You Can't Handle the TRUTH... About N-95 vs. KN-95 Respirator Masks

In recent weeks I have answered the same questions over and over (for different people). Perhaps you have some of the same questions and misunderstandings, so I thought I’d share some questions (and my answers) with you. Grab a snack and refill your drink… this is going to be a long one!

Rumors About N-95 and KN-95 Respirator Mask

1. I don’t understand why you keep telling us we have to implement an OSHA Respiratory Protection Program – we don’t use respirators.
   • The terminology around masks and respirators is the cause of a lot of confusion. You use N-95 masks, which you call “masks”. The N-95 mask is classified by OSHA as Face Filtering Respirators (FFR). As such, N-95 respirator masks are subject to the requirements OSHA’s Respiratory Protection standard (1910.134).
     
     
2. My staff doesn’t like the N-95 because they fit too snug and they are uncomfortable, so we use KN-95 masks. Is there anything I need to know about this?
   
   • Some KN-95 respirator masks are allowed for use in healthcare settings under an Emergency Use Authorization (EAU) from the Food and Drug Administration (FDA). I suggest you prepare for and expect this EAU to go away as the N-95 supply becomes capable of meeting demand, as the limited access to N-95 was the driver of the EAU. When EAU for KN-95 goes away, dentists and required staff will be forced to use N-95 or other NIOSH-approved respirator masks, which will mean that you will need to get into compliance with the Respiratory Protection standard including fit testing.
     
     
3. If we wear KN-95 masks we don’t have to do fit testing, right?
   • OSHA does not address this. N-95 have been studied and OSHA’s Respiratory Protection standard was put into place around the use of N-95 and equivalent NIOSH-approved respirators. Congress is too busy playing politics to provide OSHA with any clarification about KN-95, so there is no directive from congress to OSHA (law) and therefore nothing for OSHA to enforce regarding KN-95 respirator masks. HOWEVER, employers should always be mindful of OSHA’s General Duty Clause, which requires that providers ensure a safe work environment for their employees. With this, implement all other requirements of the Respiratory Protection standard, such as appointing someone to oversee your safety program, establish a written respiratory protection program, provide adequate employee training, provide for a medical evaluation for employees who are required to wear a respirator.
     
     
4. Do my front office staff have to wear N-95/KN-95?
   • Neither OSHA regulations, CDC guidelines nor TSBDE rule 108.7 specify whether or not front office staff have to wear N-95/KN-95. Rule 108.7 specifies that “DHCP who will be within six (6) feet of any and all procedures likely to involve aerosols shall wear N-95 respirator masks, KN-95 masks, or their substantial equivalent”. So, if front office staff will be within six (6) feet of any and all procedures likely to involve aerosols they must wear a N-95/KN-95. If not, then they are not required to wear a N-95/KN-95. However, those who are not required to wear a N-95/KN-95 may voluntarily wear a N-95/KN-95. Most the requirements that exist for required users do not exist for voluntary users. However, use of N-95/KN-95 is not voluntary whenever they are required by Rule 108.7(16)(B).
     
     
5. Help! I’m confused about the difference between a fit test, medical screen and seal check.
   • You’re not alone! First, OSHA’s Respiratory Protection standard requires employee training. As part of that training your staff should be taught how to perform a seal check. A seal check is a quick check they should perform every time they put a respirator on (regardless of what type of respirator). This is a simple check to make sure it forms a proper seal against the wearer’s face.
   • Next, before an employee who is required to wear a respirator dons (puts on) a respirator for use in a hazardous environment they must be screened for suitability/ to ensure the use of a respirator will not exacerbate underlying conditions they may have. Once an employee is medically cleared to wear a respirator they must be fit-tested. OSHA has a specific questionnaire that must be completed.
   • A fit test is a more involved process. There are two types of fit tests that may be performed (qualitative and quantitative). The qualitative fit test (QFT) is a is a pass/fail method that relies on senses - such as taste and smell - to detect air leakage from your respirator. The quantitative fit test (QNT) typically involves is the process to measure the precise amount of leakage into any tight-fitting facepieces. Instead of relying on bitter-tasting chemicals and your senses, the test is performed by a machine calculating the measurements. 
   • When a person is fit tested, they are fit tested to a specific make and model respirator. Initially, employees must be fit tested before wearing a respirator into a hazardous environment (within 6 feet of aerosol generating procedures) the first time, whenever they will need to use a respirator other than the one they are fit tested to, if the user experiences significant weight gain/loss, or traumatic injury that might change the shape of their face and annually thereafter.
   • Currently, only the annual re-fit testing requirement is set aside. Initial fit testing is still required.
     
