Saturday, January 12, 2019

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

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.

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 (, 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. 

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 : 
[ TermWhat 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) : 

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=rulesguidelines=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 standardizationpredictability, 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!

Thursday, December 27, 2018

Building a Business Case for Clinical Informatics

Hi fellow Informatics leaders,

After my last post on The Offerings of Clinical Informatics, I'm planning a follow-up post on the business case for Clinical Informatics.

After all, we all know the clinical case - More predictable workflows, better clinical decision-support strategies, better data management, better engagement of clinical staff, and better prioritization of clinical improvement projects - But what exactly is the business case? Does having certified, well-trained, and well-supported clinical informatics professionals actually save money? Improve charge capture? Improve efficiency? If so, how much?

Sure, there are plenty of industry anecdotes - but I'm searching for published data too.

If you have any good anecdotes, and would be willing to share them for my next post, please leave a comment below, so I can compile them and share your story. And if you are aware of any good published data, please feel free to leave that too. 

More to come soon, and thank you all for your help.

- Dirk :)

Have any good anecdotes about the business case for clinical informatics? Or know of any published data? Feel free to leave information in the comments below!

Sunday, December 2, 2018

The Offerings of Clinical Informatics

Hi fellow readers,

If you are involved in electronic medical record (EMR) implementations, or healthcare technology in general - Someone has probably forwarded to you the recent November 12th New Yorker article by surgeon and innovative healthcare thinker Dr. Atul Gawande :

In the style of Dr. Gawande's excellent narrative and analysis, this is a well-written, thoughtful piece about the common challenges of EMR implementation, as told from the front lines of medicine: The surgeon who feels the EMR is controlling him, instead of vice-versa. The Internal Medicine Primary Care Physician (PCP) who spends hours fter her shift documenting her notes and managing problem lists. The rigidity of EMRs, compared with the fluidity of paper. The use of physician scribes, with questionable improvement in outcomes. And the patients who lose when their provider no longer focuses solely on them during a clinic visit. These are all real - but there is more to the story.

Dr. Gawande very eloquently describes these very real and common scenarios, why they happen, and their impacts on providers and patient care, both for good and for bad. I appreciate his storytelling, and how it educates people about some very real usability issues, which impact users all across the clinical spectrum - and the patients they serve.

So this is not a rebuttal, but more of a commentary on his piece in the New Yorker. As a clinical informatics professional, I was somewhat disappointed that nowhere in his essay did he share the term "clinical informatics" - The discipline that works to implement emerging technology in the safest, most sensible, and cost-effective manner possible.

Given the wide audience for this piece, it could have been a great opportunity to educate the general public about this underrated, poorly-understood, but very important clinical discipline. 

What is Clinical Informatics?

For those of us who work hard to implement these technologies, we often to struggle to explain this (still!) emerging discipline of information engineering, and how/why it impacts clinical workflows, safety, efficiency, and provider satisfaction.

To begin : Informatics is a branch of the academic field of information engineering. Taken from the current Wikipedia page on Informatics :
"It involves the practice of information processing and the engineering of information systems, and as an academic field it is an applied form of information science. The field considers the interaction between humans and information alongside the construction of interfaces, organisations, technologies and systems. As such, the field of informatics has great breadth and encompasses many subspecialties, including disciplines of computer scienceinformation systemsinformation technology and statistics. Since the advent of computers, individuals and organizations increasingly process information digitally. This has led to the study of informatics with computational, mathematical, biological, cognitive and social aspects, including study of the social impact of information technologies."
Informatics is a branch of information sciencenot information technology, that sits right in the intersection between healthcare (clinical medicine), our health system (clinical operations), and information technology and communication : 

If IT professionals need to focus on supporting the technology that will store and route all of this clinical information, then Informatics professionals are more focused on what information will be stored, and how it will be organized and used for clinical purposes. 

