4th National Symposium on Biosafety

Controlled Access

Timothy D. Mandrell, DVM
Assistant Professor
Dept. of Comparative Medicine
University of Tennessee, Memphis
956 Court, Box 17
Memphis, TN 38163
901-448-5656

What is controlled access? Well, controlled access is the management of limited, knowledgeable and informed restrictive access for selected animal research facilities. Why is there a need to have controlled access in our facilities? Its required per the CDC guidelines. The BMBL Manual states that for animal biosafety levels 1, 2 and 3 as a standard practice access to the animal facility should be limited or restricted at the discretion of the facility director. Furthermore the laboratory director restricts access to animal rooms and to personnel who have been advised of the potential hazards and personnel who need to access those animal areas for programmatic or for service reasons. In addition, the lab director establishes policies and procedures so that only personnel who have been advised of potential risks and hazards and those personnel who meet the specific requirement such as inclusion in employee health surveillance program may enter the room. Another primary reason why we might need controlled access is for security purposes.

So what are the goals and objectives for controlled access? Our first objective is the need to accommodate research personnel so that they can conduct their research in a secure environment. I think a second objective for controlled access is to keep unauthorized personnel out. If there is not a direct need for access to that facility or the animal room then individuals should not be permitted access. If you're in an academic or a teaching institution where you have students working with investigators on projects, you always have a problem of the curious student. Maybe they want to see where the monkeys are. Maybe they want to see the baby pigs. Its not malicious, it may be unintentional but that's an example of keeping people out who don't need to be in certain areas.

Sometimes we also run into situations where an investigator may be looking for a clean cage or a water bottle. They don't want to go downstairs to the clean cage room, so maybe they take a shortcut and go into the next room. Well the next room might have a biohazard in it. Again its not malicious. Its unintentional, its innocent. But by having a controlled access system you can prevent some of these things.

I think our third goal for controlled access is to help limit the exposure to biohazardous agnts or hazardous situations. So only personnel trained in appropriate procedures and safety precautions and are aware of the hazards are permitted access to particular areas.

Last but not least I think one of our objectives for controlled access is an adjunct for containment of hazardous agents. The BMBL requires a laboratory director to establish policies and procedures governing access to the animal rooms when biohazards are used. I think that policy and procedures should be a primary tool for coordinating or restricting access into an animal facilities or animal areas.

In addition, there are physical barriers or physical devices which include all the types of devices (locks, keys, etc.) that allow you to permit access to only selected individuals. Along that same line is the intelligent or the smart use of these hardware devices so that these devices are used in conjunction with good management practice.

There are several physical barriers for keeping people out or accessing only the people that we wish to enter the facility. First and foremost is a simple lock and key system. Put a lock on the door, issue keys only to those personnel who need access to that particular area. Access is restricted to those personnel who have been issued the key or other tool to gain access into that particular area.

Posted signs. Although these technically aren't a physical barrier they can serve as a warning or a deterrent to keep unauthorized personnel out. They also serve as a method for informing potential hazards associated with those particular areas. Another option for controlling access is the use of security personnel or other types of personnel or measures which rely on communication with an individual to grant access to that area. This could include everything from the posting of the security guard at a particular area or a telephone intercom system in which the caller identifies himself and the person on the inside then buzzes that person and allows access.

Security personnel can be used in conjunction with some more advanced techniques such as closed circuit TV. The BMBL requires that at animal biosafety levels 2 and 3 a hazardous warning sign be posted which indicates special requirements for entering those particular rooms. Additional signage that may be useful in your facility include things like posted signs in particular areas – "do not enter", "restricted area", "authorized personnel only". Signs may deter a curious visitor or the curious student in your facility, and I honestly think that the majority of personnel will comply with the posted signs. There still may be a few of individuals who will not comply with signs maybe because they're curious, maybe because they have other intentions. And so we have to determine what's an acceptable risk just by posting signs alone.

