The Policy that will realign your hospital's tires

So I've been writing a lot recently about governance, and policy manuals, and how these are poorly understood mainly because nobody writes an instruction manual for a hospital. (That is, of course, with the exception of this blog.) :)

I figured I'd give insight, tonight, by giving you the clinical policy that will lay out the framework to :

1. Realign your governance
2. Re-engage your committees and physicians
3. Improve communication
4. Streamline policy development

So if your Policy Manual is your "sacred text" whereby your hospital operates...

And if your :
   1. Clinical policies - Refer to patients and patient care issues
   2. Administrative policies - Refer to employees and employee/hospital issues

Then you will want a Clinical Policy #1 that lays out your clinical policy manual, and an Administrative Policy #1 that lays out your administrative policy manual.

So for tonight, I present : The DRAFT CLINICAL POLICY #1 that will inject your hospital with new life. Look at it, and feel free to comment! Let me know what you think. (Remember, this is for education / discussion only - Your mileage may vary, and remember, with any free discussion - You get what you pay for!) :)

DRAFT VERSION - CLINICAL POLICY #1


I. Purpose : To outline the organization, development, publication, implementation, and monitoring of clinical policies at Acme Hospital


II. Policy Statement : All clinical policies at Acme Hospital will be owned, designed, formatted, tested, approved, published, implemented, and updated according to the procedures outlined in this document.


III. Scope : This document applies to all clinical policies at Acme Hospital.


IV. Definitions :

1. Policy - A written goal for the organization. Policy statements should be short and succinct, and written in clear, concise, and simple language. 
2. Procedure - The detailed outline of steps staff members should take to achieve the policy goal. Procedures should be written with the user in mind, and should be developed by users.
3. Clinical Tools - Documents and other tools which are used to guide the delivery of safe and effective patient care. These may include, but are not limited to clinical policies, procedures, documentation, order sets, protocols, guidelines/pathways, templates, staff schedules, patient education modules, staff education modules, clinical committee minutes, and committee charters. 
4. Clinical Policy Coordinator - The person responsible for the overall functioning of the clinical policy mechanism at Acme Hospital.
5. Chairperson of Medical Executive Committee - Traditionally, this is the President of the Medical Staff.
6. Owner - The person responsible for the timely review, updating, and dissemination of policies and procedures.
7. Builder [Informaticist, if your hospital is that progressive] - A trained person responsible for the design and testing of clinical tools before they are brought to a committee for approval.
8. Testing - The phase of policy development where a policy is checked for accuracy, safety, and reviewed by at least two end users before being brought to a committee for approval.
9. Approval Committee - A committee with the delegated authority to approve clinical policies, as designated by the Medical Executive Committee through a committee charter approved by the Medical Executive Committee.
10. Approval Committee Chairperson - The chairperson responsible for conducting meetings of an approval committee.
11. Publication - The process by which a clinical policy is published in a common clinical policy manual.
12. Implementation - The process by which a clinical policy is educated to front-line staff and enforced by directors and managers.
13. Monitoring - The process by which the owner continuously monitors the effectiveness and safety of a clinical policy.

V. Procedure : All clinical policies will be :

1. Owned : By a department director assigned by the Chairperson of the Medical Executive Committee.
2. Built : By an assigned builder [informaticist], assigned by the Clinical Policy Coordinator.
3. Formatted : According to the format outlined in Attachment A : Format of a Clinical Policy.
4. Tested : By the assigned builder [informaticist] and the owner, before presentation at an approval committee, using at least two front-line clinical staff members provided by the owner.
5. Presented : Shall be presented by the builder and owner to an approval committee assigned by the clinical policy coordinator. 
6. Reviewed : Shall be reviewed by the assigned approval committee. 
7. Approved : If a motion is raised to approve the tool for use, and the motion is approved, the approval committee chairperson shall document a vote of approval by signing the clinical policy during the meeting. In the event of a tie vote, or if the committee chairperson feels the policy has been incorrectly assigned, the policy may be referred back to the MEC president and Clinical Policy Coordinator for reassignment. 
8. Published : In a common policy manual organized by chapters outlined in Attachment B : Organization of the Clinical Policy Manual.
9. Implemented : By the assigned builder [informaticist] and owner.
10. Monitored : By the owner

