Reporting6

Clinical samples

Sentinel, national,regional, globallaboratories

Data management

Ministryof Health

Health care

Vaccination

Data Managementand Analysis Tips forInvasive BacterialVaccine PreventableDiseases (IB-VPD)Surveillance

Ensuring Data Security7

4The most common causes of data loss and corruption are malicious software, hardware failure, and accidental actions by people using the data. All of these can be prevented by: n using computers that are password protected n making sure the computers have the latest security patches and antivirus updates n scanning routinely for viruses. (USB flash drives and external hard drives should automatically be scanned when they are connected) n backing up the IB-VPD data and other document files at least monthly 4Back-up data files should not be stored on the same computer or server as the working database 4Log-off from the computer when done working on a database and whenever leaving the room 4Keep a data logbook of back-up data files including when back-ups are done and locations of back-up files

4 Date and chronologically file each copy of the data file 4 If patient names or other identifiable information are included on any forms or electronic data, the following procedures should be used to keep the information confidential: n restricting data access to authorized individuals n developing rules for who can and cannot access the data with the surveillance and lab focal points, and putting the rules in writing n storing all CRF/CIFs and other original documents in a secure area such as a locked room or a locked file cabinet n knowing and following any additional privacy rules for the health center 4 Check with your clinical and laboratory focal persons to ensure that any other electronic data files related to IB-VPD surveillance are backed-up, secured, and protected against computer viruses

Hospital surveillance coordinator: ___________________________ ___________________________

Hospital laboratory coordinator: ___________________________ ___________________________ Focal person fordata management & reporting: ___________________________ ___________________________

Name Phone NumberContacts

4Regular and timely reporting of the IB-VPD data to the surveillance system is extremely important

4Pay particular attention to: n the schedule for reporting to the Ministry of Health n which data files are forwarded (the entire dataset each time, only the new cases, or only the updated cases in a particular time frame) n the format of the data files

4When sending data files, make sure to confirm that the files were received. If no confirmation is received, follow up

Schedule for data reporting:________________________________________________________________________________________

Data files must be sent to:____________________________________________________________________________________________

Use the Global Information and Surveillance Bulletin to compare IB-VPD surveillance across countries and regionshttp://www.who.int/nuvi/surveillance/resources/en/index.html

Please refer to these sources for additional information about IB-VPD surveillancehttp://www.who.int/nuvi/surveillance/resources/en/index.html

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Number of Suspect Meningits Cases % with LP

Target = 90%

Number of Suspect Meningitis Cases and the Percent with a Lumbar Puncture (LP) Performed by Month, Hospital X, 2010

Number of Meningitis Cases with Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (Spn), and Neisseria meningitidis (Nm)

Isolated from Cerebrospinal Fluid Samples by Year and Vaccine Introduction, Hospital X

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Number of Laboratory-Confirmed Meningitis Cases withHaemophilus influenzae type b (Hib), Streptococcuspneumoniae (Spn), and Neisseria meningitidis (Nm)Isolated from Cerebrospinal Fluid Samples by Year andVaccine Introduction, Hospital X, 2004-2010

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% of CSF samples logged into the lab within 1 hour of LP

Target = 75%

Percent of Cerebrospinal Spinal Fluid (CSF) Samples Logged into the Laboratory within 1 Hour of the Lumbar Puncture (LP) by Month, Hospital X, 2010

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Number of Suspect Meningits Cases with an LP Performed % with Probable Meningits

Expected: ≥ 20%

Number of Suspect Meningitis Cases with a LumbarPuncture (LP) Performed and the Percent with Probable Bacterial Meningitis by Month, Hospital X, 2010

Examples of data analysis

2 Core Data Variables:Tier 1 Meningitis Surveillance

4Address? (State/District/Ward)4Received Hib vaccine? (Up to date/Partial/No/Unk)4Received PCV vaccine? (Up to date/Partial/No/Unk)4Unique medical record/patient identity (ID) number