     
6. What training do I need to do with my employees?
   • Employees who are required to use respirators must be trained on respiratory hazards to which they are potentially exposed during routine and emergency situations (COVID-19); the proper use of respirators, including putting on and removing them, any limitations on their use, and their maintenance; and procedures for regularly evaluating the effectiveness of the (respiratory protection) program. Here are some OSHA videos to supplement your office training.
     
     
7. Will we have to comply with the Respiratory Protection standard after the pandemic?
   • When the need for respirators no longer exists the requirements of the Respiratory Protection standard will no longer apply, except for employees who work in moderate to high risk environments for exposure to tuberculosis, same as before the pandemic.
     
     

State Dental Board vary (some) in their COVID-19 requirements for dentists. In Texas, the Texas State Board of Dental Examiners (TSBDE) has a rule regarding the Standard of Care. This rule (108.7) in its entirety is titled, “Standard of Care – General”, it effectively establishes the Standard of Care dentists must comply with. The rule includes many things, such as requirements for medical history reviews and physical examinations, informed consent, and checking vital signs. 

In April 2020, the TSBDE adopted subsection 16 to Rule 108.7 which has become known as the ‘COVID-19’ rule (108.7(16)). Subsection sixteen details requirements, such as what to do “Before dental treatment begins”, “During dental care”, “Clinical Technique”, and “After dental care is provided”. 

Specifically, Rule 108.7(16)(B) states, “During dental care DHCP (Dental Health Care Personnel) shall implement Transmission-Based Precautions, including N-95 respirator masks, KN-95 masks, or their substantial equivalent for all DHCP who will be within six (6) feet of any and all procedures likely to involve aerosols”.

Notice the rule says “shall” and not “should”. This means the use of respirators is required and is not optional.

So, we established that the use of N-95, KN-95, or their equivalent are required use. They are required by TSBDE rule.

Next, let discuss OSHA in relation to this requirement…

OSHA has standards and guidelines.

OSHA standards are law (compulsory compliance).

OSHA guidelines, like CDC guidelines are suggestions/recommendations to ensure safety.

OSHA Standard 1910.134(a)(2) (the law) states, “A respirator shall be provided to each employee when such equipment is necessary to protect the health of such employee. The employer shall provide the respirators which are applicable and suitable for the purpose intended. The employer shall be responsible for the establishment and maintenance of a respiratory protection program, which shall include the requirements outlined in paragraph (c) of this section (see next paragraph). The program shall cover each employee required by this section to use a respirator.

This paragraph requires the employer to develop and implement a written respiratory protection program with required worksite-specific procedures and elements for required respirator use. The program must be administered by a suitably trained program administrator. In addition, certain program elements may be required for voluntary use to prevent potential hazards associated with the use of the respirator. The Small Entity Compliance Guide contains criteria for the selection of a program administrator and a sample program that meets the requirements of this paragraph.”

According OSHA’s Small Entity Compliance Guide for the Respiratory Protection Standard (suggestions on how to comply with the law) employers must: 

1. Establish a safety program administrator
2. Implement a written Respiratory Protection Program
3. Identify and evaluate workplace hazards
4. Provide for respirator selection
5. Provide size appropriate respirators for employee use
6. Provide for medical evaluations for employees who are required to use a respirator
7. Provide for fit testing and user seal checking
8. Provide employee training
9. Create/maintain records (medical evaluations, fit testing, employee training)

Respirators Types

There are three common classifications of respirators: 

1. Face Filtering Respirators (FFR), sometimes called disposable respirators or dust masks
2. Elastomeric (Darth Vader looking masks)
3. Powered Air-Purifying Respirator (PAPR) 

N-95 masks are classified as FFR. That’s right, N-95 masks are respirators.

