Patient Safety Compliance for Dental Labs

Overview

It happens all too often that we encounter labs who view trouble-shooting as the primary purpose for our software support services.  In truth, dealing with errors-- whether they be hardware issues or user errors or conflicts between various software systems--is only a small part of our work. 

The majority of our work with software development and support involves analysis, design, programming and testing toward keeping up to date with changes in laboratory and computer technology and requirements and in providing security and control for information. Other important components of our support services are ongoing training, education and guidance on use of the software.

It is QuickBooks that provides the software support for government requirements for accounting and taxation and it is DentaLab for QuickBooks that provides software support for government and industry requirements for patient safety.

Patient Safety Requirements for Dental Labs

In the dental laboratory industry, standards have been developed for Good Manufacturing Practices (GMP).   Compliance with these standards is recommended by the National Association of Dental Laboratories (NADL) and the Food & Drug Administration (FDA) in the USA and comparable administrations in other countries.  In addition, a growing number of states and provinces have developed legislation governing dental laboratory practices.

Included in GMP are measures to assure the safety of materials used in the manufacturer of dental prostheses.   Computer records of materials used, manufacturers, manufacturer codes or part numbers, and lot or batch numbers can be useful in tracking safety measures and in recalls, if defective or dangerous materials become necessary.

Also typically included in measures toward these goals are:

·        Documenting  the procedures used by laboratories to ensure patient safety

·        Tracking of production steps in laboratory cases by date, procedures, and   technicians

·        Documenting case issues and their resolutions

·        Providing information to the dental office and patient on the location where the work was performed 

DentaLab for QuickBooks: Patient Safety Support

For labs to comply with the increased requirements without incurring substantial amounts of time and money, it becomes critical to have good software support to both guide and document the steps in lab production.  Here are some of the ways this is done in DentaLab for QuickBooks:

1. Standard Procedures can be established to provide templates of work centers, items, and schedules.  These are used to guide case entry, providing both control and fast entry into the computer records.
2. Materials Disclosure sets provide templates of manufacturer, part/description, lot/batch numbers, entry by, start and expiration dates that can be associated with items and specific cases.  Should material recalls be mandated or adverse patient reactions be reported, associated cases can be quickly accessed.
3. Case materials disclosure documentation can be provided to the dental offices for inclusion in patient files.  These can also include laboratory registrations and/or certifications, safety data.                                                                                                                   
4. Tracking of case production by customer, patient, dates, procedures and items, technicians who performed the work, quality control issues.
5. Activity logs, case communication records, technician notes and case histories can all be used to track specifications and issues, resolution of problems.
6. Laboratory notes are standard text messages that can easily be included in case memos and other note-taking areas of the system including messages added to invoices to note issues, where the work was performed.
7. Electronic images created by the dental office or by scanning in the lab can be stored with case records and quickly accessed whenever needed to resolve issues or clarify specifications.

Upcoming Requirements

 
They seemed far away at first, but as the dates for the new government compliance requirements here in the USA close in, it is time to start planning for the software support that will be needed as development and testing do not happen overnight.  

One of the new federal requirements will be the excise tax on medical devices that will be applicable for most of the work produced by dental laboratories. QuickBooks already provides for automatic taxation if you specify that an item is taxable and then assign a tax item to specify the rate and chart of accounts entry.   For those who are in states and/or counties that also require taxation, you will need to assure that you are tallying multiple taxes accurately for government reporting.



Another will be the unique device identification (UID) that will require a barcode to identify the manufacturer, manufacturer contact information, date of origin, lot number, date of shipment, product class device, and risk classification.   This will likely require that a barcoded label be affixed to any packaging and possibly also the invoice or case materials disclosure form for the patient's records.  It is anticipated that a unique barcode will need to be generated for each case and shipment date.   Labs that provide services to the USA will need to register with the Food and Drug Administration (FDA) to obtain their UID.  

Whenever your national or local government issues regulations regarding the production of work based on dental prescriptions, we ask that you let us know so that we can determine if new measures of software support will be needed.

Contact us through:  http://www.mainstreetsystems.net