Writing effective policies and procedures might be the most important piece of cultivating excellence in a Sterile Processing department.  Policies and procedures play a vital role in the reliable, safe reprocessing of surgical instruments for patient care.   They are the department’s guardrails, marching orders, recipes, and safety net. They promote conformity to industry guidelines, they support uniformity and reliability, they give education and instruction to employees, and they protect the department from risks.    Without policies and procedures, processes can vary from one technician to the next, and the motto of the department can feel like “every man for himself.”

In this 20-part educational series, we will take a deep dive into what it takes to build policies that don’t just look good on paper, but actually work in the real world. Policies that are just wishful statements about ideals and are disconnected from the actual work taking place in Sterile Processing are recipes for disaster.  Effective policies should be understandable, reasonable, accessible, and implementable.

Why Everyone Loves a Good Policy

Why Everyone Loves a Good Policy

Have you ever worked in a department with no written policies or procedures?  Or perhaps there were policies written somewhere, but nobody ever saw them or knew what they said?  The biggest problem with these situations is that front-line technicians are left to remember, interpret, or invent their own way of doing processes in the department. Mis-information gets handed down to newer generations of technician trainees, and there is no available written standard to decide whose process for decontamination is the correct way.  The problem with missing policies is the problem of unclear expectations.

Did you know that industry guidelines, such as AAMI ST79, represent the broader scope of what is recommended for Sterile Processing Departments, but that the particular application of those guidelines is left up to the individual departments?  Guidelines say what should be done, but healthcare facility policies describe exactly how they will do it.  The foreword of the AAMI ST79:2017 document states “The provisions of this recommended practice should be reviewed routinely by departmental managers and adapted to the needs of their particular institutions.” In other words, you need a policy to describe how your department interprets and carries out the standards, as opposed to all other possible interpretations of the standard.

To read more about AAMI and the ST79 document, visit: https://www.aami.org/standards/ansi-aami-st79

Policy as Communication: Staff & Patients

Communication is central to good morale on a team.  It builds the employees’ confidence in themselves, it fosters trust in the department’s processes and leadership, and it creates an environment where it is clear what the expectations are.  Well written policies are a foundational piece of developing a team that cares about things being done the right way.  Without written and well-communicated policies, employees are left to follow whatever process or decision seems best to them.  Naturally, the result of that kind of practice is team confusion, disagreements, and inconsistent quality.  But when every team member knows the department’s expectations and policies, the team can be confident that patients are receiving the best possible care, no matter which of their peers is processing their instruments.

Patients also can be positively impacted by clear, well-implemented policies in healthcare. Patients may never be aware of what is written in your Sterile Processing policy binder, but what they experience as a result of well-implemented policies is a consistent service of safe care, and an experience with healthcare employees that are confident in their job.

Policy as Communication: Malpractice & Claims

In addition to creating a positive work environment, policies and procedures are critical for limiting the legal risk to the healthcare organization.  Having well-written, carefully implemented policies can reduce an organizations risk of malpractice claims in two ways:

  • Policies and procedures can help in preventing safety incidents that could possibly turn into a malpractice claim.
  • Well written policies can help reduce the likelihood of losing the malpractice case in the event that your organization is sued.

A good example of a policy that can help reduce the risk of malpractice is your organization’s health data privacy policies.  Documenting how staff will be trained on your organization’s EHR (electronic health record) and how patient health data will be managed can reduce the likelihood of an error.  In the event of a lawsuit, your policies can help you demonstrate good faith in preventing the error from occurring.

Policy as Compliance: Direction to Clinicians

The worst time to plan out an organization’s policy and course of action is in the middle of a crisis.  Under duress, the leadership team may be tempted to make a rash decision, overreact, or even make a costly mistake.  The value of well-thought-out policies is that they create a plan of action for the clinicians.  An important example of this kind of future-planning in Sterile Processing could include a sterilization recall policy: what will your technicians do if a biological indicator shows positive growth from a sterilization cycle?  How many loads will be recalled?  Who should be notified?  What documents need to be filled out?  Having these steps in place in a standard procedure, steps A through N, can relieve stress for your employees and ensure the proper course of action is taken, no matter who is performing that recall.

Policies should be reviewed and developed by a multi-disciplinary team that understands the recommendations and guidelines impacting the decision, as well as the needs of the organization.  Once the policy has been developed by the team of experts and stakeholders, front-line clinicians can have the confidence to “get it right” when the crisis comes along.