Who Are Regulators?

Who/what is the National Institute of Occupational Safety and Health (NIOSH)? NIOSH is a non-regulatory agency that provide safety guidance and recommendations. NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS).

In short, NIOSH studies safety matters and issues advice on how to reduce safety risks. NIOSH prescribes specifications for N-95 respirator masks.

Congress establishes safety laws based in large part on NIOSH recommendations.

OSHA enforces safety laws created by congress.

Next, the Food and Drug Administration (FDA) evaluates and regulates medical devices including KN-95 masks, which were not approved for use by healthcare providers in the United States prior to the COVID-19 pandemic. After some back and forth in 2020 some KN-95 masks were granted an Emergency Use Authorization (EUA) allowing for the authorized use of some KN-95 respirator masks given the shortage of N-95 masks. While the use of KN-95 masks is allowed you should anticipate that this EUA will eventually go away as N-95 supplies return to normal levels.

Confusion About Respirator Masks

There is a LOT of confusion about respirator masks.

KN-95 respirators are the Chinese equivalent to N-95 respirators. 

N-95 and KN-95 masks are respirators (Face Filtering Respirators) as per the CDC. 

As Face Filtering Respirators, the use of N-95 is subject to the requirements of OSHA’s Respiratory Protection Standard (law). As stated above, there is nothing in the law and it is unclear if/how the law applies to KN95, since they are not regulated by NIOSH/OSHA.

OSHA is silent on whether they recognize KN-95 respirator masks as a N-95 equivalent or whether the KN-95 are subject to the Respiratory Protection standard’s fit testing requirements.

OSHA Enforcement Actions

Having supported dentists who have drawn OSHA complaints by their employees it has been my experience that OSHA is informing dentists to “comply with the CDC guidelines”.

An Actual Letter From OSHA

The following is the actual letter OSHA sends to dentists upon their receipt of a COVID-19 related OSHA complaint. I have seen a number of these letters over the past year. They’re all the same. Here it is:

On (INSERT DATE), the Occupational Safety and Health Administration (OSHA) received a notification alleged workplace hazards(s) at your worksite concerning COVID-19. The specific nature of the complaint is as follows:

1. The employer has not conducted a personal protective equipment hazard assessment.
2. Personal protective equipment is not being provided.
3. OSHA training such as, but not limited to bloodborne pathogen, hazard communication, personal protective equipment and fire extinguisher training has not been conducted.
   
   COVID-19
4. The employer has not developed an effective plan to address the specific exposure risks, sources of exposure, routes of transmission and other unique characteristics of SARS-CoV-2. The plan should focus on engineering controls, administrative controls, work practice controls and personal protective equipment. Such as but not limited to:

• The employer is not following the CDC recommendations to protect employees.
• The employer is not following State, and local safety requirements to protect employees.
• The employer is not providing sanitary/good housekeeping processes, social distancing processes, or PPE as necessary for employee safety and to reduce exposure.
• The employer is not communicating adequate information to ensure employees understand and adhere to safe work practices.
• The employer is requiring employees that are ill with symptoms, such as but not limited to fever to continue working.

Currently, there is an outbreak of COVID-19, also known as Coronavirus.  At this time, OSHA is prioritizing its enforcement resources, and OSHA does not intend to conduct an on-site inspection in response to the subject complaint at this time.  However, because allegations of violations and/or hazards have been made, we request that you immediately investigate the alleged concerns and make any necessary corrections or modifications.  Please advise me in writing no later than (INSERT DATE), of the results of your investigation.  You must provide supporting documentation of your findings.  This includes any applicable measurements or monitoring results, photographs/video that you believe would be helpful; and a description of any corrective action you have taken or are in the process of taking, including documentation of the corrected condition.  

