June 30, 2001

Guidelines for Selecting a Laboratory for Employee Testing

Peter P. Greaney , MD
Board-Certified Occupational Physician
President, WorkCare

When selecting a laboratory for employee testing, companies should consider the following guidelines to ensure the right match between employer needs and laboratory capabilities.  

Reasons to Use a Lab

Whether a company contracts directly with the lab or uses their service through a third party, such as a clinic or service provider, the employer should understand a lab's technological capabilities, its service limitations, accreditations, and quality control standards.  The primary consideration when selecting a lab is to ensure that the lab has the expertise, capabilities and credentials needed to meet the employer's need.  Employers may use a lab for the following reasons:

·         Biological Monitoring measures workplace agents or their metabolites in biological specimens, such as blood or urine. This process is used to monitor exposure or adsorption, helping companies assess the potential work-related health effects of employees.  Biological monitoring may includes tests for:  chemicals and metal, including lead, zinc, cadmium, chlorinated pesticides and aromatic solvents.

·         Medical Surveillance/Routine Clinical Laboratory Testing is used to assess an employee's health by using a variety of tests, which may include complete blood count, urinalysis, and blood chemistries.  Clinical tests characterize the status of specific organ systems and physiologic functions.  These tests can be helpful to detect such conditions as decreased renal or liver functions, and other organ disorders.  Elevated cholesterol levels and lipid abnormalities can also be detected with these tests.

·         Drug Testing Services are used to test employees for illicit drug use.  Employees subject to such tests are those that work in safety-sensitive positions. 

·         Unique Services such as toxicology and therapeutic testing may also be used by employers for case-specific needs.  For instance, in the military industry, cholinesterase testing is used per Army regulations. Specialty tests are also used for unique exposure populations, such as testing required by chemists who perform small molecule research.

A Note about Consistency of Normal Ranges

Lab results are reported in the context of reference ranges or “normal values.”  The reference ranges is a set of values obtained from a group of individuals in a defined state of health.  These reference ranges are typically defined as the range of values of the median 95% of the healthy population.  That means 5% of “normal” individuals may have values slightly below or slightly above the reference range.  In this situation, 5% of the “normal” population may fall outside (above or below) the reference range for a specific test result.  

Using a National Laboratory to Enhance Standardization of Lab Test Results

“Normal” values can differ among labs because of variances between the labs' calibration processes, reagents and instrumentations.  That is why there is an advantage to using one lab for all employee tests.  For example, a “normal” value test result taken at one lab may have a different value (possibly abnormal) if taken at another lab due to differences in lab processing procedures and/or accumulation of population data.

To ensure a standardized interpretation of a “normal” value, it is recommended to use one lab for your employee test pool.  Using a national provider for such tests would be particularly beneficial to those companies with multiple locations, ensuring consistent lab results for all sites.

Certification/Accreditation

If the employer requires drug testing services, the lab should be certified or accredited with the following organizations:

• College of American Pathologist (CAP)
• Substance Abuse and Mental Health Services Administrations (SAMHSA) formally HHS/NIDA
• Department of Health and Human Services
• U.S. Drug Enforcement Agency
• OSHA
• NIOSH
• State and local health department/agencies
• Multiple state licensing capabilities (particularly helpful for employers with multi state locations)

You should request copies of these certifications.  There are other accrediting agencies that may be used based on industry requirements.

Turn-Around Time

An employer should also assess the company's requirements for turn-around time of lab results.  The time it takes to test and produce results varies greatly from lab to lab.

Reporting Systems

Determine what type of system for reporting results would work best for your company.  Data capture and dissemination is a vital service that allows you to compare test results among different employee population groups.  Select a lab that has the capability to deliver prompt, accurate reports in a variety of formats:  Internet, printer, fax, mail, electronic transfer or computer disk. 

Quality Control

It's the responsibility of the employer to select a lab that adheres to stringent quality control guidelines.  Labs should follow the guidelines established by the U.S. Department of Health and Human Services and conform to best industry practices.  In addition, quality-focused labs will participate in Proficiency Testing Programs as an added control in ensuring quality.  Remember to request copies of proficiency testing results, which will give you valuable information on the status of their quality control programs. 

Technological Capabilities

Internet technologies makes it possible for clinical labs to market themselves on the World Wide Web, and provide services, such as receiving and processing service requests, transmitting results to practitioners and patients and sending billing data.  However, if these services are offered, they must be backed by a sound, secure system that maintains standards in the authentication process, limiting access, confidentiality, integrity, availability and attribution and non-repudiation.  The Health Care Financing Administration and the Health Insurance Portability Accountability Act of 1996 have established federal regulations regarding these standards.  In addition to web-enabled technologies, a quality lab provider should have sophisticated instruments and multiple detection systems, which may include high-speed analyzers for screening with secondary confirmatory testing.  

Customization

Determine if the laboratory has flexible systems and processes that allow you to customize specific programs to your company's needs, such as:

·         Complex or unique panel of tests

·         Ad hoc reports

·         Cumulative reports

·         Tailor-made chain of custody to ensure legality of testing program

·         Programs to assist in investigations regarding post-accident, reasonable suspicion and random testing

·         Customized reports to meet regulatory requirements

·         Customized arrangements for specimen collection

·         Methods development services (part of R&D department capabilities)

·         Project-specific consultation with scientific team

·         Expert witness testimony

Pricing

Employers with multiple sites have an opportunity to negotiate for competitive laboratory pricing by using a national provider who can offer cost-effective pricing through volume contracts.

References and Professional Affiliations

Request a client list, as well as information on the number of tests performed throughout the year and the percentage of retests.  It is also helpful to request information on professional staff qualifications and credentials, as well as a lab's leadership involvement with professional clinical lab associations and organizations.

These guidelines will help you select a provider that best meets your needs.  In addition to these guidelines, it's important that you select a lab provider with a reputation for service.  Use your network to get the real insight behind a lab's performance.