Signs may encourage curious personnel – the student or also the laboratory technician or even the investigator. If they see a sign, maybe a big sign that said "caution, non-human primates", well heck, they want to go in and see the monkeys. In a large multi-disciplined facility like the teaching institution where I am, signs may be used as a tool in conjunction with other measures for controlling access. If you have a small facility, specialized facility, limited personnel and good control on personnel, posting signs may be enough for controlling access to potentially hazardous areas.

Let's talk about security personnel. Certainly they're expensive. Relying on security as a primary tool is probably impractical. Its only going to be as effective as the information and instructions that are provided to those individuals. There's always a risk for personnel error and there's always the possibility that you get an unscrupulous security guard and problems arise from that.

Lets talk about more of the didactic controlled access systems. These range from in the realm of lock and key cobination types of locks, electronic systems, electronic security systems which have a touch pad or a keypad which you key in your individual code. Individual access key such as card keys that recognize a magnetic strip or something or some of the more advanced high tech systems which rely on identifying someone's unique characteristic, such as a hand print, finger print, something along those lines.

Lock and key systems. The basics of a lock and key system may function well especially in those institutions where access may be limited to a relatively small number of individuals or particularly access to those areas where biological hazards may be present. But there are a series of issues that have to be dealt with.

Who issues the keys to those individuals? What safeguards are in place to prevent duplication of keys? What is the policy for dealing with lost or unreturned keys? Is that going to require a change of lock, a change of the core? With a didactic system of lock and key you have little control over access to the facility once those keys are issued. You have little control, you have no prevention against borrowing or exchanging keys between individuals and you have no record of access. In one our facilities we have a quarantine room. Our access there is limited to the technician who works in quarantine, and a key system works appropriately in this particular instance. The pitfalls include leaving the key in the door, allowing someone to take the key, or losing the key.

Combination locks are a reasonable alternative in certain situations. They're good for allowing universal access to a specific group of users. Combinations can be changed. They are somewhat impractical for allowing individual access. You have little control. The combination could be given, shared with other individuals and you don't have any record of access. For a given situation, we do have combination types of locks on the doors. If managed appropriately these may work very well. If all of your locks have the same combination I'm not sure that they're necessarily serving that much of a purpose.

Touch pad, the electronic access systems which rely on an individual access code are good systems. You can assign unique access codes to an individual. Of course they're expensive systems because they are part of an advanced security type of system. Codes can be changed, access can be denied and you could create records of who's been in the facility. There's still the problem that codes can be given out and if that code has been given to someone else you don't really know who has been in unless you have photo documentation, surveillance camera to accompany that type of system.

Card reader systems are probably some of the more universally utilized controlled access systems. We have this in place in our new building.You can allow individual access to the facility and to individual animal rooms because we have readers in all of the animal rooms.You can produce a record of access, a printout of who has been in and what time those people you know entered those rooms.The individual cards are relatively inexpensive to replace or if they're lost you're not having to change the system. Its just a matter of changing the computer access and encoding a new card.

However, you still have the pitfalls – a card can be loaned to someone else, and we've certainly run into this at our facility. You find a technician who says, "well my card doesn't work." For some reason their card wasn't accessed or hadn't been accessed yet so they borrow someone else's card.

Our card reader system utilizes a photo ID. There's a magnetic strip on the back and we can generate a computer printout which identifies the individual, it identifies the date, the building and the room number. We can identify exactly who's been in what area and at what particularly time those individuals entered the building or entered that particularly room.

I think the focus of what we'd like to talk about in the break-out session revolves around the policies and practices of controlled access. I think this is the area which is going to generate the greatest amount of discussion. Issues that need to be addressed are: Who gets in? Who attains access to the facility? Who stays out? Who is in control of the access system and Who monitors that access system?

A high tech high cost state-of-the-art access system that's managed poorly may be of little value. On the other hand a simple system that's based on good policies and practices with appropriate monitoring and oversight can be exceptionally functional. When we ask the question "Who needs to have access to a particular animal area or a particular animal room?" the list can get rather long. First and foremost should be the investigator and/or their research technicians. These are the people who are going to be working in that particular area. Secondly, our animal care technicians – we have to provide appropriate animal husbandry in those areas. Well the attending veterinarians are charged with appropriate veterinary care and oversight so there's a reasonable need for the veterinarians to have access to those areas, particularly when there are concerns over animal care issues or animal health issues.

