The document discusses the Certified Dental Laboratory (CDL) program. It was created in 1974 with the goal of improving dental lab quality and service. In 2005, a committee was formed to update the program to better meet industry needs. The summary describes the CDL application and certification process, which involves submitting documentation, photographs, and fees to demonstrate compliance with standards for areas like safety, infection control, and equipment. Certification is granted once approved by an independent auditor.
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Bio-Microbics, Inc. and Scienco/FAST, a division of Bio-Microbics, bring superior products to decentralized and distributed markets (residential, commercial, marine) with economical and effective treatment (whether for wastewater, water, storm water, etc.) to help ensure a clean environment for generations. Our products, policies, and personnel make the difference.
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Rsd engineering steam, superheated water and ethylene oxide (eto) steriliza...cathy fernandez rendo
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*Design for equipment manufacturing (sterilizers, vacuum chambers,…)
*Contract Ethylene Oxide sterilization services
Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances.
Assent Compliance with offices in Canada, US and EU provides consulting services and compliance software to businesses that must comply with local, national or global environmental regulations. Visit Assent Compliance for more information.
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4. Foundations
What does “more relevant”
mean?
• Program must be current and flexible to
meet evolving industry needs
• The value to participating laboratories and
their clients must increase through
marketing and recognition
• Standards must include a broader range
of subjects to be more applicable in the
business world
5. Standards
Overview of CDL
• Business
Standards
• Quality
Practices – Labeling
– Credentials/Training – Credentialed
– Gov’t requirements • 1 CDT/15 technicians
met – Training for all
– Prescriptions/Work – Specialty specific
Authorizations – Policies
– Policies • Re-make
• Re-make • QA
• Billing
• QA
6. Foundations
Overview of CDL
•
Standards Safety
Infection Control • General
– OSHA standards met – Building needs
– Training provided – Equipment needs
– PPE utilized – Housekeeping
– Specific IC area – Storage needs
• Receiving area
• Posted procedures
• Appropriately equipped
• Wet sink
7. The Application
• Get a CDL Handbook and
Application
– From NBC via the website or mail
– At NADL component meetings
• Submit application and the fee
• And…
8. The Application
Photographic documentation
– NBC provides a photo checklist
– Can submit snapshots or printed photos
– Can return electronically
• As .jpeg, .tif, .pdf or .ppt files
9. First Aid Kit (1A)
Kit used for
minor injuries
within Dental
Laboratory
15. Acid Storage (1H)
Acids are
stored properly
and any waste
generated is
disposed of
properly. We
have an Acid
spill kit on hand
for any
accidents.
PPE & MSDS’s
are available to
all Staff.
16. Infection Control (1I)
Entry Point
w/instructions on
sliding window Work area in Lab with Sink. See attached
Infection Control Operating Instruction for
posted protocols.
17. Burnout & Gas Storage
(2A & 2B)
Burnout area with casting
well. We have Propane Burnout oven
piped into the facility with the Exhaust Hood
tank stored outside. We Torch
utilize O2 on a mobile cart Casting Well
that is securely attached and O2 Tank
anchored nightly. We
provide necessary goggles,
Warning sign
gloves, and tongs for casting
for use of non
procedures. This area also
flammable
has an overhead exhaust
materials only
system that evacuates
directly outside.
18. Workbench Exhaust (2C)
Hi-Speed Lathe
for Metal
finishing/polishing
Hand piece with exhaust & safety shield
Unit has self contained unit w/filter
20. Evacuation of Fumes for
Monomer/Polymer (2E)
Monomer use
area with
overhead
ventilation
system
21. Evacuation of Fumes for
Monomer/Polymer (2E)
Our facility was
designed with air
exchangers that
circulate the air in the
Lab continually. Each
workbench area has
individual suction
units.
29. Production Area (14, 18)
Stone Room for
pouring casts,
trimming casts, die
preparation, and
custom tray
fabrication
Articulator and
storage area
30. The Application
Other documentation
– Infection Control training
– Alloy labeling
– Brand-specific records
– Country of Manufacture disclosure
– Policies
• Re-work warranties
• Staff training
31. CDL Fees
• Initial Application • 5 Yr. Revalidation
– $200 – $200
• Includes initial review • Includes initial review
and first year of • Includes renewal
certification • Late fee <1yr $25
• Annual Renewal • Late fee >1yr $75
– $150
• Late fee <1yr $25
• Late fee >1yr $75
32. Becoming a CDL
Submit the Application
• Staff checks for completeness and
documents compliance with paperwork
requirements
• Photographs are sent to the Independent
Auditor for a determination
33. Becoming a CDL
CDL is granted!
– Notification and materials sent
– New CDLs are recognized on the website
– “Provisional Approvals” may require additional
documentation, usually supplemental
photographs
The CDL program had seen little changes since its inception, so in 2005, it was decided to update the CDL program. A number of goals were identified resulting in the new CDL program that started in 2007.
CURRENT/FLEXIBLE: Requirements must change as industry evolves & include labeling requirements, record-keeping of product use & written policies for re-work/warranties and staff training. Written policy requirements are flexible - Specifics are up to laboratory discretion. Policies must be in place but can be customized to each lab as needed. Periodic review to ensure on-going compliance through new five year Revalidation allows mechanism to verify any new standards that may become necessary VALUE/INCREASE: Portion of fee revenue specifically directed towards marketing to dentists - Over 40% of 2007 CDL budget. Redesigned logo to show linkage with NBC APPLICABLE: New program is better for dentist customers - Business requirements stricter, allows better tracking, legal standards assured, re-work policies New program is better for patients - Greater patient protection through labeling requirements and ongoing training SUMMARY More relevant since requirements will evolve and on-going compliance is ensured. Independent Review ensures impartiality.
