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Merlin Case Entering for HBsAg+ Pregnant Women For questions contact: Cristina Dusek, Statewide Perinatal Hepatitis B Prevention Program Coordinator (850) 245-4444 ext. 2396 8/2013

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Merlin Case Entering for

HBsAg+ Pregnant Women

For questions contact: Cristina Dusek, Statewide Perinatal Hepatitis B Prevention Program Coordinator (850) 245-4444 ext. 2396

8/2013

Routine Case Finding Methods • Perform case finding in Merlin on a weekly basis utilizing:

• Chronic hepatitis B & C task list search and • Electronic lab result (ELR) search

• Follow-up with physicians or laboratories that report a hepatitis B positive woman of child-bearing age

2

• Once a hepatitis B positive pregnant woman has been identified, each individual case must include the following, which is part of the Merlin surveillance system requirements:

– Profile: Each individual added to the Merlin surveillance system has a profile.

All labs and disease cases for this individual are added to this profile. The profile includes name, date of birth (DOB), and geographical information. When ELRs are received through Merlin, a profile is auto-created.

– Chronic Hepatitis B Case: Each individual who tests positive for hepatitis B will

need one chronic hepatitis B case added to their profile with an associated lab. The chronic hepatitis B case is used to track the individual over time, whereas the HBsAg+ pregnant woman case is used to track a pregnancy and infant. When a hepatitis B ELR is received in Merlin, a chronic hepatitis B case is auto-created and lab is attached. Lab results obtained after the initial chronic case is created auto attach to the chronic case and will show a recent update to the case in the Merlin Hepatitis B and C Task Lists.

– HBsAg+ Pregnant Woman Case: Obstetric providers are required to test women during each pregnancy for HBsAg. Although other hepatitis B positive labs in a pregnant women would indicate the necessity to enter a case, a HBsAg will need to be obtained to meet case definition.

Case Components

3

Case Components • The components of the case you will need to enter will depend on

how you were notified of the case and if the individual has an existing profile or chronic hepatitis B case.

• This case entering document is divided into sections based on how

you are notified of the case. • Sections in this document include:

1. Entering case without an ELR 2. Entering cases found on the Chronic Hepatitis B & C Task List in

Merlin 3. Entering cases found by ELR search in Merlin

4

Entering cases without ELR Cases without an Electronic Laboratory Report (ELR) may include the following: • Physician or laboratory reported cases that are not reported

electronically in Merlin • Paper reported cases that are not reported electronically in

Merlin

5

Profile Search

Each individual with any labs or disease cases in Merlin will need a single profile. The profile includes name, DOB and geographic information. All disease cases for the individual should be attached to a single profile.

• First search to see if a profile exists by going to the Search tab in Merlin and searching by name • If profile does not exist, create a profile (See slide on creating a profile)

6

A. If a profile exists, ensure the name and DOB in Merlin matches the name and date of birth of the reported individual • Click on the name to access the profile

B. The profile summary includes all disease cases and labs associated with an individual • Picture B illustrates an individual with an existing profile and salmonellosis case attached. In this case a

profile will not need to be created • If a profile is not found during the search, create a profile (see next slide)

A

B

Profile Search

7 7

Creating a Profile

A. While on the Search tab notice the left toolbar • Under New Profile click Create

B. Enter Profile Detail-Name, DOB, race, ethnicity, address, phone number • Click Save

A

B

8

Cases

by Ca••. by H•m•

Adv• nced

Infa nt Se• rch

Note s Se• rch

Profie Search Case Numbe r :

La b Number:

'-"st Na m e: f'iJRAL HEPATITIS

e•=.. . .. ......... _ .-............ u , ~• "' ·L .. .

Lft~t_ N nnt a l [VIIIV't... H4;QI\Tf"T"I $0

M+<k:fl·~ I -·~·-- 1..-----------

Ct.nnlc:lty :

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u9 AdU••••• rr ,. •• r NO

4 t r••• NJOrn• 1 ' ,.------------------

Stl'set N ame :z : 1

Zlp:r- • r- ft c;..tl[)' : = :::::: 1,.--------

li~oncy ~t-to.-..1 j--------

Hsle fqr th11 Paps

Firs t N a m e:

Searc h

j , I J .. , .. --- ·

- I

<.ou nt.y:

"""•'oe~Y c;qnt..D~tl ,.--------

Creating a Chronic Hepatitis B Case

• Each individual with a positive hepatitis B test (HBsAg, HBcAb, HBV DNA, HBeAg) will require one chronic hepatitis B case added to the profile

A. The Summary choice under the left toolbar Profile heading indicates all cases and labs attached to the individual’s profile

• Picture A illustrates an individual profile with a chronic hepatitis B case already attached • If a chronic hepatitis B case already exists in the Profile Summary, do not create another

B. Picture B illustrates details included in a profile. • If no chronic hepatitis B case exists on the individuals profile, create a new chronic hepatitis B case (see next

slide)

A

B

9 9

A. While in the newly created individual profile • On left toolbar under New Case click Create

B. For chronic hepatitis B use Disease Code 07032 • Add all dates (CHD Notified Date and one other date field is required) • Click Continue

A

B

Creating a Chronic Hepatitis B Case

10

Profile

o .. uol-.