VI. Owner :       President of the Medical Staff

VII. Builder :      Chief Medical Informatics Officer

VIII. Tested by : 

             Regulatory Affairs, December, 2010

             Senior Leadership, December, 2010

             Chief Nursing Officer, December 2010

             Chief Medical Officer, December 2010

IX. Keywords : Clinical Policy Manual, Clinical Policy, Administrative Policy, Owner, Builder, Testing, Approval, Approval Committee, Chairperson, Medical Executive Committee, Publication, Implementation, Monitoring

X. Approval Committee :

         Medical Executive Committee, January 2011

XI. Approval Date :     

Approval Body Chairperson :   _________________________________________________

                                                  Chairperson, Medical Executive Committee             Date 

                                                   President, Medical Staff

Effective Date : ____/____/_____

Reapproved : ____/_____/_____

Attachment A : Format of a Clinical Policy :

1. All clinical policies should contain the following headings :

          I.      Purpose

          II.     Policy Statement

          III.    Scope

          IV.    Definitions

          V.     Procedure 

          VI.    Owner :

          VII.   Builder :

          VIII.  Tested by :

          IX.     Keywords :

          X.      Approval Committee :

          XI.     Approval Date :

2. Should be formatted on 8.5" x 11"

3. Should be clearly labeled "CLINICAL POLICY - ACME HOSPITAL"

Attachment B : Format of the Clinical Policy Manual :

The clinical Policy Manual will be organized into the following sections and chapters :

1. SECTION I : HOSPITAL-WIDE CLINCIAL POLICIES

       a. Chapter 1 : General Clinical Policies     (Approved by Medical Executive Committee)

       b. Chapter 2 : Nursing Policies                  (Approved by Nursing Committee)

       c. Chapter 3 : Infection Control Policies    (Approved by Infection Control Committee)

       d. Chapter 4 : Laboratory Policies             (Approved by Laboratory Committee) 

       e. Chapter 5 : Pharmacy Policies               (Approved by P&T Committee)

       f. Chapter 6 : Radiology Policies               (Approved by Radiology Committee)

       g. Chapter 7 : HIM/Informatics Policies    (Approved by HIM/Informatics Committee)

2. SECTION II : DEPARTMENT-SPECIFIC CLINICAL POLICIES

        a. Chapter 1 : Medicine                            (Approved by Medicine Committee)

        b. Chapter 2 : Surgery / OR                     (Approved by Surgery Committee) 

        c. Chapter 3 : Pediatrics/Neonatal            (Approved by Pediatric/Neonatal Committee)

        d. Chapter 4 : Labor and Delivery           (Approved by L&D Committee)

        e. Chapter 5 : Behavioral Health             (Approved by Behavioral Health Committee)

        f. Chapter 6 : Pediatrics / Neonatal          (Approved by Pediatric Committee)
        g. Chapter 7 : Critical Care                      (Approved by Critical Care Committee)

Now remember, your hospital's Clinical Policy #1 may vary. 

To provide proper oversight, then, the President of your Medical Executive Committee should meet with all of these chairpersons on a regular basis (once every few weeks/months) to talk about the health of the policy mechanism and any issues which arise. If the committee minutes, from all of these committee meetings, are published in a central location - The minutes will then also help communicate the overall state of affairs on your front line to senior leaders. (In this way, your policy mechanism becomes a tool of organizational communication.)

Anyway... One of the first questions you'll get, after you examine this draft, is, "What about my policies?", for example, Quality Assurance might argue "We need QA policies that help guide the enforcement of error reporting...!"

Your Medical Staff President and Clinical Policy Coordinator will have two options, when faced with this argument from various places in your hospital :

1. Create a new chapter in your policy manual for QA policies (in this case, probably under hospital-wide clinical policies) :
     BENEFITS : 

             - QA will have their own chapter in the policy manual

             - They can approve QA policies without discussion at the Medical Executive Committee

     COSTS : 

             - You will need a new committee to approve the policies in this chapter

             - You will need a charter delegating authority to that committee

             - You will still need to oversee the subcommittee through regular meetings with the subcommittee chairperson.