In addition, OSHA is aware that the current pandemic has created an increased demand for some protective equipment, limiting availability for use in protecting workers from exposure to the virus.  If this situation has prevented you from furnishing protective equipment to your employees, you should provide that documentation of the efforts you have made to obtain that equipment.  Please feel free to contact the office at (***) ***-**** if you have any questions or concerns.  We are also advising you that OSHA will notify the Centers for Medicare & Medicaid Services (CMS) of substantiated complaints for their consideration.

This letter is not a citation or notification of proposed penalty which, according to the Occupational Safety and Health Act, may be issued only after an inspection or investigation of the workplace.  It is our goal to assure that hazards are promptly identified and eliminated. 

Please take immediate corrective action where needed.  Depending on the specific circumstances at your worksite, several OSHA requirements may apply to the alleged hazards at your worksite including: 

• 29 CFR § 1904, Recording and Reporting Occupational Injuries and Illnesses
• 29 CFR § 1910.132, General Requirements - Personal Protective Equipment.
• 29 CFR § 1910.133, Eye and Face protection.
• 29 CFR § 1910.134, Respiratory Protection.
• 29 CFR § 1910.141, Sanitation.
• 29 CFR § 1910.145, Specification for Accident Prevention Signs and Tags.
• 29 CFR § 1910.1020, Access to Employee Exposure and Medical Records.
• Section 5(a)(1), General Duty Clause of the OSH Act.

 OSHA's website, https://www.osha.gov, is a full-service resource center, offering a wide range of safety and health-related services in response to the needs of the working public, both employers and employees.  These services include training and education, consultation, voluntary compliance programs, and assistance in correcting hazards.

OSHA's Bloodborne Pathogens standard (29 CFR § 1910.1030) applies to occupational exposure to human blood and other potentially infectious materials that typically do not include respiratory secretions that may contain SARS-CoV-2 (unless visible blood is present).  However, the provisions of the standard offer a framework that may help control some sources of the virus, including exposures to body fluids (e.g., respiratory secretions) not covered by the standard. 

Information about these and other OSHA requirements can be found on OSHA's website at www.osha.gov/laws-regs.

If we do not receive a response from you by (INSERT DATE) as indicating that appropriate action has been taken or that no hazard exists and why, an OSHA inspection may be conducted.  An inspection may include a review of the following: injury and illness records, hazard communication, personal protective equipment, emergency action or response, bloodborne pathogens, confined space entry, lockout/tagout, and related safety and health issues. Please also be aware that OSHA conducts random inspections to verify that corrective actions asserted by the employer have actually been taken.

OSHA’s website, www.osha.gov, offers a wide range of safety and health-related guidance in response to the needs of the working public, both employers and employees. The following guidance may help employers prevent and address workplace exposures to pathogens that cause acute respiratory illnesses, including COVID-19 illness. The guidance includes descriptions of the relevant hazards, how to identify the hazards, and appropriate control measures. Additional resources are provided that address these supply issues and contain industry-specific guidance. 

1. For OSHA's latest information and guidance on the COVID-19 outbreak, please refer to OSHA's COVID-19 Safety and Health Topics Page (S&HTP) located at osha.gov/coronavirus
2. Preventing Worker Exposure to Coronavirus (COVID-19), (OSHA publication 3989), osha.gov/Publications/OSHA3989.pdf
3. Guidance on Preparing for COVID-19, (OSHA publication 3990), osha.gov/Publications/OSHA3990.pdf 

The Centers for Disease Control and Prevention (CDC) also maintains a website that provides information for employers concerned with COVID-19 infections in the workplace.  The CDC has provided specific guidance for businesses and employers at the following CDC webpage, which is updated regularly:

https://www.cdc.gov/coronavirus/2019-ncov/community/workplaces-businesses/index.html 

1. For general information and guidance on the COVID-19 outbreak, please refer to the CDC's main topic webpage at cdc.gov/coronavirus/2019-ncov/index.html.
2. For the CDC's information and guidance on the seasonal flu, please refer to their webpage located at cdc.gov/flu/about/index.html.