Sum millry

H i $ t Qty

Profile

Details

Summary

H istory

Cases

Profile 10: 645 881

Note: The fields labels in blue indicate the fields required to "Submit" a case.

SSN: r----------#~#-#~- ~~~~

Maiden: r--------------------------

Gender: F EMALE

Date o f Birth: 126/ 08/ 1975 r Unknown

Race: WHITE

Profile Summary

FL Disease Code Selection

Name: HEPA~S, BEE

SSN:

First Name: BEE

Suffix:

Date of Death: r--------

Date of Birth: 06 / 08/ 1975

Fl Disease Code: HEPATITIS 8, CHRONIC - 07032

No t e : Ente r a ll d a t es a va ila b le. CHD Not ified Date AND one o t h e r d ate field is

Date Onset:

Lab Report Date: 106/ 05/ 20! 3

Food Recalls

Age at Event: I

The earliest o f the dates above will be used to determine the EVENT DATE of t he case. The event date is used to determine which version of CASE DEFINmON should be used to

Complete Information (All items with dark blue text are required fields) • Enter Case Information • Enter Clinical Information • Diagnosis (Dx) Status will be completed in another screen • Profile Information at time of diagnosis • Sensitive Employment • Click Save

Entering Basic Case Information for a Chronic Hepatitis B Case

11

Adding a Lab Result to Chronic Hepatitis B Case

A. On left toolbar under Case heading click Lab Results B. Click on New Lab Result C. Use drop down box to select appropriate lab to attach click Continue

A

B

C

12

Profile

P rofile Deta ils

S u mma ry

H is tory

Case Overview

Summary

Cases

Case

Bas ic Data

Lab R &$u lts

EP I Link

Note: The fields labeled in blue indicate the fields that are required to save

N a m e: HEPATITIS, BEE Da t e of Birt h : 06/08/1975

S S N:

FL Disease Code : H EPATITIS B , C H RONI C - 0 7 032

Inves t iga t o r : DUSEK, CRIST I NA ( DUSEKCM)

Ox St:atus: Not reportable by surveillance case

Date of Birth : 06/08/197:5 Age at: E vent: : ~

Case Information

Name : HEPA~S,BEE

SSN :

FL Disease Code : 0703 2 - HEPA~S B, CHRONIC

Event Date: 06/05/2013

Dat e of Birth : 06/08/1975

Case # : 62139:5 Case S t a tus: I NCOMPLE T E

Age a t Ev e n t : ~

Case#:~

Case Stat us: INCOMPLET E

• Enter Merlin Test Information • Items with dark blue text are required fields • If it is a physician or paper reported case of hepatitis B, a lab result must be obtained to complete Merlin test information • Lab results added to chronic hepatitis B cases could also include: HBsAg, HBcAb, HBV DNA, HBeAg

Adding a Lab Result to a Chronic Hepatitis B Case

13

Add Facility and Provider Information to manually entered lab A. By clicking Get Lab, Get Provider, or Get Facility you may search and add facility and provider to the lab results B. Enter a facility or physician name and click Search. C. Click on the facility or provider that matches the original lab result D. Click Link Resource

• Do the same for provider and ordering facility • When done click Save

E. Enter other labs by clicking Yes on the next screen • If no more labs to enter click NO

A

B

C

D E

Adding a Lab Result to a Chronic Hepatitis B Case

14

A. On left toolbar under Case heading click Basic Data B. On the left toolbar heading Case Details click Case Definition C. Scroll to the bottom of the Case Definition page and click Set DX Status

• When Basic Data, Lab results, and DX status are completely documented you may report the case and submit for review (see next slide)

Reporting and Submitting a Chronic Hepatitis B Case A

B

C

15

Profile

Prof ile D etai ls

S urnm .il ry

H istory

Nam e: HEPA~S,BEE

SSN:

FL Dis ease Code: 07032 - HEPA~S B, C HRONIC

Event Date: 06/07/2013

Cas e#

16 2 1 3 95

Flor ida D isease C o d e

0 7032 - H EPATITIS 8 , C H RO NIC

f)••lllil:llili •• (JProfle 1 case Information

S u mmary

Case

Ba s ic Data

Lab Resu lts

EP I Unk

C.s.e Ove rvi e w

Name : HEPA~S, BEE

SSN:

FL Disease Code: 0 7 0 3 2 - HEPA~S B, CHRONIC

Event Date: 06/ 07/2013

Dat e of Bir t h : 06/08/1975

Lab # Panel # Repor t e d

0 6 / 0 7/20 1 3 l.l.l..2Z!UZ I

Date of Bir t h : 06/08/ 1975 Age at Even t: ~

Case#:~

Case Sta tu s: INCOMPLETE OX Status: PROBABLE

C."• O • finition hepati tis B in fec tio n m ay have no evidence o f liver disease or may have a sp ectrum of disease rang ing from ch ronic h epatitis t o cirrhos is or live r cancer . Persons w ith c hronic in fection may b e

