Friday, March 25, 2011

What is an Order Set?

It's funny. When I first got involved with electronic medical records at the Albany VA Hospital, as a resident, I remember one of their informatics people telling me, "You have no idea how political order sets are. The arguments I have seen over whether to check or uncheck a box... It's unbelievable."

She was right.

After you go electronic, prepare for the political discussions about order sets. Lots of people have opinions, but not many are actually are involved with building, testing, or development of order sets or using them.

So I thought I'd present this primer, to help people understand - "It's not just a bunch of orders with boxes." :

What is an Order Set?

I. BACKGROUND

An order set is a grouping of orders, used to standardize and expedite the ordering process for a common clinical scenario.

Before an order set can be created, the goal of the order set must be clear. Any necessary orders, contained in the order set, must be built first. (Order sets for new or innovative workflows should first be examined for any new orders that need to be engineered first.)

Order sets should only contain orders. They should not be confused with :
  1. PROTOCOLS - Conditional IF/THEN statements, allowing a nurse/pharmacist/other licensed medical professional to start/modify/stop orders on behalf of a licensed physician, to automate and standardize the care for a common clinical scenario.
  2. CLINICAL PATHWAYS - Tools used to standardize the discussion and goals of therapy, during rounds, for a common clinical diagnosis.
  3. CHECKLISTS - Documentation tools used to document, standardize, and expedite the screening process for a common clinical scenario.
  4. POLICIES - Agreed-upon standards for your organization
  5. PROCEDURES - Detailed steps about how to achieve a desired standard.
  6. PATIENT EDUCATION MODULES - Documents that help educate a patient about a particular subject (e.g. diet, disease, procedure, or aftercare)
  7. STAFF EDUCATION MODULES - Documents that help educate a staff member about a particular subject (e.g. diet, disease, procedure, or aftercare)
  8. DOCUMENTATION - Tools that help record and transmit patient history, condition, activities, responses, laboratory values, radiology images, and notes
  9. GUIDELINES - Educational tools to help educate a staffmember about a general clinical objective (more flexible and negotiable than a policy)
For maximum safety, order sets should be built :
  1. With clarity and a standard layout (Please see the ISMP Guidelines).
  2. With all necessary information required to safely complete the order set.
  3. With only those automating features which are absolutely necessary. (Risks/benefits of pre-checking orders must be closely examined on each order. As a general recommendation, pre-checking orders should be avoided on medication orders.)
  4. With evidence-based practices.
  5. To reduce variation and unintentional oversight.
  6. To prompt for all necessary information.
Order sets can range widely in complexity, from very simple convenience order sets, to very complex order sets used to trigger clinical pathways or protocols.

II. DESIGN / CATEGORIZATION

Order sets typically fall into one of two primary categories :
  1. Charge Order Sets - Those used by nurses and other clinical staff to create charges for common clinical materials (e.g. gauze, dressings, etc.)
  2. Physician Order Sets - Those used by physicians to standardize and expedite the ordering process for a common clinical scenario.
Physician Order Sets may vary widely in complexity, but typically come in one of several types :
  1. Admission Order Sets - (Sometimes called "Venue-specific order sets") - Used to admit a patient to a particular attending, level-of-care, and service.
  2. Transfer Order Sets - Used to transfer a patient to a particular attending, level-of-care, and service (rarely used in clinical practice, but hypothetically these could be used to standardize care on transfer of a patient)
  3. Discharge Order Sets - Used to discharge a patient from a particular level-of-care
  4. Workup Order Sets - Used to workup a particular condition of complaint
  5. Treatment/Diagnosis Order Sets - Used to standardize and expedite care orders for a common clinical diagnosis.
  6. Prep (aka Pre-procedure or pre-operative) - Used to prepare a patient for a procedure or operation.
  7. Recovery (aka Post-procedure or post-operative) - Used to recover a patient from a procedure or operation.
  8. Convenience Order Sets - Used for another common clinical scenario, other than those in 1-7 above (e.g. nursing protocols, heparin titration protocol, alcohol withdrawal protocol, insulin titration protocol, vent liberation protocol, etc.)
More complex physician order sets may fall outside one of these categories.