But how do we deal with issues such as access of maintenance personnel? What if the lights go out in that particular area? What if there's a malfunction on the switch of the biosafety cabinet in there? There may be a need for maintenance personnel to access those areas. How about security personnel? On our campus if there is an emergency the university police are the ones who respond. Should you have provisions for your security personnel to access these particular areas? And last but not least how about your safety personnel? How about those in charge of your biosafety programs on campus? Do they have a need to monitor or to check up on those particular areas?

I think first and foremost we need to look at access privileges for the investigator and the research staff. How do we start doing that? The easiest way is to look at individuals listed on the animal care and use protocol. That may also require approval by a safety committee in your individual facility but certainly requires approval by the Institutional Animal Care and Use Committee. Page two of our IACUC protocol form is a part of our primary guideline for determining who should have access to the animal facility.

Once approval has been given by the Animal Care Use Committee, that investigator, that technician, fills out a card entry data form. We record information, do a system of checks to make sure that those personnel are listed on the proof protocol and then submit the application to the facility manager. The facility manager then enters the information into the computer system. Our system is PC based and is very simple to add new cards or add access to new areas.

Once we have accessed the investigator, how do we determine access privileges for the animal care staff? It should be determined by the work schedule and at the discretion of the supervisor. Access should be limited to technicians who are trained and informed in the hazards and precautions that it should be used in those particular areas. But should there also be access granted to the animal care supervisor? Does the supervisor need to check on that individual? I think as Tom Darby spoke earlier there was a system in which the supervisor routinely came back and did checks on the qualit of work. If you're dealing with a hazardous situation, is it necessary for a supervisor to double check in that area? Is there a need for an additional person to have access to those types of areas?

Along that same line is the need for the veterinary staff to have access. Should we designate one veterinarian to have access? Should it be the entire staff? These are questions which we can discuss further in the breakout session. How do we determine access privileges for maintenance personnel? What do you do when something breaks down? We generally have a policy that rather than offer carte blanche access to maintenance personnel, the supervisor or senior technician escorts them into our restricted areas. If this is in an area with class 2 and 3 biohazards, those individuals need to be informed of the potential hazards. They need to be informed of the appropriate protective equipment and devices to be used in those areas. That may present problems because once your maintenance people find out they have to don tyvex suits or head covers, masks and and other equipment, they may become reluctant about entering those particular areas. If there's a problem with air flow and similar issues, should building engineering staff have access to those areas? And finally, what happens if there's an accident that occurs in the facility? Who's going to respond, who's going to have the ability to get into these particular areas? What access do security and safety personnel need to have? So with that I hope I have set the stage for dealing with some issues of controlled access and I look forward to having you in our discussion group in the break-out session.

Controlled Access Breakout Session
Rapporteur: Rees Thomas, PhD President Rees Scientific 1007 Whitehead Road Ext. Trenton, NJ 08638 609-530-1055

In the course of the breakout session it was clear that the people present did accept the basic concerns about access control which I think affect all animal facilities. Without access control in an animal facility you can't protect people from the experiments and you can't protect experiments from unauthorized intervention. Unauthorized personnel may attempt access to an animal facility for a variety of reasons. There's the cute little animal thing. There's the possibility that animal rights activists may go on the rampage. There's the possibility that maintenance personnel may penetrate an infected area in order to fix the HVAC control system. There's the possibility that security personnel may need to investigate a break-in or some other security-related problem. There's the possibility of an administrative tour where an unauthorized big-wig in the institution may bring people into an area where they don't belong. There's the possibility the students may need a pig to put in th president's office for April Fool's Day.

In any event it is important to control access. In most institutions at least access to the building is controlled. Perhaps by keys. Perhaps by card access systems. We talked in the breakout session about how this can be a problem in a number of ways. First of all of course, the security personnel may not understand the concerns of an animal facility. And second of all they tend to be across campus and there are delays associated both with getting people access to the facility and also, in the case where you might need a record of who went into a particular area at a particular time, there may be a delay associated with getting that information.

