Laboratory SafetyAudio Conference
Presented by Thomas A. Merrick, MD
July 18, 2001
CAP Laboratory Accreditation Program
Several scenarios are presented here concerning issues of safety encountered during an on-site laboratory inspection by a team representing the College of American Pathologists Accreditation Program.
In each case, consider what you would do if you were the inspector. Would you:
- Not cite a deficiency; the laboratory is in compliance,
- Not cite a deficiency and informally make a verbal recommendation,
- Not cite a deficiency but make a written recommendation,
- Cite a deficiency?
Inspection Scenario #1
The inspector reviewing the laboratory safety program notes that the laboratory is using electronic Material Safety Data Sheets. Are these electronic MSDS permissible as a stand-alone system without any paper or electronic back up?
QUESTION: 01:72950 PHASE: II
Do employees have access to all of the following documents:
1.The contents of current Material Safety Data Sheets and other references
that list the details of hazards and the precautions for safe handling and
storage;
2.The documented Chemical Hygiene Plan of the laboratory;
3.Code of Federal Regulations. Title 29, Part 1910.1450 and its appendices?
Inspection Scenario #2
The inspector notes that the laboratory has a well-written Chemical Hygiene Plan and the documentation of annual review consists of the director’s signature and date of review. Should they be cited for a deficiency?
CURRENT QUESTION: GEN.70500 PHASE: II
Is there annual review and evaluation of effectiveness of the laboratory's Chemical Hygiene Plan?
Inspection Scenario #3
Review of the Microbiology procedure manual reveals that the lab processes and handles specimens submitted for isolation and identification of pathologic fungi and mycobacteria. There is no mention of any specific safety precaution related to handling these specimens or working with isolated organisms.
CURRENT QUESTION GEN:71220 PHASE: I (FUTURE PHASE II)
Does the laboratory have a documented tuberculosis exposure control plan?
NOTE: This plan must include an exposure determination for all employees who may have occupational exposure to tuberculosis. Additional elements of the plan include engineering and work practice controls for hazardous procedures with the potential for generation of aerosolized Mycobacterium tuberculosis. Such procedures include the handling of unfixed tissues in surgical pathology or autopsies, and processing of specimens in the microbiology section, from patients with suspected or confirmed tuberculosis.
CURRENT QUESTION: MIC:19060 PHASE: I
Have policies and procedures been developed to minimize the occupational risk of exposure to infectious agents handled in the Microbiology laboratory, in accordance with current recommendations regarding the biosafety levels for working with different organisms?
NOTE: The four biosafety levels (B.S.L.) for working with infectious agents are described in the CDCNIH guidelines (BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES. U.S. DEPT. OF HEALTH AND HUMAN SERVICES, THIRD EDITION, 1993). Each B.S.L. consists of combinations of equipment, procedures and techniques, and laboratory design that are appropriate for the type of laboratory and infectious agent handled. The intent is for the laboratory director to know what manipulations are performed with pathogens (e.g., M. tuberculosis) and that appropriate precautions are in place to minimize the risk of laboratory personnel infection.
CURRENT QUESTION: MIC:19160 PHASE: I
Are engineering and work practice controls appropriate to the Biosafety level of the laboratory defined and implemented?
NOTE: Each increasing B.S.L. number (BSL1 to BSL4) implies increased occupational risk from exposure to an agent or performance of a procedure, and therefore is associated with more stringent control and containment practices.
Inspection Scenario #4
While observing a phlebotomist drawing blood at a site outside the main laboratory, you note that the person is using a needle with no protective safety device and is wearing latex gloves that are not powderfree. The phlebotomist says that the hospital is evaluating some safety needle devices but that most of them are awkward to use and slow her down. She has never had an allergy to latex.
FUTURE QUESTION: 01:LTEXA PHASE: I
Do phlebotomists use only nonlatex or powderfree latex gloves during patient contact?
COMMENTARY
Because of the risk of hypersensitivity to latex proteins, phlebotomists should use only nonlatex or powderfree latex gloves for patient contact.
FUTURE QUESTION: 01:GGNWA PHASE: I
Has the laboratory evaluated the effectiveness of its engineering and work practice controls in significantly reducing or eliminating exposure to bloodborne pathogens during phlebotomy and laboratory testing?
NOTE: "Engineering controls" means controls that isolate or remove the bloodborne pathogens hazard from the workplace. Examples include needleless devices, shielded needle devices, blunt needles, plastic capillary tubes, etc. "Work practice" controls are those human activities that reduce exposure risk (e.g., no-hands procedures in discarding contaminated sharps, not directly transferring a sharp from one person to another, etc.).
COMMENTARY
The application of engineering and work practice controls should significantly reduce or eliminate exposure to bloodborne pathogens during phlebotomy and laboratory testing. If engineering and work practice controls do not eliminate exposure, the use of personal protective equipment (e.g., eye protection, laboratory coats, etc.) is required.
FUTURE QUESTION: 01:SWAYA PHASE: I
Does the laboratory have a documented program to protect personnel from allergic reactions due to jobrelated exposures to natural rubber latex in gloves and other products?
NOTE: The latex program should address at least the following elements:
1. selection of products and implementation of work practices that reduce the risk of allergic reactions. If latex gloves are used, the employer should provide reduced protein, powderfree gloves to protect workers from infectious materials.
2. provide personnel with education programs and training materials about latex allergy.
3.evaluation for current prevention and control strategies whenever a worker is diagnosed with latex allergy.
Inspection Scenario #5
One of the inspectors notes that the laboratory is using plain glass capillary tubes for specimen collection. When the inspector inquires about the potential risk of injury, the inspectee states that they have never had any injuries and that the new tubes are too expensive.