H ealthcar• V i " its

nega t ive, AND a positive resul t on one o f the following tests: h epatitis B surface an tigen ( HBsAg), hepa t itis B e a n tigen ( HBeAg), or

._ __ s_e_ ·t:_D_ X_ St:_ a_ t:_u_s __ _,l --

A. On left toolbar under the Case heading click Basic Data B. At bottom of the Basic Data page click Report C. Ensure you are submitting the correct data and click Submit

• The case is now reported to CDC • No further investigation is required for chronic hepatitis B cases

A

B

C

Reporting and Submitting a Chronic Hepatitis B Case

16

, Dcl!!iU .. 'L.cl~~ nTur~.-rctoun

P r ofil e D•t~d ls

S u rnrnary Name:

H is t ory SSN :

c~se:s

Ba~ic D a<a ~·~• •••~~~•• L a b Res u lts FL Disease Code:

E P I L in k Inves tigato r :

C •s• O v&rvia w

rn; -=-~~· Intormation

Physician:

Address:

City:

Phone:

Email:

Re - Use Physician J

I Dele t e I Profile I Case Information

N.;:lmo : Ht=:PATITIS, Bt=t=

S S N :

F L D isease code: 0703 2 - HEP ATITIS D , CHRO NIC

E v ent: D a te: OG/ 07 / 2013

Cornplet:eness Requlrernent:s

The case dat::a is complet:e.

Ke~Ortif!q_ Ke_~!-'irernent:s

Valid case Uefinit::ion

Lab Rc:~ult: Rcquircrnc:nt:: POSITIVE

I General Requirements

I There are no General Requirement: violatJi ons.

I Dat:a Qualit::y Checks

-Not:e: The fields labeled in blue indicat:e t:he fields t:hat: are required t:o save

H E PATITIS, B EE Da te o f Birth : 0 6/08/1975

D x Statu s: R e p ortable by s urve illa n ce case d e fin

H E P ATITIS B , C HRONIC - 0 7 0 3 2 ~ ~

DUS EK, C RIS TINA ( DUSEK C M ) ~

State: Zip :

Fax:

I ~ I Sav e I ~

0.;:Jt:C o f Birth: 06/0B / 1975

Tho f o llo VIIi ng dat:a ar·o n o odod t o s: a vo tho c a!W. o a~ ••coMPLETI::""­VVithout: t:hi~ info l - n"lat:io n t:hc: c:::;.a ~c: -ill b e: ~avc:d a~ ""INCO MPLETE"" -

There illre. no Dill~ill Quillli~ violilltions.

OK

I

Adding a HBsAg+ Pregnant Woman Case

• A pregnant woman who is found to be hepatitis B positive will need a case and a corresponding lab created with the corresponding profile

A. Under left toolbar Profile heading click Summary B. Once in the Summary screen on left toolbar under New Case click Create C. Use drop down box to select Disease Code 07039

• Enter dates • Click Continue

A

C

17

B

Entering Basic Information for a HBsAg+ Pregnant Woman Case

Complete Information (All items with dark blue text are required fields) • Enter Case Information • Enter Clinical Information • Diagnosis (DX) Status will be completed in another screen • Profile Information at time of diagnosis • Sensitive Employment • Click Save

18

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

A. On left toolbar under Case click Lab Results B. Click New Lab Result C. Use drop down box to select test

• Click Continue

A

C

B

19

Profile

Profile Details

Sum m a ry

History

Lab Resu lts

EPI Link

Case Ove rview

Case Details

No Lab Tests are available for this Case

Case Information

Note: The fields labeled in blue indicate the fields that are required to save the case status

Name: HEPATITIS, BEE Date of Birth: 06/08/ 1975

SSN:

Ox Status: Not reportable by surveillance case definition

Fl Disease Code: HEPATITIS 8 (+HBsAg lN PREGNANT WOMEN) - 07039 T

Investigator: DUSEK, CRISTINA (DUSEKCM)

__ N_e_w_ L_a_b_R_e_s_u_lt_j --

Profile

P rofil e D e t a i ls

S u mmary

C ase-s

Case

Basic D a t a

L a b R esu lts

EPI Link

Na m e: HEPA~S,BEE

S SN :

D a t e o f 1

F L Disease Cod e : 0703 9 - HEPA~S B (+HBsAg IN PRE GNANT

Ev e n t Da t e : 0 6 /05/2013

• Enter Merlin Test Information • All items with dark blue text are required fields

• May re-use test attached to a recently entered chronic case (within 60 days) but lab will need to be re-entered

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

20

Add Facility and Provider Information to a manually entered lab: A. By clicking Get Lab, Get Provider, or Get Facility you may search and add facility and provider to the lab results B. Enter a facility or physician name and click Search. C. Click on the facility or provider that matches the original lab result D. Click Link Resource

• Do the same for provider and ordering facility • When done click Save

E. Enter other labs by clicking Yes on the next screen • If no more labs to enter click NO

A

B

C

D E

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

21

Reporting a HBsAg+ Pregnant Woman Case

A. On left toolbar under Case heading click Basic Data • Under the left toolbar heading Case Details click Case Definition

B. Check boxes if appropriate criteria are met • Scroll to the bottom of the Case Definition page and click Set DX Status

