Evaluation of Potential Sources for the Sentinel Initiative

Evaluation of Potential Sources for the Sentinel Initiative

Sentinel Draft Data Collection Survey 02-23-10 - v1.xls

Evaluation of Potential Sources for the Sentinel Initiative

OMB: 0910-0657

Document [xlsx]
Download: xlsx | pdf

Overview

General Questions
Data Attributes
Data Availability


Sheet 1: General Questions
































































OMB No. 0910-XXXX
Expirate Date ____/__/_____










































General Questions
Please fill out the following general questions regarding your organization and the relevant data sources.




































































































































































Survey Status
0%























































Total Survey
0%


















































































































1 What is the name of your organization?





















































Organization Name:




















































































2 What is your organization type? (Please select all that apply)













































































Group Practice





























Integrated Delivery System





























Hospital





























Academic Medical Center





























Medical Society





























Research Network/Collaborative





























Payor





























Health Information Exchange





























Pharmacy





























Pharmacy Benefit Manager





























Lab





























Electronic Health Record Vendor





























Personal Health Record Vendor





























Registry





























Data Aggregator





























Claims Processor





























Electronic Health Record Repository





























Other

























Comments:




















































































































































3 What is the name of your data source?





















































Data Source Name:



















































































































4 What types of electronic healthcare data are available?













































































Lab: Orders/Transactions





























Lab: Results





























Pharmacy





























Electronic Health Records





























Imaging: Orders/Transactions





























Imaging: Results





























Admission/Discharge/Transfer





























Pathology





























Operating Room





























Other

























Comments:




















































































































































5 What is the time period covered?





















































Month Day Year


























Start Date 1 1 YYYY Note: Manually enter year as YYYY

























End Date 1 1 YYYY Present
























































Comments:















































































































































































6 What care settings are included in the data source? (Please select all that apply)





















































Hospital - Emergency Department





























Hospital - Operating Room





























Hospital - Outpatient





























Hospice





























Post Acute Care Facility





























Ambulatory Surgical Center





























Home Health Agency





























Physician Office





























Urgent Care Center





























Community Health Clinic





























Pharmacy





























Other

























Comments:



















































































































































































7 Which insured population(s) are included in the data source? (Please select all that apply)





















































Commercial





























Health Maintenance Organization





























Medicaid





























Medicare





























Workers Compensation





























Self-Insured Employer





























Military Health System





























Veterans Health Administration





























None/Self-Pay 





























Other

























Comments:



















































































































































































8 What geographies are covered in the data source? (Please select all that apply)




















































AL HI MA NM SD

























AK ID MI NY TN

























AZ IL MN NC TX

























AR IN MS ND UT

























CA IA MO OH VT

























CO KS MT OK VA

























CT KY NE OR WA

























DE LA NV PA WV

























FL ME NH RI WI

























GA MD NJ SC WY

























Other

























































If your data source covers more than one state, please describe the geographic distribution of the data.















































































































































































































































































































Public reporting burden for this collection of information is estimated to average 17.5 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control numbers.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Information Management
1350 Piccard Drive, PI50
Rockville, MD 20850
OMB #__






























































































































Sheet 2: Data Attributes




























OMB No. 0910-XXXX
Expirate Date ____/__/_____






Attributes of Each Data Type
Please fill out the questions for data attributes.






































Survey Status
0%



















Total Survey
0%










































Please answer the data attribute question(s) regarding Population Coverage















1 What are the median and maximum length of time you have for any one patient in your data source?
















Provide median length:
months
















Provide maximum length:
months




















Comments:




















































2 What is the typical lag time between care provided and availability in your data source? If the lag time varies depending on the care setting, please specify duration by care setting.




Enter Care Setting:


Lag Time:





Care Setting A:


days



Care Setting B:


days



Care Setting C:


days



Care Setting D:


days



Care Setting E:


days














Comments:

































































3 If applicable, what is the typical lag time for a claim to be adjudicated? If the lag time varies depending on the type of claim (e.g., pharmacy vs. inpatient medical), please specify the duration by type of claim.




