Iowa CLIA Laboratory Program

CLIA Corner archive

The Hygienic Lab's CLIA Corner is a quarterly publication covers topical news and subjects for the clinical laboratory. The Hygienic Lab provides the personnel to oversee the CLIA program for the State of Iowa. The overall CLIA program is administrated by the Centers for Medicare and Medicaid Services (CMS). For additional information about the CLIA Laboratory program, go to www.cms.gov/CLIA

• Second Quarter 2024
• CMS-3355-F Final Rule: Proficiency Testing Changes
• First Quarter 2024
• Increase in CLIA fees;
• Explanation of the CLIA fee process; and
• Option to receive electronic certificates and certificate fees
• Fourth Quarter 2023
• Method Correlations– Who? What? When? How?
• What should be included in an employee file for non-waived CLIA laboratories?
• Third Quarter 2023
• The Public Health Emergency for COVID has ended - what does that mean for laboratory testing?
• Second Quarter 2023
• Requirements for non-waived, non-manual coagulation test systems
• First Quarter 2023
• General CLIA information: Types of CLIA certificates, applying for a certificate, making changes to certificates, fees associated with CLIA, renewal process for certificates, and terminating CLIA certificates
• Fourth Quarter 2022
• Quality Control (QC) Requirements for Non-waived Test Systems
• Third Quarter 2022
• Requirements for maintenance and function checks
• Second Quarter 2022
• Calibration and Calibration Verification Procedures for Non-waived Test Systems
• First Quarter 2022
• Requirements for transfusion services
• Fourth Quarter 2021
• Review of the Post-Analytic Quality System and Sample Audit Checklist
• Third Quarter 2021
• Conclusion of the Analytic Quality System
• Second Quarter 2021
• Introduction to the Analytic Quality System
• First Quarter 2021
• Requirements for reporting SARS-CoV-2 test results and other frequently asked questions
• Fourth Quarter 2020
• Quality Assessment (QA) Review
• Review of the Pre-Analytic Laboratory System and Sample Audit Checklist
• Introduction to the Analytic Laboratory System
• Third Quarter 2020
• Quality Assessment (QA) Overview
• Introduction to the Four Laboratory QA Systems
• Review of the General Laboratory System and Sample Audit Checklist
• First Quarter 2020
• Helpful hints for starting the New Year off in the right direction
• Fourth Quarter 2019
• Verification Checklist for New Unmodified FDA-Cleared or Approved Non-Waived Test Systems
• Third Quarter 2019
• CLIA requirements for adding a new analyte to an existing analyzer
• Second Quarter 2019
• Proficiency Testing (PT) Corrective Action: when is it necessary and what is required?
• First Quarter 2019
• Navigating the CLIA Regulations and Interpretive Guidelines
• Fourth Quarter 2018
• Procedures and Procedure Manuals
• Third Quarter 2018
• Initial and Non-Initial Proficiency Testing (PT) Failures
• Centers for Disease Control (CDC) Educational Tools
• Second Quarter 2018
• Helpful CLIA Resources
• First Quarter 2018
• Competency Assessments
• Fourth Quarter 2017
• Personnel Policies for Individuals Directing or Performing Non-waived Tests
• Third Quarter 2017
• Verification of Laboratory Personnel Qualifications and the Required CLIA Documentation
• Second Quarter 2017
• CLIA Frequently Asked Questions
• First Quarter 2017
• CLIA Updates for Prothrombin Time & INR Testing
• Fourth Quarter 2016
• Calibration Verification Requirements and NEW EXCEPTION Guidelines
• Newly Released Provider-Performed Microscopy Procedures Workbook
• Third Quarter 2016
• Laboratory Director Delegation of Responsibilities
• Second Quarter 2016
• Proficiency Testing – Testing of Samples
• Announcements: Nancy Grove Sets Retirement for Fall 2016 and Welcomes Iowa’s New CLIA Laboratory Surveyor, Melinda Bochmann
• First Quarter 2016
• Frozen Section Requirements
• Reminder: Individualized Quality Control Plan (IQCP) takes effect January 1, 2016
• Clinical Laboratory Improvement Amendments (CLIA) Retention Record Chart
• Fourth Quarter 2015
• IMPORTANT UPDATE: Waived Testing Interpretative Guidelines Final Revision
• Waived Testing Interpretative Guidelines in Final Revision
• Laboratory Personnel Qualifications – Foreign Education Equivalency Evaluation and Say “NO” to Agency Evaluations (excludes Foreign Credentials)
• Microbiology IQCP Examples
• Second Quarter 2015