A

B

22

Profile Case Information Profile Det• ils N ote: The fields label e d in b lue indicate t h e fie lds t h at a r e r e quire d

Summary

H i s t o ry Name : HEPA~S,BEE

SSN :

Date of B irth : 0 6/0 8 /19 7 5

Ox Statu s: Not r e p ortable by s urve illa n ce

Lab Re<S u l ts

E P I Li nk

Ca5& OvQrvi e v.r

Ca.se Status

."."."."."¢·~--~--~." .. 6."~-.f.i_.F.! .. itiO."~· C•s e S y mptoms

FL Disea se C ode: HEPATITIS B ( +HBsAg IN PREGNANT WOMEN) - 0703 9 ~

Investigator: DUSEK, C RlSTINA ( DUSEKCM )

CHD Reference -# :

. _, ___ r~.a..-t a /\ ,- ,.,, lircrl in l= l nr-irl:.

Name: HEPA~S, BEE

SSN:

Date o f Bi rth: 0 6/08/ 197 5 Age at E v ent: ~ s .... ..... . ,.

EPJ Lin k rsct -DX Sta tus

FL Oi5ea5e Cod e; 07039 - HEPATITIS B { +HB5 Ag IN PREG N A N T W O MEN)

e v e n t Date : 06 / 07/ 2 01:1

Hepatitis B { +HBsAg in Pregnant Women)

Clinical case definition

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Meel::; ll1e di11iLdl LdSI::! tJef'i11iliUI I u( d L U l e Ul diJUIIiL l lt:!I.Jdlilis B

Laboratory criteria for diagnosis

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Case c lassification

H .. ., e. o........ .. ,,. .. ,...,., C o n firmc:!d "

l'lli;;;;;~ A c ase that meets t h e c lin ical c ase definition and is laboratory con firmed.

" Note r .-~~:::.~=:nk Mull1e1s U1 1Ue1 l11is tJisedst:: LutJe ( 07039) s l 1uultJ dbu I.Je lt::I.JUi lt::tJ U1 1tJet tJi::oed se LutJes fu1 d L ule Ht::I.Jdlilis B { 07030) u 1 duu1 1iL Ht::I.Jdlili::o B ( 0 7032) d S di.JI.JIUI.Jiidle .

Ci'115e *:~ C.:~~c S t.ltu::;.: INC OMPLE TE <""'::r. c;P. FJCt. Str~tu<>:

10 51

:EJ 1 S92

Set OX S t n tus =---r-1.

Completion of Basic Data, Lab Results, and Dx Status will allow reporting of the case • On left toolbar under Case click Basic Data • Scroll to the Bottom of the Basic Data and click Report • The case is now reported • The next step is to investigate the case and submit for review

Reporting a HBsAg+ Pregnant Woman Case

23

Submitting a HBsAg+ Pregnant Woman Case for Review

• Investigation should be done prior to submitting a case for review (Make sure to save all information entered) • Contacts (Includes type of contact, follow-up, vaccination and disease status) • Mother Information (Includes treatment, background, delivery)

A. On the left toolbar under Case Details click Mother Information • Although only EDC is required to submit, complete other information if known • To enter contact information go to left toolbar, under Case Details click Contact Information • Enter as much information as possible

B. Click in box to Submit CRF • Click Submit

C. Case will be reviewed and sent back for more information if necessary

A

B

24

Case Entering for a Pregnant Woman Found On the Chronic

Hepatitis B and C Task List

• Hepatitis B cases reported by ELR • Merlin will automatically create a profile for individuals with an

ELR • Merlin will auto-create a chronic hepatitis B case or add an

updated lab to the existing profile if a chronic hepatitis B case is already attached

25

A. Go to Task Tab B. Under Cases click Chronic Hepatitis B & C

• Do not skip this search because there are no numbers next to the search, there will not be a number next to this option even if cases exist

C. On left toolbar click on Common Criteria D. Narrow your search to only the Chronic Hepatitis B Disease Code (07032) E. Apply Additional Filter: Females, child-bearing age, Show activity for Both Cases and Labs

Chronic Hepatitis B and C Task List Search

A

B

C

D

E

26

• When an ELR is received for HBsAg, HBV DNA, HBeAg or HBcAb, Merlin will auto-create a chronic hepatitis B case and attach the lab to the case

• When an ELR is received for HBsAg, HBV DNA, HBeAg or HBcAb, and the individual profile already has a

chronic hepatitis B case, Merlin will attach the lab to the existing chronic case and notify you of the recent lab in the task list

• The ordering provider and facility indicated will be from the original lab when the chronic case was first created

• Make sure to click on the case number and view the most recent lab and ordering facility to help determine pregnancy status

• Any women of child-bearing age who presents on this task list should be investigated to determine pregnancy status

Chronic Hepatitis B and C Task List Search

27

A. When you click on a Case # from the task list you will be taken directly to the Case Information screen B. To view the profile information and summary of cases and labs, click on Summary under left toolbar heading Profile

• Picture B illustrates a profile that has an auto-created chronic hepatitis B case and labs attached • The individual will need to be investigated to verify pregnancy status • Each lab will need to have a corresponding HBsAg+ Pregnant Woman case if pregnant

