Compliance With FDA Is Not Optional

All commercial dental appliance manufacturers must comply with the Food and Drug Administration (FDA) Title 21, Part 820 regulations. Specifically, a dental appliance manufacturer will need to have a Quality System that addresses the following:

• Determination of applicability and FDA registration (manufacture of Class II medical devices such as sleep apnea and snore guards requires registration; domestic labs who are outsourcing to off-shore labs; all off-shore labs; and domestic labs that are re-packagers and re-labelers must register with FDA)
• Assignment of management responsibility
• Defining of purchasing controls
• Identification/traceability of patient contact materials
• Production and process controls
• Acceptance of final product
• Review of Non-conforming product
• Corrective and Preventive Action procedures
• Control of Labeling and Packaging
• Handling, Storage, Distribution, and Installation of materials and finished items
• Records retention and control system

JDT Unbound

www.nadl.org/jdtunbound/index.htm

This Journal of Dental Technology online publication is loaded with news and tips to help you with your business. Mary Borg, SafeLink's President, writes monthly safety articles for JDT Unbound. Be sure to read Mary's articles under Risky Business of JDT Unbound. You can also find helpful archived articles there.

Practical Advice about Hepatitis C in the Dental Laboratory

During the past several years, it has become more evident through the questions that Safelink’s consultants have been asked by dental laboratory employees and employers that some dental healthcare workers are among the 3.9 million Americans that the Centers for Disease Control (CDC) estimates to be infected with Hepatitis C. The questions we’ve received, which are becoming more frequent, come from the employee who wants to know if he/she should inform the employer about their diagnosis and from the employer who wants to know how to respond to the knowledge when an employee discloses this information. Because of the legal issues, I asked the law firm of Fisher & Phillips to answer the following questions. I hope this information will be helpful to both employees and employers.

1. If an employee makes an unsolicited disclosure to the employer that he/she has Hepatitis C, is the employer required by law to keep this information confidential?

“Covered employers do not have a duty under the American’s with Disabilities Act (“ADA”) to keep medical information confidential that is obtained in this manner. The ADA has regulations that require employers to keep information confidential regarding an applicant/employee’s medical condition or history if it is obtained from a medical examination and/or inquiry as permitted by the ADA. Therefore, if an employee makes an unsolicited disclosure to the employer that he/she has Hepatitis C, and the employer did not learn about the employee’s condition through a medical examination, then the employer is not required to keep the information confidential under the ADA.

However, from a practical standpoint, many employers keep this information confidential to avoid the risk of potential state law claims and to keep a harmonious work environment with respect to co-workers and attempt to limit disclosure to supervisors and managers to inform them of necessary work restrictions or accommodations. Furthermore, a state may have enacted its own laws that address non-disclosure of medical information. Employer’s should consult the applicable state laws to ensure compliance.”

2. What measures should employers take in response to learning that an employee has Hepatitis C? For example, should the employer give the employee cleaning agents for blood to be used if the employee receives a cut at work?

“It is a good practice to follow the same housekeeping and universal precautions for all employees with or without Hepatitis C. Instead of waiting to find out if an employee has Hepatitis C, employees should be trained and provided with the proper equipment to deal with workplace accidents depending on the nature of the position.”

3. What is the duty of the employer to address the situation with an employee’s co-workers once an employee has told the co-workers that he/she has Hepatitis C?

“There are no federal laws that require employers to advise employees that a co-worker is infected with Hepatitis C. However, many employers do speak with the employees or have a representative from an organization or the health department provide information on Hepatitis C. This practice may alleviate or circumvent problems in the workplace that may arise from false beliefs regarding the risk of infection or the nature of the disease.

Employers should consult state laws and state boards for any additional requirements.”

4. What issues or laws should an employer consider when an employee needs time off for treatment or another accommodation?

“Under the ADA, a covered employer must provide a reasonable accommodation to a qualified person with a disability who cannot perform one or more essential functions of the job if the accommodation would not create an undue hardship for the business. An accommodation is a modification or adjustment either in the way the work is customarily done or in the work environment itself (e.g., work schedule changes). Courts have held that the ADA contemplates that every impairment, including Hepatitis C, must be evaluated on a case-by-case basis to determine if an individual is disabled under the ADA. Therefore, individuals with Hepatitis C may or may not be disabled for purposes of ADA protection.

State laws may also define disability differently and, therefore, while an individual with Hepatitis C may not be disabled under the ADA, he/she may be disabled pursuant to state law. In addition, states may have stricter confidentiality requirements. Even if a court would find that an employee is not disabled for ADA or state law purposes, we suggest consulting with an attorney to help make this determination and to select a course of action.

Further, the employee may be entitled to unpaid leave if the absence is covered under the Family Medical Leave Act (“FMLA”). In general, covered employers must provide eligible employees with up to 12 weeks of unpaid leave in any 12-month period due to the employee’s own serious health condition that renders the employee unable to perform one or more of the essential functions of the job.”

