Questions and Answers for EDs

Collecting the Data
Why Hospitals Join DAWN
DAWN LIVE! for EDs
How New DAWN Works in EDs
How to Join DAWN
Remote Reporting
HIPAA and Privacy

Collecting the Data

What is a DAWN case?

A DAWN case is any ED visit or death related to recent drug use. The criteria for inclusion in DAWN are intentionally broad and simple, with few exceptions.

What drugs are included in DAWN?

• Illegal drugs of abuse;
  
  
• Prescription and over-the-counter medications;
  
  
• Dietary supplements;
  
  
• Non-pharmaceutical inhalants;
  
  
• Alcohol in combination with other drugs (adults and children)
  
  
• Alcohol alone (age < 21).

What types of cases are included in DAWN?

Because the DAWN cases are defined broadly, DAWN captures many different types of drug-related cases.

What types of ED visits are not included in DAWN?

There are only a few exceptions to the DAWN case criteria. A visit is not included in DAWN:

• If the patient left the ED without being treated.
  
  
• If the patient consumed a non-pharmaceutical substance but did not inhale it.
  
  
• If the patient has a history of drug use but no current use.
  
  
• If alcohol is the only substance involved and the patient is age 21 or over.
  
  
• If the only documentation of a drug is in toxicology test results.
  
  
• If the drugs listed are not related to the visit (e.g., current medications).
  
  
• If there is no evidence of recent drug use.
  
  
• If the patient is being treated for under-medication, i.e., taking too little of a drug.

What types of drug-related deaths are not included in DAWN?

There are only a few exceptions to the DAWN case criteria. A death is not included in DAWN:

• If the death is not reviewed or investigated by a medical examiner or coroner.
  
  
• If the decedent consumed a non-pharmaceutical substance but did not inhale it.
  
  
• If the decedent has a history of drug use but no current use.
  
  
• If alcohol is the only substance involved and the decedent is age 21 or over.
  
  
• If the only documentation of a drug is in toxicology test results.
  
  
• If the drugs listed are not related to the death (e.g., current medications).
  
  
• If there is no evidence of recent drug use.
  
  
• If the drug did not cause or contribute to the death.
  
  
• If the death was due to under-medication, i.e., taking too little of a drug.
  
  
• If the decedent was a homicide victim, even if on drugs at the time of death.

How are DAWN cases found?

DAWN cases are found by a retrospective review of all ED medical records or ME/C case files. Patients or families are never interviewed. The review of source records is performed by a trained DAWN Reporter in each member facility. For each DAWN case found, the DAWN Reporter abstracts DAWN data items from the source record.

The DAWN Reporter submits the DAWN data items electronically through secure, Internet-based systems, which help to maintain the timeliness of the information.

Why is it necessary to review all ED medical records or ME/C case files?

Multiple field studies have shown that alternate methods miss substantial numbers of DAWN cases.

Does DAWN review records of patients who do not come through the ED?

No, DAWN only collects data on ED visits, and only the ED charts are reviewed.

Is it true that DAWN only collects data on illegal drugs?

• Illegal drugs of abuse;
  
  
• Prescription and over-the-counter medications;
  
  
• Dietary supplements;
  
  
• Non-pharmaceutical inhalants;
  
  
• Alcohol in combination with other drugs (adults and children); and
  
  
• Alcohol alone (age < 21).

How are drug abuse cases denoted in the New DAWN?

New DAWN recognizes it is often difficult to distinguish among cases of drug use, misuse, or abuse in medical records. Also, drug misuse or abuse is often not explicitly or consistently recorded. Therefore, DAWN uses an indirect method to identify drug abuse.

Each case reported to DAWN is assigned to one of eight case types according to the following hierarchy:

Cases not falling into any of the first seven case types are classified as "Other." Most drug abuse cases are classified as "Other."

For analysis, DAWN uses methods to identify different categories of non-medical use, misuse, or abuse. One approach may include combining cases of:

• Other
  
  
• Overmedication

A more expansive category of drug misuse/abuse might also include:

• Malicious poisoning
  
  
• Seeking detox
  
  
• Suicide attempt

A third approach focuses on the illicit drugs, regardless of case type.

Is it true that the drugs reported to DAWN are all based on patients’ self reports?