Policy as Compliance: Regulatory, Standards, & Certification

Did you know that many of the policies at your healthcare organization are required to be there by outside organizations?  Regulatory bodies establish requirements for healthcare organizations to follow, many times including required policies.  Accreditation organizations such as the Joint Commission or the DNV may prescribe particular policies that the healthcare organization must have in writing and abide by.  In some circumstances, other 3rd party payers (i.e. private insurance) may request an organization abide by certain policy requirements in order to be paid.

For example, the accreditation requirements for Medicare coverage includes the requirement of having a written quality management program for the organization.  To learn more about the medicare conditions for coverage, visit here: https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs

Do you have it in Writing?

You’ve heard the adage: “If it’s not documented, it didn’t happen.”  When it comes to policies and procedures in healthcare, your accreditation agency (such as The Joint Commission, DNV, AAAHC) may have expectations regarding what policies you have in writing.  Standards that dictate what your policy and procedures must include are known as “Prescriptive” standards, meaning they prescribe how your organization should operate.  Guidelines that are not “Prescriptive” give the freedom to the healthcare organization to interpret the standard and write their own policy to state how they will be successful.

One example of a prescriptive standard is the Joint Commission requiring healthcare organizations to specify what abbreviations will not be allowed in documentation.  In 2001, the Joint Commission issued a Sentinel Event Alert on the subject of medical abbreviations, calling attention to some potential misunderstandings due to abbreviation choices.  In 2004, The Joint Commission created a “Do Not Use” list, and it was integrated into the Information management standards as elements of performance.  For more information, visit https://www.jointcommission.org/resources/news-and-multimedia/fact-sheets/facts-about-do-not-use-list/

Can Policies be Verbal?

A common misunderstanding among healthcare facilities regarding policies and procedures is that they need to have a written policy about every guideline or recommendation. Not only is this not required, but it can increase your risk during an accreditation survey.  For example, if your department has an overwhelming number of policies written, it will be much more difficult for your team to know and follow all of those policies, and it creates more opportunities for there to be a difference between your department’s daily practice and the stated policy.

Many times, what is required of your team is that they are aware of their expectations and are able to speak to the correct procedure.  Let’s take an example from the Sterile Processing world:

Image you have an ultrasonic washer that, according to the manufacturer’s user manual, should be drained and disinfected every 8 hours.  Rather than writing a specific policy and procedure for the specific machine and when/how it will be cleaned, a department might choose to make it an expectation for each of their shifts to drain and clean the ultrasonic washer at the end of their shift.  They might put a sign on the piece of equipment as a reminder, and add it as a line item to the staff’s annual competency.  The surveyor will want to know that your team is aware of the expectation, they’ve been trained on the expected process, and they can speak to the process.

Policy Formats, Templates & Standardization

Because the pace of change in healthcare is so rapid, policies are continually being written, edited, and retired.  If everyone in the organization could write and publish a policy on whatever topic they chose, the policy library would quickly become a policy dump.  Having a standard format for policies is vital for preventing duplicate and overlapping policies, as well as enabling quick, seamless updates and edits.   For example, if policies are written in a stream-of-thought paragraph form, updating procedures in the document would require reading the policy in full, and thinking about how to re-word paragraphs to keep it intact.  Effective and efficient policies have standard sections with bullet point answers so that the policy reader knows exactly where to look in the document to get their question answered.

The type of standardization of policy formats will differ from organization.  A large hospital network may choose to have a header specifying which facility the policy applies to, who is the responsible party for overseeing and editing the policy, as well as signatures of who has approved the policy.  In a smaller organization, such as an Ambulatory Surgery Center, many of those details could be left out.

Approved: Organizational Hierarchy & Policy Processes

Policy approvals are critical to policy management.  Approval structures ensure that policies and procedures meet standard formats, can be implemented, are consistent with guidelines, and are consistent with the goals of the organization.  Depending on the size of the organization, the size of the policy approval hierarchy will vary.  Typically, when a policy is created, it is assigned to an individual (by job title) who will ensure the policy stays up to date and is being implemented. Additional approvals may be required an interdisciplinary team consisting of senior leadership, medical staff, quality and risk management, safety, and others.