  

2. Approve this sort of policy as a "General Clinical Policy" :

     BENEFITS : 

             - Fewer committees needed to maintain this manual = Less staff needed to fill committees!

     COSTS : 

             - Medical Executive Committee may spend time reviewing and approving many policies -

So : If Medical Executive Committee is spending too much time reviewing/approving QA policies, the Chairperson of the MEC should consider creating a QA subcommittee and approving a charter delegating that committee with the power to approve their own QA policies.

Would love to hear your feedback! Leave comments about your own Clinical Policy #1 stories! :)

Policy Manuals Made Easy

Hi folks. Happy new year! May 2011 be even better than 2010 was! :)

So I've been asked recently about where informatics policies should live, ideally, and I answered, "In the clinical policy manual."

That led to a follow-up question : "Dirk, what exactly is a clinical policy?"

This gets to the heart of a really interesting conversation about healthcare : The difference between a clinical policy and an administrative policy.

First, a word about policies in general.

Policies are probably one of the most misunderstood things in healthcare. Most doctors shudder when talk centers around, "We should make a policy for that" or "Do you know what the policy is for _______?".

A policy is a written, agreed-upon goal. (The "procedure", often attached to the same document, are the steps about how-to-get-to-that-goal.)

Policies, then, are your organization's written goals. That's why The Joint Commission asks about them, during inspections - They want to know how you organize, how you think, how you operate, etc. They also want to make sure the policies reflect the practices in your hospital.

Policies, if well-written, don't need to be painful. Policies help guide your staff behavior, they help communicate goals, and if they're well-written, they can also be used for training.

They also help protect your staff - Their activities are backed up by the organization's support for that behavior.

"Aha. So you were talking about maintaining policy manuals?"

That's right, I was. Thanks for reminding me. :)

So an interesting thing about healthcare, unlike private industries - We have two policy manuals, whereas most non-healthcare industries only have one.

"And what are those two policy manuals...?"

Interestingly, to maintain an average hospital, you need two general types of organizational control :

1. Clinical Policies - Those policies that refer to patients and patient care
2. Administrative Policies - Those policies that refer to employees and employee issues

Why do you need two? Well, an average healthcare organization is usually run by a Board of Trustees, who at some point made the decision, "We would like to run a hospital here."

To accomplish this, then, the Board usually needs :

1. A group of administrative people who are experts at running the hospital - Keeping it organized, hiring people, making sure supplies show up, paying the bills, setting up the budget, running the place, sending out bills to insurers, etc.
2. A group of clinical people who are experts at delivering patient care - Performing surgery, seeing patients, taking vitals, giving drugs, managing ventilators, etc.

And that's why most hospitals typically have two wings of government :

1. The Administrative Branch
2. The Clinical Branch

... and the policy manuals that are used to help run these two branches of government are :

1. The Administrative Policy Manual
2. The Clinical Policy Manual

"I see... So what else do I need to know?"

Well, to run an average hospital, then, you need to have both clinical and administrative policies that help guide your daily activities. The conflicts that sometimes arise, between these two branches of internal government, are sometimes very complicated - And, as a result, not every situation calls for a clear administrative or clinical policy.

"So how do I recognize an administrative policy from a clinical policy?"

An administrative policy statement usually refers to employees or employee issues, so they typically start with something like this :

"All employees at Acme Healthcare will..." or

"All physicians at Acme Healthcare will..." or

"All nurses at Acme Healthcare will..." or

"All ED staff at Acme Healthcare will..."

The collection of these administrative policies is typically kept in an administrative policy manual.

A clinical policy statement usually refers to patients or patient care issues, so they typically start with something like this :

"All patients at Acme Hospital will..." or

"All pediatric patients at Acme Hospital will..." or

"All ED patients at Acme Hospital will..." or

"All terminally ill patients at Acme Hospital will..."

The collection of these clinical policies is typically kept in a clinical policy manual.

"Aha. So how do you organize these policies, then?"

Every hospital has a slightly different way of organizing them, but I recommend a very simple system of organizing them :

1. Administrative Policy Manual

     a. General Hospital-Wide Administrative Policies

          - Human Resources

          - Safety

          - Information Management / Medical Records

          - Quality Management

          - (Other organizational administrative policies)

     b. Department-specific Administrative Policies

          - ED

          - Medicine

          - Surgery

          - OB/GYN

          - Pediatrics

          - (etc..)