No, drugs reported to DAWN come from the ED medical record or ME/C case file. There are many possible sources for this information: laboratory (toxicology) testing, the clinical assessment and diagnoses, as well as reports by patients, their friends, or their families.

For clarity, we no longer use the term “drug mention,” because it was frequently (erroneously) interpreted to mean that the patient “mentioned” the drug.

Are all the drugs reported to DAWN based on laboratory test results?

No, not all drugs reported to DAWN were confirmed by toxicology. Testing protocols vary across hospitals, clinicians, and patients. However, since 2003 DAWN has been collecting whether the drug being reported from the medical record was confirmed by toxicology.

Does DAWN collect current medications unrelated to the visit or death?

No, DAWN Reporters are trained to report only those drugs related to the ED visit or death. If a current medication is unrelated to the visit, it is not reportable.

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Why Hospitals Join DAWN

What's new about the New DAWN?

• The New DAWN is no longer just about drug abuse. DAWN now includes all types of drug-related ED visits and ME/C reported deaths. This includes visits or deaths related to the following:

  DAWN ED cases include:	DAWN mortality cases include:
  Drug abuse and misuse Suicide attempts Overmedication Adverse reactions Accidental ingestions Malicious poisoning Underage drinking Patients seeking detoxification or drug abuse treatment	Drug abuse and misuse Completed suicides Overmedication Adverse reactions Accidental ingestions Homicide by drugs Underage drinking Other deaths related to drugs

  
  This expanded coverage makes the system more useful to hospitals, medical examiners or coroners (ME/Cs), and other users of DAWN data.

• DAWN LIVE! a new benefit for members, is an interactive, Web-based system designed to give EDs and ME/Cs access to their own data in “real” time. DAWN LIVE! gives staff the ability to track the patterns of drug-related cases and deaths seen, the drugs involved, and the patients/decedents affected. This kind of information can help hospitals manage resources and staffing to respond to changing caseloads, and ME/Cs to identify serious drug-related threats to the public health.
  
  
• Metropolitan areas updated in New DAWN to reflect the 2000 Census.

What are the benefits of joining DAWN?

DAWN provides training, technical support, payment for participation, and real-time access to each member’s own data. DAWN helps EDs and ME/Cs monitor the patterns of drug-related cases seen, recognize sentinel events, and increase staff awareness of drug-related cases. This kind of information can help hospitals manage resources and staffing to respond to changing caseloads, and ME/Cs to identify serious drug-related threats to the public health.

With DAWN LIVE!—the Internet-based system for using the facility’s data—hospital staff are beginning to demonstrate the need for specialized services, such as psychiatric or detoxification units, for better and less costly patient care.

Clinicians in some participating hospitals use DAWN data regularly in preparing grant proposals. Others use DAWN data as evidence of the hospital’s contribution to the public health of its community.

Is participation in DAWN mandatory?

DAWN is mandatory for SAMHSA but voluntary for hospitals and ME/Cs.

My hospital has very few drug-related cases. How can that be useful to DAWN?

Hospitals invited to join DAWN are part of a scientific sample designed to reveal an accurate picture of drug-related ED visits for the metropolitan area and for the Nation. To get an accurate picture, hospitals with few drug-related cases and hospitals with many drug-related cases need to be represented.

Now that DAWN covers all types of drug-related ED visits and all types of drugs, it is more likely that your hospital will have at least some DAWN cases to report.

How did you choose my hospital?

DAWN uses a scientific sample of hospitals designed to represent all hospitals in each metropolitan area and the Nation as a whole. Collecting data from every hospital in a metropolitan area or the Nation would be too expensive. The best and most affordable alternative is to collect data from a representative sample of hospitals, and then use that data to make estimates for your metropolitan area and the Nation.

Non-Federal, short-stay, general medical and surgical hospitals with 24-hour emergency departments are eligible for the sample. Statisticians drew the sample based on a complete list from the American Hospital Association. If your hospital was chosen, it will represent itself and other hospitals like yours. For example, if you are a medium-size private hospital, you represent other medium-size private hospitals. That is why your participation is very important to DAWN.

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DAWN LIVE! for EDs

What is DAWN LIVE!

DAWN LIVE! is a secure, Internet-based query system that gives DAWN members access to the data submitted for their facility. Authorized staff named by their facility may use DAWN LIVE!. All data in DAWN LIVE! are de-identified.

