Tuesday, October 31, 2017

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

[ File under : FOR EDUCATIONAL DISCUSSION ONLY ] 

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 : 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R77SOMA.pdf 
... 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 : https://www.medscape.com/viewarticle/775617  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 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!

Saturday, October 14, 2017

What exactly is a "Nursing Policy"?

Hi fellow #HealthIT, #Informatics leaders, and other #clinicaljedi, 

Today's post actually started many years ago, when I was a Hospitalist taking care of a med/surg acuity patient on my service with a low magnesium level, and who needed intravenous (IV) magnesium replacement. After I entered the order for IV magnesium, the nurse taking care of the patient told me : "There is a new nursing policy on electrolyte repletion - If you want to give IV magnesium, you'll have to move the patient to a higher-acuity telemetry bed for monitoring, while we replace the magnesium." 


If you're not clinically trained, some brief explanationElectrolytes are chemicals in your blood that you need to be healthy, and so too much or too little can be potentially life-threatening scenarios -  but the dose of magnesium I was looking to replace was a fairly common practice, often used in alcoholic patients undergoing detoxification, who have not kept up with their nutritional needs. So this nursing policy would mean that alcoholics undergoing detoxification would require me to transfer the patient to higher-acuity bed and nursing care, if they needed to get their magnesium replaced intravenously.


Wanting to understand and comply with the clinical standards of the organization, I sought more information and looked up this nursing policy. It basically stated, 'All patients requiring IV electrolyte replacement must be in a monitored telemetry bed.' Even if it might increase the demand for telemetry monitoring, the standard seemed to exist for a good reason - out of an abundance of caution for these patients - and so this nursing policy was signed off by nursing leadership.


And yet, I couldn't help but wonder - Was this really just a nursing standard? Or a nursing-and-doctor standard? If the nursing policy essentially changed how and where physicians ordered magnesium on alcoholic detox patients, should it not have been reviewed by one of our physician leaders, who might have educated me about this standard at our department meetings? And yet, there was no review or signoff by anyone in physician leadership, probably because it was identified as a "Nursing Policy".




It wasn't a big deal for me to transfer the patient to a higher-acuity, monitored telemetry bed, and the patient got the IV magnesium uneventfully, but they still had to find an available bed, and it still took me a little while to get my patient transferred. 

Since then, I've often wondered about this nursing policy, and how it impacts the configuration and use of Electronic Medical Records (EMRs) - Who exactly makes clinical standards, who reviews them, and who approves them? If nursing policies are standards only for nurses, should there also be doctor policies that describe the standards for doctors

Now entering my 10th year as a HealthIT professional (CMIO), I'm busy with EMR implementation, informatics design, and engagement of clinical staff, planning for workflows that deliver great medical care. And after engaging many physicians, nurses, pharmacists, and other clinical and administrative team members, I've still continued to wonder : What exactly is a "Nursing Policy"? What is a "Pharmacy Policy"? "Radiology Policy"? Are each of these tribes of modern healthcare living on their own islands, setting their own rules? What if we need to make workflow standards across these islands?


After a great deal of analysis and evaluation, I believe I have some insight about these questions, which ultimately help answer this common EMR governance question - Who exactly designs, reviews, approves, and maintains the workflows of a healthcare organization?


So I share what I think are the three key challenges that require discussion before we can have a better understanding of a typical policy manual.

A. THE FIRST CHALLENGE - Terminology - Clinical vs. Administrative : 
We need to start by first looking at two common terms used every day in healthcare : 
  • 'Clinical Staff' - Term sometimes used to refer to those people involved in direct patient care, e.g. Doctors, nurses, respiratory therapists, pharmacists, dietitians, etc.
  • 'Administrative Staff' - Term sometimes used to refer to those people NOT involved in direct patient care, e.g. Administrators, finance, safety, engineering, human resources, etc. 
The first problem is that these are loose terms, and not solid definitions -They fray around the edges. For example : 
  • What about the Education department? Even if they don't provide front-line patient care, they are training the clinical staff on medical practice - So is that really an administrative function, or a clinical function?
  • Or what about the Clinical Directors who run the clinical departments, but don't provide direct patient care? If they are designing order sets to update the care their staff provides in treating pneumonia, is that really an administrative function, or a clinical function?
  • Often, roles that one might consider to be non-clinical, like supplies management, housekeeping, bed management, etc. actually do have a real impact in clinical operations. (E.g. Housekeeping technique can be very helpful in reducing infection rates.)
So the first step in understanding the policy chapters is accepting that these general terms may not be strict definitions, but somewhat ambiguous terms to loosely describe two different concepts - Clinical work (providing care?), and Administrative work (somehow supporting that care?). 

