Category: generalist

CDC’s Interim Guidance for Zika Virus Testing

In their most recent Morbidity and Mortality Weekly Report (MMWR), the CDC issued interim guidance for Zika Virus testing. From the report:

“On the basis of the newly available data, CDC recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset. A positive result in either specimen type provides evidence of Zika virus infection.”

 

Anatomy of a Safety Stand Down

In March of 2016, the United States Government Accountability Office (an independent agency that works for Congress) produced a report stating that stronger oversight mechanisms are needed to improve safety in high-containment laboratories. The laboratories referred to are those which work with hazardous biological agents in order to protect public and animal health and the food supply against contamination of those agents. Because of several very public lab safety lapses in the past two years, the report makes 33 recommendations to improve lab safety. These recommendations include the development and update of policies that contain missing safety elements, the reporting of oversight activity to senior officials, and the development of plans with time frames to implement the safety recommendations. The report basically recommends a “Safety Stand Down.” Has your laboratory seen a similar situation? Have you encountered a series of like safety events that created the need to stop and review?

OSHA’s definition of a safety stand down is “an event for employers to talk directly to employees about safety.” Because of the danger to employees, a more specific definition means that all work stops until the issue is corrected and all affected (or potentially affected) staff has been educated to make sure the issue does not re-occur. However, in the real world, unless someone is in imminent danger, the work of the laboratory must go on for the sake of patient care. Still, a stand down can be important, and there are ways to run one successfully.

Once you have decided there is a need for the stand-down, develop the stand-down education. This can include a set of presentation slides, a hand-out, or talking points to use as the information is delivered. Make sure you stick to the topic(s) at hand, and do not include extraneous information, but be certain to include all items that are pertinent to the stand-down subject.

The next step is deciding on the stand-down delivery approach. Will you meet with staff one-on one, in small groups, or with everyone at the same time? Choose the meeting location(s) and schedule the meetings. Because this is a stand-down and a safety issue that must be dealt with, these steps should occur quickly. If you are facilitating the stand-down but not delivering it personally, be sure to give a short deadline for its completion and mandate that all involved personnel are included. Keep documentation of attendance and subject matter for future reference.

Once the stand-down is completed, gather the documentation of attendance and any other associated information and keep it for your records. This does not end the stand-down, however. Make a plan and a schedule to follow-up on the safety issue. The plan may include daily or weekly checks to ensure new processes are being followed or that staff has understood the information completely.

Conducting a laboratory safety stand-down can seem difficult and time-consuming. It may interrupt the work you planned to do, and it may change your schedule for the next couple of days or weeks. While that may be inconvenient, remember that this course of action was chosen to help prevent harm to employees or patients, and that is what laboratory professionals are here to do.

During the week of May 2, 2016, OSHA called for a construction fall prevention safety stand-down. This was in response to a high number of preventable worker deaths due to falls on the job. What safety issues have you seen in your lab? Have you seen multiple needle sticks? What about slips, trips, and falls? If you notice a group of similar safety events, it may be time to conduct a safety stand-down. If you deliver the information, provide the education, and document the attendance of all affected staff, you will prevent further injury and continue to raise awareness in the lab of vital safety issues.

 

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-Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

New Zika Virus Test Available

On April 28th, the FDA granted Emergency Use Authorization to Quest Diagnostics for an RT-PCR test to detect Zika Virus in human samples.

From the press release: 

“The test was developed by the reference laboratory business of Quest’s Focus Diagnostics, Inc., subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early in the week of May 2.

“Zika Virus RNA Qualitative Real-Time RT-PCR test is a real-time RT-PCR test intended only for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated ). Testing is limited to qualified laboratories designated by Focus Diagnostics, Inc.

“This test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under CLIA to perform high complexity tests.”

The Final Countdown

As June 1 rapidly approaches, I hear many questions about OSHA’s final deadline in its implementation of the Globally Harmonized System (GHS) for the classification and labeling of chemicals. For laboratories in the United States, this journey began in 2013 when the first training deadline arose. All employees who work with chemicals were required to have training on the changing chemical label elements and the updated and standardized Safety Data Sheets (SDS).

Helpful Hint: Neither you nor your staff should be writing or saying “Material Safety Data Sheet” or “MSDS.” Those are outdated terms and should no longer be used. Unlike the old versions, the new SDS are standardized with 16 uniform sections that are the same no matter which chemical manufacturer provides the information.

The 2013 GHS training provided a good amount of information, and it raised many questions. Will manufacturers really be using pictograms and signal words to identify hazards? Would they truly be able to make those changes by the next deadline dates? How does that affect secondary chemical container labeling? What about changes to the lab’s chemical hygiene plan and signage? It was a great deal to absorb and digest.

The year 2015 held within it two more deadlines that would affect all laboratories. First, chemical manufacturers would have to create only products which contained GHS-compliant labels, and they would have to produce only GHS-compliant SDS. OSHA realized that these manufacturers would have a substantial amount of non-compliant inventory at this point, so there was a six month period before the next requirement would be enforced. That meant these companies would have six months to continue delivering non-compliant chemicals and SDS to laboratories. The second deadline in 2015 was the cut-off period for these manufacturers. They would no longer be permitted to ship chemicals with non-compliant labels or SDS. The last deadline would also provide a six month gap. OSHA has given laboratories time to accept and use these chemicals with non-compliant labels.

Helpful Hint: Walk around your laboratory and look at all of your primary chemical container labels. If you find any that are not GHS-compliant, you need to remove them from your lab before June 1 of this year. OSHA does NOT allow the re-labeling of primary chemical containers.