4Treated with antibiotics in past week? (Y/N/Unk) 4Signs/symptoms? (Sudden fever Y/N/Unk, Max temperature: ##.#°C, Neck stiffness Y/N/Unk, Altered consciousness Y/N/Unk, Headache Y/N/Unk, Unable to feed/Poor sucking Y/N/Unk, Petechial purpuric rash Y/N/Unk, Seizure/convulsions Y/N/Unk, Vomiting Y/N/Unk, Other______ )

4Patient outcome? (Discharged alive/Transferred/Died/Discharged against medical advice) 4Final diagnosis at discharge? (Confirmed meningitis/Unknown/Other______ )

Gathering and Recording Data1

Patient Name: ____________________________________ (Family Name, Given Name)Medical Record / Patient ID #: ________________________ Admission Date: DD/MM/YYWard/Room Number: ______________________________ Physician: _______________________

PART 1: CASE INFORMATION Sex: Male Female (circle one) Date of Birth: Age: Yrs/Months/Days (circle one)

Father’s/Mother’s Name: ________________________ Phone No.:_____________________________Address: _____________________________________District: ______________________________________ Province/Region: ________________________

PART 2: CLINICAL INFORMATIONDate of onset of illness: DD/MM/YYAdmission Diagnosis (circle):

Suspected meningitis Suspected pneumonia Suspected sepsis Unknown Other: ______________________

Treated with antibiotics in the past week? (circle one): No/Unknown/Yes (describe: ________________ )Signs/Symptoms related to current illness (check all that apply):

Sudden fever; Max temp: ___°C Neck stiffness Altered consciousness Headache Unable to feed/Poor sucking Bulging fontanelle Petechial/purpuric rash Prostration Seizure/convulsions Vomiting Other: ____________

Checking Data Quality4

Data entry and data management: 4Routinely ask the following questions n CRF/CIF completed? n Any missing data? n Data entered into electronic record? n Data entry complete? n Suspected data entry errors? 4Routinely run data analyses to check data quality. For example, check that the dates make sense (e.g., date of birth should be earlier than date of admission, date of admission should be earlier than date of specimen collection)

4Number of tubes collected? (#)

4Date collected? (DD/MM/YY)

4Time collected? (hh:mm)

4Sent to hospital lab? (Y/N/UnK) (If Y, record DD/MM/YY)

4Lab ID Number? (####)

4Date and Time CSF logged in lab? DD/MM/YY (hh:mm)

4CSF appearance? (Clear/Turbid/Bloody/Xanthochromic/Not assessed)

4CSF WBC count? (### cells/mm3)

4CSF glucose? (### mg/dl)

4CSF protein? (### mg/dl)

4CSF Gram stain result? (no organism detected, Gram positive, Gram negative)

4Physician notified within one hour of Gram stain result? (Y/N/Unk)

4CSF culture result? (Haemophilus influenzae [Hi],

Analysing Data5To properly evaluate vaccine impact, two years of stable surveillance are needed before vaccine introduction. If surveillance improves during or shortly after vaccine introduction, cases may APPEAR to increase after the vaccine is introduced.

4Routinely analyse the IB-VPD data to evaluate the quality of surveillance, understand the disease-related trends, and share the results with key stakeholders4Suggested indicators to look at are: 1 Monthly number of suspected meningitis cases and the percent of cases with a lumbar puncture performed (target = 90%) 2 Monthly % of CSF samples logged into laboratory records within 1 hour of the lumbar puncture 3 Monthly number of suspected meningitis cases with a lumber puncture performed, and the percent of suspected meningitis cases with probable bacterial meningitis 4 Monthly number of cases identified with vaccine preventable organisms (Haemophilus influenzae [Hi], Streptococcus pneumoniae [Spn] and Neisseria meningitidis [Nm])4Always create a back-up of the dataset before running the analyses to protect the original data4Be sure to provide the data source and the date processed with all analysis results to document which data were used for analyses

Entering Data3

When entering the data: 4Take your time to ensure accurate data entry 4Stop and check to make sure there are no mistakes 4 If the data entry application notes an error, be sure to review the data before proceeding 4Have someone other than the person entering data randomly check the quality of entered data 4Write the date on the CRF/CIF when the data have been entered and keep track of which records have been entered in the data logbook