B. THE SECOND CHALLENGE - WHAT EXACTLY IS A POLICY/PROCEDURE? 
Surprisingly, the definitions for policies and procedures can vary. Legal dictionaries, technical dictionaries, and even HealthIT dictionaries all offer slightly different definitions. As of this writing, Google currently offers these :

While these are perfectly reasonable, it's worthy to note that the definition of "Procedure" does not identify "workflow" as a synonym. So even if you accept the Google definitions, I'd still like to offer these slightly refined, functional definitions : 
  1. POLICY = A documented organizational standard
  2. PROCEDURES (aka workflows) = How you will achieve those standards, or "an ordered set of tasks that uses people, time, and resources to achieve a desired outcome."
Generally, both policies and procedures are often found on the same document, for good reason : 
  • If you are documenting an organizational standard with a policy statement,
  • It's important to make sure you have planned and agreed about how to achieve that standard (procedure) 
So by outlining your standards, and how you achieve them, these policies and procedures can be very helpful documents. But given the ambiguity behind the terms "clinical" and "administrative", this can make their categorization (secondary definitions) a little difficult : 
  • CLINICAL POLICIES - Are these policies for "clinical people" to follow? (Does that include education?) 
  • ADMINISTRATIVE POLICIES - Are these policies for "Administrative people" to follow? (Does that include education?)
C. THE THIRD CHALLENGE - WHO EXACTLY ARE THEY WRITTEN FOR?: 
This third challenge starts to show up when you look at the typical chapters one finds in the "Clinical" and "Administrative" policy manuals : 
A. Clinical Policies :
  1. Nursing Policies
  2. Pharmacy Policies
  3. Radiology Policies
  4. Laboratory Policies
  5. Infection Control Policies
  6. Respiratory Therapy Policies
  7. ...and so on...
B. Administrative Policies : 
  1. Finance Policies
  2. Human Resources Policies
  3. Safety / Engineering Policies
  4. Information Technology Policies
  5. ... and so on...
Looking at this index, it's only logical to ask - Who are these documents for? Are the nursing policies just for nurses? If so, where are the physician policies, outlining the physician standards? Don't we all work together to take care of patients? Where are the documents that span nursing AND pharmacy AND laboratory?

SOME THOUGHTS :

There is a fundamental truth that's important to consider before we move on. Healthcare is a team sportWe all work together. Having standards on separate islands does not seem to help us all function together, so the idea of these standards all applying to (serving) different islands does not seem conducive to good teamwork and collaboration.

So how does the Informaticist approach this challenge, and create clarity and definition? By reviewing the definitions, archetypes, and indexing for these documents!


THE INDEXING CHALLENGE : 

IF a "Nursing Policy" were really just standards for nurses, then it would be OK to have only nurses writing, reviewing, and approving them. But in my IV magnesium example above, this "Nursing Policy" impacted my (physician) ability to care for the patient in that location, and so I had to transfer the patient to another bed to get the IV magnesium. So I'd like to offer the argument that, perhaps, "Nursing Policies" are not simply 'standards for nurses only' - This nursing policy created a standard for my physician activities, too.

The same argument would also apply to "Finance Policies" and "Human Resource Policies" - If the policy manual chapters only describe the people expected to follow them, then doctors and nurses would not have to honor Finance or HR policies. (We know this is not true.)


And so I believe this is a compelling argument to say that the policy chapters are not describing who's expected to follow the policy. If that's so, then what exactly are the chapters describing?

Before we can offer up an answer, there are two final definitions to ponder and consider :
  1. Policy Author/Owner - The person responsible for writing, monitoring, and upkeep of a policy
  2. Policy Stakeholder(s) - The person(s) impacted by the policy standard, who for review and education, are responsible for reviewing (vetting) the policy before approval
If we assume that the policy author/owner is a stakeholder too, then we could potentially refine these definitions slightly : 
POLICY STAKEHOLDER(S) - The person or people impacted by the policy standard. These are categorized as : 
  • PRIMARY STAKEHOLDER (aka "Policy Author" or "Policy Owner") - The stakeholder with the time, training, expertise, and responsibility for creating, maintaining, and updating the policy.
  • SECONDARY STAKEHOLDER(S) - Additional stakeholder(s) impacted by the policy standard, who for development and education purposes, are responsible for reviewing ('vetting') the policy before final approval.
And if we can accept these expanded definitions for policy stakeholders, which separate the primary stakeholder from the secondary stakeholders, then we have a much better chance at decoding the policy manual! Maybe that "Nursing Policy" is in the chapter of "Nursing Policies" NOT because it's a 'policy that only nurses have to follow', but because nursing is the primary stakeholder - They had the time, training, expertise, and responsibility to create, update, and maintain the policy. And so as the physician who had to move my patient because of this policy, am I a secondary stakeholder, still required to follow the policy...?