I don't have a lot of time. How easy is it to use?

DAWN LIVE! is accessed via the Internet. Authorized users go to the DAWN LIVE! website and log in with their user name and password and agree to use the data within the confidentiality restrictions required.

The DAWN LIVE! search page is very simple. With just a few clicks of a mouse, users choose the types of drug-related cases, drugs of interest, time periods, and other characteristics of DAWN cases to tabulate. Drugs may be chosen or tabulated down to the brand level. Simple instructions are provided on the screen.

Who can use it? How do I get a password?

Staff must be designated by participating facilities to access DAWN LIVE! Initially, each DAWN facility designates in their participation agreement the staff members who can use DAWN LIVE!. Additional staff can be added by the facility administrator at any time. Westat assigns passwords once authorizations are received.

Can I get comparison data for the entire metropolitan area?

Yes, comparison metropolitan area became available on DAWN LIVE! in October 2004 in response to requests from members. Also available is a comparison with aggregate data from all hospitals reporting to DAWN across the Nation. Because DAWN LIVE! is a “real-time” system with facilities reporting at different rates, the system includes a measure of how complete the data are at any point in time.

Also, SAMHSA produces annual publications for metropolitan areas and the Nation, which are made available within the New DAWN Publications section.

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How New DAWN Works in EDs

What are the Reporter options?

DAWN makes reporting as easy as possible with a number of options

1. Westat Central Reporter. If your facility has electronic records that can be accessed remotely, Westat can collect DAWN data from the data center in Maryland. This option is not possible for every electronic system; it only works for systems with appropriate security features, for example, audit trails that would track our remote access.
   
   
2. Westat Field Reporter. Westat can provide a person to collect data in your ED. This option offers a lot of flexibility in terms of the days or shifts when the data are collected.
   
   
3. Hospital After-Hours Reporter. Your hospital can recommend a staff member to collect DAWN data during his or her off-duty hours.
   
   
4. Hospital Staff Reporter. Your staff collect the data as part of their regular duties during the normal workday. For hospitals, this option works best when staff are already reviewing every ED chart for another purpose, such as coding or billing.

Does the Reporter need office space?

If hospitals select the Westat Central Reporter, no space is needed since data collection is done at Westat headquarters.

For the other reporting options, some space is necessary. Westat will work with you to find the best approach for your facility. For example, a Westat Field Reporter could come during an evening shift if that is when space is available. If you don't have room for us to use a facility computer, we can provide a laptop computer which requires less space.

Our goal is to find the approach that works best for you. We don't want to change the way you do business.

How are the data submitted to DAWN?

All data are submitted electronically.

For EDs, most data are submitted using eHERS (electronic Hospital Emergency Reporting System).

• eHERS is a secure, Internet-based data entry system.
  
• If Internet access is not available at the data collection point, data are entered into a standalone version of eHERS on a laptop computer and then are uploaded to the central database later.

For ME/Cs, most data are submitted using eMERS (electronic Medical Examiner Reporting System).

• eMERS is a secure, Internet-based data entry system.
  
  
• If Internet access is not available at the data collection point, data are entered into a standalone version of eMERS on a laptop computer, and then are uploaded to the central database later.

How frequently are data submitted to DAWN?

DAWN is a continuous data collection system. We do not sample patients, visits, or time periods.

Timeliness of the data is very important. Data must be timely

• For DAWN to be a "warning" network
  
  
• For DAWN data to be useful in real-time.

What does this mean?

• For EDs, cases should always be submitted within 30 days, but we prefer to have cases submitted within 1 week of ED visits.
  
  
• It often takes longer for ME/Cs to close out cases, so they cannot be submitted to DAWN this quickly.

How much time does reporting for New DAWN take?

The amount of time can vary considerably, depending on how accessible the charts are, whether the necessary information is available all in one place, and other factors. On average, 200 to 300 ED charts or decedent records can be reviewed and DAWN cases entered during an 8-hour workday. For example, a full-time position could handle about 4,000 charts/records in a month.

What are the payment options for EDs?

The payments are designed to be equitable across facilities.

What kind of assistance can we expect from SAMHSA or Westat?

Here is what we do to assist you in participating in DAWN:

What type of equipment do we have to provide?