The CDC is recommending employers take the following steps to prevent the spread of COVID-19:

• Actively encourage sick employees to stay home.
• Accommodate sick employees through separation or telework (if possible)
• Emphasize respiratory etiquette and hand hygiene by all employees
• Perform routine environmental testing
• Check government websites (CDC, State Department) for any travel advisories (where applicable)
• Plan for infection disease outbreaks in the workplace

The concerned party involved has been advised of OSHA's response and has been provided with a copy of this letter.  Section 11(c) of the Occupational Safety and Health Act provides protection for employees against discrimination because of their involvement in protected safety and health related activity.

You are requested to post a copy of this letter where it will be readily accessible for review by all of your employees, and to return a copy of the signed Certificate of Posting (attached) to this office. In addition, you are requested to provide a copy of this letter and your response to a representative of any recognized employee union or safety committee that exist at your facility.  Failure to do this may result in an on-site inspection. The complainant has been furnished a copy of this letter and will be advised of your response. Section 11(c) of the Occupational Safety and Health Act provides protection for employees against discrimination because of their involvement in protected safety and health related activity.

Please feel free to contact the Area Office at (***) ***-**** if you have questions or concerns.  I appreciate your personal support and the interest in the safety and health of your employees.

Draw Your Own Conclusions

We unpacked a lot here.

What do you do with all this?

This pandemic could be over next month, next year, or maybe never. Heck I don’t know. 

The FDA EAU for some KN-95s could last until the end of the pandemic. Heck I don’t really know.

Would you/could you be fined for not fit testing your staff for KN-95 respirators? Maybe, but can’t say for certain one way or the other.

I am not aware of any dental office that has been cited (fined) that the lack of fit testing was the sole issue. If you can show your practice made a reasonable effort to operate a reasonably compliant dental practice you will probably come out well if you face an OSHA complaint. 

In the face of an OSHA complaint, be prepared to show your efforts.

If your office is out of compliance, expect that OSHA will force you to bring your practice into compliance and may issue you a fine. If you have made effort to meet their requirements, you can expect some reward for your efforts. If you have done little to nothing to get into compliance expect, the experience may sting your pocketbook.

The fact is fewer than a dozen dental practices (nationwide) have paid OSHA fines exceeding $10,000 for COVID-19 related safety violations.

This number does not reflect state board actions, which are (at best) difficult to track since cases take so long to resolve and are not reported to a national database, unlike OSHA’s enforcement actions.

Your odds of paying high fines are slim. To say there is an increased threat OSHA inspections or fines is overstated. Nonetheless, your compliance with safety standards is an important and necessary part of doing business. Additionally, you are morally and ethically bound to ensure the safety of your patients and employees, so put in a reasonable effort.

NOTE: On 03/21/2021, as I put the finishing touches on this article, OSHA announced their “National Emphasis Program” (NEP) whereby they indicated OSHA is cracking down. Time will tell what this will look like. The Biden administration seems ready, willing and able to do everything with extreme measure, so buckle up – it’s about to get interesting. Maybe we will see 6 figure fines for respiratory protection violations.

What will you do with what we discussed here?

What kind of shape is your practice in?

If you have to answer an OSHA complaint tomorrow…. how will you make out? 

Stop and think your way through this. What is the best strategy for your practice to navigate these challenging times?

If you need help, there are plenty of compliance professionals throughout the country (myself included) who can help you. Call someone. Get help – it’s okay to ask for help, really!

I welcome your comments. Drop me an email at Toothcop@DentalCompliance.com

About the Author

A former Law Enforcement Officer/ Dental Board investigator, Duane Tinker is the CEO of Dental Compliance Specialists. Mr. Tinker provides compliance consulting, auditing and training services for dentists and Dental Service Organizations on compliance risks including OSHA, HIPAA, Dental Board rules/ regulations, state radiology rules, DEA and state drug regulations, and Medicaid. Mr. Tinker is a frequent speaker for dental societies and study clubs. He also hosts a podcast called Talking with the Toothcop. Mr. Tinker can be reached by calling (817) 755-0035 or through his company’s website DentalCompliance.com.