Massachusetts · Regulations
105 CMR 180.00 — The operation, approval and licensing of clinical laboratories
63 sections
63 sections
- 105 CMR 180.001Purpose
- 105 CMR 180.002Citation
- 105 CMR 180.003Scope and Application
- 105 CMR 180.004Waiver of Requirements Imposed on Laboratories
- 105 CMR 180.010Definitions
- 105 CMR 180.030Licensure and Approval
- 105 CMR 180.031Special Projects
- 105 CMR 180.035Enforcement Procedures
- 105 CMR 180.040Condition: General Requirements
- 105 CMR 180.041Standard - Responsibility of Owners
- 105 CMR 180.042Standard - Collection Stations and Satellite Laboratories
- 105 CMR 180.043Standard - Advertising
- 105 CMR 180.044Standard - Reporting of Infectious Diseases
- 105 CMR 180.045Condition - Compliance with Federal, State and Local Laws
- 105 CMR 180.050Condition - Laboratory Director
- 105 CMR 180.060Standard - Laboratory Director: Qualifications
- 105 CMR 180.070Standard - Laboratory Director: Duties and Responsibilities
- 105 CMR 180.100Condition - Laboratory Supervision
- 105 CMR 180.105Standard - General Supervision
- 105 CMR 180.110Standard - Technical Supervision
- 105 CMR 180.115Standard - General Supervisor: Qualifications
- 105 CMR 180.120Standard - General Supervisor: Duties and Responsibilities
- 105 CMR 180.125Standard - Technical Supervisor: Qualifications
- 105 CMR 180.130Standard - Technical Supervisor: Duties and Responsibilities
- 105 CMR 180.150Condition - Technical Personnel
- 105 CMR 180.155Standard - Technologist: Qualifications
- 105 CMR 180.160Standard - Technologist: Duties and Responsibilities
- 105 CMR 180.165Standard - Cytotechnologist: Qualifications
- 105 CMR 180.170Standard - Cytotechnologist: Duties and Responsibilities
- 105 CMR 180.180Standard - Technician: Duties and Responsibilities
- 105 CMR 180.190Standard - Technologist Trainee: Duties and Responsibilities
- 105 CMR 180.200Standard - Training Programs
- 105 CMR 180.250Condition - Clinical Laboratory Management
- 105 CMR 180.255Standard - Laboratory Procedure Manual
- 105 CMR 180.260Standard - Facility Management
- 105 CMR 180.265Standard - Collection of Specimens
- 105 CMR 180.270Standard - Sterilization
- 105 CMR 180.275Standard - Disposal of Medical Waste
- 105 CMR 180.280Standard - Examinations and Reports
- 105 CMR 180.285Standard - Specimen Records
- 105 CMR 180.290Standard - Laboratory Report and Record
- 105 CMR 180.295Standard - Personnel Policies
- 105 CMR 180.300Standard - Special Requirements - Viral Serology (HIV Testing)
- 105 CMR 180.350Condition - Quality Control
- 105 CMR 180.355Standard - Evaluation of Equipment, Methods, Reagents
- 105 CMR 180.360Standard - Adequacy of Facilities, Equipment, Methods
- 105 CMR 180.365Standard - Labeling
- 105 CMR 180.375Standard - Quality Control Records
- 105 CMR 180.380Standard - Surveillance by the General Supervisor
- 105 CMR 180.385Standard - Instructions for Collection, Preservation, Transportation
- 105 CMR 180.390Standard - Quality Control: Specialty Areas
- 105 CMR 180.395Standard - Microbiology: Quality Control
- 105 CMR 180.400Standard - Immunology: Quality Control
- 105 CMR 180.405Standard - Clinical Chemistry: Quality Control
- 105 CMR 180.410Standard - Immunohematology: Quality Control
- 105 CMR 180.415Standard - Hematology: Quality Control
- 105 CMR 180.420Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
- 105 CMR 180.425Standard - Radiobioassay: Quality Control
- 105 CMR 180.430Standard - Histocompatibility: Quality Control
- 105 CMR 180.450Condition - Proficiency Evaluation
- 105 CMR 180.455Standard - Proficiency Test Program Participation
- 105 CMR 180.460Standard - Successful Participation
- 105 CMR 180.475Severability