Developing and Approving an Order Set

Hi fellow CMIOs, CNIOs, and other Clinical #Informatics and #HealthIT friends,

Today I thought I'd share some helpful slides from a discussion that very few people write about - Developing and approving order sets.

This is a topic where far too little has been shared openly, so many organizations struggle unnecessarily until they learn through repeated trial-and-error how to do this in a much more smooth, efficient way.

Unfortunately, it also brings up the question about maintenance of order sets : 

• Yes, order sets can help save time, reduce clicks, and reduce unexpected pages from staff, but...
• They can also take a lot of work to develop, approve, monitor, and maintain.

So our agenda for today includes : 

First, what exactly do we mean by 'Order Sets'?

Order sets are sometimes referred to as 'Ordering Tools', since different vendors use different terminology to describe these collections of orders that are used to standardize and expedite the ordering process for a common, well-described clinical scenario.

Because they look so similar (and even share some of their definitions!), Order sets are sometimes confused for order panels, pick-lists, and clinical pathways:

1. Order Set (n.) - A collection of orders used to standardize the ordering process for a common, well-described clinical scenario (e.g. workup, treatment, admission, discharge, prep, postop, protocols, etc for pediatric and adult/geriatric patients.)
2. Order Panel (n.) - A collection of common orders of a specific type, typically designed for inclusion in order sets (e.g. common pain meds, common GI meds, common labs, common nursing orders)
3. Pick-List (aka 'Quick Preference List' or 'Convenience Panels') (n.) - A collection of common orders of a specific type, typically designed for convenience only, that is not related to a specific, well-described clinical scenario (e.g. common pain meds, common IV fluids, common anti-emetics, common lab orders, common radiology orders, etc.)
4. Clinical Pathway (n.) - A collection of order sets used to standardize and expedite the daily ordering process (typically throughout the course of a planned hospitalization) for a defined clinical condition, procedure, or surgery.

Order sets also typically come in two types : 

• Oncology Order Sets - Typically broken out in a separate category, because of the unique, complex ordering needs for chemotherapy and biologic infusions (e.g. monoclonal antibodies)
• All other Order Sets (General order sets) - Typically related to working up common chief complaints, treating common conditions/diseases, admitting/transferring/discharging to/from an inpatient area, preparing for a surgery/procedure, recovering from a surgery/procedure, and special protocols (to automate common, high-risk clinical scenarios where the benefits of standardization and timely delivery of care outweigh any known risks).

For this purposes of this post, we will mostly be discussing the second category above - General order sets. (We could write a whole separate post about the unique needs of Oncology and biologic infusion ordering workflows.)

So before we get to our development discussion, let's first start with our approval discussion - In a typical healthcare organization, who is best-suited to approve an order set?

Many organizations struggle with this question, because there's usually no one person who has all of the time, expertise, and authority needed to approve an order set. I sometimes describe this as the 'Captain Kirk and Scotty' paradox : 

• Captain Kirk = Has all the authority, but little expertise
• Scotty and engineers = Have all the expertise, but little authority

So ultimately, the lesson here is : Captain Kirk, Scotty, and the other engineers have to work together to make the ship run.

Some organizations chose to focus on expediency, by assigning one person or one team - sometimes a clinical officer (CMO, CNO, or both?) or an appointed committee (chaired by a CMO, CNO, CMIO, and/or CNIO?) - But is that enough? Are there any helpful regulations or published best practices, and if so, what do they say?

Unfortunately, there's not much. As of 2024, order sets are still a bit of a mystery to most regulatory agencies. Not only does CMS use the terms "Standing Orders", "Order Sets", and "Protocols" interchangeably, but there are very few published best practices openly available on the Internet. The OHSU ClinfoWiki has some helpful information about oversight and governance in these published pieces :

• "Creating Order Sets"
• "Making Sense of Clinical Practice: Order Set Design Strategies in CPOE"
• "Enhancing Physician Adoption of CPOE: The Search for a Perfect Order Set"

... but while there's some helpful information about oversight committees and mentions of templates, these articles don't contain much concrete detail about the exact development or approval processes, or samples of templates.