2. Clinical Policy Manual

      a. General Hospital-Wide Clinical Policies

           - General Clinical Policies 

           - Quality Management

           - Nursing

           - Medical Records / Informatics

           - Laboratory

           - Radiology

           - Infection Control

           - Dietary

     b. Department-specific Clinical Policies

          - Medicine

          - Surgery / OR

          - OB/GYN

          - Pediatrics

          - ICU

          - (etc. etc.)

Again, as I said, every hospital does this a little differently, to address their different needs, but the general theme is that they are all generally clinical or administrative policies, and they generally either apply throughout the hospital or in a specific department or physical area.

"Dirk... That sounds like a lot of work, then!"

It is a lot of work. If every policy has to be approved by a person or committee, there's a lot of work that goes into maintaining these policy manuals. Many hospitals struggle with doing this efficiently.

The good news is that it doesn't have to be torture. By delegating each branch of policies to the right person/committee, you can divide up the work efficiently, for example :

1. Clinical Policies

      a. Hospital-wide Clinical Policies

           - General Clinical Policies = Approved by Medical Executive Committee

           - Nursing Policies = Approved by Nursing Committee

           - Medical Records / Informatics = Approved by Med Rec / Informatics committee

           - Pharmacy Policies = Approved by P&T Committee

           - Infection Control Policies = Approved by Infection Control Committee

      b. Department-specific Clinical Policies

           - Medicine - Approved by Medicine Committee

           - Surgery / OR - Approved by OR/Surgery Committee

           - ICU = Approved by Critical Care Committee

           - Pediatrics = Approved by Pediatric Committee

You'll notice the theme : Every branch of clinical policies will either need a committee or a person, delegated to maintain and approve that particular chapter of the policy manual.

And you'll notice how much work it takes to maintain all of this. Every time a drug gets recalled, every time the government creates new billing standards, policies have to be adjusted and re-approved.

The good news, if you do this well, is that you can use the policy manual as an education tool :

- For new staff who are orienting to your hospital

- For existing staff who would like to quickly find out daily operations

Finally, an important part about maintaining all of these separate chapters is that even if you delegate the maintenance of these chapters to different committees, it's imperative that you publish all of these policies in the same place. (That means, that all "active policies" are kept in one common place, where everyone can look at them.) By keeping the entire manual (all chapters) in one place, it :

1. Helps avoid policy conflicts between different departments, and
2. Helps make the policy manual a tool of organization and education for your staff.

Again, as I've said before, my advice is free and you get what you pay for. Every hospital does this a little differently, but I hope I've communicated the major themes. Would love to hear your stories and thoughts about best ways to organize a clinical and administrative policy manual!

What is Medicine Reconciliation, anyway?

So recently I've been hearing and reading a lot about medicine reconciliation.

Medicine reconciliation is the safety practice that, it seems, The Joint Commission has recently announced they will set new expectations for.

A friend of mine, who went to an IHI conference last year, told me that on a wall full of posters of "problem subjects", the "Med Reconciliation poster" seemed to have the most hospitals reporting challenges.

So what is this Med Reconciliation thing, anyway?

• Is it a mythical creature that people see, but nobody ever really gets a picture of?
• Is it something that inspires poets and artists, because it's so intangible?
• Is it something that we can even achieve?

Most practicing physicians learned in medical school that it's "good practice to rip up and re-write all the orders when a patient comes out of the OR". Most practicing physicians are also used to documenting the patient's home medication list in an admission H&P. The interesting thing : These are both different facets of the same med reconciliation picture.

So then, I think one of the biggest challenges in implementing "Med Reconciliation" is that it's so hard to nail down. What is it, exactly? Who does it? And how? 

So I thought I'd share some answers.

WHAT IS MED RECONCILIATION?

I. THE PREMISE :
 First, the premise is simple : It's all about safety.

Med reconciliation is built on the basic premise that a physician and a patient work best together, when they're with eachother. For the purposes of this discussion, I've lovingly decided to call the "place where they work with eachother" the "Patient Care Cubicle" (instead of the industry term, "Level of Care" which is a little confusing.).