Because of the sheer volume of policies in a healthcare organization, it is common to appoint an administrator who will take ownership of the organization’s process for policies and ensure that policies are being kept up to date.  In the absence of such an administrator, another strategy is to have a “policy on policy management” and an appointed committee to jointly oversee policy creation, review, communication, and implementation in the facility.

The Key Sections of Excellent Policies

“So what does a good policy look like?” The answer to that question is not universal: a good policy matches whatever the standard format is at your organization.  That being said, here are 7 common sections to be found in healthcare policies:

  • Title of the Organization – This section identifies what organization the policy applies to. This section is important to distinguish your policies from any others.
  • Title of the Policy – The title should describe what the policy specifically addresses.
  • Policy Statement – This is a preview of what is to come in the policy. It is usually 1 to 2 sentences in length and can be useful to give the general sense of the policy’s content and outline the goal of the policy.
  • Procedure – The procedure will usually be the majority of the policy. It describes what must be done to accomplish the goal of the policy.
  • Technique – This section describes in detail specifically how the steps of the procedures will be accomplished.
  • Considerations – This section highlights key considerations important to successfully fulfilling the policy or procedure. This section could explain everything a novice would need to know in order to be successful.
  • References – Usually the last section of the policy, the reference section includes all guidelines, research, or standards that have been consulted in developing the policy.

Policy Storage: Paper or Digital

Just as important as policy writing is how they are managed, stored, and communicated.   Whether stored on paper or digitally, policies need to be accessible to employees and be current.  Even the best written policies will do no good in keeping patients safe or protecting the organization from risk if they are not distributed, followed, and accessible.

Some departments choose to organize their policies on paper documents.  An advantage to paper is that is very simple to keep track of where the policies live.  Everybody in the department knows that the policies are in “that orange binder over there.”  It also can be simpler for employees to see all the department’s relevant policies collected in one book. The challenge, of course, is keeping the binder current, and the limited scope of a binder.  Healthcare organizations of almost every size will need to have some kind of centralized policy system, and keeping all the organization’s policies on paper would be a logistical challenge.

Digital systems can be useful for storing and distributing the organization’s policies and procedures, as all employees can be given access to the policy library, and updated policy edits can be pushed out with ease.  There is no concern about the policies on the network being the most current version. The challenge with digital systems is that all employees need to know how to access and use the policy library.  It is not enough for employees to know that the policies are on the intranet “somewhere”; they need to be able to access and read policies for themselves.

Policy Storage: Multiple or Single Manuals

Are you storing your department policies in a binder in your department?  Here are some thoughts about how to store paper policies.

It can be advantageous to pull all department policies together into one place, in one binder, as an easy-access point of reference for staff.  This way, all team members know where to go to find a policy, and they can see all the department policies in one place.  If you policies are also kept on a digital shared drive, it is important to make sure that the policy binder is updated to the current version.  Having outdated versions of policies in print in the department could become a source of confusion for staff, or even a citation in an accreditation survey.

With larger departments or organizations, it may be unwieldy to organize all policies into one binder to sort through.  Using other methods of storage, such as a file cabinet or a series of department binders, can help keep them organized.

Policy Storage: Shared Drive Best Practices

Digital policy libraries are becoming commonplace for healthcare organizations, as they provide a simple method of storing and distributing policies to all employees in the organization.  Whether the organization is managing the digital policies in their own shared drive or using a policy management software, these key considerations can be helpful in maintaining and organizing the policies:

  • Policy Owners – Every policy should have an individual responsible for the implementation and review of a policy. This should be documented on every policy and be searchable.
  • Departments – Not every department in a healthcare organization will apply to your department. Include who the policy applies to, including if it is an organization-wide (or system-wide) policy.
  • Dates for Review – The digital record should keep up with the last date of review and help organize the policies by when they will need to be reviewed next.

Staying Current with your Department Policies

The one constant in healthcare: change.  And Sterile Processing is no exception. New products or services, updated guidelines, new recommendations from accrediting organizations, updated regulations, or even new management can bring policy and procedure changes to the department.  As such, it is critical that department policies stay current with department practice.

It is common to see organizations to include references at the end of policies, citing the specific version of the standard referenced in policy writing.  So if your policy cites the AAMI ST91:2015 guidelines, and significant changes were recommended in the 2021 update of that document, then your policies need to be updated to reflect the current guidance and the reference must be changed to reflect the latest document.