5. How do the CDC directives come into play?

“Although the directives are non-binding, courts have given weight to the viewpoints of public health authorities, such as the U.S. Public Health Service, the CDC, and the National Institutes of Health. Therefore, although following CDC guidelines may not be dispositive in a court of law, a court may consider the CDC’s recommendations when determining the reasonableness of the employer’s actions.”

I asked the above question because the CDC published infection control guidelines for dentistry in December 2003. In the publication, it addresses medical conditions, work-related illness, and work restrictions. If you haven’t received a copy of that publication contact the CDC to receive a copy. To learn more about Hepatitis C visit CDC’s Web site at www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm.

In another issue, I will address public safety issues as they relate to the contact with patients by individuals known to have Hepatitis C and other infectious diseases. My thanks go to Fisher & Phillips LLC for this information.

How to Develop Your Safety Training Program

The Challenge of Safety & Health Training

Many of the techniques of safety and health training are just like any other kind of training, but there are several key characteristics that make safety training a special challenge:

• Job analysis is critical. Most trainers recommend a "needs analysis" before any training, but with safety and health training this is particularly important. Careful attention must be paid to finding out just what the employee's duties are, and just what hazards are involved in performing the job—not only in the regular routine, but also what might happen if the job is not performed safely.

• Careful evaluation and testing is necessary. After training is completed, you must check to see employees learned their lessons. You can't take a chance that a serious accident will occur just because you failed to train properly or because an employee didn't understand.

• Ongoing evaluation and motivation make it work. Just as important as being sure that your people learned the lesson is being sure that they are putting it into practice every time they perform the job.

• Some forces work against safety. There are some natural pressures or forces in most work places which push employees toward unsafe behavior. The most prevalent of these is pressure for production. The safe way to do a job is often not the quickest one. (Until there's a lost-time injury, that is.) Responsible managers know that sacrificing safety for speed is never the right decision—nor, in the long run, is it the most productive. Other negative forces include employee lack of interest, perhaps better described as "lack of motivation," lack of correct training, and distractions from the job.

OSHA's Seven-Step Voluntary Training Guidelines

What's the key to developing successful safety programs for your people? We think that by taking an organized approach and following proven techniques, you can design excellent programs for your organization. While there are many training development systems available, we recommend that for safety and health training, you follow OSHA's Seven-Step Voluntary Training Guidelines.

The voluntary training guidelines are a good place to start for several reasons.

• The Seven-Step Guidelines are sound. Training professionals and others agree that the OSHA Guidelines are well-conceived and well-executed.

• The Seven-Step Guidelines get you off on the right foot. It can't hurt that you are basing your training program on the suggestions of the agency that evaluates your compliance.

• The Seven-Step Guidelines are flexible. In developing its programs, OSHA realized that each worksite is a separate training challenge—each one has its own set of dangers and hazards. Therefore, OSHA has left the details of program design to you, knowing that you are in the best position to make the on-site hazard evaluation that will form the basis of your training program.

OSHA's Seven-Step Guidelines

Step 1—Determining if Training Is Needed
Step 2—Identifying Training Needs
Step 3—Identifying Goals and Objectives
Step 4—Developing Learning Activities
Step 5—Conducting the Training
Step 6—Evaluating Program Effectiveness
Step 7—Improving the Program

OSHA Step #1 Determine if Training Is Needed

Whenever you approach a situation which seems to call for training, be sure to step back and ask yourself whether training is the best way to handle the situation. Here's the actual text of the OSHA Voluntary Training Guidelines:

"The first step in the training process is a basic one: to determine whether a problem can be solved by training. Whenever employees are not performing their jobs properly, it is often assumed that training will bring them up to standard. However, it is possible that other actions (such as hazard abatement or the implementation of engineering controls) would enable employees to perform their jobs properly.

OSHA Step #2 Identify Training Needs

Once you establish that training is needed, you identify specific training needs. First, here's what the Voluntary Training guidelines suggest:

"If the problem is one that can be solved, in whole or in part, by training, then the next step is to determine what training is needed. For this, it is necessary to identify what the employee is expected to do and in what ways, if any, the employee's performance is deficient. This information can be obtained by conducting a job analysis which pinpoints what an employee needs to know in order to perform a job."

OSHA Step #3 Identifying Goals and Objectives

Next, you'll want to identify the specific objectives of your training. Here's what OSHA's Guidelines have to say:

"Once the employees' training needs have been identified, employers can then prepare objectives for the training. Instructional objectives, if clearly stated, will tell employers what they want their employees to do, to do better, or to stop doing.