The final GHS implementation deadline, June 1, 2016, requires that labs complete the updates of all workplace labels, Safety Data Sheets, and any hazard communication policies and procedures. The lab Chemical Hygiene Plan should be updated to include newer terminology and labeling instructions. The chemical inventory may need updating as well to include signal words or pictograms if used on that form. While this last deadline has an impact on primary chemical container labels, it does not need to affect secondary container labeling. OSHA does allow the continued use of NFPA or HMIS labels for secondary containers in the lab provided staff is trained on those hazard warning systems as well.

Helpful Hint: For consistency and better staff understanding, choose one labeling convention for secondary chemical containers in the lab. Using GHS and NFPA/HMIS may be confusing. Labeling is an important piece of hazard communication, and staff needs to be clear on what hazards they may be handling.

Some signs in the lab may need updating in certain areas. Buried in OSHA’s Formaldehyde Standard (1910.1048) is a GHS reference that points to a required wording change. If the formaldehyde warning sign is posted in your lab, the GHS implementation requires updated wording. The sign is required in labs where the formaldehyde concentration exceeds OSHA’s limits as detected via vapor badge monitoring. The updated signage must read as follows:

DANGER

FORMALDEHYDE

MAY CAUSE CANCER

CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION

AUTHORIZED PERSONNEL ONLY

The full implementation of the Globally Harmonized System is here, and it is a modern system designed to adequately communicate hazards to those who work with chemicals. Many countries around the world have been or are in the process of adopting GHS, a system which provides standardized warnings and information. Once fully implemented in your laboratory, these updated chemical hygiene practices will assist in providing an environment for working with chemicals that is both comprehensible and safe.

 

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-Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

FDA Allows Experimental Zika Virus Test

From the press release:

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

Zika Diagnositics in the Media

Today NPR featured a write up about how to test for the Zika virus. While It didn’t delve into the diagnostic testing side of things as much as Lab Medicine’s recent podcast, it does give readers a good overview. In addition, it highlights how critical laboratory professionals and pathologists are to public health and infectious disease prevention.

The Gloves Are Off … Or Are They?

The manager of the microbiology laboratory walked into the monthly staff meeting to discuss safety. Her first announcement was that the one clean hand washing sink in the department was going to be removed. The techs were shocked, and some were angry. Didn’t the manager care about infection prevention and control? Didn’t she know that hand hygiene should always occur after PPE is removed and before leaving the lab? The manager waited for the reactions to subside, then she explained that since the staff treated the lab as a clean area in many instances, that there should be no need for hand washing. The staff went on to argue that they were working with microbiological pathogens, and that they did wear lab coats and gloves, especially when handling specimens and setting them up for cultures. Some of those specimen containers were pretty disgusting, in fact.

That was when the manager dropped the charade. She had no real intention of removing the sink, but she wanted to make a point. She was tired of watching her staff reading culture plates with no gloves. She had spoken about it before, but no one agreed- they had been handling incubated plates for years.

One of the most common issues lab managers and safety professionals face is maintaining Personal Protective Equipment (PPE) compliance in the work area. An effective weapon in this battle is telling stories of lab incidents with bad outcomes, or explaining the consequences of this unsafe behavior. That is a valuable piece of lab safety education. It is unfortunate that we sometimes have to learn from others’ mistakes, but when it comes to safety, that’s better than learning from your own. Some lab accidents and exposures can be career-altering or career-ending.

OSHA’s Bloodborne Pathogen Standard states that PPE (specifically gloves) must be worn when there is a risk of exposure. That is as specific as they get on the topic. Anytime patient specimens are handled or opened, it follows that gloves should be worn. That means that in the microbiology area, staff is handling specimens and agar plates with gloves while they streak plates and set up gram stain slides. These contaminated gloves are handling plate after plate, and then those plates are placed into the incubators. Like any other contaminated item in the lab, those plates should be treated and handled with gloves until properly discarded. That means that gloves are necessary when removing plates from the incubator, and when reading those cultures. Not only is staff handling contaminated plates, but they are working with bacterial and fungal colonies. There is a high risk of exposure in those processes.

OSHA also requires PPE under its Chemical Hygiene Standard (or Lab Standard). Gloves are required when handling chemicals, so they would be needed when performing simple chemical tests (oxidase, catalase, etc.) and when performing gram stains. Make sure you use chemical-resistant gloves when selecting the appropriate PPE for these tasks.

In 2010, OSHA responded to an inquiry specifically about the use of gloves while handling culture plates in the microbiology laboratory. The letter “strongly suggests” the use of gloves for the task, but OSHA’s own standards already address the issue and clearly require the need for PPE in that situation.

The story at the beginning of this entry is true- there was a lab manager who was fed up with her staff not wearing gloves, so she told them she was removing the sink. She was kidding, but she made her point. In that microbiology lab they all wear gloves to read cultures today.

Laboratory-acquired infections occur every year, and some of the easiest ones to investigate are the cases in which techs are infected with pathogenic bacteria. It is fairly easy to trace the sources of those exposures. What is the staff doing in your microbiology laboratory? Are they doing everything they can to prevent exposure to pathogens? As a manager or safety professional, are you enforcing the use of PPE when exposure is possible? Keep your staff from becoming a safety statistic- provide PPE, teach consequences of unsafe behaviors, and monitor the continual use of those safe work practices in your lab.

 

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-Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

FDA Gives Emergency Use Authorization to CDC-Developed Zika Test

At the end of February, the FDA authorized the emergency use of the CDC’s test for Zika infection. This test is called the CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), and detects antibodies against the Zika virus. This test will be distributed to qualified laboratories that perform high-complexity testing.

For more information, read the FDA and CDC press releases.

Along the same lines, Siemens Healthcare Diagnostics has developed a real-time PCR assay for Zika virus and intends to apply for Emergency Use Authorization for the test in the US, according to GenomeWeb.