Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
- Section 180.001 - Purpose
- Section 180.002 - Citation
- Section 180.003 - Scope and Application
- Section 180.004 - Waiver of Requirements Imposed on Laboratories
- Section 180.010 - Definitions
- Section 180.030 - Licensure and Approval
- Section 180.031 - Special Projects
- Section 180.035 - Enforcement Procedures
- Section 180.040 - Condition: General Requirements
- Section 180.041 - Standard - Responsibility of Owners
- Section 180.042 - Standard - Collection Stations and Satellite Laboratories
- Section 180.043 - Standard - Advertising
- Section 180.044 - Standard - Reporting of Infectious Diseases
- Section 180.045 - Condition - Compliance with Federal, State and Local Laws
- Section 180.050 - Condition - Laboratory Director
- Section 180.060 - Standard - Laboratory Director: Qualifications
- Section 180.070 - Standard - Laboratory Director: Duties and Responsibilities
- Section 180.100 - Condition - Laboratory Supervision
- Section 180.105 - Standard - General Supervision
- Section 180.110 - Standard - Technical Supervision
- Section 180.115 - Standard - General Supervisor: Qualifications
- Section 180.120 - Standard - General Supervisor: Duties and Responsibilities
- Section 180.125 - Standard - Technical Supervisor: Qualifications
- Section 180.130 - Standard - Technical Supervisor: Duties and Responsibilities
- Section 180.150 - Condition - Technical Personnel
- Section 180.155 - Standard - Technologist: Qualifications
- Section 180.160 - Standard - Technologist: Duties and Responsibilities
- Section 180.165 - Standard - Cytotechnologist: Qualifications
- Section 180.170 - Standard - Cytotechnologist: Duties and Responsibilities
- Section 180.180 - Standard - Technician: Duties and Responsibilities
- Section 180.190 - Standard - Technologist Trainee: Duties and Responsibilities
- Section 180.200 - Standard - Training Programs
- Section 180.250 - Condition - Clinical Laboratory Management
- Section 180.255 - Standard - Laboratory Procedure Manual
- Section 180.260 - Standard - Facility Management
- Section 180.265 - Standard - Collection of Specimens
- Section 180.270 - Standard - Sterilization
- Section 180.275 - Standard - Disposal of Medical Waste
- Section 180.280 - Standard - Examinations and Reports
- Section 180.285 - Standard - Specimen Records
- Section 180.290 - Standard - Laboratory Report and Record
- Section 180.295 - Standard - Personnel Policies
- Section 180.300 - Standard - Special Requirements - Viral Serology (HIV Testing)
- Section 180.350 - Condition-Quality Control
- Section 180.355 - Standard - Evaluation of Equipment Methods, Reagents
- Section 180.360 - Standard - Adequacy of Facilities, Equipment Methods
- Section 180.365 - Standard - Labeling
- Section 180.375 - Standard - Quality Control Records
- Section 180.380 - Standard - Surveillance by the General Supervisor
- Section 180.385 - Standard - Instructions for Collection, Preservation, Transportation
- Section 180.390 - Standard - Quality Control: Specialty Areas
- Section 180.395 - Standard - Microbiology: Quality Control
- Section 180.400 - Standard - Immunology: Quality Control
- Section 180.405 - Standard - Clinical Chemistry: Quality Control
- Section 180.410 - Standard - Immunohematology: Quality Control
- Section 180.415 - Standard - Hematology: Quality Control
- Section 180.420 - Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
- Section 180.425 - Standard - Radiobioassay: Quality Control
- Section 180.430 - Standard - Histocompatibility: Quality Control
- Section 180.450 - Condition - Proficiency Evaluation
- Section 180.455 - Standard - Proficiency Test Program Participation
- Section 180.460 - Standard - Successful Participation
- Section 180.475 - Severability
Current through Register 1531, September 27, 2024
REGULATORY AUTHORITY
105 CMR 180.000: M.G.L. c. 111, § 3; c. 111D; c. 111 §§ 51 through 53.
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