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This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 97
Developing Central Service Policies and Procedure
[Reprinted from Communiqué: November/December 2007]

Policies and procedures can help Central Service staff perform in a predictable and consistent manner. They can be effective operating resources and useful training tools to enhance performance, promote the standardization of processes in the department, and help the staff achieve optimal quality of care. When policy and procedure documents are poorly written, these potential advantages are lost. This Self-Study Lesson provides information for developing and maintaining Central Service policies and procedures.

Objective 1: Explain the difference between a policy and a procedure.

Policies state the organization’s position on a subject or issue, generally including rules regarding what should be done, and when. Most departmental policies are adapted from those of the healthcare facility. For example, a facility’s personnel attendance policy is typically the basis for the Central Service. Policies may also be based on industry-recognized recommended practices and guidelines. A facility’s policy about use of biological indicators (BIs), for instance, will be based on information published by the Association for the Advancement of Medical Instrumentation. A reprocessing policy may cover many procedures (“only FDA-approved medical devices will be used within this department”), or it may address only specific procedures, instruments, manufactured items, or equipment.

By contrast, procedures are specific guidelines on performing departmental tasks and functions. Each department should have a set of procedures—step-by-step, easy-to-follow instructions—that specify how work should be performed. To be effective, departmental procedures should break down each step in a process and indicate how each should be done.

Procedures should be researched carefully using governmental publications from the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and other agencies. Accrediting standards, such as those from The Joint Commission, industry-recognized recommended practices, standards, guidelines, and technical recommendations from manufacturers are also very useful.

These procedures should be written specifically for the department and address equipment that is available to staff. Generic procedure statements can also be obtained from commercial sources, but must be adapted to the specific department by focusing on such specifics as available instruments, staffing mix, hours of operation, and functions.

Objective 2: Review the steps in developing policies and procedures.

A written policy or procedure is needed for every Central Service task. Most staff will never be required to create an original departmental manual of policies and procedures. If this does become one’s responsibility, several steps should be followed:

• Monitor the department’s activity for several days and document what staff members do. Then write a procedure for each documented task.

• Use industry-accepted guidelines and standards—such as those from the Association for the Advancement of Medical Instrumentation (AAMI), the Association of peri-Operative Registered Nurses (AORN), and published technical manuals—to determine standards to be attained for each function. For example, AAMI ST79 states that a biological indicator (BI) should be run in steam sterilizers at least weekly, and with every load containing implants.¹
  A facility’s policy and procedures should use this standard as a minimum; the facility’s requirements can be more, but not less, stringent. For example, a BI policy may state that each load should be monitored, because this is more stringent than the nationally-recognized standard. A procedure calling for monthly use of BIs is unacceptable, however, because it does not meet the basic standard requirements.

• Determine the facility policies, if any, which require revision. An attendance policy may need changes, for example, to allow time for staff to change into and out of scrubs.

Whenever possible, allow the staff to participate in the data gathering and development of policies and procedures. This should result in more-accurate procedures and may help develop teamwork. Working with other facilities and peers can help ensure the manual is complete.

When updating an existing manual, consider whether new or revised procedures have been implemented since the last update. Review the tasks Central Service technicians are performing, and see if they are covered adequately, and accurately, in the manual. A team approach can also be beneficial if other procedures need updating.

After the necessary policies and procedures are identified, set a priority for writing the documents. Consider:

• the frequency with which the procedures are performed,
• the importance of the policy or procedure,
• the potential for harm if the policy or procedure is not available, and
• the amount of information available.

Who should write the document? While the department manager may be the best choice, after the appropriate style and format are selected, others with the proper grammatical and composition skills can also contribute. Staff members with lesser writing skills, but who want to be involved, may develop a first draft, and the other team members can then make revisions. This involvement can yield valuable input from staff members and enable them to develop new skills.

Objective 3: Select the proper style for expressing policies and procedures.

Many facilities use a standard format and style for policies and procedures. The needs, requirements, and circumstances for designing and developing policies and procedures vary between organizations, and even within them. If the department does not use a specific format for policy and procedure documents, there are six recommended steps that can be used: ²

• Step 1–Use a format that makes it easy for the staff to understand and use the information. Outlining and sequencing techniques include the numerical outline, such as Roman numerals (I, II, III, etc.) or decimals (1.0, 1.1, 1.1.1, etc.). Mechanical (or physical) outline formats include indentations, sub-headings, and variations in type fonts. Also, determine how pictures, graphs, and tables should be used, if at all.

• Step 2–Determine if policies should be stated in the same document as the procedures that apply to them, or whether they should be in separate documents. It is common to use one manual for all policies and a separate manual for procedures. Stating a policy and following it with the applicable procedures may reinforce the policy and clarify the procedure. Also, a policy statement can be applicable to multiple procedures. Whichever style is selected should be based on facility and departmental requirements.

