Vol. 20 Issue 5
Evaluating Your Lab Design for CAP
Use these helpful tips to immunize your facility from future violations.
As an architectural firm specializing in planning and designing clinical laboratories, we often field calls from laboratory managers anxious to correct design-related deficiencies cited by CAP inspectors. If the same problems have been cited multiple times by inspectors, the lab manager's anxiety level expands exponentially. Few lab managers wish to risk their lab's valued CAP certification. Fewer still wish to risk a negative referral to a state health department for repeated serious citations. Therefore, a basic familiarity with CAP criteria related to lab design is part of every laboratory manager's compendium of lab knowledge.
CAP evaluates laboratory design based on five areas of concern. The initial evaluation focuses on safety for those outside of the laboratory. There must not be any recirculation of laboratory air into any inpatient or outpatient areas, a code issue as well as a CAP issue. In particular, there should not be open testing areas that might expose immuno-compromised patients to aerosols. Phlebotomy and fine needle aspiration outpatients, also likely to be immuno-compromised, must be protected from aerosol contamination. From a design perspective, all patient areas must be totally separate from testing areas. Patient access to phlebotomy areas and restrooms must be separate from the laboratory. Laboratory egress to corridors shared by patients must be separated by a door to maintain airflow separation.
In an effort to protect those outside the laboratory, CAP inspectors also investigate whether specimens and used media are disinfected, sterilized or contained in a manner to minimize the hazard of an accident during transportation to a remote autoclave or incinerator. As most hospital laboratories do not maintain their own autoclave or incinerator, it is advisable to provide a separate room to store red bags until collected for removal by hospital staff or a licensed disposal company. Such a provision removes hazardous waste from traffic areas and contains potential spills and odors. Ensure room is provided for waste containers in the lab as well as the storage room.
Staff safety is the second major design-related area on which CAP inspectors focus. Specifically, they want to know if a documented policy prohibits smoking, eating, drinking, application of lipstick and lip balm, contact lens manipulation and mouth pipetting in all technical work areas.
The design response to these concerns starts with eliminating drinking fountains, food and drink refrigerators, and mirrors in the lab. Staff eating areas should be completely separate from the lab. Break rooms opening into the testing area and requiring staff to carry food and drinks through could create contamination of these items. Note neither aerosols nor CAP inspectors respect tape on the floor demarking the separation between clean and dirty zones.
Some consideration for second and third shift technologists should be given when locating a break room. Proximity to the lab, easy access and a view of the lab are desirable features for thinly staffed shifts whose personnel can't venture far or long from their work. Locating the break room so a door or window into the lab may be provided is certainly desirable, as long as there is another door coming from a clean corridor in which to bring food and drinks. Keep in mind the break room must be positively pressurized to keep aerosols out if a door to the lab is provided.
Staff safety concerns require an emergency eyewash is provided within 100 feet or 10 seconds of travel from every area where hazardous chemicals or biohazards are present. Eyewash stations must meet OSHA criteria. CAP also requires laboratories have a policy to protect personnel from excessive noise levels. A hearing conservation program is required by OSHA when noise exposures equal or exceed 8 hours of 85 decibel noise.
A design response to noise control incorporates materials absorbing noise in the lab. High sound absorbance acoustic ceiling tiles, rubber flooring, cork instead of fabric bulletin boards, and cork acoustic panels behind instruments can be effective dampers. Within the boundaries of maintaining optimal workflow, isolating noise producers such as freezers in adjacent rooms or alcoves is also a good strategy for limiting noise levels in the lab.
CAP also supports an OSHA voluntary upgrade program to prevent musculoskeletal disorders. Ergonomic factors may be addressed by designing workstations allowing staff to change positions. Providing adjustable monitor arms, keyboard trays and chairs can be quick, easy and relatively inexpensive solutions to ergonomic issues. Adjustable mechanical tables offer employees such as cytotechnologists, who must sit for long periods, the opportunity to occasionally change position.
The possibility of lifting injuries should also be addressed. Tall storage cabinets are often a better design solution than overhead storage options. Reaching to the tops of tall cabinets is usually easier than other alternatives and heavier items may be placed at a lower level in the cabinets. Adding carts to casework may also prevent many lifting injuries. Heavy items, such as isoton cubes, can be stored directly on the carts and wheeled, rather than carried to instruments when needed.
Cleanliness is the third major area of CAP review carrying design implications. Inspectors are concerned with the general cleanliness and maintenance of work areas including walls and ceilings, as well as the decontamination of workbenches and sinks. From a design perspective, this is primarily a materials issue. Counter and floor materials that can withstand round-the-clock exposure to water, heat and chemicals must be specified.
