4th National Symposium on Biosafety

Quality Assurance Techniques in Animal Facilities

Thomas Darby
Lab Products, Inc.
3606 Ridgebriar Dr.
Dallas, TX 75234

My presentation this morning will consist of three areas: First, this presentation is limited to 20 minutes but we will have more time during the break-out sessions after the morning presentation to discuss areas of interest that may include: simple techniques such as adding mineral oil to urine collection vessels on metablic cages to prevent evaporation of the urine or applying Pam or RainX to the funnels of metabolic cages to prevent urine from sticking to the funnel, the indiscriminate usage of "sample" chemicals, how to use specialized caging systems such as cubicles effectively, the monitoring of environmental controls and automatic watering, new developments in animal identification techniques, etc. Second, the main emphasis of this presentation will be documenting that animal care personnel are properly trained in, and understand, their job responsibilities, and third, a little about the use and misuse of ventilated caging systems.

And with that, I will go ahead with my first slide which is of an animal technician working in an animal room. This is where QA starts in an animal facility – with people at the bottom of the organizational chart. Now what is interesting about this is that the technician in this slide is often among the lowest paid and least educated employees in your institution. But, they are exposed to everyone of the hazards that you have heard previous speakers discuss, often on a daily basis. In addition, any mistakes that they make with the lab animals will introduce unknown variables into the research study.

And so, one of the concerns that I will address today is how to document and verify that technicians can actually perform the job tasks for which they have been trained. Nearly all facilities using laboratory animals have implemented training programs for their animal care personnel. However, all too often, it is assumed that a technician knows how to do their job properly simply because they sat through some classes on animal care or they passed an examination. Such assumptions may be a major source of problems in an animal facility.

Animal technician training programs run the gamut from simply taking a new technician into an area and telling them what to do through very sophisticated class room or videotaped programs that require significant contributions of time and monies. However, the effectiveness of any training program can only be assured by physically documenting the technicians performance in the work environment. To do this I recommend that each facility develop and use three forms as follows:

A Training Checklist form that lists all of the job responsibilities for each area of responsibility in an animal care facility. I helped develop the checklist shown in this slide while at the University of Texas Southwestern Medical Center at Dallas in the mid 1980's. We attempted to identify all work areas within the animal facility such as: clean cage wash room, dirty cage wash room, bedding storage area, animal receiving, species specific animal rooms, specialized animal care areas (i.e., SPF, breeding, biohazard), weekend duties. Then we listed all of the duties required in each specific work area. From this a checklist was devised that allowed the animal technician, the technician's trainer and the animal care supervisor to note when a technician had demonstrated the ability to perform a specific job function. This checklist was kept in the technicians personnel file and that technician was only allowed to work in areas where the technician initialed that they understood the duties and both the supervisor and trainer had initialed that they had seen the technician demonstrate proficiency in the task.

Each area covered in this checklist listed all of the work responsibilities for that area. For example, a technician working in a rabbit room would need to demonstrate: an understanding of the SOP for that room, know when and how to clean the floors; when and how cages were to be changed; when and how excreta pans were to be changed/cleaned; when and how to clean walls, air handling vents, sinks, etc; how to check light timers; when and how to do the animal census; ho to complete animal ID cards and special instruction tags (such as sick/dead animal reports, special feed tags, special water tags), able to handle animal properly, checks nails and teeth, and operation of automatic watering system. Once the technician demonstrated an ability to perform all of these duties he/she would be allowed to work in that area but not in other areas until checked off for that area.

I left the Univ. of Texas Southwestern Medical Center in late 1989, but they have continued to update and improve this checklist since then to where it is so extensive that it takes up nearly 19 type-written pages and covers virtually every job responsibility in the operation of an animal care facility. In addition, since the Univ. of Texas Southwestern Medical Center is so large, they have taken this a step further and developed the wall chart shown in this slide listing the general work areas for the animal care operation and which technicians have demonstrated proficiency in each area. An obvious benefit from this wall chart is that supervisors can easily see who has demonstrated proficiency in a given work area when they are making work assignments. But another less obvious benefit is that it creates a little peer pressure on the animal care technicians because it is obvious to everyone who has, and has not, demonstrated proficiency in each work area.