Enter Type of Claim:


Lag Time:





Type of Claim A:


days



Type of Claim B:


days



Type of Claim C:


days



Type of Claim D:


days



Type of Claim E:


days














Comments:

































































4 How frequently is the data source updated?
















Provide in days:
days














Comments:




















































5 What is the total number of unique encounters for the most recent full year available?
















Provide number of encounters:
















Comments:




















































6 What is the total number of unique patients for the most recent full year available?
















Provide number of unique patients:
















Comments:

































































7 What is the total number of prescriptions in the data source for the most recent full year available?
















Provide number of prescriptions:
















Comments:




















































8 What is the total number of lab results in the data source for the most recent full year available?
















Provide number of lab results:
















Comments:




















































9 How many hospitals are included in the data source for the most recent full year available?
















Provide number of hospitals:
















Comments:




















































10 What is the total number of admissions for the most recent full year available?
















Provide number of admissions:
















Comments:




















































11 How many physicians are in the data source for the most recent full year available?
















Provide number of physicians:
















Comments:

































































12 How many group practices are included in the data source for the most recent full year available? A group practice is defined as practices of more than one physician sharing a common Tax ID.
















Provide number of group practices:
















Comments:




















































13 Is there a specific demographic group that is well represented in your patient population? (e.g., pediatrics)
























Please describe:






























































14 What percentage of your population has health insurance that includes a prescription benefit?
















Provide number of prescriptions:
















Comments:




















































15 Can you identify pregnancy occurrences in your data source?





































Comments:

































































Please answer the data attribute questions regarding Structure and Coding















16 Is the data source structured in flat files or a relational database?

















Flat File











Relational Database











Other




















Comments:




















































17 What standard coding sets/standard controlled terminologies do you use?














Please describe:









































18 What is your process for remaining compliant with emerging national standards? (e.g., emerging standards from Health Information Technology Standards Panel)














Please describe:





















































19 What standardized drug dictionary is used to represent all drug data elements, particularly Trade and Generic names?














Please describe:


































































20 Are there local conventions to represent Trade or Generic names?














Please describe:





















































21 Are prescription drugs, over the counter drugs, and supplements reported using a standardized drug dictionary? If so, which one?














Please describe:


































































Please answer the data attribute question(s) regarding Data Linkage Capabilities















22 Does each unique individual have more than one identification number (ID) in your system?





































If so, are you able to link these multiple IDs together?












































Comments:




















































23 Does your system(s) interface with registries?





































If Yes, please give details:












































24 Does your system(s) interface with biospecimen management and tracking systems?





































If Yes, please give details:

























































25 Does your system(s) interface with the medical examiner/coroner's office?





































If Yes, please give details:












































26 Does your system(s) interface with medical image management and tracking systems?





































If Yes, please give details:












































27 Does your system(s) interface with electronic prescribing systems?





































If Yes, please give details:












































28 Does your system(s) interface with personal health record systems? (e.g., Google Health, Microsoft HealthVault, WebMD, MyHealtheVet, etc.)





































If Yes, please give details:

























































29 Does your system(s) interface to vital statistics? (e.g., birth and death records)





































If Yes, please give details:












































30 What industry standards do you use for storage and exchange of clinical data? (Please select all that apply)

















HL7 V2.x











HL7 V3











HL7 Clinical Document Standard (CDA)











ASTM CCR











Continuity of Care Document (CCD)











None











Other




















Comments:

































































Please answer the data attribute question(s) regarding Data Validation Capability















31 For systems that do not contain electronic health records, please describe any processes you have in place to validate information in your system.














Please give details:


























































































Please answer the data attribute question(s) regarding Medication Reconciliation Capability















32 Do you have Clinical Decision Support software or homegrown logic in place to identify drug-drug interactions?





































If Yes, please give details:

























































Please answer the data attribute question(s) regarding Devices















33 Are all devices included?





































If "No" what subset of devices are included?












































34 Where is the device information captured? (e.g., at hospital purchasing department, in operating suites via bar code reader, in Electronic Health Record)














Please describe:









































35 Is the device information linked to medical records?


















































Comments:

































































36 Can the device information be linked to medical records?


















































Comments:

































































37 Is the device information linked to claims data?





































Comments:




















































38 Can the device information be linked to claims data?


















































Comments:

































































Please answer the data attribute question(s) regarding Clinical Trials and Research















39 Is there a field in your databases that identifies if the patient is/was enrolled in a clinical trial; and provides a reference to the trial?





































