DOMAIN: OPERATIONAL/ CLINICAL RISK


Implement clearly written policies and standard operating procedures (SOPs) consistent with SAMHSA mandatory guidelines, state or local requirements, and industry best practices and standards for the three parts of the drug testing process. 1. Specimen collection: • Provide specimen donors with information about specimen collection, laboratory analysis, and results reporting processes and responsibilities.


• Adhere to strict SOPs for specimen collection, packaging and shipping, pick up, and chain of custody. Tese may include, but are not limited to: • Timeframe for notice to the donor for specimen collection and testing.


• Completion of an accurate history of all drugs (including prescribed and OTC), food, and herbals used prior to sample collection.


• Measures taken to eliminate or detect sample adulteration or substitution.


• Appropriate accommodation (as may be required under the Americans with Disabilities Act for specimen collection while maintaining compliance with SOPs).


• Inspections of collection sites/ facilities with evidence of compliance with SOPs documented. Known or suspected errors/lapses in specimen collection practices are addressed immediately and reported for further investigation and system-wide corrective action.


2. Specimen laboratory analysis: • Tere is a Laboratory Director (or other title) role in place, responsible for the overall operation and administration of the laboratory.


• Determine where initial and confirmatory testing will be performed.


• Confirmatory testing of positive drug test results is done using established, analytical methods that meet a legal standard.


14 datia focus


• Highly accurate immunoassays that meet a legal standard are used.


• A rigorous quality control/quality assurance program is in place.


• Specimen chain of custody is strictly maintained. Known or suspected errors or lapses in specimen chain of custody practices are addressed immediately and reported for further investigation and system-wide corrective action.


3.Medical review of results: • Te Medical Review Officer (MRO) role is in place to ensure that test results are properly reviewed and interpreted before verifying the results as positive, and before reporting the results to the contracted employer/federal agency representative. SAMHSA provides guidance in the 2017 MRO Manual.3


• Te MRO is a qualified, licensed physician certified as an MRO.


DOMAIN: HUMAN CAPITAL RISKS Personnel • All job applicants are screened using a process consistent with state and federal employment practices requirements. Te organization conducts background checks, including: criminal records (misdemeanors and felonies); Fair Credit Act-authorized inquiries; motor vehicle (DMV) driving record; screening on sex-offender registries; and multi- state background checks.


• All personnel are qualified for their role or function within writen job descriptions, and demonstrate competency for their job duties on initial hire and periodically aſter that.


• Te organization consistently and fairly administers a system-wide, drug-free workplace and workplace drug testing program. Information about drug testing and impact on employment is communicated in ads, to potential job applicants, and to current employees.


DOMAIN: HUMAN CAPITAL Training • Drug testing service personnel receive documented initial and ongoing training


on their job duties, organizational policies and SOPs, and applicable new laws and regulations in order to demonstrate competency.


DOMAIN: HAZARD RISK Security • Facilities for specimen collection, laboratory testing, and results confirmation are safe and secure for donors, staff, and visitors.


• Te security and integrity of specimens are maintained. Te DOT has published guidance on this.4


• Compliance with applicable information privacy and data security regulations and laws, and the confidentiality of donor and drug test information.


DOMAIN: TECHNOLOGY/LEGAL/ REGULATORY RISK Documentation/Records • Clearly defined writen policies and SOPs for documentation requirements are in place to ensure effective communication regarding the entire drug testing process, results reporting, and to decrease risk exposure for inspections, audits, and other regulatory and legal maters.


• Provide training on documentation expectations, policies, and SOPs.


• Develop an enterprise document release, eDiscovery, and retention and destruction plan.


DOMAIN: TECHNOLOGY/LEGAL/ REGULATORY RISK


Specimen Retention, Storage and Destruction • Develop enterprise specimen retention, storage and destruction policies and procedures for different specimen types, specimens under legal challenge or hold, and how to maintain specimens for DNA testing, research, or any other purposes.


• Develop a policy and procedure for the release of a donor specimen.


Te examples of potential risk management strategies for a drug testing spring 2018


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