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Inside This Issue:
DATIA Finds Major Problems with Proposed HHS Rule
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The Drug & Alcohol Testing Industry Association (DATIA) submitted comments on July 12, 2004 to the Department of Health and Human Services (HHS) that highlight inconsistencies, confusion, omissions, and other concerns with HHS’ Proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs.
The comments were submitted on behalf of DATIA’s 1,200+ members and were compiled with input from members, the legislative and regulatory committee, and board of directors.
The proposed rule would update current HHS
guidelines to include new technologies for
alternative specimen and on-site testing
methods—both of which are widely used in the
private sector. DATIA is concerned, however,
that many of the requirements in the new rule will be hard (if not impossible) to implement and may negate the benefits of using new technologies.
While DATIA has many concerns about the proposed rule, the comments focus on the ten most important problems. These concerns are outlined below; full text of DATIA’s comments is available at www.datia.org.
• The proposed rule lacks consistency among federal agencies. The Department of Transportation’s (DOT) regulations were developed with considerable input from the industry and employers, and have been effective. HHS regulations should mirror DOT’s and avoid confusion.
• The outlined collection procedures for alternative specimens take a “cookie cutter” approach. Some proposed requirements simply do not apply to the type of specimen.
• Hair specimen collection requirements in the rule are irrational—applying a sweat patch to the back of the arm is not considered invasive, yet taking hair from the same region constitutes a privacy concern in HHS’ eyes. Allowing only head hair specimens also allows donors to skirt the test by shaving their heads.
• The oral fluid collection procedures don’t reflect current industry standards and employer preferences. Employers and donors prefer oral fluid samples to be taken with a collection pad placed in the mouth rather than the donor “spitting” into a vial. It is less invasive, more professional, and easy to perform anywhere.
• The requirement for chain of custody forms (CCF) unique to each specimen type—and the lack of an electronic CCF— will lead to confusion, paperwork errors, and overburdened collectors. DATIA suggests a single, comprehensive form developed with input from the industry, and other departments and agencies.
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• A requirement for semi-annual inspections of all collection sites is burdensome and unrealistic. Further, the rule does not address the specifics of inspection: training, what is included in an inspection, inspection failure, fees, etc. Many collection sites are temporarily set-up on-site at a workplace, while others are located in remote areas of the country or the world, and the rule does not address how these sites could be inspected. DATIA recommends that this requirement be removed entirely.
• The training requirements for point of collection test (POCT) testers and specimen collectors are different. DATIA feels that the training should, at the very least, be the same for both—and favors more stringent training for POTC testers.
• The outlined quality control testing requirements are nonsensical in some areas, and incomplete in others. Lot testing should be done by the manufacturer before shipment, and by the POCT tester before placing the test into use. Daily testing risks a damaged lot being overlooked. Further, the quality control testing isn’t specific for each drug class that a particular device tests for.
• The prohibition of a relationship between an MRO and POCT operation will drive some businesses out of drug testing for federal workplace programs, as most occupational medicine clinics, wellness centers, consortia, third party administrators, etc., provide specimen collections, point of collection testing, and MRO services.
• The addition of Instrumented Initial Test Facilities (IITF) adds potential problems of additional administrative error, chain of custody problems, and loss of specimens or paperwork. Further, the “SAMHSA Certified” label attached to a different sort of testing facility can only lead to confusion by unknowing employers and service providers.
“DATIA commends the department on their efforts to update the guidelines to include new technologies that are widely used in the private sector,” said DATIA Executive Director Laura Shelton. “But DATIA’s members are concerned that many of the requirements established in this proposed rule will negate the benefits of using these new technologies.” |
A Winner Has Been Selected for DATIA’s New Program Management Course
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In April, DATIA announced that the Secrets to Successful Drug and Alcohol Program Management course was going to be revamped. DATIA issued an RFP to all members asking for their ideas on a new course curriculum. The response was wonderful, and DATIA received a number of proposals. The final decision was very difficult, but DATIA’s C/TPA committee was able to narrow down the selection to three proposals with one of them being the winner.
Debra Kennedy of Carolina Analysis, Inc., in Spartanburg, South Carolina, was awarded third place with a prize of $250. Joseph Reilly of Florida Drug Screening was awarded second place with a prize of $500, and Lori Lal of LGS Drug Testing in Upland, California, was awarded the winner with the grand prize of $750. Lori will also write the first draft of the course manual.