Surfaces must be cleanable, hence the CDC prohibition of fabric and carpeting in laboratory testing areas. Metal or molded plastic casework systems stand up best to the rigorous demands of laboratory use. Laminated custom millwork does not function as well in the lab due to the issue of damage or delamination, providing a growing environment for bacteria and fungus in the particleboard. Monolithic and epoxy countertops are best, but chemically resistant plastic laminate is acceptable if constructed with PVC edging. Stainless countertops also perform well in the lab with the drawbacks of initial expense and tendency to pit if bleach is used in cleaning.
Air quality is the fourth design related factor CAP inspectors review. Inspectors must determine whether examination and storage areas are adequately ventilated by an exhaust fan or hood to remove noxious fumes and odors. It is also verified that ventilation is adequate for the workload and procedure types performed in the lab and if vapor concentrations are maintained below the recommended maxima. Specifically, formaldehyde concentration should be no more than 0.5ppm over 8 hours, 2.0ppm over 15 minutes and xylene concentration should not exceed 100ppm over 8 hours, 150ppm over 15 minutes.
Note that after initial monitoring, further periodic monitoring is expected particularly when initial monitoring exceeded action levels. Initial monitoring must be repeated when circumstances demand. From an architect's perspective, the CAP air quality requirements speak to the need for proper design and engineering of laboratory air handling systems. Monitoring is equally important, though, as we have encountered clients whose facilities have received citations because their labs lacked a built in monitoring system. While not specifically required by CAP criteria, full monitoring systems best meet the requirement for initial and periodic air quality testing.
Room to Breathe
Space is the final aspect of design-related criteria evaluated by CAP inspectors. One of the space issues concerning CAP is whether adequate room is available for technical and clerical work. The typical architectural design response to this concern centers on offices and spaces for continuing education. Of course, space must be provided for those functions. Of equal importance and often overlooked by planners is the space available for such work adjacent to instruments. Space must be available for specimen preparation and laboratory information system computers. There must also be some room just to put down some papers, check standards of procedure and check reference materials.
CAP suggests inspectors determine if sufficient space has been provided and if utilities are adequate for the collection, gross examination and storage of specimens. These concerns ideally should be met when a laboratory is first constructed. Throughout the course of time as procedures and equipment change and/or are added, this requirement highlights the necessity to design in system redundancies and perhaps some room to grow. During design of a laboratory, specific requirements for specimen storage (e.g., type of specimen, length of time to be stored, refrigerated, frozen, special ventilation requirements for tissue and agar plates) must be discussed and accounted for in the design.
The final space concerns relate to safety. A CAP inspection includes a review of whether sufficient space is available so there is no compromise in the quality of work or safety of personnel and whether adequate space is provided for accession of potentially biohazardous specimens.
The overarching issue of adequate space to ensure work quality and personnel safety is, again, best addressed during the initial planning and design of a laboratory. A CAP citation for this problem may be difficult to address. Laboratories that have initially been designed with some flexibility are better suited to modification to improve workflow and safety later. In the case of specimen safety, several design-related issues exist. Adequate space must be available for receiving and triaging specimens as they arrive in the lab. If space is constrained at this point in specimen movement, the likelihood of an error in labeling or paperwork increases greatly. Space must be provided at other areas in the lab (e.g. next to instruments, workstations) to separate already accessioned specimens before actual testing begins. In some areas, space must also be provided to organize specimens before they are sent to pathologists for review or before they are routed to storage. Above all, when planning for the movement of specimens in the lab, it should be remembered every specimen entering the lab is an unknown and is potentially biohazardous.
From our interaction with laboratory managers over the years, we have experienced, albeit secondhand, the anxiety accompanying a CAP inspection. In particular, CAP citations involving design-related issues can be particularly worrisome to lab managers, and for good reason.
Unlike many other concerns a CAP inspector may express, design-related deficiencies often cannot be remedied by a change in process or procedure. The correction of many design-related deficiencies involves major construction. Indeed, repeated serious CAP citations regarding space issues often lead to complete laboratory renovation.
If you find yourself at that juncture and wish to somewhat immunize your facility from future CAP violations, the best advice to leave you with is to anticipate your lab's potential for growth, anticipate the potential for changes in procedure and equipment, and to respond to those potentialities by incorporating adequate space and as much flexibility in utilities and casework as possible in your laboratory's design.
Karen K. Mortland is a certified medical technologist and a registered architect. She is president of Mortland Planning and Design. Daniel B. Mortland is vice president of Mortland Planning and Design and is a technical writer.