A

B

Chronic Hepatitis B and C Task List Search

28

• Investigate pregnancy status by contacting ordering provider of hepatitis B lab • If the woman is pregnant, add a HBsAg+ Pregnant Woman case • If a lab other than HBsAg was done, obtain required HBsAg result from provider

• Providers are required to test for HBsAg at initial pregnancy visit and again at 28 to 32 weeks gestation for every pregnancy regardless of past test results

Investigating Cases on Chronic Hepatitis B and C Task List

29

lll•llitziliill:l··~ Prollc I Cd..., l n formdliOn .,....,,l. o.~--.<1. N i~me: tlt:PATITIS. DCC

J.vmm•ry

'--....... lu

IPI L.lftk

c ••• o..- .....

:·: :::::::.::

I """''" to tut

O• t • o t Dwth : 06/00 /197!)

SSN:

rL Dl••aM C~: 070.32 IICPATTnS D, C IIRONI C

Ev•nt One; 06/ 0 1/2.013

Merin I C:lit Info rmation Cl)1,m l y A•. !--if l n Cd : LeON

Acc-cclon •= fi"""'oo:::o:-:o::::ooo= o:::0::::00::-:0,---------

Inv••t .gat o.-: OUSFKC M • 8 Test: HO.sAg

Mf•rtin S p ,..t,;lnuon Co •h •: 8t..OOO VENOUS • fl)

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~b Evant o .. to: 06/ 0 S/2013

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LLR Raw Dat.B

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Lab • : 116781 7 !;t.tu•: C LOS CO

Adding a HBsAg+ Pregnant Woman Case

• A pregnant woman who is found to be hepatitis B positive will need a case and corresponding lab created under the profile

A. Under left toolbar Profile heading click Summary • Once in the Profile Summary screen on left toolbar under New Case click Create

B. Use drop down box to select Disease Code 07039 • Enter dates • Click Continue

A

30

B

Entering Basic Information for HBsAg+ Pregnant Woman Case

Complete Information (All items with dark blue text are required fields) • Enter Case Information • Enter Clinical Information • Diagnosis (Dx) Status will be completed in another screen • Profile Information at time of diagnosis • Sensitive Employment • Click Save

31

Adding a Lab Result to HBsAg+ Pregnant Woman Case

A. On left toolbar under Case click Lab Results B. Click New Lab Result C. Use drop down box to select test

• Click Continue

A

C

B

32

Profile

Profile Details

Summary

History

Cases

Case

Basic Data

Lab Results

EPI Link

Case Overview

Case Details

Summary

c .. .. lliils

Case

Bas ic Data

L • b R e:su lt:a

EPI Link

No lab Tests are available for this Case

Case Information Note: The fields labeled in blue indicate the fields that are required to save the case status a•

Name: HEPATITIS, BEE Date of Birth: 06/ 08/ 1975

SSN:

Dx Status: Not reportable by surveillance case definition

Fl Disease Code: HEPATITIS 8 (+HBsAg IN PREGNANT WOMEN) - 07039 •

Investigator: DUSEK, CRISTINA (DUSEKCM)

New Lab Result~ N a m e: HEPA~S,BEE

SSN:

Date of I

F L Disease Cod e : 07039 - HEPA~S B ( + HBsAg IN PREGNANT WC

Even t Date: 06/05/ 2013

• Enter Merlin Test Information • All items with dark blue text are required fields

• May re-use test attached to a recently entered chronic case (within 60 days) but lab will need to be re-entered.

Adding a Lab Result to HBsAg+ Pregnant Woman Case

33

Add Facility and Provider Information to manually entered lab A. By clicking on Get Lab, Get Provider, or Get Facility you may search and add facility and provider to the lab results B. Enter a facility or physician name and click Search. C. Click on the facility or provider that matches the original lab result D. Click Link Resource

• Do the same for provider and ordering facility • When done click Save

E. Enter other labs by clicking Yes on the next screen • If no more labs to enter click NO

A

B

C

D E

Adding a Lab Result to HBsAg+ Pregnant Woman Case

34

Reporting a HBsAg+ Pregnant Woman Case

A. On left toolbar under Case heading click Basic Data • Under the left toolbar heading Case Details click Case Definition

B. Check boxes if appropriate criteria are met • Scroll to the bottom of the Case Definition page and click Set DX Status

A

B

35

Profile Basic Case I nformation P r ofile D e t a ils Not:e: The fields labeled in blue indicat:e t:he fields t:hat: are required t:o

S u mm a ry

H i s tory N ame : HEPA~S,BEE

SSN:

D ate of Birth : 06/08/1975

ox St:at:us: Not: reportable by s urveillance

FL Disease Code: HEPATms B (+HBsAg IN PREGNANT WOMEN) - 0 7 039 ~

Investigator : DUSEK, C RISTINA (DU SEKCM)

CHD Ref e rence # :

N A.m • : H~PATI"n.S1 H F'1

S:;N :

1-&. O.s•3s• Cod•: 0 ./03 9 • H I!PA rn l !!i U ( + H Q $ .1\l] IN PJC ... C NAN I WOM~N)

event Date: 06/0, /2013

~~.:::~~~ Hepatitis B (+HBsAg in Pregnant Women) Clinica l case d efin ition C.•• lt.at ....

c.-O•Ilftit O.•

C•••••~crt~• e. .. - 1 M ........ .