The process is then pretty simple. To perform med reconciliation, a physician needs two separate documents :

1. The 'home medication list', to know what the patient is 'usually on'.
2. The 'active medication list', to know what the patient is 'currently on' while sitting in this "patient care cubicle".

And the steps for doing med reconciliation? A doctor should basically follow these four steps :

1. Look at the Patient
2. Look at the HomeMedList
3. Look at the CurrentMedList
4. Make a new CurrentMedList!

This allows a physician can make the decision : What meds does the patient need to be on right now.

So remember, the recipe for med reconciliation needs these four ingredients :

   MED RECONCILIATION = [ Patient ] + [ Physician ] + [ HomeMedList ] + [ CurrentMedList ]

(While they are connected, remember - Med reconciliation is NOT the process of collecting the home med list - But you will need to collect the home med list before a doc can do med reconciliation.)

So... when does a physician actually do these four steps of "med reconciliation"? Optimally, it happens at two times :

1. When the patient appears in your cubicle (in hospital terms this is known as a "change in level of care")
2. When the patient has had some significant event (like delivering a baby, a code blue, a surgery, etc.)

So far, so good. Now comes the implementation challenges.



B. THE BASIC IMPLEMENTATION

The first thing you might do to map out the implementation of med reconciliation, is to make a general map of all of the "patient care cubicles" your patient might pass through, when he/she goes through your hospital. Typically, this map will start with the outpatient cubicle, and end with the outpatient cubicle. (On discharge, then, you need to do med reconciliation one last time to define the "new home med list", aka the "discharge medication list").

So if each "cubicle" has the patient and a physician :

1. The physician covering the "outpatient cubicle" is the primary care physician.
2. The physicians covering the other cubicles are the ones you assign.

And so if you need two lists - The home med list, and the current med list - To perform med reconciliation, you can see by the above slide that the first challenge will be getting the home med list available in your ED.

This brings us to some challenges with med reconciliation...



C. THE FOUR BIG CHALLENGES

The first challenge is just getting the home med list in your ED. How long does it take to actually assemble the list of home medications? (Remember : THIS IS NOT MED RECONCILIATION YET - Collecting this list is probably the thing most commonly confused with the term "med reconciliation".)

I did an informal study of this, while working clinically last year, and found that my median time for most adult medical inpatients was about 20 minutes. About 2/3 of my population was less than this, but about 1/3 of my patients were more than this, and there were some significant outliers - some patients took up to 45 minutes or more. (While slightly tongue-in-cheek, I called the standard I used the "mother standard", figuring I would work to achieve the same accuracy I would expect for my own mother.)

The reason it can take some time to assemble is this : There are up to seven data sources a person can use to assemble the home medication list. They include :

1. The patient - Who usually knows their home med list... but not always.
2. The family - Who is often helpful at establishing an accurate med list, but not always
3. The PCP - Who is usually accurate, as long as the office is open and they know what the specialist might be prescribing, so...
4. The specialist - Who sometimes needs to be contacted for clarification about new specialty medications
5. The outpatient pharmacist - Can be helpful to get a broad view, assuming the pharmacy is open and the patient doesn't use a mail-order pharmacy
6. The previous chart - Can also be helpful, assuming the last visit wasn't too long ago
7. The "insurance-based electronic prescription database", available at some hospitals - Which also still sometimes takes time to sort through, and you have to make certain assumptions...

So if the first step is to assemble this list in the ED, then the first challenge is to figure out who will assemble this list, and how?

Curiously, if you examine med reconciliation needs in the ED department, it usually falls along these steps :

1. Triage desk Officer : Generally drug classes are most important, not actual drug names. (E.g. a triage officer may consider bringing someone in if they are on blood thinners, or antibiotics.)
2. ED physicians : Generally drug names are most important, sometimes doses. Most ED visits are short, so there has not traditionally been much focus on doing med reconciliation in the ED. Of course, if we expect ED physicians to perform med reconciliation, they will need more information. (Some patients do miss medication doses while waiting for care in the ED.)
3. Inpatient Physicians : Here is where the drug, dose, route, frequency, indication, and last dose are most important, because the patient staying in-house will need to continue the right medications at the right times.

