Question

1. Excited at the opportunity you accepted a job, site unseen, in a suburban medical lab. On your first day you are horrified to learn of the lack of attention to safety details and observe many OSHA code violations, despite the handling of BSL-2 organisms. Bob, the head med lab tech, loosely refers to the MSDS book and gestures for you to pick up some gloves, goggles, and lab coat, but the only PPE he is wear is a lab coat. You ask which quality control protocol sheets you are supposed to fill out daily, which is customary for the position you accepted, and he hands you a binder which only has initials and dates for each entry.
   1. List aseptic techniques and BSL-2 regulations that should be followed in the lab.
   2. What is missing from the quality control sheets?
   3. Shortly after you are hired, as you tried to stick it out, Bob is replaced with Marge who is determined to turn this lab around. Describe the actions and performance improvement plans that she would need to put in place to get employees on the right track and avoid being shut down due to OSHA violations.

Answer 1

1) Aseptic technique refers to a set of routine procedures done to prevent sterile solutions and cultures from becoming contaminated by unwanted microorganisms in the laboratory. Such techniques are essential for experiments that require growing cells.

Biocontainment
​Personal Protective Equipment​
Biosafety Level Requirements
Biosafety Cabinets
Biosafety Cabinets vs. Fume Hoods
Laboratory Design
Risk Assessment
FESAP Best Practices Checklist
Waste Management

​Biosafety Level Requirements
​​Laboratory biosafety describes the application of specific practices, safety equipment and specially designed laboratories to create a safe environment, both within and outside the laboratory, for work conducted with infectious agents and toxins. In addition, there is monitoring for occupationally acquired infections and staff training, as appropriate.

“Biosafety Lev​els” (BSLs) are designations applied to projects or activities conducted in laboratories in ascending order of containment based on the degree of the health-related risk associated with the work being conducted. In the United States, the designations BSL-1, BSL-2, BSL-3, and BSL-4 describe the minimum safe work practices, specially designed buildings, and safety equipment required to conduct work on infectious microorganisms and other biological hazards. BSL-4 is the highest biosafety level.

The appropriate BSL for a project is determined jointly by the principal investigator, the institutional biosafety professionals and biosafety committees. The BSL assigned to a project is based on a biological risk assessment that takes into account:​

The nature of the infectious agent, toxin, or other biological hazard, including:

Its ability to cause disease and the way(s) in which it causes disease (transmissibility and pathogenicity);
How much of it is required to cause disease (infectious dose);
How many different organisms are susceptible to infection (host range); and
​Its prevalence in the community (epidemiology);
​The specific laboratory activity or activities being performed; and
The availability of preventive medical coun​termeasures (i.e., vaccines) or effective treatment (i.e., post-exposure vaccination and/or use of antimicrobials, antivirals and chemotherapeutic agents).
The BSL assigned to a project determines the controls required to conduct the work safely:

Engineering controls, including facility construction and design elements in the laboratory space;
Safety equipment, including personal protective equipment (PPE)​ and biosafety cabinets;
Administrative controls, including specific access, training, and occupational medicine policies; and
Laboratory practices and procedures workers use when working in the laboratory.
Every biological laboratory, regardless of biosafety level, follows standard microbiological practices. Each biosafety level builds on the controls of the next lower level. Each biosafety level has its own specific containment controls. The assignment of a biosafety level to a particular work process is made through a protocol driven risk assessment.
Biosafety Lev​els” (BSLs) are designations applied to projects or activities conducted in laboratories in ascending order of containment based on the degree of the health-related risk associated with the work being conducted. In the United States, the designations BSL-1, BSL-2, BSL-3, and BSL-4 describe the minimum safe work practices, specially designed buildings, and safety equipment required to conduct work on infectious microorganisms and other biological hazards. BSL-4 is the highest biosafety level.The appropriate BSL for a project is determined jointly by the principal investigator, the institutional biosafety professionals and biosafety committees. The BSL assigned to a project is based on a biological risk assessment that takes into account:​
The nature of the infectious agent, toxin, or other biological hazard, including:

Its ability to cause disease and the way(s) in which it causes disease (transmissibility and pathogenicity);
How much of it is required to cause disease (infectious dose);
How many different organisms are susceptible to infection (host range); and
​Its prevalence in the community (epidemiology);
​The specific laboratory activity or activities being performed; and
The availability of preventive medical coun​termeasures (i.e., vaccines) or effective treatment (i.e., post-exposure vaccination and/or use of antimicrobials, antivirals and chemotherapeutic agents).

2) With its robust quality control process, Suburban Diagnostics assures accurate and precision test results.Make Suburban your trusted partner in diagnostics.To ensure results that are accurate and precise.To translate into correct diagnosis and optimum patient care.Proficiency testing is an inter-laboratory comparison, conducted by societies like CAP, Biorad and Randox. It compares results obtained by different by different laboratories for tests performed on unknown samples to check for the closeness of results to the actual known mean.
Suburban diagnostics is a NABL accredited and CAP accredited laboratory.

The laboratory uses stringent IQC and EQC for ensuring accurate and precise results and also successfully participates in Biorad, EQAS and CAP assessments, for increased clinical and patient confidence.

3) Relationship to the 1989 Guidelines and Existing Legal Requirements.These guidelines update and replace the Occupational Safety and Health Administration’s (OSHA’s) voluntary Safety and Health Program Management Guidelines, first published in 1989.They build on lessons learned about successful approaches and best practices under OSHA programs such as the Voluntary
Protection Programs (VPP) and the Safety and Health Achievement Recognition Program (SHARP). The
guidelines are also consistent with many national and international consensus standards.To help you implement the guidelines, Appendix A: Implementation Tools and Resources describes several
available tools and resources. OSHA will add to these resources through the guidelines website at
www.osha.gov/shpmguidelines.Appendix B: Relationship of Guidelines to Existing OSHA Standards identifies existing OSHA standards that
include provisions similar or identical to action items in these guidelines. These guidelines do not change
employers’ obligations to comply with the requirements of any OSHA standard.The guidelines are advisory and informational in content. They are not new standards or regulations; they
also do not create any new legal obligations or alter existing obligations created by OSHA standards,
OSHA regulations, or the Occupational Safety and Health Act of 1970 (OSH Act). Pursuant to the OSH Act,employers must comply with safety and health standards and regulations issued and enforced either by OSHA or by an OSHA-approved State Plan. In addition, the OSH Act’s General Duty Clause, Section 5(a)(1),
requires employers to provide their workers with a workplace free from recognized hazards likely to cause death or serious physical harm. Implementing a safety and health program in accordance with these guidelines can aid employers in their efforts to comply with the OSH Act.