So the most concrete regulatory guidance seems to come from the Centers for Medicaid Services (CMS) 42 CFR § 482.24, under section (3) which states : 

So if CMS expects the Medical Staff and the hospital's Nursing and Pharmacy leadership to be 'reviewing' order sets - Does that mean three committees need to be involved in the review/approval process? (E.g. Medical Board/Medical Executive Committee, Nursing Council, and Pharmacy and Therapeutics?) Or should those committees delegate a separate team to just focus on order sets? 

Or should the clinical leadership of those areas (e.g. CMO, CNO, and VP of Pharmacy) approve the order sets? Even if they have the time and expertise to approve order sets, do they have the time to develop them? And if they don't have the time and bandwidth to 'get into the weeds' to develop them, how can they feel confident about approving them?

And what about the other supporting departments in a clinical enterprise - Laboratory, Radiology, and other ancillary services? When the OHSU ClinfoWiki article on "Creating Order Sets" says, "They have their needs thoroughly examined by their practice management oversight group, nursing, support staff and anyone who might be affected by the order set," who exactly might be affected by the order set? After all, don't doctors just write orders, and other people in the organization have to execute/follow-through with them?

Well, it's not that simple. Clinical staff affected by the order set include both : 

• The staff writing/creating orders (typically Ordering Providers, including Attendings, Residents/Fellows, Advanced Practice Providers/APRNs/PAs/CRNAs etc.)
• The staff following/executing orders (commonly everyone else in a clinical enterprise, including Nursing, Pharmacy, Lab, Radiology, Bed Management, Case Management, Dietary/Nutrition, and other ancillary support services)

Some doctors initially bristle when they learn that other specialties are involved in reviewing and approving their order sets. But if we take a step back - Order sets create patterns of clinical care and utilization that have an impact across the whole organization, so it shouldn't be a surprise that other people are involved in reviewing the best practices, and planning utilization and resource needs to execute and follow-through with those orders.

So how do we make sense of this? It helps to imagine a 'pyramid' of delegation and oversight, one that helps to connect Captain Kirk (all authority, little expertise) with Scotty and his engineers (all expertise, little authority) :

... which is a very basic operational unit that can be employed in developing a process for reviewing and approving order sets. So in a typical clinical enterprise, there are similar pyramids for the major clinical disciplines involved in the delivery of care (Nursing, Pharmacy, and Physicians):

Note there are also similar pyramids for Lab, Radiology, and other Ancillary Services (such as Physical Therapy, Occupational Therapy, Dietary/Nutrition, Case Management, Social Work, etc.) :

So now, let's see if we can answer the question : Who exactly is affected by an order set? Well it depends largely on the complexity of your order set. Small, short order sets typically have fewer stakeholders, and larger, complex order sets typically have more. 

Exactly who needs to participate in the discussion will depend on the type(s) of orders in your order set. You can create a very helpful order set development template by identifying and aggregating your most common order types. Most healthcare organizations can divide up all patient care orders into one of sixteen (16) groups : 

Since each order type has a unique function, usually executed/performed by a unique stakeholder - You can then take these sixteen (16) order types, import them into a spreadsheet, and next identify the common stakeholders for each order type : 

Once you've identified the common stakeholders for each order type, you can then create a standardized order set template, that not only helps define expected standards for each order type (e.g. medication orders with medication doses, routes, frequencies, etc.), but also the stakeholders necessary to participate in the review and approval of the order set :

Once you have this template, you can first try it out with a simple order set, say, with just a Procedure order, some Activity and Nursing orders, some Diet orders, and some IV fluid orders :

Or, you can try it with a more complex order set, one that includes : ADT orders, Code Status orders, Procedure orders, Activity orders, Blood Bank orders, Nursing orders, Diet orders, IV Fluid orders, Medication orders, Laboratory orders, Diagnostic Radiology orders, Consult/Referral orders, and Discharge Education orders -

This is helpful when trying to plan new order sets, so you can identify who to invite to your build discussions.

Now, since I'm discussing order sets, I thought it would be helpful to mention the surprising importance of solid, well-planned naming conventions. 

Early in my Informatics career, I would have never have guessed the importance of naming conventions. A few people warned me, but at first I was skeptical. I actually once said something like this : "What does it matter, what you call it? As long as they can find it!"