Another form that should be used widely is the SOP. In this day and age there are very few animal facilities that do not have Standard Operating Procedures for the various work areas in the animal facility. This can be one of your most helpful quality assurance tools if used properly. l recommend that a copy of every SOP be laminated and posted in an obvious place in each work area. This then allows anyone entering that area to note what work is to be done in that area, and when, and to report any discrepancies to the animal care supervisor. For example, if an investigator enters a rodent room at 4 in the afternoon on cage changing day and notices that the cages have not been changed then they can notify the supervisor of a potential problem. By posting SOP's in animal care areas you allow everyone entering that area to be aware of what activities are to take place and when. This then lets all of these people become involved in the monitoring of the care of the animals and minimizes the possibility of misunderstandings or of problems going undetected .

The third and last form is a standardized animal room inspection checklist that is also used at the Univ. of Texas Southwestern Medical Center in Dallas. I recommend the use of such a standardized checklist for two reasons. First it gives the supervisor a method to insure that every room is inspected in the same manner (and makes sure that some items are not overlooked). Secondly copies may be given to animal care personnel to make sure they are aware of what will be checked on weekly animal room inspections. Completed inspection checklists are kept on file for a prescribed period of time and inspections which identify problems in an area may be kept in the employee files or elsewhere.

One hint that I can give you here is that consideration be given to using color coded special instructions card and animal ID cards. Color coded cards are a lot more obvious than simple notations on animal cage cards and they allow anyone entering an animal room to notice immediately where special care is to be given. This is especially important where there are employees with reading or language barriers. While this might seem pretty simple, it should be kept in mind that most mistakes are made on the simplest tasks. Tasks that require the least forethought are usually the ones where problems occur most frequently.

Let me talk about the use and misuse of ventilated caging systems. As Dr. White mentioned earlier there has been an increasing demand for ventilated caging systems during the past decade. These include workbenches, laminar flow units, clean rooms, biocontainment cabinets, ventilated micro-isolators, cubicles, etc. What becomes obvious is tha there are a lot of different systems in use today. Some new, some old and many being misused. Most of the ventilated caging systems have a distinct purpose and most of them work for their intended purpose - but when misused they may be ineffective or even dangerous. For example this slide shows a positive pressure laminar flow cabinet for housing rodent cages. It works well for for housing clean animals by HEPA filtering air and blowing this air across the caging. However, while providing good animal protection this unit does not provide any protection whatsoever for animal care personnel. Whatever is in the animal s cage environment is being blown directly into the face of anyone standing in front of the unit. Animals exposed to biohazards should not be routinely housed in such units and personnel with allergies to animals should not work in areas with positive pressure laminar flow units without taking protective measures such as the use of respirators. Negative pressure laminar flow units, on the other hand, protect personnel by drawing air from the room across the animals cages and HEPA filtering the air before it is returned to the room. These units provide reasonable protection for animal care personnel but do not provide any protection for the animals.

Positive pressure (relative to the room) workbench/hood or other models are available that operate under negative pressure or that have recapture systems. In addition, the air flow in these units may be either horizontal or vertical and all of these factors have an effect on how the unit will perform. To determine which unit is best for you, you must look at each unit to see how it will satisfy your specific needs. Air flows along the path of least resistance similar to water flowing down a stream. When the water hits an obstruction it goes over, under or around the obstruction and in doing so creates ripples, currents, eddies and swirls. Air does the same when it hits an obstruction such as a technician's arms, animal cages, animals, etc. While an air flow diagram indicates the ideal airflow of a piece of equipment, the real air flow is determined by how, when and where the equipment is used. You have to make the decision as to what best suits your specific needs. Smoke tests may be helpful in determining air flow patterns under actual working conditions. Also, one common misconception is that biohazard cabinets can be portable. By definition, a true biohazard cabinet must be certified prior to operation. However, if the cabinet is moved, it must be recertified prior to use — the reason for this requirement for recertification after each move is that the movement of the unit to another area or a new room location may affect the seals of the HEPA filters.