FUTURE QUESTION: 01:CAPLA PHASE: I
Has the laboratory discontinued use of plain glass capillary tubes for specimen collection and specimen handling?
NOTE: A 2/22/99 advisory letter from the U.S. Food and Drug Administration, National Institute for Occupational Safety and Health, Centers for Disease Control, and the Occupational Safety and Health Administration concerns the potential risk of injury and/or infection due to accidental breakage of glass capillary tubes. To reduce the risk of injury due to breakage of glass capillary tubes, laboratories should adopt blood collection devices that are less prone to accidental breakage, including:
1.capillary tubes not made of glass,
2.glass capillary tubes wrapped in puncture-resistant film,
3.products that use a method of sealing that does not require manually pushing one end of the tube into putty to form a plug,
4.products that allow the hematocrit to be measured without centrifugation.
Inspection Scenario #6
At an on-site inspection, an inspector notices that secondary containers of hazardous chemicals are not labeled with first aid instructions. When questioned by the inspector, the technologist working at the bench responds that the bottles are too small to include the labeling requirements. He/she also states the bottles are immediately tossed after use.
CURRENT QUESTION: GEN.72850 PHASE II
Are precautionary labels present on the containers of all hazardous chemicals (flammable liquids Classes I, II, and IIA; corrosives; irritants; asphyxiants, potential carcinogens; etc) indicating type of hazard and what to do if accidental contact occurs?
Inspection Scenario #7
One of your inspection team members is observing a pathologist examining a specimen for frozen section. The specimen is in two parts and includes a breast lumpectomy for carcinoma and a sentinel lymph node. Both samples had been exposed to radioactive materials (technetiumsulfur colloid) as part of a lymphatic mapping procedure. The pathologist handling the specimen is in street clothes but does wear gloves. A frozen section is performed and the inspector notes that the cryostat needs defrosting and contains numerous trimmings and sections of tissue that have accumulated at the bottom of the cryostat. There is no documentation of regular maintenance or cleaning of the cryostat. The inspector asks the pathologist if there is any written procedure for the safe handling of radioactive specimens. None are found. Should the inspector site the laboratory for any deficiencies?
CURRENT CHECKLIST QUESTION: GEN.71050 PHASE II
Have personnel been instructed in the proper use of personal protective clothing/equipment (e.g. gloves, gowns, masks, eye protection, etc)?
FUTURE QUESTION: 08:RADN PHASE: I
Are there specific policies and procedures for the safe handling of tissues that may contain radioactive material (e.g., sentinel lymph nodes, breast biopsies, prostate "seeds", etc)?
NOTE: These pathology department documents should be developed in conjunction with the institutional radiation safety officer, and in compliance with any State regulations for the safe handling of tissues containing radionuclides. The pathology department may wish to monitor these specimens for radioactivity, with safe storage of specimens until sufficient decaying has occurred, before proceeding with processing in the histology laboratory. The policy should distinguish between low radioactivity specimens such as sentinel lymphadenectomy and implant devices with higher radiation levels.
COMMENTARY
There should be specific policies and procedures for the safe handling of tissues that may contain radioactive material (e.g., sentinel lymph nodes, breast biopsies, prostate "seeds", etc). These pathology department documents should be developed in conjunction with the institutional radiation safety office, and in compliance with any state regulations for the safe handling of tissues containing radionuclides. The pathology department may wish to monitor these specimens for radioactivity, with safe storage of specimens until sufficient decaying has occurred, before proceeding with processing in the histology laboratory. The policy should distinguish between low radioactivity specimens such as sentinel lymphadenectomy and implant devices with higher radiation levels.
FUTURE QUESTION: 08:CRYO PHASE: I
Is there a documented procedure for the routine decontamination of the cryostat at defined intervals, and are decontamination records evident?
COMMENTARY
The interior of cryostats should be decontaminated regularly with 70% ethanol. Trimmings and sections of tissue that accumulate inside the cryostat should be removed during decontamination. The cryostat should be defrosted and decontaminated with a tuberculocidal disinfectant at an interval appropriate for the institution; this should be weekly for instruments used daily. Although not a requirement, steel mesh gloves should be worn when changing knife blades.
Inspection Scenario #8
The laboratory has records of monitoring of formaldehyde vapors and both 8 hour and 15 minute exposure levels are within normal limits; however, while questioning one of the histology technicians you uncover a potential problem. This individual says that while dumping tissue in the morgue he experiences symptoms of watery eyes, sore throat and nausea. He is not aware of any monitoring of vapor levels during the dumping of tissues.
CURRENT QUESTION: ANP.24150 PHASE: II
Are formaldehyde and xylene vapor concentrations maintained below the following maxima, expressed as parts per million?
8 hr Time-Weighted Average / 15 min Short-Term Exposure LimitFormaldehyde / 0.75 ppm / 2.0 ppm
Xylene / 100 ppm / 200 ppm
NOTE: Initial monitoring must be repeated any time there is a change in production, equipment, process, personnel, or control measures which may result in new or additional exposure to formaldehyde. Periodic monitoring is mandated only if the initial monitoring is at or exceeds 0.50 ppm (8hr TWA) or 2.0 ppm (STEL). The laboratory may discontinue periodic formaldehyde monitoring if results from two consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level and the shortterm exposure limit, and no change in production, equipment, process or personnel or control measures that may result in new or additional exposure to formaldehyde, and no reports of conditions that may be associated with formaldehyde exposure.
Safety Audio ConferencePage 1 of 1July 18, 2001