What I didn't know at the time (and learned with experience) is that naming conventions : 

• Determine the size of your order set library - More coarse/vague naming conventions result in fewer order sets, and more specific/granular naming conventions result in more order sets.
• Determine how easy it will be for your users to find (and bookmark) the order set.
• Help determine whether you are clearly building a time-saving order set - Or if you are confusing it for a Pick-List, Order Panel, or Clinical Pathway. 
• Strongly influence the number of clicks and unexpected pages your users will experience - The more clear and specific the naming convention is, the more you can pre-configure and pre-click default settings (so your users don't have to!)

Knowing that well-described, scenario-specific order sets help reduce clicks and unexpected pages more than general Pick-Lists (aka 'quick preference lists' or 'convenience panels'), I thought I'd share one way to index your order set catalog, based on your most common patient types, common chief complaints, common treatments, common surgeries and procedures, and common protocols :

So with that - First, some helpful take-home reminders : 

... and a few more to consider as you create and develop your governance and order set development, review, and approval processes with your Clinical, Legal, Compliance/Regulatory, Finance, and other leadership :

I hope this quick review has been helpful and provides some helpful food for thought for your own team discussions! Since there is not much written about this subject, please feel free to share feedback in the comments section below.

Remember, this blog is for educational and discussion purposes only - Your mileage may vary!

Have any experiences building order sets, leading order set teams, or creating or an order set development and approval process? Feel free to share any helpful feedback or experiences in the comments section below! 

Building your #Workflow Glossary

Hi fellow Clinical #Informatics and other #workflow enthusiasts, 

Happy 2019! While I continue to work on compiling the business case for Clinical Informatics, I thought I'd take a minute to talk about #workflow terminology. 

A. THE BACKGROUND :
Simply put - words matter. Any bilingual person who has ever tried to translate the phrase 'scram' or 'hit the road' into another language knows that a word-for-word translation does not always work. (Really? Hit the road..?) One might try to translate it as 'it's time to leave', but even that fails to convey the certain informal, vernacular quality that the phrase 'hit the road' conveys so well. So my advice to anyone working in a translational role - Do your best, but always translate at your own risk. 

In healthcare, we have a number of terms that people generally understand, but their exact definitions may vary from organization to organization. They include such common terms as : 

• Order
• Order Set
• Protocol
• Policy
• Procedure
• Guideline
• Standing Order
• Clinical Pathway
• Documentation
• Templates
• ... and more!

While almost all clinical staff have a general sense of these terms, their true understanding may not be exactly the same - And so, with regard to the term ‘protocol’, for instance, they may quietly have overlapping circles of a common understanding :

The problem is that these differences in understanding may result in dramatically different expectations about how exactly a 'protocol' works, and what it can do to help their workflow : 

• Can a protocol be used to allow a Registered Nurse to titrate an IV heparin drip?
• Can a protocol be used to allow a Registered Nurse to give a pneumonia vaccination?
• Can a protocol be used to allow a Respiratory Therapist to titrate the settings on a ventilator in the ICU?
• Can a protocol be used to allow a Registered Dietitian to modify a diet for an inpatient?
• What is the difference between a protocol and a standing order?

To increase the amount of common understanding, it's helpful to look at your federal and state regulations, along with your own safety and operational needs, to see if they offer any definitions that help clarify the answers to these questions :

After all, once there is a clear definition - then you can create a standardized template, development procedure, and staff education to give everyone on your team a greater, more standardized understanding of the tool and what it can do. Remember - It all starts with the definition.

B. THE PROBLEM :
Healthcare faces some challenges in harmonizing this terminology - What a protocol can do in some organizations is different than what a protocol can do in others. And despite CMS regulations which refer to the use of protocols, many federal and state regulations use these terms interchangeably - See this 2013 letter from the Centers for Medicaid Services (www.cms.gov), page 4 : 

Standing orders: Drugs and biologicals may be prepared and administered on the orders contained in pre-printed and electronic standing orders, order sets and protocols (collectively referred to as “standing orders” in our guidance) only if the standing orders meet the requirements of the medical records CoP.

And this, from the Interpretive Guidelines §482.24(c)(3) on page 78 : 

There is no standard definition of a “standing order” in the hospital community at large (77 FR 29055, May 16, 2012), but the terms “pre-printed standing orders,” “electronic standing orders,” “order sets,” and “protocols for patient orders” are various ways in which the term “standing orders” has been applied. For purposes of brevity, in our guidance we generally use the term “standing order(s)” to refer interchangeably to pre-printed and electronic standing orders, order sets, and protocols. However, we note that the lack of a standard definition for these terms and their interchangeable and indistinct use by hospitals and health care professionals may result in confusion regarding what is or is not subject to the requirements of §482.24(c)(3), particularly with respect to “order sets.” 

