Evaluation of Potential Sources for the Sentinel Initiative

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Overview

General Questions
Data Attributes
Data Availability

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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 #__

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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 #__

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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 #__