To do this, Clinical informatics professionals ('Informaticians') need to focus on what care is being delivered, and how exactly clinical staff is using (or planning to use) the information and new technology to improve outcomes :
  • How will the technology impact the delivery of patient care?
  • In which workflow(s) will clinical staff use the technology?
  • Is the technology safe, efficient, and well-configured?
  • Are any technical, process, or terminology standards needed to support the technology in a harmonious way?
  • Does the technology make it easier to deliver good patient care within the planned workflow(s)?
  • What kind of training will clinical users need to correctly use the technology?
  • What other things might be needed to achieve a successful implementation of the technology?
  • What research opportunities will the technology make possible?
So to accomplish their mission, clinical informaticists have to care about organizing both data in and data out : 
... and the breadth of workflows that clinical staff will use to deliver quality care. This means studying a wide variety of disciplines :
  • Clinical medicine, terminology, roles, and operations
  • Cognitive and behavioral science
  • Evidence-based design principles
  • Interface design, usability and interoperability
  • Data structure design (e.g. data indexing, archetypes, hierarchies, and logical functioning)
  • Heuristics
  • Process analysis and engineering
  • Linguistics and terminology management
  • Project management
  • Legal/compliance environmental analysis
... and more. It's this kind of detailed analysis and workflow ownership that is necessary to convert turbulent workflows into laminar workflows : 

I know this because I am one of the many physicians who is now board-certified in Clinical Informatics by the American Board of Preventive Medicine (ABPM), a program supported by the American Medical Informatics Association (AMIA). With over twelve years of practical, applied clinical informatics experience, I have seen the problems created by turbulent clinical workflows, and worked hard to make them laminar again - And seen the improved outcomes and provider satisfaction that informatics can offer.

Why Clinical Informatics?

Clinical Informatics professionals are especially helpful when implementing electronic medical records because, as Dr. Gawande points out - EMRs enforce a certain sense of operational rigidity and role accountability that is difficult to identify (or enforce) in a paper-based clinical environment. If operational standards are not strictly enforced prior to EMR go-live, then these roles will be re-aligned after go-live : 

Given this realignment of roles and responsibilities, a significant amount of workflow analysis and engineering must occur for EMR configurations to align with user needs and expectations. Clinical informaticists ('Informaticians') are particularly adept at this sort of workflow analysis and design, translating the needs between the clinical and IT realms, and providing design and project management support.

Where are the Clinical Informaticists?

It can be difficult to identify the clinical informatics professionals on many EMR implementations, because there are often challenges in separating them out from other common HealthIT roles - few of which require clinical backgrounds. While these roles commonly overlap, and many people fill more than one role, here are some gross generalizations - As a caveat, your mileage may vary : 
  1. Clinical analysts - These are generally the professionals who work with end-users to analyze, build, test, and implement clinical content in an EMR. While analysts are the backbone and workhorses of configuration for most EMRs - they generally focus mainly on the tools inside the EMR, which occupies most of their time - and often do not have time or expertise to manage additional workflow tools that may be necessary outside the EMR. 
  2. Application Support Professionals - These are often the 'second-tier help desk' or 'second-tier support' professionals who work together with the help desk, to respond to more detailed user questions, troubleshoot issues, and provide elbow-to-elbow support to end-users who might need additional assistance.
  3. Clinical/credentialed trainers - These are the professionals who are experts at  studying clinical workflows, studying application features, developing training materials and curricula, and delivering that training in classroom and online settings. They also sometimes assist application support professionals in direct elbow-to-elbow settings.
  4. Project Managers - These are the professionals (many with PMP certificates), who are experienced at planning, budgeting, scoping, and leading projects. Their tasks include meeting frequently with stakeholders, developing detailed project plans, timelines, and deliverables, and keeping the work team on schedule and on budget.
  5. Analytics professionals / report writers - These are professionals who are focused on getting data out of the system, validating it, interpreting it, and displaying it in a meaningful way, to help advance clinical care and research needs.
  6. Process Improvement Specialists (E.g. Lean or Six Sigma- These are trained professionals who typically report to quality to study clinical processes, study outcomes, and improve upon them. They may or may not have clinical experience.