III. OWNERSHIP

Order sets are typically owned by a defined clinical director.

IV.  CONSTRUCTION

Order sets should generally be constructed by a person trained/experienced in building order sets (e.g. clinical informaticist) in conjunction with a Subject Matter Expert (SME) and a Clinical IT Analyst.

V. TESTING

Order sets should be tested by all parties involved in the use and function of the order set. Generally, at a minimum :
  1. One end-user physician should be able to understand and complete the order set
  2. One end-user nurse should be able to understand and complete the orders from the order set
Additional users (e.g. Pharmacists, respiratory therapists, etc.) may be necessary for testing, depending on the type, complexity and goal of the order set. 

Testing needs shall be determined by the clinical Informaticist in conjunction with the chairperson of the Order Set Committee.

VI. APPROVAL

After testing is completed, the order set may be brought to a committee for approval. The chairperson of the Order Set Committee will put the order set on the agenda, and allow a period of comments from voting members before the order set is brought to a vote.

Voting will be conducted by the Order Set Committee Chairperson.

If the order set is approved by committee, the chairperson will forward the order set to the Clinical Analysts for publication.

In the event of a tie vote, the order set will be brought to the Medical Executive President for further discussion or placement on the Medical Executive Committee.

VII. PUBLICATION

After approval by committee, the order set will be published for use :
  1. An electronic version will be published in the EMR Order Set Catalog.
  2. A paper version will be published into the Emergency Downtime Order Set Folder
  3. An electronic version will be published in the Printshop Order Set Catalog, for creation of any paper order sets needed for remaining paper functions.
VIII. EDUCATION

After publication, staff education on the existence, goal, and use of the order set is the responsibility of the owner.

It is helpful if users are made aware of order sets, how to use them, changes, and reasons for change.

IX. MONITORING

After publication, all order sets will be monitored by their owner.

X. CITATIONS

ISMP's Guidelines for Standard Order Sets : http://www.ismp.org/tools/guidelines/StandardOrderSets.pdf

Tuesday, March 15, 2011

How to Install an Informatics Policy Framework, and Why?

A common question I get asked is :

Q: "Dirk... We have over 600 different order sets... Now we can't save money on formulary costs, because the doctors still keep ordering the old antibiotics on the old order sets. What can I do?"

The answer is simply : You need to define your standards. By defining a standard way in which your order sets will be built, you can do a lot to "clean up the order set catalog".

STEP 1 : You will need to decide : Should we let doctors make their own order sets?
Pros : Less work to build order sets, and docs can build exactly what they want.
Cons : Less organizational control over standardizing care, less control over costs, higher maintenance costs.
If you decide 'we want to standardize our order sets', proceed to Step 2.

STEP 2 :  You will need to convince your medical staff of the need for such standards. Create the following policy, then bring it to your medical executive committee for approval as a "General Clinical Policy". This will allow you to have a chapter of informatics policies in your clinical policy manual, and then start building a number of informatics policies to fill that chapter.
POLICY NAME : Chapter of Informatics Policies
POLICY : "All patients at Acme Hospital will be cared for with clinical information tools developed according to policies outlined in the chapter of Clinical Informatics Policies."
DEFINITIONS :
Clinical Tools - Any documents or other tools used to guide the delivery of clinical care. These may include, but are not limited to : Policies, Procedures, Orders, Order Sets, Protocols, Documentation/Forms, Templates, Patient Education Modules, Staff Education Modules, Charters, Schedules,  and Minutes. 
PROCEDURE :
A. Staff will consult the chapter of Clinical Informatics Policies prior to the construction of any clinical tool.
B. Staff may ask the Director of Clinical Informatics for guidance if any questions arise regarding the construction of these tools.
If you've designed this correctly, and your medical staff understands the issues, this should generate some discussion before it gets approved.