"••~the-• "" .... Trevell"'lstert

M eU.•• , ,., .......... ,.

t nfaM I.,f<Oonn•~

Oenl~ l,..,otwrn•n <)l'l

fto-llo-up

M••t. the chntcal caa• d•ftnttion of acut• or c hron.c hepabba 0

La boratory crit e r ia for dia gnos is

PostDVe M p aDt iS D surt ac• ant tgen (HDsAg) resul t .

Cast!l c las s ification

O.;.t• of 91rth: 06/0A/1 Q7~

case • : 1LLI..5..3!t Clot• S Ut\11: IN( : ()M..,l..t-U ... C.t e lixt. S taru. :

.... P l6S l

[j;J ••• ,

Completion of Basic Data, Lab Results, and Dx Status will allow reporting of the case • On left toolbar under Case click Basic Data • Scroll to the Bottom of the Basic Data and click Report • The case is now reported • The next step is to investigate the case and submit for review

Reporting a HBsAg+ Pregnant Woman Case

36

Submitting a HBsAg+ Pregnant Woman Case for Review

• Investigation should be done prior to submitting case for review (Make sure to save all information entered) • Contacts (Includes type of contact, follow-up, vaccination and disease status) • Mother Information (Includes treatment, background, delivery)

A. On the left toolbar under Case Details click Mother Information • Although only EDC is required to submit, complete other information if known • To enter contact information on left toolbar under Case Details click Contact Information • Enter as much information as possible

B. Click in box to Submit CRF • Click Submit

• Case will be reviewed and sent back for more information if necessary

A

B

37

Entering Cases Found by ELR Search

38

Performing an ELR Search to Find HBsAg+ Pregnant Women

A. Perform an ELR search • Go to the Search tab in Merlin

B. On left toolbar under Labs click ELR Search C. Select county D. Select date range and

• Use Disposition drop down box to select ALL labs E. Click Search

A

B

C

D E

39

A. An ELR search will create a line list of all ELRs reported • Be watchful of hepatitis B lab results in women of child-bearing age that may not have appeared on the

Chronic Hepatitis B and C Task List B. Click on the accession number to go directly to the lab result C. Test information and ordering facility and provider can be found in the Lab Details

• Investigate positive hepatitis B labs in women of child-bearing age to obtain pregnancy status

A

C

Performing an ELR Search to Find HBsAg+ Pregnant Women

40

B

Creating a Chronic Hepatitis B Case

• Each individual with a positive hepatitis B test (HBsAg, HBcAb, HBV DNA, HBeAg) will require one chronic hepatitis B case added to their profile

A. The Summary choice under the left toolbar Profile heading indicates all cases and labs attached to the individual’s profile

• Picture A illustrates an individual profile with a chronic hepatitis B case already attached • If a chronic hepatitis B case already exists in the Profile Summary, do not create another

B. Picture B illustrates details included in a profile • If no chronic hepatitis B case exists on the individual’s profile, create a new chronic hepatitis B case (see next slide)

A

B

41

A. While in the individual profile • On left toolbar under New Case click Create

B. For Chronic Hepatitis B use Disease Code 07032 • Add all dates (CHD Notified Date and one other date field is required) • Click Continue

A

B

Creating a Chronic Hepatitis B Case

42

Su mmary

His tory

~ses

Admin On!Y Profile ID: 645 881

Se~rcl"l Oi 5qu~lify (e.g., T w in !! ) ; r

Pmfilc Dct" il Nolo: Tho fio ld"!; labo l"!; in bluo indicato tho fiold"!; roquirod to "Subn1it" a c a"!;o .

SS N : ,-----1F # #+##+#1F # #

~stNume: r.~Ht~eA~II~I~I~---------~

M iddle: ,-------------

Maiden: ,-------------

Gende r ; 1'-t::MAU:

natP of Rirth~ 106/00/ 197~ r UuiuMJWII

Race: W HTTF

Name: HEPA~S,BEE

SSN:

rir:st Na m e : l::l t::t:

Suffix:

Date of Birth: 06/08/ 1975

Fl Disease Code: HEPATITIS 8, CHRONIC - 07032

Note: Enter all dilltes illvilli lable . C HD Notified Date AND one other dillte field is required.

