You've given a very interesting perspective in many areas. I just thought of another subtlety: given this entire process, from the writing of the SOP, to calibration of instruments, training, etc., is there any sampling performed to observe the final results of the process? There should be some sampling in order to evaluate how good or bad the entire process is.
Clinical laboratories are required to subject a method to a rigorous validation procedure before the method is offered for clinical testing. Among other things this includes evaluation of experimental accuracy and precision over the full analytical measurement range and over a period of time.
Clinical laboratories are also required to participate in proficiency testing programs. In most cases this means that an independent body (such as the College of American Pathologists) sends samples to the laboratory, and the laboratory's performance on the proficiency test is evaluated. Proficiency testing is repeated on a regular schedule, generally several times per year, and if a laboratory consistently fails proficiency testing for a given analyte they will no longer be allowed to offer that test until they have corrected the problem. Furthermore, if misconduct occurs then the person in the laboratory who has overall clinical responsibility for the laboratory is at risk of criminal prosecution and could serve jail time.
There is also the matter of quality control and quality assurance. To give a taste of this aspect, the generally accepted standard for quality control includes the use of "Westgard rules" which are designed to assure that a clinical test stays within an acceptable accuracy range over a period of time. The use of Westgard rules is not universal, but they are are widely used.
There is also the matter of laboratory inspections. At a large laboratory that serves a national clientele there are multiple inspection authorities. The most important of these are the College of American Pathologists and the New York Department of Health. Both engage in very rigorous inspections of the laboratories, and if problems are found then deficiencies may be cited. If deficiencies are not corrected then serious consequences may follow.
There is also a matter of ISO certification. There is a growing trend for clinical laboratories to seek and obtain ISO certification, and this is quite an involved process.
There are also matters of certification of laboratory workers. For example, California has stringent requirements on the education and training of clinical laboratory staff, such as medical technologists, and if a laboratory performs testing on samples originating in California then they should (I believe they must) follow California's regulations in this realm. At a higher level of the lab, most labs have several medical directors that oversee sections of the laboratory. They are generally required to have certifications. For example, a PhD medical director who oversees a special chemistry section would typically have a DABCC certification, or if it is an MD medical director they would typically be a board certified pathologist, or in some cases may have DABCC certification or other equivalent level of certification. (I am DABCC certified.)
I don't know what regulations relate to preparation of drug doses, and the regulations may vary from country to country. For the sake of patient safety I hope the regulations are strict.