105 CMR, 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories

  1. § 180.001 - Purpose
  2. § 180.002 - Citation
  3. § 180.003 - Scope and Application
  4. § 180.004 - Waiver of Requirements Imposed on Laboratories
  5. § 180.010 - Definitions
  6. § 180.030 - Licensure and Approval
  7. § 180.031 - Special Projects
  8. § 180.035 - Enforcement Procedures
  9. § 180.040 - Condition: General Requirements
  10. § 180.041 - Standard - Responsibility of Owners
  11. § 180.042 - Standard - Collection Stations and Satellite Laboratories
  12. § 180.043 - Standard - Advertising
  13. § 180.044 - Standard - Reporting of Infectious Diseases
  14. § 180.045 - Condition - Compliance with Federal, State and Local Laws
  15. § 180.050 - Condition - Laboratory Director
  16. § 180.060 - Standard - Laboratory Director: Qualifications
  17. § 180.070 - Standard - Laboratory Director: Duties and Responsibilities
  18. § 180.100 - Condition - Laboratory Supervision
  19. § 180.105 - Standard - General Supervision
  20. § 180.110 - Standard - Technical Supervision
  21. § 180.115 - Standard - General Supervisor: Qualifications
  22. § 180.120 - Standard - General Supervisor: Duties and Responsibilities
  23. § 180.125 - Standard - Technical Supervisor: Qualifications
  24. § 180.130 - Standard - Technical Supervisor: Duties and Responsibilities
  25. § 180.150 - Condition - Technical Personnel
  26. § 180.155 - Standard - Technologist: Qualifications
  27. § 180.160 - Standard - Technologist: Duties and Responsibilities
  28. § 180.165 - Standard - Cytotechnologist: Qualifications
  29. § 180.170 - Standard - Cytotechnologist: Duties and Responsibilities
  30. § 180.180 - Standard - Technician: Duties and Responsibilities
  31. § 180.190 - Standard - Technologist Trainee: Duties and Responsibilities
  32. § 180.200 - Standard - Training Programs
  33. § 180.250 - Condition - Clinical Laboratory Management
  34. § 180.255 - Standard - Laboratory Procedure Manual
  35. § 180.260 - Standard - Facility Management
  36. § 180.265 - Standard - Collection of Specimens
  37. § 180.270 - Standard - Sterilization
  38. § 180.275 - Standard - Disposal of Medical Waste
  39. § 180.280 - Standard - Examinations and Reports
  40. § 180.285 - Standard - Specimen Records
  41. § 180.290 - Standard - Laboratory Report and Record
  42. § 180.295 - Standard - Personnel Policies
  43. § 180.300 - Standard - Special Requirements - Viral Serology (HIV Testing)
  44. § 180.350 - Condition-Quality Control
  45. § 180.355 - Standard - Evaluation of Equipment Methods, Reagents
  46. § 180.360 - Standard - Adequacy of Facilities, Equipment Methods
  47. § 180.365 - Standard - Labeling
  48. § 180.375 - Standard - Quality Control Records
  49. § 180.380 - Standard - Surveillance by the General Supervisor
  50. § 180.385 - Standard - Instructions for Collection, Preservation, Transportation
  51. § 180.390 - Standard - Quality Control: Specialty Areas
  52. § 180.395 - Standard - Microbiology: Quality Control
  53. § 180.400 - Standard - Immunology: Quality Control
  54. § 180.405 - Standard - Clinical Chemistry: Quality Control
  55. § 180.410 - Standard - Immunohematology: Quality Control
  56. § 180.415 - Standard - Hematology: Quality Control
  57. § 180.420 - Standard - Exfoliative Cytology, Histopathology, Oral Pathology: Quality Control
  58. § 180.425 - Standard - Radiobioassay: Quality Control
  59. § 180.430 - Standard - Histocompatibility: Quality Control
  60. § 180.450 - Condition - Proficiency Evaluation
  61. § 180.455 - Standard - Proficiency Test Program Participation
  62. § 180.460 - Standard - Successful Participation
  63. § 180.475 - Severability

Notes

105 CMR, 105 CMR 180.000

REGULATORY AUTHORITY

105 CMR 180.000: M.G.L. c. 111, § 3; c. 111D; c. 111 §§ 51 through 53.

State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.

No prior version found.