Contents

INTRODUCTION ____________________________________________________________________ 7 

Terminology _______________________________________________________________________ 9 

Acronyms / Abbreviation___________________________________________________________________________ 11 Module I Governance Standards____________________________________________________________________ 13 

Regulatory Compliance ___________________________________________________________________________ 15 1.1 Compliance with Applicable Laws and Regulations___________________________________________________ 15 1.2 Licensure and Certification______________________________________________________________________15 

Leadership _____________________________________________________________________________________ 16 2.1 Dental Organization Managing Director ___________________________________________________________ 16 2.2 Organizational Plan and Budget_________________________________________________________________ 17 2.3 Outsourced Services__________________________________________________________________________ 18 3. Organizational Ethics __________________________________________________________________________ 19 3.1 General ___________________________________________________________________________________ 19 3.2 Discrimination and Work Environment _____________________________________________________________ 20 4. Quality Management System _____________________________________________________________________21 4.1 General ____________________________________________________________________________________ 21 4.2 Control of Documented Information _______________________________________________________________ 22 5. Patient Safety System _________________________________________________________________________ 23 5.1 General ____________________________________________________________________________________ 23 5.2 Performance Improvement _____________________________________________________________________ 23 5.3 Opioid Oversight _____________________________________________________________________________ 23 6. Staffing Management __________________________________________________________________________ 24 6.1 Licensure, Registration, and Certification _________________________________________________________ 24 6.2 Staff Competence____________________________________________________________________________ 24 6.3 Health Promotion_____________________________________________________________________________ 25 7. Professional Dental Staff ________________________________________________________________________ 26 7.1 General ____________________________________________________________________________________ 26 7.2 Professional Dental Staff Organization, Accountability, and Responsibility _________________________________ 26 7.3 Performance Data____________________________________________________________________________ 27 7.4 Continuing Education _________________________________________________________________________ 27 

8.Risk Management ______________________________________________________________________________ 28 8.1 Planning, Assessment, and Management __________________________________________________________ 28 Module II Clinical Standards______________________________________________________________________________________ 29 9. Patient’s Rights________________________________________________________________________________ 31 9.1 General ____________________________________________________________________________________ 31 9.2 Informed Consent____________________________________________________________________________ 32 

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10 Emergency Services __________________________________________________________________________ 33 10.1 General ___________________________________________________________________________________ 33 11 Radiology Services  ___________________________________________________________________________ 34 11.1 General ___________________________________________________________________________________ 34 11.2 Safety for Patients and Staff____________________________________________________________________ 34 12 Medication Management _______________________________________________________________________ 35 12.1 General ___________________________________________________________________________________35 12.2 Education, Monitoring, and Measuring ___________________________________________________________ 36 12.3 Documentation ______________________________________________________________________________36 12.4 Controlled and Non-controlled Medications Security _________________________________________________ 36 12.5 Medication Errors____________________________________________________________________________ 37 13 Moderate Sedation ____________________________________________________________________________ 38 13.1 General ___________________________________________________________________________________ 38 13.2 Procedures and Protocols _____________________________________________________________________ 39 13.3 Equipment _________________________________________________________________________________ 39 13.4 Medication Requirements _____________________________________________________________________ 40 13.5 Records ___________________________________________________________________________________ 41 13.6 Delivery of Moderate Sedation _________________________________________________________________ 42 13.7 Quality Monitoring ___________________________________________________________________________ 43 

14. Infection Prevention and Control _________________________________________________________________44 14.1 General ____________________________________________________________________________________44 14.2 Organization and Policies _____________________________________________________________________ 44 15 Dental Records _______________________________________________________________________________ 46 15.1 General ___________________________________________________________________________________ 46 15.2 Content of Dental Record______________________________________________________________________ 47 16 Laboratory and Pathology Services________________________________________________________________ 48 16.1 General ___________________________________________________________________________________ 48 17. Sterilization and Decontamination Services_________________________________________________________ 49 17.1 General ___________________________________________________________________________________ 49 17.2 Selection of Medical Devices and Equipment ______________________________________________________ 50 17.3 Storage, Segregation, and Transport _____________________________________________________________51 Module III Facility Standards _______________________________________________________________________ 53 18 Physical Environment__________________________________________________________________________ 55 18.1 Facilities ___________________________________________________________________________________ 55 18.2 Life and Fire Safety Process ___________________________________________________________________ 55 18.3 Security Management Process__________________________________________________________________ 56 18.4 Emergency Management Process ______________________________________________________________ 56 18.5 Hazardous Materials (HAZMAT) Process _________________________________________________________ 57 18.6 Medical Equipment Process ___________________________________________________________________ 58 18.7 Utility Systems Process_______________________________________________________________________ 58