Your DAWN Reporter will use a computer workstation with Internet access provided by your facility. If you do not have a workstation or Internet access available for DAWN, Westat will provide all necessary equipment or Internet connections.

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How to Join DAWN

Whom do I contact to discuss joining DAWN?

For information on joining DAWN, please call 800-FYI-DAWN and ask for Facility Relations. Facility Relations staff are trained to answer all your questions about joining DAWN.

Who should sign the participation agreement in our facility?

Any individual who has the authority to sign hospital agreements or contracts can sign the DAWN participation agreement. These individuals include CEOs, ED Directors or Administrators, or Chief Nursing Officers. For MEs, it is usually the Chief Medical Examiner or Office Administrator.

What kind of staff in our facility would be eligible to be a Reporter?

In most hospitals, staff who already review all ED charts are the best candidates. Staff who code the charts for billing or conduct quality assurance functions often fall into this category. Of course, it is necessary to consider the volume of charts. Hospitals with very large caseloads may not have staff to perform DAWN reporting. If this is the case, other Reporter options are possible.

Our hospital may soon convert to electronic charts? Should we consider " remote reporting? Should we wait until the electronic charts are available to join DAWN?

Absolutely. Please review Remote Reporting questions and answers to see what is involved.

There is no need to wait. You can start reporting to DAWN using one method and switch to remote reporting when your system changes are in place.

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Remote Reporting

What kind of system does the hospital need to have to take advantage of remote reporting?

Remote reporting is not restricted to particular systems or vendors, but certain technological and security requirements must be met. At a minimum, the hospital must have the following to qualify for remote reporting:

• All sections of the ED chart must be electronic, including demographic information, physicians'/nurses' notes and/or dictation, diagnoses, toxicology results, and patient disposition.
  
  
• A method for access outside the hospital. For example, if physicians can access the charts from home, remote reporting is possible.
  
  
• An internal method for authenticating remote users and tracking their access (in an "audit trail"). We want you to know who is accessing your system, when this is occurring, and what they are seeing.
  
  
• A method of restricting our access to the ED chart. For example, we have no need to review an inpatient record for a patient admitted from the ED. Electronic systems are usually able to restrict our remote access to the ED chart.

What is involved with getting remote reporting started at my hospital?

This depends on your system and what we need to do in order to access it. For example, for some hospital systems we need a modem to connect directly to their server; for some all we need is secure Internet access. Our staff can work with your IT staff to deal with the technology issues.

How long will it take to get started?

This depends on what resources we need to get started. We need your staff to communicate your system's requirements to us in a timely manner. We will start reporting as soon as everything is in place.

Who does the reporting?

The reporting is done by one or two Westat employees physically located at our home office in Rockville, Maryland.

How often will they access the records?

The Westat Reporter will access your records as often as necessary to keep the data collection current within 30 days. How frequently this happens depends on the volume of ED visits you have and how much time it takes to review a complete chart—for example, how many screens does the reporter have to review for each chart? For some hospitals, the Reporter will access charts every day; for others, only once or twice a week

What security protections do you provide for remote reporting?

Remote reporting is performed in a secure, access-controlled space set up specifically for this purpose. Computer monitors are situated away from doors and windows. Locked cabinets are provided to store materials. The Westat Reporter(s) and the DAWN Field Director will be the only people with knowledge of your system and access to your ED charts. We will send in a high level manager to learn about your system, and they will train the reporters. No direct identifiers are retained or submitted on the DAWN cases. All DAWN personnel receive specific training about confidentiality and data protection. All DAWN personnel sign confidentiality agreements and are subject to stiff penalties for violations.

Will my hospital still receive an annual access payment if we choose remote reporting?

Yes, your hospital will still receive the annual access payment for each participating ED.

Can we change our minds and choose a different reporting option even after we have chosen remote reporting?

Yes, you can always change your reporting option. We ask that you provide written notice of your intent to change so we can make the corrections to our internal systems.

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HIPAA and Privacy

Can my hospital participate in DAWN and still comply with HIPAA?

Yes, DAWN meets all of HIPAA's requirements.

