Federal (United States) · Agency guidance
Chapter 6
419 sections
419 sections
- State Operations Manual (Pub. 100-07), Ch. 6 § 6000Background
- State Operations Manual (Pub. 100-07), Ch. 6 § 6002CLIA Applicability
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006Application and Certificate Process
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.1Certificate of Registration
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.2Certificate of Waiver
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.3Certificate for Provider-performed Microscopy (PPM)
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.4Certificate of Compliance
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.5Certificate of Accreditation
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.6Effective Dates
- State Operations Manual (Pub. 100-07), Ch. 6 § 6006.7Verification of Laboratory Director Qualifications
- State Operations Manual (Pub. 100-07), Ch. 6 § 6008Assignment of CLIA Identification Numbers
- State Operations Manual (Pub. 100-07), Ch. 6 § 6009Multiple CLIA Certificates at the Same Location
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010Regulatory Exceptions for a Multiple Site Certificate
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.1Mobile Laboratory Units and Temporary Testing Sites
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.1.1Mobile Laboratory Units
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.1.2Temporary Testing Sites
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.1.2.1Home Health Agencies (HHAs) and Hospices Temporary
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.2Laboratories Performing Limited Public Health Testing
- State Operations Manual (Pub. 100-07), Ch. 6 § 6010.3Laboratories within Hospitals
- State Operations Manual (Pub. 100-07), Ch. 6 § 6012Chemical Toxicity Public Health Laboratories Exceptions
- State Operations Manual (Pub. 100-07), Ch. 6 § 6014CLIA Certificate Status Changes
- State Operations Manual (Pub. 100-07), Ch. 6 § 6016Notification of Change in Laboratory Operations and Retention
- State Operations Manual (Pub. 100-07), Ch. 6 § 6016.1Change in Laboratory Operations
- State Operations Manual (Pub. 100-07), Ch. 6 § 6016.1.1Change in Laboratory Director for Certificate of
- State Operations Manual (Pub. 100-07), Ch. 6 § 6016.1.2Change in Specialty or Subspecialty (Certificate of
- State Operations Manual (Pub. 100-07), Ch. 6 § 6016.2Retention Requirements
- State Operations Manual (Pub. 100-07), Ch. 6 § 6018Replacement and Revised Certificates
- State Operations Manual (Pub. 100-07), Ch. 6 § 6020Fee Adjustments
- State Operations Manual (Pub. 100-07), Ch. 6 § 6022CLIA Data System
- State Operations Manual (Pub. 100-07), Ch. 6 § 6024Consultative CLIA Activities
- State Operations Manual (Pub. 100-07), Ch. 6 § 6026CMS Role
- State Operations Manual (Pub. 100-07), Ch. 6 § 6028Laboratories Under Direct Federal Jurisdiction
- State Operations Manual (Pub. 100-07), Ch. 6 § 6030CMS Review of State Agency (SA) Certification Activities
- State Operations Manual (Pub. 100-07), Ch. 6 § 6032State Agency (SA) Role
- State Operations Manual (Pub. 100-07), Ch. 6 § 6034CLIA Laboratories - Compliance with Civil Rights Requirement
- State Operations Manual (Pub. 100-07), Ch. 6 § 6036Referrals to the Office of Inspector General (OIG) for CLIA
- State Operations Manual (Pub. 100-07), Ch. 6 § 6038Transfusion Services Covered by CMS/FDA Memorandum of
- State Operations Manual (Pub. 100-07), Ch. 6 § 6038.1Inspections of Transfusion Services
- State Operations Manual (Pub. 100-07), Ch. 6 § 6040Transfusion-Related Fatalities
- State Operations Manual (Pub. 100-07), Ch. 6 § 6042Proficiency Testing (PT)
- State Operations Manual (Pub. 100-07), Ch. 6 § 6044PT Enrollment and CASPER System Reports
- State Operations Manual (Pub. 100-07), Ch. 6 § 6046PT Enrollment Information
- State Operations Manual (Pub. 100-07), Ch. 6 § 6048PT Participation and Testing Requirements
- State Operations Manual (Pub. 100-07), Ch. 6 § 6050Monitoring of PT Scores
- State Operations Manual (Pub. 100-07), Ch. 6 § 6054Unsuccessful Performance in Proficiency Testing
- State Operations Manual (Pub. 100-07), Ch. 6 § 6056Excused Failure to Participate in a Testing Event for a Particular
- State Operations Manual (Pub. 100-07), Ch. 6 § 6060Reinstatement After Failure to Successfully Participate in
- State Operations Manual (Pub. 100-07), Ch. 6 § 6061PT Referral
