Rikky1 said...
>>Always read equivocal or IND as a positive, especially if it's on a Lyme specific band or on an ELISA or IFA test.
Some consider IND's as weak positives but there are other reasons why it may not be positive hence the additional tests. Have to find the articles I read on machine calibrations, etc.
All labs have to have their machines all tested for all kinds of things 3 times a year (
goo.gl/y6uRXT bottom of page 5), plus if there are any complaints, they have to undergo another inspection.
Basic Inspection Requirements:
Laboratories are required to permit CMS or its representatives to conduct an inspection. CLIA-exempt and accredited laboratories must permit validation and complaint inspections. As part of the process, laboratories may be required to:
Test samples, including proficiency testing, or perform procedures.
Permit interviews of all personnel concerning the laboratory's compliance.
Permit personnel to be observed performing all phases of the testing process.
Permit CMS or its representative access to all areas encompassed under the certification, including, but not limited to:
Specimen procurement and processing areas
Storage facilities for specimen reagents, supplies, records, and reports
Testing and reporting areas
Provide CMS or its representatives with copies or exact duplicates of all records and data it requires.
A laboratory must have all records and data accessible and retrievable within a reasonable amount of time during the inspection. Further, a laboratory must provide (upon request) all information and data necessary for CMS or its representatives to make a determination of the laboratory's compliance. CMS or its representative may re-inspect a laboratory at anytime to evaluate the laboratory's ability to provide accurate and reliable test results.
Note: CMS or its representatives may conduct an inspection when there are complaints alleging non-compliance with the regulations. Failure to permit an inspection of any type results in suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment and suspension or limitation of or action to revoke the laboratory's CLIA certificate.
www.aafp.org/practice-management/regulatory/clia/inspections.html