The CDL Modernization Committee developed these standards for the new program. (QA = quality assurance)
The CDL standards are mostly based on the Code of Federal Regulations, Title 21, Volume 8 (Rev 4/1/2005): 21CFR820. In the handbook, we have indicated specific references for you.
What do you do to become a CDL? Start with the handbook – it explains all of the requirements so that you can make sure your lab is a CDL candidate. How long does it take to finish the application so you can submit it? It depends on laboratory, but it can take extra time if items are missing so make sure it is complete before you send it in. Plan on at least two weeks. Fees are explained later in ppt. The section that seems to cause the greatest stress is…
The photos. The NBC provides a checklist to make it easier for you and inside of the Handbook each requirement is explained with the details that the auditors will be looking for when they review your photos. The following photos are selected examples from an application that was submitted to the NBC in a power point format. The applying lab gave the NBC permission to use their photos and we appreciate their participation. I will point out key areas that often require second audits. All photos must be labeled, but they can be labeled any way you want as long as we can match them up with the NBC checklist. Many labs use a permanent marker to label their photos. Some prefer labels or printing the number on their pages. Some name electronic files according to the checklist.
The first aid kit should be shown open and should not include any medications – just basic first aid supplies.
There should be fire extinguisher(s) and fire blanket(s). Both should have clear signage that is included in the photo. Multiple photos are welcome for the same item if necessary.
Other cautionary signs are welcome, but the exit signs are mandatory.
The location of the emergency gas shut off may be indicated with an evacuation map if need be, but it must be clearly visible and posted. A photo of the map can be used, or a copy of the map itself may be submitted.
Some photos may count towards multiple requirements.
Additional explanations may be included for the auditors, if necessary, but care should be taken not to have any specific lab identifying information included. Storage containers must be labeled. A spill kit should be photographed too.
Make sure to include a photo of the posted protocols or a copy of what you have posted. Also, the wet sink must be visible and a photo of an employee in this area wearing full PPE is recommended.
Local, direct exhaust should be shown. It should be located within 18” of the source equipment. If there is no local exhaust, other documentation (such as air sampling data) may be submitted. Some labs also include photos of the rooftop vent. It is important to pay attention to the gas and oxygen storage requirements as this is often a trouble area. “Storage” means overnight too – any time when they are not actively being used. Oxygen and any flammable gas (like propane) must be separated by at least 20 feet or by a 30 minute fire barrier. Tanks should be stored upright, marked as ‘Full’ or ‘Empty’ and secured. The O2 tank in the photo here is only on the storage carboy while in use, but the lab noted that it is properly anchored to a wall nightly for storage.
Suppressors are required on all air nozzles. Some labs choose to submit a close-up photo of their safety tips on handpieces.
Make sure any gear worn is worn properly.
Please block out the lab or individual technician names when sending this in. It helps to ensure confidentiality and impartiality for the auditors.
This lab was asking for certification in Crown & Bridge and Ceramics. This photo illustrated the model & die prep area.
This photo would likely have received a comment from the auditors about the unguarded left side of dental lathe. Even an unused, or inactive, side of the lathe should be shielded.
The photos are sent to the auditor for independent review. NBC staff reviews the other documentation that is provided with your application. Trouble areas: Infection control – unless yours is a one-man lab, the IC CE that you get as a CDT will not be sufficient unless it was provided to all production employees. This is asking about laboratory–wide training and the training must be completed annually. Alloy labeling – Usually satisfying by attaching a sticker, like an Identalloy sticker, in the area. Brand-specific records – This is usually explained by saying that the NBC is trying to verify that, if there were a specific product recall, you have a mechanism to track which restorations had been made using that product. A written statement that records (including products utilized) are maintained electronically, on the prescription or in laboratory files is usually acceptable and is the most common submission. Country of Manufacture disclosure - A n address on an invoice or work order fulfillment form is usually sufficient, ideally with a statement like “Manufactured by…”. Labs that use the NBC Case Box Stuffers may use those to document their system. Others may provide a copy of some sort of communication with the dentists for whom they work stating that items are “Made in the USA” or “Created in our Lab”. Policies – Many labs, especially smaller labs, do not have formal written policies. If this is the case, a written statement of procedure is sufficient. For the rework/warranty requirement, the NBC needs to know how your policy is communicated to the dentists with whom you work. For the training requirement, the NBC is trying to determine how you support staff training. Do you offer new hire training? Support conference of course attendance (with time, finances or spirit)? Offer in-house classes on new products and techniques? Support the reading of industry publications?
Once the NBC receives your application, it usually takes about 4-6 weeks for a response.
The NBC is reaching out, not only about CDTs, but about the CDL too. The NBC helps CDTs and CDLs promote the educational and professional standards they have proved through certification.
The NBC will even customize a powerpoint for anyone who might be interested in speaking to local dentist study groups about the CDL program.
I like the idea of a dark background, but am not sure how that would work with the logos. Also, since we’re not just CDTs, maybe the NBC swoosh would be better?