While clinical informaticists ('Informaticians') may work with all of the above, or fill some of all of these roles, the informatics role is unique in their ownership of implementing clinical workflows, change management, standards, clinical terminology and translation, information design, indexing, archetype analysis, usability, and clinical outcomes. Clinical informaticists are skilled at critically evaluating details of workflows and configuration, and adjusting them, when necessary. While it is not always necessary, most clinical informaticists come from clinical backgrounds, which is very helpful when trying to interface with clinical staff and navigate clinical terminology, roles, or processes : 

Despite their important role, there are other things that may make it more difficult to identify a clinical informatics professional:
  • For many years, clinical informatics was a poorly-understood, poorly-controlled term. Since clinical analystsapplication support professionalsclinical/credentialed trainers, project managers, analytics professionals/report writers, and process improvement specialists are all involved in information design and EMR support - some of them might refer to themselves as 'Informaticists' or 'Informatics professionals' - Unfortunately this loose association clouded the role for the new generation of clinical informaticists who come prepared with formal informatics training and certification
  • Clinical informatics often reports to IT departments, where there can be a competition for resources. (It can be challenging to budget for informatics when there are also valid and competing IT needs.) 
  • Some people seeking to lower the cost barriers-to-entry for their projects, may sometimes minimize the importance of having clinical informatics professionals available on projects to help support the clinical analystsclinical trainersreport writersapplication support professionals and process improvement specialists who help develop content and support end-users. 
  • Some organizations believe that 'sample content' can help save significant time by replacing clinical workflow evaluations and operational discussions with sample content that has already been developed by another organization. Unfortunately, these workflow evaluations and clinical discussions are still necessary for gap analysis and proper scoping, and to validate and align configuration with end-user needs, expectations, and training - and so there generally not much time saved from using sample content.
  • Many workers fulfill the role of clinical informatics, but with other vague job titles like 'solutions engineer' or 'clinical workflow analyst' or 'EMR implementation specialist'.
This somewhat-ironic 'Informatics terminology issue' was recently highlighted in this humorous (!) segment from the November 2018 AMIA conference in San Francisco, featuring AMIA President and CEO Douglas B. Fridsma : 

Given these terminology, budget, and support challenges, many HealthIT projects and EMR implementations occur with little or no significant informatics support. 

The Cost of No Informatics

The easiest way to demonstrate the importance of clinical informatics comes from an examination of a best-practice model for implementing clinical workflow changes : 

The change management procedure outlined above is a sort of 'best-practice' series of steps which, only if performed in order, will help ensure that a new workflow is safe, best-practice, compliant, and efficient before it is built, tested, and expertly delivered with a minimum of disruptions. It will also help engage users, ensure that testing is complete, align expectations, and ensure that users are properly trained and supported during go-live. 

Making great clinical configuration, workflows, and outcomes is a great deal of work. Many organizations struggle to have the time or resources to fully complete all steps, so to meet project deadlines, they often have to make compromises - while still trying to fulfill as many of the steps as possible. 

Without well-trained, well-defined clinical informaticists there to support the project team, a few things become clear :
  1. It is usually difficult to manage all of the steps of a 'best-practice' change control and project management process. This can result in user dissatisfaction, lack of engagement, and unplanned outcomes.
  2. Terminology and naming conventions may be difficult to manage. This can result in reporting challenges, and difficult validation of data.
  3. Other roles (clinical analystsapplication support professionalsclinical/credentialed trainers, project managers, analytics professionals / report writers, and Performance Improvement specialists) may have translational challenges when trying to engage with clinical staff.
  4. Prioritization of projects may be difficult, without an accurate assessment of needs, and proper scoping and prioritization.
  5. Without adequate analysis, scoping, prioritization, and design pre-work - analysts may spend time re-building workflows that require frequent adjustments.
In my experience, organizations that support the role of clinical informatics to augment their project team generally see better use of their technology, improved user satisfaction, better staff engagement, and improved outcomes.

