*Mary Borg writes a monthly article in JDT / JDT Unbound in which she alternates her topics monthly with Health and Safety concerns and Quality System information.

FREQUENTLY ASKED QUESTIONS

Dental Laboratory Health and Safety:

• What kind of disinfectant should I use in my laboratory’s receiving area?

This list is not complete but the most common ones we see. The quats are Cavicide, Opti-Cide, and DisCide ULTRA.  The phenols are Birex, Sporicidin, and Vital Defense.  The sodium hypoclorites are bleach sold to the public and the other chemical is MicroStat 2 which comes in a solution and a tablet (2 tablets that you mix together).  You can refer to Mary Borg’s written article about disinfectants in JDT Unbound for the Nov 06 issue and also her latest article in JDT November 2008. 

• How long should I disinfect an item? 

The baseline for disinfection has been determined by the Centers for Disease Control guidelines for dentistry to be how long it takes to kill TB.  Read the label on the disinfectant and use that bacteria as the determining factor in how to disinfect an item.

• What are the requirements for an evacuation plan map?

You are required to have emergency fire exits/routes marked.  Check with your local Fire Marshall to find out if there are any specific requirements for your map besides primary fire exit routes (such as secondary fire exit routes, location of firefighting equipment, etc). 
We recommend that you also show the location of certain safety items such as fire extinguishers, eyewash stations, etc., however, it will be imperative that you modify your evacuation route map should you move any of the items shown on the plan.  For instance, if you relocate a fire extinguisher or an eyewash station or remove one of those items, then the evacuation plan must be changed to reflect the change.  Should OSHA visit your facility and not find the items that are shown on the evacuation plan to be located where shown, you could be cited by OSHA.

• Is the Hepatitis B Vaccination mandatory?

It is mandatory that the employer evaluate which employees perform Category I tasks – the tasks that could involve exposure to potentially infectious items.  Then the employer must educate the employee on the risk and offer the Hepatitis B vaccination to the Category I Task employees.  The employer should coordinate with their company’s doctor or health dept. to administer the vaccine and it should be offered at the expense of the employer and on company time (not on the employee’s own time nor at the employee’s cost).  Mileage is also reimbursable to the employee if they have to drive to the doctor’s location for the vaccine.  The employer cannot require that the employee have the vaccine but if they refuse it, then the employee needs to sign the Refusal of Vaccination form (they can always change their mind later).  Other Category employees can be offered it, but it is not required nor does it have to be provided or paid for by employer.

• Should employees who respond to the vaccine have a booster?

The CDC (Centers for Disease Control) does not recommend a booster for Hepatitis B for responders to the vaccine.  The question here is whether or not the employee has had a titer test after he/she completed the 3 vaccine series to determine if he/she responded to the vaccine.  If the employee knows he/she was a responder to the original series, then the answer is “no” the employee does not need a booster.  If the employee does not know if he/she responded to the original series, then the employer should offer the complete series again. The only exception is if they are HepB positive, then the employer is exempt from offering the vaccine, but this must be documented, signed and put in the employee’s medical file.
The vaccine should be administered as follows:

• 3 shot series – spans 6 months
• Titer drawn 1-2 months after 3rd shot
• If positive, covered for life. No need to draw titers.
• If negative, repeat the shot series, draw titer 1-2 months after third shot.

If still negative, the employee needs to be counseled by physician regarding what he/she will do if they have an exposure and that they must receive the HepB anti-globulin within 7 days of their exposure.

• If I have not had air sampling done and my employees are exposed to silica dust, what type of respirator should they be wearing? 

The disposable respirators (masks with 2 straps and sometimes an exhale valve) made by Moldex or 3M are fine for your purpose rather than the cannister type. You can use the N-100 or the N-95. However, other workers who want to wear one can use the N-95. We recommend the 3M mask with the exhale valve because it's softer and doesn't get as hot.

• We are receiving bloody impressions from one of the dentist offices. How do I go about handling this situation? Is it okay to call the dentist office to talk to them about it?

There are several actions you can take. Besides the usual Universal Precautions, you can rinse the impression with water and then use a soft brush to remove the excess blood.  Also, you can carefully scrub the impression with a mixture of stone and water or you can soak the impression in an enzyme cleaner.
You can contact the dentist and ask him what procedures he is taking to clean and disinfect the impressions prior to shipment to the lab.  Sometimes the dentist is not aware of what the staff is doing to prepare impressions and other items that have been in the mouth to ship to the lab so be open with the dentist of how these items appear when they’re received.  Try to point out to the dentist or his/her staff to rinse the items, remove cotton rolls and retraction cords prior to disinfecting them and/or packaging them for shipment to the lab.

• Our chemicals are not properly labeled and our MSDS sheets are a mess. How do we solve this problem?

