Enterobacter sakazakii, Centers for Disease Control (Word) · Web viewThe purpose of this form is to collect clinical and epidemiologic data on cases of E. sakazakii (E. sak) infection,

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Enterobacter sakazakii Outbreak Investigation Form

The purpose of this form is to collect clinical and epidemiologic data on cases of E. sakazakii (E. sak) infection, both individual and outbreak-related cases. The questions have been organized into 3 sections: Epidemiology, Environment and Laboratory. Completion of the form may require input from multiple individuals. Web sites and references are given to assist in the collection and analysis of laboratory samples.

The following are items to consider at the first notification of E. sakazakii case(s): Save the isolate and arrange to have the identification confirmed at a state public health laboratory or at CDC. Save and securely store any associated powdered infant formula that was fed to the infant or acquired at the same time (same brand, lot, place and time of purchase). Isolates of E. sak (patients, formula or other environmental) associated with the case should be sent to: Centers for Disease Control and Prevention

o Data and Specimen Handling c/o Matthew Arduinoo 1600 Clifton Road, G12o Atlanta, GA 30333

Determine if there are other infants potentially ill with E. sak associated with the index case. Determine if cohort of potentially exposed infants can be identified and accessed at the time of report. Identify contacts in the hospital and at the appropriate health department.

Name of investigator: ___________________________ Title: ________________________________________Contact information: ____________________________ ____________________________Name of investigator: ___________________________Title: ________________________________________Contact information: ____________________________ _____________________________

Name of investigator: ___________________________Title: ________________________________________Contact information: ____________________________ _____________________________Name of investigator: ___________________________Title: ________________________________________Contact information: ____________________________ _____________________________Name of investigator: ___________________________Title: ________________________________________Contact information: ____________________________ _____________________________

Enterobacter sakazakii investigation form Page 2 of 175/12/2023

Case definition: any infant with E. sakazakii cultured from blood, cerebrospinal fluid (CSF), brain tissue, or urine (obtained from bladder aspiration) in one manifesting systemic symptoms.

For single cases, skip to page 3, EPIDEMIOLOGY SECTION. For outbreaks with > 2 cases, complete the following information. Please complete a separate form for each infant who meets clinical definition.

Outbreak with > 2 cases meeting case definition:

Outbreak ID:____

Number meeting case definition: _____

Onset date range for cases (MM/DD/YEAR): ____ to ____

Number cases hospitalized: _____

Number male cases: ____ Number female cases: ___ Number colonized: ____ (specify specimens yielding E. sakazakii) ______________________________________________________

Total number tested: ________

Ward census on first date of first case: ______

Outbreak setting: ____Newborn nursery ____Neonatal Intensive Care Unit (NICU)/Pediatric Intensive Care Unit (PICU)____ Other hospital ward____ Daycare____ Other community setting


SECTION 1: EPIDEMIOLOGYThis section deals with demographic and clinical information.

A. Illness history Age at onset of illness: ______ days ___weeks ___ months

Date of onset of illness (month/day/year) ___________

State where illness occurred: ___________

Location where infant became ill: ___ home _____hospital ward ___ hospital intensive care unit (ex. NICU/PICU)

Duration of illness: ____hours ____days ___ illness ongoing

Patient hospitalized: (Y N) If yes, is patient currently hospitalized: (Y N) Type of hospital setting: ____Intensive care unit (ex. NICU, PICU) ____regular wardAdmission date (MMDDYY):______________Discharge date (MMDDYY):__________

Clinical syndrome (check all that apply): ____sepsis (bacteremia) ____meningitis ____other (specify)_____________________________________

Complications: seizures (Y N) brain abscess (Y N) brain infarct (Y N) hydrocephalus (Y N) ventricular shunt (Y N) Other (Y N)

Died: ____yes (date(MMDDYY):_____________) ____no

B. Medical history:

Sex: ___male ___female Race: ___white ____black ____Hispanic ___Asian ___other (specify____________)

Birth history: ___ Caesarian section ____vaginal delivery

Gestational age (weeks): ____

Birth weight: _____ grams or _______lbs.____oz.

