Laboratories regulation

Responsible disposal of chemicals, samples and consumables is likewise an important aspect of good operating procedures in the laboratory. Regulations are fairly strict in terms of what may be disposed of into the drainage system. It may be permissible to dispose of some chemicals directly down the drain, flushed down with copious volumes of water. For other chemicals, specific disposal instructions, where available, must be followed. These will include collection of specific types of chemical waste in containers for disposal by incineration, landfill, etc. 

Overview of the Clinical Immunohistochemistry Laboratory Regulations and Troubleshooting Guidelines... 

Regulatory Affairs The FDA s Office of Regulatory Affairs is increasingly active in international standards activities relevant to quality control and conforming assessment, including activities relevant to ISO—9001 and laboratory regulation. 

Methods of analysis Preferably optional to the laboratories, regulations on validation Preferably method standardisation, additional regulations on validation (going further than DG III)... 

Peddecord KM, Hammond HC. Clinical laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988 Can it be done Clin Chem 1990 36 2027-35. 

Current federal regulation of clinical laboratories is found within the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988) and implementing regulations.The law is quite comprehensive, but this wasn t always so. Prior to 1965, there was very little federal involvement in laboratory regulation. In fact, only a few states regulated or licensed medieal laboratories. Those states that did regulate laboratories did so mostly in conjunction with hospital licensing requirements. 

After 1965, federal government involvement in clinical laboratory regulation increased, somewhat indirectly, through conditions of participation in Medicare... 

CLIA 1988 significantly increased the scope of federal laboratory regulation both in terms of the number of laboratories regulated and quality standards.Under CLIA 1988, any facility that examines or tests material derived from the human body for patient care purposes is subject to federal regulation. Furthermore, the law provides for personnel, patient test management, quality control and quality assurance standards, as well as proficiency testing to identify poorly performing laboratories. 

Eetsch PA, Abati A. Overview of the clinical immunohistochemistry laboratory Regulations and troubleshooting guidelines. Methods Mol Biol. 1999 115 405. 

Various studies have reported the occurrence of human errors in the area of laboratory testing [2,23]. For example, as per New York State laboratory regulators there were around 66% testing errors in the laboratories offering drug-screening services [23,26]. This shows that there is a definite need to improve the laboratory testing system to reduce the occurrence of human errors. 

H. J. Elston and W. E. Lutrell. The CHO s spectrum of responsibilities. Journal of Chemical Health and Sctfety 5(3 ) 15-18 (1998). H. J. Elston. A whistle-stop tour of OSHA for laboratories regulations and standards for the Chemical Hygiene Officer. Journal of Chemical Health and Safety 5(6) 9-11 (1998). 

Organic solvents and solution (separated as halogenated and nonhalogenated) should be disposed in accordance with the locally effective laboratory regulations. Solids obtained in the above procedure may be disposed as nontoxic waste. Fluoride-containing solutions should not be treated with acids. The fluoride content can be precipitated by treatment of the solution with Ca(OH)2 and disposed as solid chemical waste. 

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