STEP 3 : You will then need a committee to help approve the policies that go in that chapter of Clinical Informatics Policies. Develop a committee charter, and bring it to your medical staff for approval.
Charter : Clinical Informatics Committee
Meeting Frequency : Monthly
Jurisdiction : Reports to Medical Executive Committee
Purpose/Task : To approve Clinical Informatics Policies on behalf of the Medical Executive Committee
Quorum : 50%
Voting Structure : By majority
Chairperson : The CMIO
Voting Members : ___________, ___________, ____________, _____________ 
If you can't get this committee approved by your Medical Executive Committee, then you will need to bring all Clinical Informatics Policies to the MEC for approval.

STEP 4 : Come up with a standard policy definition for an order set.
"An order set is a grouping of orders used to expedite and standardize the ordering process for a common clinical scenario."
or...
"An order set is a document with a group of orders, used to expedite and standardize the ordering process for a common clinical scenario."
or even better yet...
"An order set is a document with a group of orders, with evidence-based links, that is used to expedite and standardize the ordering process for a common clinical scenario. All orders on an order set are started, modified, and stopped by a licensed physician."
Any of the above definitions should suffice, depending on your need for clarity.

STEP 5 : Use that definition to write your first good informatics policy, in your chapter of informatics policies, to standardize your order set development.
POLICY NAME : Order Set Development Policy 
POLICY : "All order sets will be built according to the procedure outlined below."
DEFINITIONS : 
Order Set - A document with a group of orders, with evidence-based links, that is used to expedite and standardize the ordering process for a common clinical scenario. 
PROCEDURE :
A. Order sets will be owned by a Clinical Director.
B. Order sets will be designed by an Informaticist and a Clinical IT Analyst.
C. Order sets will be tested by the Clinical Director and Informaticist and subject matter expert, using  at least (1) doctor and (1) nurse, in a testing environment.
D. Order sets will be presented by the Informaticist to the Chairperson of the Order Set Committee for placement on the Order Set Committee Agenda.
E. Order set creation, change, and deletion will be approved by the Order Set Committee at the next available meeting.
F. Order sets will be published in the Order Set Catalog in the Electronic Medical Record.
G. Order sets will be monitored by the Owner (Clinical Director). 
STEP 6 :  Bring the policy you wrote in Step 5 to your Clinical Informatics Committee (so they can approve it on behalf of your Medical Executive Committee), OR if you can't get your Med Exec to approve the committee charter, bring the policy to the Med Exec for approval.

Voila! If you were successful, you should now have :
  1. A chapter of Clinical Informatics Policies, in your clinical policy manual, that has been approved by your Medical Executive Staff.
  2. A charter giving authority to a Clinical Informatics Committee to approve Informatics Policies on behalf of the MEC.
  3. Your first Clinical Informatics Policy outlining the steps required to build, test, approve, and publish a standardized, evidence-based order set
  4. Your first meaningful change management mechanism for implementing electronic decision support and clinical workflows.
Once you have this rudimentary framework in place, you can then start working on updating the old 600 or more order sets. And if your order set committee is multidisciplinary and well-balanced, you can get balanced input before the order set goes live.

And your Informatics Committee can nimbly continue to develop informatics standards/policies that govern all of your clinical tool development.

This then brings you to Step 7 :
- Bring any old order sets to your order set committee for consideration of speedy deletion from your catalog.
- Build any new order sets according to the standard procedures outlined in the Order Set Development Policy (outlined above).
(You will probably need to tweak/format these policies to meet your organization's needs.)

I hope this was educational! Would love to hear how other folks handled their Informatics Policy framework! Remember, my advice is free, and as always, you get what you pay for. :)

Thursday, March 10, 2011

What exactly is a Policy and a Procedure?