Did mother receive antibiotics during labor or delivery?(Y N)

Previous diagnoses or treatments: twin (Y N) mechanical ventilation (Y N)patent ductus arteriosus(Y N) (if yes, was this treated with indomethacin (Y N) Non-GI surgery (Y N) GI surgery (Y N)


Did infant have one of the following during 10 days prior to illness? G-tube (Y N) OG or NG tube (Y N) jejunal tube (Y N) If yes, to OG/NG/OJ, is tube left in place for multiple feeds? (Y N) Or is same tube re-inserted for multiple feeds? (Y N)

Concomitant medical problems: ___________________________________

C. Medication history:

Was infant treated with antibiotics during the 30 days prior to illness? (Y N) If yes, was antibiotic treatment completed at least 7 days prior to illness?(Y N)

Did the infant take any of the following oral medications or oral substances during the 10 days prior to illness? Vitamins (Y N)___iron (Y N)___antacids (Y (specify________) N) Fluoride(Y N) other_____________________________________________

Drug Given? Administration routeYes No Oral IV

1. Nutritional supplements (if yes, specify below) a. Multivitamin b. Iron c. Other (specify_________________)2. Antibiotics (If yes, when was the last date of administration before infection onset? MMDDYY___________)3. Antifungals4. Code drugs (eg, dopamine, dobutamine, epinephrine)5. Steroids6. Acid suppressing medications7. Fluoride


Feeding history

Was infant fed enterally during the 10 days prior to illness? (Y N) If yes, orally (Y N) per NG or OG tube (Y N) per G-tube (Y N) per jejunal tube (Y N) Was tube left in place for multiple feeds? (Y N) Or is same tube re-inserted for multiple feeds? (Y N)

In week before onset of illness was the infant ever fed:

Breast milk (Y N) If yes, specify dates: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Received banked breast milk? (Y N) Fed breastmilk exclusively?_(Y_N) Delivered via: bottle (Y N) enteric tube (Y N) breast (Y N)

Was powdered infant formula or powdered breast milk fortifier used in week prior to onset of illness, including in the preparation of infant cereal? (Y N)

If yes: Powdered formula #1:

Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital: (Y N) If yes, name/city of hospital: _________________________ Purchased in store: ( Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) _______________ Is any formula left? (Y N) Delivery route: ____ nasogastric tube ___ gastrostomy tube ____ orally NOTE: If there is more than one Powdered Infant Formula and is prepared differently, copy and complete this section for each appropriate formula type.

Where was product prepared: ___home ____hospital If prepared at home: where in the home is product prepared (kitchen, bathroom, etc)_____________ hand hygiene protocol(Y N) type of water used: ___ municipal ____non-municipal** (well, spring, surface source) ___ bottled


Was water used to prepare formula usually: boiled Y/N warmed in water bath (Y N) not heated(Y N) temperature of water: ___ boiled ____warmed in hot water bath ___ room temperature

**if non-municipal, sterile water is used and is not heated, please take a water sample**

If prepared in hospital: temperature of water: ____warmed in hot water bath ___ room temperature dedicated formula preparation room: (Y N) dedicated formula nurse or other dedicated personnel (Y N) hand hygiene protocol (Y N) blender/mixer used for formula preparation: (Y N) formula prepared by bottle _____ or batch _____ if batch, maximum storage time ____ minutes ___hours _____days

Powdered formula #2: Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital:(Y N) If yes, name/city of hospital: _________________________ Purchased in store: (Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) ______________ Is any formula left? (Y N) Delivery route: ____ nasogastric tube ___ gastrostomy tube ____ orally

Powdered formula #3: Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital: (Y N) If yes, name/city of hospital: _________________________ Purchased in store: (Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) ________________ Is any formula left? (Y N) Delivery route: ____ nasogastric tube ___ gastrostomy tube ____ orally


Liquid formula used in week prior to onset of illness: (Y N)

Liquid formula #1: Ready-to feed ____ liquid concentrate _____ Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital: (Y N) If yes, name/city of hospital: _________________________ Purchased in store: (Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) ____________

Liquid formula #2: Ready-to-feed ______ liquid concentrate _____ Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital: (Y N) If yes, name/city of hospital: _________________________ Purchased in store: (Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) _______________

Liquid formula #3: Ready-to-feed _______ liquid concentrate _______ Brand name: ___________________ Manufacturer: ____________________ Dates consumed: ____ (MM/DD/YEAR) to ____ (MM/DD/YEAR) Lot number(s) (if known): ___________ Obtained from hospital: (Y N) If yes, name/city of hospital: _________________________ Purchased in store: (Y N) If yes, name/location of store: _________________ Date of purchase: (MM/DD/YEAR) ________________


Did infant take any solid foods in the week prior to illness? (Y N) If yes, purees (Y N) finger foods (Y N)

Has the infant ever been fed cereal? (Y N) If yes, cereal type (rice, wheat, etc): ________

Brand: __________________________Lot #: ___________________________

Was cereal mixed with formula? (Y N)If yes, is it the same as:

__powdered formula #1__powdered formula #2__powdered formula #3__liquid formula #1__liquid formula #2__liquid formula #3

Was cereal mixed with water? (Y N)If yes, source of water:

____municipal ____non municipal ** (well, spring, surface source) ____bottled

**if non-municipal, sterile source of water is used and is not heated, please take sample**

List any other foods that have been given:Name of food:_______________________________________________________Brand of food: _______________________________________________________Lot number:_________________________________________________________


SECTION 2: ENVIRONMENTThis section focuses on storage and delivery of powdered formula as well as cross contact issues.

