Q&A with Lee Murdaugh, BS Pharm, PhD
Director of Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions
Pharmacy Purchasing & Products: What are the steps for developing policies and procedures (P&Ps) for hand hygiene and garbing?
Lee Murdaugh, BS Pharm, PhD: P&Ps for hand hygiene and garbing, including the use of personal protective equipment (PPE), must be comprehensive and should include detailed, step-by-step descriptions of the required hand hygiene and garbing activities in the order that they should be performed. When developing P&Ps, be sure to include the following elements:
- Appropriate Attire. Describe what is and is not appropriate personal attire. When entering the compounding area, jewelry, coats, hats, etc, should not be permitted.
- Utilize Approved Hand-Hygiene Products Only. Specify which hand-hygiene products to use and when. For example, P&Ps should specify that only soap approved by the infection control department be used for hand-washing. In addition, specify when hand hygiene should occur during the garbing donning and doffing processes.
- Donning PPE. Specify how and where to don PPE. P&Ps should delineate the specific garbing requirements for staff entering the hazardous drug (HD) compounding area as well as the requirements for staff entering the non-HD compounding area.
- PPE for Auxiliary Staff. Define what PPE is required for non-pharmacy personnel who enter the compounding area. For example, if the environmental services department will provide cleaning services, specify what PPE they must wear. In addition, maintenance workers may occasionally enter the compounding area to perform activities such as changing filters or repairing a sink. P&Ps must delineate proper garbing for staff performing these tasks as well.
- Doffing PPE. It is not uncommon for an organization to detail correct donning procedures in P&Ps but to neglect doffing procedures. Specify how and where doffing should occur and when. For example, PPE used during HD compounding must be doffed prior to leaving the HD compounding area.
- PPE Disposal and Reuse. Detail how garb is to be safely disposed. PPE used for HD compounding must be disposed of in specific waste containers. Be sure the P&P also addresses reuse of PPE; garb such as gowns, gloves, and booties used for HD compounding cannot be reused, and this should be clearly spelled out. For non-disposable reusable PPE, such as goggles and respirators, policies should address cleaning and storage of these items.
PP&P: What information should be included in a P&P for cleaning and disinfecting the cleanroom?
Murdaugh: P&Ps for cleaning and disinfecting should be comprehensive, specific, and include detailed descriptions of cleaning and disinfection activities for each area. P&Ps should include the following:
- All Areas Requiring Cleaning and Disinfecting. Specify each area (eg, hood, floors, walls, etc) and the items in the areas (eg, furniture, equipment, supplies) that must be cleaned and/or disinfected, and delineate the order in which they are to be cleaned and the cleaning frequency.
- Equipment to Use. Define the types of equipment that are to be used for cleaning, including how and where they are used. For example, mops used to clean HD compounding areas should be dedicated to that area and not taken into or used in any other area.
- Cleaning Agents. Delineate which cleaning agents are to be used for which surfaces. If agents must be prepared or diluted, include this process in the P&P. Specify how to apply the cleaning agent. For example, in some areas a spray product may be used; however, in the HD compounding area spray products should be avoided to prevent aerosolization and spread of HD residues.
- PPE Use. Describe what PPE must be worn during cleaning and disinfecting, including garb and protective equipment such as goggles.
- Responsibility for Cleaning Activities. Define who is to perform the cleaning activities. Although it is permissible for properly trained environmental services staff to perform cleaning activities, best practice dictates that sensitive equipment, such as primary engineering controls (hoods) and automated compounding devices, be cleaned only by appropriately trained pharmacy staff.
- Disposal and Storage of Cleaning Equipment. Specify how disposable cleaning equipment, such as wipes and mop heads, are to be disposed, and indicate how reusable items, such as goggles and mop handles, are to be cleaned and stored.
- Documentation Process. Cleaning activities must be documented. Be sure an easily retrievable record is available.
PP&P: How does training impact ongoing compliance with hand hygiene, garbing, and cleaning and disinfecting practices?