If Yes, please describe:












































40 Is your organization a member of / does it contribute to any clinical research networks? (e.g., National Cancer Institute Cooperative Groups, research networks, practice networks, private networks)





































If Yes, please specify:

























































Please answer the data attribute question(s) regarding Uses of the Data for Population Health















41 What are prior and current uses of the data for population health?
















Describe uses for pharmacovigilance, pharmacoepidemiology, pharmacoeconomics, administrative











purposes, quality assessment/improvement, academic/industry research, clinical research, health











services research, and/or other research:












































Please specify any representative publications:
























































42 What barriers, if any, exist for your organization to participate in the Sentinel Initiative? (e.g. privacy and/or security concerns related to the use of electronic health data; resource concerns related to the availability, experience and interest of investigators at your organization in using electronic health data for post-market product surveillance within a distributed data system; compatibility of existing operations and/or business models with participation in a distributed data system for post market safety surveillance; conflict with commercial interests of data sources, etc.)
















Please describe:
































































Public reporting burden for this collection of information is estimated to average 17.5 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control numbers.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Information Management
1350 Piccard Drive, PI50
Rockville, MD 20850
OMB #__























Sheet 3: Data Availability




























OMB No. 0910-XXXX
Expirate Date ____/__/_____






Data Availability
For each question, unless otherwise noted, please indicate whether or not the Field / Data Type is available in your data sources and the % of missing or unknown (e.g. dummy values) for that Field / Data Type.






































Survey Status
0%



















Total Survey
0%










































Field / Data Type Category: General
















Field / Data Type


Is the field available? If yes, % missing or unknown



1 Unique Patient Identifier

%


2 Patient Zip Code

%


3 Unique Provider Identifier

%


4 National Provider Identifier

%


5 Provider Specialty

%



If Yes, what type of provider specialty codes are you using? (Please select all that apply)












ANA











Homegrown











Other




















Comments:



























6 Unique Encounter Identifier

%


7 Date of Service

%












Provide any comments for the General category




Enter comments:

































































Field / Data Type Category: Demographics













Field / Data Type


Is the field available? If yes, % missing or unknown



8 Birth Year

%


9 Gender

%


10 Race/Ethnicity

%


11 Year of Death

%















Provide any general comments about the Demographic category




Enter comments:













































































Field / Data Type Category: Insurance Coverage













Field / Data Type


Is the field available? If yes, % missing or unknown



12 Population Type (e.g., Medicare, Commercial, Self Insured)

%


13 Benefit Coverage (e.g., medical benefit and Rx formulary indicators)

%


14 Formulary Benefits Structure




Are you able to provide the patient-level formulary benefits structure?
























Select:






















Comments:

























































Provide any comments for the Insurance Coverage category




Enter comments:













































































Field / Data Type Category: Conditions/Diagnosis













Field / Data Type


Is the field available? If yes, % missing or unknown



15 Primary Diagnosis

%


16 Primary Discharge Diagnosis

%


17 Secondary Diagnoses

%



If Yes, how many secondary diagnoses fields are available?





























Provide number of secondary diagnoses fields:



















Comments:































18 Secondary Discharge Diagnosis

%



If Yes, how many secondary discharge diagnoses fields are available?





























Provide number of secondary discharge diagnoses fields:



















Comments:































19 Type of Coding System




What coding system(s) do you use? (Please select all that apply)












ICD-6











ICD-9











ICD-9-CM











ICD-10











SNOMED











Homegrown











RxNorm











Other




















Comments:































20 Disease Severity

%



If Yes, what type of severity system do you use?