• Step 3–Consider how the information should be organized. If a centralized structure is used, everything a user needs to know about a piece of equipment, or a procedure, is in one section of the manual. This structure is convenient for locating information, but it can make procedures long and cumbersome if not managed correctly. If a decentralized structure is used, the reader is referred to several locations in the manual for information about various aspects of the same subject. Reprocessing an instrument set, for example, may require one procedure for tray assembly and a separate procedure for packaging the tray. While each procedure will be shorter than combining them (an advantage), this structure is difficult to maintain because more documents must be changed when procedures change. Always organize the material using whichever structure is best for the department.

• Step 4–Select the tone, or style for the document. Terms such as shall and will, for example, relate to the future and may seem vague. For example, “The sterilizers shall be cleaned on a regular basis,” does not identify when, or how often this action must take place. Writing in the present tense sounds more clear and authoritative: “All sterilizers will be cleaned each Saturday during the evening shift.” Be sure the writing level is appropriate for those using the document, without being either overly sophisticated or too simple. Avoid over-using technical jargon. Compare the statements, “six Geobacillus stearothermophilus D-values” with “15 minutes at 250 degrees F,” and “place the stuff into the cooker” versus “place instrument trays into the steam sterilizer.”

• Step 5–Describe each step of the process clearly and concisely, so that anyone can perform the task in an emergency.

• Step 6–When considering ease of use, determine how the manual will be organized. Separating procedures by departmental responsibility (such as, Administration, Decontamination, and Assembly) may be useful. Procedures could also be placed in numerical or alphabetical order. A clear, concise index will help users quickly locate policies and procedures. An index that includes the policy’s last review or revision date is helpful in keeping the manual current.

Objective 4: Indicate required information for policies and procedures.

To communicate the correct ways to complete tasks within time and budget constraints, all policies and procedures require:

• Purpose of procedure – This clarifies why something must be done a certain way. For example, “The purpose of the procedure is to provide guidelines to properly assemble procedure trays.”
• Scope – Explain to whom this procedure applies, such as the decontamination staff only, or all sterile processing and perioperative staff.
• Responsibility – Specify who is responsible for monitoring the procedure. It may be the sterile processing shift lead technicians or the director of sterile processing, for example.
• Policy statement – List the policies that pertain to this procedure, unless the policies are maintained in a separate manual. For example, “No Central Service technician will use a dynamic air removal steam sterilizer unless properly orientated, and until competencies for operation have been demonstrated and documented.”
• Forms – Include any forms required to implement the documented task, with completion instructions.
• References – List any references upon which the policy is based. This provides sources of additional information, adds validity, and identifies the origin of the requirement.

A procedure should indicate all the information necessary to perform the stated task. For example, a procedure for manual instrument cleaning should indicate:

• proper attire,
• tools and equipment to be used,
• required chemicals, with proper dilution,
• step-by-step instructions to disassemble, clean, and inspect the instruments,
• procedures to rinse and dry the instruments,
• how to transport clean instruments from the decontamination to assembly areas, and
• what to do if instruments are damaged.

Procedure documents should be clear, concise, and accurate. Well-written procedures can help resolve questions that arise in the department, can be used for orientation of new staff members, and may be useful for in-service education and quality assurance reviews. Also, surveying and certification agency personnel procedure documents can help ensure that sterile processing staff members follow proper protocols.

Objective 5: Review the importance of and procedures for updating (maintaining) a policy and procedure manual.

Historically, policies and procedures were reviewed at least every three years, when a Joint Commission survey was expected. Now, most departmental surveys are unannounced, so it is important to keep manuals current. This requires an effective development and monitoring process.

Before introducing new instrumentation, equipment, or processes, policies and procedures must be developed for them. These can be introduced formally, in one-on-one training or departmental in-service activities. Staff members should then sign a document acknowledging that they have read the information and understand it.

Regularly review each policy and procedure, and plan a streamlined approval process. Divide manuals into manageable sections and review each section for accuracy and compliance standards. Each document can be reviewed by an experienced Central Service technician and a peer who has not performed the specific task. Comply with the facility’s approval process before any changes are made to the document, and obtain the approval of all necessary personnel. Note: Some policies and procedures may require approval from other departments, committees (such as Infection Control, Safety, and Facilities), or administrative levels.

Whenever a standard, technical manual, or manufacturer’s recommendation is revised, each procedure relating to it should be reviewed as soon as possible after the update is published. This review is usually done by a supervisor, manager, or educator.

Endnotes:

1. American National Standards Institute/Association for the Advancement of Medical Instrumentation. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. ANSI/AAMI ST 79: 2006.
2. This section is adapted from: 7 Steps to Better Written Policies and Procedures. Stephen Page, Society for Technical Communication Journal. Nov, 2002.

References:

• Urgo, R. The Use of Shall and Will in Policies and Procedures Documents. 2001. (See: www.urgoconsulting.com).
• Designing Policies and Procedures Information. In: Proceedings for the 47th Annual Conference of the Society for Technical Communication. 2000.
• Telegraphic Style: An Often Unknown, Yet Useful Writing Technique. Society for Technical Communication. 2000.
• 13 Common Mistakes about Communicating Policies and Procedures Information and How to Avoid Them. 2005.

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