To help improve physician satisfaction...

To help clinical staff in Dr. Gawande's organization better utilize their technology, it's important to critically assess the configuration and workflows that the providers and their teams are working in every day :  

... and ask some of these questions : 
  1. Have all of the steps of this workflow been properly organized, designed, and budgeted? 
  2. What is the clinical governance like? Is it shared or siloed? And how does it interact with administrative governance?
  3. Healthcare is a team sport - Do the physician, nursing, and pharmacy leaders need to meet to critically assess and re-evaluate their shared clinical goals and needs?
  4. Have the current-state and future-state workflows in all service lines been well-documented?
  5. Are there templates for common operational tools and documents found both inside and outside the EMR?
  6. Do directors and clinical chiefs have adequate support for their participation in EMR discussions (analysis, design, and testing)?
  7. What is the request intake, prioritization, and project management process like?
  8. How many ways can users find solutions? Is end-user education easily available on the organizational intranet?
  9. How is clinical terminology managed and harmonized?
  10. How many clinical staff have been trained in workflow development, project management, or document writing (e.g. policies, orders, order sets, protocols, guidelines, clinical documentation, clinical decision support, etc.)?
And : Are there trained clinical informatics professionals available to help educate, evaluate, and oversee all of the above?

FINALLY - A big thank you to Dr. Gawande for writing such a great, real, and thought-provoking piece. Provider burnout is a real issue, and we need to work together to combat it. I hope my discussion helps shed light on how clinical informatics can help change the environment for both providers and patients. 

Remember, the above discussion is for education purposes only. Your mileage may vary. What are your thoughts? Are there other ways to improve clinical workflow and provider satisfaction? If you have any comments or feedback, leave them in the comments box below!

Friday, July 27, 2018

Easy recipe for baking gourmet clinical #workflow changes

Hi fellow #Informatics leaders,

It's been a while since my last post, but today I thought it was finally time to write again. What inspired me was a discussion at work about a concept I'd like to describe as the "spaghetti-bowl workflow" : 

Many Informatics professionals spend time untangling these 'spaghetti-bowl' workflows, optimizing them, and making them look like the "AFTER" category above. But how exactly do they do this?

In short, it's helpful to have a solid recipe for making great, predictable, build-once "gourmet-style" clinical workflows that make everyone happy - Including patients, clinical staff, regulatory/compliance, finance, and IT. After all, good workflows are like good food - They should be healthy and nourishing, and taste (feel) great. (Both good food and good workflows are made by experienced chefs and informaticists/analysts!
If it's a cupcake you want, then it's helpful to follow the cupcake recipe.
While experienced people in #Informatics and #HealthIT might know the recipe for gourmet changes, that satisfy all the stakeholders and don't result in unexpected outcomes that need rebuilding - this recipe is not commonly written anywhere. So for clinical education purposes, I thought I would share a version of the change recipe that I think works pretty well 
This is a slight variation on the "Eight steps to workflow happiness" that I usually teach clinical staff, the first time I introduce the concept of following a recipe to achieve desired outcomes : 
While the eight steps in blue above make a good introduction - the earlier gourmet recipe fills in more details. It also highlights the importance of detailed analysis work before even scoping or planning a project. 

Sometimes, clinical staff (or clinical IT staff) can be surprised to learn the basics of project (and workflow) management. While it might at first seem daunting, it's important to remember a few things : 
  • Learning a good workflow change recipe (the basics of project scoping, planning, and execution) is vital to building solid, predictable workflows that meet all the right needs : Clinical, financial, and legal/compliance. 
  • It's not hard to learn (and is actually kind of fun once you know it!)
  • For small projects, you don't need to make elaborate efforts for each step. Just being aware of each step will help you avoid pitfalls.
  • It will make you a better informaticist, clinical project leader, and clinical workflow designer.
  • It will help you work quickly with IT analysts, to build the desired workflows you're looking for.
  • The investment in analysis and planning time will usually more than pay for itself in not having to troubleshoot or rebuild workflows after your go-live. 
  • Skipping one or more of those steps, or doing the steps out-of-order, may lead to unexpected outcomes in your desired project or performance improvement initiative. 
What these recipes do raise, however, is a common clinical informatics question : Who exactly should be responsible for each step? The IT analyst? The clinical staff? The regulatory and finance staff? The project manager? It's helpful to start with your IT and Informatics teams, look at each step, and discuss who would be the optimal person to do each step, before you bring the discussion to additional stakeholders for buy-in.