Enroll all suspect meningitis cases c Use standard Case Report Form (CRF) or Case Investigation Form (CIF) c Responsibilities for completing CRF/CIFs should be defined and communicated with staff c Regularly search for completed CRF/CIFs c Check to make sure all data are collected

Keep a data logbook of suspected errors and missing data to use to go back to the source documents to confirm the findings 4Update the data logbook with the follow-up result4Periodically review the data logbook to see if there are data fields which consistently have the same problems. These problems generally indicate some part of the data flow is not functioning. Work with clinical and laboratory focal persons to determine a better way to obtain that information Gather all core data variables to complete CRF/CIFs 4Work with doctors, nurses and laboratory staff to collect core data variables 4Data sources may include logbooks, medical records, clinical and laboratory databases, and laboratory test reports Use a unique medical record/patient identification number (ID) to link clinical and laboratory information 4Ensure all forms related to a patient include the unique medical record/patient ID Before entering the data:

4Review each CRF/CIF to verify that core data variables are complete (See “Core Variables”) 4 If the CRF/CIF is missing information that should be available, such as onset date or initial diagnosis, follow up with clinical or laboratory focal point immediately 4 If the CRF/CIF is missing information that is not yet available, such as patient outcome or laboratory results, document the missing variables in the data logbook and follow up at a later date 4Record any discrepancies on the CRF/CIF in the data logbook and follow up with the clinical or laboratory focal point immediately

Streptococcus pneumoniae [Spn] and Neisseria meningitidis [Nm], other (specify: ), no growth)

4CSF immunochromatographic kit (e.g. Binax© kit) result? (Streptococcus pneumoniae [Spn] positive, Streptococcus pneumoniae [Spn] negative)

4CSF latex agglutination (LA) kit result? (Haemophilus influenzae [Hi], Streptococcus pneumoniae [Spn] and Neisseria meningitidis [Nm], other (specify: ))

4CSF PCR result? (Haemophilus influenzae [Hi], Streptococcus pneumoniae [Spn] and Neisseria meningitidis [Nm], other (specify: ), no organism detected)

4CSF sent to RRL? (Y/N/Unk); 4 If yes, date sent to RRL? (DD/MM/YY)

4CSF frozen? (Y/N/Unk); 4 If yes, temperature frozen? (-20°C or -70°C)

4Culture isolate sent to RRL? (Y/N/Unk) (If Y, record DD/MM/YY)

4All laboratory results received from RRL? (Y/N/Unk) (If Y, record DD/MM/YY)

Cerebrospinal Fluid

Meningitis Surveillance – An example Case Report Form

After entering the data: 4Maintain an easily accessible documentation of data sources used to complete CRF/CIS (e.g., laboratory reports, medical records). 4CRF/CIS paper copies and other records of data sources should be kept in a file for future reference 4 If data sources include documents that need to be returned to other departments (e.g., medical

4Use the unique medical record/patient ID on all paperwork (CRF/CIFs, sample labels, sample collection and reporting forms, laboratory log book, surveillance logbook) 4Laboratory data may be identified by case ID, sample ID, or patient name. Know data sources and which information to find to update lab data Update records every week4Track cases for which additional data are expected, and update CRF/CIF records 4 Identify cases with missing discharge data and work with doctors and nurses to gather these data when the patient is discharged 4Follow up to get hospital laboratory test results as necessary 4Track all cases with samples sent to the Regional Reference Laboratory (RRL) for testing and follow- up if results are not returned in a timely manner. Share RRL results with doctors, nurses, and hospital laboratory staff and record the data into the database

Develop and follow a written protocol for gathering and recording clinical and laboratory data for each suspected case

4Last name 4First name 4Sex M/F4Date of birth? (DD/MM/YY)4Date of illness onset? (DD/MM/YY)4Date of admission? (DD/MM/YY)

4 Identify records with missing or unusual values for each variable. Unusual values include numeric data outside the expected range (e.g., a temperature of 45°C) 4Compare variables with one another to identify records with inconsistent data.For example, there should be a sample identification number for all cases from whom a sample was collected. Missing sample identification numbers should always be followed up

records), indicate in the data logbook where the document is filed 4Follow up on missing information such as lab results which may not be available until later 4Make sure that you receive all the data that are needed to complete the CRF/CIF