Dat e Onset:

Lab Report Date : 106/ 05/ 2013

He l p for this P~Qe

Age at Event : I

The earliest of the dates above will be used to determine the EV ENT DATE of the case. The event date is used to determine which v ersion of CASE DEFINmON should be used to

Complete Information (All items with dark blue text are required) • Enter Case Information • Enter Clinical Information • Diagnosis (Dx) Status will be completed in another screen • Profile Information at time of diagnosis • Sensitive Employment • Click Save

Entering Basic Case Information for a Chronic Hepatitis B Case

43

Adding a Lab Result to a Chronic Hepatitis B Case

A

B

C

A. On left toolbar under Case heading click Lab Results B. Click on New Lab Result C. Use drop down box to select appropriate lab to attach click Continue

44

Pro file

Sut'T'It'T'Iary

H i s t ory

Cases

C.•• Ovarvi •vv

Profile Detai ls

Summary

C•ses

C ase

L,_b R•-su lts

E P I Link

Not:e: The fields labeled in blue indicate t:he fields t:hat: are required to save

Name : HEPA~S,BEE

SSN :

FL Oise.,se Code: HEPATITI S B , C HRO N I C - 07032

I nvestiga t o r : DUSEK, C RISTI NA ( D U S EKC M )

Date of Birth : 06/ 08/1975

ox st: .. t:u s: N ot rep ort.,ble by s urve il!., nee c..se d

------~~e

oat:e of'" B i r t:h: Otii/OB/ .L97::> A.ge at: e ·ve: n t:: 37

Name: HEPA~S, BEE

SSN :

FL Disease Cod e: 0703 2 - H E PATTTIS B , C HRONIC

E vent Date: 0 6/0 5/20 13

Dat e of Birth : 06/ 0 8 /1975

: Ca~c ...-~ 62::L 3 9.;ii • Case S t atu s : INC:O._.,.PLETE

Age at Event: ~

Case #: 6 213 9 5 case S t atus: INC OMPLE T E

• Enter Merlin Test Information • Items with dark blue text are required fields • If it is a physician or paper reported case of hepatitis B, a lab result must be obtained to complete Merlin test

information • Lab results added to chronic hepatitis B cases could also include: HBsAg, HBcAb, HBV DNA, HBeAg

Adding a Lab Result to a Chronic Hepatitis B Case

45

Add Facility and Provider Information to manually entered lab A. By clicking on Get Lab, Get Provider, or Get Facility you may search and add facility and provider to the lab results B. Enter a facility or physician name and click Search C. Click on the facility or provider that matches the original lab result D. Click Link Resource

• Do the same for provider and ordering facility • When done click Save

E. Enter other labs by clicking Yes on the next screen • If no more labs to enter click NO

A

B

C

D E

Adding a Lab Result to a Chronic Hepatitis B Case

46

A. On left toolbar under Case heading click Basic Data B. On the left toolbar heading Case Details click Case Definition C. Scroll to the bottom of the Case Definition page and click Set DX Status

• When Basic Data, Lab results and DX status is complete you may report the case and submit for review (see next slide)

Reporting and Submitting a Chronic Hepatitis B Case

A

B

C

47

H is tory

L.-b Re~ulb

EPI L ink

Name ; HEPA~S,BEE

SSN;

FL D isease Code: 07032 - H E PATITIS B, C HRONIC

Event D a te ; 0 6/07/2013

Attac h e d Lab R e sults

Case #

I~ Florida Disease Code

107032 HEPATIT I S B, CHRONIC

rJ••IilimD••(!Profle case Information

Hi .. t o ry

Case

Lab Res u lts

EPI Li n k

Case Details

c. ... S te tu ,.

Name : HEPA~S, BEE

SSN;

FL Disease Code: 07032 - HEPA~S B, CHRO N IC

Ev en t Date : 06/ 07/ 2013

Dat e o f Birt h; 06/0 8/1 9 7 5

Lab# Reported 10 6 / 0 7/2013

Test

JHBsAg

Dat e o t Btr t:h : 0 6/08/ 1 9 7 5 Age at Ev ent:

Case # : 621 3 95 case Status: INCOMPLETE

hepa titi~ 0 in fectio n may have n o evid e n ce o f liver di ~ease or may h ave a s p e ctrum o f di sea~e rang ing fro m c h ro n ic h e p atiti s t o cirThosi~ o r liv e r c ancer . Pe,.~on~ wi th c h ro n ic in fec tio n may b e

Ag

~fe11el.l l u dS d l ll i- HBl.. Ul IyM HBl..A y ) llt:!Yd liv~. AND d fJUl:>i l ivt:! rt:!sul l Ull Ull~ u r U 1~ fullu w i11y lesls: lle t.Jdlilis B sutfd l..e d llliy e u ( HBsAy), heJJd l i lis B t:! dlll.iy~u ( HBeAy ), VI

~--_:~~:::_ __ ~~~~~~~~~~~~~~~~~~~~~~~a~n~d~~~p t e s ting ) ;

A. On left toolbar under the Case heading click on Basic Data B. At bottom of the Basic Data page click Report C. Ensure you are submitting the correct data and click Submit

• The case is now reported to CDC • No further investigation is required for chronic hepatitis B cases

A

B

C

Reporting and Submitting a Chronic Hepatitis B Case

48

Adding a HBsAg+ Pregnant Woman Case

• A pregnant woman who is found to be hepatitis B positive will need a case and a corresponding lab created under the profile

A. Under left toolbar Profile heading click on Summary B. Once in the Summary screen on left toolbar under New Case click Create C. Use drop down box to select Disease Code 07039