Please describe:











































21 Pregnancy Status

%















Provide any comments for the Conditions/Diagnosis category




Enter comments:













































































Field / Data Type Category: Drug Prescribing/Administration Data













Field / Data Type


Is the field available? If yes, % missing or unknown



22 Drug Generic Name

%


23 Drug Trade Name

%


24 Unit of Measure

%


25 Unique Encounter Identifier

%


26 Unique Ingredient Identifier

%


27 Formulary Status (i.e., do you have a flag to indicate the drug is included/excluded in various formularies?)

%


28 Dosage Strength

%


29 Route of Delivery

%


30 Drug Dose

%


31 Quantity Prescribed

%


32 Prescriber Identifier

%


33 Prescribing Physician Specialty

%


34 Indication for Therapy

%


35 SIG Specification

%


36 Dates of Administration

%


37 Stop Order

%


38 Drug & Primary Packaging Integrity

%















Provide any comments for the Drug Prescribing/Administration Data category




Enter comments:









































































Field / Data Type Category: Drug Dispensing Data













Field / Data Type


Is the field available? If yes, % missing or unknown



39 Drug Generic Name

%


40 Drug Trade Name

%


41 NDC Code

%


42 Drug Coding System




What coding system(s) do you use? (Please select all that apply)












First DataBank (NDDF)











NDF-RT











Multum











RxNorm











Other




















Comments:































43 Manufacturer

%


44 Lot Number

%


45 Date Dispensed

%


46 Expiration Date

%


47 Quantity Dispensed

%


48 Days Supplied

%


49 Unit of Measure

%


50 Unique Encounter Identifier

%


51 Unique Ingredient Identifier

%


52 Formulary Status (i.e., do you have a flag to indicate the drug is included/excluded in various formularies?)

%


53 Dosage Strength

%


54 Route of Delivery

%


55 Indication for Therapy

%


56 SIG Specification

%


57 Drug Dose

%


58 Duration of Drug Therapy

%


59 Instructions for Use

%


60 Prescriber Identifier

%


61 Prescribing Physician Specialty

%


62 Pharmacy Identifier

%


63 Refill Indicator

%


64 Emergency Department Drugs

















Where are medications that are administered in the Emergency Department recorded?












































Provide any comments for the Drug Dispensing Data category




Enter comments:













































































Field / Data Type Category: Other Drug Data













Field / Data Type


Is the field available? If yes, % missing or unknown



65 Previous Therapies

%


66 Concurrent Drug Therapies

%


67 Over the Counter (OTC) Drugs




Do you capture OTC Drug data?



















If you capture OTC data, which fields do you capture?












































Are the fields structured or free text?





























Comments:



























68 Prescriptions Not Filled

%


69 Reason Drug Discontinued, If Discontinued

%


70 Days Between Dispensing

%















Provide any comments for the Other Drug Data category




Enter comments:













































































Field / Data Type Category: Vaccines













Field / Data Type


Is the field available? If yes, % missing or unknown



71 Manufacturer

%


72 Lot Number

%















Provide any comments for the Vaccines category




Enter comments:













































































Field / Data Type Category: Other Biologics













Field / Data Type


Is the field available? If yes, % missing or unknown



73 Manufacturer

%


74 Lot Number

%















Provide any comments for the Other Biologics category




Enter comments:













































































Field / Data Type Category: Hospital-Based Care













Field / Data Type


Is the field available? If yes, % missing or unknown



75 Encounter/Admission Date

%


76 Discharge Date

%


77 Length of Stay

%


78 Primary Discharge Diagnosis

%


79 Days Spent in Intensive/Critical Care Unit

%


80 Admission Source

%


81 Discharge Disposition

%















Provide any comments for the Hospital-Based Care category




Enter comments:













































































Field / Data Type Category: Devices













Field / Data Type


Is the field available? If yes, % missing or unknown



82 Product Code

%


83 Device Type

%


84 Manufacturer/Brand

%


85 Model

%


86 What is electronically captured that identifies devices specifically? (at least at the level of the manufacturer)




Please describe:

























































Provide any comments for the Devices category




Enter comments:













































































Field / Data Type Category: Procedures (Outpatient and Inpatient)













Field / Data Type


Is the field available? If yes, % missing or unknown



87 Procedure

%


88 Type of Coding System




What coding system(s) do you use? (Please select all that apply)












