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Join me in jumping the shark with the following fantasy. Imagine this. Early on Monday morning, you arrive at your job and receive the green light to call the Hookup Regulatory Cable Company. Your instructions are to have them implant holographic interactive wires into your brain and the brains of your laboratory coworkers. These bio-regulatory wire connectors will be linked to ten feet high 4-D television screens, which will be mounted on each of the four walls, ceiling and floor of your department.
Like many of the new theaters being created, the laboratory will be outfitted with surround sound amplifiers. The office chairs will be attached to hydraulic pumps that will automatically rotate, raise and lower chair heights to fit the intensity of the regulation you are trying to learn at the time.
Being plugged in to this new way of accessing compliance requirements will be more pleasurable. You learn as you walk, run even swim in a color-enriched Avatar-like holographic experience.
No More Wire Hangers
Your current muscle-building exercise of pulling and replacing huge paper manuals, housed on space-limited office shelves will be eliminated forever when the holographic regulations arrive. As a compliance auditor who juggles literally tons of manuals containing written detailed requirements, I am waiting for the day:
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when a click of my remote control will blast away volumes of FDA regulatory manuals and transform the motionless words into Netflix mini action movies, starting Harrison Ford;
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when the mountain of CLIA pages that we store in binders will come alive in the form of an exciting interactive Star Trek Holodeck or Avatar-like world. So that rather than reading about it, we will be able to step into it the regulation; and
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when an interactive version of the Joint Commission standards will be woven into an exciting holographic amusement park ride. A high flying roller coaster ride, where as you whirl thru psychedelic colored tunnels as the pictographic requirements flash on and off like strobe lights for rapid learning.
All of the above imaginings are not as farfetched as it may seem. The future will bring opportunities to both you and I where we will not only see the written procedural regulations, but will be able to hear, touch, smell and even taste the intent of those very requirements. With all of the rapid technological advances, I know this new sensory experience is coming to a laboratory manual near you. And I can hardly wait.
 Regulatory Bodies Expectations
As laboratorians, we literally eat from a large bowl of alphabet soup requirements everyday.
We are required to comply with all of the accreditation, certification and licensure regulations and federal, state and municipal laws which apply to our practices. We must be well versed in the requirements of several agencies, including but not limited to the following:
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American Association of Blood Banks (AABB)
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Center for Disease Control and Prevention (CDC)
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Centers for Medicare and Medicaid Services (CMS)
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Clinical Laboratory Improvement Amendments (CLIA)
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College of American Pathologists (CAP)
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Commission on Laboratory Accreditation (COLA)
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Food and Drug Administration (FDA)
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Health Human Services, Substance Abuse and Mental Health Agency (HHS, SAMSHA)
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Health Insurance Portability and Accountability Act (HIPAA)
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International Standards Organization (ISO)
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Occupational Safety and Health Act (OSHA)
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United States Department of Transportation (DOT)
Each of the above listed agencies has its own individual focus which spans across, clinical laboratory quality control, equipment, software and method validation activities and patient-focused approaches.
Employer Expectations
In addition to the external agencies, each institution in which the laboratory employee is hired, develops, implements, and maintains written policies and procedures designed to meet relevant requirements.
The topics include cconfidentiality of test results, patient safety goals, specimen identification, turnaround time (TAT), hazardous waste disposal, paper and electronic record retention, reportable disease notification, referral of tests to another laboratory, transportation and handling, infectious materials; and lab activities in event of local, regional or national disasters, diagnosis coding, professional courtesy and other similar job-related expectations.
Yes, as you can see without a doubt, there is a volume of requirements that auditors and those being audited are accountable to know and stay abreast of. The quantity increases almost daily as changes in healthcare approaches and laws occur.
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