Sunday, January 30, 2011

The Financial Costs of Hidden Protocols : How Regulatory Bodies Can Help

Know that very common tool known as the “Heparin protocol”? Whether your hospital is electronic, or paper-based, you probably have some version of it.

Take a good look at it. Is it titled “Heparin protocol”? Or “Heparin Order Set”?

Know the difference? Many people don’t. This is one of the hidden costs of healthcare that few people appreciate or understand.

A protocol is a document with a clear set of specific instructions, which allow a nurse, pharmacist, or other licensed medical professional to activate, modify, or discontinue a patient care order on behalf of the protocol. Any conditional (IF/THEN) statements should refer to well-described, discrete data elements. Protocols must be activated and deactivated by a physician order. Clinical protocols are commonly published internally in either an electronic or paper protocol manual.

An order set is a grouping of patient care orders (medication orders and other orders) to help expedite the ordering process for a common clinical scenario. Order sets are commonly published internally in either a paper printshop/order set catalog or an electronic medical record.

The problem is : Many hospitals confuse the definitions for these terms, and as a result, they engineer and publish protocols incorrectly. Instead of being published as protocols, they get designed, approved, and published as order sets.

Now look again at your order set. Are there any conditions that would make a nurse enter a new order, modify an existing order, or discontinue an order? “Discharge patient when criteria are met”, “This order should only be used in the ___”, “Advance diet as tolerated”, “If pain is uncontrolled, titrate IV to …” – Do you see any of those? If so, you may have protocols hidden in your order set.

Why is this a problem? Because protocols and order sets have different functionality, which brings unique engineering needs :
  1. Order sets - Contain orders that are activated/modified/deactivated by a physician.
  2. Protocols - Contain orders that are activated/modified/deactivated by a nurse/pharmacist. (based on a well-defined condition.)

The problem doesn’t just stop there. Protocols are sometimes confused with clinical policies.

A clinical policy is a written goal for a defined patient population. The clinical policy applies to the defined patients, from the time of approval to the time of discontinuation, both executed by an order of the President of the Medical Staff or an appointed chairperson.

A procedure is a written list of explicit instructions about how to achieve a particular goal. Procedures related to policy goals are commonly attached to policy documents and published in a policy manual. Procedures related to other goals are commonly published internally in either a paper or electronic procedure manual.

Now look at your clinical policies. Do you have protocols hidden in your policies?

What does this confusion cost a healthcare institution?

When the common clinical tools are not well-defined in hospital policies and charters, they can be poorly engineered. Poorly engineered clinical tools may not create their desired impact. This makes change management very challenging.

The cost of this confusion, unfortunately, generally goes unnoticed until an EMR (Electronic Medical Record) ultimately forces a hospital to contend with these definitions. In a paper world, the clinical environment will generally continue to function, even if the borders between all of these are blurry. In an electronic world, most software is not as forgiving as paper – Order sets appear in one place electronically, protocols appear in another, and policies appear in yet another. These may all need to be re-engineered to work electronically. (This is one of the reasons why hospitals see a performance benefit after they "go electronic".)

To contend with the management of these tools, even on paper, hospitals often designate committees to help review, approve, publish, and implement these tools. But because there are no widely-accepted standard definitions for these tools, the policies and committee charters that refer to these tools may be vague.

The net result : A committee that works to create a protocol, that mistakenly gets published as a policy, may not have the desired impact on front-line patient care. When this happens, the administrative costs of managing these tools can skyrocket, and those committees can feel powerless to make change. 

Why are there no widely-accepted standard definitions for these tools? Surprisingly, none of the common regulatory or standards organizations in American healthcare seem to publish nor endorse common definitions. So where did the above definitions come from? I wrote them.

As a result of this lack of definition, hospitals are forced to contend with these engineering issues individually. Some will navigate this easily. Others will not.

My recommendation would be for CMS and Joint Commission to announce the publication of standard policy definitions for these very common clinical tools. While some hospitals will initially contend with meeting the new definitions, the long-lasting efficiency to the American healthcare system will be enormous.

They are welcome to start with my definitions, which are free. (Remember, you get what you pay for.) :)

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