Do you need to stay current with the Federal CLIA laboratory
requirements (Clinical Laboratory Improvement Amendments)? Does your
laboratory have the tools to provide quality testing for its clients and
patients? UHL's CLIA Corner can help. This quarterly publication
covers topical news and subjects for the clinical laboratory. UHL
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 program, go to
www.cms.hhs.gov/clia.
| Fourth Quarter 2009 |
 In This Issue...
- 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
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| Third Quarter 2009 |
 In This Issue...
- Requirements to perform streamlined quality control for microbial
identification systems
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| Second Quarter 2009 |
 In This Issue...
- 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.
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| First Quarter 2009 |
 In This Issue...
- Notification Requirements Update
- Policy Clarification for Laboratories Performing Only PPM Procedures
- New Email Addresses for Kristi and Nancy
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| Fourth Quarter 2008 |
 In This Issue...
- Verifying Performance Specifications
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| Third Quarter 2008 |
 In This Issue...
- Top Ten Deficiencies Cited by the Iowa CLIA Surveyors
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| Second Quarter 2008 |
 In This Issue...
- Calibration vs. Calibration Verification
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| First Quarter 2008 |
 In This Issue...
- Mandatory Training Equals Mandatory Citations
- Other News and Clarifications
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| Fourth Quarter 2007 |
 Answers to Questions on the Following Topics
- MLT qualifications as general supervisor
- Validation of a new test kit
- Affirm VP test system QC
- Fungal/yeast culture PT requirements
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| Third Quarter 2007 |
 Prepare your laboratory for its next inspection.
- Pre-survey checklist
- During the survey checklist
- Post-survey checklist
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| Second Quarter 2007 |
 Celebrate National Laboratory Week with laboratory puzzles.
- Jumble
- Word Search
- Crossword
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| 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.
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| 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.
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| Third Quarter 2006 |
 Prothrombin Time & INR Testing
- Specimen collection and processing
- Establishing a new normal patient mean
- Programming the correct ISI into analyzer
- Comparison INR studies with old and new reagent lot numbers
- Checking automated INR calculation manually
- Example worksteet
- Miscellaneous information: policies and procedures, quality control, calibration and calibration verification and test requests/standing orders.
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| Second Quarter 2006 |
 Celebrate National Laboratory Week
- CLIA Corner Challenge - Trivia Quiz
CLIA Records Retention Requirements
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| First Quarter 2006 |
Common Deficiencies
- Proficiency Testing
- Personnel
- Micro Quality Control
Frequently Asked Questions
- Waived Testing
- HEW Card Replacement
Proficiency Testing Example Forms
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