Insights

OSHA Violations and the Bloodborne Pathogens Standard

Did you know that the most frequent cause of OSHA violations related to the Bloodborne Pathogens Standard is outdated, or otherwise non-compliant, Exposure Control Plans?

It is generally known in the biotech community that Exposure Control Plans are required to be in place for any facility working with blood or other potentially infectious material (OPIM). What is often overlooked is that there is a specific regulatory requirement to update the Plan.

The Bloodborne Pathogens Standard (in section 1910.1030(c)(1)(iv) ) specifies that the Exposure Control Plan must be reviewed and updated at least annually and whenever necessary to include new or modified tasks and procedures which affect occupational exposure and to address new or revised employee positions with occupational exposure.

The review and update of the Exposure Control Plan must also reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and document annually consideration and implementation of appropriate commercially available and effective safer medical […]

Remember to Post OSHA Form 300A!

OSHA Form 300A, Summary of Work-Related Injuries and Illnesses, is used to summarize the recordable injuries and illnesses for the previous year and includes the number of days work was lost or restricted, and the types of injuries and illnesses that occurred.

Information about the company, including the average number of employees and total hours worked by all employees, must also be recorded.

Form 300A must be posted from February 1 through April 30 each year.  If no recordable incidents or illnesses occurred during the previous year, the form must still be completed and posted reflecting zero recordable cases. The information in Form 300A is based on information recorded in OSHA Form 300, Log of Work-Related Injuries and Illnesses. However, certain employers are exempt from these reporting requirements.

Employers with 10 or fewer employees are not required to prepare Form 300 or Form 300A. In addition, only industries within certain North American Industrial Classification (NAICS) codes are […]

New Watertown Regulation Biotechnology & the Use of rDNA Molecule Technology: Sharing Our Tips!

In my April 16th  2020 blog, I wrote about the new Watertown regulation Biotechnology and the Use of Recombinant DNA Molecule Technology which became effective July 1, 2020. Existing facilities located in Watertown​ will have one year from the effective date to come into compliance, but new companies moving to Watertown must comply before work covered by the regulation can begin.

The regulation covers recombinant DNA (rDNA) work as well as non-rDNA research involving biologic agents at Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3). (BSL-4 work is prohibited in Watertown.) Examples of agents at BSL-2 include non-recombinant work with Salmonella entericaStaphylococcus aureus, Hepatitis B, and Herpes Simplex Virus.

Non-exempt rDNA work and work with regulated biologic agents requires a permit. However, low risk facilities may conduct rDNA work without a permit provided that they register with the Watertown Biosafety Committee (WBSC).  A low risk facility is one that creates, propagates, imports or uses rDNA […]

Safety Doesn’t Break for Parties: IANM V5

With the holidays, there’s a guarantee of rushing around which makes errors more likely to happen in the lab. Many people are typically off on vacation which adds another variable for accidents to happen.

Learn how to prevent accidents this season with this ‘near miss’ from our publication Incidents, Accidents, and Near Misses Volume 5:

It was the annual institute-wide holiday party and everyone in Charlie’s lab was excited to celebrate, relax, and have fun! It was the end of a long week and the weekend before many would be taking time off to go home for the holidays.

Charlie and most of his lab went just as the party was starting, but Ed stayed behind to finish up some of his work.

It wasn’t until Saturday morning that Charlie checked his email and noticed a flurry of messages from Ed the night before.

Ed is a graduate student in Dr. Brown’s lab and was finishing up some of […]

Have you Conducted Your Annual Fit Testing?

 Have you Conducted Your Annual Fit Testing?

The OSHA Respiratory Protection Standard requires that respirator fit testing be performed initially (before the employee is required to wear a respirator), and it must be repeated at least annually when respirator use is required.

Fit testing must also be conducted whenever respirator design or facial changes occur that could affect the proper fit of the respirator. Examples of conditions that would require additional fit testing include the use of a different size or make of respirator, weight loss, cosmetic surgery, facial scarring, the installation of dentures, or the absence of dentures that are normally worn by the individual.

What is the purpose of fit testing? Fit testing confirms the correct fit of any respirator that forms a tight seal on the user’s face. This ensures that users are receiving the expected level of protection by minimizing contaminant leakage into the facepiece.