• How to complete the Statement of Deficiencies and Plan of Correction, Form CMS-2567
• First Quarter 2015
• Quality Assessment in Relation to the Individualized Quality Control Plan (IQCP)
• Fourth Quarter 2014
• Quality Control Plan (QCP) in Relation to the Individualized Quality Control Plan (IQCP)
• Third Quarter 2014
• Risk Assessment in relation to the Individualized Quality Control Plan (IQCP)
• Second Quarter 2014
• Pay.gov—New payment option for laboratories to pay CLIA user fees
• First Quarter 2014
• Introduction to Individualized Quality Control Plan (IQCP);
• Free on-line CLIA educational courses; and
• Updates in Blood Bank record retention requirements.
• Fourth Quarter 2013
• Week D (Rh₀) antigen testing using the ID-Micro Typing System (ID-MTS)^TM
• Blood product storage regulations and requirements
• Third Quarter 2013
• Top Ten List of the most common CLIA deficiencies cited nationally in 2012—numbers five (#5) through one (#1)
• Second Quarter 2013
• Top Ten List of the most common CLIA deficiencies cited nationally in 2012—Numbers ten through six (Next quarter's CLIA Corner will continue with numbers five through one.)
• Fourth Quarter 2012
• When Proficiency Testing (PT) performance is less than perfect
• When corrective action is necessary; and
• The requirements for corrective action.
• Third Quarter 2012
• A Checklist for Test System/Method Verification Process
• Second Quarter 2012
• Fun & Games
• First Quarter 2012
• Quality Assessment Introduction
• Fourth CLIA Quality System—Post-analytic
• Correction Process
• Fourth Quarter 2011
• Quality Assessment Introduction
• Third CLIA Quality System - Analytic
• Correction Process
• New Name, Address and Website for SHL
• Third Quarter 2011
• Quality Assessment Introduction
• Second CLIA Quality System - Preanalytic
• Correction Process
• Second Quarter 2011
• Quality Assessment Introduction
• First CLIA Quality System - General Laboratory
• Correction Process
• New Contact for Replacement of HEW Cards
• First Quarter 2011
• CLIA requirements for waived tests
• The Manufacturer’s instructions
• Good laboratory practices for waived tests
• WE MOVED! Our new address
• Second Quarter 2010
• Celebrate National Laboratory Week (April 18-24, 2010) with fun puzzles:
  CLIA Trivia Game, National Medical Laboratory Fallen Phase, Laboratory Jumbo, and Laboratory Word Find
• First Quarter 2010
• The CLIA requirements for laboratories performing PPM procedures.
• Fourth Quarter 2009
• Clarification: CLIA requirements for immunohematology compatibility testing using the gel test system.
• Questions and Answers:
• PT enrollment requirements for MRSA screening
• CLIA requirements for synovial fluid examination for crystals
• Record retention using a laboratory information system (LIS)
• Multiple sites under one CLIA certificate exceptions
• Second Quarter 2009
• Process for applying for an initial CLIA certificate, including specifics for certificates of waiver, provider-performed microscopy procedures (PPMP), compliance and accreditation.
• Billing and renewal process for each type of certificate.
• First Quarter 2009
• Notification Requirements Update
• Policy Clarification for Laboratories Performing Only PPM Procedures
• New Email Addresses for Kristi and Nancy
• Fourth Quarter 2008
• Verifying Performance Specifications
• Third Quarter 2008
• Top Ten Deficiencies Cited by the Iowa CLIA Surveyors
• Third Quarter 2007
  Prepare your laboratory for its next inspection.
• Pre-survey checklist
• During the survey checklist
• Post-survey checklist
• Second Quarter 2007
  Celebrate National Laboratory Week with laboratory puzzles.
• Jumble
• Word Search
• Crossword
• First Quarter 2007
  Frequently Asked Questions.
• Verification of performance standards for a new influenza test system.
• Frequency of checking the temperature alarm system of blood bank refrigerators/freezers.
• Quality control requirements for D-Dimer testing.
• Fourth Quarter 2006
  Laboratory Procedures and Procedure Manuals
• CLIA requirements for procedures and procedure manuals.
• Laboratory director and personnel responsibilities in regards to procedures.
• Record retention requirements for procedures.
• First Quarter 2006
  Common Deficiencies
• Proficiency Testing
• Personnel
• Micro Quality Control
Frequently Asked Questions
• Waived Testing
• HEW Card Replacement
Proficiency Testing Example Forms