Lori has been a member of DATIA since 2001.
LGS Drug Testing is a southern-California based company providing a full range of drug and alcohol testing as well as consortium and training services to clients nationwide. Besides assisting clients in the U.S. and internationally in all aspects of the drug and alcohol testing industry, LGS Drug Testing has also worked with the Ministry of Public Health in Thailand in developing and implementing a drug testing and treatment approach in that country.
DATIA’s goal with the new course is to bring the class up to date with current issues affecting consortia and thrid party administrators. The old course focused primarily on Depatment of Transportation (DOT) mandated drug and alcohol testing programs. However, DATIA is well aware of the growing need for guidance on non-mandated drug and alcohol testing. Lori’s proposal includes both of these programs. Her proposal also addresses some of the pitfalls that C/TPA’s encounter with client contracts and standard operating procedures.
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Although the course will be totally restructured, DATIA will continue to follow its original standards of the National Accreditation for Administration of Drug and Alcohol Testing Programs (NAADATP). DATIA will unveil the new curriculum and course during its fall courses in September or October of 2004.
DATIA would like to thank the C/TPA committee for their assistance in choosing the new curriculum. |
DATIA’s 4th Annual July Workshop Was a Big Hit!
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On July 15, 2004, DATIA held its 4th annual July workshop titled Alternative Specimen and On-site Testing--Making it Work for You. The meeting was hosted at the beautiful Ronald Reagan International Trade Center in the heart of downtown Washington, D.C. The meeting was a grand success. There was record attendance of over 170 attendees, and many of them expressed that this was the best workshop held so far.
We began promptly with the first speaker, Mr. Walt Vogl from SAMHSA. DATIA was pleased to be the first drug and alcohol testing industry organization to have a SAMHSA representative speak on the proposed rules. Mr. Vogl’s presentation enlightened attendees on the reasoning behind many of the recently proposed changes to the Mandatory Guidelines for Federal Drug Free Workplace Programs. He gave a detailed overview of the new rules focusing on major changes like lab analysis procedures, validity tests, and the reporting of results.
Mr. Vogl was followed by a panel of four alternative specimen experts. Mr. Ken Kunsman of Orasure Technologies, Inc., Neil Fortner of Pharmchem, Inc., Bill Thistle of Psychemedics Corporation, and Murray Lappe of eScreen, Inc., spoke about the effects of the newly proposed rules on oral fluid, hair, sweat, and on-site urine testing. Each representative gave presentations outlining pros and cons of the proposed rules from the testing device manufacturer’s perspective. Each session, although questioning some of the proposed rules, supported SAMHSA for realizing the need for guidelines on alternative specimen testing in the workplace.
The attendees were then treated to an elaborate lunch catered by the Reagan building. Attendees networked with one another while enjoying salmon, roast beef, and an assortment of desserts. When they returned to the workshop, things continued with a presentation from Peter Susser of Littler Mendelson, LLC. Mr. Susser has an extensive legal background, which he shared with us to explain the legalities of alternative specimen and on-site testing in the United States. His presentation not only covered the 50 states, but Puerto Rico as well. Mr. Susser addressed federal law, state law, state regulations, and case law for hair, sweat, on-site, and oral fluid testing.
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Before the last session, DATIA treated all of the attendees to an ice cream break. Smiles were on everyone’s faces while they enjoyed their afternoon treats.
The last presentation was delivered by a panel of individuals from companies that have implemented alternative specimen testing into their drug free workplace programs. Christine Bell-Delafield of Publix Super Markets, Jennifer Scales of Palm Beach Gardens Marriott, and Louise Dandridge of IMC Phosphate discussed how instant testing and alternative specimen testing benefits employers. They discussed the many cost savings that their companies have seen as a result of incorporating these new techonologies.
DATIA would like to thank all of the presenters for sharing their knowledge with us. We hope that everyone gained insight into the future of alternative specimen testing. The industry is constantly advancing and evolving. It is wonderful to see that DATIA’s members are constantly seeking educational opportunities that will keep their businesses in line with regulations, laws, and techonology.
