USP 797 - Personnel Training, Evaluation, Hygiene, & Garbing

contamination risks

• USP <797> applies to anyone who is directly or indirectly involved in sterile compounding activities, since each of these roles can impact the quality of the preparation

• humans shed squamous cells at a rate of a million per hour every day and many of those particles are “viable” particles

• viable particles are the particles with at least one microorganism-like bacteria, mold, and fungi that may lead to contamination or infection, affecting the sterility of a preparation

• nonviable particles are the particles without microorganisms that act as a transporting agent for viable particles

• personnel in the sterile compounding area without proper training pose a serious risk of contaminating compounded sterile preparations by enhancing the count of living microorganisms known as the bioburden

• USP <797> standards help to ensure that patients receive quality preparations that are free of contaminants and are consistent in the intended identity, strength, and potency

• USP <797> provides the minimum requirements regarding personnel training and evaluation that all compounding facilities must follow

• it is the compounding facility’s responsibility to have standard operating procedures, or SOPs, to ensure that the appropriate training is provided

• facilities must also comply with the requirements of USP <797> and laws and regulations of the applicable regulatory jurisdiction

designated person(s)

USP <797> standards for personnel training requirements:

• the compounding facility must designate one or more individuals are designated person(s) to be responsible and accountable for:

  • the performance and operation of the facility

  • the personnel in the preparation of CSPs

  • the personnel performing other functions as described in USP <797>

• a designated person must oversee the training of personnel. training and observation may be performed by the designated person(s) or an assigned trainer

• the designated person(s) must ensure that any person who enters the sterile compounding area maintains the quality of the environment

personnel training program

USP <797> training requirements:

• each compounding facility must develop a written training program that describes:

  • required training

  • frequency of training

  • process to evaluate the performance of an individuals involved in preparing CSPs (including those who compound and have direct oversight of compounding personnel and who perform in-process checks, final verification, and dispensing of CSPs)

• this program should equip personnel with the appropriate knowledge and should train them in the skills necessary to perform their assigned tasks

• designated person(s) must oversee the training program

• training and evaluation of personnel must be documented

• if the facility has only one person in the compounding operation, that person must document that they have obtained training and have demonstrated competency

overview of USP <797> training requirements

• before being allowed to perform their job functions independently, all personnel who compound or have direct oversight of compounding must:

  • complete training initially and at least every 12 months in appropriate sterile compounding principles and practices as described in USP <797>

  • perform a garbing competency evaluation and an aseptic manipulation competency evaluation

• personnel who perform only restocking or cleaning and disinfecting duties outside fo the PEC must be initially trained and demonstrate competency in maintaining the quality of the environment in which they are performing their assigned task

  • at a minimum, these personnel must meet the requirements for personal hygiene and garbing that are described later in this module

  • they must also complete ongoing training as required by the facility’s SOPs

• any other personnel accessing the compounding area must at a minimum meet the requirements for personal hygiene and garbing. they must also complete ongoing training if required by the facility’s SOPs

which of the following statements is false per USP <797> standards?

a) if fully trained in USP <797> standards for training, personnel preparing the CSP do not require future training to ensure quality sterile compounding

b) facilities must have a written training program that describes the process for evaluating the performance of individuals involved in preparing CSPs

c) personnel who prepare CSPs must complete training at least every 12 months in appropriate sterile compounding principles and practices

d) personnel who perform restocking cannot be permitted in the sterile compounding area, when no compounding is taking place, unless they are trained as defined by the facility’s SOPs (e.g. personal hygiene and garbing)

a

Sharon, an assigned trainer at Cityville Hospital, has just completed a review of the USP <797> training procedures with Mike, the new pharmacy technician she is onboarding. Sharon is now planning to perform compounding, Mike is confident and eager to start helping in the cleanroom. Sharon is also available to help him with any questions he may have. what is the appropriate action for Sharon and Mike?

even though Sharon is assigned trainer, she must still follow the compounding facility’s written training program when training Mike

competency of core skills

proficiency in following core competencies must be demonstrated at least every 12 months:

• hand hygiene and garbing

• cleaning and disinfection

• calculations, measuring, and mixing

• aseptic technique

• achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile components)

• use of equipment

• documentation of the compounding process (e.g., master formulation records, compounding records)

• principles of high-efficiency particulate air (HEPA)-filtered airflow

• proper use of primary engineering controls (PECs)

• principles of movement of materials and personnel within the compounding area

demonstrating competency in core skills

• all compounding personnel and personnel who have direct oversight of compounding must demonstrate proficiency in the core competencies, hand hygiene, garbing, and aseptic technique before they are allowed to perform sterile compounding independently

• demonstrating competency in garbing and hand hygiene:

  • visual observation while garbing

  • gloved fingertip and thumb sampling on both hands

  • initially, personnel must successfully complete three competency evaluations in a row

  • each of the three initial competency evaluations must occur after performing a separate and complete hand hygiene and full garbing procedure

  • for personnel compounding category 1 and 2 CSPs, the competency must be repeated every months