Another common example to see is product names mentioned in the policies.  If your policy is specific to a particular piece of equipment or brand of disinfectant, it will need to be updated when the department changes disinfectants or replaces the equipment, as you will not want a policy that mentions a product or process that is no longer relevant to the organization.   As your processes, products, and guidance chance, so must your policies in order to stay current and timely.

All Eyes on Your Policies: Reviewing 101

The most important practice in maintaining and managing policies in an organization is to have an organized process for policy approval and review.  It is recommended that policies be reviewed at least annually, although your local or state regulation may require a different frequency.  These are the key factors to consider during a policy review:

  • Does the policy match current guidelines and regulation? – Review updated guidelines and regulations to be certain the current policy supports best practices. Because policy decisions will likely have an impact on other departments in the organization from various specialties, it is wise to have a multi-disciplinary team be involved in policy review and updates.
  • Does the policy match our practice? – A policy is only as good as it’s implementation. When reviewing the policy, it is good practice to confirm that the department is consistently following what has been written.
  • Is the policy written well? – Does the policy match the organization’s standard format? Are there ways to make the policy more clear or concise?  Are additional comments needed to clarify intentions?

Noted: Keeping Track of Policy Revisions

Did you know that the older versions of your department policies have to be kept and archived? As policies and procedures are reviewed and edited from year to year, there should be a standardized format of making updates and changes to the document, as well as a way of documenting those revisions and changes.  Older versions of the policy get archived, along with the date that policy was effective.  The paper trail of policy revisions help leaders be able to see how policies have evolved over the years. Also, in the event of a legal case requesting the hospital policy on a particular subject from 8 years ago, the current policy would be irrelevant.  What would be needed is the archived policy revision that was in effect during the time of the incident in question.

Present & Accounted For: Documenting Policy Education

Part of your efforts in risk mitigation is documenting that you have taken steps to communicate policies and procedures to employees and offered training to them.  Having this audit trail of policy training can protect your organization from accusations of negligence and can assist with accreditation.  It is not enough to have policies available to employees; you need to be able to show that all employees have read and understood the policy, as well as have been given the tools and training to be able to comply with those expectations.

Documentation of policy education can take many forms.  Modern policy management software can help with this task by digitally delivering policies to employees, documenting that they have been read, and testing employees on their understanding of the material.  Departments can also record this information manually by requiring employees to read and sign off on hospital policies and procedures.  Ultimately the organization gets to choose how they will document this information.

Policies that Work: Integrating Policies into Practice

Have you ever read a policy that sounds good on paper, but would never work in the real world?  Or what about a policy that was so specific that it took far longer to read and interpret than was necessary?  These common problems highlight the importance of developing policies that can be easily integrated into the daily processes of the department.  When writing a policy, it is a good idea to only be as specific as you need to be.  When policies are overly specific, it can unnecessarily increase the workload for the department, create long and confusing policies, and become burdensome to keep up with the policy management.  Keep the policies general, hit the high levels of what needs to be said, and defer to other specific documents such as the manufacturer’s instructions for use or equipment operators’ manuals for specifics.

For implementing policies into daily practice, it is best to include your department’s policies and procedures into employee training.  Have preceptors walk new employees through policies and procedures during the training process and show them how to reference those documents.  Make a “policy review” a part of annual competencies to confirm everyone is on the same page. And when it is time for the department leader to formally review a policy, involve front-line staff in the evaluation of the policy’s effectiveness.  People are more likely to engage with a document that they had some input to influence.

Series Wrap Up

Policy management is vital to the success of a healthcare organization.  It supports safe care for patients, influences the employee experience, gives instructions to providers, and protects the organization from risk. As you participate in the maintenance and management of your department’s policies, remember these key considerations:

  • Keep Policies Current and Timely – Polices must be relevant to the organization as it operates today. Updated guidelines, new equipment, and current processes should be reflected in policies.
  • Policies should be reviewed and updated at least annually – Policy updates can be difficult to manage. Have an organized system in place for reviewing policies at least annually, but more frequently as may be required by local or state regulations. Involve front-line staff, as well as leaders from other disciplines in the review and editing of policies.
  • Policy revisions should be notated and archived- Any updates or revisions to your policies should be annotated including the date. When a revision is made, a copy of the previous policy should be kept.
  • Staff must have documented education on policies – However the organization chooses to collect this, whether it is a list of names or individual personnel files, each employee should have documentation they have received the organization’s policies and have received training on them.

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