Because of these varying needs, at these different levels, it's sometimes hard to figure out who's responsible for how much of the puzzle.

The second challenge, assuming you can get the home med list assembled in the ED, is figuring out : Which physicians will be responsible for actually doing med reconciliation in each cubicle?

While it's tempting to answer :

1. ED - Would be performed by ED physicians, 24/7
2. Floor - Would be performed by hospitalist physicians, 24/7
3. ICU - Would be performed by intensive care physicians, 24/7
4. Etc...

...the PreOP setting/OR/PACU usually presents some unique challenges (challenge #3)

The challenge for many ORs/PACUs is this : Operating room schedules are tight. Hospitals count on maximum efficiency in an operating room. Even small delays can be magnified into cancelled procedures if everything doesn't run like clockwork. Also : Surgeons and anesthesiologists spend a good part of their day in procedures that simply can't be interrupted. Briefly pulling a hospitalist out of a family meeting to "do med reconciliation" will have a very different cost than briefly pulling a surgeon / anesthesiologist out of a surgery.

To accommodate with these demands, many anesthesiologists focus mainly on anesthesia meds, and many surgeons write post-operative orders in the PACU. If the patient goes up to the floor, after the PACU, then the nurses depend on the post-op orders written by the surgeons in the PACU. Unless you create a cubicle where the PACU has the same level of care as the floor, you might have to do med reconciliation again after the patient reaches the floor.

Figuring out this workflow can be very challenging. It's why my friend, going to the IHI conference last year, saw Med Reconciliation as one of the 'top challenges' hospitals face.

The fourth, and final challenge, is deciding on the "triggers" you will use for med reconciliation. As described above, there are typically two things that should trigger a physician to actually perform med reconciliation :

1. Patient arrives in your patient care cubicle (aka "Change in level of care") - This is usually pretty easy to enforce electronically.
2. Patient has a significant change in status (e.g. delivery, surgery, code blue) - This can only be enforced by a policy/clinical practice.

So you will need to decide on these two triggers, knowing that

1. For your EMR to trigger med reconciliation electronically, you will need to organize your levels of care and their relationship to your patient locations.
2. For your staff to trigger med reconciliation during a significant patient event, you will need good policy design and education.

D. THE NEXT STEPS / SOLUTIONS

Fear not, my reader! This may seem daunting, but the problem can be solved! Many hospitals have started down this pathway already, and many more will continue as The Joint Commission and other regulatory bodies reinforce med reconciliation practices.

To help you, I've offered the following recommendations and steps you can take to advance the discussion in your own hospital.

1. Define who is responsible for collecting the home med list in the ED
2. Define what home medication information they will collect, and how? (It's challenging to figure out how many of the seven potential data sources to use, but until our whole country is wired together electronically, your organization will need to decide this.)
3. Define where this home med list will be kept, once assembled, so that every doctor in the "chain of cubicles" will be able to access it and use it to perform and document "med reconciliation".
4. Define your "patient care cubicles", where your EMR can help trigger the med reconciliation process.
5. Define your policy that will help educate physicians about clinical scenarios in which you expect med reconciliation to be performed (e.g. delivery, code blue, surgery, etc.)
6. Define which physician's will be responsible for the med reconciliation process in each cubicle, 24/7.

Regarding the unique challenges that most Operating Rooms/PACUs present, this is a very common challenge, but I'll present the following possible scenarios I came up with :

1. Your hospital might consider asking the surgeons to perform med reconciliation after the patient arrives back up on the floor. (This may cost your hospital in OR time/efficiency.)
2. Your hospital might consider transferring all post-op patients to your hospitalist group, to allow the hospitalists to perform med reconciliation on the floor. (This may cost your hospital by needing more hospitalists to care for these patients.)
3. Your hospital might consider hiring a Physician's Assistant (PA) or Nurse Practitioner (NP) to assist the surgeons with the med reconciliation process. (This may also cost money, but I believe in most settings this would be more affordable than option #1 or  #2 above.)

Enjoy - I hope this discussion has been helpful. A good sample policy to support med reconciliation is available here from the University of Wisconsin Hospital and Clinics.  Again, I'm eager for any feedback folks have. Feel free to leave your own stories about tackling med reconciliation! :)