  • for personnel compounding category 3 CSPs, the competency must be repeated every 3 months

  • personnel who direct oversight of compounding personnel but do not compound must complete a garbing competency evaluation every 12 months. the evaluation should correspond to the type of garbing activities of the personnel they oversee

gloved fingertip and thumb sampling

successful completion of gloved fingertip and thumb sampling is defined as zero colony-forming units

USP <797> action levels for gloved fingertip and thumb sampling results:

aseptic technique

• aseptic technique is a set of methods used to keep objects and areas free of microorganisms through practices that maintain the microbe count as an irreducible minimum

• competency testing in aseptic technique:

  • demonstrate competency in aseptic technique before preparing CSPs for patient use

  • all compounding personnel and personnel who have direct oversight of compounding must perform a competency assessment in aseptic manipulation

  • for personnel compounding category 1 and 2, this must occur initially and every 6 months

  • for personnel compounding category 3, this must occur initially and every 3 months

  • personnel who have direct oversight of compounding personnel must complete an aseptic manipulation competency evaluation annually. the evaluation should correspond to the type of activities of the personnel they oversee but does not require the same quantities

  • consists of visual observation and media-fill testing followed by glove fingertip and thumb sampling and surface sampling

aseptic compounding: media-fill tests

• media-fill tests verify the skill of personnel to aseptically prepare compounded sterile preparations without introducing microbial contamination

• simulate the most difficult and challenging compounding procedures

• replace all the components used in the CSPs with soybean-casein digest media

• the simulation must capture elements that could potentially affect the sterility of the CSP, including but not limited to:

  • factors associated with the length of the process that can pose contamination risk, such as operator fatigue and quality of equipment

  • number of aseptic additions or transfers

  • number, type, and complexity of manipulations

  • number of personnel in the buffer room or SCA

• media-fill failure is indicated by visible turbidity of other visual manifestations of growth

• gloved fingertip and thumb sampling must be performed inside of an ISO class 5 PEC after media-fill tests

• surface sampling of the direct compounding area must occur after the media fill

• a failure in the media fill, gloved fingertip and thumb sampling, or surface sampling constitutes an overall failure of the aseptic manipulation competency

• upon successful completion of the aseptic manipulation competency, personnel are allowed to prepare compounded sterile preparations independently

competency assessments for core skills

documentation of completion of competency assessments by personnel in garbing, hand hygiene, and aseptic technique testing must be done per USP <797> requirements

• results of the evaluation and corrective actions, in the event of failure, must be documented

• documentation maintained to provide a record and long-term assessment of personnel competenncy

• documentation must at a minimum include:

  • the name of the person evaluated, evaluation date and time

  • media and components used (e.g., manufacturer, expiration date, and lot numebr)

  • starting temperature for each interval of incubation and dates of incubation

  • the results, and the identification of the observer and the person who reads and documents the results

sharon, an assigned at Cityville Hospital, must ensure that her pharmacy technician trainee, Mike, is appropriately tested for competency in garbing, hand hygiene, and aseptic technique following USP <797> requirements. place the steps she must take in chronological order from first (step 1) to last (step 6) by clicking, holding, and dragging your selections up and down the list.

1. mike washes his hands and dons garb and gloves three separate times while sharon observes his technique and provides feedback

2. mike performs media-fill testing to demonstrate sterile technique and aseptic practices

3. sharon documents the visual audit of the media fill and the results of the GFT sampling, surface sampling, and media-fill testing. if mike fails any of these steps, sharon documents appropriate corrective actions.

4. each time after garbing and gloving, mike performs gloved fingertip and thumb (GFT) sampling

5. sharon documents the visual audit of hand hygiene and garbing and the results of the GFT sampling after garbing

6. immediately after the media fill, mike completes a GFT sampling and surface sampling of the direct compounding area

1, 4, 5, 2, 6, 3

personal hygiene

factors that must be controlled to prevent CSP contamination:

• personal hygiene

• health conditions

• hand hygiene

• aseptic technique

personnel must be trained in:

• aseptic techniques

• personnel preparation

• hand washing procedures

• gloving

• garbing

entering a compounding area

• individuals entering a compounding area must maintain proper personal hygiene

• personal conditions that may increase the risk of contamination of the CSP include but are no limited to:

  • rashes

  • recent tattoos

  • oozing sores

  • conjunctivitis

  • active respiratory infection

• personnel must report these conditions to the designated person(s). the designated person(s) is responsible for evaluating their conditions because of the risk of contamination

personal hygiene—minimizing risk

• items not needed for compounding should not be taken into or left in sterile compounding areas

• personal items that cannot be easily cleaned should not be taken into sterile compounding areas. these items can shed viable and nonviable particles or may compromise the integrity of garb

• personnel preparation for entering into sterile compounding areas include:

  • removing personal outer garments and all cosmetics

  • removing all hand, wrist, and other exposed jewelry including piercings

  • covering any jewelry that cannot be removed

  • not wearing earbuds or headphones

  • not bringing electronic devices that are not necessary for compounding

  • keeping nails clean and neatly trimmed and not using nail products

  • wiping eyeglasses, if worn

• the designated person(s) may permit accommodations as long as the quality of the CSP and environment will not be affected. accommodations must be documented

hand hygiene requirements

• improper hand hygiene poses the danger of contaminating CSPs

• cleaning, sanitizing, and gloving hands is critical

  • personnel must wash hands and forearms up to the elbows with soap and water

  • brushes and hand dryers must not be used for hand hygiene

  • disposable soap containers must not be refilled or topped off

hand washing, sanitizing, and gloving

all personnel entering the compounding area must follow hand hygiene procedure as described by USP <797> standards.

hand washing procedure:

• remove visible debris from underneath fingernails under warm running water using a disposable nail cleaner

• wash hands and forearms up to the elbows with soap and water for at least 30 seconds

• dry hands and forearms to the elbows completely with low-lint disposable towels or wipers

hand sanitizing procedure:

• apply an alcohol-based hand rub to dry skin following the manufacturer’s instructions for the volume of product to use

• apply product to one hand and rub hands together, covering all surfaces of hands and fingers

• hands must be thoroughly dried before donning sterile gloves

knowledge check

false: a designated person may allow accommodations to personal preparation if she determines that the quality of the CSPs and environment will not be affected. these do not need to be documented

true: personnel must wash hands and forearms up to the elbows with soap and water for at least 30 seconds

false: skin particles shed from healthy human bodies never includes microorganisms

true; hand dryers are not allowed to be used to dry hands

gloving and garbing

USP <797> requirements for gloving:

• gloves used for sterile compounding must be sterile and powder free

• application of sterile 70% isopropyl alcohol (IPA) to gloves must occur:

  • immediately before compounding

  • throughout the compounding process

• all gloves must be inspected for holes, punctures, or tears and must be replaced immediately

• sterile gloves must be donned in a classified room or segregated compounding area (SCA)

• skin must not be exposed inside the ISO class 5 primary engineering control (PEC)

restricted-access barrier system (RABS):

• sterile gloves must be worn over gloves attached to the RABS sleeve

• manufacturer’s recommendations and facility’s SOP must be followed for changing the sleeves and gloves

• disposable gloves (e.g., nonsterile, sterile) should be worn inside gloves attached to the RABS sleeves)

the ordering of garbing

USP <797> requirements for garbing:

• any person entering a compounding area must be properly garbed in accordance with the facility’s SOPs

• the order of garbing must be determined and documented in the facility’s SOPs

• garb must be donned and doffed in an order that reduces the risk of contamination

• donning and doffing garb should not occur in the anteroom or in the SCA at the same time

• garb must be replaced immediately if it becomes visibly soiled or if its integrity is compromised

• gowns and other garb must be stored to minimize contamination (e.g., away from sinks to avoid splashing)

• garb, except for gowns, cannot be reused and must be discarded

• if compounding only category 1 and 2 CSPs, gowns may be reused within the same shift if the gown is maintained in a classified area, such as in a buffer room or an anteroom, or is adjacent to or within the SCA in a manner that prevents contamination

• the facility’s SOPs must describe disinfection procedures for goggles, respirators, and other reusable equipment

additional garbing requirements for category 3 CSPs

• no exposed skin is allowed in the buffer room (i.e., the face and neck must be covered)

• all low-lint outer garb must be sterile, including the use of sterile sleeves over guantlet sleeves when a RABS is used

• disposable garb must not be reused, and laundered garb must not be reused without being laundered and resterilized with a validated cycle

• the facility’s SOPs must describe disinfection procedures for goggles, respirators, and other reusable equipment

minimum garbing requirements

• covers for head

  • low-lint covers for the head that cover the hair and ears should be used. if applicable, disposable cover for facial hair should be used

• goggles

  • the entire face and neck must be covered if compounding category 3 CSPs

• face mask

  • a low-lint face mask in also required by USP <797>

• gloves

  • gloves should be sterile and powder free

• gowns or coveralls

  • garments, such as gowns or coveralls, with sleeves that fit snugly around the wrists and that are enclosed at the neck

• show covers

  • low-lint covers are necessary for shoes

mike observed sharon while she was preparing parenteral nutrition using an automated compounding device within the ISO class 5 PEC. sharon accidentally splashed lipid emulsion on her gown and gloves. mike brought her a fresh pair of gloves as she prepared to clean up the workstation. select the appropriate option(s) for sharon from the following choices that align with USP <797> requirements for gloving and garbing. be sure to choose all that apply.

a) sharon needs to change gown, gloves, and any other visibly soiled garb before she continues compounding

b) sharon should change gloves immediately in the ISO class 5 workstation if compounding is done and she is cleaning the station

c) sharon must go to the anteroom to change her gown before she continues compounding. she may then don a new pair of gloves in the anteroom or buffer room

d) sharon should follow doffing and donning order per her organization’s SOPs

e) sharon finds out that they have run out of sterile gloves. she may use powder-free nonsterile gloves only after thoroughly sanitizing them

a, c, d