Category 1 CPT Codes











Category 2 CPT Codes (Performance Measurement)











Category 3 CPT Codes (Emerging Technologies)











HCPCS Codes











ICD-9 Procedure Codes











SNOMED











LOINC











Other




















Comments:





































89 Procedure Date

%












Provide any comments for the Procedures (Outpatient and Inpatient) category




Enter comments:













































































Field / Data Type Category: Test Data/Result Data













Field / Data Type


Is the field available? If yes, % missing or unknown



90 Ordered Test

%



If Yes, what coding system(s) do you use? (Please select all that apply)












LOINC











Other




















Comments:





































91 Date Ordered

%


92 Date of Test

%


93 Date of Results

%


94 Test Results (actual test results)

%



If Yes, what coding system(s) do you use? (Please select all that apply)












SNOMED











Other




















Comments:








































95 Blood Cell Counts

%


96 Electrolytes

%


97 Lipids

%


98 Glucose

%


99 Urinalysis

%


100 Liver Biochemistry

%


101 Coagulation

%


102 Renal Function (Serum Creatinine)

%


103 Microbiology

%


104 Imaging

%



If Yes, what coding system(s) do you use?

























































Provide any comments for the Test Data/Result Data category




Enter comments:













































































Field / Data Type Category: Vital Signs













Field / Data Type


Is the field available? If yes, % missing or unknown



105 Date of Measurement

%


106 Time of Measurement

%


107 Height

%


108 Weight

%


109 BMI Indicator

%


110 Blood Pressure

%



If Yes, do you track systolic and diastolic data in separate data fields?
























Select:






















Comments:








































111 Orthostatic Blood Pressure Measurement

%


112 Temperature

%


113 Heart Rate

%


114 Respiratory Rate

%












Provide any comments for the Vital Signs category




Enter comments:













































































Field / Data Type Category: General Medical History













Field / Data Type


Is the field available? If yes, % missing or unknown



115 Medical Product Allergies (i.e., prescription drug, over the counter, devices, etc.)

%
















If you capture medical product allergies, which data elements do you capture?
































Is the information structured or free text?




























Comments:



























116 Other Allergies (i.e., dietary supplements, food, food additives, cosmetics, etc.)

%
















If you capture other allergies, which data elements do you capture?
































Is the information structured or free text?




























Comments:



























117 Past Medical Conditions

%


118 Existing Medical Conditions

%


119 Family Medical History

%


120 Smoking Status

%


121 Alcohol Use

%


122 Illicit Drug Use

%


123 Quality of Life Scores

%


124 Activities of Daily Living

%


125 Special Diets

%












Provide any comments for the General Medical History category




Enter comments:













































































Field / Data Type Category: Availability of Data on Implant Associated Procedures













Field / Data Type


Is the field available? If yes, % missing or unknown



126 Physician Experience

%


127 Procedure Volume

%


128 Technique

%















Provide any comments for the Availability of Data on Implant Associated Procedures category




Enter comments:













































































Field / Data Type Category: Dietary Supplements, Food, Food Additives, Cosmetics, and Infant Formula













Field / Data Type








129 Dietary Supplements















Do you capture dietary supplements data?


















If you capture dietary supplements data, which fields do you capture?








































Are the fields structured or free text?




























Comments:



























130 Food















Do you capture food data?


















If you capture food data, which fields do you capture?








































Are the fields structured or free text?




























Enter comments:



























131 Food Additives















Do you capture food additives data?


















If you capture food additives data, which fields do you capture?




































Is the information structured or free text?




























Comments:



























132 Cosmetics















Do you capture cosmetics data?


















If you capture cosmetics data, which fields do you capture?




































Is the information structured or free text?




























Comments:



























133 Infant Formula















Do you capture infant formula data?


















If you capture infant formula data, which fields do you capture?




































Is the information structured or free text?




























Comments:








































Provide any comments for the Dietary Supplements, Food, Food Additives, Cosmetics, and Infant Formula category




Enter comments:
























































Public reporting burden for this collection of information is estimated to average 17.5 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control numbers.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Information Management
1350 Piccard Drive, PI50
Rockville, MD 20850
OMB #__






















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