Tag Archive for: osha

Nationwide Shortage of TB Skin Test Antigens

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There is an update to this article, available here…

The Centers for Disease Control and Prevention (CDC) has issued an alert concerning a shortage of Aplisol®, one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the FDA for use in performing tuberculin skin tests. Par Pharmaceuticals notified CDC that they expect a 3 to 10-month nationwide shortage of the product, but this is only an estimate and is subject to change.

The CDC advises:

In settings with a low likelihood of TB exposure, the deferment of routine serial testing should be considered in consultation with public health and occupational health authorities. Annual TB testing of healthcare personnel is not recommended unless there is known exposure or ongoing transmission.

To accomplish baseline TB testing, or if testing becomes necessary in response to a known exposure to TB disease, Tubersol® may be substituted for Aplisol®, or an interferon-gamma release assay (IGRA) blood test may be used instead. Allocation of TSTs should be prioritized in consultation with state and local public health authorities. 

To monitor the status of this supply interruption, you may visit FDA’s Center for Biologics Evaluation and Research (CBER)-regulated products: current shortages webpage:  https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages

Deadline to Obtain Reformatted Safety Data Sheets

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The Hazard Communication Standard Revision of 2012 required manufacturers of hazardous chemicals to reformat all safety data sheets to a standardized 16-section format.  This process was to have been completed by June 1, 2015.

The compliance date for employers to obtain the newly formatted safety data sheets was June 1, 2016.  If your practice has not already collected the new safety data sheets, you should begin requesting/searching for them now. We recommend searching for safety data sheets online, as many manufacturers will post them on their website.  If safety data sheets cannot be found online, you may request a copy from the manufacturer by letter.  Retain a copy of the letter to demonstrate your effort to comply with the requirement.

When revised safety data sheets are obtained, you may discard the original material safety data sheets, as long as the hazardous ingredients have not changed.

Compliance is More than Training

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The following information provides a brief roadmap to achieving compliance, and is intended to help you understand the need to do more than employee training in order to avoid enforcement action from regulatory agencies.

Many practices view compliance training as the primary element for meeting regulatory requirements.  Although training is a key component, the reality is that compliance requires more than training.  Here are the basic major elements for ensuring compliance with any set of regulations:

Written Policies – Regulations, such as HIPAA and OSHA, require that you have written policies explaining your intent and process for meeting requirements.

Updates – Additionally, regulatory agencies require that you monitor for changes, new requirements, and new interpretations to ensure your policies remain current.

Training – All regulations include various requirements ranging from initial or new hire training to annual training on certain key elements.

Documentation – Records or documentation must be maintained.

Active Program – Having an active compliance program is a key element that you will not find specifically stated in a regulation, but can prevent the practice from being penalized if investigated. Regular audits help to ensure policies are being followed, and will ensure your compliance program remains active and relevant.

Note – These elements are provided for in Eagle Associates’ compliance programs. However, attention to provided updates, participation in employee training and use of included compliance tools is necessary to ensure your programs remain active.

OSHA Injury & Illness Recordkeeping Requirements

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OSHA has (again) partially exempted certain industries from regular injury and illness recordkeeping on OSHA forms 300 and 300A.  While certain healthcare practices are included in the list of such industries, the Bloodborne Pathogens Standard, state laws and pending interpretations may still require recordkeeping of all work-related injuries and illnesses.  Therefore, we recommend continuing to maintain these records, as usual, to ensure compliance.

Small employers (i.e., fewer than 10 employees at all times during the previous year), regardless of industry classification, continue to be exempt from routinely recording work-related injuries and illnesses on OSHA forms 300 and 300A.  However, certain severe injuries and illnesses, as well as needlestick and other sharps injuries that involve occupational exposure to blood or other potentially infectious materials, must still be recorded.

OSHA has also issued a new list of severe injuries and illnesses that must be directly reported (to OSHA) within specified time periods of their occurrence.

Please refer to the article in the upcoming December Advisor for detailed information.

OSHA TB Enforcement

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OSHA updated an enforcement directive for tuberculosis on June 30, 2015.  The directive verifies that OSHA enforces the 2005 Centers for Disease Control and Prevention (CDC) “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings.”

Some medical and dental practices have questioned whether TB guidance applies to them, either because of their size, or because they are a specialty practice that does not routinely see patients with active TB. The instruction clarifies that “For purposes of this instruction, ‘healthcare setting’ is defined as any setting in which healthcare is delivered and workers might share air space with persons with TB disease or come in contact with clinical TB specimens.”  Further, the instruction specifically lists medical and dental care offices among the outpatient healthcare settings that are subject to inspection.

The CDC’s TB guidelines require affected settings to have TB infection control plans, conduct annual risk assessments, perform baseline tuberculin skin testing for new hires, train staff on recognizing signs and symptoms of TB, among other elements.

You may find more information on OSHA’s enforcement directive in the September 2015 issue of the American Practice Advisor.  Please contact Eagle Associates if you need information regarding a Tuberculosis Exposure Control Plan.