When a respirator doesn’t fit properly, a portion […]

Have You Conducted Your MWRA Wastewater Sampling?

For Category 2 MWRA permit holders, semi-annual wastewater sampling results for the July through December sampling period must be conducted by December 31st.

Even though the sampling results are sent directly to the MWRA by the analytical testing laboratory using the MWRA’s electronic reporting system, permit holders are responsible for reviewing the results and notifying the MWRA of any issues of non-compliance.

If the sampling results show that any regulated chemicals are detected above the discharge limits specified in the facility’s permit or the Sewer Use Regulations (360 CMR 10), the MWRA must be notified within 24 hours of becoming aware of the violation. 360 CMR 10.024 specifies the specific daily maximum discharge limitations for regulated pollutants including formaldehyde, cyanide, phenol, specific metals, and listed toxic organics for both the Metropolitan Sewerage Service Area and the Clinton Sewerage Service Area.

If a violation is identified, the permit holder is responsible for repeating the sampling and submitting the […]

Have You Conducted Refresher Safety Training in 2020?

It’s not too late to conduct your annual refresher safety training! With all the COVID 19-related changes that everyone has had to make in the workplace this year, it’s easy to see how this requirement could slip through the cracks.

In light of the pandemic, OSHA is making some allowances for lapses in annual training requirements such as for companies that were required to close for a period of time.

That said, OSHA is requiring that companies demonstrate that they have made a good faith effort to comply with annual training requirements including the use of virtual training options and other means of remote communication. The use of virtual training has been a great option for many companies and has even proven to make annual refresher training easier to schedule!

Which OSHA standards specifically require refresher training?

  • The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) requires that annual training be provided within one year (i.e., 12 months) […]

The 6th Edition of the BMBL Has Been Published!

In a November 17th, 2020 Lab Advisory, the CDC announced the release of the 6th Edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL)! The BMBL has become the foundation of biosafety practice since it was first published in 1984. Historically, the information in this publication has been advisory in nature although some legislation and regulations, in particular local recombinant DNA ordinances, have made compliance with the guidance provided mandatory. The previous version of the BMBL (5th Edition) was published in December 2009.

So what’s different about the 6th Edition? The updated BMBL is more detailed in many sections and has increased in length by ~160 pages! For example, the section describing Standard Microbiological Practices (Section IV) for BL1 and BL2 labs now includes a detailed description of content requirements for a written Biosafety Manual.

In addition, there is a new requirement that long hair be restrained so that it cannot contact hands, specimens, containers, or […]

Boston Lab Space Expands to the Suburbs

Over the last few years in Boston, we’ve seen an increasing trend of limited lab space in the city and more companies moving out to the suburbs – COVID-19 has only sped up this process.

This trend is partly due to the health crisis exacerbating shortages in the already tight Boston market, particularly in Cambridge (the epicenter of the state’s life sciences industry), and companies seeking lower rents found in the suburbs.

In this post, we’ll share what experts have been seeing with this phenomenon and what benefits they see in having lab and office space in the suburbs vs. Cambridge/Boston.

This past August, Safety Partners hosted a webinar with a group of partners representing architects, construction management, project management, and real estate brokers called a Primer on Moving Out, where we gave an overview of the keys to a successful lab relocation.  Understanding the markets is an important factor to consider.

In September, we had the opportunity to […]

The Bloodborne Pathogens Standard and the Needlestick Safety & Prevention Act: Not Just for OSHA Compliance

Often companies seek to check off all of the regulatory boxes so non-compliance doesn’t interfere with their work and timelines. While this may be reasonable, regulations can be general and do not always achieve safety standards that appropriately address workplace hazards.

The OSHA Bloodborne Pathogens Standard went into effect in 1991 and was updated in 2001 to incorporate the requirements of The Needlestick Safety and Prevention Act.

This Standard is an example of a sweeping and effective regulation that has significantly reduced the risk of occupational transmission of bloodborne viruses.

In this post, we’re going to focus on the Needlestick Safety and Prevention Act and the changes that have been made to reduce sharps injuries. The Act itself is only four pages and lays out the problem (occupational exposure to contaminated sharps), the empirical evidence for the need to resolve it, and specifies the requirements related to sharps with engineered sharps injury protections that were added to […]