The Clinical and Laboratory Standards Institute (CLSI) Consensus Committee on Clinical Chemistry and Toxicology is inviting experts to participate on the document development committee of a new consensus guideline concerning laboratory support of pain management.
This new CLSI guideline will be a joint effort with the American Association of Clinical Chemistry’s National Academy of Clinical Biochemistry. This guideline will specify requirements and recommendations for laboratory support of pain management clinics and services. It will provide recommendations for sample types and collection, testing methodologies (screening and confirmation), and result reporting and interpretation. The sections related to specimens, collection, and testing will provide a brief discussion of the advantages and limitations of each. Additionally, this new document will include drugs other than the opiates and opioids as these patients are frequently prescribed benzodiazepines, along with other medications. Several tables of expected metabolites for common drugs will be provided. While a very brief overview of a drug or class may be provided, the document will not include information that would relate to dosing or prescribing.
The document development committee will require representatives with expertise and/or experience from clinical laboratory science and personnel management, hospital administration, risk management, and pharmacy, as well as health care providers tasked with establishing pain management testing for their institution and/or network.
Proposed Document Outline
I. Background and drugs used to manage pain and drugs frequently encountered (eg, cocaine, tetrahydrocannabinol) – This section will include a brief statement about pain management, and will describe the clinical significance of the testing (compliance vs raising the suspicion of noncompliance). It will describe the medications used in treating these patients with most focus on opiates/opioids, while recognizing that patients typically require additional treatment for anxiety, depression, etc.
II. Specimens and collection – This section will cover the specimen types encountered as well as a discussion of the overall issues of collection in this population and the issues/questions often posed to the supporting laboratory. The subsections focusing on sample types, i.e. urine, oral fluid, serum/plasma, and hair, will contain specifics regarding the use of that type – for example, physiology, when most appropriate, advantages/limitations or issues, and specifics for collection
III. Testing – This section will include a brief description of methodologies, settings in which each may be warranted, and benefits and limitations.
A. Screening methods – These are typically immunoassay based although some chromatography-based methods for screening have been developed. The discussion will include information regarding desired sensitivity/cutoffs, analytical measurement range requirements, specificity/interferences, turnaround time requirements/expectations for clinics, etc. It will address central laboratory vs point-of-care setting testing.
B. Confirmation methods – Typically, chromatography mass spectrometry–based methods are used for confirmation. Testing may not be performed in-house, but rather sent out to a larger reference laboratory. Normally, in toxicology, one thinks only of confirming positive screening results, but in pain management, the limitations of some of the screens necessitate confirmation of negative results.
IV. Reporting and interpretation of results – This section will provide suggestions regarding reporting formats for clarity and will provide tables listing common drugs with metabolites. For example, many laboratories have found health care providers confused by the traditional way of reporting a screening result as negative or positive.