• Enter dates • Click Continue

A

49

B

C

Entering Basic Information for a HBsAg+ Pregnant Woman Case

Complete Information (All items with dark blue text are required fields) • Enter Case Information • Enter Clinical Information • Diagnosis (Dx) Status will be completed in another screen • Profile Information at time of diagnosis • Sensitive Employment • Click Save

50

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

A. On left toolbar under Case click Lab Results B. Click New Lab Result C. Use drop down box to select test

• Click Continue

A

C

B

51

Profile

Profile Details

Summary

History

Cases

Case Overview

Case Details

No Lab Tests are available for this Case

Case Information Note: The fields labeled in blue indicate the fields that are required to save the case status a•

Name: HEPATITIS, BEE Date of Birth: 06/08/1975

SSN:

Dx Status: Not reportable by surveillance case definition

Fl Disease Code: HEPATITI S 8 (+HBsAg lN PREGNANT WOMEN) - 07039 T

Investigator: DUSEK, CRISTINA (DUSEKCM)

~======~===N=e=w==La==b=R=e=s=u=lt==~~ ..

P rofila Dlliiilt~ il~

5 U rT'1rT'1l!!lry

C a s •-s

Case

Basic Data

L a b Resul ts

EPI L ink

CaS-e Overview

Date o f I

SSN :

FL D isease Code: 07039- HEPATITIS B (+HBsAg IN PREGNANT WC

Event Date : 06/05/2013

• Enter Merlin Test Information • All items with dark blue text are required fields

• May re-use test attached to a recently entered chronic case (within 60 days) but lab will need to be re-entered.

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

52

Add Facility and Provider Information to manually entered lab A. By clicking on Get Lab, Get Provider, or Get Facility you may search and add facility and provider to the lab results B. Enter a facility or physician name and click Search C. Click on the facility or provider that matches the original lab result D. Click Link Resource

• Do the same for provider and ordering facility • When done click Save

E. Enter other labs by clicking Yes on the next screen • If no more labs to enter click NO

A

B

C

D E

Adding a Lab Result to a HBsAg+ Pregnant Woman Case

53

Reporting a HBsAg+ Pregnant Woman Case

A. On left toolbar under Case heading click Basic Data • Under the left toolbar heading Case Details click Case Definition

B. Check boxes if appropriate criteria are met • Scroll to the bottom of the Case Definition page and click Set DX Status

A

B

54

Profile Case I nformation P r ofi l e D eta i l s Not:e : The fields labeled in blue indicat:e t:he fields t:hat: are required t:o

S u rnrna ry

I-I i story

e. ••• • ,.mpt_,•

C:OI'\vo4 ....... Uf'e. Weallh<.e,.. Vi•ib

,. .. .... ,"'" <NY N o thet lnlc.o""•t~

l flf •nt Info"'"•~

Ocwolad. l ftf-m•lio"'

f'Oil~-'"P,

Nam e: HEPATITIS, BEE Date o f B ir t h : 06/08/1975

SSN :

Dx S t:a t:us: Not: reportable by s urve illance

FL Disease Code: H E PATITIS B { +<HB sAg I N PREGNANT WOM E N ) - 07039 ~

I n v es tigator: DUSEK, CRISTIN A { DUSEKCM )

C H D Re fe ren ce #:

N.tm (J: H t;PATTTI.S, RFE

SSN :

FL Ot$Q~SO COdo: 07039 - H EPATTTIS B (+HB,..Ag I N P RECNANT W O M EN)

e ven t Da te: 06/07/20.13

Hepatitis B (+HBsAg in Pregnant Women)

Clinical case definition

M••l :t th• Cl• 'ltC• I C • i• d• flntltOt'l o f 01C vl• Or ChcOt'tiC h <lip• ll ll!t 0

Laboratory criteri a for diagnosis

POSi l iVV hvp.;, tJ b 'S 8 !OudJCO ;inl.lgon (~::):Ag) 1 0~ull.

Case c lassification

Confirme d · A c:~so th o.H mcot.s tho chf'tlc.;.~l CiiSO dcfirw t•or• and t5 l.;.~bor"LOf"Y c:onf.rrned. Note

O ... •lo o f Swth: 06/08/ t 4J75

C.;~S;Q:• :~

c_.,, .,. St.:.tu.t~: I NC:O tr.oU.•t .. 1.­C.-.e Ext. s t .. w•:

165 1

&SOl

Completion of Basic Data, Lab Results and Dx Status will allow reporting of the case • On left toolbar under Case click Basic Data • Scroll to the Bottom of the Basic Data and click Report • The case is now reported • The next step is to investigate the case and submit for review

Reporting a HBsAg+ Pregnant Woman Case

55

Submitting a HBsAg+ Pregnant Woman Case for Review

• Investigation should be done prior to submitting case for review (Make sure to save all information entered) • Contacts (Includes type of contact, follow-up, vaccination and disease status) • Mother Information (Includes treatment, background, delivery)

A. On the left toolbar under Case Details click Mother Information • Although only EDC is required to submit, complete other information if known • To enter contact information on left toolbar under Case Details click Contact Information • Enter as much information as possible

B. Click in box to Submit CRF • Click Submit • Case will be reviewed and sent back for more information if necessary

A

B

56