Another commonly used piece of ventilated caging equipment in the cubicle. These are made by a number of manufacturers and come in fixed, mobile or relocatable units. The older style cubicle was usually built into a room that would hold 4 to 6 cubicles. The cubicle doors were either telescoping or front opening. Air was supplied through vents in the ceiling above the common corridor in the room and exhausted through exhaust vents inside of each cubicle. Therefore, the air came down to the floor level of the room and was drawn under the door of the cubicle and exhausted out through the ceiling of the cubicle. This system allowed for some potential cross contamination between cubicles. Later cubicles incorporated air handlers into the cubicles with air supply vents in the cubicle ceiling and exhaust vents near the floor. Later designs provided a little more protection from cross contamination than the older style units, but there is still a significant problem area. That is the shared corridor between cubicles which remains a major source for cross contamination. To best use the cubicle system a procedure must be devised where no two cubicle doors in one room can be open at the same time and the cubicle corridor should be disinfected between each cubicle opening. One method that has worked is to hang a key the room door outside the room. Anyone entering the room must remove the key, open the door and take the key into the room with them. After finihing in their cubicle, they close the cubicle, disinfect the room floor, leave the room and rehang the key outside. This procedure keeps two groups of people with different cubicles from being in the cubicle area at the same time. Portable type cubicles produced by different manufacturers operate in basically the same manner.

Obviously I am running out time and will have to finish this part of the presentation. But the main point with which I would like to leave you about ventilated caging systems is not to take anything for granted. If you are going to use ventilated equipment in your animal facility, whether new or old equipment, please take the time to examine it and make sure that 1) it will work properly for your needs and 2) that it will not jeopardize the health of your personnel or animals.

Quality Assurance Techniques in Animal Facilities Breakout Session
Rapporteur: Christopher S. King, DVM Director of Animal Resources College of Arts and Sciences C126 Life Sciences Bldg. The University of Georgia Athens, GA 30602-7228 706-542-6084

As with many endeavors it may be best to start our short discussion this morning on quality assurance techniques by starting with the end in mind. In the first of my quotable quotes from Tom Darby this morning will be our take home message from our sessions yesterday. And that is we really need to watch the simple things. Its the simple things the get screwed up the most.

Animal facilities must function effectively at many different levels to assure that we realize the goal of producing safe, reproducable research. Using healthy animals while keeping the people who work with these animals healthy as well. The resources we depend on to assure safe and high quality animal research are facilities, equipment, leave and material, and the personnel. As a laboratory animal veterinarian I come with a prejudice that I'm sure that many of you are guilty with. I spend an inordinate amount of time worrying about the first two items on this list. Our facilities, and the equipment and material, but really not enough time worrying about the personnel. I think if I hire good people, train them and set them to a task, that they're going to accomplish it flawlessly. I spend a lot of my time worrying about making sure our facilities are at the proper temperature. That the light cycles are appropriate. That our air handling is functioning appropriately. As far as our equipment and material, I often worry about whether or not our autoclaves are functioning as they should. Whether they've been certified recently. Whether our cage washers are reaching appropriate temperatures. Assuring that our feed has appropriate milling dates. Making sure that we're getting clean aniamals into animal facilities and keeping them clean. Are our biosafety cabinets operating correctly? Are our respirators working well?