Remember - Planning, and planning ahead, are vitally important to success. These recipes can help you do that. 

Hope this generates some good discussion with you and your analyst and informatics teams, before you tackle your next project. If you have any feedback, thoughts, or favorite change recipes - Please feel free to share them in the comments section below!

Best of luck with your upcoming clinical workflow changes!

- Dirk :)  

This page is for educational purposes only. Open discussion is encouraged, education is a priority. Have any thoughts or feedback? Feel free to leave them in the comments below!

Tuesday, October 31, 2017

An Opinion : What exactly are "Protocols" and "Standing Orders"?


Hi fellow CMIOs, CNIOs, Informatics leaders, and other #clinicaljedi,

Protocols and standing orders. Next to order sets, these are two of the most ubiquitous tools in modern healthcare, used to create predictable routines and outcomes in clinical care. So what exactly are they? And what exactly is the difference between a "protocol" and a "standing order"?

For the Informaticist, these are not easy questions to answer. The confusion starts with the search for regulations and definitions, where there is a curious paucity of information. As of this writing, most major regulatory bodies have somewhat vague or conflicting information. 

Historically, it seems many regulatory bodies simply frowned upon the use of "protocols" or "standing orders". Why? Probably because of their function - If a doctor writes an order like "Vent liberation per protocol", he/she is actually asking someone else to take on the responsibility of managing a ventilator on his/her behalf. So it's actually a tool of delegation.

So I'm guessing the concern was, if the 'protocol' was a tool of delegation, then it's someone else providing that care at the direction of, and on behalf of the doctor. This raises some valid operational questions : 
  1. By using "per protocol", does the order actually refer to a approved, documented set of well-definedclearreasonableevidence-based, and agreed-upon instructions?
  2. If a nurse, pharmacist, or someone else can follow those instructions - What if something doesn't go according to plan? Would the nurse, pharmacist, or other care team member have the same skills and training as the doctor to manage any unexpected outcomes or scenarios?
  3. As the nurse, pharmacist, or other ancillary team member follows the written instructions - Are there any key points in the patient's care that the ordering doctor should at least be aware of? (e.g. if the protocol keeps asking the nurse to give  higher levels of oxygen, is that OK?)
  4. If the doctor is effectively unaware of the minute-by-minute details of what the nurse or pharmacist is doing, or the patient status, will the doctor still be responsible for the outcome of their pre-defined instructions? Or will the nurse or pharmacist be responsible?
  5. How do we know this delegation agreement was clear, effective, and appropriate?
So for many years, many of those regulatory agencies were concerned and understandably frowned upon the use of protocols and standing orders. Not enough was known about them, and the risks seemed to outweigh the benefits. And let's face it - If it's a tool of delegation, what's to stop a doctor from writing the "Dr. ______-is-away-this-weekend-protocol", making the nurses shoulder all of the responsibility for care? 

