Screening laboratory definition

Screening laboratory means any building, place, or facility in which operations and procedures for the biological, serological, immunological, chemical, immuno- hematological, or other examination of materials derived from the human body are performed for the purpose of drug testing and which is not SAMHSA-certified or CAP- FUDT-certified for forensic urine drug testing and if the following apply to the drug testing of said "screening laboratory":
Sample 1Sample 2Sample 3
Screening laboratory means the laboratory the department selects to perform screening.
Sample 1Sample 2
Screening laboratory means an entity contracted with the Department under A.R.S. § 36-694(C) to perform the bloodspot test.
Sample 1

Examples of Screening laboratory in a sentence

  • Laboratory tests that comply with the requirements specified in protocol Section 6.15 and performed as part of clinical care, during the first 3 days of life, may be abstracted from the participant’s medical record to meet the Screening laboratory requirements and do not need to be repeated.

  • Albumin  1  LLN  Total bilirubin < 1  ULN  AST value  1  ULN  ALT value  1  ULN  Alkaline phosphatase  1  ULN  α-fetoprotein  1  ULN  Negative Hepatitis B surface antigen (HBsAg)  Negative Hepatitis B core (HBc) antibody  Negative HCV antibody  Screening laboratory evaluations (hematology, fasting lipids, chemistry, and urinalysis) must be within the normal range unless the results have been determined by the investigator to have no clinical significance.

  • Screening laboratory assessments may be repeated once within 28 days prior to administration of study drug to rule out laboratory error.

  • Screening laboratory tests may be repeated one time in order to confirm out of range results clinical significance at the discretion of the investigator.The central laboratory must be used for any laboratory testing required for a subject during study participation, including laboratory testing needed for unscheduled visits.

  • Screening laboratory tests done within 10 days of treatment initiation can be used for C1D1.

  • Screening laboratory tests and routine blood samples as described in Table 6-1 will be collected and analyzed by the central lab during Study Part One.

  • If a subject’s medical record contains hematology and blood chemistry profile results within 14 days of Screening, the existing values may be used and Screening laboratory measurements are not required.

  • The FSH result must be >40 IU/mL for the subject to be permitted not to use adequate contraception.Central laboratories will perform laboratory tests for hematology, serum chemistries, and urinalysis as well as specialty testing outlined above with the exception of the urine pregnancy tests, which will be done on site.All Screening laboratory tests can be repeated once at the discretion of the principal investigator.

  • The following action will be taken by the Scheme Director if any English Neonatal Screening laboratory falls below the standards for Poor Performance described above:The identity of the laboratory and the poor performance status will be disclosed to the Director of the UK Neonatal Screening Programme Centre by the Scheme Director as soon as the poor performance has been identified (at the same time as the Scheme Organiser contacts the laboratory, usually within 5 working days of the scheme closing).

  • Plaintiff Berríos brings claims against Defendants for violations of his First Amendment and Fourteenth Amendment rights pursuant to Section 1983.

Related to Screening laboratory

  • Testing laboratory means a laboratory, facility, or entity in the state that offers or performs tests of cannabis or cannabis products and that is both of the following:

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Approved laboratory means a laboratory that is listed in the national conference of interstate milk shipments list of sanitation compliance and enforcement ratings distributed by the United States food and drug administration and as approved by the director.

  • Laboratory or “LANL” means the geographical location of Los Alamos National Laboratory, a federally funded research and development center owned by the DOE / NNSA.

  • Screening means the evaluation process used to identify an individual's ability to perform activities of daily living and address health and safety concerns.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Dental laboratory means a person, firm or corporation

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Certified laboratory means a laboratory that is on an approved list issued by us.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Diagnosis means the definition of the nature of the Client's disorder. When formulating the Diagnosis of Client, CONTRACTOR shall use the diagnostic codes and axes as specified in the most current edition of the DSM published by the American Psychiatric Association. DSM diagnoses will be recorded on all IRIS documents, as appropriate.

  • Collaborating physician means the physician who,

  • Screening Test Technician (STT) means anyone who instructs and assists individuals in the alcohol testing process and operates an ASD.