In most facilities there are more people who need to get into the building itself than who need to get into particular rooms or areas of the animal facility. Therefore, it is desirable to have local control over access. That is, to have room by room control and to have the control of the system be in the hands in the people running the animal facility.

A misapprehension that we discovered in the breakout session which may be wide spread, is the idea that with card access systems the information about where you are allowed to go was encoded on the card. It is not. The card itself is merely encoded with information that tells the system who that person is. At that point, whether that person is allowed in or not is information that is encoded into the computer. So the person running such a system in an animal facility may use the cards that are all ready on campus for other purposes. Then when a person is to be allowed access they just go into the computer, and it takes about two seconds to change the parameters for a given area of the facility.

It's also important to point out that with a computerized access control system such as that which can allow room by room access you can allow particular people access to particular rooms only during particular periods of time. Holidays can be excluded, and an expiration can be put on the card so that if you have a temporary worker or other transient their card will expire automatically after a certain time. These things can prevent the kind of thing where, for example, somebody needs a material that is in the next room over so they go in not realizing that that room was a contaminated area.

The computerized access control systems allow maximum control with maximum flexibility. They're easier to use and easier to deal with than keys. A person may take a key. Whey they leave, how do you get the key back? With an access card you just write them out of the computer and it's done. They don't return the card. You don't really care.

There is an under utilized technology in the animal field. Proximity cards have become widespread and relatively less expensive at least than they used to be. They are more expensive than the mag stripe cards but they're also more durable. The big advantage is that if you can get the proximity card within seven inches or so of the reader the door will open automatically. This allows for hands free operation. In a facility where you may have dirt or whatever on your hands, you may be gowned up and so on, that could confer considerable advantage.

We also spoke of the need for free egress. In an animal or any other facility, it's important that people must be able to get out in the event of an emergency. Particularly in the case of a fire but there are other types of emergencies also. There are different requirements depending on which kinds of doors you're talking about. If you're talking about the individual doors to the rooms the requirements are lighter then they are for the major exits from the facility. In the case of the room doors in genral exit request buttons are considered sufficient. In animal facilities the over-the-door PIR which you're familiar with from supermarket doors can provide hands off operation, but people are concerned that they may cause problems in the event that the animals get out of their cages and they then may let them out of the whole facility. So the exit request buttons are desirable alternative in the rooms themselves. However, for the exits from the building these are not generally deemed accepted by fire marshals. The reasons being that some people may get confused in a panic situation. They're not sure how to get out of this building and they're just pushing on the door. They require a touch bar on the door. You've probably seen the electronic touch bars though you may not have recognized them. They look like the regular panic bars, but they don't move when you touch them. The over-the-door PIR detectors that will detect somebody walking up to the door and release are also usually acceptable. In the case of many facilities also when the fire alarm goes off all of the doors open automatically. Their locks are disconnected by the fire alarm system. That can be a security problem of course and it has to be planned as to how to deal with that. This is a problem because a person can then just pull the fire alarm lever and then they can go in and out of anywhere.

Stairwells can cause particular problems also. In the case of fire, considerable pressure differentials can develop across stairwell doors, and fire marshals don't like doors that are just unlocked and unlatched on stairwell doors. There are panic bars which both have a mechanical latch and an electronic switch for that purpose. Its also worthy of note that access control can be integrated in an animal facility into the other monitoring functions such as monitoring for temperature, humidity, pressures, levels and flows and lighting controls, watering controls, and so on. It is desirable to have one coordinated system that does the entire job.

In summary, access control is quite important in an animal facility. It needs to be to be dealt with. Keys have serious disadvantages in terms of getting lost, duplicated, or whatever else. Computerized access control where you have local control is nice. That allows you to let people in or keep people out as needed. With better access control, infection potential can be better controlled and the experiments can be more reliably protected.

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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Controlled Access