SO WHAT EXACTLY IS A "NURSING POLICY"?
If these arguments are compelling to you, and your organization formally accepts the definitions I've proposed (ask your legal counsel), then we can first summarize some of our findings here :
  1. Healthcare is a team sport - We all work together to take care of patients.
  2. The terms "Clinical" and "Administrative" are not as well-defined as we wish they were - There are plenty of examples of roles and functions that overlap both.
  3. The chapters of the policy manual are probably not just describing the 'people expected to follow the standard'.
  4. More likely, the chapters of the policy manual are describing the primary stakeholders, with the time, training, and expertise to create, maintain, and update the policy. But each policy may have additional secondary stakeholders.
If the above (#4) is true, and a policy can have multiple secondary stakeholders, then the policy chapters are more likely describing only the primary stakeholders - Those expected to create and maintain the policies. And so the chapters could maybe be better described as: 

A. Clinical Policies - policies maintained by clinical departments
B. Administrative Policies - policies maintained by administrative departments

And so we might further describe the policy manual as : 

A. Clinical Policies - Organizational policies maintained by clinical departments

  1. Nursing Policies - Clinical Policies maintained by the Nursing Department
  2. Laboratory Policies - Clinical Policies maintained by the Laboratory Department
  3. Pharmacy Policies - Clinical Policies maintained by the Pharmacy Department
  4. Radiology Policies - Clinical Policies maintained by the Radiology Department
  5. Infection Control Policies - Clinical Policies maintained by the Infection Control
  6. ... and so on...
B. Administrative Policies - Organizational policies maintained by administrative departments

  1. Finance Policies - Administrative policies maintained by the Finance department
  2. Human Resource Policies - Administrative policies maintained by the Human Resources department
  3. Safety Policies - Administrative policies maintained by Safety department
  4. Education Policies - Administrative Policies maintained by the Education Department
And each of these policies, both clinical and administrative, could apply to physicians if the physicians are one of the secondary stakeholders in the policy. This now helps us [DRAFT] some answers to some common policy questions : 

  • Q : "What exactly is a clinical policy?" - A : It's an organizational standard that is maintained by a clinical department and listed in the clinical section of the policy manual.
  • Q : "What exactly is a nursing policy?" - A : It's a clinical policy maintained by the nursing department.
  • Q : "Do doctors have to honor nursing policies?" A : If physicians are a secondary stakeholder in the policy, and the procedure was reviewed and vetted by physician leadership, the answer is clear - absolutely, yes.
  • Q : "If there are nursing policies, why are there no physician policies?" A : Probably because of the definition of the primary stakeholder (aka policy author / owner) - E.g. "A person with the time, training, and expertise to create, maintain, and update the policy." While physicians may have expertise about evidence-based practice, they also cost a lot in salary, and generally don't have the time, training, or responsibility to create or update policies. As long as healthcare continues to see this function as a nursing-only responsibility, these policies will probably continue to be published in the chapter of nursing policies
  • Q : "What's about education policies? Are they clinical or administrative?" - A : They can be either, it doesn't matter so much about which section (clinical or administrative) they are found in. What really matters is that they create standards to ensure reliable education of all employees on important operational issues.
  • Q : "So do we really need to divide the policy manual into clinical and administrative policies? What good does this serve?" - A : I think many in healthcare have historically made this distinction because, in general, it's hard to be good at both, e.g. there are not many people who are good at both financial planning and treating pneumonia. The terms loosely describe a focus, with different skill sets that both require a long and different educational pathways. So using these terms may loosely help us plan for resources, such as the general hiring/training of staff. But it's still important to note that these terms are somewhat vague, and may also create unnecessary divisions and confusion when it comes to shared decision-making across the organization
  • Q : "So if I want to write a policy, how do I do it?" A: It probably makes sense to first identify the standard (policy), and the steps you will use to accomplish it (procedure). Once you have the procedure written, it should help you figure out all of the stakeholders involved - Nursing, physician, pharmacy, lab, education, HR, housekeeping, finance, etc. Once you have all of the stakeholders identified, then you'll need to figure out who will be the primary stakeholder, responsible for getting all of the secondary stakeholders together, talking about the policy, and securing their buy-in, working out the details, getting it approved, and then finally, publishing it in your chapter of the policy manual so that you will revisit it regularly and make sure it's still meeting your needs.
Please remember, this is all just an educational discussion, and since I'm not a lawyer, the [DRAFT] answers I've offered above depend largely on your organization's willingness to adopt some of the [DRAFT] definitions and processes I've offered in this post. Your mileage may vary considerably, and so before making any changes, changing any definitions, or answering these questions in your own organization - Please make sure to discuss with your senior leadership and review these definitions with your own legal and clinical informatics teams, to make sure they make sense to your organization, before you consider  formally adopting them.

A big special thank you to mentor and quality guru Dominick Lepore, MS CTRS for sharing every lesson learned.

Have any thoughts or comments you would like to contribute? Feel free to respond in the box below.