But our session yesterday with Tom reminded that without properly trained personnel the best facilities and equipment in the world are essentially worthless. So the proper training of personnel has been a key and repeated theme during this symposium. All aspects of working safely with animals requires proper training. The safe, effective, handling of research animals. Proper management of chemical and physical hazards. Sound operation of containment devices and efficacious application of sanitation and decontamination procedures. All require properly trained personnel.

But what exactly is proper training? That was the core of yesterday's presentation and breakout session. It simply is not enough to expose people to the necessary information that they need to do their jobs. Neither in a classroom situation, nor just saying "go review these SOP and that's how you do your job" will do. We need to go a lot further in the proper training of our personnel. Additionally, effective training also requires monitoring performance. Validating this performance. And documenting the validation of this performance. So how do we go about documenting that procedures that we taught are actually, and trained for, are actually being performed appropriately? Now Tom Darby has suggested using a form which is essentially an extensive checklist which covers every category of work or task that needs to be accomplished in the animal facility. There are species specific categories. SOPS are on this list. Once a particular procedure is mastered, the checklist is then initialed by the trainee, the trainer, and the supervisor. The checklist can then be filed in the employee's record where it can also function as a evaluation tool and as a legal document.

Another tool that Tom recommended using was a marker board and posting in a obvious place in the facility with the technicians names along one side and procedures which need to be validated along the other side. As the procedures are validated they're checked off and this provides a visible means of tracking progress of your personnel and also serves to motivate personnel. This is a very simple and effective management tool. At a quick glance you can really see where your gaps are in the training and the personnel can see that too.

Training does not stop with the simple acquisition and validation of a technique however. There must be routine, formal follow-up and monitoring. The monitoring of performance should be a multi-level process performed by the technicians, by investigators, by research technicians, managers, and facility veterinarians. This results in necessary checks and balances.

This is another technique that aids in this process. These are the posting of SOPs in the facilities and areas where particular procedures are perfomed. Such as posting a SOP for room sanitation at the room where the SOP for feeding or sanitizing cages in the room where its actually performed. Posting an SOP for operating an autoclave or cage washer right next to the autoclave or cage washer. So the personnel who are monitoring that process can actually see what the correct procedure is that needs to be followed.

That leads me to my second quotable quote fom Tom Darby this morning. Someone who does not value effective performance evaluation does not understand the value of their work. In the breakout session it became clear in our discussion at least, that decreasing support for animal resource programs is adversely effecting the way we train our personnel.

The decrease support of animal resource programs or research programs using animals leads to a decrease in salary. These decreases or flatened salaries lead to increased turnover of our personnel and this dramatically increases our training needs in our animal facilities. At this point this discussion evolved into a discussion of ways to retain these trained employees. How do we keep these people on board? We've spent so much time and money training them, validating their training, how do we keep them here? There were a number of excellent suggestions by participants in our breakout session.

The first was to offer benefits above and beyond what they normally get in their salary. Some suggestions were education, let them go to classes if you can provide that sort of benefit. Get them certified. Send them to certification courses. Another suggestion was positive incentives. If they perform adequately, they exceed in their work place, send them to a seminar. Show them you appreicate their work. A third suggestion was to enfranchise and empower your personnel. And this was a theme that was repeated in many other breakout sessions I attended. Let your people know how important their job is in the great big scheme of things. Another suggestion was principle investigator seminars. Have your investigators come talk to your personnel. Tell them in lay terms what they're doing and why their job is so important in what they do.

The last suggestion, was recognition of the technicians by the investigative staff. Tom Darby mentioned a Noble Laureate that sent letters to animal care staff after he had been presented with his award telling them how much he appreciated their work and how much they contributed to his success. So to summarize, quality assurance allows us to avoid problems and errors. Assuring quality performance requires proper training which includes formal monitoring, validating, documenting, and follow up. Using these techniques we can effectively deal with those simple things that we tend to screw up the most.

Office of Health and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road N.E., Mail Stop F05 Atlanta, Georgia 30333, USA Last Modified: 1/2/97
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Quality Assurance Techniques in Animal Facilities