- State Operations Manual (Pub. 100-07), Ch. 6 § 6062Onsite Observation of Proficiency Testing
- State Operations Manual (Pub. 100-07), Ch. 6 § 6063Survey Protocols for Compliance with Cytology Proficiency
- State Operations Manual (Pub. 100-07), Ch. 6 § 6100The Survey Process - Emphasis, Components, and Applicability
- State Operations Manual (Pub. 100-07), Ch. 6 § 6101The Outcome-Oriented Survey Process (OOSP)
- State Operations Manual (Pub. 100-07), Ch. 6 § 6102Scheduling Surveys
- State Operations Manual (Pub. 100-07), Ch. 6 § 6102.1Scheduling Priorities
- State Operations Manual (Pub. 100-07), Ch. 6 § 6102.2Survey Due to Unanticipated Events
- State Operations Manual (Pub. 100-07), Ch. 6 § 6102.3Change of Location of Laboratory
- State Operations Manual (Pub. 100-07), Ch. 6 § 6102.4Change of Testing Performed by a Laboratory
- State Operations Manual (Pub. 100-07), Ch. 6 § 6106Announced and/or Unannounced Surveys
- State Operations Manual (Pub. 100-07), Ch. 6 § 6106.1Testing Outside the Certificate Type
- State Operations Manual (Pub. 100-07), Ch. 6 § 6106.2Accredited Laboratories
- State Operations Manual (Pub. 100-07), Ch. 6 § 6106.3CLIA-Exempt Laboratories
- State Operations Manual (Pub. 100-07), Ch. 6 § 6108Laboratory Refuses to Allow Survey
- State Operations Manual (Pub. 100-07), Ch. 6 § 6110Survey Team Size and Composition
- State Operations Manual (Pub. 100-07), Ch. 6 § 6112Pre-Survey Preparation
- State Operations Manual (Pub. 100-07), Ch. 6 § 6114Entrance Interview
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116Information Gathering
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.1Organizing the Survey
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.2Observation of Laboratories and Processes
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.3Interviews
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.4Record Review
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.5Credentialing of Foreign Trained Laboratory Personnel
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.6During the Survey
- State Operations Manual (Pub. 100-07), Ch. 6 § 6116.7Assessing Outcome or Potential Outcome
- State Operations Manual (Pub. 100-07), Ch. 6 § 6120.1Regulatory Compliance Decision
- State Operations Manual (Pub. 100-07), Ch. 6 § 6124Preparation for Exit Conference
- State Operations Manual (Pub. 100-07), Ch. 6 § 6126Exit Conference
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130Statement of Deficiencies, Plan of Correction and Allegation of
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130.1Development of the Statement of Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130.2Citing Standard-Level Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130.3Citing Condition-Level Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130.4Choosing the Appropriate Condition
- State Operations Manual (Pub. 100-07), Ch. 6 § 6130.5Mandatory Citations
- State Operations Manual (Pub. 100-07), Ch. 6 § 6132Certification Actions Performed After the Survey
- State Operations Manual (Pub. 100-07), Ch. 6 § 6132.1Generating the Statement of Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6132.2Plan of Correction (PoC)
- State Operations Manual (Pub. 100-07), Ch. 6 § 6132.3Allegation of Compliance (AoC)
- State Operations Manual (Pub. 100-07), Ch. 6 § 6134Review of Plan of Correction or Allegation of Compliance by State
- State Operations Manual (Pub. 100-07), Ch. 6 § 6134.1Strategy for Repeat Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6134.2Follow-Up on AoC/PoCs and Revisit Survey
- State Operations Manual (Pub. 100-07), Ch. 6 § 6134.3Form CMS-2567B
- State Operations Manual (Pub. 100-07), Ch. 6 § 6136Evaluation of Compliance
- State Operations Manual (Pub. 100-07), Ch. 6 § 6136.1Compliance With all CLIA Conditions With No Deficiencies
- State Operations Manual (Pub. 100-07), Ch. 6 § 6136.2Compliance Based on an Acceptable AoC/PoC
- State Operations Manual (Pub. 100-07), Ch. 6 § 6136.3Noncompliance Based on an Unacceptable AoC
- State Operations Manual (Pub. 100-07), Ch. 6 § 6136.4Survey Report Documentation and Data Entry
- State Operations Manual (Pub. 100-07), Ch. 6 § 6137Data Management
- State Operations Manual (Pub. 100-07), Ch. 6 § 6138Retention of CLIA Certification Records
- State Operations Manual (Pub. 100-07), Ch. 6 § 6138.1No Deficiencies Cited
- State Operations Manual (Pub. 100-07), Ch. 6 § 6138.2Deficiencies Cited
- State Operations Manual (Pub. 100-07), Ch. 6 § 6138.3Exception