The first step is to take an inventory of all items in the lab and then begin procuring MSDSs for the items.  SafeLink offers an online MSDS service that can help you with this task.  After you have the MSDS, then you should begin labeling all containers that do not contain sufficient information to provide warnings of the health, flammability, reactivity, and target organs.  You must determine a system to use for quick reference to the hazards such as the National Fire Protection Agency’s system (NFPA) or the Hazardous Materials Identification System (HMIS).  These systems use numbers to indicate the severity of the hazard which makes it much easier for workers to have immediate warnings at their work area.
Begin labeling with secondary containers, i.e. those products that have been removed from the original container and placed in a secondary container.  You may want to begin with the hazardous items such as acids, porcelain, metals, cleaning agents, investment, gypsum, etc.  If a drawer contains one product, then you could label the drawer.  Don’t forget to label the bins used for storing the plaster or gypsum or investment.

• Does OSHA require lathes to have a guard or shield?

OSHA requires all rotary equipment to have guards or shields.  Most eye injuries in dental labs seem to occur in the model department.  Remember that you don’t want to create a greater hazard by installing a shield, for instance, on the model trimmer if it impairs the worker from seeing well enough to perform the task.  If you decide not to install the guard, then you need to have the workers wear close fitting safety eyewear or goggles. 

• What is the difference between lockout and tagout?

Lockout is the placement of an energy isolation device on a piece of equipment to render it inoperable. A lockout uses a lock to hold an energy isolation device in a safe position and prevents the energization of the machine or equipment. Tagout is when a tag is placed on a piece of equipment to indicate that the equipment being controlled may not be operated until the tagout device is removed.

•  Does OSHA require a dress code for dental laboratory employees?

A dress code should be established based on identified workplace hazards.  Employers try to develop dress codes using OSHA as a reason for certain attire.  In most states an employer may set whatever dress code they desire, but you should consult with a local attorney to ensure that your dress code doesn’t infringe on any employment law in your state.  OSHA requires you to identify all workplace hazards and if wearing shorts or open-toed shoes presents a safety hazard, then, you have the right to require long pants and closed-toed shoes.  You should review OSHA’s Personal Protective Equipment Standard.

Dental Laboratory Quality System:

• Who is getting inspected?

An FDA representative stated that when you register, you are put into "investigational inventory" and at some point in time you will be inspected.  The majority of the dental labs that we are familiar with who have been visited were visited either due to a complaint or being registered with FDA.

• What should classify as a “customer complaint”?

A remake is a complaint, but other issues should also be logged in as complaints such as:

• Any negative comments regarding the service in general
• Late delivery time
• Rude behavior on behalf of the lab
• Condition of case when it arrived at the client site

All complaints require corrective action with the corrective action being documented. 
Complaints need to be reviewed on a scheduled basis with corrective action taken noted. 

• What do you have to do to evaluate a vendor/supplier?

The lab must have a formal system in place for the evaluation of all vendors, suppliers, and subcontractors.  These evaluation forms must be reviewed initially upon receipt to determine if the supplier/subcontractor meets the lab’s requirements.  After that initial evaluation, then we recommend that a formal review be conducted again each two years. 

• Do you have to do a formal evaluation of suppliers/vendors that you have used for years?

You must be able to produce a list of all of your suppliers/subcontractors and the names of the materials you purchase from them.  The list should show why you do business with the supplier/subcontractor.  It is not acceptable to FDA to show "historical relationship" for reason for doing business with vendors/subcontractors/consultants. 

• How do you show the competency of your workers?

At a minimum you should have an employment application or resume showing the work experience of each worker.  Tracking internal reworks to technicians will provide a system for determining when additional training is required.  All training whether in-house or with outside resources must be documented.

• How do you determine the effectiveness of your quality system?

Each year you must conduct an internal audit.  This can be conducted by your own staff as long as they are not auditing a system that they are involved in.  You can hire a firm such as SafeLink to conduct an External Audit and it is highly recommended that each year you have someone from outside your lab conduct an audit.  At a minimum of annually, you must conduct a Management Review Meeting.  In that meeting, the quality team, and it must include the Lab Owner/President/CEO, must review all of the quality records to determine the effectiveness of the quality system.

• How do you track lot numbers and batch numbers of materials?

At a minimum you must track the lot numbers of patient contact materials.  This would include porcelain, acrylic, denture teeth, implants, zirconia blocks/cylinders, alloys.  You should test your system to ensure that you can track the lot numbers by each case.  The reason for this is that if there is a recall of any of these materials, you must be able to determine which dentists need to be notified so they can notify the appropriate patients.

• How do I track the lot numbers for subcontracted work such as copings, partial frameworks, PRM’s, etc.?

You must qualify your subcontractors by having them inform you in writing that they are tracking the lot numbers and can relay that information to you should there be a recall.  FDA may ask you if you have visited the facility where your subcontracted work is manufactured.  This is a part of your due diligence in determining whether or not to do business with a subcontractor.  If that subcontractor is in another country, then it is just as important for you to do your due diligence prior to accepting work from that subcontractor.