Murdaugh: Per USP <797>, effective training requires both didactic and experiential elements. Training processes should be standardized throughout the organization to ensure staff duties are consistently performed.
The didactic portion must be knowledge-based and include all the basic principles of hand hygiene, garbing, cleaning, and disinfecting. Staff should read and understand the organization’s sterile compounding P&Ps. Many organizations utilize printed materials, recordings, and Web-based elements in their didactic training process.
Experiential training comprises hands-on demonstrations of the required tasks. The person providing this training must be qualified and competent to perform sterile compounding. After each skill is demonstrated, the trainee in turn must demonstrate the skill. It is not sufficient for the trainer to simply display the correct procedure; the trainee must demonstrate that he or she can perform the activity correctly.
Moreover, ensure that all training processes include opportunities for timely feedback and mentoring. The trainer should review the results of written tests with the trainee, explain the correct answers to any questions answered incorrectly, and actively seek feedback from the trainee. When assessing skills, the trainer should offer feedback when the trainee performs the skill, providing positive feedback on the activities done correctly and explaining and demonstrating the correct practices for activities needing improvement. For example, when assessing donning of garb, the assessor could ask the trainee to select and don the appropriate PPE for entering the HD compounding area.
PP&P: What are the key components to include in a competency assessment for hand hygiene, garbing, and cleanroom cleaning?
Murdaugh: A staff competency assessment should cover all the elements necessary to properly perform hand hygiene, PPE donning and doffing, and cleanroom cleaning and disinfecting activities. The overarching purpose of a competency assessment is to evaluate staff’s understanding of the principles behind best practices, ascertain their knowledge of the facility’s specific hand hygiene, garbing, and cleaning P&Ps around sterile compounding, and to ensure they actually perform the activities according to defined expectations.
USP <797> requires initial and periodic competency assessments that include both a didactic and an observational evaluation. Hand hygiene and garbing competencies must be assessed at least annually for personnel compounding low- and medium-risk preparations and semiannually for high-risk compounding. Cleaning competencies must be assessed at least annually. However, it is important to note that state board of pharmacy regulations (or other state regulations) may dictate more frequent assessments. The method of assessment should be appropriate for each of the elements of performance being assessed and reflect actual application of knowledge and skills.
For the knowledge element, staff must complete a written test. For the skill-based assessment, direct observation of activities is required. A good way to accomplish this is to develop a checklist for the assessor to notate as the staff member performs each skill. Utilizing a checklist ensures standardization and consistency of competency assessments for all staff members.
The person conducting the competency assessment must be trained and competent to perform that activity, preferably someone who routinely works in the area and performs the activities under evaluation. For example, if environmental services staff performs cleaning activities in the compounding area, someone who works in the compounding area should conduct their competency assessments.
Documentation is a key component of the assessment. Commercial software programs are available that assist in competency documentation, and some organizations use spreadsheets. Regardless of the method used, be sure to include all the elements of performance that are assessed in the competency assessment. The checklist approach can be especially helpful in ensuring proper documentation occurs.
Be sure to include the date and the reason for the assessment. For example, is it an initial training assessment, a routine annual/semiannual assessment, or a re-evaluation due to deficiencies noted in a previous assessment or unacceptable results from personnel monitoring (eg, media fill and gloved fingertip tests) or environmental monitoring (eg, surface testing)? Detail the method or methods used to assess competency. Document the outcomes of the assessment, any recommendations resulting from the assessment, areas for improvement, or if a certain element or a reevaluation is needed in the future. Finally, note who performed the assessment and indicate when the next assessment is due.
In addition to formal competency assessments, personnel should be observed on an ongoing basis and corrective actions taken and documented when incorrect practices are noted.
Lee Murdaugh, BS Pharm, PhD, is director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions. She is the author and editor of the American Society of Health-System Pharmacists (ASHP) publication Competence Assessment Tools for Health-System Pharmacies and co-author of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide. Lee’s experience also includes providing USP <797> and <800> expertise and support to pharmacies.
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