One, write in the name and dosage of the primary
antimicrobial therapy for gonorrhea and dosage that was
administered.
26. Treatment Two (Second antibiotic used for treatment of
gonorrhea and (if appropriate) treatment of chlamydia): In
many cases, two antibiotics may be prescribed for patients
diagnosed with gonorrhea. Dual therapy (treatment with a
cephalosporin
antibiotic
and
either
azithromycin
or
doxycycline) has been recommended for treatment of gonorrhea
since 2010. In addition, patients that are diagnosed with and
GISP Coding Guide, updated December 2013
7
treated for gonorrhea are often treated for chlamydia at the
same time. The recommended therapies for chlamydia are
doxycycline
and
azithromycin.
Seven-day
courses
of
erythromycin, amoxicillin, levofloxacin, and ofloxacin are
alternatives for selected patients.
If dual therapy was administered, indicate the second
antimicrobial used. If therapy for chlamydia alone was given,
indicate this therapy. Please use the treatment codes below.
Code "88" for other only if the dual therapy did not include
any of the listed treatment options. You must enter a twodigit code in this field, including leading zeros.
00=
01=
09=
10=
11=
15=
21=
22=
88=
99=
no secondary treatment given
ampicillin/amoxicillin
doxycycline (Vibramycin)/tetracycline
erythromycin
azithromycin (Zithromax) 1 g
ofloxacin
azithromycin (Zithromax) 2 g
levofloxacin
other
therapy data unknown/missing
Previously collected variables
Monthly Clinic Totals for Gonorrhea: Not collected after 2013.
The total numbers of gonorrhea episodes diagnosed during the
entire month for male and for female patients at the site, and
the sum of these two numbers. Multiple episodes in one patient
in a given month were to be counted individually. Sites with
more than one clinic submitting isolates to GISP were to enter
sum of totals for all contributing clinics.
Date of Birth (mm/dd/yyyy): Not collected after 2013.
If year of birth was known, but month and/or day was unknown,
"01" was entered for month and/or day.
Reason for Visit: Not collected after 2013.
This variable was coded "volunteer" when the patient has
requested treatment of his own volition. Patient were coded as
“contact” if they had requested treatment because he is a sexual
contact of a patient with gonorrhea, or because he had been
informed of a potential exposure to gonorrhea by a health
department/DIS. Patients who sought treatment because of sexual
contacts having other diagnosed STDs or were referred by a
private physician were coded as "other".
1= volunteer
GISP Coding Guide, updated December 2013
8
2=
3=
8=
9=
contact to gonorrhea
test of cure
other
unknown
Zipcode: Not collected after 2013.
00000= homeless
99999= unknown zip code
GISP Coding Guide, updated December 2013
9
GONOCOCCAL ISOLATE SURVEILLANCE PROJECT
Instructions for completing
Form 2 - Antimicrobial Susceptibility Testing
ITEMS:
1.
Sentinel Site (3 letter code): Enter the appropriate 3 letter
code.
Albuquerque
Atlanta
Birmingham
Boston
Buffalo
Chicago
Cleveland
Columbus
Dallas
Greensboro
Honolulu
Indianapolis
Kansas City
ALB
ATL
BHM
BOS
BUF
CHI
CLE
COL
DAL
GRB
HON
IND
KCY
Las Vegas
Los Angeles
Minneapolis
New Orleans
New York City
Orange County
Phoenix
Pontiac
Portland
San Diego
San Francisco
Seattle
Tripler
LVG
LAX
MIN
NOR
NYC
ORA
PHX
PON
POR
SDG
SFO
SEA
TRP
2.
Specimens collected during (Year/Month): Enter all four
digits of the current calendar year followed by the two digit
code indicating the month (01 for January, 02 for February,
etc). Example: The Year/Month code for March, 2004 would be
200403.
3.
Isolate
patient
enter a
instead
Number: Sequential identifier corresponding to the
number in the demographic/clinical data. You must
two digit number, including leading zeros (i.e. "01"
of "1").
GISP Coding Guide, updated December 2013
10
ANTIMICROBIAL SUSCEPTIBILITY TESTING: Please use only the
dilutions indicated for each drug. Currently recommended testing
range is bolded.
4.
β-Lac: (β-lactamase test)
1=positive
2=negative
5.
Pen: (Penicillin MIC)
Valid dilutions: 0.008; 0.015; 0.03; 0.06; 0.125; 0.25; 0.5;
1.0; 2.0; 4.0; 8.0; 16.0; 32.0; 64.0
6.
Tet: (Tetracycline MIC)
Valid dilutions: 0.06; 0.125; 0.25; 0.5; 1.0; 2.0; 4.0; 8.0;
16.0; 32.0; 64.0
7.
Spc: (Spectinomycin sensitivity)
1= sensitive (MIC < 128 μg/ml)
2= resistant (MIC ≥ 128 μg/ml)
8.
Cfx: (Cefixime MIC)
Valid dilutions: 0.002; 0.004; 0.015; 0.03; 0.06; 0.125;
0.25; 0.5; 1.0; 2.0
9.
Cro: (Ceftriaxone MIC)
Valid dilutions: 0.001; 0.002; 0.004; 0.008; 0.015; 0.03;
0.06; 0.125; 0.25; 0.5; 1.0; 2.0
10. Cip: (Ciprofloxacin MIC)
Valid dilutions: 0.001; 0.002; 0.004; 0.008; 0.015; 0.03;
0.06; 0.125; 0.25; 0.5; 1.0; 2.0; 4.0; 8.0;
16.0
11. Azi: (Azithromycin MIC)
Valid dilutions: 0.008; 0.015; 0.03; 0.06; 0.125; 0.25; 0.5;
1.0; 2.0; 4.0; 8.0; 16.0
12. Date Tested (mm/dd/yyyy):
isolate testing.
GISP Coding Guide, updated December 2013
Enter
month,
day,
and
year
of
11
13. Control ID (A, B, C, or D): Enter control ID for control
strains that are tested with the batch of sentinel site
strains.
This must correlate with information entered on
Form 3 Control Strain Susceptibility Testing.
GISP Coding Guide, updated December 2013
12
GONOCOCCAL ISOLATE SURVEILLANCE PROJECT
Instructions for completing
Form 3 - Control Strain Susceptibility Testing
ITEMS:
1.
Regional Laboratory (3 letter code): Enter the appropriate 3
letter code.
Atlanta, Emory University
Birmingham, University of Alabama
Austin, Texas Department of State Health Services
Seattle, University of Washington
Baltimore, Johns Hopkins University
EMO
UAB
AUS
UWA
JHU
2.
Control ID: Distinguishes different test runs for group of
control strains by date tested. No data entry required.
3.
Strain Number: Identifier for specific control strains.
ANTIMICROBIAL SUSCEPTIBILITY TESTING: Enter as for Form 2. For
complete instructions, including valid value ranges for each
drug, see instructions for Form 2 in this handbook.
4.
Date tested (mm/dd/yyyy): Enter the month, day, and year on
which antimicrobial susceptibility testing for the isolate
was completed.
GISP Coding Guide, updated December 2013
13
File Type | application/pdf |
File Title | GISP Coding Guide |
Author | Division of STD Prevention, CDC |
File Modified | 2014-01-07 |
File Created | 2014-01-07 |