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Spotlight: DATIA's New Chairman of the Board
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During DATIA’s 2004 Annual Conference in Seattle, Washington, Joseph Reilly of Florida Drug Screening was elected DATIA’s new chairman of the board. Mr. Reilly is no stranger to DATIA’s executive board. He was the vice-chairman of the board for a year prior to becoming chairman. Mr. Reilly is one of DATIA’s charter members and has always remained very active within the organization. In an effort to familiarize the membership with their new chairman, we’ve conducted an interview with him. He has provided us with his personal views about the future of the drug and alcohol testing industry and where he sees DATIA fitting into that picture.
DATIA: Why did you decide to join DATIA, and eventually serve on DATIA's board?
Mr. Reilly: I joined DATIA based on the first notice I received from the association announcing its formation and some of its benefits. What attracted me was the ability to be listed in a national database of collection sites and to have access to this database. This enabled me to receive business from other providers who needed collections done in my area and also enabled me to provide services throughout the nation. Additionally, a source for education and training was an important benefit that I desperately needed.
I decided to run for a board position after encouragement by a fellow board member - Jim Campbell. Jim spoke to me at the annual conference in 1999 and suggested that I get more involved in DATIA. I had up to this point been very involved as a member and this was taking it to the next level. All organizations need leadership and I felt I had the experience and qualifications to serve in this capacity. I wanted to step up to the plate and participate at a higher level and work hard to help DATIA represent the drug and alcohol testing industry in Washington, D.C., on key legislative and regulatory issues; expand the workplace drug and alcohol testing market; provide members information, resources and benefits important to their operations; and promote the highest possible standards for the industry. I am excited about our industry and particularly about DATIA, an organization that has experienced phenomenal growth over the past nine years.
DATIA: Where do you see the drug and alcohol testing industry in the next 5-10 years?
Mr. Reilly: Tough question. We must be prepared for many changes. New markets are opening up, including student drug testing, sports testing and smaller businesses implementing drug free workplace programs. The proposed federal guidelines for alternative specimen testing, once finalized, will have major impacts on how we do business. Change is certainly coming and industry members must be prepared. The potential of increased demand for alternative specimen testing will cause many to re-evaluate their businesses. Although we are currently involved with instant testing, hair testing and lab based oral fluid testing, we need more sophistication with these and all of the various testing methods, which may become acceptable under the new rules. We must be ready for the potential increased demand. Over the next 5-10 years I see the industry growing tremendously and becoming more sophisticated. I believe our tasks, as service providers, will become more difficult with the increased products and services to be offered. We will face many new challenges revolving around alternative testing methods and our industry taking much more advantage of current and future technologies available for elimination of paperwork and electronic data transmission.
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DATIA: How do you envision DATIA's role in the future of drug and alcohol testing?
Mr. Reilly: DATIA will serve as an important component of our industry’s growth and maturity. As a very young industry, DATIA has helped us to show professionalism and provide consistent industry standards. DATIA will continue to be recognized as the leading authority regarding drug and alcohol testing issues. The leadership and representation provided by DATIA will become increasingly important. As the industry grows, the importance of a strong well organized trade association will prove to be beneficial to all involved in drug and alcohol testing. I believe that education and training will become the most crucial benefit of DATIA membership.
DATIA: What are some of your goals to accomplish for DATIA as the new chairman of the board?
Mr. Reilly: I have several key goals I hope to accomplish for DATIA as the new chairman of the board including membership growth, organizational development, and creating plans for the future of our association. I will work towards continual growth in membership so that our organization remains strong and that a cohesive group of a majority of drug/alcohol testing providers is working together towards a strong and professional industry. I intend to serve as the # 1 cheerleader for fellow board members helping and encouraging them to work hard for DATIA utilizing their vast experience and resources to assist the DATIA management team with the many projects and programs that are currently on line. Finally, I will attempt to motivate and work with the board of directors and membership to increase board and member involvement in order to assist with the growth of the association with focus on policy and planning and particularly long range plans. Effective leadership with member input and involvement will provide for the framework of the continual growth of DATIA. |
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The Department of Transportation’s Office of Drug and Alcohol Policy and Compliance (ODAPC) has been busy this summer clarifying compliance questions for the drug and alcohol testing industry. Two Q and A’s were issued in June and ODAPC Senior Policy Analyst Jim Swart answered one of DATIA’s most pressing questions.