Got back from the HIMSS11 conference in Orlando. First, a few quick impressions :

  1. It was BIG. Lots of vendors, lots of people. Everyone selling you "a solution". With this many vendors, it's almost impossible to find a standard. Lots of portable toys, but no clear agreements about what's going to run on those toys. Looks like the industry has a ways to go before being mature, and HITECH has made lots of people "get into the Health IT business".
  2. No meaningful standards yet. The discussion on the PCAST report was particularly interesting, as people debated .CCR, .CCD, HL7, and other standards that either "didn't meet payor needs" or "didn't meet physician needs" or "didn't meet software needs". As the guy behind SpeakFlower.org, I can tell you nobody was addressing a standard that meets patient needs
  3. The cabs and food were expensive. Taking a cab anywhere was $30 or more. Remember this the next time you book a hotel away from the convention center.
  4. Lots of interesting people. Got into a robust debate with some tech and social media leaders about HITECH. My opinion : HITECH is going to drive small practices/hospitals to merge with larger practices/hospitals. Got into an interesting evening debate with some of those tech leaders, who seemed pretty blase and felt that was a necessary part of healthcare reform. Still, it underscores my belief that HITECH is about much more than just "let's get the docs to use computers".

Overall, definitely worth attending once, but remember - virtually everything at the conference is paid for with healthcare dollars. (If you want to save healthcare dollars, consider eating PB&J instead of a fancy dinner.) :)

Anyway, also at HIMSS, I spoke with several other informatics leaders who seemed puzzled by IT/Informatics governance, and how it relates to overall hospital governance.

To help, I thought I'd reinforce this basic informatics concept the same way I explained "What is Medicine Reconciliation, anyway?" -

So our lessons, for tonight, are "What exactly is a Policy?", "How is it different than a Procedure?", and finally, "What's the best way to make a policy / procedure?"

1. What exactly is a Policy?

A policy is a written goal of standardization for your organization. (E.g. "All patients will get low-salt meals." - The goal is to get low-salt meals to all of your patients.). It explains the who, what, when, where, and sometimes why.

A procedure is then the written steps it takes to get to that goal (E.g. "Step 1: Call kitchen  Step 2 : Order low-salt meal   Step 3 : Wait for meal to arrive") A procedure explains the how.

Both the policy and the associated procedure are generally kept on the same paper or electronic document, so that your employees can find and read those documents, and if they are written well, they will quickly understand :
    - What is the standard/goal of your organization?
    - How can he/she achieve this goal?

Writing a good policy statement is not easy. The focus has to be clarity. Short and sweet. In general, it shouldn't be more than one sentence - If it is, it's a warning sign that you may not have a clear goal.

A common mistake is to try to write several different policies into one policy - While it's tempting to do that to help avoid excessive committee discussion, putting several policies into one usually results in a policy that is unclear and ineffective.

So, some examples of unclear policy statements might be :
  1. "Acme Hospital strives to provide low-salt meals which are nutritious and served warm and only to patients who need them. This is to meet the needs of the American Heart Association guidelines and other evidence-based recommendations. All employees will reinforce this rule."
  2. "Acme hospital, to meet consumer demand, will make free parking available for any OB/GYN patients who are discharged." 
  3. "Wiping feet before entering the hospital has been shown to save floor cleaning costs. Floor mats will be used by all employees before entering the hospital."
Their corresponding improvements would be :
  1. "All CHF patients will receive low-salt meals."
  2. "All OB/GYN patients will receive free parking vouchers on discharge."
  3. "All employees will wipe their feet before entering the hospital."
Remember, the trick to writing a policy statement is clarity. To do this, you will need to know :
  1. Who/what does the standard apply to?
  2. What is the standard?
By defining both of these, you can use the following template to write a good policy statement :

                "[who/what does the standard apply to?] will [what is the standard?]"

And so you should only write a policy when :

1. You have a need to standardize something, and
2. You have the resources to enact and enforce the policy. (Just writing a good policy is not enough!)

Writing good policy requires proper balance between specificity and ambiguity. If you do it well, you will create clarity, and your policy manual will become a meaningful change management mechanism.