OSHA Step #4 Developing Learning Activities

In this step, you'll select and design the activities that will enable trainees to reach your objectives. You'll also prepare any materials and training aids you need. Here's what the Guidelines suggest:

"Once employers have stated precisely what the objectives for the training program are, then learning activities can be identified and described. Learning activities enable employees to demonstrate that they have acquired the desired skills and knowledge. To ensure that employees transfer the skills or knowledge from the learning activity to the job, the learning situation should simulate the actual job as closely as possible. Thus, employers may want to arrange the objectives and activities in a sequence which corresponds to the order in which the tasks are to be performed on the job, if a specific process is to be learned."

OSHA Step #5 Conducting the Training

"With the completion of the steps outlined above, the employer is ready to begin conducting the training. To the extent possible, the training should be presented so that its organization and meaning are clear to the employees. To do so, employers or supervisors should:

1) provide overviews of the material to be learned;
2) relate, wherever possible, the new information or skills to the employees' goals, interests or experience; and
3) reinforce what the employees learned by summarizing the program's objectives and the key points of information covered.

OSHA Step #6 Evaluating Program Effectiveness

Evaluation of safety training is critical! Remember, the objective of training isn't to have a "great" training session. The real objective is safe work practices on the job. Training isn't successful just because people sit through it—it's successful if people learn from it and act safely and think safety back at the work site.

These steps are easy to overlook, because once the training program is rolling along, the tendency is to assume that it is going well and doing the job, and that employees are thinking and acting safely. This is a dangerous mistake.

Constant evaluation is necessary to be sure that the program is accomplishing its objectives, and constant improvement is necessary to be sure that the program stays current and covers those matters that employees need to know. Here's what the OSHA Guidelines recommend:

"To make sure that the training program is accomplishing its goals, an evaluation of the training can be valuable. Training should have, as one of its critical components, a method of measuring the effectiveness of the training. A plan for evaluating the training session(s), either written or thought-out by the employer, should be developed when the course objectives and content are developed. It should not be delayed until the training has been completed. Evaluation will help employers or supervisors determine the amount of learning achieved and whether an employee's performance has improved on the job.

OSHA Step #7 Improving the Program

Based on your evaluations of the program, you will want to make any improvements that your evaluation shows are necessary. Be on the lookout for changes in the job that require changes in the training. New equipment, new procedures, new hazards appear every day. Make sure your training program includes them. Here's what the Guidelines say:

"If, after evaluation, it is clear that the training did not give the employees the level of knowledge and skill that was expected, then it may be necessary to revise the training program or provide periodic retraining. At this point, asking questions of employees and of those who conducted the training may be of some help. Among the questions that could be asked are:

(1) Were parts of the content already known and, therefore, unnecessary?
(2) What material was confusing or distracting?
(3) Was anything missing from the program?
(4) What did the employees learn, and what did they fail to learn?

Evaluation and Improvement Are Ongoing

Change in training programs is inevitable. New equipment, new systems, new products, new processes, new laws, new employees, and many other factors demand that training programs change to keep up. In safety training, as we have pointed out again and again, there is little margin for error. You must keep your training activities in parallel with your hazard evolvement. It is only by regular evaluation and revision that our safety training—and our employees safety—are as excellent as they can be.

Complying with the Hazard Communication Standard

As consultants working in facilities around the country, we find that there is still a lot of work to be done by most employers in regard to understanding and complying with the Hazard Communication Standard. Hazard Communication relates to chemical hygiene. OSHA continues to cite facilities of all sizes for failure to have a written hazard communication program which includes proper labeling of hazardous chemicals, procuring and maintaining Material Safety Data Sheets, and training employees on this part of health and safety. Those of you with 10 or fewer employees are also covered by this Standard.

OSHA has posted a revised version of "Chemical Hazard Communication" (OSHA 3084) on its web site. The bulletin addresses common questions about the Standard, including who it covers, when and why a written hazard communication program is necessary, and how chemicals must be labeled. This information is available at here. We have developed the MSDS Toolkit to help facilities meet OSHA's Chemical Safety requirements.

There are many other Standards set forth by OSHA that also affect facilities. Workplace violence has exploded into the headlines and dominated national attention. Workplace violence is now a daily story and must be dealt with by employers. As an employer, you need to understand how these standards affect your responsibility to eliminate workplace hazards.

By Mary A. Borg

OSHA Bulletins

Preventing Adverse Health Effects From Exposure To Beryllium in Dental Laboratories

http://www.osha.gov/dts/hib/hib_data/hib20020419.pdf

CDC Guidelines and Information

CDC's Morbidity and Mortality Weekly Report (MMWR)
Guidelines for Infection Control in Dental Health-Care Settings - 2003

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

Slide presentation and speaker notes that provide an overview of the basic principles of infection control that form the basis for the CDC guidelines for infection control in dental health-care settings - 2003

http://www.cdc.gov/OralHealth/infectioncontrol/guidelines/ppt.htm

CDC's Morbidity and Mortality Weekly Report (MMWR)
Silicosis in Dental Laboratory Technicians - Five States, 1994 - 2000

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5309a3.htm