But then, around 2008, after more rigorous discussion and a few safety incidents where nurses were unable to initiate common life-saving treatments because their patients needed them and no doctor was immediately available - it seems like some agencies may have re-looked at protocols and standing orders, had a change of heart. In 2011, CMS issued this communication : 
... which says : 
"Standing orders 
Hospitals may adopt policies and procedures that permit the use of standing orders to address well- defined clinical scenarios involving medication administration. The policies and procedures must address the process by which a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by physicians or practitioners responsible for the care of the patient. The specific criteria for a nurse or other authorized personnel to initiate the execution of a particular standing order must be clearly identified in the protocol for the order, i.e., the specific clinical situations, patient conditions or diagnoses in which initiating the order would be appropriate. Policies and procedures must address the education of the medical, nursing, and other applicable professional staff on the conditions and criteria for using standing orders and the individual staff responsibilities associated with their initiation and execution. An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter. Likewise, standing order policies and procedures must specify the process whereby the physician or other practitioner responsible for the care of the patient acknowledges and authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal polysaccharide vaccines, which do not require such authentication in accordance with §482.23(c)(2). 
The policies and procedures must also establish a process for monitoring and evaluating the use of standing orders, including proper adherence to the order’s protocol. There must also be a process for the identification and timely completion of any requisite updates, corrections, modifications, or revisions." 
This was a big step forward in creating some clarity around the subject of "standing orders", but does this also apply to "protocols"? It seems there is still a great deal of confusion over this issue. Articles like these :  suggest that people are still trying to understand if these are legal, and if so, how to design them safely.

So from a terminology standpoint, most Informaticists routinely have to struggle with questions like : 
  1. "What exactly is a protocol?" and 
  2. "Is it the same as a standing order?" or 
  3. "Is it the same as a clinical protocol?" and 
  4. "Is it the same as an oncology protocol?"
These are not easy questions to answer when the regulations and definitions don't guide you very well. 

So what is an Informaticist to do to help resolve the issue? Focus on the function, and work backwards to redefine the archetype and definition!

Let's look at a few things we *do* know : 
  1. The terms "Protocol" and "Standing Order" are almost used interchangeably - But not quite - So they still must have some kind of relationship.
  2. They seem to allow someone else than the provider to enter, modify, or stop an order, on behalf of the provider - so they appear to be some kind of tool of delegation.
  3. They seem to follow some kind of documented instructions, explaining exactly WHICH order(s) to start, modify, or stop, and when.
  4. For safety, the reasons that someone else is starting, modifying, or stopping an order should be very concrete and clear, without need for interpretation.
So if we can accept the above as true, then we can start drafting a definition :
DRAFT ] DEFINITION - PROTOCOL (n.) - A tool of delegation that allows a __________ to INITIATE, MODIFY, or DISCONTINUE an order on behalf of a Licensed Independent Practitioner (LIP), Advanced Practice Registered Nurse (APRN) or Nurse Practitioner (NP), Resident Physician, or Physician Assistant (PA).
Now, who exactly can start/modify/stop an order on behalf of a provider? From the patient care standpoint, you want the person following the protocol to have the training and clinical understanding to follow the protocol properly, and know how to navigate when things don't go as planned. Commonly, there are four roles that could likely fill this role : 
  1. Registered Nurses
  2. Registered Pharmacists
  3. Registered Dietitians
  4. Registered Respiratory Therapists
But if you want to include other care team members (like Medical Assistants), it is probably in an organization's best interest to make sure all team members expected to follow the protocol have a solid system of certification, training, and supervision. Either way, you'll need to work this into your organization's definition of a protocol : 
DRAFT ] DEFINITION - PROTOCOL (n.) - A tool of delegation that allows a Registered Nurse, Registered Dietitian, Registered Pharmacist, Registered Respiratory Therapist, (or certified and trained Medical Assistant) to INITIATE, MODIFY, or DISCONTINUE an order on behalf of a Licensed Independent Practitioner (LIP), Advanced Practice Registered Nurse (APRN) or Nurse Practitioner (NP), Resident Physician, or Physician Assistant (PA).
This is a pretty good start, but let's see if we can help craft some additional functionality and safety into this definition. 