Refrigerator temperature reading :temperature of food that has been in the refrigerator for >24 hours and is located near to where formula was stored home:____ _◦C ____◦Fhospital:____◦C ____◦F

Product administration: Hand hygiene protocol (Y N)

If administered by nasogastric or gastrostomy tube, maximum hang-time: ___ hours ___min

If given by bottle, maximum duration between refrigeration (or preparation if not refrigerated) and completion of infant feed:___ minutes _____hoursWas formula ever left with infant in crib overnight during the 10 days prior to illness? (Y N)

Equipment cleaning:If prepared at home:

How often are mixing equipment and other contact surfaces cleaned? ____immediately after preparing formula____once daily____several times daily (list frequency)

____other

Describe how mixing equipment and other contact surfaces are cleaned (type of cleaning product(s), sink versus dishwasher, etc):

If prepared in hospital:

How often are mixing equipment and other contact surfaces cleaned? ____immediately after preparing formula____several times daily (list frequency)

____other If blenders/mixers are used, are they disassembled and cleaned?(Y N) If yes, how often? _________

Describe how mixing equipment and other contact surfaces are cleaned (type of cleaning product(s), etc): _________________________________________________________________________________________________________


SECTION 3: LABORATORY This section pertains to laboratory methods, analysis and results. In preparation for environmental testing, please consider sampling product contact surfaces, such as countertops, mixing equipment, utensils, bottles, residual formula such as spills in refrigerator, nipples, sink, drain, faucet, faucet handle, bar soap, etc. Where possible, include quantification of organism.

Protocols and jurisdiction for the federal laboratories involved (CDC/DHQP, FDA/ORA and FDA/CFSAN):

1) Clinical isolates will be collected and analyzed by CDC/DHQP. When possible, multiple colonies from the primary plate should be obtained and stored.

2) Unopened container formula testing will be done at FDA/ORA regional laboratory in Atlanta. FDA needs to test these specimens for regulatory reasons.

3) Open container formula testing will be done at FDA/ORA regional laboratory in Atlanta primarily, but could be done at CDC/DHQP on an individual investigation basis as agreed upon by both agencies.

4) Case investigation home or hospital environmental samples will be tested primarily at CDC/DHQP laboratory, but could be done at an FDA laboratory on an individual investigation basis as agreed upon by both agencies.

5) Results of culture and PFGE analysis, including the PFGE pattern images, will be shared among the three laboratories. If sharing of PFGE images cannot be done effectively because of differences in protocols, then the isolates used for PFGE analysis will be shared between CDC and FDA laboratories.

6) CDC/DHQP will share clinical isolates with FDA/CFSAN laboratories to collaborate in a study of microbiologic and virulence characteristics of E. sak.

7) Questions regarding laboratory methods can be directed to CFSAN:Robert Buchanan (301) 436-2369Don Zink (301) 436-1693

Clinical Specimens

Isolates of E. sakazakii can be shipped on an all purpose agar (TSA agar slants, Blood Agar slants, Chocolate Agar Slants, Semi solid) under ambient conditions (usually an over night culture).

For Blood and CSF samples, refer to the standard methods for the collection and processing of these type of specimens. References:


The ASM Clinical Microbiology Procedures Handbook, 2nd Edition, Section 13, Chapter 13.10 (Editor in Chief: Henry D. Isenberg), ASM Press 2004.

Inspection Operations Manual (IOM) 2005 Sections 426 and 427http://www.fda.gov/ora/inspect_ref/iom/contents/ch4_toc.html

Which of the following specimens were obtained during the evaluation of the patient’s illness?

1. CSF (Y N)Date collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________ complete resistance: ________________________________________

2. Blood (Y N)Date collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________

complete resistance: _____________________________________________

3. Urine (Y N)If yes, obtained via (circle one): bag bladder aspiration clean catchDate collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________ complete resistance:________________________________________________

Pharyngeal swab and rectal swabs (can use commercially available swabs with transport media, i.e. Copan, Starplex.. Swabs can be refrigerated if they can not be cultured in a short period of time after collection. Ship swabs with cold packs if being shipped to an outside lab.