Making it even worse is when Informatics professionals then have to compare this with their state regulations :

... which may have slightly different understandings and definitions of these terms.

Fortunately, there are some very talented medicolegal and compliance experts out there, who can help an organization to develop a strategy for navigating these regulations, while planning their workflows, both before and after an EMR implementation. One of the best I've seen is Sue Dill Calloway, BSN MSN JD, who has a fantastic series of lectures on the importance of this terminology, for regulatory, financial, and patient safety reasons.

But in the absence of a simple, standardized national glossary, with good functional definitions of these tools - It can be very hard to develop the templates, development procedure, and education you need for your team. 

C. THE SOLUTION :
Given the lack of clarity about these terms, what's the average CMIO, CNIO, or clinical informaticist to do? Fortunately, there is a strategy you can employ, and that is expanding upon a fairly simple template for functional definitions : 

[ Term: What It's Called ] - [ Functional Definition: What It Does ] 

This simple template is helpful in separating terminology for tools that have slightly different functions, e.g. : 

Term1 - FunctionalDefinition1
Term2 - FunctionalDefinition2
 ...and so on...

So if we can accept this simple template for separating terminology and function, we can then start to draft a 'conceptual map' for these common terms in healthcare (click the image below to enlarge) : 

(REMEMBER - THIS GRID IS JUST A DRAFT AND IS NOT COMPLETE!)

As you start to do this exercise, you'll see that there are some terms which have very similar functions, and other terms which don't : 

• Guidelines and Policies initially look like they might have similar functions - until you consider that policies might result in root cause analysis and disciplinary action, and guidelines don't. (Policies=rules, guidelines=suggestions).
• Protocols and Standing Orders seem to have very similar functional definitions, so we need to figure out if they are true synonyms, or if there is some kind of a difference between them.
• Procedures and Plans also have similar definitions - So we will need to figure out how to separate them. In this case, I've taken the liberty of separating them in time, suggesting that procedures describe current tasks, and plans describe future tasks. 

Given the similarities between protocols and standing orders, it's helpful to separate them by considering their risk - and thus their initiation/triggering mechanisms, FOR EXAMPLE: 

• Standing Orders = Used for common, LOW-risk clinical scenarios in which the benefit to the patient of rapid evaluation and care outweighs any known risks. Standing orders may be initiated ('triggered') by a clinical POLICY (e.g. 'All clinic patients will be screened and potentially administered for pneumonia vaccination, according to the Standing Orders for Pneumonia Vaccination.) All orders and outcomes of standing orders will be attributed to the attending provider.
• Protocols = Used for common, HIGH-risk clinical scenarios in which the benefit to the patient of improved care standardization outweighs any known risks. All protocols must be initiated ('triggered') or discontinued by an ORDER (e.g. 'Initiate Ventilator Liberation Protocol' or 'Discontinue Ventilator Liberation Protocol'). All orders and outcomes of clinical protocols will be attributed to the ordering provider.

While you undergo this exercise, it's important to look at your regional, state, and federal regulations, and to speak to experts (like Sue Dill Calloway, BSN MSN JD as I mentioned above). If there are no regulations to guide you in this grid, then you and your clinical and administrative leadership will have to make local decisions about how your organization wants to define these tools.  

As you work on these definitions, keep in mind other things you can do to improve safety and clarity, e.g. "Orders are documented instructions [ that ] must be signed within 24 hours."

As you start to build out this grid for your own organization, talk to people who use these tools, and you'll start to better understand the form, function, and other issues related to their design. And once you think your grid is complete? Bring it back to your senior leadership for review, discussion, and formal approval. Voila! You now have your own organizational glossary that will help you develop the templates, procedures, and education that create a greater understanding, and improved standardization, predictability, and efficiency, for both your clinical and administrative teams. 

Hope this is helpful in guiding you to build your own workflow glossary! If you have any other tips, suggestions, or comments, leave them in the comments section below!

Remember - This blog is for educational discussions only. Do not use any of these definitions without formal review and discussion with your own informatics, legal, administrative, and clinical teams. Have any other clinical terminology tips you'd like to share? Feel free to leave in the comments below!