Since the 49 CFR Part 40 revisions in August of 2001, DATIA has questioned whether or not it is a refusal to test when a donor refuses to wash his or her hands prior to a collection. It was DATIA’s understanding that refusing to wash hands was not a refusal to test. DATIA decided to send an email to ODAPC for clarification on this issue. Jim Swart responded with authoritative guidance, indicating that a donor’s refusal to wash their hands can indeed cause a refusal to test.
Mr. Swart wrote, “There are several steps in the collection process that are vital to protecting the integrity of the urine specimen. The collection step at 40.63 (b) is designed to ensure that the employee has nothing on the hands or under the nails that could be used to adulterate a specimen or to interfere with a laboratory’s obtaining a valid test result. As with any other part of the testing process designed to reduce specimen tampering by the employee--for example, emptying pockets when directed to do so--the Department would want the collector to take measures warn the employee of potential consequences of a failure to cooperate; and if need be, seek assistance from the DER or supervisor to ensure that the employee understood the ramifications, although accomplishing the latter would not be an absolute requirement.” All of DATIA’s training materials have been revised to include this change.
The first Q and A issued in June addresses the Federal Motor Carrier Safety Administration’s (FMCSA) and Federal Aviation Administration’s (FAA) requirements to obtain an employee’s drug and alcohol testing records according to 40.25 of the federal regulations. Read the complete Q and A below.
40.25 06/04
Question:
Will FMCSA-and FAA-regulated employers complying with the drug and alcohol information records check requirements contained in the Federal Motor Carrier Safety Administration (FMCSA) regulation 49 CFR Part 391 and the Federal Aviation Administration (FAA) Pilot Record Improvement Act be considered compliant with 40.25?
Answer:
• Yes, employers who are required by and who comply with the FMCSA's three-year requirement for obtaining and providing employee drug and alcohol testing information are considered to have satisfied the two-year requirement contained in 40.25.
• Likewise, employers who are required by and who comply with the FAA's five-year requirement for obtaining and providing employee drug and alcohol testing information are considered to have satisfied the two-year requirement contained in 40.25.
• These employers do not need to seek separately the 40.25 information if the employer adheres to the FMCSA and FAA regulations, as appropriate, for obtaining an employee's prior drug and alcohol testing information.
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The second Q and A addresses what an MRO should do when there is no split laboratory capable of testing an adulterant identified by the primary laboratory.
§40.187 06/04
Question:
What must an MRO do when he or she determines that there is no split laboratory capable of testing the adulterant identified by the primary laboratory after the employee has asked for the split to be tested?
Answer:
The Department views this situation closely paralleling the MRO reporting requirement, at 40.187 (d), when the split specimen is not available for testing after the request to test the split is made by the employee. Therefore, the MRO needs to follow similar steps.
• The MRO must first report to the employer that the specimen, "Failed to Reconfirm: Split Laboratory not Available for Testing."
• The MRO must also report to the DER and the employee that the test result must be cancelled and the reason for the cancellation.
• The MRO must direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
• Finally, the MRO must notify ODAPC of the failure to confirm.
The result of the collection under direct observation will be the result of record for this testing event.
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The Future of Drug Testing Technology
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It used to be that a pair of high-top Keds were the only available athletic shoes. This is certainly not the case today. Over the last couple of decades, the use of specialized products and services created to more advantageously serve specific needs has become the norm. The future of drug testing will see a shift from the “Keds model” of using urine for all purposes and increasingly will rely on the use of the specimen most appropriate for specific needs. Advances in instrumentation and in the technology used for both screening and confirmation have created the ability of labs to offer forensic quality commercial analysis of fluids and materials other than urine for the detection of drugs of abuse. These tests, chiefly utilizing hair or oral fluids (saliva), have now become established after having been used forensically for years.
The use of different specimen types can provide distinct advantages and disadvantages when compared to urine testing. One primary difference is due to the detection window created by the specimen. Typically, basic drugs (cocaine, opiates, PCP and amphetamines, for example) or their metabolites, will appear in urine a short time after ingestion and will be detectable for several days. With saliva, drugs may be detectable very close in time to ingestion (similar to blood testing), but become rapidly undetectable usually within a day or so. At the other end of the spectrum, hair can provide a several month window of detection, depending on the length of hair tested. However, since it takes time for hair to grow above the scalp, cut hair will not reveal ingestion in the approximate week prior to collection. (Plucked or pulled hair used sometimes for forensic law enforcement purposes may reveal use much closer in time.)