• At 45 CFR 164.512(b)(1), HIPAA permits disclosures of protected health information for public health without patient consent or authorization.
• DAWN is a public health surveillance system, operated by SAMHSA, a public health authority authorized by law to conduct public health surveillance.
• Westat is a public health authority by virtue of its contract with SAMHSA.
• Consistent with the Privacy Rule, DAWN requests only the minimum necessary information to fulfill DAWN's public health surveillance purpose.

How are the data protected once they leave my hospital?

Once DAWN data leave your hospital, they are no longer protected by HIPAA. Instead, your data are protected by two Federal laws that restrict the uses of DAWN data by SAMHSA and Westat. These laws are

• Section 501(n) of the Public Health Service Act (42 U.S.C. 290aa)
• Title V of the E-Government Act of 2002 (P.L. 107-347).

These laws restrict SAMHSA and its agent Westat to

• Use identifiable data only for the purpose for which they are collected
• Disclose identifiable data only with the consent of the subject.

We collect DAWN data only for public health surveillance and associated statistical purposes. Consequently, no identifiable data can be used for any other purpose. We do not seek consent from patients; consequently, we do not disclose individually identifiable information.

Unlawful disclosure of information by employees of SAMHSA or Westat is subject to stiff penalties—up to 5 years in prison and up to $250,000 in fines.

Can anyone else access my hospital's information?

Only authorized staff of SAMHSA and Westat can access identifiable data from your hospital.

Data provided via DAWN LIVE! are not identifiable. De-identified data for an individual hospital can only be disclosed with the hospital's permission. For example, some hospitals give permission for local public health officials to use their de-identified data.

Can I use DAWN to identify a patient who is shopping around for drugs at my hospital and other hospitals in my area?

No. Under Federal law, we cannot disclose individually identifiable information without the consent of the subject. Therefore, we do not collect direct identifiers that could be used to link multiple visits for the same person, and we cannot disclose data that could be identifiable indirectly.

You can use your hospital's DAWN data to gain a better understanding of the types of drug-related cases treated in your ED, but Federal law does not permit re-identification of cases for any purpose.

How can Westat help in accounting for disclosures to DAWN?

Under the Privacy Rule, hospitals must account for disclosures of protected health information for public health. The Office for Civil Rights, the agency responsible for enforcement of the Privacy Rule, has clarified the accounting provisions that apply specifically to DAWN.

Westat can produce an accounting for disclosures to DAWN that complies fully with the Privacy Rule. Such an accounting can be made available to you upon your request or on a set schedule of your choosing. For more information about DAWN and HIPAA, contact our Facility Relations staff at 800-FYI-DAWN.

Do we need a Business Associate Agreement with Westat?

NO. Here’s why:

• Under the HIPAA Privacy Rule, hospitals may disclose protected health information for public health surveillance to entities other than business associates.
• A Federal public health authority does not become a business associate simply because it receives disclosures of PHI. For example, hospitals routinely inform public health authorities about the incidence of certain infectious diseases or medical device failures; this information does not make the recipient a “business associate” of the hospital. SAMHSA is a public health authority, and Westat, as SAMHSA’s agent, is functioning as a public health authority for DAWN on SAMHSA’s behalf.
• Westat receives DAWN data from the hospital and compiles that data for SAMHSA. Westat provides services for SAMHSA, not for the hospital.
• Westat does not engage in “data analysis” with individually identifiable health information (§160.103). We do not perform any data analysis in our role as DAWN operations center. We provide each hospital with access to its own data after it has been de-identified, and we provide a tool for authorized staff to conduct their own limited analyses if they desire to do so. The hospital has not asked us to analyze data on its behalf.
• Westat provides the general public, through an Internet site, with access to de-identified tabulations of DAWN data. Those data cannot be associated with any particular hospital. Moreover, Westat does not perform those analyses under this contract or on behalf of the hospital.
• Westat does not provide data aggregation services to the hospital as defined at §164.501. In fact, we are prohibited by Federal law from providing you with access to data that would make a patient identifiable or data that would make another DAWN hospital identifiable.

Do we need to go through an IRB (Institutional Review Board)?

NO. Here’s why:

• DAWN is public health surveillance, not research. Under HIPAA, IRB approval is not required for public health surveillance.
• DAWN data collection does not involve any direct contact with patients (human subjects). All DAWN data are collected by a retrospective review of medical records. Patients, their physicians, or their families are never interviewed.

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