If protocols should address common, well-understood clinical scenarios, then we need to consider what types of common, well-understood scenarios we might need protocols for : 
  1. Scenarios that only apply to a specific patient (e.g. Heparin titration protocols, Vent Liberation Protocols), and
  2. Scenarios that apply to a population of patients (e.g. Nurse vaccination protocols, pharmacy substitution protocols, etc.)
And so it seems like there is a need for two different kinds of protocols : 
  1. Protocols that only apply to a specific patient (e.g. Heparin titration protocols, Vent Liberation Protocols), and
  2. Protocols that apply to a population of patients (e.g. Nurse vaccination protocols, pharmacy substitution protocols)
And so, this suggests that the term "Protocol" might actually comes in two types : 
DRAFT ] DEFINITION - PROTOCOL (n.) - A documented tool of delegation that allows a Registered Nurse, Registered Pharmacist, Registered Dietitian, Registered Respiratory Therapist, (or certified and trained Medical Assistant) to INITIATE, MODIFY, or DISCONTINUE an order on behalf of a Licensed Independent Practitioner (LIP), Advanced Practice Registered Nurse (APRN) or Nurse Practitioner (NP), Resident Physician, or Physician Assistant (PA). All protocols are categorized as either : A. Protocols that apply only to a specific patient, or B. Protocols that apply to a defined population of patients. 
So if a protocol only applies to a specific patient, there must be some way that a provider can specify which patient(s) to use the protocol on - A way of turning the protocol "on-and-off", to tell a nurse when to follow the protocol, and when NOT to follow the protocol.

Likewise, for those protocols that apply to a defined population of patients, there must be some way to define which population of patients the protocol should be applied to.

And this brings us to the question of how to initiate/activate, or 'trigger' a protocol - If you need to activate/deactivate the protocol, then a handy trigger would be an ORDER, e.g. :
  • "Initiate/Follow heparin titration protocol" and 
  • "Discontinue/stop heparin titration protocol".
But if it's a protocol that is 'always on' for a defined group of patients (say, adult inpatients), then a handy 'trigger' could be a POLICY, e.g. "All adult inpatients will be on the pharmacy PPI substitution protocol" that allows a pharmacist to STOP one PPI and START another PPI (to replace one for the other).

So if we can accept that there are probably two ways to activate/'trigger' a protocol : 
  1. ORDERS - For those 'on-off'-type protocols, that need to be initiated/discontinued for a particular patient
  2. POLICY - For those 'always-on'-type protocols, that are always in effect for a defined patient population
... then we can work this into our drafted definition of a PROTOCOL (click below to enlarge): 
... and for additional clarity, we can bring in a few common, real-world examples below : 
So this is a reasonable starting point. But does this help us, yet, with a definition for "Standing Order"? I think it does - The term "Standing Order" is commonly used to describe scenarios where the provider has granted pre-approved, written, delegated authority to perform an action without their input or awareness. This is especially helpful in common scenarios where the risks/benefits of administration outweighs the risks/benefits of getting a provider order - E.g. For Public Health reasons, many states allow Registered Nurses to order and administer (low-risk) vaccinations without a provider's input.

So is it possible that the term "Standing Order" is actually a synonym for all or part of this protocol definition? I think it works pretty well for part 1.b below : 
And so, a "Standing Order" could then be defined, simply, as a PROTOCOL that is initiated/triggered by a POLICY (See section 1.b above.)

This leads me to ask about other common terms/synonyms - E.g. "Nurse-driven protocol", "Pharmacy-Driven Protocol", "Respiratory Therapy Protocol", etc. What exactly are these?

The problem with these other synonyms is that the terminology overlaps a bit, and when referring to a protocol, it's important to note both the method of initiation (e.g. Policy or Provider), and the team member(s) expected to follow the protocol, to initiate orders on behalf of the attending or ordering provider (e.g. Registered Nurse, Registered Dietitian, Registered Pharmacist, etc.)