4. Rectal (Y N)Date collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________

http://www.fda.gov/ora/inspect_ref/iom/contents/ch4_toc.html


Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________ complete resistance:_______________________________________________

5. Tracheal (Y N)Date collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________ complete resistance: _____________________________________________

6. Other (specify___________________________)Date collected (mm/dd/yy):___________Where tested (lab, city, state):______________________________Results:___________________________Was antibiotic resistance testing completed? (Y N)If yes, please list antibiotics with: intermediate resistance:____________________________________________ complete resistance:________________________________________________

Formula Samples

Samples collected from infant formula manufacturing plants:All samples are collected according to aseptic techniques following the guidelines in the Inspections Operations Manual (IOM), section 426. All the samples collected are from the same lot. Each sample contains 20 sub-samples weighing 227 grams.

Sample 1-raw material protein component. Sample 2-raw material fat component.


Sample 3-raw material carbohydrate component.Sample 4-final packed product.

The samples are identified as Sample 1, 2, 3 or 4 and then using lower case alphabet to identify the sub-samples. The samples are then shipped to the lab to assure a weekday delivery.

Sample analysis

Per Sample:

Four-500 gram composites are prepared from the 20 sub-samples. The composite is made by taking 100 grams from 5 of the sub-samples. The raw material will then be tested for the presence absence of Enterobacter sakazakii. The MPN analysis is carried out on the final product samples only. The procedure for the isolation and enrichment of the infant formula can be found on the CFSAN@s website: http://www.cfsan.fda.gov/~comm/mmesakaz.html and is also attached at the end of this document.

The only modification to the MPN analysis is as follows: The three-1 gram samples are not run unless all 6 of the other tubes (3 X 100 gram and 3 X 10 grams) are positive.

Below is the table of MPNs and 95% confidence intervals for a two-dilution MPN test for E. sakazakii in infant formula. The units are MPN per 100 g. Thus, for the result (1,0), i.e., 1 of the three flasks with 100g each is positive and all other flasks are negative we have a most probable number MPN of E. sakazakii of 0.36/100g.

MPNS AND 95% CONFIDENCE INTERVALS FOR A 3-TUBE, 2-DILUTION MPN WITH 10-FOLD DILUTIONS AND INOCULUM LEVELS OF 100G AND 10G (RESULTS ARE MPN PER 100G)

Outcome MPN Low High(0,0) <0.31 N/A 0.95(0,1) 0.31 0.015 1.04(0,2) 0.63 0.13 1.8(1,0) 0.36 0.017 1.8(1,1) 0.74 0.13 2.0

http://www.cfsan.fda.gov/~comm/mmesakaz.html


(1,2) 1.2 0.36 4.2(1,3) 1.6 0.45 4.2(2,0) 0.93 0.14 4.2 (2,1) 1.5 0.37 4.2(2,2) 2.2 0.45 4.3(2,3) 2.9 0.90 10.1(3,0) 2.4 0.46 10.1(3,1) 4.6 0.90 20(3,2) 11 1.8 41(3,3) >11 4.2 N/A

Note: (0,3) is too improbable to include in this table.

For samples taken from the home or hospital:Obtain as much formula as possible from the site. While there may not be enough sample to carry out an MPN analysis (you need at least 333 grams), the presence/absence analysis can be done. Samples should still be collected as aseptically as possible.

c. Results of analysis:

Food Samplesa. Methods of collection:

b. Methods of analysis:

Sample Number

Formula name

Lot number

TotalAmount ofProduct Tested

Date cultured

Result (Agent)

PFGE Quantity of organism


c. Results of analysis:

Environmental SamplesReferences:The ASM Clinical Microbiology Procedures Handbook, 2nd Edition, Section 13, Chapter 13.10 (Editor in Chief: Henry D. Isenberg), ASM Press 2004.

Inspection Operations Manual (IOM) 2005 Sections 426 and 427www.fda.gov/ora/inspect_ref/iom/contents/ch4_toc.html

a. Sites cultured: (check all that apply) ___countertops___mixing equipment___utensils___bottles___nipples___formula spills___sink___drain___faucet___faucet handle___bar soap

b. Methods of collection (swab, sponge, transport medium, diluent, etc):

Sample Number

Product name

Lot number

TotalAmount ofProduct Tested

Date cultured

Result (Agent)

PFGE Quantity oforganism

http://www.fda.gov/ora/inspect_ref/iom/contents/ch4_toc.html


c. Methods of analysis:

d. Results of analysis:

Sample Number

Specimen (bottle, countertop, mixing equipment, etc.)

Date cultured

Result (Agent)

PFGE Quantity oforganism

Name of participating laboratory ____________________________Location of laboratory ____________________________________ ____________________________________

If more than one laboratory, complete information below:

Name of participating laboratory ____________________________


Location of laboratory ____________________________________ _____________________________________

Documents

Enterobacter sakazakii, Centers for Disease Control (Word) · Web viewThe purpose of this form is to collect clinical and epidemiologic data on cases of E. sakazakii (E. sak) infection,