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105 C.M.R. 180.00 – The operation, approval and licensing of clinical laboratories | Midpage
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Code of Massachusetts Regulations (CMR)
Title 105
Chapter 180.00
105 C.M.R. 180.00
The operation, approval and licensing of clinical laboratories
MGL c. 111 §§ 3, and 51 through 53 MGL c. 111D
Department of Public Health
180.001
Purpose
180.002
Citation
180.003
Scope and Application
180.004
Waiver of Requirements Imposed on Laboratories
180.010
Definitions
180.030
Licensure and Approval
180.031
Special Projects
180.035
Enforcement Procedures
180.040
Condition: General Requirements
180.041
Standard - Responsibility of Owners
180.042
Standard - Collection Stations and Satellite Laboratories
180.043
Standard - Advertising
180.044
Standard - Reporting of Infectious Diseases
180.045
Condition - Compliance with Federal, State and Local Laws
180.050
Condition - Laboratory Director
180.060
Standard - Laboratory Director: Qualifications
180.070
Standard - Laboratory Director: Duties and Responsibilities
180.100
Condition - Laboratory Supervision
180.105
Standard - General Supervision
180.110
Standard - Technical Supervision
180.115
Standard - General Supervisor: Qualifications
180.120
Standard - General Supervisor: Duties and Responsibilities
180.125
Standard - Technical Supervisor: Qualifications
180.130
Standard - Technical Supervisor: Duties and Responsibilities
180.150
Condition - Technical Personnel
180.155
Standard - Technologist: Qualifications
180.160
Standard - Technologist: Duties and Responsibilities
180.165
Standard - Cytotechnologist: Qualifications
180.170
Standard - Cytotechnologist: Duties and Responsibilities
180.180
Standard - Technician: Duties and Responsibilities
180.190
Standard - Technologist Trainee: Duties and Responsibilities
180.200
Standard - Training Programs
180.250
Condition - Clinical Laboratory Management
180.255
Standard - Laboratory Procedure Manual
180.260
Standard - Facility Management
180.265
Standard - Collection of Specimens
180.270
Standard - Sterilization
180.275
Standard - Disposal of Medical Waste
180.280
Standard - Examinations and Reports
180.285
Standard - Specimen Records
180.290
Standard - Laboratory Report and Record
180.295
Standard - Personnel Policies
180.300
Standard - Special Requirements - Viral Serology (HIV Testing)
180.350
Condition - Quality Control
180.355
Standard - Evaluation of Equipment, Methods, Reagents
180.360
Standard - Adequacy of Facilities, Equipment, Methods
180.365
Standard - Labeling
180.375
Standard - Quality Control Records
180.380
Standard - Surveillance by the General Supervisor
180.385
Standard - Instructions for Collection, Preservation, Transportation
180.390
Standard - Quality Control: Specialty Areas
180.395
Standard - Microbiology: Quality Control
180.400
Standard - Immunology: Quality Control
180.405
Standard - Clinical Chemistry: Quality Control
180.410
Standard - Immunohematology: Quality Control
180.415
Standard - Hematology: Quality Control
180.420
Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
180.425
Standard - Radiobioassay: Quality Control
180.430
Standard - Histocompatibility: Quality Control
180.450
Condition - Proficiency Evaluation
180.455
Standard - Proficiency Test Program Participation
180.460
Standard - Successful Participation
180.475
Severability