(I recommend "Writing Effective Policies and Procedures" by Nancy J. Campbell as a reference - It's really well-written and clear and provides ample education about how to write a good policy.)

2. How is it different from a Procedure?

If the policy is the goal, then the procedure is the steps it takes to get to the goal.

So, if we use the three policy statements we improved up above :
  1. "All CHF patients will receive low-salt meals."
  2. "All OB/GYN patients will receive free parking vouchers on discharge."
  3. "All employees will wipe their feet before entering the hospital."
... then we can write clear procedures to achieve those goals :

Policy : "All CHF patients will receive low-salt meals."
Procedure :
  1. Physicians will identify all patients with a CHF diagnosis on admission.
  2. Physicians will communicate the full name/MRNO of all patients with CHF to the nurse.
  3. Nurses will send the name/MRNO of all CHF patients to the kitchen with an order for a low-sodium meal.
  4. Patients will wait for meal to arrive.

Policy : "All OB/GYN patients will receive free parking vouchers on discharge."
Procedure
  1. Discharge Planners in OB/GYN department will place a free parking voucher in all discharge packets.
  2. Nurses in OB/GYN department will review free parking voucher with all patients on discharge.
  3. Patients in OB/GYN department who have not received a free parking vouchers will be provided one on request.

Policy : "All employees will wipe their feet before entering the hospital."
Procedure :
  1. Maintenance staff will maintain a mat at the entrance to the hospital.
  2. All employees, before entering, will stand on the mat and wipe their feet for 10 seconds before entering the hospital.
  3. After wiping their feet, employees may enter the hospital.
Obviously, writing real policies will be more complicated, as you work to address the myriad of clinical, regulatory, and organizational challenges that you will face in running a modern hospital. 

The first pitfall about procedures is knowing the difference between :
  1. A procedure kept in a policy document ("How do you achieve the goal?")
  2. A procedure kept in a procedure manual (usually a nursing procedure manual, kept on most floors to help nurses review the best way to perform a particular procedure.)
If you're really fastidious, you can reference the procedure manual from your policy documents, so that you don't have to write the procedure over again (E.g. "Procedure to insert Foley : See procedure manual page 23 on 'Inserting Foleys'")

The problem with this approach is that while it may save you some time, you will still need to maintain both the procedure manual as well as your policy documents.

Another common pitfall of procedures is the "complicated procedure" where you have a bunch of complex, logical and conditional arguments, like :

Policy : Nurses will maintain blood sugars between 60 and 200 for all diabetic patients.
Procedure :
  1. Nurse will check patient's fingerstick every 2 hours
  2. If fingerstick < 60 then nurse will give 1 amp D50 IV and call physician
  3. If fingerstick = 200 - 249 then nurse will give Insulin 2 units SQ
  4. If fingerstick = 250 - 299 then nurse will give Insulin 4 units SQ
  5. If fingerstick = 300 - 349 then nurse will give Insulin 6 units SQ
  6. If patient becomes dizzy, nurse may call a rapid response.
  7. Fingersticks may be checked more often for patients who feel dizzy.
  8. If a nurse checks more than 4 fingersticks in a 2 hour period, nurses should call MD.
There are a few problems with writing this type of procedure :
  1. It doesn't have a good "trigger" that makes a nurse start to follow these instructions.
  2. It has a lot of "IF/THEN" statements. 
  3. It also has a lot of orders in it ("give Insulin 4 units IV" requires an order to be placed in your EMR.)
These are all giveaways that this is not really a procedure, but a protocol. (Remember, a protocol is a series of instructions and well-defined conditions that allow a nurse/pharmacist to start/modify/stop an order on behalf of the protocol.)