Drug testing programs can be adapted to utilize these differences so that the appropriate specimen is collected to obtain the information desired. For example, in making a pre-employment decision, the larger history provided by a hair test will generally uncover several times the number of users since abstaining from use several days before the test will have little impact on the result. This is far more effective than detecting only the applicants foolhardy enough to consume drugs immediately prior to their interview or test. In a post-accident situation, the longer window is not as advantageous, as a result representing use closer in time (saliva, urine) to the accident is generally sought.
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Other differences for hair and saliva when compared with urine include a less invasive collection, as well as one that is more secure, with a true chain of custody. With both hair and saliva the collection is observed, creating virtually no opportunity to substitute samples. The typical urine collection is not observed and the donor is behind closed doors providing a sample in private. As such, the chain of custody is compromised at its very inception. Hundreds of web sites tout the availability of clean urine, complete with heater packs and built in temperature strips for that authentic warm feeling. The magnitude of this problem is unknown since there is no way to tell if the substitution ever occurred in the first place. There are no mechanisms in place for a laboratory to distinguish when one human urine sample has been substituted for another.
As with urine, accurate and reliable FDA cleared assays are available for testing with saliva and hair. Depending on the drug of interest, however, one specimen may be far more effective than another, as detection of certain drugs may be problematic in some matrices. For example, while MDMA (ecstasy) and 6 acetylmorphine (the metabolite necessary to confirm heroin ingestion) dissipate rapidly in urine and may not be detectable for even one day post-use, these substances accumulate in hair and are easily detectable.
The implementation of any drug-testing program has always required careful thought and evaluation. As we shift toward specialization (and away from the “Keds model”), that process will increasingly involve the use of different specimen types, singly or in combination. As a result of the broadening in scope of options, testing can now advance from “one size fits all” and be tailored to take advantage of the specimen differences to more efficiently and effectively meet the needs of specific programs.
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FAA Comment Period Extended
The Federal Aviation Administration (FAA) is re-opening the public comment period on their proposed rule that clarifies some of their drug and alcohol testing rules. Originally published in 2002, the FAA rule attempted to make it clear that each person who performs a safety sensitive function directly or by contract--including by subcontract at any tier--for an employer is subject to testing.
Several comments submitted at that time indicated that the clarification would impose a serious economic burden on the aviation industry. In the new notice, published May 17, 2004, the FAA retains the original language from the rule, and is asking for additional public comments on the rule.
Many aviation industry representatives assert that drug and alcohol testing subcontractors will impose a serious financial burden on the contracting companies without enhancing safety.
The FAA points out that recent years have seen a significant increase in the amount of aircraft maintenance done by contractors instead of direct employees of the air carriers. The proposed rule would assure that all individuals who perform safety sensitive functions, including maintenance, would be drug and alcohol tested as it potentially affects the safety of the aircraft.
DATIA will submit comments on behalf of the industry that mirror the comments submitted in 2002. Members are urged to read the rule and submit comments before August 16, 2004. Text of the entire proposed rule, plus instructions for submitting comments, can be found at www.datia.org.
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HHS Specimen Validity Rule Change
In addition to the much discussed proposed Department of Health and Human Services (HHS) rules on alternative specimen testing, the department has new mandatory guidelines about specimen validity testing conducted on all urine specimens collected under mandatory guidelines. These guidelines are effective November 1, 2004.
The guidelines include new definitions associated with the federal CCF, adulterated specimen, confirmatory validity test, dilute specimen, initial validity test, invalid result, and substituted specimen.
The revisions grant donors the right to request that a split (Bottle B) specimen be tested to confirm an adulteration or substitution result that was reported by the primary laboratory on the primary (Bottle A) specimen. Validity testing must be done by a laboratory and the revision establishes the criteria that must be used by a laboratory to report a specimen as adulterated, substituted, invalid, or dilute. Updated drug test cutoff levels are also part of the revisions, namely 2,000 ng/mL for opiates and specific gravity tests to validate specimens with creatinine levels of less than 2 mg/dL.
Further, the revisions clarify and expand the MRO's duties to review positive, adulterated, substituted, and invalid test results reported by a laboratory. Donors have the same right to challenge the accuracy of a positive, adulterated, or substituted result reported for a single specimen collection as for a split specimen collection.
The revisions also expand the performance testing program to include inspection and evaluation of SVT procedures.
The full mandatory guidelines are available at www.datia.org.
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