So when referring to a protocol, it's always important to consider both : 
  • "____________-INITIATED protocol" - Describes the mechanism for initiating/triggering the policy (e.g. Provider-initiated, Policy-initiated)
  • "____________-DRIVEN protocol" - Describes the team member(s) who is/are expected to follow the protocol (to start/modify/stop orders, on behalf of a licensed prescriber) (e.g. Nurse-driven, Pharmacy-driven, Dietary-driven, etc.)
We can use these terminology concepts to help fill out our definition of a protocol / standing order even more - see 'synonym : Provider-initiated Protocol' in 1.a below :

And if we want to give some examples of each type of trigger, to help make the definition even more clear, we could include them too  - See 1.a.i and 1.b.i below : 
This is a pretty good start, but we'll want to work in some features of attribution, for the orders that are initiated, modified, or discontinued by these protocols. Since we now have a definition with two types of protocols : 
  1. Order-Initiated (aka Provider-initiated protocols)
  2. Policy-Initiated (aka Standing Orders)
It makes sense that for the resulting 'child' orders : 
  1. Order-Initiated (aka Provider-initiated protocols) - Attributed to the ORDERING provider
  2. Policy-Initiated (aka Standing Orders) - Attributed to the ATTENDING provider
And we can work this into our definition, too - See 1.a.ii and 1.b.ii below : 
Finally, for safety, we should consider the circumstances in which someone else other than a doctor might assume responsibility for INITIATING, MODIFYING, or DISCONTINUING an order - We want it to be very clear about WHENexactly, to start/modify/stop that order - In other words : 
  1. ACCEPTABLE = Clear, discrete data elements
  2. UNACCEPTABLE = Vague, ambiguous, or complex data elements
So we can work this safety feature into our definition too - See #2 below : 
This definition is much more robust than many regulatory agencies currently offer or publish. Some might see the adoption of such a definition as risky ("You don't want to paint yourself in a corner!") - However, it does provide a great deal of clarity and predictability, and if it exceeds the expectations of the regulatory agencies, then you are still meeting their expectations while simultaneously creating clarity and predictability - Which creates more predictable outcomes, which can lead to faster development time, higher development standards, and more standardized care. Before deciding whether or not to adopt such a definition and approach in your organization, your legal counsel, senior leadership, and informatics leadership will need to discuss the risks and benefits in detail.

However, if after rigorous examination and debate, you do adopt a similar definition, then it could help you answer questions like : 
  • Q : "What exactly is a protocol?"
  • A : See the [ DRAFT ] definition below (click to enlarge) : 
  • Q : What exactly is a standing order?
  • A : It is a PROTOCOL which is activated/triggered by a POLICY. The provider is not required to initiate action, and child orders are attributed to the ATTENDING provider. See the definition of PROTOCOLsection 1.b above.  
  • Q : Do I always need to activate a PROTOCOL with an order?
  • A : No - See the definition of PROTOCOL, section 1.b (aka 'Standing Order'). 
  • Q : Is a PROTOCOL the same as a 'research protocol'?
  • A : Without a solid definition of 'research protocol' it is not easy to answer this, but research protocols are typically used to guide the screening of research subjects, plan their data collection and management, with the goal of studying a subject. A PROTOCOL is only used to define a common clinical scenario where a licensed prescriber is delegating the authority to start, modify, or stop an order on his/her behalf.
  • Q : Is a PROTOCOL the same as an 'EMS protocol' or 'Emergency Protocol'?
  • A : Without a solid definition of 'EMS protocol' or 'Emergency Protocol', this is difficult to answer concretely - But in fact, many state EMS protocols have the same sort of functionality as a clinical PROTOCOL - Allowing a trained medical professional (paramedic or EMT) to initiate care in the field, on behalf of a supervising Emergency provider or Medical Director.
In my next blog post, I'll show how such a [ DRAFT ] definition could help you develop a protocol template that supports your protocol definition by creating an easy way for your protocol-builders to plan and build a professional-looking protocol document that supports your desired workflow and EMR configuration.

Remember this blog is for educational discussions only - You should consult your own legal counsel, senior leadership, and informatics professionals before considering adoption of any of the above approaches or definitions. Have any good definitions or regulations to share, or other ideas or comments? Leave them in the comments box below!