So the way to clean this up is to make a procedure that says this :
Policy : Nurses will maintain blood sugars between 60 and 200 for all diabetic patients.
Procedure :
  1. Physicians with diabetic patients will place an order for "Diabetic Protocol" in the EMR.
  2. Physicians will verbally notify the nurse that an order for "Diabetic Protocol" has been entered.
This then lets you make a Diabetic Protocol :
  1. Nurse will check patient's fingerstick every 2 hours and as needed
  2.      If fingerstick < 60 then nurse will give 1 amp D50 IV and call physician
  3.      If fingerstick = 200 - 249 then nurse will give Insulin 2 units SQ
  4.      If fingerstick = 250 - 299 then nurse will give Insulin 4 units SQ
  5.      If fingerstick = 300 - 349 then nurse will give Insulin 6 units SQ
  6.      If a nurse checks more than 4 fingersticks in a 2 hour period, nurses will page MD
  7. Nurses will check patients mentation every 2 hours
  8.      If patient becomes dizzy, nurse will dial operator to call a rapid response.

3. What's the best way to make a policy / procedure?

The funny thing is, most people aren't aware of the cognitive processes behind their daily activities. For example, you've probably sent lots of emails, right?

You probably didn't think about the steps you took to send an email :
  1. You owned the email - Your brain decided, "I need an email to accomplish a goal."
  2. You built the email - You actually typed the text of the email
  3. You tested the email - You looked at it to see whether it was fit to send
  4. You approved the email - Your brain felt the email was good enough to accomplish the goal
  5. You published the email - Your finger clicked the mouse on the "SEND" buttom
  6. You monitored the email - You waited to see the effectiveness of the email - If no response, you will probably repeat at step #2
So writing a good policy requires the same steps : Ownership, construction/building, testing, approval, publication, and monitoring. Let's just quickly review these before we wrap up for tonight :
  1. Policy Ownership - If the point of a policy is to set a goal/standard, and your leadership/directors are the ones setting and enforcing the goals/standards, then it makes sense for policies to be owned by a director/leader.
  2. Policy construction/building - This can be someone with training in building policies. (At a minimum, they should read the book I mentioned above, or attend some classes in policy writing so they can help the owner have clear and effective policies.) Informaticists are generally pretty good at understanding the construction issues, but you may choose to have someone special just to write your policies.
  3. Policy vetting / testing / reviewing - Before bringing the policy to a committee for approval, you may need to "vet" or "appraise, verify, or check for accuracy" the policy. Who you bring it to, before approval, should depend on the committee chairperson for the committee you are seeking to approve the policy.
  4. Policy Approval - This generally should be done by a committee with expertise in approving the policies. (If the policy has been properly vetted, there should be little discussion at the approval committee.) The committee chairperson should put the policy on the agenda, and at the meeting conduct a vote for approval for the policy. If the committee approves, the chairperson should sign the policy to show committee approval.
  5. Policy Publication - After approval, this generally should be done by putting the signed policy into a policy manual, and then surrounding the arrival with some education to staff about the new policy.
  6. Policy monitoring - This generally should be done by the owner, so if there is a change/update that is needed, they can go back to step #2.
It is for these reasons, then, that I put on my propeller-hat and recommend the following headings for your policy documents (these are not standard, but I would use them if I were to design a policy manual): 

ORGANIZATION NAME
POLICY TITLE
CREATION DATE

I. PURPOSE :
II. POLICY STATEMENT :
III. SCOPE :
IV. DEFINITIONS :
V. PROCEDURE :
VI. OWNER :

VII. BUILDER :
VIII. CITATIONS : (This will help keep your policy manual evidence-based!)
IX. TESTED/VETTED BY :
X. APPROVAL COMMITTEE :
XI. APPROVAL DATE : (with chairperson signature)
XII. REVISION HISTORY :


Not everyone will have these headers, but if you're at the point of actually starting a policy manual, I think this could be really helpful in getting your organization to better understand these policy development, implementation, and maintenance issues.

Remember : My advice is free, and you get what you pay for. :)

(In all seriousness, this is how I might set up my policy headers and development process, but your mileage may vary.)

Would love to hear your thoughts/opinions! Please comment or ask questions - I would love to discuss other healthcare informatics issues! :)